(OXYS) Adds Chile to Fast Growing Global Distribution Footprint

(CYTR) Continued Big Gains

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced highly positive top-line efficacy results from a multicenter, randomized, open-label global Phase 2b clinical trial. The trial investigated the efficacy and safety of aldoxorubicin compared with doxorubicin in subjects with first-line metastatic, locally advanced or unresectable soft tissue sarcomas (STS). Aldoxorubicin combines the chemotherapeutic agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of higher amounts of doxorubicin (3½ to 4 times) without the major dose-limiting toxicities seen with administration of doxorubicin alone.

In this 123-subject, 31-center global Phase 2b clinical trial, subjects with advanced soft tissue sarcomas were administered either 350 mg/m² of aldoxorubicin (83 subjects) or 75 mg/m² of doxorubicin (40 subjects) every 3 weeks for up to 6 cycles. Subjects were followed every 6 weeks with CT scans to monitor tumor size. The primary endpoint was progression-free survival (PFS) as determined by both investigators at study sites and by a blinded radiology review performed at an independent central laboratory. Secondary endpoints included overall response rates (complete and partial) and PFS at 6 months for each group, and overall survival which will be reported when the clinical trial is complete.

Consistent with the trial protocol, CytRx used two approaches to evaluate the efficacy of aldoxorubicin compared to doxorubicin in patients with soft tissue sarcomas: assessment by the study investigators, as well as assessment by a blinded central laboratory review. In this study, both investigator assessment and central lab review showed an unambiguous 80-100% improvement in PFS among patients treated with aldoxorubicin. In an intent-to-treat analysis, the investigator-assessed median PFS was 8.4 months for aldoxorubicin patients versus 4.7 months for doxorubicin patients (p=0.0002), while the blinded central lab review indicated that median PFS for aldoxorubicin patients was 5.7 months versus 2.8 months for doxorubicin patients (p=0.018). Per investigators, 67.1% of aldoxorubicin patients had not progressed at 6 months, compared with 36.1% of doxorubicin-treated patients (p=0.005). By blinded central lab review, 46.8% of aldoxorubicin patients had not progressed at 6 months, compared with 23.7% of doxorubicin patients (p=0.038).

The overall response rate as determined by the investigators was 25.4% for aldoxorubicin subjects (2.7% complete response and 22.7% partial response) versus 5.4% for doxorubicin subjects (0% complete response and 5.4% partial response). As assessed by blinded central lab review, 23.0% of aldoxorubicin subjects had a partial response while 0.0% of doxorubicin subjects exhibited any objective response.

As determined by both the trial investigators and by blinded central radiology review, subjects treated with aldoxorubicin demonstrated highly statistically significant better clinical outcomes than those receiving standard doxorubicin therapy for their soft tissue sarcomas.

”These results are extraordinary for a single agent treating these chemotherapy-resistant tumors,” said study principal investigator Sant Chawla, M.D. of the Sarcoma Oncology Center in Santa Monica, California. “Aldoxorubicin is the first and only single agent to surpass doxorubicin as a first-line treatment for soft tissue sarcomas.”

Dr. Chawla added, “Previous results from this trial presented at the Connective Tissue Oncology Meeting in October indicated that subjects treated with aldoxorubicin demonstrated no significant cardiotoxicity whereas doxorubicin shows cardiotoxicity at certain cumulative dose levels. No subjects left the study due to aldoxorubicin side effects. These findings together suggest that aldoxorubicin could become the treatment of choice for soft tissue sarcomas. Yet this drug’s potential extends much further because doxorubicin in particular and anthracyclines in general are indicated as first- or second-line therapy for many other common cancers including breast, ovarian, small-cell lung, multiple myeloma, acute myelocytic leukemia and more. As such, the ability of aldoxorubicin to safely administer high doses of doxorubicin holds tremendous therapeutic potential to oncologists and their patients worldwide.”

CytRx President and CEO Steven A. Kriegsman commented, “Aldoxorubicin is a major advance for treating soft tissue sarcomas. We extend gratitude to the investigators who so adeptly managed the conduct of this trial and to the patients and their families who participated in it. These data prove that by applying our proprietary linker technology to target the release of doxorubicin directly at the site of cancer we are able to safely increase the dosage of doxorubicin by approximately three and one-half to four times with tremendous clinical benefit to the patient.”

In the Phase 2b clinical trial aldoxorubicin was found to be safe and well tolerated. All adverse events in subjects treated with aldoxorubicin were consistent with the known side effects of doxorubicin, resolved before the administration of the next dose and did not require treatment discontinuation. There were no treatment-related deaths in the aldoxorubicin group.

About the Phase 2b Trial Design

The study examined 123 subjects who received either aldoxorubicin or doxorubicin in a 2:1 randomization, respectively. Aldoxorubicin was administered to 83 subjects at a dosage of 350 mg/m² (doxorubicin equivalents of 260 mg/m²) as a 30-minute intravenous infusion on Day 1 of each cycle, while doxorubicin (75 mg/m²) was administered to 40 subjects as a 5-30 minute infusion on Day 1 of each cycle. A cycle of therapy was defined as a 3-week (21-day) period. Multiple cycles were administered until the subject was withdrawn from therapy or until a maximum of 6 cycles were administered. CT scans were obtained every 6 weeks to assess tumor response and progression, and adverse events were collected in a case report form.

About Soft Tissue Sarcoma

STS is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of STS; and in 2013 more than 11,400 new cases will be diagnosed in the U.S., and approximately 4,400 Americans will die from STS. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 500 mg/m². Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2 g/m².

Conference Call and Webcast

CytRx management will be hosting a conference call and webcast today beginning at 10:30 a.m. Eastern time. To access the conference call, dial 888-463-4383 (U.S. and Canada) or 706-679-5355 (international callers). A webcast will be available in the investor relations section of the company’s website, www.cytrx.com. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial 855-859-2056 (U.S. and Canada) or 404-537-3406 (international callers) and enter the conference ID number: 19821609.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b study of aldoxorubicin in combination with doxorubicin in subjects with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in subjects with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a potential pivotal Phase 3 global trial with aldoxorubicin as a therapy for subjects with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in subjects with late-stage glioblastoma (brain cancer), and plans to initiate a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx’s clinical trials, the risk that the results of any future human testing of aldoxorubicin, including the final data from the Phase 2b clinical testing of aldoxorubicin as a first-line treatment in patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy, might not produce objective response or safety results similar to the data described in this press release, risks related to CytRx’s ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

(ARCW) Announces New Director Todd Grimm

DELAND, Fla., Dec. 10, 2013 — ARC Group Worldwide, Inc. (NASDAQ: ARCW; the “Company” or “ARC”) announced today that Todd Grimm was appointed as an Independent Director to the Company’s Board of Directors.  Mr. Grimm will also be a member of the Compensation and Audit Committee.

Todd Grimm has been active in the field of 3D printing since 1990 and is considered to be one of the top experts in the industry.  Mr. Grimm is currently President of T. A. Grimm & Associates, Inc., where he consults leading companies on their 3D printing strategy.  From 1990 to 2002, Todd held various positions in additive manufacturing service bureaus.  He serves on the board of directors of the Additive Manufacturing Users Group (AMUG) and has recently been appointed as a founding board member of the 3D Printing Association.  In 2012, Todd was named one of the “Top 20 Most Influential” by The TCT Magazine.

Mr. Grimm has published dozens of articles on rapid prototyping, including his book the “User’s Guide to Rapid Prototyping”, and he regularly serves as the 3D printing industry expert on numerous panels.  Mr. Grimm holds a Master Certificate in rapid prototyping & manufacturing.  He also has a B.S. in Mechanical Engineering from Purdue University.

Chairman and CEO Jason Young said, “We are honored to have Todd join our board.  As one of the leading experts in 3D printing with over 20 years of experience with additive manufacturing, we look forward to Todd’s guidance as we more aggressively pursue our 3D printing efforts.”  Mr. Young further commented, “ARC has been utilizing 3D printing for several years now, and we have identified it as a major area of focus for our Company going forward, particularly in the areas of rapid prototyping and short production runs.  Todd’s lengthy experience is very helpful as we build our in house capabilities of utilizing additive manufacturing in our production process and as a service to our customers.”

About ARC Group Worldwide, Inc.

ARC Group Worldwide is a diversified, global manufacturing company, as well as the unequivocal world leader in Metal Injection Molding (“MIM”).  ARC was founded in 1987 and has a long history as a technology innovator in manufacturing.  ARC has significant expertise in lean manufacturing and utilizes cutting edge technology including robotics, automation, and 3D printing.  ARC’s mission is to bring innovation and technology to manufacturing.  ARC’s core manufacturing businesses are in precision components, flanges, fittings, and wireless technology, through its operating subsidiaries, www.FloMet.com, www.AFTmim.com, www.Injectamax.com, www.TeknaSeal.com, www.GeneralFlange.com and www.ArcWireless.net.  For more information about ARC Group Worldwide, please visit www.ArcGroupWorldwide.com.

IMPORTANT INFORMATION

This press release may contain “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995, which are based on ARC’s current expectations, estimates and projections about future events. These include, but are not limited to, statements, if any, regarding business plans, pro-forma statements and financial projections, ARC’s ability to expand its services and realize growth.  These statements are not historical facts or guarantees of future performance, events or results.  Such statements involve potential risks and uncertainties, and the general effects of financial, economic, and regulatory conditions affecting our industries. Accordingly, actual results may differ materially.  ARC does not have any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  For additional factors that may affect future results, please see filings made by ARC with the Securities and Exchange Commission (“SEC”), including its Form 10-K for the fiscal year ending June 30, 2013.

CONTACT: Drew Kelley
PHONE: (386) 736-4890
Email: InvestorRelations@ArcGroupWorldwide.com

(ENTA) 96 Percent SVR12 in Hep-C SAPPHIRE-II Study

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) today announced results from the SAPPHIRE-II study, the second of six phase 3 registrational studies being conducted by AbbVie for the treatment of hepatitis C virus (HCV) genotype 1 (GT1) infection, using a regimen containing Enanta’s lead protease inhibitor ABT-450. ABT-450 is part of AbbVie’s investigational three direct-acting antiviral (3D) regimen, consisting of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. The SAPPHIRE-II study used this 3D regimen plus ribavirin.

Results from the 394-patient SAPPHIRE-II trial demonstrated a sustained virologic response at 12 weeks post-treatment (SVR₁₂) of 96 percent in chronically infected GT1 HCV treatment experienced adult patients who had previously failed pegylated interferon and ribavirin treatment. Approximately 49 percent of these patients were prior null responders, namely patients defined as not achieving a significant reduction in the HCV virus during their prior treatment. The majority of patients were GT1a, considered the more difficult-to-treat subtype, and the SVR₁₂ rates of GT1a and GT1b were 96 percent and 97 percent, respectively. These results were based on an intent-to-treat analysis and were achieved after 12 weeks of treatment. Virologic relapse or breakthrough was noted in 2 percent of patients receiving the 3D regimen plus ribavirin. The treatment regimen was well tolerated, with 1 percent of patients discontinuing treatment due to adverse events.

“The high SVR rates in this SAPPHIRE-II trial and the previously reported SAPPHIRE-I trial further validate this 3D regimen plus ribavirin for both treatment-naive and treatment-experienced patients,” stated Jay R. Luly, Ph.D., President and Chief Executive Officer. “We look forward to the remaining phase 3 studies reading out using the same 3D regimen with and without ribavirin, as well as in the treatment of HCV patients with cirrhosis.”

About Study M13-098 (SAPPHIRE-II)

Following SAPPHIRE-I, SAPPHIRE-II is the second placebo-controlled trial and the second of six phase 3 trials supporting AbbVie’s investigational 3D regimen for the treatment of GT1 hepatitis C patients. AbbVie will disclose detailed SAPPHIRE-II results at future scientific congresses and in publications.

SAPPHIRE-II is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with ABT-333 (250mg), ribavirin (weight-based), both dosed twice daily, and the fixed-dose, co-formulated combination of ABT-450/ritonavir (150/100mg) and ABT-267 (25mg) dosed once daily in non-cirrhotic, GT1a and GT1b HCV-infected, treatment-experienced adult patients who previously failed treatment with pegylated interferon and ribavirin.

The study population consisted of 394 GT1 treatment-experienced patients with no evidence of liver cirrhosis. 297 patients were randomized to the 3D regimen plus ribavirin for 12 weeks, and 97 patients were randomized to placebo for the initial 12 weeks. Patients initially randomized to placebo for the first 12 weeks then received open-label treatment with the 3D regimen plus ribavirin for 12 weeks. In the study, 49 percent of patients were prior null responders to pegylated interferon and ribavirin, generally considered among the most difficult to treat successfully.

Following 12 weeks of treatment with AbbVie’s 3D regimen plus ribavirin, 96 percent (n=286/297) of patients achieved SVR₁₂ based on an intent-to-treat analysis, where patients with missing values for any reason were considered treatment failures. The SVR₁₂ rates in GT1a and GT1b patients were 96 percent (166/173) and 97 percent (119/123), respectively. One subject had HCV genotype 1 and achieved SVR₁₂, but was unable to be sub-genotyped.

The most commonly reported adverse events in both the 3D and placebo arms were headache, fatigue and nausea. Discontinuations due to adverse events were reported in three (1 percent) patients receiving the 3D regimen and no patients receiving placebo. Virologic relapse or breakthrough was noted in 2 percent of patients receiving the 3D regimen plus ribavirin.

AbbVie has announced that results from the remaining four ABT-450 containing studies in AbbVie’s phase 3 program will be available in the coming months.

Overview of AbbVie’s phase 3 clinical programs:

^a projected study population
^b ABT-450/ritonavir
^cABT-267 is co-formulated with ABT-450/r, administered as two pills once daily

Additional information about AbbVie’s phase 3 studies can be found at www.clinicaltrials.gov.

Protease Inhibitor Collaboration with AbbVie (formerly the research-based pharmaceutical business of Abbott Laboratories)

In December 2006, Enanta and Abbott announced a worldwide agreement to collaborate on the discovery, development and commercialization of HCV NS3 and NS3/4A protease inhibitors and HCV protease inhibitor-containing drug combinations. ABT-450 is a protease inhibitor identified as a lead compound through the collaboration. Under the agreement, AbbVie is responsible for all development and commercialization activities for ABT-450. Enanta received $57 million in connection with signing the collaboration agreement, has received $55 million in subsequent clinical milestone payments, and is eligible to receive an additional $195 million in payments for regulatory milestones, as well as double-digit royalties worldwide on any revenue allocable to the collaboration’s protease inhibitors. Also, for any additional collaborative HCV protease inhibitor product candidate developed under the agreement, Enanta holds an option to modify the U.S. portion of it rights to receive milestone payments and worldwide royalties. With this option, Enanta can fund 40 percent of U.S. development costs and U.S. commercialization efforts (sales and promotion costs) for the additional protease inhibitor in exchange for 40 percent of any U.S. profits ultimately achieved after regulatory approval, instead of receiving payments for U.S. commercial regulatory approval milestones and royalties on U.S. sales of that protease inhibitor.

About Hepatitis C Virus (HCV)

Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is typically spread through direct contact with the blood of an infected person. Hepatitis C increases a person’s risk of developing chronic liver disease, cirrhosis, liver cancer and death. There is an acute need for new HCV therapies that are safer and more effective for many variants of the virus.

About Enanta

Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. Enanta is discovering, and in some cases developing, novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes – protease (partnered with AbbVie), NS5A (partnered with Novartis) and nucleotide polymerase – as well as a host-targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistant Staphylococcus aureus) infections.

Forward Looking Statements Disclaimer

This press release contains forward-looking statements, including with respect to clinical data, plans for announcing additional data, and the planned clinical development and regulatory submissions for ABT-450. Statements that are not historical facts are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors that may affect actual results include final results of ongoing clinical trials, the development and marketing efforts of AbbVie (our collaborator on ABT-450), regulatory actions affecting clinical development of ABT-450 and clinical development of competitive product candidates. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

(BGMD) Final Determination by CMS of 2014 Reimbursement for BGM Galectin-3® Test

WALTHAM, Mass., Dec. 10, 2013 — BG Medicine, Inc. (Nasdaq:BGMD) announced today that the Centers for Medicare and Medicaid Services (CMS) have published the final determination of the 2014 Medicare national limitation amount for the Company’s galectin-3 blood test (analyte-specific CPT® Code 82777) at the amount of a crosswalked test (analyte-specific CPT® Code 84244) whose 2014 national limitation amount is $30.01. This national limitation amount will replace the galectin-3 blood test’s national limitation amount of $17.80 that was effective in 2013.

“We are very pleased that CMS has finalized the previously announced preliminary determination of the Medicare reimbursement rate for our galectin-3 test,” said Dr. Paul R. Sohmer, President and Chief Executive Officer of BG Medicine.

This final determination by CMS comes in response to BG Medicine’s request for reconsideration of the 2013 CMS determination and will apply effective January 1, 2014. The 2014 national limitation amount applies across the U.S. except in Ohio and West Virginia where rates of $23.99 and $26.40, respectively, will apply. In addition, the 2014 national limitation amount is subject to a 2% sequestration applicable to Medicare services if the current sequestration is extended beyond January 15, 2014.

The Company’s BGM Galectin-3^® test is a novel blood test, which is cleared by the U.S. Food and Drug Administration for use as an aid in assessing the prognosis of patients with chronic heart failure. The BGM Galectin-3 test has been studied in over 10,000 heart failure patients in dozens of distinct clinical studies. Earlier in 2013, galectin-3 testing was included for the first time in the 2013 American College of Cardiology Foundation/American Heart Association Guideline for Management of Heart Failure.

About BG Medicine, Inc.

BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3^® Test, is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.bg-medicine.com. The BG Medicine Inc. logo is available for download here

CPT® is a registered trademark of the American Medical Association.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: our belief that the BGM Galectin-3 test provides a critical tool for physicians who make decisions regarding the care of patients with chronic heart failure. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond the Company’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. These risks and uncertainties include, among other things, the factors discussed under the heading “Risk Factors” contained in BG Medicine’s annual report and quarterly reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and BG Medicine disclaims any obligation to update the information contained in this press release as new information becomes available.

CONTACT: BG-Medicine Investor Inquiries:
         Stephen Hall
         EVP & Chief Financial Officer
         781-890-1199

(HOTR) Announces Grand Opening of New Hooters Restaurant in Pretoria, South Africa

(BTHE) Appoints Three to Management Positions

Company Appoints Edward Shea as VP Business Development, Tina M. Gagnon as Consulting Director of Finance, and Yael T. Bobruff, Ph.D. as Clinical Affairs Manager

(ESYS) Reports Second Quarter Financial Results

Revenues Increase 19% and Net Income Grows 58% Over Prior Year Quarter

OLATHE, Kansas, Dec. 9, 2013 — Elecsys Corporation (Nasdaq:ESYS), a provider of innovative machine to machine (M2M) communication technology solutions, data acquisition systems, and custom electronic equipment for critical industrial applications, today announced the financial results for its second fiscal quarter ended October 31, 2013.

Revenues for the quarter were $7,330,000, an increase of 19% from $6,138,000 in revenues during the second quarter of fiscal 2013. Total revenues year-to-date increased 36% to $14,104,000 from $10,395,000. The overall increase in both quarterly and year-to-date revenues resulted from the combined growth of revenues from both of the Company’s business segments.

Operating income for the quarter was $1,116,000, compared to operating income of $700,000 for the same quarter in the prior year. For the first six months of fiscal 2014, operating income grew to $1,569,000 from $471,000 in the first six months of fiscal 2013.

Net income was $653,000, or $0.17 per diluted share, for the quarter ended October 31, 2013. For the quarter ended October 31, 2012, net income was $413,000, or $0.11 per diluted share. For the six-month period ended October 31, 2013, net income totaled $917,000, or $0.23 per diluted share, while for the comparable prior year period net income was $252,000, or $0.06 per diluted share.

Revenues from proprietary products and services were $3,742,000 for the quarter ended October 31, 2013, an increase of 19%, or $594,000 from the previous year quarter. For the six-month period ended October 31, 2013, proprietary product and services revenues improved $1,352,000, or 28%, to $6,206,000 compared to $4,854,000 in the comparable period of the prior fiscal year. Sales of wireless remote monitoring and industrial data communication solutions increased almost 42%, or $920,000, from the previous year to $3,112,000 for the current quarter. This overall rise in sales was due to increased customer orders for Watchdog remote monitoring equipment and recurring data management services combined with the introduction of a new remote monitoring product for the commercial transportation industry. Revenues of Radix mobile data acquisition solutions declined $334,000, or 39%, for the period as compared to the prior year.

The Company’s custom solutions for original equipment manufacturers (“OEM”) business segment reported revenue growth of 20% to approximately $3,588,000 for the quarter ended October 31, 2013, an increase of $598,000 from $2,990,000 in the prior fiscal year. Fiscal year-to-date OEM revenues were $7,898,000, an increase of 43%, or $2,357,000, from $5,541,000 in the six-month period ended October 31, 2012.

The Company expects that total revenues for its proprietary products and services business segment will continue to grow during the second half of the fiscal year due to its continued investments in both sales and marketing and new product development. The Company anticipates that both its wireless remote monitoring solutions and industrial data communications will show increases in revenues from the current period while revenues for its mobile data acquisition products and services will likely be consistent with revenues reported in the current period. The Company also expects OEM revenues to grow moderately over the longer term based upon the current scheduled orders in backlog and the anticipated addition of new OEM customers.

Backlog, which represents orders that are scheduled for delivery over the next twelve months, was approximately $12,423,000 at October 31, 2013, an increase of $3,930,000, or 46%, from a backlog of $8,493,000 on April 30, 2013. The increase in backlog was primarily due to an increase in OEM bookings during the quarter combined with an increase in proprietary product backlog including the previously announced $1.25 million order from the Al Rushaid Group in Saudi Arabia.

Gross margin for the quarter ended October 31, 2013 was approximately 41%, or $3,029,000, versus 39%, or $2,410,000 for the quarter ended October 31, 2012. The increase in both gross margin dollars and gross margin percentage for the quarter was a function of the overall increase in sales volume and the product mix between higher margin proprietary product sales and OEM revenues. Gross margin for the six-month period remained consistent at 37% of sales, increasing to $5,236,000 from a gross margin of $3,800,000 during the six-month period ended October 31, 2012. The growth in gross margin dollars was the direct result of higher overall revenues during the year-to-date period.

Total selling, general and administrative expenses were approximately $1,913,000 during the quarter ended October 31, 2013 compared with $1,710,000 in the comparable quarter of the prior fiscal year. The increase of $203,000, or 12%, primarily resulted from increases in sales and marketing expenses and research and development costs. Selling and marketing expenses increased as a result of higher sales commissions and the increase in research and development costs included continued investment in engineering design personnel engaged in new product development. Total selling, general and administrative expenses for the six-month periods ended October 31, 2013 and 2012, were $3,667,000 and $3,329,000, respectively. The $338,000 increase was due to growth in research and development expenses due to additional investments in engineering design personnel, higher sales commissions as a result of increased revenues, and a rise in professional fees, office costs and other administrative personnel expenses.

Karl B. Gemperli, Chief Executive Officer, stated, “We are pleased to report the results of our second quarter as we continued to generate revenue growth and improved bottom-line performance compared to the prior year. Sales increased 19% from the second quarter of last year and net income grew by 58% while our order backlog continued to expand. Most significantly, we intensified our investments in new product development and expanded market development during the quarter in order to accelerate our growth rate over the long term.”

Gemperli continued, “During the second quarter, we began volume shipments of a new remote monitoring product for application in the commercial transportation industry. Despite lingering uncertainty about the direction of the global economy, we remain focused on the numerous exciting opportunities to apply M2M solutions in the rapidly growing industries we target. We expect the positive trends in both revenues and earnings to continue during the coming quarters.”

About Elecsys Corporation

Elecsys Corporation provides innovative machine to machine (M2M) communication technology solutions, data acquisition and management systems, and custom electronic equipment for critical industrial applications. The Company’s primary markets include energy production and distribution, agriculture, transportation, safety and security systems, and water management. Elecsys proprietary equipment and services encompass wireless remote monitoring, industrial data communication, and mobile data acquisition technologies that are deployed wherever high quality and reliability are essential. Elecsys develops, manufactures, and supports proprietary technology and equipment under several premium brand names. In addition to its proprietary products, Elecsys designs and manufactures rugged and reliable custom solutions for multiple original equipment manufacturers in a variety of industries worldwide. For more information, visit www.elecsyscorp.com.

Safe-Harbor Statement

The discussions set forth in this press release may contain forward-looking comments based on current expectations that involve a number of risks and uncertainties. Actual results could differ materially from those projected or suggested in the forward-looking comments. The difference could be caused by a number of factors, including, but not limited to the factors and conditions that are described in Elecsys Corporation’s SEC filings, including the Form 10-K for the year ended April 30, 2013. The reader is cautioned that Elecsys Corporation does not have a policy of updating or revising forward-looking statements and thus he or she should not assume that silence by management of Elecsys Corporation over time means that actual events are bearing out as estimated in such forward-looking statements.

CONTACT: Investor Relations Contact: Todd A. Daniels
         (913) 647-0158, Phone
         (913) 982-5766, Fax
         investorrelations@elecsyscorp.com

(HIHO) Receives OEM Tooling Order for Plastic Components From Leading U.S. Printer Company

Complements Its Existing Relationship as Metal Components Supplier

HONG KONG, Dec. 9, 2013 — Highway Holdings Limited (Nasdaq:HIHO) today announced it has received three tooling orders designed to produce plastic components for printers offered by a leading U.S. printer company.

“This new additional business represents an expansion of an OEM relationship that has evolved since 2007. We are gratified by the confidence of our customer in the company’s quality and capabilities and look forward to further opportunities to expand our valued-relationship,” said Roland Kohl, president and chief executive officer of Highway Holdings.

Kohl noted that the commencement of plastic component production represents a significant strategic opportunity to expand the relationship with this prestigious customer, which to date has only utilized Highway Holdings’ metal component manufacturing services. “We are now well-positioned to leverage our established metal parts supplier relationship to expand and become a leading plastic parts supplier for this customer in the near future.  This is particularly significant since the plastic components business is much larger than metal components and the opportunities for future growth much greater,” Kohl said.

About Highway Holdings

Highway Holdings produces a wide variety of high-quality products for blue chip original equipment manufacturers — from simple parts and components to sub-assemblies and finished products. Highway Holdings’ administrative offices are located in Hong Kong, and its manufacturing facilities are located in Shenzhen in the People’s Republic of China.

Except for the historical information contained herein, the matters discussed in this press release are  forward-looking statements which involve risks and uncertainties, including but not limited to economic, competitive, governmental, political and technological factors affecting the company’s revenues, operations, markets, products and prices, and other factors discussed in the company’s various filings with the Securities and Exchange Commission, including without limitation, the company’s annual reports on Form 20-F.

CONTACT: Gary S. Maier
         Maier & Company, Inc.
         (310) 471-1288

(DRWI) Saab and DragonWave Upgrade Sweden’s National Security Communication Network

Nationwide network expansion follows agreement to work together addressing key vertical markets throughout the Nordic countries

Nadine Kittle
Marketing Communications
DragonWave Inc.
nkittle@dragonwaveinc.com
Tel: 613-599-9991 ext 2262

Russell Frederick
CFO
DragonWave Inc.
rfrederick@dragonwaveinc.com
Tel: 613-599-9991 ext 2253

Becky Obbema
Interprose Public Relations
(for DragonWave) Becky.Obbema@interprosepr.com
Tel: (408) 778-2024

(HDSN) Reports the EPA’s Issuance of Proposed Rule on HCFC Allowances

Second graph, last sentence of release should read: A final rule, which is expected to be issued next year… (sted A final rule, which is expected to be issued later this year…).

The corrected release reads:

HUDSON TECHNOLOGIES REPORTS THE EPA’S ISSUANCE OF PROPOSED RULE ON HCFC ALLOWANCES FOR 2015 THROUGH 2019

Hudson Technologies, Inc. (NASDAQ:HDSN), announced that on December 5, the Environmental Protection Agency (EPA) issued a proposed rule pertaining to allowances for virgin production of HCFCs, primarily R-22, for 2015 through 2019. The proposed rule sets the schedule for the final stage of the phase out of virgin R-22 production, as was agreed to under the Montreal Protocol. R-22 is a widely used refrigerant in the residential and commercial setting, but it is a harmful greenhouse gas if not properly managed.

The proposed rule discusses various methods and ranges of allowances under consideration by the EPA – all of which would eliminate virgin R-22 production by 2020. The EPA’s preferred method, according to the proposed rule, would provide for virgin R-22 allowances of approximately 30 million pounds in 2015, 24 million pounds in 2016, 18 million pounds in 2017, 12 million pounds in 2018 and 6 million pounds in 2019, with a final ban of all production effective January 1, 2020. A final rule, which is expected to be issued next year following a comment period and the EPA’s review and analysis of any comments received, will specify the final HCFC allowances for years 2015 through 2019.

Kevin Zugibe, Hudson’s Chairman and CEO, stated, “The EPA’s proposed rule would return to the step down approach for the phase out of R-22, which, as stated previously, we believe is the best method for the orderly phase out of R-22 and for the establishment of reclamation as the principal, and ultimately the sole source of supply of R-22. Under the EPA’s preferred method, the 2015 allowances of 30 million pounds would represent an approximate 40% reduction from the 2014 levels. We continue to believe that as the R-22 phase out progresses, the aftermarket demand for R-22 will exceed the total allowances and that reclaimed R-22 will bridge the supply and demand gap, we believe creating a significant long term opportunity for Hudson as one of the largest reclaimers in the marketplace. We look forward to the EPA’s issuance next year of its final rule.”

A pre-publication copy of the proposed rule is available at http://www.epa.gov/ozone/downloads/2015-2019_HCFC_Proposed_Rule_Pre-publication_version_12-5-13.pdf

About Hudson Technologies

Hudson Technologies, Inc. is a leading provider of innovative solutions to recurring problems within the refrigeration industry. Hudson’s proprietary RefrigerantSide^® Services increase operating efficiency and energy savings, and remove moisture, oils and other contaminants frequently found in the refrigeration circuits of large comfort cooling and process refrigeration systems. Performed at a customer’s site as an integral part of an effective scheduled maintenance program or in response to emergencies, RefrigerantSide^® Services offer significant savings to customers due to their ability to be completed rapidly and at higher purity levels, and can be utilized while the customer’s system continues to operate. In addition, the Company sells refrigerants and provides traditional reclamation services to the commercial and industrial air conditioning and refrigeration markets. For further information on Hudson, please visit the Company’s web site at www.hudsontech.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

Statements contained herein which are not historical facts constitute forward-looking statements. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changes in the laws and regulations affecting the industry, changes in the markets for refrigerants (including unfavorable market conditions adversely affecting the demand for, and the price of, refrigerants), the Company’s ability to source refrigerants, regulatory and economic factors, seasonality, competition, litigation, the nature of supplier or customer arrangements which become available to the Company in the future, adverse weather conditions, possible technological obsolescence of existing products and services, possible reduction in the carrying value of long-lived assets, estimates of the useful life of its assets, potential environmental liability, customer concentration, the ability to obtain financing, risks associated with the Company’s joint ventures which include the ability of the parties to perform their obligations under the joint venture agreements, any delays or interruptions in bringing products and services to market, the timely availability of any requisite permits and authorizations from governmental entities and third parties as well as factors relating to doing business outside the United States, including changes in the laws, regulations, policies, and political, financial and economic conditions, including inflation, interest and currency exchange rates, of countries in which the joint ventures may seek to conduct business, the Company’s ability to successfully integrate any assets it acquires from third parties into its operations, and other risks detailed in the Company’s periodic reports filed with the Securities and Exchange Commission. The words “believe”, “expect”, “anticipate”, “may”, “plan”, “should” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date the statement was made.

(MEIL) Signs Letter of Intent to Acquire the Assets of OTC Energy Tech

(AUXL) Announces FDA Approval for XIAFLEX® for the Treatment of Peyronie’s Disease

XIAFLEX is First and Only FDA-Approved Treatment Proven Effective for Peyronie’s Disease Company to Host Conference Call Today at 1:30 p.m. ET

CHESTERBROOK, Pa., Dec. 6, 2013  — Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved XIAFLEX^® (collagenase clostridium histolyticum, or CCH), an in-office, biologic for the treatment of Peyronie’s disease (PD). XIAFLEX is the first and only FDA-approved treatment proven effective for PD in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy.

(Logo:  http://photos.prnewswire.com/prnh/20101202/MM10881LOGO)

“In my practice, treating PD has been a challenge as, until now, we have had few options to offer our patients,” said Martin K. Gelbard, M.D., clinical trial investigator and clinical faculty member of UCLA School of Medicine, Department of Urology. “I believe the FDA approval of XIAFLEX is a significant achievement and offers a new option for urologists: the first approved in-office treatment to be administered non–surgically that is proven safe and effective for this physically and psychologically devastating disorder.”

PD is a condition that involves the development of collagen plaque, or scar tissue, on the shaft of the penis.  The scar tissue, known as a Peyronie’s plaque, may harden and reduce flexibility, which may cause bending or arching of the penis during erection. PD can result in varying degrees of penile curvature deformity and disease “bother” (encompassing concern about erection appearance, erection pain and the impact of PD on intercourse and on frequency of intercourse). PD is a disease with an initial inflammatory component. This inflammatory phase is poorly understood with a somewhat variable disease course and spontaneous resolution occurring in less than 13 percent of casesⁱ. After approximately 12 months of disease, the disease is reported to often develop into a more chronic, stable phaseⁱ. The incidence of PD is estimated between 3 and 9 percentⁱⁱ; however the disease is thought to be underdiagnosed and undertreatedⁱ.  Based on U.S. historical medical claims data, it is estimated that between 65,000 and 120,000 PD patients are diagnosed every year, but only 5,000 to 6,500 PD patients are treated with injectables or surgery annuallyⁱⁱⁱ.

“Auxilium is delighted about the FDA approval of XIAFLEX for Peyronie’s disease and we believe we are well prepared for commercialization of this important new indication,” said Adrian Adams, CEO and President of Auxilium. “We believe that this milestone, along with other recent additions to our urology portfolio, anchors our position as a leading company in the men’s healthcare area. We are proud of the strength of what is an increasingly more diversified portfolio of products, which covers treatments for low testosterone, erectile dysfunction, and now Peyronie’s disease and we feel that this positions us well for future potential growth and shareholder value creation.”

The FDA review and approval was based on the results of safety and efficacy data from the pivotal IMPRESS (The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) trials, the Phase 3 double-blinded placebo-controlled studies that assessed XIAFLEX for the treatment of PD. In IMPRESS I and IMPRESS II at 52 weeks, both co-primary endpoints met statistical significance for mean percent change in penile curvature deformity and mean change in the PDQ bother domain score for XIAFLEX subjects vs. placebo patients.

The dose of XIAFLEX is 0.58 mg per injection administered into a Peyronie’s plaque. Up to eight injections (four treatment cycles) may be administered in the course of treatment.  Also, a penile modeling procedure is recommended after every treatment cycle of two injections in an effort to further disrupt the plaque. If more than one plaque is present, it should be injected into the plaque causing the curvature deformity. XIAFLEX has already been approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren’s contracture (DC) patients with a palpable cord. XIAFLEX for the treatment of DC is marketed under the trade name XIAPEX^® in the EU.

To support access to XIAFLEX, Auxilium has created Auxilium Advantage™ which is intended to provide a single point of contact for health care providers and patients for help accessing the product. Additionally, Auxilium worked with the FDA to develop a risk evaluation and mitigation strategy (REMS) for XIAFLEX that went into effect after the product first received FDA approval in February 2010 for adults with DC with a palpable cord. Auxilium has further collaborated with the FDA to update the REMS with an Elements to Assure Safe Use (ETASU) for XIAFLEX for the drug’s use in the treatment of PD in men with a palpable plaque and curvature deformity of 30 degrees or greater at the start of therapy. The goal of the XIAFLEX REMS with an ETASU for PD is to certify that the appropriate physicians and practice sites are trained in the use of XIAFLEX and to attempt to mitigate the serious risk of penile fracture (corporal rupture) and other serious injuries to the penis such as hematoma. These serious risks are highlighted in the Boxed Warning within the Full Prescribing Information (the label).

If you have questions about XIAFLEX, please contact the product call center at: 1-877-XIAFLEX (1-877-942-3539).

Conference Call
Auxilium will hold a conference call today at 1:30 p.m. ET, to discuss the FDA approval of XIAFLEX for PD. The presentation slides to be used during the call will be available on the “For Investors” section of the Company’s web site under the “Presentations” tab.  A question and answer session will follow the presentation. The conference call and the presentation slides will be simultaneously web cast on the “For Investors” section of the Company’s web site under the “Events” tab.  The conference call will be archived for future review until December 16, 2013.

About XIAFLEX

XIAFLEX (collagenase clostridium histolyticum, or CCH) is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren’s contracture (DC) patients with a palpable cord and for the treatment of adult men with Peyronie’s disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy in the U.S. XIAFLEX consists of a combination of two subtypes of collagenase, derived from clostridium histolyticum. Together, the collagenase sub-types are thought to work synergistically to break the bonds of the triple helix collagen structure. XIAFLEX has been granted Orphan status in the U.S. by the FDA for DC and PD.

About Auxilium

Auxilium Pharmaceuticals, Inc. is a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing products to predominantly specialist audiences. Auxilium markets Testim (testosterone gel) for the topical treatment of hypogonadism in the U.S. and XIAFLEX (collagenase clostridium histolyticum (CCH) for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy in the U.S., and XIAFLEX for the treatment of adult Dupuytren’s contracture patients with a palpable cord in the U.S. Ferring International Center S.A. markets Testim in certain countries of the EU and Paladin Labs Inc. markets Testim in Canada.  Swedish Orphan Biovitrium AB has marketing rights for XIAPEX (the EU tradename for CCH) in 71 Eurasian and African countries. Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico. Auxilium also markets TESTOPEL®, a long-acting implantable testosterone replacement therapy, Edex®, the leading branded non-oral drug for erectile dysfunction, Striant®, a buccal system for testosterone delivery, Osbon ErecAid®, the leading device for aiding erectile dysfunction, and also has a non-promoted respiratory franchise, including Theo-24® and Semprex®-D, along with  other non-promoted products, in the U.S. Auxilium has exclusive marketing rights in the U.S. and Canada for STENDRA™, an oral erectile dysfunction therapy. Auxilium has two projects in clinical development. CCH is in Phase 2 of development for the treatment of Frozen Shoulder syndrome (adhesive capsulitis) and Phase 2 of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.

IMPORTANT SAFETY INFORMATION FOR DC AND PD

What is XIAFLEX?
XIAFLEX is approved for two uses: Dupuytren’s contracture and Peyronie’s disease.
XIAFLEX is a prescription medicine used to treat adults with Dupuytren’s contracture when a “cord” can be felt.
XIAFLEX is a prescription medicine used to treat adult men with Peyronie’s disease who have a “plaque” that can be felt and a curve in their penis greater than 30 degrees when treatment is started.
It is not known if XIAFLEX is safe and effective in children under the age of 18.
Who should not receive XIAFLEX?
Do not receive XIAFLEX if you:

• have been told by your healthcare provider that the Peyronie’s plaque to be treated involves the “tube” that your urine passes through (urethra).
• have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product.  See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

What is the most important information I should know about XIAFLEX for the treatment of Dupuytren’s contracture?
XIAFLEX can cause serious side effects, including:

1. Tendon rupture or ligament damage.  Receiving an injection of XIAFLEX may cause damage to a tendon or ligament in your hand and cause it to break or weaken.  This could require surgery to fix the damaged tendon or ligament.  Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit.
2. Nerve injury or other serious injury of the hand.  Call your healthcare provider right away if you get numbness, tingling, or increased pain in your treated finger or hand after your injection or after your follow-up visit.
3. Allergic reactions.  Severe allergic reactions can happen in people who receive XIAFLEX, because it contains foreign proteins.
   Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX:

• hives
• swollen face
• breathing trouble
• chest pain

What is the most important information I should know about XIAFLEX for the treatment of Peyronie’s disease?
XIAFLEX can cause serious side effects, including:

1. Penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora.  After treatment with XIAFLEX, one of these tubes may break during an erection.  This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area.  Damage to your penis might not get better after a corporal rupture.

• After treatment with XIAFLEX, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin.
  Symptoms of corporal rupture or other serious injury to your penis may include:
  • a popping sound or sensation in an erect penis
  • sudden loss of the ability to maintain an erection
  • pain in your penis
  • purple bruising and swelling of your penis
  • difficulty urinating or blood in the urine

Call your healthcare provider right away if you have any of the symptoms of corporal rupture or serious injury to the penis listed above.
Do not have sex or have any other sexual activity for at least 2 weeks after the second injection of a treatment cycle with XIAFLEX and after any pain and swelling has gone away.

XIAFLEX for the treatment of Peyronie’s disease is only available through a restricted program called the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program.  For more information about the XIAFLEX REMS Program go to www.XIAFLEXREMS.com or call 1-877-942-3539.

2. Allergic reactions.  Severe allergic reactions can happen in people who receive XIAFLEX, because it contains foreign proteins.
Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX:

• hives
• swollen face
• breathing trouble
• chest pain

XIAFLEX when used for either Dupuytren’s contracture or Peyronie’s disease can cause serious side effects, including:

• increased chance of bleeding.  Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you.

The most common side effects with XIAFLEX for the treatment of Dupuytren’s contracture include:

• swelling of the injection site or the hand
• bruising or bleeding at the injection site
• pain or tenderness of the injection site or the hand
• swelling of the lymph nodes (glands) in the elbow or armpit (axilla)
• itching
• breaks in the skin
• redness or warmth of the skin
• pain in the armpit

The most common side effects with XIAFLEX for the treatment of Peyronie’s disease include:

• a small collection of blood under the skin at the injection site (hematoma)
• swelling at the injection site or along your penis
• pain or tenderness at the injection site, along your penis and above your penis
• penis bruising
• itching of your penis or scrotum (genitals)
• painful erection
• erection problems (erectile dysfunction)
• changes in the color of the skin of your penis
  • blisters at the injection site
  • pain with sex
  • a lump at the injection site (nodule)

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist.

Please see the full Prescribing Information and Medication Guide available at www.xiaflex.com.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, including statements made with respect to: Auxilium’s strategic focus; the impact of XIAFLEX as an option for the treatment of PD; whether the Company is well prepared for the commercialization of this new PD indication; the importance of XIAFLEX to Auxilium’s urology portfolio; whether and to what extent XIAFLEX and other Auxilium products have the potential to help patients with men’s health conditions; whether the addition of the PD indication for XIAFLEX, together with our other diversified portfolio of products, positions us well for future potential growth and shareholder value creation; Auxilium’s reputation as a company committed to men’s healthcare; the success of Auxilium Advantage to support health care providers’ and patients’ access to XIAFLEX; whether the XIAFLEX REMS and an ETASU will mitigate any of the risks associated with the use of XIAFLEX; the progress and timing of development programs and related trials; and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ”may”, ”will”, ”should”, ”would”, ”expect”, ”intend”, ”plan”, ”anticipate”, ”believe”, ”estimate”, ”predict”, ”potential”, ”seem”, ”seek”, ”future”, ”continue”, or ”appear” or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Although forward-looking statements are based on Auxilium’s current plans or assessments that are believed to be reasonable as of the date of this press release, they inherently involve certain risks and uncertainties. These forward-looking statements are subject to a number of risks and uncertainties, including those discussed under ”Risk Factors” in Auxilium’s Annual Report on Form 10-K for the year ended December 31, 2012 and in other public filings with the SEC, including, without limitation, as such Form 10-K was updated in Item 8.01 of the Current Report on Form 8-K filed on April 29, 2013 and Auxilium’s Quarterly Reports for 2013. While Auxilium may elect to update the forward-looking statements made in this news release in the future, Auxilium specifically disclaims any obligation to do so.  Auxilium’s SEC filings may be accessed electronically by means of the SEC’s home page on the Internet at http://www.sec.gov. There may be additional risks that Auxilium does not presently know or that Auxilium currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements.

 ⁱ L.A. Levine Peyronie’s Disease: A Guide to Clinical Management. Humana Press: 10-17, 2007.
 ⁱⁱ Ralph D et al. J Sex Med. 2010;7(7):2359-2374.
 ⁱⁱⁱ SDI and data on file, Auxilium

(BTHE) Investor Presentation Now Available for On-demand Viewing

Company invites individual and institutional investors to log-on to view presentation

NEW YORK, Dec. 6, 2013 — Boston Therapeutics, Inc. (OTCQB: BTHE) today announced its December 5th RetailInvestorConferences.com presentation is now available for on-demand viewing.

Boston Therapeutics’ presentation will be available 24/7 for 90 days. Investors may download shareholder materials from the “virtual trade booth” for the next three weeks.

LINK: www.retailinvestorconferences.com > click on the red “register/ watch event now” button

About Boston Therapeutics, Inc.:

Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is a leader in designing drugs using complex carbohydrate chemistry. The Company’s product pipeline is focused on developing and commercializing therapeutic molecules that address Type 2 diabetes, including: PAZ320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes.

About RetailInvestorConferences.com:

Since 2010, RetailInvestorConferences.com has been the only monthly virtual investor conference series that provides an interactive forum for presenting companies to meet directly with retail investors using a graphically-enhanced online platform.

Designed to replicate the look and feel of location-based investor conferences, Retail Investor Conferences unites PR Newswire’s leading-edge online conferencing and investor communications capabilities with BetterInvesting’s extensive retail investor audience network.

Jameson Stanford Resources Corp. (JMSN)

Jameson Stanford Resources Corp. is a metals and minerals exploration, development, and production company focused on the acquisition and consolidation of mining claims and mineral leases. Targeting projects located in historic mining districts, the company is currently engaged in exploration and development activities in connection with two high-grade copper, gold, silver, and base metals properties located in historic mining districts in Beaver County and Juab County, Utah.

The company’s Star Mountain project consists of 117 lode mining claims and four metalliferous mineral lease sections located in the Star Mountain range, Star Mining District. The project covers a total area of 4,998 acres with borders expanding as exploration warrants. Based on geological analysis, magnetometry studies, and reverse circulation drilling samples, the total inferred reserves at this site may ultimately involve more than 100 million metric tons of copper ore, plus precious and PGM base metals.

Jameson Stanford’s Spor Mountain project encompasses nine lode mining claims and three metalliferous mineral lease sections located in Juab County, Utah. The project covers a total area of 2,098 acres. Based on preliminary geological analysis and two prospect pit excavations, this site has been estimated to possibly involve more than 4 million ounces of silver, significant concentrations of beryllium, and other precious and base metals. The company’s Ogden Bay Minerals project nearby is another promising prospect with the potential to produce an estimated 100,000 metric tons of silica product per year, as well as other valuable minerals and metals.

Based on engineering and geophysical studies conducted by the company since inception in 2010, current mining claims and mineral properties have aggregate inferred reserves exceeding $10 billion of gross value at current market prices. In addition to initiating and expanding production operations through exploration discoveries and the development of existing mining claims and mineral properties, management’s growth strategy includes the identification and acquisition of additional under-developed mining claims and mineral leases in established mining districts.

Methes Energies International Ltd. (MEIL)

Methes Energies uses its own proprietary technology to produce high-quality biodiesel processors and systems to capitalize on the growing demand for renewable energy, surging energy prices, and the value of biodiesel as a practical and realistic long-term replacement for conventional diesel fuel. The Company’s processors are flexible and can use a variety of virgin vegetable oils, used vegetable oil and rendered animal fat feedstock, allowing operators to take advantage of feedstock buying opportunities. Methes Energies also markets and sells high-quality biodiesel fuel produced at its 1.3 MGY (5 MLY) showcase production facility in Mississauga, Ontario, and at it’s 13 MGY (50 MLY) facility in Sombra, Ontario, to customers in the U.S. and Canada.

Methes Energies’ broad range of expertise and solutions include all aspects of the engineering, manufacturing, production, logistic, marketing and distribution processes. Among other services, the company leverages its cutting-edge biodiesel processors, pre-treatment systems, and other solutions to address real and specific biodiesel production challenges for large and small-scale biodiesel producers and entrepreneurs seeking to produce their own fuel.

In 2007 the company introduced the Denami 600, the industry’s first compact, full automated continuous flow biodiesel processor designed to run on a wide variety of feed stocks. This reliable, cost-effective and superior method of producing top-grade biodiesel exceeds current ASTM standards.

The company also sells feedstock to its network of biodiesel producers, selling their biodiesel production and providing clients with proprietary software to operate and control their processors. Methes Energies remotely monitors the quality and characteristics of its clients’ production, upgrades and repairs their processors as necessary, and advises clients on adjusting their processes to use varying feedstock to improve the quality of their biodiesel.

As a competitive and highly respected revenue-generating player in the North American biodiesel sector, Methes Energies is fast building a network of biodiesel operators and facilities to capitalize on buying power and economies of scale. The North American demand for biodiesel is sizeable and the company is well positioned for global expansion throughout Europe, South America, Africa and Asia.

CytRx Corp. (CYTR)

CytRx Corp., a biopharmaceutical research and development company, specializes in the enhanced delivery of proven oncology therapies to treat cancer. The company’s novel linker platform technology can be utilized with multiple chemotherapeutic agents and could allow for greater concentration of drug at tumor sites while minimizing side effects.

Aldoxorubicin, the company’s flagship compound, is an improved version of the widely used chemotherapeutic agent doxorubicin. CytRx is conducting a global Phase 2b clinical trial comparing aldoxorubicin to doxorubicin as a treatment for 1st-line soft tissue sarcomas. Top-line results are expected in Q4 2013. Preparations are underway for a Phase 3 trial in 2nd-line soft tissues sarcoma to begin in Q1 2014 based on results from a completed Phase 1b/2 clinical trial. The FDA granted CytRx a Special Protocol Assessment (SPA) for the Phase 3 clinical trial. The company is conducting a Phase 1b pharmacokinetics clinical trial and in Q4 2013 plans to start a Phase 2b trial in glioblastoma multiforme (stage IV brain cancer) and a Phase 2 trial in Kaposi’s sarcoma.

With no debt and significant cash resources, CytRx has the capital position necessary to support near and mid-term milestones across its entire oncology pipeline. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib, for which it plans to seek a partner for further development.

Collectively, CytRx’s management and Board of Directors have significant oncology experience and have brought numerous oncology drugs to market. Daniel Levitt, M.D., Ph.D., EVP and Chief Medical Officer, served as President of R&D at Protein Design Labs, as head of oncology drug development at Sandoz Pharmaceuticals, as director of clinical oncology at Hoffmann-LaRoche, and was instrumental in the development of five approved cancer drugs. Joseph Rubinfeld, Ph.D., a director since July 2002 is a renowned expert in the field of oncology, was one of the four initial founders of Amgen, Inc. and was a founder of SuperGen, Inc. Max Link, Ph.D., Chairman of the Company’s Board of Directors since 1996, was a former Chairman and CEO of Sandoz Pharma (now Novartis) and is currently the Chairman of the Board of Alexion Pharmaceuticals.

Chanticleer Holdings, Inc. (HOTR)

Chanticleer Holdings, Inc. owns and operates Hooters® branded restaurants in emerging international markets. As one of the most well-known restaurant brands in the world, Hooters has a menu that consists of moderately-priced American bar food and the world-famous Hooters girls. The company has ownership interests in the parent company of the Hooters brand, Hooters of America (HOA), four Hooters restaurants in South Africa, one restaurant in Hungary, one Hooters restaurant in Australia, and the exclusive franchise rights to develop and operate Hooters restaurants in three of the most populous states of Brazil: Rio De Janeiro, Minas Gerais, and Espirito Santo.

The first Hooters® restaurant opened October 4, 1983, in Clearwater, Florida. Today there are more than 430 Hooters restaurants in 28 countries. During its history, Hooters has continued to rank high amongst the industry’s growth leaders. The Hooters concept has stayed true to its roots with its beach-themed concept, logo, uniform, menu and ambiance being similar to what existed in its original store, and has proven successful in small-town America, major metropolitan areas, and internationally.

In 2011, Chanticleer (NASDAQ: HOTR; HOTRW), together with a group of major private equity investors, acquired Hooters of America (HOA) and its largest franchisee Texas Wings, Inc. Today HOA is the Atlanta-based operator and the franchisor of over 430 restaurants in 28 countries. Chanticleer has rights to develop and operate restaurants in South Africa, Hungary, and parts of Brazil, and has joint ventured with the current franchisee in Australia, while evaluating several additional opportunities.

Chanticleer’s core growth strategy involves expanding the Hooters® brand in emerging markets and other rapidly developing global economies. The rising number of middle class consumers in emerging markets is driving the demand for recognized international brands. Targeting underpenetrated international markets with proven market success, the company aims to achieve consistent, above-average growth rates and favorable financial returns for its shareholders.

Key Investment Highlights:

• Capitalizing on Globally Recognized Brand with Long History of Success
• Established and Expanding Presence in International Emerging Markets
• Franchise Model Allows for Rapid Turn-key Operations and High Returns
• Well Positioned with Projected Annual Growth Rate > 50%

Calpian, Inc. (CLPI)

Calpian, Inc. is focused on providing cutting-edge financial services in the payment processing and mobile phone-based transaction markets. In addition to earning revenue from the sale of point-of-sale terminals and various transaction fees, the company also receives strong cash flows from recurring income streams that stem from payment processing contracts in place at about 16,000 small retailers throughout the United States.

Calpian Commerce, a wholly owned subsidiary of Calpian, provides technology-focused payment solutions to assist customers in closing the gap between payment and their information technology requirements. Calpian Commerce can provide the merchant community with an integrated suite of payment services and related software enabling products by offering credit and debit card processing, ACH, mobile acceptance, and gateway payment solutions to merchants in the U.S. in traditional “brick and mortar” business environments and/or over the Internet in settings requiring wired as well as mobile payment solutions.

Money on Mobile, the fast-growing mobile payment platform known as the “PayPal” of India, has already signed up over 53 million users and more than 135,000 retailers. Only beginning to penetrate a massive mobile market, the service enables unbanked/underserved populations to handle everyday payments and transfers using simple SMS text functionality. The distribution model utilized offers strong incentives to retailers, distributors, and consumers. Historically, Money on Mobile has been growing 8-10% per month.

Calpian has established itself as a multi-faceted payments company by combining a large emerging market mobile payments service and an electronic point-of-sale payment solutions under one corporate umbrella. Led by a management team with a combined 60 years of relevant business experience, the company is a well-managed operation with exceptional growth potential in burgeoning markets across the globe.

Key Investment Highlights:

• Steady Cash Flow Business and Explosive Growth Potential
• Targets Rapidly Growing Demographic with Underserved Needs
• Mobile Business has Limited Competition and First Mover Advantage
• Leading Buyer in the Consolidation of a $1 Billion Niche Industry with Numerous Opportunities

Boston Therapeutics, Inc. (BTHE)

Boston Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of novel compounds based on complex carbohydrate chemistry to address unmet medical needs. An IP portfolio solidifies the company’s position in the pharmaceutical industry. Boston Therapeutics’ current product pipeline, PAZ320 and IPOXYNT, is comprised of therapies developed to treat patient populations with Type 2 diabetes.

PAZ320 is a non-systemic, non-toxic, chewable drug candidate for prevention of diabetes and its complications. PAZ320 inhibits the enzymes that release glucose from complex carbohydrate in foods during digestion. Boston Therapeutics believes PAZ320 is a safe and effective drug compound for people with pre-diabetes and diabetes in their daily management of blood glucose levels, fulfilling an unmet medical need. PAZ320 has completed a Phase ll clinical trial at Dartmouth Medical Center. 45% of the patients responded with a 40% reduction in the elevation of post meal blood sugar compared to baseline with no serious adverse events.

IPOXYN, a universal oxygen carrier, is an injectable Rx for prevention of necrosis and treatment of ischemic conditions which may lead to necrosis. This compound is not a biologic, but a second generation New Chemical Entity HBOC (hemoglobin based oxygen carrier). The potential for this product goes well beyond Lower Limb Ischemia into a range of areas from anemia and blood loss (injury), to cardiovascular disease and surgical blood supplementation.

The Boston Therapeutics management and advisory team has extensive expertise in complex carbohydrate chemistry, regulatory affairs, and clinical development, with multiple submissions and approvals to U.S. Food and Drug Administration. Backed by a team with more than five decades of expertise in public and private business management, the company is well positioned to advance its status as a premier developer of complex carbohydrate-based new chemical entities.

Advaxis, Inc. (ADXS)

Advaxis, Inc. (NASDAQ:ADXS) is a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases. The company’s immunotherapies are based on a novel platform technology that uses live, bio-engineered bacteria to secrete antigen/adjuvant fusion protein(s) that redirects the powerful immune response all human beings have to the bacteria to fight off cancer and disease. A second effect is to reduce the immune suppressive cells cancer tumors recruit to protect themselves from immune attack by over 80%. It is this combination that makes Advaxis special.

The company has more than fifteen distinct constructs in various stages of development, many in strategic collaborations with recognized centers of excellence such as the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, the Karolinska Institutet, and others.

Advaxis’ lead construct, ADXS-HPV, is currently in Phase 2 clinical development for recurrent/refractory and advanced cervical cancer, anal cancer, and HPV caused head and neck cancers. This important construct was recognized as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards by the vaccine industry and the journal Expert Reviews of Vaccines.

The estimated global market for immunotherapies is projected to exceed $37.2B by 2012, with cancer vaccines forecast to grow into an $8B market. Protected by 75 issued and pending patents, Advaxis is extremely well positioned to capitalize on the burgeoning opportunities in the healthcare sector as it advances the development of next-generation treatments for today’s most challenging diseases.

(OXYS) Announces Update From Medica 2013 Trade Fair

Highly Successful Exhibit Bringing New Contracts

(HOTR) Signs Binding Letter of Intent to Acquire Spoon Bar & Kitchen

(CLPI) Mentioned in New York Times Article on Mobile Payments

Calpian, announced today that the Company was mentioned in a New York Times article featuring the growing popularity of mobile payments in India. The article, which was published on December 4, 2013, is currently available on the New York Times website.

Calpian President & CEO Harold Montgomery said: “We are excited to see Money-on-Mobile being recognized by a publication of the stature of the New York Times. We believe that this article is a reflection of the rapid increase in use of mobile payments throughout Asia and Africa, and it is our hope that additional awareness will lead to increased usage and ultimately significant growth of Calpian’s Money-on-Mobile business.”

A copy of the article can also be accessed on the Company website, at www.calpian.com.

About Calpian, Inc.

Calpian, Inc. (OTCQB: CLPI) is a publicly traded company with corporate offices in Dallas, Texas and mobile payments emerging-market operations through its subsidiary in India. Calpian’s Indian subsidiary offers Money-on-Mobile, a pre-paid mobile payment solution, to more than 163,000 Indian retail locations with over 71 million unique users. Calpian’s management team has over 70 years in combined experience in the payments business. Calpian’s CEO, Harold Montgomery, is a recognized industry leader who has provided expert testimony to the U.S. Congress and Federal Reserve Bank on payments-related issues and regularly appears in numerous industry publications, such as Transaction World Magazine. Please visit our website at www.calpian.com for more information.

Note to Investors:

This press release contains certain forward-looking statements based on our current expectations, forecasts and assumptions that involve risks and uncertainties. This release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity. Forward-looking statements in this release are based on information available to us as of the date hereof. Our actual results may differ materially from those stated or implied in such forward-looking statements, due to risks and uncertainties associated with our business, which include the risk factors disclosed in our Form 10-K-A filed on April 30, 2013 and the Form 10-Q filed on August 14, 2013. Forward-looking statements include statements regarding our expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” and “would” or similar words. We assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise.

(HOTR) Hooters Arrives in Rio de Janeiro

American Chain Announces Its Fourth Store in Brazil in ‘Carioca’ Soil, the Unit Will Be Located in Carrefour Barra, Projected to Open in April of 2014 in Partnership With Chanticleer Holdings, Inc.

(CYTR) to Present at the Oppenheimer 24th Annual Healthcare Conference Dec. 11

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that President and CEO Steven A. Kriegsman and Executive Vice President and Chief Medical Officer Dr. Daniel Levitt will present at the Oppenheimer 24^th Annual Healthcare Conference on Wednesday, December 11^th 2013 at 4:30 p.m. Eastern time. The conference is being held December 10-11 at the Crowne Plaza Hotel in New York City.

Interested parties can access the audio webcast with slide presentation at http://www.cytrx.com/investors/presentations. An archived presentation will be available for 90 days.

About the Oppenheimer Healthcare Conference

Management teams from more than 100 companies will be presenting at the Oppenheimer 24^th Annual Healthcare Conference. The presenters represent a broad spectrum of public and private healthcare companies spanning all major sectors of the healthcare industry, including bio & specialty pharmaceuticals; biotechnology; medical devices; healthcare facilities; life science tools and diagnostics; healthcare information technology and distribution, and healthcare providers and servicers.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx is conducting a global Phase 2b clinical trial with aldoxorubicin as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and has completed a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a potential pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx also has initiated a Phase 2 clinical trial with aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and plans to initiate a Phase 2 clinical trial for AIDS-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.

(CXM) Excellagen Assigned Q Code For Product Reimbursement

SAN DIEGO, Dec. 4, 2013 — Cardium Therapeutics (NYSE MKT: CXM) today announced that Cardium’s Excellagen®, a wound care product indicated for the treatment of hard to heal wounds such as diabetic foot ulcers and pressure ulcers as well as other dermal wounds, has been assigned a new and unique, Level II HCPCS (Health Care Common Procedure Coding System) product reimbursement code, Q4149.  The Centers for Medicare and Medicaid Services (CMS) made their determination to assign Excellagen a Q code after review of Cardium’s HCPCS Level II Code Modification Request and subsequent supporting information. This new reimbursement code takes effect January 1, 2014.

Excellagen is a syringe-based prescription-only product for treating a wide range of wounds that is applied weekly in the office or hospital outpatient setting by a licensed clinician.  This unique Q code is an important designation for providing a method for billing a product under Medicare and is utilized by many private payers as well.  Q code designations represent an important step forward for the reimbursement process under Medicare.

Cardium’s submission to CMS focused on Excellagen’s unique product formulation and format, as well as maintenance during manufacture of collagen’s structural properties that support chemotaxis, cellular adhesion, migration and proliferation, and granulation tissue development.  The unique Q code assigned by CMS designates Excellagen as a single source product with a structural and functional role in providing a favorable wound healing environment.

“The Q code designation places Excellagen under the same code classification as well-known skin substitute wound care products such as Dermagraft®, Graftjacket® Xpress, EpiFix® and Integra® Flowable Wound Matrix. We believe Excellagen offers a compelling relative economic value proposition for wound care professionals in comparison to many of its competitors.  The assignment of a new and unique Q code is an important building block in our strategy as we continue to credentialize and establish the evidence-based value for Excellagen,” commented Christopher Reinhard, Cardium’s CEO.

Excellagen is a sterile, syringe-based, professional-use, physiologically formulated homogenate of purified bovine dermal collagen (Type I) in its native, 3-dimensional fibrillar configuration, providing a structural scaffold for chemotaxis, cellular adhesion, migration and proliferation, and wound granulation. Excellagen’s FDA clearance provides for very broad labeling including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.  Excellagen is intended for professional use following standard debridement procedures.  Excellagen’s unique fibrillar Type I bovine collagen homogenate formulation is topically applied through easy-to-control, pre-filled, sterile, single-use syringes and is designed for application at only one-week intervals.

About Cardium

Cardium is a health sciences and biotechnology regenerative medicine company. Cardium has three business units: (1) Angionetic Therapeutics™, focused on the late-stage clinical development of Generx^®, an angiogenic gene therapy product candidate for the treatment of cardiac microvascular insufficiency due to advancing coronary artery disease; (2) Activation Therapeutics™, a regenerative medicine wound healing technology and commercialization platform, that includes Excellagen^®, an FDA-cleared advanced wound care product; and (3) LifeAgain® Insurance Solutions, an advanced medical data analytics platform that supports the Company’s BlueMetric Select term life insurance program underwritten by Symetra Life Insurance for men with active localized prostate cancer.  For more information about Cardium visit www.cardiumthx.com.

Forward-Looking Statements 

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from expectations. For example, there is no assurance that receipt of a Q code for Excellagen will effectively improve its reimbursement or sales; that Excellagen will be favorably compared to other wound care products; that planned product development efforts and clinical studies can be performed in an efficient and effective manner; that regulatory approvals can be obtained in a timely manner or at all; that partnering, distribution or other commercialization efforts can be achieved; that our products or proposed products will prove to be sufficiently safe and effective; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that third parties on whom we depend will behave as anticipated; or that necessary regulatory approvals will be obtained.  Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development, testing and marketing of biologics, medical devices and other products, and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, whether our efforts to launch new products and expand our markets will be successful or completed within the time frames contemplated, our dependence upon proprietary technology, our ability to obtain necessary funding, regulatory approvals and qualifications, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission.  We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Copyright 2013 Cardium Therapeutics, Inc.  All rights reserved.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics^®, Generx^®, Excellagen^®, LifeAgain^®, BlueMetric™, Decision Rule Adaption™, ADAPT™, Angionetic Therapeutics™, Activation Therapeutics™ are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.  Other trademarks belong to their respective owners.

(BTHE) Appoints Conroy Chi-Heng Cheng and S. Colin Neill to Board of Directors

Anthony D. Squeglia Appointed Chief Financial Officer

(ETRM) Announces 18 Month ReCharge Study Results

VBLOC Therapy Continues to Demonstrate Durable and Safe Weight Loss

(OMED) and Celgene Announce Strategic Collaboration

Celgene Invests in OncoMed’s Demcizumab and up to Five Additional Preclinical Biologics Programs; OncoMed Leads Early Clinical Trials and Retains Co-Development, Co-Commercialization and Profit-Sharing Rights

OncoMed to Receive $177.25 Million Upfront, Including a $22.25 Million Equity Investment

OncoMed to Host a Conference Call This Morning for Investors at 8:30 a.m. ET

REDWOOD CITY, Calif., Dec. 3, 2013 — OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED) and Celgene Corporation (Nasdaq:CELG) today announced an agreement to jointly develop and commercialize up to six anti-cancer stem cell (CSC) product candidates from OncoMed’s biologics pipeline, including demcizumab (OMP-21M18, Anti-DLL4).

OncoMed will control and conduct initial clinical studies at which point Celgene has an option to license worldwide rights to up to six novel anti-CSC therapeutic candidates. OncoMed retains global co-development and U.S. co-commercialization rights for five of the six anti-CSC product candidates with 50/50 U.S. profit sharing, and royalties to be received in other territories. Celgene will also have research, development and commercialization rights to small molecule compounds in an undisclosed cancer stem cell pathway.

Celgene obtains an exclusive option on one of OncoMed’s most advanced clinical candidates, demcizumab, during or after the completion of certain future planned Phase II clinical trials to be conducted by OncoMed. Demcizumab is currently in three Phase Ib clinical studies in combination with standard-of-care therapeutics, including a trial in patients with first-line advanced pancreatic cancer. Subsequent to option exercise, the parties will co-develop demcizumab, sharing global development costs on a 1/3 OncoMed and 2/3 Celgene basis. The companies will co-commercialize demcizumab in the United States with 50/50 profit sharing. Outside the United States, Celgene would lead development and commercialization, with OncoMed eligible to receive milestones and tiered double-digit royalties on sales outside the United States.

In addition to demcizumab, the collaboration includes up to five preclinical- or discovery-stage biologics programs: OncoMed’s anti-DLL4/VEGF bispecific antibody and up to four additional biologics programs targeting either the RSPO-LGR CSC pathway or an additional undisclosed CSC pathway. Celgene obtains exclusive options on these programs during or after completion of certain Phase I clinical trials to be conducted by OncoMed. For the anti-DLL4/VEGF bispecific antibody and three of the four additional biologics programs, OncoMed retains 50/50 U.S. profit sharing and co-commercialization terms, plus 1/3 OncoMed and 2/3 Celgene global development cost-sharing and mid-single digit to mid-double digit royalties outside the profit-sharing territory. On the fourth biologics program, Celgene would receive an exclusive worldwide license, with OncoMed receiving high-single digit to mid-double digit royalties on worldwide sales. Celgene also obtains an option to conduct small molecule research, development, and commercialization in an undisclosed CSC pathway, with OncoMed eligible to receive milestones and low- to mid-single digit royalties on any resulting small molecule anti-cancer product candidates.

Under the terms of the agreement, OncoMed will receive an upfront payment of $155 million, and Celgene will also purchase approximately $22.25 million in a private placement of newly issued shares of OncoMed’s common stock at a price of $15.13 per share.

The collaboration also includes option exercise payments and payments for achievement of development, regulatory and commercial milestones, paid on a per-program basis. For demcizumab, these payments could total up to approximately $790 million, and include an undisclosed payment for achievement of pre-determined safety criteria in Phase II clinical trials. For the anti-DLL4/VEGF bispecific antibody, option exercise, development, regulatory and commercial payments could total up to $505 million. For the other four biologics, each program is eligible for approximately $440 million of option exercise, development, regulatory and commercial payments. OncoMed could also receive more than $100 million in option exercise, development and regulatory approval payments for the small molecule program. Such total payments include milestones for regulatory approvals in multiple indications per program. OncoMed retains worldwide rights to certain targets in multiple pathways that do not become collaboration programs with Celgene.

“Through this major alliance with Celgene, we gain substantial resources that will enable us to continue to discover and develop new therapeutics independently while positioning OncoMed for substantial potential downstream value and profits. Importantly, by retaining co-development and co-commercialization rights to up to five biologic product candidates in our pipeline, we expect to add commercial capabilities to our core research and development competencies as we continue to build a premier oncology biotherapeutics company,” said Paul J. Hastings, OncoMed’s Chairman and CEO. “Celgene is a preeminent biopharmaceutical innovator with a successful track record of translating unique science into disease-altering therapies that benefit patients, healthcare and society. We can greatly benefit from their expertise and look forward to many years of successful collaboration.”

Tom Daniel, President, Global Research & Early Development, of Celgene said, “We are very pleased to enter into this broad based collaboration with OncoMed, one that holds great promise for cancer patients.  Demcizumab’s substantial early clinical activity warrants aggressive yet careful evaluation in several indications where we have strength, including non-small cell lung cancer and pancreatic cancer. The earlier partnerships in the RSPO-LGR and another, undisclosed cancer stem cell pathway provide us complementary and strategically valuable targeting opportunities across both biologic and small molecule modalities in the cancer stem cell arena where OncoMed has provided leadership and great strength.”

Latham & Watkins LLP and Leerink Swann LLC acted as advisors to OncoMed for this transaction.

OncoMed Conference Call

OncoMed management will host a conference call today beginning at 8:30 a.m. ET/5:30 a.m. PT to discuss today’s announcement regarding this strategic collaboration with Celgene Corporation.

Analysts and investors can participate in the conference call by dialing (855) 420-0692 for domestic callers and (484) 756-4194 for international callers. The live conference call will also be webcast and available on the Investor Relations page of OncoMed’s website at www.oncomed.com. Please access the webcast at least 10 minutes prior to the start of the call to ensure time for any software downloads that may be required. A telephone replay will be available following the conclusion of the call by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers using the passcode 19812706.

About Cancer Stem Cells

Cancer stem cells, or CSCs, are the subpopulation of cells in a tumor responsible for driving growth and metastasis of the tumor. CSCs, also known as tumor-initiating cells, exhibit certain properties which include the capacity to divide and give rise to new CSCs via a process called self-renewal and the capacity to differentiate or change into the other cells that form the bulk of the tumor. Common cancer drugs target bulk tumor cells but have limited impact on CSCs, thereby providing a path for recurrence of the tumor. OncoMed has advanced five distinct anti-CSC targeting product candidates into clinical trials, including demcizumab (OMP-21M18). OncoMed believes its product candidates are distinct from the current generations of chemotherapies and targeted therapies, and have the potential to significantly impact cancer treatment and the clinical outcome of patients with cancer.

About Demcizumab (OMP-21M18)

Demcizumab is a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signaling pathway.  Two Phase Ib combination trials of demcizumab are ongoing: demcizumab with standard-of-care in first-line advanced pancreatic cancer patients, and demcizumab with standard-of-care carboplatin and pemetrexed (Alimta™) in first-line advanced non-small cell lung cancer (NSCLC) patients. In addition, a Phase Ib/II trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer is ongoing at MD Anderson Cancer Center. Demcizumab is part of OncoMed’s collaboration with Celgene Corporation.

About OncoMed Pharmaceuticals

OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells.  OncoMed has five anti-cancer product candidates in clinical development, including demcizumab (Anti-DLL4, OMP-21M18), OMP-59R5 (Anti-Notch2/3), OMP-52M51 (Anti-Notch1), vantictumab (Anti-Fzd7, OMP-18R5), and OMP-54F28 (Fzd8-Fc), which target key cancer stem cell signaling pathways including Notch and Wnt. OncoMed has two other antibodies in preclinical development, Anti-DLL4/Anti-VEGF bispecific and Anti-RSPO3, with Investigational New Drug filings planned for as early as 2014. OncoMed is also pursuing discovery of additional novel anti-CSC product candidates.  OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK). Additional information can be found at the company’s website: www.oncomed.com.

Forward-Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, Inc., they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including OncoMed’s expectations regarding the ability of OncoMed to advance its research and development pipeline, including its discovery and preclinical pipeline and its anti-CSC therapeutics in clinical trials; OncoMed’s expectations regarding its ability to co-develop and co-commercialize demcizumab or any other product candidate; the receipt of the upfront payment from Celgene and the completion of the private placement of shares of OncoMed’s common stock; OncoMed’s ability to discover and develop novel anti-CSC therapeutics; OncoMed’s expectations regarding its ability to realize substantial potential downstream value and profits from its alliance with Celgene; and the potential of OncoMed’s product candidates to significantly impact cancer treatment and the clinical outcome of patients with cancer. Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; OncoMed’s dependence on its collaboration partners, including Celgene, Bayer and GSK, for the funding of its partnered programs; OncoMed’s dependence on the development and marketing efforts of its partners for the commercial success of its partnered product candidates; OncoMed’s reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed’s reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed’s ability to validate, develop and obtain regulatory approval for companion diagnostics; OncoMed’s ability to achieve market acceptance and commercial success of its product candidates once regulatory approval is achieved; OncoMed’s ability to discover, develop and commercialize additional product candidates; the ability of competitors to discover, develop or commercialize competing products more quickly or more successfully; OncoMed’s dependence on its Chairman and Chief Executive Officer, its Chief Scientific Officer, its Chief Medical Officer and other key executives; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate OncoMed’s patents or proprietary rights; and the ability of OncoMed’s proprietary rights to protect its technologies and product candidates. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed’s business in general, see OncoMed’s Prospectus filed with the Securities and Exchange Commission on July 18, 2013 and OncoMed’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2013, filed with the Securities and Exchange Commission on November 13, 2013.

CONTACT: OncoMed Pharmaceuticals
         Investors
         Shari Annes
         (650) 888-0902
         shari.annes@oncomed.com

         Media
         BCC Partners
         Karen L. Bergman or
         Michelle Corral
         (650) 575-1509 or (415) 794-8662
         kbergman@bccpartners.com or mcorral@bccpartners.com

         Celgene Corporation
         Investors:
         (908) 673-9628
         investors@celgene.com

         Media:
         (908) 673-2275
         media@celgene.com