|After the bell: Pozen moves higher on milestone payment, Vertex soars after Hep C trial meets goal, GTx plummets after failed prostate cancer study|
|By BioMedReports.com Staff|
|Tuesday, 25 May 2010 18:31|
Below is a list of the companies that made news in the healthcare sector on Tuesday, May 25, 2010.
POZEN Inc. (NASDAQ: POZN), jumped higher after the bell after the company announced after the market closed the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration approval of VIMOVO (combo of naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application (IND) and New Drug Application (NDA) for VIMOVO to AstraZeneca over the next few weeks.
An additional $25 million milestone will be payable if VIMOVO receives marketing approval in a major ex-U.S. market (including pricing and reimbursement approval). Under the terms of the agreement, AstraZeneca will pay POZEN royalties on net sales of VIMOVO worldwide and POZEN could receive up to $260 million in sales performance milestones, if certain sales thresholds are achieved. AstraZeneca has responsibility for all commercialization activities.
VIMOVO is approved for the relief of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is a fixed-dose combination of enteric-coated naproxen, a pain–relieving non-steroidal anti-inflammatory drug (NSAID) and immediate-release esomeprazole, a proton pump inhibitor.
Shares of Pozen rose nearly 4% in the extra session.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) soared in the extended session today after the company announced that 75% of people chronically infected with genotype 1 hepatitis C virus (HCV) who had not previously been treated achieved a sustained viral response (SVR or viral cure) after receiving a 12-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone, in the Phase 3 ADVANCE trial. 69% of people achieved SVR after receiving an 8-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone. 44% of people in the control arm achieved SVR after 48 weeks of treatment with the currently approved regimen of pegylated-interferon and ribavirin.
The safety and tolerability profile of telaprevir in the ADVANCE trial was consistent with the profile reported in Phase 2 studies, with an improvement in treatment discontinuation rates due to adverse events. Adverse events leading to discontinuation of all study drugs occurred in 6.9%, 7.7% and 3.6% of patients in the 12-week telaprevir-based arm, the 8-week telaprevir-based arm and the control arm, respectively.
"These first Phase 3 results are important for people with hepatitis C, as they represent a potential new era of therapy where doctors may be able to use direct acting antiviral medicines to improve treatment and help patients potentially avoid life-threatening liver-related consequences associated with chronic hepatitis C," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, and an Investigator for the ADVANCE trial. "The ADVANCE results confirm findings seen in earlier trials of telaprevir and highlight that telaprevir-based combination regimens may increase viral eradication rates and shorten treatment time for many patients."
"These groundbreaking data are the result of our more than decade-long commitment to improving care for people with hepatitis C and should provide new hope for patients with this disease," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "As fewer than half of people with genotype 1 hepatitis C achieve a viral cure with currently approved therapies, new and more effective medicines are urgently needed.
"These results for telaprevir show that 75 percent of patients in the 12-week telaprevir arm achieved a viral cure, with the majority receiving only 24 weeks of therapy, marking what we believe may be a potentially dramatic improvement in the future treatment of hepatitis C," concluded Dr. Kauffman.
Telaprevir is an investigational, oral inhibitor of HCV protease, an enzyme essential for viral replication, and is being developed by Vertex Pharmaceuticals in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration for telaprevir in the second half of 2010 for both treatment-naïve and treatment-failure patients.
Shares of Vertex surged more than 13% or $4.45 in the after hours session.
GTx, Inc. (Nasdaq: GTXI) saw its shares plunge in the after hours session. After the bell today the company announced top line results of the Phase III clinical trial evaluating toremifene 20 mg, a selective estrogen receptor modulator, for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia, or PIN, a premalignant lesion of the prostate. The company reported that the incidence of prostate cancer was lower in men receiving toremifene 20 mg compared to placebo but was not statistically significantly different.
"We designed the Phase III trial based upon the successful outcome of our Phase IIb clinical trial. Toremifene 20 mg did also reduce prostate cancer in our Phase III study but based on our review of the topline data, there is not a sufficient reduction in cancers compared to placebo over a three year period to demonstrate the statistical significance required for this study," said Dr. Mitchell S. Steiner, CEO of GTx. "We intend to review all data from the study this summer to better understand the trial results and the ability of toremifene 20 mg to reduce cancer among these high risk men.
The company said the outcome of this study will not affect its partnership with Ipsen, with whom the company is co-developing toremifene 80 mg, a drug that is supposed to reduce fractures in men with prostate cancer who are undergoing androgen deprivation therapy.
Shares of GTx fell 98 cents or more than 32% in the after hours session, closing at $2.04.
In news from earlier in the day:
Abiomed Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced that updated clinical data from USpella will be presented at EuroPCR 2010. USpella is a U.S. multicenter, observational registry of Impella 2.5 patients.
Alkermes, Inc. (NASDAQ: ALKS) today announced that the supplemental New Drug Application (sNDA) for VIVITROL (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration. The designation is assigned to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists and accelerates the FDA’s target review timeline from ten to six months. The FDA has issued an action date for the sNDA of October 12, 2010 under the Prescription Drug User Fee Act. If approved for opioid dependence, VIVITROL would be the first and only non-narcotic, non-addictive medication for the treatment of opioid dependence available in a once-monthly formulation.
Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced Cook Medical, a license holder of Angiotech's paclitaxel technology, presented one-year data at Euro PCR that confirms sustained clinical outcomes with Cook Medical's drug-eluting peripheral stent, Zilver(R) PTX(TM). According to data presented today by Prof. Dierk Scheinert, medical director at Park Hospital Leipzig, 86.2% of all patient subgroups treated with Zilver PTX Drug-Eluting Peripheral Stent demonstrated vessel patency at 12 months(1) without the requirement for an additional intervention. "Angiotech is excited by these encouraging top line clinical results as our partner, Cook Medical, further validates the effectiveness of paclitaxel for treatment of peripheral vascular disease (PVD)," said Dr. William Hunter, President and CEO of Angiotech. "We are optimistic that the full results of this trial will support Cook's application with the FDA to become the first drug-coated peripheral stent available for the management of the millions of patients suffering from PVD in the United States."
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the independent Data Monitoring Committee (DMC) of the Phase 3 SUCCEED trial has completed the second interim efficacy analysis as specified in the study protocol and has recommended that the randomized, placebo-controlled trial of oral ridaforolimus in patients with metastatic sarcomas continue to its final analysis, without modification to the study protocol.
The DMC review comprised approximately two-thirds of the progression-free survival (PFS) events anticipated in the trial. PFS is the primary end-point of the trial. The safety and efficacy of oral ridaforolimus is being evaluated in approximately 650 patients with metastatic soft-tissue and bone sarcomas who have achieved a favorable response to chemotherapy. The DMC also stated that no new safety signals were noted. Full enrollment of the trial was reached in December 2009. The final analysis of PFS is expected in the second half of 2010.
Biostar Pharmaceuticals, Inc. (Nasdaq:BSPM), the Xianyang-based manufacturer of a leading over-the-counter Hepatitis B medicine, Xin Aoxing Oleanolic Acid Capsule, and a variety of pharmaceutical products and medical nutrients, today announced that it has commenced assembly of its production line for its proprietary Zushima product.
Clinical Data, Inc. (NASDAQ: CLDA) edged higher today after the company announced that data from clinical trials of vilazodone, a novel investigational compound for the treatment of major depressive disorder (MDD), as well as preclinical data characterizing its mechanism of action, will be presented at the annual meetings of the American Psychiatric Association (APA) and the Society of Biological Psychiatry (SOBP). The presentations include positive results from the second placebo-controlled Phase III clinical trial of vilazodone, a long-term safety study, and findings from nonclinical studies supporting the potential benefits of vilazodone’s unique mechanism of action. The Company’s New Drug Application (NDA) for vilazodone for the treatment of MDD was accepted by the U.S. Food and Drug Administration for filing and is currently under review.
"We are pleased to be able to present these data at major scientific meetings, which together support the uniqueness and promise of vilazodone for the treatment of depression," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "Vilazodone, if approved, will be a welcome addition to the treatment armamentarium for patients who suffer from depression, due to its overall efficacy and safety profile, combined with a novel mechanism of action as both an inhibitor of serotonin reuptake and a serotonin 1A receptor partial agonist."
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced the receipt of $5 million from Nycomed for reaching a clinical milestone under the license and collaboration agreement, entered into on July 11, 2008. Nycomed has the worldwide rights to develop, manufacture and commercialize veltuzumab, in the subcutaneous formulation, for the treatment of all non-cancer indications.
This is the second milestone payment received by the Company from Nycomed. Under the terms of the agreement, Immunomedics could potentially receive up to $580 million from Nycomed upon achievement of certain clinical, regulatory, and sales-based milestones. The agreement also provides the Company with escalating double-digit royalties on net sales of veltuzumab.
NovaMed, Inc. (Nasdaq: NOVA), a leading operator of ambulatory surgery centers in partnership with physicians, today announced that its stockholders approved an amendment to the Company’s Certificate of Incorporation to effect a one-for-three reverse split of the Company’s outstanding shares of common stock. NovaMed expects that the reverse stock split will take effect prior to the opening of markets on June 1, 2010 and will be effective with respect to stockholders of record at the close of business on May 28, 2010. As a result of the reverse stock split, each three shares of common stock will be combined into one share of common stock and the number of shares of common stock issued and outstanding or held in treasury will be reduced proportionately based on the reverse stock split ratio of 1-for-3.
NMT Medical, Inc. (NASDAQ: NMTI) announced today at EuroPCR 2010 that it launched its RT2 Delivery System, a pivotal breakthrough in septal implant delivery.
The RT2 Delivery System is a rapid transport enhancement that is pre-attached to NMT’s BioSTAR and STARFlex implants. The delivery system is designed to allow physicians to easily set the implant to conform to a patient’s individual anatomy and avoid septal distortion and unnecessary repositioning.
NovaBay Pharmaceuticals, Inc. (NYSE Amex:NBY), a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, today announced the completion of enrollment in a Phase 2a proof-of-concept trial for the treatment of impetigo. Impetigo is a highly contagious skin infection afflicting more than 1 million people annually in the United States, primarily children and infants.
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) today announced that it has opened enrollment in its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The Company had previously received approval from the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct the trial in those countries, respectively. Oncolytics intends to conduct the first stage of the trial at approximately 25 centres in the U.S., U.K., and Belgium but may elect to add centres in additional countries.
Vical Incorporated (Nasdaq:VICL) announced today that the company is collaborating with leading pediatric infectious disease researchers Stuart P. Adler, M.D., and Michael A. McVoy, Ph.D., of Virginia Commonwealth University (VCU) under a five-year, approximately $4.0 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The grant will support development and animal testing of novel vaccine approaches designed to protect women of child-bearing potential from infection with cytomegalovirus (CMV). Vical will produce the DNA vaccines and Vaxfectin adjuvant, and will conduct the animal studies funded by the grant.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Andrew R. Blight, Ph.D., Chief Scientific Officer, has been invited to deliver the G. Heiner Sell Memorial Lecture at the opening plenary session of the American Spinal Injury Association (ASIA) 36th Annual Scientific Meeting on May 26, 2010.
Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, invites common stock shareholders and other interested parties to the 2010 Advaxis Annual General Meeting of shareholders (AGM).
AMRI (NASDAQ: AMRI) today announced that it is repositioning itself to meet a continued shift in demand from customers for services in Asia and Europe.
Biogen Idec (NASDAQ: BIIB) will join the global multiple sclerosis (MS) community to commemorate the second annual World MS Day. Biogen Idec is a leader in the fight against MS, bringing hope to the thousands of patients across the globe who benefit from the company's MS therapies and ongoing research programs.
Biostar Pharmaceuticals, Inc. (Nasdaq: BSPM), the Xianyang-based manufacturer of a leading over-the-counter Hepatitis B medicine, Xin Aoxing Oleanolic Acid Capsule, and a variety of pharmaceutical products and medical nutrients, today announced that it has commenced assembly of its production line for its proprietary Zushima product.
Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is the first treatment approved in the United States specifically to treat patients with late-onset Pompe disease.
Hop-on, Inc. (PINKSHEETS: HPNN) announced today that, in conjunction with USAcig, Inc. (http://www.usacig.com/), the Company has shipped thousands of units of its disposable version of The Electric Cigarette™ to 600 grocery, liquor and variety stores in the State of Michigan.
Incyte Corporation (Nasdaq:INCY) announced that Wendy Dixon, Ph.D., former Chief Marketing Officer and President, Global Marketing at Bristol-Myers Squibb Company (BMS), has joined Incyte's board of directors.
Kinetic Concepts, Inc. (NYSE:KCI), a global medical technology innovator and worldwide leader in pressure ulcer therapy and prevention, has partnered with Wounds International to issue a landmark publication that shares the latest insights from global experts on the etiology and the treatment of pressure ulcers.
La Jolla Pharmaceutical Company (OTCBB: LJPC) announced today that the Company has entered into definitive agreements with institutional investors and affiliates for a private placement of common stock, convertible preferred stock and warrants to purchase convertible preferred stock totaling up to $16.3 million in gross proceeds.
MMR Information Systems, Inc. (OTCBB:MMRF) announced today that Fred Middleton, Managing Director of Sanderling Ventures, and Ivor Royston, M.D., Founding Managing Member of Forward Ventures and a co-founder of IDEC Pharmaceuticals (now Biogen Idec), have joined MMR's Board of Advisors in order to advise Chairman and CEO Robert H. Lorsch on the strategy for maximizing the value of the Company's biotech assets for the benefit of MMR's shareholders.
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Temazepam Capsules USP, 7.5 mg.
Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has completed manufacturing the first batch of its prescription pain reliever, Nyloxin Rx, and has successfully released it for initial marketing-related distribution within the United States.
Omnicare, Inc. (NYSE:OCR), a leading provider of pharmaceutical care for the elderly, today held its Annual Meeting of Stockholders.
Radient Pharmaceuticals Corporation (NYSE Amex:RPC), a US-based pharmaceutical company specializing in the research, development and sales of In Vitro Diagnostic (IVD) cancer tests, is sad to announce the death of RPC board member Edward R. Arquilla M.D. Ph.D.
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today that nineteen research and clinical papers on thymosin beta 4 (Tβ4) have been published in the May 2010 issue of the Annals of the New York Academy of Sciences, volume 1194.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) will host a live audio webcast at the 2010 Citi Investment Research Global Health Care Conference with Eyal Desheh, Chief Financial Officer, Teva Pharmaceutical Industries Ltd., presenting on Thursday, May 27, 2010 in New York.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.