|FDA Advisory Committee Recommends Against Approval of Actavis' Nebivolol/Valsartan; PTC Completes Enrollment of Landmark Trial in DMD|
|By Staff and Wire Reports|
|Tuesday, 09 September 2014 19:18|
Actavis plc (NYSE: ACT) confirmed the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted to recommend against approval of Actavis' New Drug Application (NDA) for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. The committee vote was six to four recommending against approval.
The committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for the fixed-dose combination of nebivolol and valsartan by the fourth quarter of 2014.
"Although we are disappointed in the Committee's recommendation regarding the fixed-dose combination of nebivolol and valsartan, we remain fully committed to supporting the NDA for this important potential new treatment option for patients with hypertension," said David Nicholson, Senior Vice President, Global Brands Research and Development, Actavis. "We remain confident in the safety and efficacy of the combination of these two widely used and well-tolerated treatments, and we look forward to working with the FDA as it completes its review."
Data presented at today's Advisory Committee meeting included phase III efficacy and safety data from the almost 5,000-patient nebivolol/valsartan clinical development program. In the pivotal efficacy study published in The Lancet, the fixed-dose combination (FDC) of nebivolol and valsartan met its primary and key secondary endpoints, demonstrating statistically significant reductions from baseline in diastolic and systolic blood pressure at eight weeks in patients with hypertension versus both nebivolol alone and valsartan alone. The adverse event profile of the fixed dose combination was similar to that observed with the monotherapies and placebo. In addition, a 52-week open-label safety study further supported the favorable long-term safety profile of the nebivolol/valsartan combination.
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced it has completed enrollment of ACT DMD, the Phase 3 confirmatory trial of Translarna™ (ataluren) for patients with nonsense mutation Duchenne muscular dystrophy (nmDMD). Top-line data from the trial is expected in the second half of 2015 and will support further approvals globally, following European approval received earlier this year.
ACT DMD is a 48-week clinical trial designed to confirm the effect of Translarna on ambulation in patients with nmDMD. The primary endpoint is the change in walking distance as measured by the six-minute walk test. The trial has reached full enrollment across 54 sites globally. All patients in the trial are eligible to participate in an open-label extension study, which has already begun enrolling patients who have completed the initial 48 weeks of treatment.
"The enrollment of this trial represents a significant achievement in our efforts to develop disease-modifying treatments that advance the standard of care in DMD and improve the quality of life for patients," stated Dr. Haluk Topaloglu, Dept. of Neurology, Hacettepe Children's Hospital in Ankara, Turkey. "The enormous commitment on the part of patients and their families, advocacy groups, study investigators and PTC Therapeutics should be commended.''
"The completion of enrollment marks an important milestone in the ACT DMD study," stated Stuart Peltz, Ph.D., Chief Executive Officer of PTC Therapeutics. "We utilized the previous results demonstrating Translarna's clinical activity, as well as the natural history data from ours and other studies to optimize the ACT DMD trial design. This study is one of the largest DMD trials ever performed and we believe it is well powered for a successful outcome. We are pleased to reach this important landmark as it brings us one step closer to broadening Translarna's availability to all patients who may benefit."
3D Systems (NYSE:DDD) announced today that it will showcase its clinical capabilities in planning and instrumenting for personalized surgical procedures and patient-specific medical devices at the American Association of Oral and Maxillofacial Surgeons (AAOMS) 96th Annual Meeting in Honolulu, Hawaii from September 11 – 13, 2014. 3DS will display a full range of Medical Modeling solutions for personalized surgery, including VSP® (Virtual Surgical Planning) for orthognathic and reconstructive surgeries, along with ClearView® and OsteoView® anatomical models, used for pre-operative planning and intra-operative surgical guidance.
Accuray Incorporated (Nasdaq:ARAY) announced today that it has been awarded a new, exclusive three-year group purchasing agreement with Premier, Inc., covering the CyberKnife® M6™ and TomoTherapy® HDA™ product portfolios.
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced the completion of an End-of-Phase 2 (EOP2) Meeting with the United States Food and Drug Administration (FDA), for its lead Lm-LLO cancer immunotherapy, ADXS-HPV, for the treatment of recurrent cervical cancer in women.
Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), a leading designer and manufacturer of rapid diagnostic screening and testing products, announced a contract valued at $864,000 for sales of its innovative Tri-Cholesterol "Check" tests in Australia, Singapore, the United Arab Emirates and Oman.
Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), a leading designer and manufacturer of rapid diagnostic screening and testing products, announces that its Executive Chairman, Raymond F. Akers Jr., Ph.D, will present this week at the Rodman & Renshaw 16th Annual Global Investment Conference and the Aegis Capital Corporation 2014 Healthcare and Technology Conference.
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the development of diagnostic and therapeutic interventions for Alzheimer's disease, Parkinson's disease and orphan ophthalmological disorders, today announced positive 15-day non-GLP toxicology data for a single intravitreal administration of MANF in an ocular safety animal model, relevant to MANF's development in ocular diseases, including orphan indications such as Retinitis Pigmentosa.
Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced that data from its recently launched product, DALVANCE™ (dalbavancin) for injection, was presented during the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), which took place in Washington DC from September 5-9, 2014.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Patent and Trademark Office has issued a composition of matter patent (No. 8828440), entitled "Corticosteroids for the Treatment of Joint Pain," which provides coverage for FX006, the company's lead clinical product candidate.
ForceField Energy Inc. (Nasdaq:FNRG), a designer, seller and distributor of energy products and solutions, today announced that management will present a corporate overview and business update at the Aegis Capital Corp. 2014 Healthcare & Technology Conference at 10:45 am PT (1:45 pm ET) on Thursday, September 11, 2014, at The Encore at Wynn in Las Vegas.
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced the first patient has been dosed in the GALE-401, or Anagrelide Controlled Release (CR), Phase 2 Clinical Trial.
HealthEquity, Inc. (Nasdaq:HQY), a leader and an innovator in technology-enabled healthcare saving and spending platforms, today announced financial results for its second quarter ended July 31, 2014.
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, announced today that the Inogen One G3 portable oxygen concentrator has received coverage for reimbursement within France.
Intuitive Surgical, Inc. (Nasdaq:ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 43 new employees. Pursuant to NASDAQ Marketplace Rule 5635(c)(4), the equity awards were granted under the Intuitive Surgical, Inc. 2009 Commencement Incentive Plan, which the Board of Directors of Intuitive Surgical, Inc. adopted for the granting of equity awards to new employees.
Marrone Bio Innovations, Inc. (MBI), (Nasdaq:MBII), a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, today announced that Scott Peoples has joined the company as its Vice President of Marketing.
Myriad Genetics, Inc. (Nasdaq:MYGN) today presented results from a pivotal clinical utility study of the Myriad myPath™ Melanoma test at the 2014 College of American Pathologists (CAP) annual meeting in Chicago, Ill.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, announced today that the Company and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), will present at multiple upcoming conferences in September.
Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, announced today that data from the IMPACT study, a phase II clinical trial evaluating Squalamine eye drops (OHR-102) for the treatment of the wet form of age-related macular degeneration (wet AMD), will be presented in two separate sessions at the Retina Society 47th Annual Scientific Meeting, being held in Philadelphia, Pennsylvania from September 11-14, 2014.
Quotient Limited (Nasdaq:QTNT), a commercial-stage diagnostics company, today announced the appointment of Heino von Prondzynski to the Company's Board of Directors.
RedChip Companies, Inc., an international small-cap research, investor relations, and media company, today announced that "The RedChip Money Report: Small Stocks Big Money"™ television program will feature three companies on Fox Business nationwide on Tuesday, September 9 at 10:00 p.m. Pacific (1 a.m. EDT).
Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that it has entered into a multi-year commercial manufacturing and supply agreement with Patheon, Inc. for finished product manufacture of patiromer, Relypsa's novel polymer in development for the treatment of hyperkalemia.