|Orexigen® Announces Agreement From the FDA on a Special Protocol Assessment; Acorda Announces Launch of Generic Version of ZANAFLEX|
|By Staff and Wire Reports|
|Monday, 06 February 2012 19:41|
Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Contrave® outcomes trial. On January 31, 2011, the Company received a Complete Response Letter to its New Drug Application (NDA) noting a single approval deficiency related to cardiovascular safety, requiring Orexigen to conduct a randomized, double-blind, placebo-controlled cardiovascular outcomes trial prior to approval. The objective of the trial is to demonstrate that Contrave does not unacceptably increase the risk of major adverse cardiovascular events (MACE). The Company plans to initiate the Contrave outcomes trial late in the second quarter of 2012.
"We are pleased to receive agreement on the SPA from the FDA after just one cycle of review," said Michael Narachi, President and CEO of Orexigen. "A few months ago, we received detailed written correspondence from the FDA's Director of the Office of New Drugs that identified a clear and feasible path forward for this important potential obesity therapy. We believe the rapid progress we have since made with the FDA's Division of Metabolic and Endocrinologic Products on the detailed protocol and plans for analysis is further indication of the alignment we have reached within the FDA on the requirements for resubmission of the Contrave NDA."
As previously outlined, approximately 10,000 patients will be enrolled in this streamlined trial which is focused on capturing infrequent MACE events. An interim analysis and NDA resubmission is planned once approximately 87 MACE events have occurred, which is anticipated to be less than two years from the start of the trial. If marketing approval is received for Contrave, the trial will continue toward the final analysis in the post-approval setting.
The Company plans to provide more details on the trial design and protocol on its fourth-quarter and year-end 2011 conference call in early March.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced the Company has partnered with Watson Pharma, Inc., a subsidiary of Watson Pharmaceuticals, Inc. (NYSE: WPI) to introduce tizanidine hydrochloride capsules, an authorized generic version of ZANAFLEX CAPSULES® (tizanidine hydrochloride).
Tizanidine hydrochloride capsules is a short-acting drug indicated for the management of spasticity. Because of the short duration of effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important.
Acorda will receive a royalty from Watson based on product sales. Additional terms of the agreement have not been disclosed.
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that it will present at the 14th Annual BIO CEO & Investor Conference on Monday, February 13, 2012, at 9:30 a.m. Eastern Time at The Waldorf=Astoria Hotel in New York City.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the Company has partnered with Watson Pharma, Inc., a subsidiary of Watson Pharmaceuticals, Inc. (NYSE: WPI) to introduce tizanidine hydrochloride capsules, an authorized generic version of ZANAFLEX CAPSULES® (tizanidine hydrochloride).
AdCare Health Systems, Inc.(NYSE Amex: ADK), a nursing home and assisted living company, has been invited to present at the UBS 22nd Annual Global Healthcare Services Conference.
Alkermes plc (NASDAQ: ALKS) announced today that its corporate presentation will be webcast live at the 14th Annual BIO CEO & Investor Conference on Monday, February 13, 2012, at 2:30 p.m. EST (7:30 p.m. GMT) from the Waldorf=Astoria Hotel in New York City.
Amyris, Inc. (NASDAQ: AMRS) announced today that it will provide an investor update regarding its progress and near term goals on a conference call commencing after market close on Thursday, February 9, 2012, starting at 5:00 p.m. Eastern Standard Time.
Anacor Pharmaceuticals (NASDAQ: ANAC) announced today that its partner GlaxoSmithKline (GSK) has voluntarily paused enrollment in its current clinical trials of GSK2251052 (GSK ‘052) due to a recently identified microbiological finding in a small number of patients in the Phase 2b trial of GSK ‘052 for the treatment of complicated urinary tract infections (cUTI).
Astex Pharmaceuticals, Inc. (NASDAQ:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced that James S.J. Manuso, PhD, chairman and chief executive officer, will present at the following conferences: BIO CEO & Investor Conference in New York on February 14th at 11:30 am ET and Citi Global Health Care Conference in New York on February 29th at 11:30 am ET.
BASi (NASDAQ:BASI) has opened its new Discovery Center, located at its corporate headquarters in the Purdue Research Park of West Lafayette.
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced that its fourth quarter and full year 2011 financial results will be released on Thursday, February 16, 2012.
BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today it has signed a worldwide, exclusive license agreement with Genoscience and RFS Pharma to develop and commercialize BL-8030, an orally available treatment for Hepatitis C.
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced results of its 30 patient Canadian Augment® Rotator Cuff Graft clinical trial. The goal of the randomized (2:1), controlled study was to assess the safety and performance of Augment Rotator Cuff for primary surgical treatment of full thickness rotator cuff tears as compared to standard surgical repair (suture alone).
Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that an article was published in HemOnc Today, reporting on the promise of Biovest’s BiovaxID® personalized cancer vaccine for the treatment of non-Hodgkin’s lymphoma, an incurable form of blood cancer.
Cerus Corporation (NASDAQ:CERS) announced today that William “Obi” Greenman, president and chief executive officer, is scheduled to present a corporate update at the 14th Annual BIO CEO & Investor Conference in New York at 10:30 AM ET on Monday, February 13, 2012.
Clovis Oncology, Inc. (Nasdaq: CLVS) today announced that Company management will present at the Leerink Swann Global Healthcare Conference on Wednesday, February 15, 2012 at 1:30 PM Eastern Time and the Citi 2012 Global Health Care Conference on Wednesday, February 29, 2012 at 8:30 AM Eastern Time.
Compugen Ltd. (NASDAQ: CGEN) announced today that Dr. Anat Cohen-Dayag, Compugen's President and CEO, is scheduled to present at the upcoming BIO CEO & Investor Conference 2012 at 10:00 AM (Eastern Time) on Monday, February 13, 2012 at the Waldorf Astoria Hotel in New York City.
CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced that President and Chief Executive Officer Steven A. Kriegsman and Vice President of Business Development David Haen will provide a business update at the 14th Annual BIO CEO & Investor Conference on Tuesday, February 14, at 11:30 a.m. Eastern time (8:30 a.m. Pacific Time).
DHS Holding, Co. (PINKSHEETS: DHSM) has announced today that SalesKing.com, acquired in 2011, is expanding their business model to include GPS-based marketing solutions.
Exact Sciences Corp. (Nasdaq: EXAS) will make its presentation at the UBS 22nd Annual Healthcare Services Conference at 4 p.m. ET on Feb. 7 and not 3 p.m. ET, as previously announced.
Idera Pharmaceuticals (Nasdaq: IDRA) today announced that Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer, is scheduled to present at the 14th Annual BIO CEO & Investor Conference on February 13th at 10:30 am ET.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it will be participating in the 14th Annual BIO CEO & Investor Conference on Monday, February 13, 2012, at 3:00 p.m. ET and in the 2012 Citi Global Healthcare Conference on Monday, February 27, 2012, at 11:00 a.m. ET.
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today provided an update on the development program for suvorexant, the company's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR"), a leading provider of Personal Health Records ("PHR"), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced its global lineup at the annual HIMSS Conference and Exhibition, February 21-24, 2012, in Booth #2062.
Novelos Therapeutics, Inc. (OTCBB: NVLT), a pharmaceutical company developing novel drugs for treatment and diagnosis of cancer, today announced that Harry S. Palmin, President and CEO of Novelos, will present a corporate update at the 14th Annual BIO CEO & Investor Conference on Monday, February 13, 2012.
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that its President and CEO, Dr. Paul Ashton, will present an update on pSivida at the 14th Annual BioCEO & Investor Conference, being held at the Waldorf-Astoria Hotel in New York, Monday and Tuesday, February 13 and 14.
SDIX (NASDAQ: SDIX), a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic and food safety applications, and BD Diagnostics, a segment of BD (Becton Dickinson and Company), a leading global medical technology company, today announced the signing of a comprehensive agreement whereby the two companies will collaborate in the development of a microbiology detection solution.
SurModics, Inc. (Nasdaq:SRDX), a leading provider of surface modification and in vitro diagnostic technologies to the healthcare industries, today announced results for its fiscal 2012 first quarter.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that the Company will be presenting at the 2012 Biotechnology Industry Organization CEO & Investor Conference on Monday, February 13 at 9:30 am (ET) in New York.