FDA Panel: Teva's Azilect Doesn't Slow Disease; NeoStem Acquires Amorcyte Print E-mail
By Staff and Wire Reports   
Monday, 17 October 2011 18:41
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 17, 2011.

A federal advisory panel said clinical data wasn't strong enough to show Teva Pharmaceutical Industries Ltd.'s (NASDAQ:TEVA) Parkinson's disease drug Azilect, currently approved in the U.S., slows the progression of the disease.  The FDA usually follows the advice of its panels but isn't required to do so.

In a review of Azilect prepared for the meeting, one FDA medical reviewer wrote, "there is no demonstrated benefit of rasagiline (Azilect) for slowing the rate of progression of Parkinson's disease."

Teva is seeking FDA approval to market the product to slow the clinical progression the neurodegenerative illness.  However, the panel of non-FDA medical experts unanimously voted against approval of the product as a drug to alter disease course. The panel vote won't impact Azilect's current status as a Parkinson's disease treatment.

Several doctors on the advisory panel said there was some evidence in clinical studies of Azilect showing it might slow the progression of Parkinson's disease.

Teva said data from two clinical studies involving Azilect showed that a 1-milligram dose of the drug resulted in a reduction of a score that measures disease progression.

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NeoStem Inc (AMEX:NBS) and Amorcyte Inc. announced the closing of their previously announced merger transaction following approval by the shareholders of both companies on October 14, 2011.

NeoStem, which closed on a financing raising $16.5 million in gross proceeds on July 22, 2011, intends to initiate, no later than the first quarter of 2012, a Phase 2 clinical trial for Amorcyte's lead product candidate, AMR-001, for the treatment of acute myocardial infarction(AMI).

Pursuant to the terms of the Merger Agreement, NeoStem issued 5,843,483 shares as the base stock consideration; will issue up to 4,092,768 shares of common stock upon the achievement of certain specified business milestones; issued warrants to purchase 1,881,008 shares of common stock exercisable over a seven year period at a price of $1.466 per share; and upon the successful commercialization of AMR-001 will pay certain earn out payments on sales.

The shares of common stock issued and underlying the warrants are subject to certain transfer restrictions.


Also Monday:


Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company, announced that they have been informed by Pfizer, Inc. (NYSE: PFE) that Pfizer has commenced executing its commercialization plan for OXECTA® (oxycodone HCl, USP) Tablets CII in the United States.

AdCare Health Systems, Inc.(NYSE Amex: ADK), a leading skilled nursing and assisted living provider, has signed a definitive purchase agreement for five skilled nursing facilities in Oklahoma for $16 million.

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, today announced that Tom Moore, Chairman and Chief Executive Officer, will present at the 10th Annual BIO Investor Forum on Tuesday, October 25th in San Francisco.

ALR Technologies Inc., (OTCBB: ALRT) (the "Company"), a healthcare technology company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Health-e-Connect (HeC) System for remote monitoring of patients in support of effective diabetes management programs.

Anadys Pharmaceuticals, Inc. (NASDAQ: ANDS) today announced that it has entered into a definitive merger agreement to be acquired by Roche (SIX: RO, ROG; OTCQX: RHHBY).

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will host a live webcast of its quarterly conference call at 8:30 a.m. (ET) on Thursday, November 3, 2011. Harvey J. Berger, M.D., chairman and chief executive officer, will host the call.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that Stephen M. Simes, BioSante’s president & CEO will present at two healthcare conferences in October.

China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP)
("China Botanic" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ("TCM") in China, today announced the results of its annual general meeting of stockholders ("Annual Meeting") held on Saturday, October 15, 2011 in Harbin, China.

CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company working to save lives through blood purification, announced the launch of its HemoDefend purification technology platform for use in blood transfusion applications.

Dendreon Corporation (Nasdaq: DNDN) today announced that the company has begun enrolling patients into a Phase 2 trial for DN24-02, Dendreon’s investigational active cellular immunotherapy being evaluated for the treatment of HER2 positive cancer.

Elan Corporation, plc (NYSE: ELN) announced today the expiration and final results of the previously announced offers to purchase of the senior notes issued by Elan’s wholly-owned subsidiaries, Elan Finance public limited company (“Elan Finance”) and Elan Finance Corp. (“Elan Finance Corp.” and, together with Elan Finance, the “Co-Issuers”).

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced updates to its development program for IPI-926, including that the company has completed enrollment of its Phase 2 trial of IPI-926 in patients with previously untreated pancreatic cancer.

IntelliCell BioSciences, Inc. (OTCQB: SVFC) (PINKSHEETS: SVFC) ("IntelliCell" or the "Company"), a leader in regenerative medicine and the manufacturing of stromal vascular fraction (SVF) containing adipose derived adult stem cells, announced today it has appointed media veteran, Jack Schneider to its Board of Advisors.

Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based antibody therapeutics, has initiated dosing in its Nexus clinical trial, in which iSONEP™ is being investigated as a treatment for wet AMD (age-related macular degeneration).

MMRGlobal, Inc. (OTCBB: MMRF) today announced that it has entered into an agreement with UST Global®, a leading provider of IT services and solutions for Fortune 500 and Global 1000 enterprises, to offer its unique MyMedicalRecords Personal Health Record (PHR) to UST Global's clients and strategic partners including some of the largest healthcare providers, payers and pharmacy retailers in the world. MMR is also providing 1,500 UST employees in the U.S. PHRs (www.mmrvideos.com) under the company's employee benefit program.

NeoStem, Inc. (NYSE Amex: NBS) ("NeoStem" or the "Company"), an international biopharmaceutical company with a focus on cell-based therapeutic development, and Amorcyte Inc., a development stage cell therapy company focusing on novel treatments for cardiovascular disease, announced today the closing of their previously announced merger transaction following approval by the shareholders of both companies on October 14, 2011.

Christopher Henney, Chairman of the Board of Oncothyreon Inc. (Nasdaq: ONTY) and of Anthera Pharmaceuticals (Nasdaq: ANTH) and Vice Chairman of the Board of Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC), received this year's Hall of Fame - special recognition of outstanding individual contributions award at the annual Biotech CEO Meeting at Laguna Beach.

Oncothyreon Inc. (Nasdaq: ONTY) announced today that the company will be presenting at the BioCentury NewsMakers in the Biotech Industry Conference in New York on Friday, October 21, 2011 at 8:30 a.m. Eastern time.

PROTEONOMIX, INC. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announced today that it has decided to examine the possibility of licensing its stem cell diabetes related technology to another company in light of continued progress toward its trial of UMK-121, its stem cell treatment for patients awaiting liver transplant to overcome End Stage Liver Disease ("ESLD").

Ushering in a new era in the treatment of spinal cord injuries (SCI), InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), announced today that world-renowned spinal cord injury (SCI) researcher Edward Wirth, M.D., Ph.D., will join InVivo as its Chief Science Officer (CSO) effective December 5, 2011.

Marijuana, Inc. (PINKSHEETS: HEMP) is proud to announce that after over two years in the development, and the funding, costing over $1.2 million dollars, it has completed the Eco-Harmony Loyalty Benefits and Rewards Card, targeting the cultural creative merchants and the cultural creative consumers from a wide variety of industries.

Oncothyreon Inc. (Nasdaq: ONTY) announced today that the company will be presenting at the BioCentury NewsMakers in the Biotech Industry Conference in New York on Friday, October 21, 2011 at 8:30 a.m. Eastern time.

Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced that its wholly-owned subsidiary, Sequenom Center for Molecular Medicine (Sequenom CMM),  launched its noninvasive proprietary MaterniT21 laboratory developed  test (LDT).

VIVUS, Inc. (NASDAQ: VVUS) today announced that the company has resubmitted the New Drug Application (NDA) for Qnexa® to the U.S. Food and Drug Administration (FDA).



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