Teva to Initiate Third Phase III Trial of Oral Laquinimod; Amgen Ends Ganitumab Study Print E-mail
By Staff and Wire Reports   
Wednesday, 08 August 2012 18:46
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 8, 2012.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
and Active Biotech (NASDAQ OMX NORDIC: ACTI) provided an update on the clinical development program of once-daily oral laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS). The companies are to initiate a third Phase III study of laquinimod, following the written agreement reached with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA).

The third Phase III laquinimod trial CONCERTO will evaluate two doses of the investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months. The primary outcome measure will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).

"The results achieved in the previous Phase III trials of laquinimod support the clinical utility of this compound as a unique treatment option for multiple sclerosis," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer, Teva Pharmaceutical Industries Ltd. "We are encouraged by the FDA's agreement on the trial design and planned analysis, and look forward to further developing laquinimod as a potential treatment option for RRMS patients."


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Amgen (NASDAQ: AMGN)
announced a decision to stop the ganitumab (AMG 479) Phase 3 GAMMA  (Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas) trial following the recommendation of an independent Data Monitoring Committee (DMC) overseeing the trial.  

Based on the review of a pre-planned interim analysis, the DMC concluded that the addition of ganitumab to gemcitabine is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to gemcitabine alone. There were no safety concerns raised in the DMC review of the study.



Also Wednesday:



Abaxis, Inc. (NasdaqGS: ABAX)
, a medical products company manufacturing point-of-care blood analysis systems, announced today that Clint Severson, chairman and chief executive officer, will present at the Canaccord Genuity 32nd Annual Growth Conference on Wednesday, August 15, 2012 at 8:00 a.m. ET.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") will announce its second quarter 2012 financial and operating results after market close on Tuesday, August 14, 2012.

Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL)
today announced that executive management will participate in the Canaccord Genuity 32nd Annual Growth Conference to be held August 14-16, 2012 at the InterContinental Hotel in Boston.

BioMed Realty Trust, Inc. (NYSE: BMR)
today unveiled a new brand identity that highlights the company's commitment to the life science industry by delivering state-of-the-art laboratories and office spaces to meet the unique needs of its tenants.

Biostar Pharmaceuticals, Inc. (NASDAQ GM: BSPM)
("Biostar" or "the Company"), a PRC-based manufacturer and marketer of pharmaceutical and health supplement products in China for a variety of diseases and conditions, today announced that it will establish a call center as its new business to customer ("B2C") sales platform.

Genetic Technologies Limited (ASX: GTG) (NASDAQ: GENE)
announced today that it has received European CE Mark approval for BREVAGen™, the Company's breast cancer risk test.

Gevo, Inc. (NASDAQ: GEVO)
, a leading renewable chemicals and next-generation biofuels company, said today that the latest lawsuit filed by Butamax™ Advanced Biofuels LLC (Butamax) alleging infringement by Gevo of Butamax's U.S. Patent No. 8,222,017 ('017 Patent), like the last one filed by Butamax against Gevo, will be shown to have no merit.  Gevo said it is also challenging the validity of Butamax's '017 Patent.

Home Health International Inc. (PINKSHEETS: HHII)
, a Medicare-certified home health agency and durable medical equipment (DME) supplier, announced today that it is close to completing the initial framework for its home health agency website.

Ingen Technologies, Inc. (PINKSHEETS: IGNT)
, an emerging medical device manufacturer with proprietary medical products for the growing $4B respiratory markets announced today that the company Chairman, Gary B. Tilden, has made the following statements regarding an upcoming acquisition.

Lightlake Therapeutics Inc. (OTCBB: LLTP)
(the "Company" or "Lightlake"), an early stage biopharmaceutical company developing modern addiction treatments based on its expertise using opioid antagonists, announced today compelling final data from a Phase II study of the Company's proprietary opioid antagonist naloxone nasal spray treatment for patients with Binge Eating Disorder (BED).

Medical Marijuana Inc. (OTC: MJNA)
a leading hemp industry innovator, is pleased to announce that Company Director of CanChew Biotechnologies Inc. Dr George E. Anastassov has recently appeared on Small Cap Voice's internet radio network.

Northwest Biotherapeutics (OTCBB: NWBO)
announced today that it is entering into amended agreements to double the production capacity in the U.S. for the manufacture of the Company's DCVax®-L immune therapy for Glioblastoma multiforme (GBM) patients.

Omeros Corporation (NASDAQ: OMER)
today reported the completion of enrollment in the first of two planned Phase 3 clinical trials evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery.

Oncothyreon Inc. (Nasdaq: ONTY)
announced today that management will present at the 2012 Wedbush Pacgrow Lifesciences Management Access Conference in New York on Wednesday, August 15, 2012 at 8:35 a.m. Eastern.

Oncothyreon Inc. (Nasdaq: ONTY)
today announced that it will conduct a conference call on Thursday, August 9, 2012 at 4:30 p.m. Eastern Time to discuss its financial results and related matters and provide a review of its pipeline of products in development.

Quture International, Inc. (OTCQB: TCLN) (PINKSHEETS: TCLN) and its operations subsidiary Quture, Inc. ("Quture") announce that its QualOptima product demonstrations are on target with hospital IT leaders' demands and the urgent needs of senior management for healthcare analytics.

Oxford BioMedica plc (LSE: OXB), the leading gene-based biopharmaceutical company, and its partner Sanofi (EURONEXT: SAN and NYSE: SNY) today announce a positive interim review of the RetinoStat® Phase I study in neovascular "wet" age-related macular degeneration (AMD) and the StarGen™ Phase I/IIa study in Stargardt disease by the Data Safety Monitoring Board (DSMB); an independent panel of specialists in the fields of ophthalmology, virology and vectorology.  RetinoStat® and StarGen™ were designed and developed by Oxford BioMedica using the Company's proprietary LentiVector® gene delivery technology.

Perrigo Company (Nasdaq: PRGO:TASE)
today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for morphine sulfate 100ml/5% oral solution. Perrigo will commence shipment of the product immediately.

Rosetta Genomics Ltd. ("Rosetta") (NASDAQ: ROSG)
, a leading developer and provider of microRNA-based molecular diagnostics, today announced the closing of an underwritten public offering of 5,500,000 ordinary shares at an offering price of $5.00 per share.

Savient Pharmaceuticals, Inc. (NASDAQ: SVNT)
today reported financial results for the three and six months ended June 30, 2012, which reflects the Company's continuing commercialization of KRYSTEXXA® (pegloticase) in the U.S.

Synthetic Biologics, Inc. (NYSE Amex: SYN)
, a developer of synthetic biologics and innovative medicines for unmet medical needs, and Intrexon Corporation (Intrexon), a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, today entered into a second worldwide exclusive channel collaboration through which Synthetic Biologics intends to develop and commercialize a series of monoclonal antibody (mAb) therapies for the treatment of certain infectious diseases not adequately addressed by existing therapies.



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