Astra and Pozen get European backing for Vimovo. ALXA gets response letter from FDA Print E-mail
By Mary Davila   
Monday, 11 October 2010 15:10

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 11, 2010.


More safety studies needed for ALXA- Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA - News) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato® loxapine), submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg.  

A CRL is issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form.  AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.

In the CRL, the FDA stated that their primary clinical safety concern was related to data from the three Phase 1 pulmonary safety studies with AZ-004.  This concern was primarily based on observed, dose-related post-dose decreases in forced expiratory volume in one second, or FEV1, a standard measure of lung function, in healthy subjects and in subjects with COPD and asthma.  

The agency also noted that decreases in FEV1 were recorded in subjects who were administered device-only, placebo versions of AZ-004.  Alexza intends to meet with the FDA in the near future to discuss steps to address this FDA concern.  As Alexza has previously reported, there were no serious or severe respiratory adverse events in these trials or reported in the two Phase 3 clinical trials of AZ-004.  All respiratory symptoms that developed after treatment in the Phase 1 subjects with COPD and asthma were either self-limiting or readily managed with an inhaled bronchodilator.


Astra and Pozen get European backing for Vimovo - AstraZeneca PLC and Pozen Inc. say their osteoarthritis drug Vimovo has received backing for market approval in 23 countries in the European Union.

The two companies said Monday that the drug is indicated for the treatment of osteoarthritis, rheumatoid arthritis and a type of arthritis of the spine called ankylosing spondylitis. The 23 countries will now pursue pricing agreements and national approvals for the drug.

Vimovo has already been approved for use in the United States.

The drug is a combination of naproxen, a common painkiller, and esomeprazole magnesium, which is the active pharmaceutical ingredient in the heartburn drug Nexium.


Also Monday:


Access Pharmaceuticals, Inc. (OTC:ACCP), a biopharmaceutical company specializing in products for cancer and supportive care, announced the highlights from a poster presentation on European clinical experience of MuGard at this year's European Society of Medical Oncology Conference in Milan, Italy.  

Agilent Technologies Inc. (NYSE:A) today introduced the SurePrint G3 Human CGH+SNP microarray platform, an innovative system for simultaneous analysis of chromosomal copy number changes and copy-neutral aberrations.

Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA) announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato® loxapine), submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg.

Alphatec Holdings, Inc. (NASDAQ:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced the appointment of Michael O'Neill, FCMA, as the Company's Chief Financial Officer, Vice President and Treasurer, effective October 11, 2010.

The Amergence Group (OTC:AMNG), a company that focuses on developing, nurturing, and rapidly expanding selected emerging or "disruptive" companies across a wide range of industries and disciplines, announced the terms and additional detail of its successful acquisition of Altitude Organic Licensing Corporation (AO) which is headquartered in Denver, Colorado.

Amgen (Nasdaq:AMGN) announced results from two integrated analyses of head-to-head pivotal Phase 3 trials comparing denosumab to Zometa® (zoledronic acid), the current standard of care in the prevention of skeletal related events (SREs) in patients with advanced malignancies involving bone.

Auxilium Pharmaceuticals, Inc. (Nasdaq:AUXL), a specialty biopharmaceutical company, announced the first subject has been dosed in the global phase III program of XIAFLEX® for the treatment of Peyronie's disease.

AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based drugs, announced data presentations for AVI-4658, the Company's investigational exon skipping therapy for the treatment of Duchenne muscular dystrophy, at the 15th International Congress of the World Muscle Society taking place Oct. 12-16, 2010 in Kumamoto, Japan.

BioTime, Inc. (NYSE:BTIM), Cell Cure Neurosciences Ltd., and Hadasit Bio-Holdings Ltd. jointly announced Cell Cure and Teva Pharmaceutical Industries Ltd. have entered into an exclusive license option agreement to develop and commercialize Cell Cure's OpRegenTM product for the treatment of age-related macular degeneration (AMD).

Brocade (Nasdaq:BRCD) announced the Saudi Arabia based Al-Nahdi Medical Company (NMC), a leading pharmacy retailer in the Middle East and North Africa region, has selected Brocade as its solution provider of a high-performance IP network to connect all of the company’s 487 pharmacies to a centralized data center running tier-one applications.

China-Biotics, Inc. (Nasdaq:CHBT), the leading developer, manufacturer and distributor of probiotics products in China, announced its management will attend the BNP Paribas 17th Annual China Conference on October 13-15 in Guilin, China.

The Clorox Company (NYSE:CLX) has released its first corporate responsibility (CR) report, which shares the company's formal CR strategy and commitments across five pillars: Performance, Products, People, Planet and Purpose.

CytoSorbents Corporation (OTC:CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, was chosen to present at the AdvaMed 2010 MedTech Conference at the Walter E. Washington Convention Center in Washington, D.C. next week.

DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the signing of an Enterprise Agreement for three new Phase III oncology studies with an existing client.

Diagnostic Imaging International Corp. (OTC:DIIG), owns and operates CTS, a Teleradiology company, announced its estimated preliminary revenues for the third quarter ended September 30, 2010.

Dynavax Technologies Corporation (NASDAQ:DVAX) said Dr. William L. Heyward, Vice President, Clinical Development, will make an oral presentation of new data from a subset of diabetes subjects evaluated as part of the company's previously reported multicenter, observer-blinded phase 3 study.

Eli Lilly and Company (NYSE:LLY) announced today that its global Phase III trial evaluating ALIMTA® (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) did not meet its primary endpoint for overall survival. Data were presented for the first time today at the 35th Annual Meeting of the European Society for Medical Oncology (ESMO).

Enzo Biochem, Inc. (NYSE: ENZ), will hold a conference call to discuss fiscal 2010 fourth quarter and year-end results on Friday, October 15, 2010, at 8:30 AM ET.

Exelixis, Inc. (NASDAQ:EXEL) announced it has entered into two new collaboration agreements with Bristol-Myers Squibb Company (NYSE:BMY).

Express Scripts, Inc. (Nasdaq:ESRX)
, is now able to accurately predict up to a year in advance which patients are most at risk of falling off their physician-prescribed drug therapy — and to intervene in customized ways to improve those patients' adherence.

Generex Biotechnology Corporation (Nasdaq:GNBT) announced it plans to initiate a rights offering of common stock and warrants to its existing stockholders in the event the stockholders approve a reverse stock split at the reconvened special meeting of stockholders scheduled for 10 a.m. EDT on Friday, October 15, 2010.

Genesis Biopharma, Inc. (OTC:GNBP), a biotechnology company developing targeted cancer therapies, announced President and CEO Robert Brooke will present a company overview during Precision IR's Informed Investors Forum Biotech, Healthcare & Pharma Virtual Conference.  

ImmunoGen, Inc. (Nasdaq:IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics using its Targeted Antibody Payload (TAP) technology, announced the presentation of encouraging clinical data for the Company’s lorvotuzumab mertansine (IMGN901) targeted anticancer compound at the 35th European Society for Medical Oncology (ESMO) Conference being held in Milan, Italy, October 8-12, 2010.

Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) announced the U.S. Food and Drug Administration (FDA) has sent the company a complete response letter (CRL) regarding the company's New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia.

JC Data Solutions (OTC:JCDS), a provider of innovative and cost-effective solutions for digital office workflow and data management focusing on the Oil & Gas, Legal and Healthcare industries, has entered into an agreement to provide their Payment Manager™ services to Legacy Reserves, LP of Midland, TX.

Kraig Biocraft Laboratories, Inc. (OTC:KBLB) announced numerous financial websites experienced a temporary disruption in their Company related data stream last Thursday, October 7, 2010.

ImmunoGen, Inc. (Nasdaq:IMGN), a biotechnology company that develops targeted antibody-based anticancer products, announced it will host a conference call at 8:30 am ET on Monday, October 11, 2010 to discuss the Company's new collaboration announced this morning and its updated financial guidance for ImmunoGen’s fiscal year ending June 30, 2011.

Generex Biotechnology Corporation (Nasdaq:GNBT) announced it has entered into a definitive agreement to acquire a majority interest (51%) in Global Medical Direct, LLC ("GMD") of Lenexa, Kansas, a nationwide Durable Medical Equipment and Pharmaceutical provider specializing in direct-to-consumer diabetes supplies and medications (www.globalmeddirect.com).

NuPathe Inc. (NASDAQ:PATH), a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, announced the completion of two recently completed Zelrix pharmacokinetic trials and a tolerability trial. Zelrix is a single-use, transdermal sumatriptan patch in development for the treatment of migraine.

Ogilvy CommonHealth Worldwide, a WPP (NASDAQ:WPPGY) company, representing the largest assembly of creative talent in the world of healthcare communications, announced the network has won a total of 31 awards in the 24th Annual Rx Club Awards.

PowerSafe Technology Corporation (OTC:PSFT) announced its wholly owned subsidiary Amplification Technologies Inc. (ATI) (www.ampti.net) has successfully completed its research contract with Lockheed Martin awarded in April '10.

Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) today announced that it is partnering with the Child Neurology Foundation (CNF) in support of the 2nd annual Infantile Spasms (IS) Awareness Week, which will take place October 11-17, 2010, in conjunction with the Child Neurology Society (CNS) Annual Meeting in Providence, Rhode Island.

Roche Molecular Systems, Inc. (OTC:RHHBY) and the German Cancer Research Center (DKFZ) announced they have entered into a research collaboration to enable more specific prediction of a woman's risk for developing cervical cancer.

ImmunoGen, Inc. (Nasdaq:IMGN)
, a biotechnology company that develops targeted antibody-based anticancer products, announced updated guidance for the Company’s fiscal year ending June 30, 2011.

Savanna East Africa, Inc. (OTC:NVAE) has released an on-demand Webcast providing a corporate update and previewing the Company's plans for the fourth calendar quarter of 2010.

Seattle Genetics, Inc. (Nasdaq:SGEN) reported data from a phase I clinical trial of SGN-75 in patients with non-Hodgkin lymphoma or renal cell carcinoma (RCC).

Shire plc (NASDAQ:SHPGY), the global specialty biopharmaceutical company, announced Philip J. Vickers, PhD, has been appointed Senior Vice President of Research & Development (R&D) for its Human Genetic Therapies (HGT) business.

SMART Modular Technologies, Inc. (NASDAQ:SMOD), a leading independent manufacturer of memory modules and solid-state storage products, announced the Xcel-100 solid-state drive (SSD) for mission-critical defense and industrial applications.

Spencer Pharmaceutical Inc. (OTC:SPPH) announced the official launch of its website with added investor relations tools.

Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), announced positive top-line results from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30.

Stellar Pharmaceuticals Inc. (OTCBB:SLXCF) is pleased to announce the Company has completed a non-brokered private placement consisting of 1,000,000 units of the Company ("Units") at a price of US$1.00 per Unit for gross proceeds of US$1,000,000.

Talecris Biotherapeutics Holdings Corp. (Nasdaq:TLCR) will issue its third quarter 2010 earnings release before the market opens on October 28, 2010.

Trinity Biotech plc (NASDAQ: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, will report financial results for the third quarter of 2010 on Wednesday, October 20, 2010.

Unity Management Group, Inc. (OTC:UYMG), a Health Resource Company specializing in Physician and Hospital Practice Management, Medical Discount Plans, Business Services, Billing Software and Technologies.

Waters Corporation (NYSE:WAT) will webcast its Q3 2010 financial results conference call live on Tuesday, October 26th at 8:30 a.m. eastern time. To listen to the conference call connect to Waters' website, www.waters.com choose "Investors" and click on the Live Webcast.

Weikang Bio-Technology Group Co., Inc. (OTC:WKBT), a leading developer, manufacturer and marketer of Traditional Chinese Medicine (TCM), Western prescription and OTC pharmaceuticals and other health and nutritional products in the People's Republic of China, announced the Company is reiterating its fiscal 2010 revenue guidance of $55 million, net profit of $21 million and earning per share of $0.75.

WuXi PharmaTech (NYSE:WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, extended its congratulations to Dr. Richard Heck, Dr. Ei-ichi Negishi, and Dr. Akira Suzuki on winning the 2010 Nobel Prize in Chemistry.




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