English Court of Appeal Finds in Favor of Teva on Copaxone®; Anacor Submits NDA for Tavaborole Print E-mail
By Staff and Wire Reports   
Monday, 29 July 2013 19:27

Below is a look at some of the headlines for companies that made news in the healthcare sector on July 29, 2013. Teva Pharmaceuticals Industries Ltd (NYSE: TEVA) announced today that the Court of Appeal for England and Wales has found in favor of Teva, upholding the validity of the asserted claims of UK patent 762,888 relating to Copaxone® (glatiramer acetate injection), following an appeal brought by Generics [UK] Limited, a subsidiary of Mylan Laboratories Inc.

In the litigation, Generics [UK] had applied to the court to revoke the patent and also grant a declaration of non-infringement for its purported generic version of Copaxone®. The High Court and the Court of Appeal have now both upheld the validity of the patent and denied the application for a declaration of non-infringement. The patent is not due to expire until May 2015.

Teva's President and CEO, Dr. Jeremy Levin, welcomed the court's decision: “This decision upholding the patent strengthens Teva's exclusivity of Copaxone® in the UK until at least the date of the patent expiry. Thousands of patients in the UK and elsewhere depend on Copaxone® for relief in relapsing-remitting multiple sclerosis, and we are pleased that the English Court of Appeal has upheld the validity of the patent until its expiry in 2015.”

Any potential generic version of COPAXONE® would require a marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) before it could be commercialized.

Given the complexity of COPAXONE®, unpredictable differences between a proposed generic product and COPAXONE® could lead to immunogenic effects in patients. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of COPAXONE® would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in relapsing-remitting multiple sclerosis (RRMS) patients.


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Anacor Pharmaceuticals (NASDAQ: ANAC) announced on July 26, 2013 it submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavaborole, its drug candidate for the topical treatment of onychomycosis.

Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.


Also Monday:

Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, today announces its support for the fact that North Carolina has become the 12th state to pass a dense breast notification law, HB 467, the Breast Density Notification & Awareness bill.

BioLineRx (NASDAQ: BLRX) (TASE: BLRX)
, a biopharmaceutical development company, announced today that it has filed the necessary regulatory submissions to commence a pivotal, CE-Mark registration trial for BL-5010P - for the non-surgical removal of skin lesions - with the German Federal Institute for Drugs and Medical Devices (BfArM), as well as with the relevant ethics committees.

BioMed Realty Trust, Inc. (NYSE:BMR)
today announced it will report results for its second quarter ended June 30, 2013 after the market closes on Tuesday, August 6, 2013.

Bio-Rad Laboratories, Inc. (NYSE: BIO)
and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, today announced the launch of its QX200 Droplet Digital™ PCR (ddPCR) system, the second generation of the company's Droplet Digital™ PCR technology.

BrainStorm Cell Therapeutics (OTCQB: BCLI)
, a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that the European Commission has granted Orphan Drug Designation for NurOwn™, the Company's stem cell therapy consisting of autologous bone marrow-derived mesenchymal stromal cells secreting neurotrophic factors, for the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease.

Goldman Small Cap Research, a stock market research firm focused on the small cap and microcap sectors, notes in a recent article on its website that Nuvilex Inc.'s (OTCQB: NVLX) recent acquisition of all of the oncology-related assets and licenses for the use of a live-cell encapsulation therapy serves as a catalyst to accelerate the research engaged by its subsidiary, Medical Marijuana Sciences, Inc.

HP (NYSE: HPQ) today announced that Orion Health, a New Zealand-based leader in health information exchange (HIE), electronic health records (EHR) and healthcare integration solutions, has selected HP Converged Cloud to support its global managed health services.

Insmed Incorporated (NASDAQ: INSM)
a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, today announced the appointment of Christine A. Pellizzari as General Counsel and Corporate Secretary.

InspireMD, Inc. (NYSE MKT: NSPR)
, a leader in embolic protection stents, said the first patient has been enrolled in the Master II IDE clinical trial to evaluate the safety and effectiveness of the MGuard™ Prime Embolic Protection Stent (EPS) in patients suffering from ST Elevation Myocardial Infarction (STEMI).

LipoScience, Inc.,  (NASDAQ: LPDX)
a diagnostic company pioneering a new field of personalized nuclear magnetic resonance (NMR) diagnostics to advance the quality of patient care in cardiovascular, metabolic and other diseases, today announced an agreement to place the Vantera® Clinical Analyzer within ARUP Laboratories' facilities.

Luminex Corporation (NASDAQ: LMNX)
today announced financial results for the second quarter ended June 30, 2013.  

Mallinckrodt (NYSE: MNK)
today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-795 and granted priority review. MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.

Medistem, Inc. (PINKSHEETS: MEDS)
announced today it has entered into collaboration with Reza Abdi, M.D., Transplant Nephrologist at Brigham and Women's Hospital and Assistant Professor of Medicine, Harvard Medical School.

MMRGlobal, Inc. (OTCQB: MMRF)
welcomes International Music Star Guy Sebastian as MyMedicalRecords' Australian Spokesperson to Los Angeles. MMRGlobal CEO Robert H. Lorsch met with Sebastian to discuss plans to launch a "Don't Worry Be Happy" campaign (www.guysebastian.com.au) to call attention to how the safety and security from having a Personal Health Record (PHR) can prevent worry and help promote a happier healthier lifestyle.

MWI Veterinary Supply, Inc. (NASDAQ: MWIV)
announced financial results today for its third quarter ended June 30, 2013.

Novelos Therapeutics, Inc. (OTCQX: NVLT)
, a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that Harry Palmin, the company's President and CEO and a Director, will step down from his positions with the company, in order to pursue other opportunities, upon the naming of his successor.

pSivida Corp. (NASDAQ:PSDV)
, a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, has announced that pSivida President and Chief Executive Officer, Paul Ashton, Ph.D., will speak today at the International Symposium on Integrated Functionalities 2013 meeting at the Hilton DFW Lakes Executive Conference Center in Grapevine, Texas.

SK3 Group, Inc. (PINKSHEETS: SKTO)
announces that it has obtained licenses for several proprietary technologies for the extraction, purification, and creation of medicines consisting of cannabinoids from hemp and marijuana.

Stereotaxis, Inc. (Nasdaq:STXS)
announced today that it has been granted 510(k) clearance by the Food and Drug Administration (FDA) to market its Vdrive™ Robotic Navigation System with V-Sono™ Intracardiac Echocardiography (ICE) catheter manipulator in the U.S.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS)
today reported financial results for the quarter ended June 30, 2013.

Ventripoint Diagnostics Ltd. (TSX VENTURE:VPT) (OTCQX:VPTDF)
announces that it has completed the second closing of the second of its two previously announced non-brokered private placements.

Viralytics Limited (ASX: VLA; OTC: VRACY)
, an oncolytic virotherapy company developing new drugs to treat a wide range of cancers, today announced that progress in its Phase 2 clinical trial of intratumourally administered CAVATAK™ for the treatment of late-stage melanoma (the CALM study) continues to accelerate with the recent reporting of strong interim results at the 8th World Congress of Melanoma, Hamburg, Germany.

Walgreens (NYSE:WAG) (Nasdaq:WAG)
today introduced its “Healthcare Clinic” at select Walgreens as the new branding for the more than 370 in-store retail clinics, replacing the former Take Care Clinic name that has stood since the brand’s inception in 2004.




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