HALO, Halozyme, BAX, Baxter, announce positive results, 03/22/2013

Baxter And Halozyme Announce Positive Opinion For HyQvia For Treatment Of Primary And Secondary Immunodeficiencies In The European Union

LONDON, March 22, 2013 /PRNewswire/ -- Baxter International Inc. (BAX) and Halozyme Therapeutics, Inc., (HALO) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies. The product is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC.
"This recommendation supports our efforts to improve the overall quality of care for patients. This therapy, when approved by the European Commission, would offer patients the option to administer their therapy at home, in a single subcutaneous site every three to four weeks, resulting in potentially lower systemic adverse reactions compared to intravenous treatments," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. "We look forward to introducing HyQvia as a new patient-friendly therapeutic option for immunodeficient patients."
The application was based on results from a phase III, prospective, open-label, non-controlled design clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of the study was to infuse a 3-or 4-week dose of the therapy in a single subcutaneous site. The acute serious bacterial infection rate in the study was 0.025 per patient per year, which is below the required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In the tolerability assessment of HyQvia, the most frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% of infusions). Upon receiving marketing authorization from the European Commission, Baxter plans to launch HyQvia in selected countries in the European Union later this year.
"Recognizing that the path to approval for any biologic is a long journey, I would like to thank and congratulate the teams at Halozyme and Baxter who have worked tirelessly to advance this therapeutic option for patients," said Gregory I. Frost, Ph.D., president and chief executive officer, Halozyme Therapeutics.
Sources: Baxter, Halozyme, OxBridge Research, Daily Stock Deals

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ANAC, Anacor Pharmaceuticals, announce positive results, 03/22/2013

ANAC, Anacor Pharmaceuticals, announce positive results, 03/22/2013
Anacor Pharmaceuticals Announces Positive Results From Phase 2 Dose-Ranging Study of AN2728 in Adolescents With Atopic Dermatitis



PALO ALTO, Calif.--(BUSINESS WIRE)--
Anacor Pharmaceuticals (ANAC) today announced positive results from a Phase 2 dose-ranging trial (AN2728-AD-204) of its topical boron-based phosphodiesterase-4 (PDE-4) inhibitor, AN2728. The study included 86 adolescents (ages 12 – 17) with mild-to-moderate atopic dermatitis, a chronic rash which predominantly affects children and is characterized by inflammation and itching. In this study, lesions treated with AN2728 ointment, 2.0% twice daily for 28 days achieved a 71% improvement from baseline in their Atopic Dermatitis Severity Index (ADSI) score, with 66% of lesions in this treatment group achieving total or partial clearance. AN2728 was generally safe and well-tolerated. Most adverse events were mild and largely unrelated to study drug.
“These results demonstrate a clear dose response across the four dosing regimens and identify the AN2728 ointment, 2.0% BID dosing regimen as optimal for a Phase 3 program, which we expect to initiate around the end of 2013,” said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. “In all arms of the study, lesions treated with AN2728 ointment improved throughout the 28 day treatment period. The majority of the improvement occurred within the first week of treatment, which is important to both patients and physicians. AN2728 also continues to demonstrate an excellent safety profile - a key factor in treating this disease that primarily affects children.”
“There is a tremendous clinical need for safe and effective treatments for pediatric atopic dermatitis. It is very exciting to see these promising positive data for a novel molecule with excellent anti-inflammatory properties and that appears very safe to use,” said Lawrence F. Eichenfield, M.D., Chief of Pediatric and Adolescent Dermatology and Professor of Pediatrics and Medicine (Dermatology) at Rady Children's Hospital, University of California, San Diego. “AN2728 has the potential to be an outstanding addition to the treatment armamentarium for physicians and a great benefit to children with atopic dermatitis.”

Sources: Anacor Pharma, OxBridge Research, Daily Stock Deals

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