HAYWARD, Calif., Dec. 14, 2010 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with abnormal auto-immune responses and inflammation, has selected the Merck BioManufacturing Network in the UK, to manufacture the large scale GMP clinical and pre-commercial supplies of A-623, an investigational novel peptibody in development for a number of autoimmune diseases.
"Establishing a rapid and high quality supply of A-623 for our current and future clinical programs is a critical element of our strategic plan and provides a number of potential development options," stated Paul F. Truex, President and Chief Executive Officer of Anthera. "The selection of the Merck BioManufacturing Network provides world-class, large molecule manufacturing capabilities at all stages of production with the necessary expertise to accelerate the development of A-623 in Systemic Lupus Erythematosus and other autoimmune diseases."
Steve Bagshaw, Site General Manager of the Merck BioManufacturing Network, said, "We are delighted that Anthera has chosen to work with us, recognizing our many years of development experience in microbial biologics and our capacity that offers appropriate scales for their manufacturing needs." A-623 will be manufactured in the Billingham, UK facility of the Network.
A-623 is a novel peptibody inhibitor of B-Cell activating factor – a promoter of B-Cell survival in humans. Abnormal levels of soluble and membrane BAFF and resulting B-Cell elevations have been implicated in a number of autoimmune diseases including systemic lupus erythematosus, Sjogren's Syndrome and rheumatoid arthritis. Anthera has previously begun enrollment in PEARL-SC, a Phase 2b clinical study in Lupus patients. The PEARL-SC study (A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A623 AdministRation in Subjects with Systemic Lupus Erythematosus), is designed to demonstrate that inhibition of both membrane bound and soluble BAFF with A-623 will improve patient clinical outcomes as measured by a composite SLE responder index. Lupus patients suffer from an inappropriate, chronic autoimmune response which often leads to severe skin rash, fatigue, joint pain, organ complications and cardiovascular disease.
About B-Cell Activating Factor (BAFF) and A-623
BAFF has been associated with a wide range of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren's Syndrome, Graves' Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on BAFF's potential positive role in treating lupus and rheumatoid arthritis. Anthera is advancing its development of A-623, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. A-623 is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to A-623 in all potential indications.
About Merck BioManufacturing Network
Merck BioManufacturing Network (known outside the USA and Canada as MSD BioManufacturing Network) is a full service CMO providing development and manufacturing services for biologics to pharmaceutical and biotechnology companies. It comprises the operations at Billingham, UK (formerly Avecia Biologics), and at Research Triangle Park, NC, USA (formerly Diosynth Biotechnology). Merck is known as MSD outside USA and Canada. For additional information about Merck BioManufacturing Network, please visit www.biomanufacturingnetwork.com.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as sPLA2. Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease (CAD). Anthera's Phase 2 product candidate, A-623, targets elevated levels of B-lymphocyte stimulator (BAFF) which has been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus). For more information, please visit www.anthera.com.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera's clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera's products through future stages of clinical development. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company's public filings with the Securities and Exchange Commission, including Anthera's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., email@example.com or 510.856.5586.