Anthera Enters Into Manufacturing Agreements for Varespladib in Preparation for Pivotal Phase III Trials

SAN MATEO, Calif., Jan. 31 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. today announced it has entered into manufacturing agreements with Albemarle Corporation and Patheon Inc. The agreements provide for the large-scale clinical production of Varespladib (A-002), which is expected to be necessary in preparation for Anthera's Phase III clinical trials and planned New Drug Application submission to the Food and Drug Administration. Varespladib is Anthera's oral drug candidate for the treatment of cardiovascular disease.

Building on the work done by Anthera's licensor, Eli Lilly, Albemarle will be responsible for process optimization and manufacture of cGMP quantities of the API. Patheon will be responsible for finished tablet production. The agreement also provides an option for the commercial production of Varespladib in the future. Financial terms were not disclosed.

"These agreements with Albemarle and Patheon provide Anthera with key supply chain resources for the manufacture of Varespladib," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. "We are pleased to have secured outstanding technical organizations with significant commercial expertise that will contribute to the future success of the Varespladib program."

"We're delighted that Anthera has selected Albemarle as its API manufacturing supplier for its next phase of development," said David Clary, Albemarle Division Vice President of Fine Chemistry Services. "Our relationship with Anthera further demonstrates our proven abilities to support the chemistry and cGMP needs of emerging pharmaceutical companies."

"This agreement with Anthera illustrates our continued progress towards becoming the development and manufacturing partner of choice to global pharmaceutical and biotechnology companies," said Dr. Shabbir Anik, Patheon's President of Global Pharmaceutical Development Services. "We look forward to continuing to work with Anthera on the dosage form development and commercial scale up of Varespladib."

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a privately-held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases and autoimmune disorders. The Company has acquired from Eli Lilly and Company and Shionogi & Co.‚ Ltd. worldwide rights (excluding Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase A2 (PLA2) family -- a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes‚ prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel‚ upstream steps in the inflammation cascade and have the potential to address a variety of diseases. The company has also acquired exclusive and worldwide rights to a peptide fusion protein, A-623, for the treatment of systemic lupus erythematosus (SLE) and other autoimmune diseases from Amgen. For more information, please visit http://www.anthera.com.

Contact: Anne Bowdidge (650) 218-6900

[email protected]

SOURCE Anthera Pharmaceuticals, Inc.

Suggested Articles

All 12 members of an FDA advisory committee voted to recommend the approval of teprotumumab for a rare, autoimmune eye disease.

Early data out of former Fierce 15 winner Gritstone Oncology have been heralded as a big win for the early-stage biotech by analysts.

Biogen will drop work on gosuranemab in progressive supranuclear palsy but continue on in Alzheimer's.