Medindia
Medindia LOGIN REGISTER
Advertisement

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

Thursday, January 31, 2008 General News
Advertisement
SAN MATEO, Calif., Jan. 31 Anthera Pharmaceuticals, Inc.today announced it has entered into manufacturing agreements with AlbemarleCorporation and Patheon Inc. The agreements provide for the large-scaleclinical production of Varespladib (A-002), which is expected to be necessaryin preparation for Anthera's Phase III clinical trials and planned New DrugApplication submission to the Food and Drug Administration. Varespladib isAnthera's oral drug candidate for the treatment of cardiovascular disease.
Advertisement

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

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

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

"This agreement with Anthera illustrates our continued progress towardsbecoming the development and manufacturing partner of choice to globalpharmaceutical and biotechnology companies," said Dr. Shabbir Anik, Patheon'sPresident of Global Pharmaceutical Development Services. "We look forward tocontinuing to work with Anthera on the dosage form development and commercialscale up of Varespladib."

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a privately-held company committed todeveloping and commercializing clinical pharmaceutical products that addressunmet medical needs of patients with life-threatening, chronic and acuteinflammatory diseases and autoimmune disorders. The Company has acquired fromEli Lilly and Company and Shionogi & Co.? Ltd. worldwide rights (excludingJapan) to a series of clinical and pre-clinical compounds that inhibit theenzymatic activity of members of the phospholipase A2 (PLA2) family -- a groupof enzymes responsible for the release of arachidonic acid and subsequentproduction of leukotrienes? prostacyclins and other mediators of inflammation.These highly potent compounds inhibit novel? upstream steps in theinflammation cascade and have the potential to address a variety of diseases.The company has also acquired exclusive and worldwide rights to a peptidefusion protein, A-623, for the treatment of systemic lupus erythematosus (SLE)and other autoimmune diseases from Amgen. For more information, please visithttp://www.anthera.com.

Contact: Anne Bowdidge (650) 218-6900

[email protected] believes the agreements position the company to: -- Secure a cost-effective, long-term supply of Varespladib active pharmaceutical ingredient (API) and tablets. -- Quickly scale current manufacturing efforts to meet production requirements, potentially accelerating Varespladib's time-to-market. -- Reduce manufacturing related risks to the Varespladib clinical program. -- Ensure a cost-effective transition to registration and commercial production.

SOURCE Anthera Pharmaceuticals, Inc.
Sponsored Post and Backlink Submission


Latest Press Release on General News

This site uses cookies to deliver our services.By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use  Ok, Got it. Close