Albemarle Corp. has entered into a manufacturing agreement with Anthera Pharmaceuticals in preparation for the Phase III trial of Varespladib (A-002), a potential new, oral anti-inflammatory drug for treating preconditions that can lead to heart disease. Anthera licensed the drug from Eli Lilly.
   
Albemarle will be responsible for process optimization and manufacture of cGMP quantities of the API. The agreement also provides an option for the commercial production of Varespladib in the future.
       
Varespladib is aimed at helping patients who use statin therapies reduce harmful cholesterol levels and inflammation, two factors that can lead to hardening of the arteries. Phase II results showed that A-002 treatment resulted in significant positive changes on lipoproteins and inflammation — major factors believed to lead to narrowing or hardening of the arteries among cardiovascular patients treated with statins.
   
As part of the manufacturing agreement, Albemarle’s Fine Chemistry Services (FCS) scientists at the company’s South Haven, MI facility will conduct additional research on the chemical synthesis of Varespladib and enhance the production process to make a larger-scale quantity of the drug in preparation for Phase III trials.
       
“The Albemarle FCS group was selected as our primary API supplier because of their technical skill set, and their expertise in the chemical development of small-molecule APIs and cGMP manufacturing,” said Debra Odink, Ph.D., vice president of pharmaceutical R&D at Anthera Pharmaceuticals. “We are very pleased that they will be working with us on the Varespladib program.”