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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 active pharmaceutical ingredient (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.
Anthera recently reported results of small-scale (or Phase II) studies of Varespladib and their plans to scale up production for the Phase III trial, a large-scale, pre-commercial research study of drug safety and effectiveness.
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As part of the manufacturing agreement, Albemarle's Fine Chemistry Services (FCS) scientists at the company's South Haven, Michigan facility will conduct additional research on the chemical synthesis of Varespladib and fine tune the production process to make a larger-scale quantity of the drug in preparation for Phase III clinical 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 Research and Development at Anthera Pharmaceuticals. "We are very pleased that they will be working with us on the Varespladib program."
"We are delighted that Anthera has selected Albemarle FCS to manufacture
this important compound," said
California-based Anthera Pharmaceuticals is a privately held company that develops and commercializes clinical products to address the unmet medical needs of patients with life-threatening chronic and acute inflammatory diseases. For more information please visit www.anthera.com.
Albemarle Corporation, headquartered in
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Albemarle Corporation's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report on Form 10-K.
SOURCE Albemarle Corporation