Albemarle Enters Agreement to Produce Active Ingredient of Potential New Heart Drug
Thursday January 31, 5:46 pm ET
Fine Chemistry Services unit to scale up manufacturing in preparation for Phase III trial of Varespladib
BATON ROUGE, La., Jan. 31 /PRNewswire-FirstCall/ -- Albemarle Corporation, a leading global provider of custom pharmaceutical manufacturing services, has entered into a manufacturing agreement with Anthera Pharmaceuticals in preparation for the Phase III clinical trial of Varespladib (A-002), a potential new, oral anti-inflammatory drug aimed at treating preconditions that can lead to heart 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 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.
In October 2007, Anthera reported that the first Phase II trial revealed 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.
Earlier in January 2008, Anthera reported preliminary results of a second Phase IIb clinical trial of Varespladib, in which "administration of once- daily A-002 lowered both lipoproteins and inflammation levels, confirming the positive effects of A-002 treatment seen in an earlier twice-daily study announced in October 2007."
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 David Clary, Albemarle Division Vice President of Fine Chemistry Services. "Our ability to support our customers' needs from pre-clinical trials into commercialization has resulted in a positive response from the pharmaceutical industry, as evidenced by the steady growth in our chemistry services business. Anthera's selection underlines our proven abilities to support the chemistry needs of developing pharmaceutical companies."
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.
Albemarle Corporation, headquartered in Richmond, Virginia, is a leading global developer, manufacturer and marketer of highly engineered specialty chemicals for consumer electronics; petroleum and petrochemical processing; transportation and industrial products; pharmaceuticals; agricultural products; and construction and packaging materials. The Company operates in three business segments -- Polymer Additives, Catalysts and Fine Chemicals, and serves customers in approximately 100 countries.
Source: Albemarle Corporation
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