Catalent Pharma Solutions' pharmaceutical softgel facility in Buenos Aires, Argentina has successfully completed its first FDA general cGMP audit and pre-approval inspection, with no reported observations on FDA Form 483.

Catalent has been operating in Argentina since 1953 serving local and regional pharmaceutical and consumer health markets, and is completing a substantial expansion of the facility designed to meet FDA and other global regulatory standards. Catalent now has 20 sites approved to produce products registered with the FDA, with two site approvals coming in the last 12 months. In Fiscal 2009 alone, Catalent underwent 10 pre-approval and other inspections by the FDA, along with hundreds of other audits from regulatory authorities and customers, according to a company statement.

“As we celebrate the 75th anniversary of our softgel business, I am very pleased to have reached this important milestone for our global network. This brings our customers an important new supply chain option which further expands Catalent’s global sourcing flexibility. We welcome the opportunity for our experienced team in Buenos Aires to serve new customers, and to build upon their long history of operational performance, quality and compliance,” said Thomas Stuart, the group president of Catalent’s Oral Technologies segment.

Christopher Smith, CQE, RAC has been appointed to vice president of quality and regulatory affairs at AAIPharma Services Corp. This is the company’s first appointment since partnering with private equity firm, Water Street Healthcare Partners, to separate from AAIPharma, Inc. and become an independent company.

Mr. Smith will lead efforts to support customers with their regulatory strategy and submission needs and head the company’s GMP compliance efforts. He has more than 30 years of experience in the pharmaceutical industry and has held management positions in regulatory affairs and quality assurance with the FDA, Abbott Laboratories and Endeavor Pharmaceuticals. Most recently, he built the global quality assurance function for AAIPharma Services’ former parent company, AAIPharma Inc.

“We are very pleased that Chris has agreed to be part of the AAIPharma Services team," said Lee Karras, senior vice president Global Pharmaceutical Services."He brings extensive regulatory and compliance experience to AAIPharma Services and will, no doubt, have a tremendous impact on our company’s future."

Look for our Newsmakers Interview with Lee Karras in the September issue of Contract Pharma!

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CSL Biotherapies, a subsidiary of CSL Limited, received licensure from the FDA for its newest vaccine filling and packaging facility in Kankakee, IL. The facility is part of an investment to expand CSL’s U.S. influenza vaccine production capabilities and includes a high-speed, single-dose vaccine syringe filling line. The company also recently signed an initial contract for at least $180 million to supply the U.S. Department of Health & Human Services (HHS) with Novel Influenza A (H1N1) antigen.

The facility will provide filling and packaging services for CSL Biotherapies’ influenza vaccine supply, which is manufactured in Australia, to the U.S. market. CSL completed production of its seasonal influenza vaccine, Afluria, in early July and will deliver more than eight million doses for the upcoming flu season. The majority of that delivery will be in thimerosal-free, prefilled syringes.

“The licensure of this facility enables CSL Biotherapies to rapidly deliver quality, ready-to-administer, flu vaccines to U.S. healthcare providers,” said Wally Casey, senior vice president and general manager of Kankakee operations. “This milestone demonstrates once more CSL’s expertise and commitment to addressing pressing U.S. public health needs. It also underscores our support to enhance vaccine administration safety through the use of ready-to-use prefilled syringes.”

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Covance has closed its transaction with Merck to provide genomics analysis services under a five-year contract valued at $145 million. Covance has acquired Merck's gene expression lab in Seattle, WA, and as of August 17th, assumed control of the facility and took on Merck’s Seattle employees.

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After a five-year Phase III study, Lilly has decided not to submit arzoxifene to regulatory authorities. The osteoporosis treatment met its primary endpoints in the trial, but failed to demonstrate efficacy against placebo in the secondary endpoints. In addition, some adverse events occurred more frequently than in the placebo.

"At Lilly, our goal is to provide innovative therapies that result in better patient outcomes," said M. Johnston Erwin, global brand development leader for the musculoskeletal platform at Lilly. "While arzoxifene met its primary efficacy objectives in this study, we are disappointed that the [trial] data did not convincingly demonstrate that arzoxifene would represent a meaningful advancement in the treatment of osteoporosis."

"The results of arzoxifene's [Phase III] study serve as a reminder of the high risks associated with pharmaceutical innovation," commented John Lechleiter, Ph.D., Lilly's chairman and chief executive officer.

The drug significantly reduced the risk of vertebral fracture and invasive breast cancer in postmenopausal women, but was no better than placebo at such endpoints as non-vertebral fractures, clinical vertebral fractures, cardiovascular events and cognitive function. The trial's results will be published in 2010.

Read Lilly's profile in this year's Top 20 Pharma Report!

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