The FDA voted not to approve Merck's NDA for Arcoxia for the symptomatic treatment of osteoarthritis (OA). Arcoxia has been under review by the FDA as an investigational selective COX-2 inhibitor since December 2003 for a 60 mg once-daily dose along with review of a separate related NDA for a 30 mg once-daily dose submitted in April 2004. The FDA's letter indicated that Merck would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of the drug in order to gain approval.

"We are disappointed with today's decision," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We pursued FDA approval of Arcoxia because we believe strongly that new medicines are needed for patients whose osteoarthritis pain is inadequately managed with currently available therapies. In addition, there is more long-term safety data from controlled clinical trials, in terms of patient-years on treatment, for Arcoxia than for any other NSAID, including traditional NSAIDs and Cox-2 selective inhibitors."

Arcoxia is available in 63 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa. Merck will continue to market Arcoxia outside the U.S., where it has been approved for a broad range of indications, including OA.

Three representatives from JLL Partners, Paul S. Levy, Ramsey A. Frank, and Thomas S. Taylor, have joined Patheon, Inc.'s board of directors, effective immediately. These appointments follow the approval by Patheon's shareholders on April 19, 2007 of a $150 million convertible preferred share investment in Patheon by JLL Partners.

"We are pleased to welcome Messrs Levy, Frank and Taylor to our board of directors," said Peter Green, chairman of Patheon. "They are highly experienced investors who have significant knowledge of the healthcare sector, having made a number of successful investments in this space. We look forward to working with them to drive strong growth in Patheon's revenues and earnings."

Paul Levy is a managing director of JLL Partners, which he founded in 1988. Prior to that, he served as a managing director of Drexel Burnham Lambert and as a chief executive officer of Yves Saint Laurent, Inc. He also served as vice president of administration and general counsel of Quality Care, Inc. and as an attorney at Stroock & Stroock & Lavan LLP.

Ramsey Frank is a managing director of JLL Partners. Prior to joining JLL in 1999, Mr. Frank served as a managing director of Donaldson, Lufkin & Jenrette Securities Corp. and as managing director of Smith Barney & Co.

Thomas Taylor joined JLL in 2005 after serving as president and chief executive officer of EPIX Holdings, a human resource outsourcer. Prior to that, he served as vice president and chief financial officer of Colorado Prime Corp. He has also worked at Kraft Foods as vice president of finance and strategy and at Central Soya as vice president and controller.

Almac Clinical Services has launched two new clinical trial supply systems that help to remove bottlenecks within the supply chain process with its new system of automated label verification. The Almac system was introduced following analysis of the current industry practice of 200% manual checking of both fixed and variable text on clinical trial study kit labels, and how lead time could be reduced.

According to the company, manual checking of study labels is no longer required with its new system, enhancing the speed of availability and providing a more robust audit trail. This label verification system is different in that variable content including randomization details are checked and verified by the system as well as industry standard fixed text checking.

The company has also introduced a fully automated modular over-encapsulation system for blinding of comparator products in clinical trials. With this system, individual tooling for each tablet shape/size is no longer required, resulting in improved timelines, according to the company.

Dr. Robert Dunlop, president, Almac Clinical Services, said, “We have identified bottlenecks that are common within the clinical supply chain and targeted our solutions to these two key areas. We are confident that our automated label verification system and new array of comparator blinding options will assist in ensuring trials are started on time and lead times are shortened to bring drug to market.”

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