Wyeth and Catalyst Biosciences, Inc. have formed an exclusive worldwide collaboration for the discovery, development and commercialization of Factor VIIa products to treat hemophilia and other bleeding conditions. Total payments under the collaboration could exceed $500 million and include an upfront payment of $21 million, research funding and milestone payments.

Wyeth will fund the discovery, research and preclinical development by Catalyst of Factor VIIa products, including Catalyst's CB 813 for the treatment and prophylaxis of acute bleeding in patients with hemophilia. The term of the research agreement is two years, which Wyeth may extend for as many as three additional years. Wyeth will be responsible for the development, manufacturing and worldwide commercialization of products resulting from the collaboration. Wyeth will also have the right of first negotiation for any additional clotting factors discovered by Catalyst.

Catalyst may earn as much as $40 million during the next two years, including the upfront payment, research funding and preclinical and clinical milestone payments. Catalyst will be eligible to receive development and commercialization milestones, plus royalties on sales of products resulting from the collaboration.

"This collaboration serves as an excellent fit with our recombinant Factor VIII and Factor IX hemophilia products and provides us with an opportunity to expand Wyeth's hemophilia franchise," said Mikael Dolsten, president, Wyeth Research. "We have been impressed by the caliber of Catalyst's therapeutic protein engineering skills used in the Factor VIIa program and the lead candidate CB 813. We look forward to a highly productive collaboration."

"We are thrilled to join forces with Wyeth, a biopharmaceutical company at the forefront of both hemophilia treatment and the development and commercialization of biologic therapies," said Nassim Usman, Ph.D., chief executive officer of Catalyst Biosciences. "This collaboration highlights the value Catalyst has created in our Factor VIIa portfolio of products. Revenues generated from research collaborations such as this one allow us to continually expand and support existing discovery efforts around bleeding disorder product candidates and the engineering of new Alterase therapeutic products."

Sanofi-Aventis is restructuring its R&D operation and plans to close eight of its 27 R&D sites. The new R&D model, which is expected to be in place by 2013, aims to group researchers in more productive structures, working more closely with academics and hospitals to help drive innovation. The company will focus on diabetes, cancer and age-related diseases as well as anti-inflammatory and anti-infectious diseases, according to Christian Lajoux, head of Sanofi-Aventis France.

Under the reorganization, four sites in France and sites in Britain, Japan, Spain and the U.S. will close. According to the company, there will be no layoffs at this time but a plan for voluntary departures is being considered. The company employs 13,000 people in R&D and administrative positions.

“The objective of this new R&D model is to propose innovative solutions that respond to specific, unmet needs of patients and continue our success in a very competitive international environment,” said Christopher A. Viehbacher, chief executive officer of Sanofi-Aventis. “It is centered on the real needs of patients, the development of scientific networks and openness toward outside entities to strengthen creativity, and a flexible and entrepreneurial approach to research.”

Covance, Inc. is expanding its analytical and stability services facility in Madison, WI, doubling capacity for large-scale, long-term stability and release programs for preclinical, clinical, and chemistry, manufacturing, and control (CMC) development of pharmaceutical and animal health products.

The expanded facility includes upgraded stability chambers equipped with high-density tracked shelving to help increase pharmaceutical analysis service capacity and utilization, and will have as many as ten walk-in chambers and several reach-in chambers. The facility will also provide space for further expansion.

"Covance is committed to providing world-class CMC analytical services for our clients to provide the highest quality data and reduce developments timelines," said Henry Hummel, vice president and general manager, Madison sites, Covance. "Together with our integrated discovery, preclinical, and clinical service offerings and dedicated program management team, we can now offer CMC analytical services as part of an entire molecule development program."

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