Agreements and pacts - Pharmaceutical Technology

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Agreements and pacts
The latest pacts from the pharmaceutical supply chain

PTSM: Pharmaceutical Technology Sourcing and Management
Volume 3, Issue 9

Edmonton, AL, Canada (Aug. 8)Biomira and Merck KGaA (Darmstadt, Germany) signed amended and restated collaboration and supply agreements related to "Stimuvax." Biomira is entitled to development and sales-based milestone payments and a royalty on net sales; and it retains responsibility for the manufacture of Stimuvax, including process development and scale-up for commercial manufacturing. Merck will exclusively purchase Stimuvax from Biomira; with respect to purchases for commercial sales, the purchase price will be subtracted from Biomira's royalty. The restated agreements provide Biomira with revised payments based on certain milestones related to manufacturing scale-up and process transfer. Stimuvax is an investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed in common cancers.

Winnipeg, MB, Canada (Aug. 13)Cangene met the regulatory and manufacturing requirements for the "usable product" milestone on contracts with the US government for products to treat botulism and inhalational anthrax. The contracts, the largest in Cangene history, were signed last year and are managed by the US Biomedical Advanced Research and Development Authority within the Department of Health and Human Services. The usable product designation means the company met specific regulatory and manufacturing requirements that allow it to deliver the products to the US Strategic National Stockpile and begin invoicing once delivery has been accepted.

Pasadena, CA (Aug. 14)Jacobs Engineering received a contract from Pfizer to provide construction management services for a new small-scale clinical biotech manufacturing center in Shanbally, Ireland. Officials did not disclose the value of the contract. The facility will accommodate a production plant, laboratories, administration, and associated infrastructure.

Emeryville, CA (Aug. 14)KineMed, a pathway-based drug-discovery and development company, extended its strategic alliance with CMIC (Singapore), a contract research organization providing clinical development services in Asia. KineMed and CMIC initiated their collaboration in May 2006. Under the terms of the extended agreement, CMIC will seek compounds within Japanese pharmaceutical firms for in-licensing by KineMed, with a focus on metabolic disease, fibrosis and reverse cholesterol transport. CMIC will have the option to become KineMed's partner and cofund clinical development for the Japanese market.

Philadelphia (Aug. 3)GlaxoSmithKline (GSK) reports that the US Department of Health and Human Services (HHS) placed another order to purchase bulk H5N1 antigen for the US national stockpile of prepandemic vaccines.

GSK received a second task order for 22.5 million doses of 15-μg H5N1 bulk vaccine antigen from HHS under contract HHS100200700027I, awarded in November 2007. This order is in addition to the 5 million doses of H5N1 clade 2 bulk antigen at 15 μg HA/dose ordered in November 2006. The new task order procures 9 million more doses of H5N1 clade 2 bulk vaccine produced in the 2006 manufacturing campaign and 13.5 million doses of H5N1 clade 2 bulk vaccine expected to be produced in the 2007 manufacturing campaign.

Under the terms of the contract, GSK will manufacture the bulk vaccine product at its manufacturing site in Ste. Foy, Canada, and store bulk H5N1 antigen at its site in Marietta, Pennsylvania. Terms of the contract also state that HHS may direct GSK to formulate this bulk antigen at some point in the future. HHS also has the option to purchase prepandemic vaccines together with one of GSK's proprietary adjuvant systems, which could mean that less antigen would be needed per dose to achieve a protective immune response. Funding for this contract is provided through the Office of Biomedical Advanced Research and Development Authority (BARDA) of the Assistant Secretary for Preparedness and Response (ASPR).


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