Agreements and contracts

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-10-09-2007, Volume 3, Issue 10

The latest pacts from the pharmaceutical supply chain.

South San Francisco, CA (Sept. 21)Exelixis signed an extension of the company's research collaboration agreement with Bristol-Myers Squibb to develop and commercialize novel therapies targeted against the liver X receptor, a nuclear hormone receptor implicated in various cardiovascular and metabolic disorders. The collaboration was extended through January 12, 2009. Bristol-Myers Squibb also retained the option to further extend the research collaboration by a year. Terms of the extension include $7.5 million in additional research funding paid to Exelixis. Under the terms of the collaboration, the two companies jointly identify drug candidates that are ready for investigational new drug application-enabling studies. Bristol-Myers Squibb then undertakes further preclinical development and has responsibility for clinical development, regulatory, manufacturing and sales and marketing activities for the compounds.

Deerfield, IL (Sept. 10)Baxter International and Halozyme Therapeutics (San Diego, CA) agreed to apply Halozyme's proprietary "Enhanze" technology to the development of a subcutaneous route of administration for Baxter's "GAMMAGARD LIQUID 10%" [Immune Globulin Intravenous (Human)], known as "KIOVIG" in Europe. Under the terms of the agreement, Baxter will provide Halozyme an initial upfront payment of $10 million. Pending successful completion of a series of regulatory and sales milestones, Baxter may make further milestone payments totaling $37 million to Halozyme. Baxter also will assume development, manufacturing, clinical, regulatory, and sales and marketing costs. Halozyme will be responsible for the supply of the recombinant human hyaluronidase (rHuPH20) enzyme that provides the basis for Enhanze Technology. Upon regulatory approval, Halozyme will also receive royalties on GAMMAGARD LIQUID 10% administered subcutaneously using Enhanze Technology both in kits and in coformulations.


Blue Bell, PA (Sept. 10)VGX Pharmaceuticals was awarded a contract from the Defense Threat Reduction Agency to develop VGX's constant-current electroporation technology for the intradermal delivery of DNA vaccines and therapeutics. The contract is for $1.9 million over 12 months. Under the contract, VGX will work to demonstrate in vivo efficacy of novel vaccines derived from DNA plasmid-based pox virus antigens delivered using a skin micro-electroporation system.

Hayward, CA and Lenexa, KS (Sept. 6)Aradigm and CyDex entered into a two-year collaboration agreement for the development and commercialization of combination products containing inhaled corticosteroids, anticholinergics, and beta-2 agonists for the treatment of asthma and chronic obstructive pulmonary diseases.

Mississauga, ON, Canada (Sept. 5)DRAXIS Pharma, the contract-manufacturing division of DRAXIS Health, expanded its existing contract manufacturing relationship with Johnson & Johnson Consumer Companies (New Brunswick, NJ). DRAXIS Pharma entered into a definitive supply agreement to provide commercial manufacturing services for a broad portfolio of multiple nonsterile, specialty, semisolid products. The new multiyear contract runs to the end of 2013. It includes approximately two years of manufacturing-site transfer and process-validation activities, followed by five years of commercial production, which is scheduled to begin in 2009.