Agreements and contracts - Pharmaceutical Technology

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Agreements and contracts
The latest pacts from the pharmaceutical supply chain.

PTSM: Pharmaceutical Technology Sourcing and Management
Volume 3, Issue 6

Pasadena, CA(June 11)Jacobs Engineering Group Inc. received a contract from Wyeth's (Madison, NJ) Medica Ireland to provide detailed design and construction management services for a new pilot-scale laboratory facility at the Wyeth Grange Castle site, Clondalkin, Ireland. The value of the project is estimated at $40 million. The development includes expanding and consolidating all development activities on site to support manufacturing and finishing operations.

Cambridge, MA (June 11)Archemix Corporation and Merck Serono, a division of Merck KGaA (Darmstadt, Germany) formed a multiyear strategic alliance to discover, develop and commercialize aptamer therapeutics with a focus on cancer treatments. The alliance combines Archemix's "SELEX" technology to discover and generate aptamer candidates with Merck's oncology drug development and commercialization capabilities. Merck KGaA will invest $29.8 million in Archemix and will have the option to acquire additional stock upon an initial public offering.

In addition, Archemix and Takeda Pharmaceutical (Osaka, Japan) signed a multi-year, three-target agreement that also focuses on the discovery, development and commercialization of aptamer-based therapeutics.

Under the agreement with Takeda, Archemix will receive a $6 million upfront payment to discover and generate product candidates to three disease-associated targets identified by Takeda. Takeda will be granted exclusive, worldwide rights for research, development, manufacturing and commercialization for any aptamer-based products resulting from the collaboration. Archemix will also receive research funding and clinical development milestone payments for each target selected for development. Archemix will also earn royalties and milestones on worldwide sales of the developed aptamers commercialized by Takeda.

Buffalo Grove, IIL (June 8, 2007)Akorn, Inc added two injectable drug products to its API supply and margin-sharing agreement with Natco Pharma Limited (Hyderabad, India). One abbreviated new drug application (ANDA) drug product is indicated for the prevention of nausea and vomiting associated with cancer chemotherapy, while the other ANDA drug product is indicated in the reduction of renal toxicity and xerostomia in cancer patients undergoing chemotherapy and radiation. Under the API supply and margin sharing agreement that was signed May 21, 2007, Natco will be responsible for the supply of the API for both drug products, while Akorn will be responsible for the manufacturing, regulatory submissions, marketing and distribution in the hospital, clinic, and home healthcare markets in the United States and Canada.

Kvistgård, Denmark (June 4)Bavarian Nordic received a $1.6-billion contract from the US Department of Health and Human Services (HHS, Washington, DC) to manufacture and deliver 20 million doses of its smallpox vaccine "Imvamune."

HHS is supplying a base contract payment of $500 million to support additional research and development of Imvamune for the vaccine's potential use during an emergency. The payment also will fund nonclinical and clinical studies for the vaccine.

The contract includes advance and milestone payments worth as much as $150 million and contractual options worth $1.1 billion. The contractual-options payment would fund further clinical studies of the vaccine that extend the license to include those infected with HIV, children, and the elderly. The payment also could be used to procure up to 60 million additional doses of Imvamune.

Newark, DE (May 30)The Fraunhofer USA Center for Molecular Biology was awarded a $2.6-million contract from the US Department of Defense (Arlington, VA) through the Defense Advanced Research Projects Agency (DARPA, Arlington, VA). The contract is to develop and validate a system for accelerated manufacturing of biopharmaceuticals for use in a pandemic. Under the first phase of the contract, Fraunhofer will validate its plant-based technology platform for the production of vaccines and monoclonal antibodies. The company has reached out to members of the industry and academia to help Fraunhofer complete the project. The process will be designed by the Fraunhofer USA Center for Manufacturing Innovation, Integrated BioPharma, Inc. will scale-up downstream protein purification, AMEC Biopharmaceuticals, Inc will have responsibility for process and facility engineering, and Delaware State University will optimize nontransgenic seed production and storage.

Princeton, NJ and Osaka, Japan (May 30)–BioWa, Inc entered into an agreement with Takeda Pharmaceutical Company Limited. The agreement gives Takeda access to BioWa's "Potelligent" antibody-development platform. Takeda will have nonexclusive rights to research, develop, manufacture, and commercialize antibodies based on the Potelligent platform. BioWa will receive upfront and milestone payments, license fees, and royalties on products developed using the Potelligent platform.

Nantes, France (May 30)Vivalis granted license agreements for its EBx cell lines to several pharmaceutical companies. Nobilon (Parkville, Victoria, Australia), CSL Limited (Parkville, Victoria, Australia), and GlaxoSmithKline (London) all have been granted the right to use EBx cell lines to produce seasonal and pandemic influenza vaccines.

Gurgaon, India (May 29)–A Norwegian appeals court sided with Ranbaxy Laboratories Limited in a patent dispute with Pfizer(New York). The four patents in dispute relate to atorvastatin, the key ingredient in Pfizer's blockbuster cholesterol drug "Lipitor." Norwegian courts found that Ranbaxy had not infringed on two of Pfizer's Norwegian patents covering intermediate compounds. The appeals court ruled that Pfizer's Norwegian process patent relating to the process for manufacturing amorphous atorvastatin was invalid. The ruling paves the way for Ranbaxy to market generic atorvastatin tablets in Norway. Pfizer is appealing the case to Norway's supreme court.

Basel, Switzerland (May 29)Roche formed an agrement with two African manufacturing companies, Addis Pharmaceutical Factory in Ethiopia and Varichem Pharmaceuticals in Zimbabwe, to transfer technology related to the manufacture of HIV medication. The agreement is part of Roche's Technology Transfer Initiative, which provides technical expertise and guidance for the processes to produce "Saquinavir," Roche's HIV medication. A team from Roche will work onsite at the manufacturing facilities in Africa and from the company's headquarters in Switzerland to transfer the technology. The companies will be able to produce Saquinavir for Ethiopia, Zimbabwe, and any other country within sub-Saharan Africa or defined as "least developed" by the United Nations.

Cambridge, UK (May 17)–Acambis plc's smallpox vaccine, ACAM2000, received positive recommendations from the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration (Rockville, MD). The recommendation clears the way for Acambis to form a warm-base manufacturing contract with the Center for Disease Control and Prevention (CDC, Atlanta, GA,). Under the contract, Acambis would provide smallpox vaccine production in the United States.

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Source: PTSM: Pharmaceutical Technology Sourcing and Management,
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