Agreements and pacts

September 5, 2007

Source: PTSM: Pharmaceutical Technology Sourcing and Management

Issue 9,Volume 3

The latest pacts from the pharmaceutical supply chain.

The latest pacts from the pharmaceutical supply chain.

Scottsdale, AZ (Aug. 20)AstraZeneca(London) selected Axway's"Synchrony" supply-chain integrity suite to enable track-and-trace as part of product safety data management (PSDM) initiative. AstraZeneca's PSDM initiative implements a global infrastructure and strategy across multiple packaging lines and production sites. The initial scope of PSDM includes 25 packaging lines and 12 worldwide sites, not including the US sites or supply chain.

Deerfield, IL and London (Aug. 16)Baxter International announced that its subsidiary in the United Kingdom entered into an advanced supply agreement with the UK Department of Health that contains an option to purchase pandemic influenza vaccine in the event that the World Health Organization declares a pandemic. Baxter will manufacture its pandemic vaccine in a serum-free, vero cell-based system at a cell-culture vaccine facility.

Winnipeg, MB, Canada (Aug. 16)Cangene reported that its contract with the US Centers for Disease Control and Prevention for the supply of vaccinia immune globulin intravenous (human) (VIG) was extended for five more years. The original five-year contract was signed in August 2002. Under that contract, Cangene developed and delivered VIG product to the US Strategic National Stockpile.

London (Aug. 20)Chi-Med's Hutchison MediPharma R&D Limited (Hutchison MediPharma)entered into a drug-discovery and development agreement with Eli Lilly and Company (Indianapolis, IN). Lilly and Hutchison MediPharma will initially collaborate on the discovery and development of pharmaceutical agents focused on targets in oncology and inflammation. Hutchison MediPharma will assume primary responsibility for the discovery phase activities necessary for the identification and selection of several clinical candidates, and Lilly will be responsible for ongoing technical advice and the subsequent Investigational New Drug filing and clinical development of these candidates

Billerica, MA (Aug. 15)Millipore expanded its agreement with Novo Nordisk to provide the biopharmaceutical market with recombinant human insulin, a key cell-culture supplement used to manufacture biologic drugs. Under the terms of the agreement, Millipore will have exclusive worldwide rights to market and sell Novo Nordisk's recombinant human insulin, branded by Millipore as "Incelligent SG" and "Incelligent AF," for cell-culture media applications.

Research Triangle Park, NC (Aug. 14)—Icagen signed a worldwide collaboration and licensing agreement with Pfizer (New York) for the discovery, development, and commercialization of compounds that modulate three specific sodium ion channels. Pfizer will provide $38 million to Icagen during the first two years of the collaboration, including a license fee of $12 million, as much as $15 million through an equity commitment, and research and development funding. The equity commitment comprises a $5-million initial investment in Icagen common stock on the effective date of the agreement and an equity put option that would permit Icagen to sell as much as $10 million of common stock to Pfizer at fair market value during the first 18 months following the signing of the agreement. In addition, Icagen is eligible to receive $359 million in research, development, regulatory, and commercialization milestones for each product.

The ion channel targets of the collaboration help generate electrical signals in nerve fibers that mediate the initiation, transmission, and sensation of pain. Icagen identified compounds that have demonstrated efficacy in pain models during preclinical studies. Icagen also accumulated intellectual property in this area that includes several promising compounds that target sodium channels.

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).

Mumbai (Aug. 6)Novartis (Basel, Switzerland)reported that the High Court in Chennai dismissed its writ petition challenging the constitutionality of Section 3(d), and deferred to the World Trade Organization (WTO) forum to resolve the TRIPS compliance question. India denied Novartis's patent application for the anticancer drug "Gleevec/Glivec" (imatinib) in 2006.

"We disagree with this ruling, however we likely will not appeal to the Supreme Court. We await the full decision to better understand the Court's position," said Ranjit Shahani, vice-chairman and managing director with Novartis India Limited, in a company release. "Our actions advanced this essential debate in India; now local and international leaders in both industry and academia recognize the inadequacies of Section 3(d) and are raising serious concerns about the deficiencies of the Indian patent system."

Novartis originally filed the appeal in India because the Indian patent office rejected the Gleevec/Glivec patent application. "Because the patent rejection was based on Section 3(d), we challenged this specific provision in India," said Shahani. "We had hoped to resolve this question on Section 3(d) locally in order to receive a patent for Glivec."

Novartis says still at issue is why a patent for Glivec was denied in India in 2006. The Glivec patent appeal will be decided separately by the newly-operational Intellectual Property Appellate Board (IPAB). Novartis also is petitioning the High Court for a new technical member because the current technical member is the former Controller General of the Indian Patent Office, responsible for the original rejection of the Glivec patent.

"We expect the appellate board to conduct an independent and impartial review of our appeal and ensure transparency of the decision-making process," said Shahani in a company release.

London (Aug. 2)AstraZeneca selected Kuehne + Nagel (Jersey City, NJ) to handle part of its exports of temperature-sensitive pharmaceutical products from Europe to the rest of the world. Under the agreement, Kuehne + Nagel will supply a complete solution for the transportation by air and sea of products indicated for therapeutic categories, including oncology and anesthetics, as well as active pharmaceutical ingredients.