Bioscope ‘09

by  Dr. Barbara Price

Following the money around the world

           In 2008, the US Department of Health and Human Services spent over $1.23 billion on vaccine doses for smallpox and influenza. Only $364 million went to a US company, the remainder went to global pharmaceutical companies with headquarters overseas (ASA 09-2): Acambis (UK), Sanofi Pasteur (France), Novartis (Switzerland) and Bavarian Nordic (Denmark). During May and the first part of June 2009, the US announced contracts for influenza treatments and vaccines worth $977 million. Again, the global pharmaceutical companies were Sanofi Pasteur, Roche, Novartis, Medimmune (AstraZeneca UK), GlaxoSmithKline (UK) and Commonwealth Serum Laboratories, CSL (Australia). Each of these has at least a manufacturing plant in the US, as well as plants in Europe and Asia, with some in Mexico.

           This year Sanofi Pasteur, the vaccine division of Sanofi Aventis, announced that its new US influenza vaccine manufacturing facility in Stillwater, Pennsylvania was licensed by the US FDA and received contracts for $202 million. Sanofi Pasteur also announced its plans for additional vaccine manufacturing in France and Mexico.

           On May 12, Roche donated 5.6 million courses of treatment of the antiviral drug Tamiflu (oseltamivir) to WHO primarily as replenishment doses. On May 1, 2009 the Roche subsidiary in the US received a contract for 110,000 bottles of Tamiflu (worth $2.2 million) from the US Department of State.

           Novartis is developing cell culture vaccines for influenza with a production facility in Germany and a new cell-based influenza vaccine manufacturing facility, funded by the US, being built in North Carolina.

          AstraZeneca (UK) acquired MedImmune, a company based in Maryland and manufacturer of the FluMist vaccine, in 2007. Last year, according to MedImmune, they boosted AstraZeneca's profits because of the increase in profitable products MedImmune makes. MedImmune's new DHHS contracts call for MedImmune to manufacture a nasal spray vaccine for Novel Influenza A or H1N1.

           GlaxoSmithKline in the UK, has manufacturing facilities in the US, Canada and Germany, etc., in addition to a new strategic partnership with Dr. Reddy's laboratory in India.

          CSL Limited in Australia has CSL Biotechnologies in the US, which was awarded a contract with the US DHHS to provide H1N1 antigen that will be manufactured in Australia, although vaccine filling may be done in the company's plants in Illinois or Germany.

          The issue is not that contracts are awarded to best bid, the concern is that when drugs are needed in a severe pandemic, who will the drugs go to first? Will the population of the country in which the company is headquartered really permit drugs, intermediates or end product, to be shipped to another country before its own population is taken care of? Also will the EU permit shipments to outside of Europe before the needs of its 27 members are met? Is the US content to conduct R&D but not develop its own manufacturing base including all API - intermediates and final product?

For the Professional in Government and Industry with an interest in Nuclear, Biological and Chemical Defense, Disarmament and Verification; Emergency and Disaster Medical Planning; Industrial Health and Safety; and Environmental Protection