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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Chiron and Novartis Advance Programs for Pandemic Flu
Chiron Corporation (Emeryville, CA, www.chiron.com) and Novartis International AG (Basel, Switzerland, www.novartis.com) advanced separate strategies to treat pandemic flu, with Chiron moving on a vaccine and Novartis therapeutics based on RNA interference (RNAi).
Chiron seeks European regulatory approval for a pandemic influenza vaccine
Chiron has submitted an application for a pandemic flu vaccine to the European Medicines Agency (EMEA, London, England, www.emea.eu.int), making it the second company to do so. GlaxoSmithKline PLC (London, England, www.gsk.com) had filed an application with the EMEA in January 2006.
Both applications use the “core dossier” approach, which allows the evaluation and approval of an application based on a “mock-up vaccine” before the outbreak of a pandemic. Once the actual virus strain has been identified at the time of the outbreak of the influenza pandemic, a variation to the core dossier is submitted to incorporate that strain.
Chiron’s mock-up file for the pandemic influenza vaccine contains its MF59 adjuvant and is based on previous avian influenza vaccine clinical studies that will be augmented with an upcoming study of the H5N1 vaccine to take place in Italy this year.
Chiron also entered into a supply contract with the UK government for stockpiled prepandemic influenza vaccines based on the H5N1 avian influenza virus strain. Under the UK contract, Chiron agreed to supply the British government with H5N1 avian influenza vaccine containing its MF59 adjuvant. The delivery of the stockpile remains subject to internal and regulatory-release procedures.
The UK stockpile vaccine is based on an inactivated influenza strain similar to the H5N1 avian subtype that has circulated throughout Southeast Asia and more recently in Central Asia and part of Europe, said Chiron in statement. Chiron will produce vaccine for this stockpile at its manufacturing facilities in Italy.
US extends delivery terms for stockpile of H5N1 bulk influenza vaccine
Meanwhile, Chiron reported that the US Department of Health and Human Services (HHS, Washington, DC, www.hhs.gov) agreed to extend delivery terms for a stockpile of H5N1 bulk influenza vaccine for the US government. Chiron entered into a contract with the US government to stockpile H5N1 bulk vaccine in October 2005.
Chiron is producing this stockpile at its facility in Liverpool, England, and expects to complete roughly 70% of the order before turning operations to annual production of “Fluvirin” influenza virus vaccine in March. Chiron expects to resume work on fulfilling the contract following the conclusion of the Fluvirin vaccine campaign in the fall of 2006.
As part of its avian flu vaccine strategy, Chiron expects that it can manufacture avian flu vaccines during the traditional break between seasonal influenza vaccine campaigns, finishing these activities in time for the seasonal influenza vaccine production to avoid interruption of the normal manufacturing cycle, the company said in statement.
Novartis, Alynlam Team in RNAi therapeutics for pandemic flu
Novartis and Alnylam Pharmaceuticals Inc. (Cambridge, MA, www.alnylam.com) formed a new collaboration to develop therapeutics for pandemic flu based on RNAi. The two companies already have a multiyear alliance focused on developing RNAi therapeutics across multiple disease areas,
Alnylam announced in December 2005 that it was developing a pandemic flu program. It received initial government funding from the US Department of Defense’s “Defense Advanced Research Projects Agency” to develop RNAi therapeutics targeting sequences, both specific for particular strains and conserved strains across all flu strains, including those of avian origin. This RNAi therapeutic would be expected to have antiviral activity against any newly emerging strain of influenza, including any variant for the H5N1 strain.
The pact further positions Novartis in developing therapeutic approaches to the pandemic flu. Novartis agreed to acquire the vaccine maker Chiron last year for $5.1 billion. The deal is expected to close in the first half of 2006.
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