|Baxter Advances to Full-Scale Production of A/H1N1 Vaccine
|Anticipates Delivery As Early As July
DEERFIELD, Ill., June 12, 2009 — Baxter International Inc. (NYSE: BAX) announced today that it has completed testing and evaluation of the A/H1N1 influenza virus and is now in full-scale production of a commercial A/H1N1 vaccine using its Vero cell culture technology. Baxter received an A/H1N1 strain from the U.S. Centers for Disease Control and Prevention [a World Health Organization (WHO) Collaborating Center] in early May and is diligently working to deliver a pandemic vaccine for use as early as July.
WHO raised the pandemic alert level to phase 6, indicating a global influenza pandemic involving the 2009 A/H1N1 strain. Baxter is in contact with WHO and other global public health authorities regarding the pandemic. A number of national public health authorities have existing pandemic agreements with Baxter that allow them to place orders for a vaccine now that a pandemic has been declared by WHO. These public health authorities will be evaluating their needs to determine their orders for vaccine supply. Despite the company's existing obligations to supply vaccine under a pandemic phase 6 alert, Baxter is also committed to working with WHO to allocate a portion of the company's commercial production to address global public health issues deemed most urgent.
Using its Vero cell technology, Baxter has received European Medicines Agency (EMEA) approval for a mock-up pandemic vaccine called CELVAPAN, the brand name for the company's pandemic vaccine. The qualification, development and manufacturing processes used in gaining mock-up licensure for CELVAPAN apply as the company uses this new influenza A/H1N1 virus strain to produce a pandemic vaccine. The CELVAPAN EMEA licensure supports fast track approval of a pandemic vaccine containing the A/H1N1 virus strain. Baxter will submit the A/H1N1 vaccine for approval upon completion of initial manufacturing runs.
Baxter's research and development, manufacturing capabilities and pandemic planning expertise allow the company to efficiently develop candidate vaccines against potentially emerging influenza viruses. Baxter believes that its Vero cell technology can be used to safely and reliably produce a vaccine in response to this global public health issue. It is possible that Baxter's Vero cell technology may offer advantages, in that it may allow more rapid production and delivery of pandemic vaccines.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning the company's vaccines products, including with respect to potential delivery timelines. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: continued success in advancing a new technology through full-scale production, including with respect to steps required for finishing and release; remaining regulatory approvals; governments' decisions with respect to orders; and other risks identified in the company's most recent filing on Form 10-K and other Securities and Exchange Commission filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.
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Christopher Bona, (847) 948-2815
Mary Kay Ladone, (847) 948-3371
Clare Trachtman, (847) 948-3085