Baxter Inc: vaccine in full scale production now, commerically available early July

[Siegfried X]

Baxter Inc: vaccine in full scale production now, commerically available in July

Baxter in 'full scale' production of swine flu vaccine

3:52 PM CDT, June 12, 2009

Baxter International Inc. said it is now in "full scale" production of a vaccine for the H1N1 virus, known as swine flu, and anticipates the first commercially available dosages to be available in early July.

The announcement by the Deerfield-based medical product giant comes a day after the World Health Organization declared a global pandemic.

Baxter is believed to be a leader in cell-based technology, which allows the company to cut production times roughly in half compared with the older process that involves processing by hand millions of chicken eggs.

The cell-based method can generate yields in about 13 weeks, compared with 24 weeks in egg-based manufacturing, Baxter said.

Baxter is among several vaccine makers working with the WHO and the U.S. Centers for Disease Control and Prevention to combat the swine flu.

[Siegfried X]

Re: Baxter Inc: vaccine in full scale production now, commerically available early July

Baxter Advances to Full-Scale Production of A/H1N1 Vaccine

Anticipates Delivery As Early As July

Baxter Advances to Full-Scale Production of A/H1N1 Vaccine

DEERFIELD, Ill., June 12, 2009 ? Baxter International Inc. 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 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.