Bayer completes acquisition of US biologics manufacturing facility from Novartis

Mumbai: Bayer Schering Pharma AG, Germany,  has completed the acquisition of a biologics manufacturing facility in Emeryville, California from Novartis. Bayer Schering Pharma is the pharmaceuticals business of Bayer HealthCare, a subsidiary of Bayer AG.

Bayer Schering Pharma plans to manufacture its multiple sclerosis (MS) drug Betaseron (interferon beta-1b) at the Emeryville site, retaining full control of all manufacturing and process technologies used in the production of Betaseron and has retained the employees associated with the manufacture of the product.

As part of the transaction, which was announced in March 2007, Novartis has transferred the manufacturing responsibility of Betaseron to Bayer Schering Pharma and has received a total one-time payment of approximately $200 million for the transfer of production equipment, inventory and the leasing of buildings at the site.

Bayer Schering Pharma will continue to pay Novartis royalties equivalent to those being paid currently on net sales of Betaseron manufactured by Bayer at the Emeryville facilities until expiration of the original regulatory filing, development and supply agreement in October 2008. After this date, no more royalties will be due to Novartis on the sales of Betaseron.

Bayer Schering Pharma will support Novartis in the regulatory filing process of a Novartis brand of the 250mcg version of interferon beta-1b. When approved by health authorities, Bayer Schering Pharma will supply the 250mcg version of interferon beta-1b to Novartis from 2009 forward and receive in return a double-digit royalty payment from Novartis.

Betaseron, which is marketed outside the US and Canada under the trademark Betaferon, was the first disease-modifying drug introduced for MS and is a well-established treatment around the world.

Betaferon is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Betaferon has the broadest experience of any MS medication. In the US, Europe and Japan, the drug has been approved for all relapsing forms of MS.

It is able to reduce the number of MS episodes by one-third, and the frequency of moderate to severe episodes by as much as 50 per cent. Sixteen years' follow up of people treated with Betaferon has shown that it is safe and well tolerated.