Wednesday, January 24, 2007

New info on Mircera changes forecasts in Amgen/Roche litigation

Reuters noted: Citing court documents filed late on Friday [Jan. 19], analysts said it appears that a rival anemia drug made by Roche called Mircera was made using the same amino acid sequence and composition as Epogen.

"We think this means Amgen's probability of winning its patent infringement case has increased dramatically," said Mark Schoenebaum, an analyst at Bear Stearns, in a research report.

Monsters and Critics noted: documents released last week indicate it`s a pegylated version of an EPO product.

M&C also noted: Michael Aberman acknowledged in a research report the documents rule out the possibility Roche uses a semi-synthetic manufacturing method for Mircera, which could have aided its case. But he goes on to note, 'Roche`s amended counterclaims provide details about the inequitable conduct argument and suggest to us that they could prevail.'

If this holds true, 'this would not only put all of Amgen`s existing EPO patents at risk but also put Roche`s anti-trust arguments into play,' Aberman stated. 'The net result is we are not changing our probability of Amgen`s success in the case.'

M&C also discussed possible implications of Democratic control of Congress:

To fund their proposal, Democrats are expected to recommend changes to biotech drug reimbursement covered under Medicare Part B, including accelerating follow-on biologics and reducing ASP+6 percent reimbursement.

'Both of these proposals may weigh on Amgen, since its blockbusters Epogen and Aranesp could get hit both on follow-on biologics (following Epo`s patent expiration in 2013), and on a reduction in ASP+6 percent in the nearer term (since these are somewhat discretionary drugs for doctors, who may end up losing money on these drugs if ASP+6 percent is reduced too much),' Reddoch stated.


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