A BLOODY BATTLE
AMGEN AND ROCHE ARE GOING head-to-head over the lucrative market of erythropoietin (EPO) stimulators. Though the case is not yet entered the courts, Amgen is trying to maintain the upper hand, saying that Roche's product, Micera, infringes on six Amgen patents. Amgen's Epogen and Aranesp are both erythropoiesis stimulating proteins (ESPs). These artificial forms of human protein EPO stimulate the production of red blood cells (RBC).
According to Daniel Whelan, director of nephrology corporate communications at Amgen, "All ESPs have the same mode of action. They activate the EPO receptor." And that's the trouble, because Roche's Micera is also an artificial EPO, with a twist: Micera is attached to polyethylene glycol, which makes it a so-called pegylated-EPO. Since it still turns on the same receptor, Whelan says, "Peg-EPO does not represent innovation."
Mitra Thomson, a pharmaceuticals research analyst at Global Insight in Waltham, Mass., says that a legal victory for Roche looks unlikely. "Once the court case gets underway, Roche will need to disclose detailed information on the Micera production process," says Thomson. Another hurdle Roche faces is having to stop accepting new lung cancer patients in a Micera study, after a greater than expected number died. Now the safety concerns could further delay Micera's approval in the United States.
On the other hand, says Thomson, Amgen faces its own EPO safety issues. The FDA has just ordered all EPOs to have Black Box warnings on their labels, and Amgen is dealing with the halt of a clinical trial for Aranesp, leading the Center for Medicare and Medicaid Services to plan a review of its Medicare coverage of EPO treatments. Amgen's two most successful products may experience some financial damage due to the safety scare, says Thomson, but adds, "it will take a lot for Micera to unseat them," even if it does attain FDA approval.
At present, Roche is choosing to let the legal proceedings play out. When asked to describe what makes Micera different from Amgen's drugs, Linda Dyson, director of public affairs at Roche, declined because of the pending litigation. Instead, she merely says, "We are confident that Micera does not infringe any of Amgen's patents."
For now, it's a waiting game. Roche's submission of additional data to the FDA in December 2006 in a bid to get a Biologic License Application postponed Micera's review period to May of this year. When asked about the status of the process, Dyson says, "We cannot speculate on an expected approval as the time involved in the review process is determined by the FDA."
Amgen, on the other hand, takes a more aggressive stance. Says Whelan, "I can say we are fully prepared and will take all appropriate commercial and legal actions to answer this threat of unfair competition. Amgen is confident in its intellectual property portfolio and proven ability to protect its products from infringers and will continue to vigorously enforce its patents."
In the meantime, onlookers can only wait and see if Amgen must make room for competition in this lucrative market. "As it stands," says Thomson, "Roche's much-anticipated 2007 approval for Micera in the US has been severely compromised by both the patent litigation brought by Amgen, and the heightened safety awareness surrounding EPOs in general."
