Ready to Recover
Amgen (AMGN) scored two straight wins in their patent lawsuit against Roche, and the next big win for the company will be with the FDA on September 11. The Federal District Court in Boston ruled that Roche's CERA drug clearly infringes on one of the five patents that Amgen alleged, and the court granted Amgen's motion for summary judgment. This was the same composition-of-matter patent that Amgen used to beat Transkaryotic Therapies, before the same judge. The judge also ruled against Roche on a number of its other defenses. A trial starts on September 4 on the other patents, if Roche really wants to fight an endgame before settling and paying legal costs and royalties.
On September 11, the FDA's Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will hold a joint meeting to consider the risks and benefits of Aranesp, Epogen and Johnson & Johnson's Procrit in kidney dialysis. The agenda will be available about 48 hours prior to the meeting. I do not expect any change to the current treatment recommendations, but these types of meetings can be unpredictable.
The new Medicare rules on when Aranesp and Epogen will be reimbursed when used for cancer patients have been out long enough for the medical community to come to a consensus: They are unworkable and will not save any money. Private payers, which account for 60% of cancer reimbursement, are likely to adopt an 11 grams per deciliter (g/dl) cutoff for hemoglobin before using the drugs, down from the current 12 g/dl but more practical than Medicare's 10 g/dl limit. At some point, Medicare will be forced up to 11 g/dl due to stresses on the blood supply and poor patient outcomes, but that could take a year or two.
With the patent win, the September 11 meeting soon to be behind us and private payers about to adopt a less damaging hemoglobin policy than Medicare, Amgen's stock should be ready to recover.
