After being called the equivalent of a snake oil salesman, Roche execs accepted terms imposed by a federal judge in order to begin selling their new Mircera anemia medication. The tentative arrangement follows Roche’s defeat last October in a Boston courtroom, where the drugmaker was found to have violated patents on Amgen’s best-selling Aranesp and Epogen drugs.

In November, however, Roche won FDA approval to sell Mircera and, hoping to bolster its 2008 budget with fresh revenue, worked with US District Court Judge William Young to negotiate a deal with Amgen. And so Roche has agreed to pay Amgen a royalty of 22.5 percent of US sales, compared with the 20 percent offer that Amgen rejected. Roche must also guarantee it won’t charge higher prices than Amgen.

Amgen, however, is still angling for better terms. A spokesman tells the Associated Press allowing US sales of Mircera would amount to “rewarding theft of intellectual property,” and discourage development of drugs for unmet medical needs. And so the biotech wants Young to permanently ban Mircera sales. “We believe a permanent injunction is the appropriate remedy in this case and look forward to the court’s decision on that matter,” he says.

While Amgen argues that Mircera would not offer patients significant benefits compared with its own medications, Roche says its treatment would give patients an important new option, the AP writes. Roche argues that Mircera is the only FDA-approved med capable of stabilizing hemoglobin levels with either a single dose every two weeks, or a dose every four weeks.

Patents on Amgen two anemia drugs, which generated $6.2 billion, or more than 40 percent of sales last year, begin expiring in 2013. However, sales of have declined after the FDA last year required stronger warnings for Aranesp and asked for additional studies. Using too much of the drug can increase the risk of blood clots, heart attack and death, according to the FDA.

And last week, an FDA advisory panel proposed sales of both drugs be sharply restricted to a segment of cancer patients. If the FDA follows the panel’s advice, the restrictions are expected to eliminate a large portion of Aranesp sales - about 40 percent, by one analyst’s estimate. Epogen is better insulated because it’s used almost exclusively by kidney dialysis patients.

In August, Amgen announced plans to cut up to 14 percent of its work force, or 2,200 to 2,600 positions, and it lowered its profit expectations because of declining Aranesp sales.

Source: The Associated Press