PHARMACY

Judge grants Amgen’s request for injunction against Roche’s Mircera

BY Drew Buono

BOSTON On Thursday, Amgen won a preliminary injunction that temporarily prevents Roche Holding from launching its anemia drug Mircera, according to published reports.

U.S. District Court Judge William Young said he would consider within the next month if he would allow Mircera on the market if Roche agreed to pay a slightly higher royalty than it had initially proposed and to ensure that it won’t charge prices above those for existing anemia drugs.

Last month, Roche submitted a proposal to the court to launch Mircera by paying a 20 percent royalty, the judge suggested a royalty of 22.5 percent for Roche.

Mircera received approval from the Food and Drug Administration in November for the treatment of anemia associated with kidney disease, but has not been launched because of the injunction.

Anemia treatments Aranesp and Epogen together accounted for about 40 percent of Amgen’s sales of $14.8 billion last year.

Roche is deciding on whether to appeal or take a different course of action.

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Combo vaccine for kids linked to fever and seizures

BY Adam Kraemer

ATLANTA A study by the Centers for Disease Control and Prevention has shown that children suffered higher rates of fever-related convulsions when they got a Merck combination vaccine instead of two separate shots, according to published reports.

Prior to the findings, the CDC’s Advisory Committee on Immunization Practices had stated a distinct preference for the ProQuad vaccine, which protects against measles, mumps and rubella as well as chickenpox. The committee’s argument was that it would be better to give children the fewest injections possible.

Now, however, the committee has withdrawn its preference for ProQuad, choosing not to exhibit any preference at all. “Safety, shortages, delivery issues—lots of reasons not to state such a strong preference,” said a committee member. ProQuad costs $124 per dose, about the same as the two other shots combined.

In the study of children ages 12 months through 23 months, the rate of seizures was twice as high in toddlers who got ProQuad, compared with those who got one shot for chickenpox and one for the three other diseases. Neither the convulsions, nor the fevers that engendered them resulted in any child deaths. Merck has conducted its own study with similar results: 1 occurrence in approximately 2,000 children.

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Procter & Gamble wins patent suit for Actonel

BY Adam Kraemer

CINCINNATI The United States District Court of Delaware today ruled in favor of the Procter & Gamble Company in the patent infringement lawsuit filed by P&G against Teva Pharmaceuticals. The positive ruling protects P&G’s rights in the U.S. to exclusively market the osteoporosis therapy Actonel (risedronate sodium tablets).

P&G filed a patent infringement lawsuit in August against Teva to enforce P&G’s U.S. composition of matter patent for risedronate, the active ingredient in Actonel. Teva was seeking to market a generic version of Actonel in the United States under the assertion that the Actonel patent was not valid due to obviousness of the invention.

The court ruled today in favor of the patent. “We are pleased that the Court recognized and acknowledged the uniqueness of the risedronate molecule,” said Tom Finn, P&G president of global health care. “We are very proud of the extensive R&D efforts which brought Actonel to market, providing patients help that they need to manage their osteoporosis and prevent fractures.”

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