Momenta Pharmaceuticals Inc. (MNTA), owner of patents on the blood-thinner Lovenox, fell the most in four months after an appeals court cleared the way for Watson Pharmaceuticals Inc. (WPI) to sell a generic version of the drug.
The U.S. Court of Appeals for the Federal Circuit granted Watson partner Amphastar Pharmaceuticals Inc. a stay yesterday of an October order that prevented sales of the drug copy. The court, which heard an appeal of the order two days ago, gave no reason for its decision in the stay. Watson said today it and Amphastar plan to begin sales immediately.
Momenta owns two patents for Lovenox and gets a share of the profit earned from generic Lovenox sold by partner Novartis AG (NOVN)’s Sandoz unit. A federal judge in Boston blocked Watson and Amphastar from selling their copy, saying Momenta was likely to win a patent-infringement suit it had filed. The Federal Circuit said its order yesterday “does not represent a final decision with respect to the merits of the pending appeal.”
Momenta tumbled $3.98, or 21 percent to $15.13 in Nasdaq composite trading of 7.6 million shares, or nine times the three-month daily average, at 4 p.m. in New York. It’s the biggest drop since Sept. 19, when the Food and Drug Administration approved Amphastar’s Lovenox copy. Watson rose $1.04, or 1.8 percent, to $58.65 in New York Stock Exchange trading.
Amphastar is shipping its drug to Watson today, and Watson expects to begin distributing generic Lovenox by tomorrow, Patty Eisenhaur, a spokeswoman for Watson, said in a telephone interview.
The copy of Lovenox may add 20 cents to 25 cents a share to Watson earnings in the first year, Michael Tong, an analyst with Wells Fargo Securities in New York, said in a note to clients today.
Watson would have to begin sales knowing there’s a risk it may later lose the case, Tong said. Under federal law, it could be forced to reimburse Momenta and Sandoz three times the amount of any lost profits should Parsippany, New Jersey-based Watson later lose the case.
Momenta, based in Cambridge, Massachusetts, has two patents for a process of making enoxaparin, the main Lovenox compound.
“While disappointing, this decision does not reflect a final ruling on the appeal or the ultimate case,” Momenta Chief Executive Officer Craig Wheeler said in a statement. “Any launch by Watson or Amphastar would be at risk and we continue to pursue our claims in the District Court. We have confidence in the strength of our patents.”
Sanofi, the Paris-based maker of the branded medicine, reported $1.6 billion in Lovenox sales in the first nine months of last year.
The appeals court case is Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 12-1062, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 11cv11681, U.S. District Court for the District of Massachusetts (Boston).
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