Apotex must stop selling cheaper copies of the anticoagulant Plavix but doesn't have to pull product already sold, said a federal judge who granted a preliminary injunction to Plavix co-marketers Bristol-Myers Squibb (BMS) and Sanofi-Aventis.
US District Court Judge Sidney Stein said the two big companies negotiated away their right to a recall of products already sold or shipped when they attempted to settle patent litigation with Apotex earlier this year.
Neither of the two big companies made formal statements after the ruling, although Sanofi-Aventis cut its 2006 guidance Friday.
Apotex, in a statement following the decision, said it planned to file an emergency appeal to stay the injunction.
The Plavix marketers had argued that generic clopidogrel—which began flooding the market Aug. 8 when it was launched by Apotex in defiance of the patent—would cause permanent price erosion.
Judge Stein agreed, saying that BMS and Sanofi-Aventis would not be able to recoup losses if generic sales continued. Plavix had $3.8 billion in US and $6.2 billion in global 2005 sales. The patent was likely to be enforceable, he added.
However, Judge Stein ruled that the brand-drug companies must post a $400 million bond, the purpose of which is to provide security to Apotex should it win in patent litigation, set to begin next year.
While the exact amount of generic clopidogrel in the hands of pharmacies and wholesalers was being debated, the generic captured nearly 75% of the market, causing US sales of branded Plavix to plummet 77% to $14.4 million for the week ending Aug. 25, down from $62.7 million for the week ending Aug. 4, according to Verispan, The Wall Street Journal reported.
While BMS and Sanofi-Aventis avoided permanent loss of marketing exclusivity for Plavix, and analysts say the injunction likely will prompt BMS to preserve its dividend, its chief executive, Peter Dolan, may not be out of the woods.
Deutsche Bank Analyst Barbara Ryan told The New York Times that Dolan could be replaced by the board, possibly before the start of the patent trial, due to management missteps including negotiations in March to settle the Plavix patent suit.
The two sides agreed to a settlement in March that reportedly paid Apotex at least $40 million to delay the generic introduction for several years. The agreement was later amended to include a five-day window for Apotex to launch the drug without legal action if regulators scuttled the deal, as a group of state attorneys-general eventually did in June. The big companies also waived their rights to collect triple Apotex’s sales of the generic.
The negotiations, and accusations that the companies entered a secret side deal, are the subject of a Justice Department investigation.
Sanofi-Aventis has cut its earnings guidance warning that generic copies may already have eaten up the remaining 2006 demand for its blockbuster anticoagulant Plavix on the US market.
The French pharmaceutical company said it expects 2006 adjusted earnings per share (EPS) growth of around 2% above last year’s $6.09 adjusted EPS. That’s well below the 12% growth the firm forecast previously.
Meanwhile, Sanofi-Aventis said it received a non-approvable letter from the FDA for Multaq (dronedarone), a treatment for atrial fibrillation.
Sanofi said it planned to make a new US filing for Multaq in early 2008 on the basis of an ongoing clinical trial, which it wants to expand by 600 patients by the end of this year.
The ongoing Multaq trial, called Athena, is designed to test the drug’s tolerability in patients with atrial fibrillation, which is the most common type of irregular heart beat and can cause palpitations, shortness of breath and fatigue.