Schering-Plough has responded to Glenmark Pharmaceuticals’ plans to launch a generic version of its cholesterol absorption inhibitor Zetia by filing a lawsuit against the Indian drugmaker.
Glenmark confirmed that that it has been hit by a lawsuit from S-P in response to its filing of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market a generic version of Zetia (ezetimibe) last October. The Mumbai-based firm added that it believes it is the first, and only, firm to have filed an ANDA which included a Paragraph IV certification on S-P patents listed in the FDA’s ‘Orange Book,’ which will entitle it to a 180-day exclusivity period once Zeltia’s patent runs out in October 2016, if its challenge is successful.
The lawsuit has been filed in a New Jersey federal court, and S-P alleges that Glenmark “had no adequate good faith basis” for claiming to the FDA that its version of Zetia would not infringe any valid and enforceable patents. The US firm is seeking a court order to ensure that any approval by the agency does not happen before the firm’s patent expires.
S-P markets Zetia through its joint venture with Merck & Co as a monotherapy and in combination with Merck’s statin Zocor (simvastatin) as Vytorin. Revenues from the JV in the fourth quarter of last year came to $1.1 billion, an increase of 45.7%, and S-P’s share was $541 million. The two partners have also just revealed plans to capture a bigger slice of the cholesterol-lowering market by developing a combination of Zetia and Pfizer’s Lipitor (atorvastatin), once the latter comes off-patent around 2010-2011.
Glenmark buys Czech firm to get foothold in Europe
Meantime, Glenmark also noted that it has acquired Medicamenta, a pharmaceutical marketing and manufacturing company in the Czech Republic, giving the firm “its first commercial foothold into the strategically important market of Europe.“ Medicamenta operates in Slovakia as well as the Czech Republic, “two of the fastest-growing and attractive markets in Europe,” the Indian drugmaker noted, saying that the newly-bought firm will also provide a base for its branded business in Europe. Financial details of the transaction were not disclosed but Glenmark said that Medicamenta’s revenues for 2007 should be around $8 million.
Glenn Saldanha, Glenmark’s chief executive, said the acquisition “is a landmark event” for the firm and is another part of “our long-term strategy to emerge as a speciality/brand company marketing novel drugs, by acquiring front-ends in key branded generics markets.”
