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Generics firm Mylan said it filed an ANDA application with the FDA to market copycat versions of Merck cholesterol drug Vytorin and that it may be the first company to do so. The firm also said it has been sued by Schering and MSP Singapore in connection with the Vytorin filing. The lawsuit triggers a 30-month stay on approval until first quarter 2012. If Mylan's ANDA is the first, the submission would qualify the company for 180 days of marketing exclusivity. Collins Stewart analyst Louise Chen estimated an exclusive generic launch of Vytorin could bring in $100 million in sales. For the year ending last September, Vytorin tablets posted about $1.6 billion in sales for the same four strengths included in Mylan's application, said the company citing IMS Health figures. Vytorin combines cholesterol-reducing agents ezetimibe and simvastatin.
Novartis said it is buying Corthera, a privately held US biopharma company, for $120 million and gaining rights to Phase-III heart-failure treatment Relaxin. Corthera shareholders are eligibile for additional milestone payments of up to $500 million. Novartis hopes to file Relaxin for US and European marketing approval in 2013. Separately, the Swiss company is likely to increase its stake in eyecare company Alcon, various news outlets reported. Novartis owns a 25% stake in Alcon, purchased last year from Nestle for $11 billion, and an option to buy 52% more starting next month. Nestle can also push Novartis to buy the 52%. Analysts said the deal seems likely to occur soon after the New Year, ever since Alcon's share price rose above a threshold where it makes sense for both sides. If the second step goes through, Novartis is expected to pay about $28 billion for Nestle's remaining stake.