Gilenya, Jevtana ANDA filings lift Natco
This article was originally published in Scrip
Shares of Natco Pharma spurted on Indian bourses after the firm said that it had, through its partners, filed ANDAs with the US FDA for fingolimod 0.5mg capsules and cabazitaxel 60mg/1.5ml injection, generic versions of Novartis's Gilenya and Sanofi's Jevtana respectively.
Natco and its marketing partners believe that they are the first-to-file (FTF) a ''substantially complete'' ANDA which includes a paragraph IV certification for both products, making them eligible for 180-days of marketing exclusivity upon final FDA approval, a statement from the Indian firm said.
Natco's shares rose by about 4.5% to end at INR1420.50 ($22.8) on 10 February on the Bombay Stock Exchange.
Sales of the oral multiple sclerosis therapy, Gilenya, for the first nine months of 2014 were $1.81bn, while in 4Q 2014, the product's sales were the highest of Novartis' ''growth products'' (scripintelligence.com 27 January 2015). Jevtana reported sales of around $116.8m for the 12-months ended September 2014, as per IMS data.
Natco did not share specifics on the partnered applications for the two products but court filings indicate that Mitsui and Mitsubishi Tanabe and licensee Novartis had, in December last year, filed an infringement suit in the US district court of Delaware against Actavis' ANDA filing, alleging infringement of the Gilenya patent No 5,604,229.
Natco has a clutch of partners for the US market including Mylan, Actavis, Lupin, Breckenridge Pharmaceuticals and Dr Reddy's Laboratories. The alliances cover significant FTF opportunities including those for generic versions of Revlimid (lenalidomide) with partner Actavis and for Tykerb (lapatinib ditosylate) with Lupin. The partnership-based model allows Natco to leverage its product development and manufacture strengths generally without the risk of litigation on its balance sheet. The partners focus on marketing.
Natco has also partnered with Mylan for generic Copaxone (glatiramer acetate) and recently suffered a setback after the US Supreme Court ruled in favour of Teva Pharmaceutical Industries and remanded a case concerning the Israeli firm's money-spinning multiple sclerosis drug back to the US Court of Appeals for the Federal Circuit (scripintelligence.com 21 January 2015).