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In its second alliance with Hyderabad-based Natco, drug-maker Lupin Ltd has said that the two companies would jointly commercialise the generic similar of Glaxo's breast cancer product Tykerb® tablets, for the US market.
Tykerb is the brand name under which GSK's Lapatinib ditosylate is sold and the product's patent expires in 2017, a Lupin spokesperson said.
Lupin will be involved with the marketing and distribution of the product, said Mr S. Ramesh, Lupin's President-Finance and Planning, without giving a timeline on when the product was expected to hit the US market. Natco had filed an abbreviated new drug application (ANDA) seeking the USFDA's approval for marketing generic equivalent of Tykerb® 250 mg tablets, Lupin said.
Natco and Lupin believe that they are the ‘first-to-file' the Abbreviated New Drug Application containing a Paragraph IV certification for Lapatinib.
A Para IV involves a patent challenge, and if a company gets regulatory approval, it will get to market the drug exclusively, after the patent on the original drug expires.
Kidney drug alliance
In early 2009, Lupin and Natco had collaborated to jointly commercialise the generic equivalent of Shire Plc' s kidney drug Fosrenol (lanthanum carbonate) tablets.
In this case too, Natco and Lupin had said they were among one of the first-to-files, that could lead to 180 days exclusivity. Fosrenol's was at an estimated $108 million, as of December 2008, and according to media reports, patents on the product expire in 2018 and 2024.
Following the 2009 deal, Lupin's Group President and Executive Director, Mr Nilesh Gupta, had said that the alliance would help expand Lupin's portfolio, besides consolidating its presence in the US market. “Lupin's proven IP (intellectual property) management capabilities, marketing reach and expertise coupled with Natco's solid development and manufacturing abilities make for a great combination,” he had said, then.
On the BSE, Lupin shares were up one per cent at Rs 430 while Natco Pharma shares were up over 4 per cent at Rs 272.
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