Natco joins forces with Lupin to sell generic Tykerb; gets orphan status for cancer drug candidate

24 June 2011

Indian drugmakers Lupin Ltd (500257: BY) and Natco Pharma (524816: BY announced yesterday that they have entered into an alliance to jointly commercialize a generic equivalent of UK drug giant GlaxoSmithKline’s (LSE: GSK) cancer drug Tykerb (lapatinib ditosylate) tablets. Natco had filed an abbreviated new drug application (ANDA) seeking US FDA's approval for marketing generic equivalent of Tykerb® 250 mg tablets.

Natco and Lupin believe that they are first-to-file an Abbreviated New Drug Application with the US Food and Drug Administration containing a Paragraph IV certification for lapatinib. Tykerb had sales of $113.6 Million in the 12 months to March 2011, according to IMS Health.

This is the second time the two companies are entering into such a pact. Lupin and Natco had in 2009 agreed to jointly sell generic equivalents of Shire's Fosrenol (lanthanum carbonate) tablets, which are used to reduce serum phosphate levels in patients with kidney dysfunction (The Pharma Letter April 6, 2009.

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