The Hindu Business Line : Natco Pharma signs pact with US co for oral drugs

IN a bid to enter the American and European markets, Natco Pharma Ltd (NPL) has signed a Letter of Intent (LoI) with the US-based Akorn Inc to develop and supply two ANDA (Abbreviated New Drug Application) oral tablet drug products for cancer patients suffering from nausea and vomiting. The LoI anticipates executing a definitive agreement within 90 days upon terms and conditions agreeable to both Akorn and NPL. The two ANDA products focus on the anti-emetic market and have a current market potential of approximately $800 million.

NPL will develop and manufacture of both the drugs. Akorn will be responsible for marketing and distribution in hospitals, clinics, and home healthcare markets in the US and Canada.

Akorn manufactures and markets sterile specialty pharmaceuticals. It has manufacturing facilities across the US and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals.

The marketing of these products by Akorn will complement its own oncology line of injectable products already in development. The broad terms of the Lol make it obligatory on the part of the company, as the ANDA holder and owner of these products, to develop and file the ANDA in the US (primary market) and obtain Canadian approvals as well.

Commercialisation of the products will, however, be the responsibility of Akorn. Akorn will acquire the marketing and distribution rights for these products in the US and Canada.

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