Mumbai: In its efforts to enter the US and European markets, Natco Pharma Ltd has signed a into a letter of intent (LoI)with the US-based Akorn, Inc, (located in Buffalo Grove) to develop and supply two ANDA 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 Natco.
The two ANDA drug products will focus on the anti-emetic market and have a current market size of approximately $800 million. Natco will develop and manufacture both the drugs, while Akorn will be responsible for the marketing and distribution in the US and Canada.
Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals and has manufacturing facilities in the US at Decatur in Illinois and Somerset in New Jersey, and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Marketing the products to be developed by Natco would complement Akorn''s oncology line of injectables already in development.
The broad terms of the Lol makes it obligatory on the part of Natco, as the ANDA-holder and owner of these products, to develop and file the ANDA for the US primary market and obtain Canadian approvals as well. Commercialisation of the products would, however, be the responsibility of Akorn. Akorn would acquire the marketing and distribution rights for these products in the US and Canada.