In its effort to enter the US and European markets, the Hyderabad-based Natco Pharma Limited has signed a Letter of Intent (LoI) with Akorn Inc to develop and supply two ANDA oral tablet drug products for cancer patients suffering from nausea and vomiting.
According to a company release, the Letter of Intent anticipates executing a definitive agreement within ninety 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 be responsible for the development and manufacturing of both drug products, while Akorn will be responsible for marketing and distribution in the hospital, clinic, and home healthcare markets in the United States and Canada.
The broad terms of the LoI makes it obligatory on the part of Natco, as the ANDA holder and owner for 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 USA and Canada, added the release.
Akorn Inc manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals.