Natco Pharma, a Rs.325 crore Hyderabad based pharma major, has entered into an exclusive agreement with Mabxience, the bio-similar division of Chemo Sa Lugano, Switzerland, an integrated healthcare multinational involved into different fields of pharmaceutical business, including bio-similars and branded pharmaceuticals.
Under the agreement, Natco will purchase four mAb (monoclonal antibodies) drug substances from Chemo and use the same for manufacturing finished dosage pharmaceutical formulations. Three of these products, viz., Trastuzumab, Bevacizumab, Rituximab belong to the oncology segment, while Etanerceptis for auto-immune disease. Natco's obligations under the agreement will include manufacture of drug products, undertake local clinical trials, filing registration of dossiers, to apply for market authorizations and to commercialize the product in India and a few other Asian countries.
Oncology is the largest therapy area within the mAb market, with eight marketed products. The mAb market is highly innovative and a key trend has been the move from murine to humanized and fully human antibodies, with insignificant generic presence.
World-wide, the market for mAbs has grown rapidly and is currently at a revenue level of around US$35 billion. With the product combinations chosen by Natco, the mAb initiative is likely to be completed in a period of 2 to 3 years.