Natco Pharma is preparing to launch about four to five new products in the US market by the end of next year, through what it terms as a differentiated product pipeline of niche and complex generic products. As a result, the company is upgrading its existing manufacturing facilities in India with new product lines, R&D capabilities, while also expanding its formulation facility in Hyderabad.
“We have a pipeline of niche and complex generics products in the US besides a collaborative research model to grow in the US markets,” Rajiv Nannapaneni, vice-chairman and CEO, said. “We will be launching about four to five products in US by next calendar year.”
According to him, the company has to its credit 36 ANDA filings including 15 Para IV filings with USFDA as on August 25. Some of them are First-to-file (FTF) ones targeting a combined market of $15 billion and 14 approved ANDAs including two tentative approvals. Natco is looking to partner with other global pharma majors to develop and market products for the US. “The US products portfolio is predominantly focused on high barrier products that are difficult to formulate, difficult to manufacture or may face complex legal and regulatory challenges; 15 Para IV filings with combined market size of $11.8 billion,” the CEO said.
According to Nannapaneni, the company has entered into de-risked arrangements with marketing partners wherein the partner undertakes the responsibility of lengthy and complex litigation and regulatory issues and securing the ANDA approval.
Some of the key products include Copaxone, Tamiflu, Nexavar, Revlimid, etc. While the US market contributes to about 15% of its sales revenues and India’s share is 45%. Going forward, the R850-crore company expects a organic growth of 15-20% .
The company board has also approved the company’s proposal to issue and allotment of eligible securities to qualified institutional buyers (QIBs) to the tune of R450 crore. In the domestic market, the focus is on oncology and hepatitis segment.