Ranbaxy to enter US anti-cancer segment

NEW DELHI: In line with the company’s strategy to focus on speciality drugs in the US, drug major Ranbaxy is set to foray into the anti-cancer drug market.

Ranbaxy executive director and COO Atul Sobti told ET, “The company plans to file Abbreviated New Drug Applications (ANDA) for five oncology drugs in the US by the end of the year. With this, we will enter the oncology drug segment in the US.” After an ANDA application, it usually takes one to two years for companies to get marketing approval.

These oncology drugs would be manufactured by Hyderabad-based Zenotech Laboratories in India. Last year, Ranbaxy and Zenotech had entered into a strategic tie up to jointly develop and market oncology drugs. Under the agreement, Zenotech will develop, submit for regulatory approval and manufacture 11 oncology products while Ranbaxy will market the products in the US and Canada under the Ranbaxy’s label.

When contacted Zenotech CEO Jayaram Chigurupati said, ”We are planning to file a total of nine drugs in the US by next year, including five drugs in the oncology segment. The market size of these drugs is around $3.5 billion.”

At present, Dabur Pharma markets three products in the US market and has 10 ANDA applications, including one first to file with the USFDA. To strengthen its presence, Dabur has also recently opened a marketing office in the US. Sun Pharma is also present in oncology in US market through its US subsidiary.

According to industry officials, oncology is a niche segment and provides high margin for companies. Says Dabur Pharma CEO Ajay Vij, “In each drug segment, there are about 5-10 generic companies.” Other domestic companies who have presence in oncology are also expected to explore the lucrative US market.

Says E&Y partner (transaction advisory services) Utkarsh Palnitkar, “There has been a spate of new entrants over the past two years in this segment. The larger companies are Ranbaxy, Sun, GSK, Zydus Cadila, Alkem, Cipla, Nicholas Piramal and Wockhardt. All these companies export to lesser regulated markets, especially Latin America, Africa and CIS countries.”