Sun Pharma receives US FDA approval for anti-cancer drug Gleevec

Sun Pharmaceutical Industries Ltd. announced that one of its subsidiaries has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for a generic version of Gleevec, Imatinib Mesylate tablets 100mg and 400mg. Imatinib Mesylate tablets, are therapeutic equivalents of Novartis blockbuster Gleevec tablets. Novartis' US patent for the drug expired in July 2015. As per global drug sales, the tracking agency IMS MAT, these tablets have an annual sales of approximately USD 2.5 billion in the US. These tablets are indicated for the treatment of chronic myeloid leukemia.

The Sun Pharma subsidiary, being the first-to-file an ANDA for generic Gleevec , is eligible for 180-days marketing exclusivity in the US. Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec in the United States on February 1, 2016. The commercial launch of this product is scheduled for February 1, 2016. Sun Pharma had agreed to sell the Gleevec generic in the U.S.in 2007, a move that was initially challenged by Novartis. However, the company entered into a settlement with Novartis last May 2014.

US Food and Drug Administration (FDA) approval for the generic version of the anti-cancer drug Gleevec is set to further improve Sun's short-term prospects.With an exclusivity period of six months, it is widely expected that Gleevec will add anywhere between USD 250 million and USD 450 million to Sun Pharma's sales. On an overall basis, Gleevec may be roughly 10-15 percent of Sun's US sales of USD 2.5 billion.

Sun Pharma shares have crashed 41 percent from its 52 week high of Rs 1200 touched in April 2015 to Rs 706 in November 2015. Interestingly, during the same period the foreign institutional investors stake rose to 27.56% from 18.82% in the company between April and September. This indicated a continued liking for the stock as the share price factored in all the troubles related to Ranbaxy integeration and Halol plant. The stock had fallen 20 percent in November alone. The Stock has rallied more then 7 percent in the past two trading sessions on receiving this positive news. The stock has seen buying from lower levels as the news flow has been positive and contributed to the change in investor sentiment.

Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is supported by 50 manufacturing facilities spread across 6 continents.