Sun Pharma up 6% on USFDA nod for anti-cancer drug Gleevec

After a long time, Sun Pharmaceutical which is India’s largest drug maker proclaimed that it was received approval from the US FDA for generic copies of Gleevec, a drug that treats chronic myeloid leukemia, a rare form of blood cancer.

Sun Pharma is expected to commercially launch the product on February 1, 2016.

Sun Pharma will be eligible for 180-day marketing exclusivity in the US.

Shares of Sun Pharmaceutical Industries surged more than 6 percent intraday Friday after its subsidiary has received approval from the USA health regulator for anti-cancer drug.

Gleevec has been sold by Novartis AG since it was approved a decade ago.

Sun Pharmaceutical, one of the world’s biggest makers of generic medicines, says it will begin selling the pills in the USA on February 1, 2016.

Sun Pharma acquired US’ Taro Pharma in 2010, making itself the largest generic dermatology company in that country. “Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis’ Gleevec tablets”, it added.

Sources told CNBC, a business news network, that Sun Pharma filed the application for production at an alternate site and not from the Halol plant in the western state of Gujarat, which has been investigated by the FDA over concerns about the quality of its manufacturing processes.

Another Indian drugmaker, Dr. Reddy’s Laboratories Ltd., also entered a settlement with Novartis and its date of launch is “a few quarters after Sun’s launch”, Chief Operating Officer Abhijit Mukherjee said in a call with analysts on October 29.

The [generic] drug targets chronic myeloid leukemia; this is a bone marrow cancer. The first generic company successfully challenging a patent will get six month exclusive sales in the USA, upon patent expiry, as per the rules for generic drug sales in the US.