Sun Pharma gets USFDA nod for generic Gleevec

Sun could see sales of $300 mn in the 180-day period allowed for exclusive market access

India’s largest drug maker, Sun Pharmaceutical Industries, has got approval from the US Food and Drug Administration (FDA) for its generic version of anti-cancer drug Gleevec-Imatinib Mesylate tablets, 100 mg and 400 mg.

These tablets are prescribed in treating chronic myeloid leukemia, where the bone marrow makes too many white blood cells. These are therapeutic equivalents of Novartis’ Gleevec tablets. By IMS MAT data for August, these tablets have annual sales of approximately $2.5 billion in the US.

For Sun, it could mean sales worth up to $300 million in the 180-day period allowed for exclusive market access.

“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 company stated.

Novartis’s US patent for the drug expired in July. The Sun Pharma subsidiary, being the first-to-file an Abbreviated New Drug Application (ANDA) for a generic Gleevec with a Para-IV certification, is eligible for 180 days of marketing exclusivity under US law. Sun gets half its overall revenue from the US.

According to Sarabjit Kour Nangra, vice-president at Angel Broking, the product can easily contribute sales and net profit of $250-300 mn and $75-90 mn,  respectively, during the six-month exclusivity period, on a conservative basis. “The product can easily enhance the earnings per share of the company in 2016-17 by eight to nine per cent,” she added.

“Growth (in the US) will be mainly driven by the launch of innovative speciality products and lower impact from patent expirations. Implementation of the Affordable Care Act (also known as Obamacare) may have a positive impact on demand for medicines but increase pressure on payers who fund medicine consumption,” said Sun Pharma in its 2014-15 annual report.

As of March 31, 2015, a total of 159 ANDAs of the company were pending for FDA approval, including a combination of complex generics, Para-IV opportunities and pure generics.

“Efforts to strengthen Taro’s research and development (R&D) pipeline gained further momentum during 2014-15. As of March 31, Taro had a pipeline of 35 ANDAs awaiting FDA approval, compared to 27 ANDAs a year back,” said the annual report.

Sun Pharma acquired US’ Taro Pharma in 2010, making itself the largest generic dermatology company in that country.

DECODING THE DRUG

• The drug is used in treatment of chronic myeloid leukaemia, a cancer in which the bone marrow makes too many white blood cells
   
• The tablet has annual sales of approximately $2.5 billion in the US
   
• Novartis’s original patent for the drug expired in July this year; Sun Pharma will launch its generic version on February 1, 2016
   
• The product can contribute sales and net profits of $250-300 million and $75-90 million, respectively, to Sun Pharma
   
• As of March 31, 2015, 159 ANDAs of Sun Pharma were pending USFDA approval