Sun Pharmaceuticals announced settlement of a legal dispute with Novartis AG in the US on a generic version of patented leukemia drug Gleevec. This settlement is a positive development as it wards off litigation risks and formalizes Sun's launch plans for generic Gleevec, reports CNBC TV18's Archana Shukla.
Sun Pharmaceuticals announced settlement of a legal dispute with Novartis AG in the US on a generic version of patented leukemia drug Gleevec.
This settlement is a positive development as it wards off litigation risks and formalizes Sun's launch plans for generic Gleevec.
While, Sun Pharma had earlier plans of an 'at-risk' launch of the generic version in December 2015. But considering Sun has recently coughed up USD 500 million as a settlement for a similar at-risk launch of Protonix, the agreement with Novartis is a breather.
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So now, according to the settlement, Sun Pharma can launch generic version of Gleevec on Feb. 1, 2016 in the US market. The other terms of the agreement are confidential, Sun Pharma said in a statement on Thursday. Sun Pharma's subsidiary already holds a tentative approval from the US Food and Drug Administration for a generic version of Gleevec.
Gleevec (chemical name: Imatinib mesylate) is used to treat chronic myeloid leukemia and as per IMS data, had annual sales of about USD 2 billion in the United States.
Sun Pharma is reportedly the first generic filer for this drug which means it is entitled to 6 months of marketing exclusivity post patent expiry. It is expected to enter the market with Sandoz, which is the authorized generic (AG) for this drug. With just three players in the market, analysts anticipate Sun Pharma may be able to garner as much as USD 150-160 million revenues in six months of generic Gleevec sales.
HSBC Securities Girish Bhakru in a note said, "With this settlement the risk involved in launching the product is removed. Plus settlement only pushes product launch by 2 months from earlier best estimate. We had so far not built gGleevec in FY16 estimates. Assuming 40 percent share and 60 percent price erosion in six months Sun will make USD160mn easy."
After Sun Pharma, other generic filers for Gleevec are Dr Reddy , Intas, Cadila among Indian generics and Teva, Mylan among MNCs. These players are expected to heat up the competition after the six months exclusive period.
Shasun Pharma stock price
On May 16, 2014, Shasun Pharmaceuticals closed at Rs 149.80, down Rs 7.85, or 4.98 percent. The 52-week high of the share was Rs 168.50 and the 52-week low was Rs 45.60.
The company's trailing 12-month (TTM) EPS was at Rs 6.08 per share as per the quarter ended December 2013. The stock's price-to-earnings (P/E) ratio was 24.64. The latest book value of the company is Rs 50.37 per share. At current value, the price-to-book value of the company is 2.97.
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