Shares of Dishman Pharmaceuticals rose as much as 20 percent on BSE on news that one of its contract research and manufacturing services (CRAMS) customer Tesaro got an approval from US FDA to market its new ovarian cancer drug Zeluja.
"We believe that the increase in the stock price is based upon market estimation that we are one of the suppliers of the API for Zeluja capsules, which got approved by the US FDA," the company said in a clarification to stock exchanges.
Dishman, however, did not confirm whether it is the API supplier for Tesaro's Zeluja citing confidentiality agreements.
"We, as an API supplies, are bound by strict confidentiality agreements with our customers and will not have any prior knowledge of the stage of development of the customer's end product, Dishman said.
"Since the company does not manufacture the innovator's end product in the CRAMS segment, it is Tesaro, which has received the US FDA approval for cancer drug Zeluja capsules and not Dishman Pharmaceuticals," it further added.
"There are several products pending for approval and will be in talks with Tisaro for further action. It is tough to predict revenue potential from Zejula approval," said JR Vyas, CMD of Dishman Pharma to CNBC-TV18 earlier in the day.
Dishman as part of its CRAMS business supplies active pharmaceutical ingredients (APIs) to various global innovator pharmaceutical companies for their drug candidates in various stages of clinical trials.
CRAMS division contributed about two-thirds of company sales of Rs.1562 crore in FY16.
Currently, the company has about 13 molecules in late phase-III development across various customers.
Typically, CRAMS companies tend to benefit with contracts to supply higher volumes of APIs at better margins if the drug in clinical trials make it to the market.
US FDA on Tuesday approved an innovative new drug to treat recurrent forms of ovarian cancer giving a huge boost to Tesaro, the Massachusetts-based biotech that developed the medicine.
The drug, expected to be launched in the United States next month under the brand name Zejula, significantly increased patient survival rates in a late-stage clinical trial whose findings were reported last year.
US FDA gave Zejula a priority review, were scheduled to rule on Tesaro’s new drug application by late June, but issued their decision three months early — an unusually quick turnaround.
Shares of Dishman gained 19.9 percent and were trading at Rs.278.20 on BSE at 2.11 pm, the benchmark Sensex was trading at 0.60 percent to 29,409.12 points.
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