Cipla jumps 8% on completing Phase-3 clinical study of asthma drug

NEW DELHI: Shares of Cipla jumped 8 per cent in Friday's trade after the drug maker announced completion of Phase-3 clinical study for generic fluticasone propionate and salmeterol inhalation powder.

The study showed that the drug is therapeutically equivalent to Advair Diskus 100/50 mcg, Cipla said in a statement. The generic would be used for treatment of asthma and chronic obstructive pulmonary disease.

According to IQVIA, Advair Diskus and its generic equivalents registered a total US sales of approximately $2.9 billion for the 12-month period ending February 2020, Cipla said.

"Currently, Mylan's Wixela Inhub is the only generic in the market. Mylan received product approval in January 2019 and launched the drug at a 70 per cent discount. Sandoz has shelved off the gAdvair project after the USFDA rejected its application, while Hikma's (partnered with Vectura) application is currently under review. Among Indian generics, Lupin, partnered with Celon, is currently in the development stages," Emkay Global said.

The brokerage, which has a target of Rs 522 on the stock, said that the drug maker will now file the product with the USFDA in another 3-4 months.

Being a complex product, and based on past experience with other players, it is highly likely that the approval pathway will be longer than the usual one-year cycle, it noted.

The shares of the company closed 8.60 per cent higher at Rs 449.10 on BSE.