Shares of Cipla surged 8 per cent in an otherwise weak market, to Rs 447.2 apiece, on the BSE on Friday after the pharmaceutical firm completed Phase-3 clinical end-point study for fluticasone propionate and salmeterol inhalation powder, used to treat asthma patients.
"Fluticasone propionate and salmeterol inhalation powder 100/50 mcg, 250/50 mcg and 500/50 mcg are generic versions of GSK’s Advair Diskus. The product is indicated to treat asthma in patients 4 years and older as a twice-daily prescription medicine and in long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups," it said in an exchange filing. READ HERE
The Phase-3 study was conducted over a period of 15 months, at over 100 sites in the US enrolling 1400 asthma patients, it added. According to IQVIA (IMS Health), Advair Diskus and its generic equivalents had US sales of approximately US$2.9bn for the 12-month period ending February 2020.
"Cipla will now file the product with the USFDA (another 3-4 months). Being a complex product and based on past experience with other players (Mylan, Hikma, Sandoz), it is highly likely that the approval pathway will be longer than the usual one-year cycle," analysts at Emkay Global said in a recent report. The brokerage has 'buy' rating on the stock with a target price of Rs 414.
At 11:20 am, the stock was trading 7.9 per cent higher at Rs 446.5 on the BSE. In comparison, the benchmark S&P BSE Sensex was at 27,869.82 level, down 395 points or 1.26 per cent. A total of 7.43 million shares have changed hands on the counter on the NSE and BSE till the time of writing of this report.
"Fluticasone propionate and salmeterol inhalation powder 100/50 mcg, 250/50 mcg and 500/50 mcg are generic versions of GSK’s Advair Diskus. The product is indicated to treat asthma in patients 4 years and older as a twice-daily prescription medicine and in long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups," it said in an exchange filing. READ HERE
The Phase-3 study was conducted over a period of 15 months, at over 100 sites in the US enrolling 1400 asthma patients, it added. According to IQVIA (IMS Health), Advair Diskus and its generic equivalents had US sales of approximately US$2.9bn for the 12-month period ending February 2020.
"Cipla will now file the product with the USFDA (another 3-4 months). Being a complex product and based on past experience with other players (Mylan, Hikma, Sandoz), it is highly likely that the approval pathway will be longer than the usual one-year cycle," analysts at Emkay Global said in a recent report. The brokerage has 'buy' rating on the stock with a target price of Rs 414.
At 11:20 am, the stock was trading 7.9 per cent higher at Rs 446.5 on the BSE. In comparison, the benchmark S&P BSE Sensex was at 27,869.82 level, down 395 points or 1.26 per cent. A total of 7.43 million shares have changed hands on the counter on the NSE and BSE till the time of writing of this report.
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