Cipla share price up 8% on successful completion of Phase-3 clinical study of asthma drug

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26 Aug, 2025 12:21

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The share price of Cipla gained 8.3 percent intraday on April 3 after the pharma company announced the successful completion of Phase-3 clinical study for a generic version of GSK's Advair Diskus.

The stock has gained 19 percent in the last week after hitting a six-year low following  the selloff triggered by the coronavirus outbreak. It was trading at Rs 443.30, up Rs 29.75, or 7.19 percent, on the BSE at 1307 hours.

"...announced the successful completion of Phase-3 clinical end-point study for fluticasone propionate and salmeterol inhalation powder (100/50 mcg)," the pharmaceutical company said in a BSE filing.

Fluticasone propionate and salmeterol inhalation powder 100/50 mcg, 250/50 mcg and 500/50 mcg are generic versions of GSK's Advair Diskus.

It is used in treating asthma in patients 4 years and older. It is also used in the long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flareups.

"This is an important milestone and is a testament to Cipla's strong respiratory capabilities and will go a long way in strengthening our respiratory franchise in the US," Umang Vohra, MD and Global CEO said.

According to IQVIA (IMS Health), Advair Diskus and its generic equivalents had US sales of approximately $2.9 billion for the 12-month period ending February 2020.

"Cipla will now file the product with the USFDA (another three-four 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," said Emkay.

The brokerage has a buy call on the stock with a target at Rs 522, implying a 26 percent potential upside.

The brokerage said it was unlikely that generic Advair's would be launched by FY22, hence the same was not a part of its estimates.

At present, 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 percent discount.

"Sandoz has shelved off the generic Advair project after the USFDA rejected its application, while Hikma's (partnered with Vectura) application is currently under review (had received a CRL in the first review cycle). Among Indian generics, Lupin, partnered with Celon, is currently in the development stages," said Emkay.

Disclaimer: The above report is compiled from information available on public platforms. Moneycontrol.com advises users to check with certified experts before taking any investment decisions.