Cipla Completes Phase-3 Clinical Study Of A Billion-Dollar Asthma Generic
Advair Diskus and its generic equivalents had U.S. sales of about $2.9 billion for the 12-month period ending February 2020.
Cipla Ltd. said it successfully completed the clinical endpoint study evaluating the safety and efficacy of a generic of Glaxo SmithKline Plc.’s respiratory drug Advair Diskus.
The Phase-3 clinical trial for fluticasone propionate and salmeterol inhalation powder (100/50 mcg)—successfully completed in the first attempt—was conducted over a period of 15 months at more than 100 sites in the U.S. enrolling 1,400 asthma patients, the Mumbai-based drugmaker said in an exchange filing.
The product is indicated to treat asthma in patients four years and older as a twice-daily prescription medicine and in long term to treat chronic obstructive pulmonary, including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups disease, it said.
Advair Diskus and its generic equivalents, according to pharma researcher IMS Health, had U.S. sales of about $2.9 billion for the 12-month period ending February 2020.
Emkay analyst Praful Bohra said being a complex product and based on past experience of other players, it was highly likely that the approval pathway for Cipla will be longer than the usual one-year cycle.
But if approved, Cipla’s copy-cat version will be the fourth such drug after innovator GSK and authorised generics of Prasco and Mylan. U.K.-based Hikma Pharmaceuticals has guided for a launch in the second half of calendar year 2020, while Germany’s Sandoz discontinued the drug’s development.
Credit Suisse said although Cipla might receive an approval after two to three years, it was an important drug, given the large size of the market and the company being the fourth generic. Advair Diskus, the brokerage said, can add 10 percent to Cipla’s earnings per share in the first year of launch.
According to Investec, with complexity around development and the high capital outlay, this is a big opportunity for Cipla, which can generate revenue of $100 million annually after launch. Cipla is in with a realistic chance of launching the product in calendar year 2022, and a timely launch could boost Cipla’s FY23 earnings and possibly FY22 depending on approval, Anshuman Gupta, analyst at the brokerage said in a note.