Cipla announces successful completion of Phase-3 clinical study

Cipla announced the successful completion of Phase-3 clinical end-point study for fluticasone propionate and salmeterol inhalation powder (100/50 mcg).

The announcement was made before market hours today, 2 April 2020. Domestic stock markets are shut today on account of Ram Navami. Shares of Cipla settled 2.23% lower at Rs 413.55 yesterday, 1 April 2020.

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.

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

The Phase-3 study, successfully completed in the first attempt, was conducted over a period of 15 months at over 100 sites in the US enrolling 1400 asthma patients. The study results demonstrate that Cipla's fluticasone propionate and salmeterol inhalation powder 100/50 mcg is therapeutically equivalent to Advair Diskus 100/50mcg. The study demonstrated therapeutic equivalence by assessing the primary end points which is in accordance with regulatory recommendations and guidelines. There were no safety concerns identified during the trials.

Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in home markets of India, South Africa, North America, and key regulated and emerging markets.

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