Cipla- Completes Phase 3 studies for gAdvair in US

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 Cipla has successfully completed Phase 3 studies for gAdvair (Fluticasone propionate
+Salmeterol inhalation powder) in the US. This was an extensive study conducted over
1400 asthma patients and showed therapeutic equivalence with no safety concern. Cipla
believes that its product is substitutable to Advair.
 gAdvair is indicated for the treatment of Asthma in patients four years and older. It is also
indicated to treat Chronic Obstructive Pulmonary Disorder in the long term, including
chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.
 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.
 As per IMS, Advair sales (brand + generic) are around USD2.9b (12M ending Feb-20) in
the US. We do not expect gAdvair’s launch by FY22 and hence, it is not a part of our
estimates. Currently, Mylan’s Wixela Inhub is the only generic in the market. Mylan
received product approval in Jan-19 and launched the drug at a 70% 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 (had received a CRL in the
first review cycle). Among Indian generics, Lupin, partnered with Celon, is currently in the
development stages.

 

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