In FY19 alone, Glenmark had signed four major licensing deals that included Otiprio (antibiotic) in the US with Otonomy, anti-diabetes drug Remogliflozin in India in partnership with BHV Pharma, a wholly-owned subsidiary of Avolynt, and the generic version of Boehringer Ingelheim's Spiriva Handihaler (Tiotropium Bromide dry powder inhaler).
Analysts feel that licensing deals are becoming common as companies
are reeling from pricing pressure and following the generic only strategy may not prove to be profitable.
On the other hand, the US Food and Drug Administration issued a Complete Response Letter (CRL) regarding the new drug application for Ryaltris, a respiratory drug. The CRL cited deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing facilities, the company said in a regulatory filing.
Glenmark noted that the CRL does not specify any deficiencies with the clinical data supporting the new drug application for Ryaltris. "We feel confident that we should be able to resolve these issues within the next six to nine months," it added.
The company further said it would continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.