Glenmark Pharmaceuticals stock slips to 6-year low on USFDA woes

It was a mixed day for Mumbai's Glenmark Pharmaceuticals. The company's stock on Monday hit a six-year low of Rs 460 on the BSE after the US health regulator raised concerns over its new drug application for respiratory drug Ryaltris. But on the other hand, it announced an exclusive deal with Novartis Biosciences for three respiratory products in Brazil which is expected to boost its business the South American nation by 35-40 per cent. Keeping in line with its strategy to sign in-licensing deals with pharma majors for branded products, Glenmark's Brazilian subsidiary, Glenmark Farmacêutica, entered into an exclusive partnership agreement with Novartis Biosciences S.A, a subsidiary of Novartis AG, for three respiratory products indicated towards treatment of the symptoms of chronic obstructive pulmonary disease (COPD) in Brazil. This agreement will be effective from July 1. According to the agreement, Novartis will manufacture the products, and Glenmark will exclusively commercialise them in Brazil. The products involved in the agreement are Seebri, Onbrize and Ultibro.    

 
Amey Chalke, analyst with HDFC Securities, said that the deal would enhance the profitability of the Brazilian business provided the products were sizeable.  Its Brazilian operations posted revenues worth Rs 400 crore in FY19.
 
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.