Glenmark Pharma hits 6-year low after USFDA issues CRL on Ryaltris

The drug maker on Saturday said the USFDA has issued a Complete Response Letter (CRL) regarding the new drug application for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate.

Shares of Glenmark Pharmaceuticals hit a 52-week low of Rs 467, down 7 per cent on the BSE in the early morning trade on Monday after the US health regulator USFDA cited deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients (API) and in manufacturing facilities. The stock was trading at its lowest level since April 4, 2013.

The drug maker on Saturday said the US Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) regarding the new drug application for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray.

"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 6 to 9 months," the company said in a regulatory filing.

Glenmark Pharma said it will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.

Moreover, the pahrma company on Monday announced that its Brazilian subsidiary, Glenmark Farmacêutica has 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 01, 2019 onwards.

The products involved in the agreement are Seebri (Glycopyrronium bromide), Onbrize (Indacaterol) and Ultibro (combination of Indacaterol and Glycopyrronium), which are indicated for relief of symptoms in adults with COPD (Chronic Obstructive Pulmonary Disease).

In the past three months, the stock of Glenmark Pharma has underperformed the market by falling 27 per cent, as compared to a three per cent rise in the S&P BSE Sensex.

At 10:37 am, shares of the company were trading 6 per cent lower at Rs 471, against 0.15 per cent decline in the benchmark index. A combined 3.27 million shares changed hands on the counter on the BSE and NSE, till the time of writing this report.