Glenmark Pharmaceuticals slumps after USFDA issues CRL for Ryaltris

Glenmark Pharmaceuticals fell 6.05% to Rs 469.95 at 10:09 IST on the BSE after the company said that US drug regulator issued complete response letter For Ryaltris.

Meanwhile, the S&P BSE Sensex was down by 76.69 points, or 0.20% to 39,117.80.

On the BSE, 68,000 shares were traded in the counter so far compared with average daily volumes of 28,000 shares in the past two weeks. The stock had hit a high of Rs 495 so far during the day. It hit a 52-week high of Rs 711.55 on 10 September 2018. The stock has hit an intraday low and a 52-week low of Rs 467.75 today, on 24 June 2019.

Glenmark Pharmaceuticals announced on Saturday, 22 June 2019, that 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 cites deficiencies in the drug master file (DMF) pertaining to one of the active pharmaceutical ingredients (APIs) and in the manufacturing facilities.

The CRL does not specify any deficiencies with the clinical data supporting the new drug application for Ryaltris. The company said that it will be able to resolve these issues within the next 6 to 9 months. Glenmark Pharmaceuticals said it will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.

Ryaltris is a nasal spray used as a treatment for seasonal allergic rhinitis.

In a separate announcement before market hours today, 24 June 2019, the company said that its Brazilian subsidiary, Glenmark Farmactica a 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 1 July 2019 onwards. The products involved in the agreement are Seebri (Glycopyrronium bromide), Onbrizee (Indacaterol) and Ultibro (combination of Indacaterol and Glycopyrronium), which are indicated for relief of symptoms in adults with COPD. Under the terms of the agreement, Novartis remains the holder of the registration of these medicines and will be responsible to manufacture them with all technical excellence in line with its global commitment to quality, effectiveness and safety. Glenmark will be responsible for promoting, commercializing and distributing of these products in Brazil.

On a consolidated basis, Glenmark Pharmaceuticals' net profit rose 6.6% to Rs 161.66 crore on a 12.4% rise in the net sales to Rs 2526.08 crore in Q4 March 2019 over Q4 March 2018.

Glenmark Pharmaceuticals (GPL) is a research‐driven, global, integrated pharmaceutical organization.

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