Glenmark Pharma gains on USFDA nod for Crofelemer delayed-release tablets

The company made the announcement during trading hours today, 2 January 2013.

Meanwhile, the BSE Sensex was up 131.06 points or 0.67% at 19,711.87.

On BSE, 19,000 shares were traded in the counter as against average daily volume of 1.08 lakh shares in the past one quarter.

The stock hit a high of Rs 548.15 and a low of Rs 542.30 so far during the day. The stock had hit a 52-week high of Rs 550.50 on 27 December 2012. The stock had hit a 52-week low of Rs 285.10 on 2 January 2012.

The stock had outperformed the market over the past one month till 1 January 2013, surging 23.8% compared with the Sensex's 1.25% rise. The scrip had also outperformed the market in past one quarter, jumping 29.03% as against Sensex's 4.02% gain.

The large-cap pharmaceutical company has equity capital of Rs 27.07 crore. Face value per share is Re 1.

The United States Food and Drug Administration (USFDA) has provided marketing approval to Glenmark's partner in US, Salix Pharmaceuticals, for Crofelemer 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).

Commenting on the development, Glenn Saldanha, Chairman & MD, Glenmark Pharmaceuticals said, "The USFDA approval of Crofelemer for HIV associated diarrhea will pave the wave to launch Crofelemer across our territories. This is a significant approval milestone and will enable the first NCE launch by Glenmark across emerging markets. Most importantly, this is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience non-infectious diarrhea, which often can lead to reduced treatment compliance. This will also help us accelerate filing across countries and also propel our development in additional diarrhea indications including the acute indications".

Mr. Saldanha added, "Crofelemer, a locally-acting, minimally-absorbed drug is believed to act by blocking chloride secretion and thus reducing the accompanying high volume water loss seen in HIV associated diarrhea. It is this secretion that is believed to lead to diarrhea with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency. Crofelemer is believed to improve HIV associated diarrhea via dual mechanism of action with inhibition of both CFTR (Cystic Fibrosis Transmembrane Conductance Regulator Protein) and CaCC (calcium-activated chloride channel) resulting in reduced chloride ion secretion into the GI lumen".

Glenmark has obtained rights to crofelemer under license from Napo Pharmaceuticals, Inc.

Separately, Glenmark Pharma before market hours today, 2 January 2013, said that Glenmark Generics Inc, USA, the US subsidiary of Glenmark Generics (GGL) has secured final approval from United States Food and Drug Administration (USFDA) for Rizatripan Benzoate Tablets 5 mg and 10 mg. These are generic version of Merck's Maxalt Tablets. The company has commenced shipping of the product immediately upon approval, Glenmark said in a statement.

According to IMS Health data, the Rizatripan Benzoate Tablets had annual sales of $333 million in the United States for the twelve months ended September 2012.

Glenmark's current portfolio consists of 82 products authorized for distribution in the US marketplace and 46 abbreviated new drug application's (ANDA) pending approval with the USFDA. The company remains focused on strategic planning and development and continues its aggressive filing schedule for the new ANDA submissions, Glenmark said in a statement.

Glenmark Pharmaceuticals' consolidated net profit jumped 177% to Rs 156.75 crore on 18.9% growth in net sales to Rs 1255.19 crore in Q2 September 2012 over Q2 September 2011.

Glenmark Pharmaceuticals is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). The company has a significant presence in branded generics markets across emerging economies including India. The company, along with its subsidiary, has 13 manufacturing facilities in four countries and has five R&D centers. Its subsidiary, Glenmark Generics services the requirements of the US and Western Europe generic markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.

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