Glenmark Pharmaceuticals rose 0.23% to Rs. 280.40 at 13:59 IST on BSE after the company said it has obtained the DCGI (India) approval for conduct of the pivotal study of Crofelemer in acute watery diarrhoea patients.
The company made this announcement during trading hours today, 28 December 2011.Meanwhile, the BSE Sensex was down 175.85 points, or 1.11% to 15,698.10.On BSE, 12,000 shares were traded in the counter as against average daily volume of 51,684 shares in the past one quarter.The stock hit a high of Rs. 282.40 and a low of Rs. 278.05 so far during the day. The stock had hit a 52-week high of Rs. 372.10 on 6 January 2011. The stock had hit a 52-week low of Rs. 241.60 on 28 February 2011.The large-cap stock had underperformed the market over the past one month till 27 December 2011, falling 11.71% compared with Sensex's 1.14% rise. The scrip had also underperformed the market over the past one quarter, declining 13.82% as against Sensex's 3.93% fall.The company has an equity capital of Rs. 27.04 crore. Face value per share is Re 1.Glenmark Pharmaceuticals (GPL) said that post approval from the DCGI (India) for conducting the pivotal study of Crofelemer in acute watery diarrhoea patients, dosing in patients has also commenced. This is a randomized, double blinded, placebo controlled, parallel Group, three arm, multicenter and multinational pivotal study that is being carried out to assess the efficacy and safety of two dosage regimens of Crofelemer tablets in the treatment of moderate to severe Acute Watery Diarrhoea in adult patients including cholera. This phase III study will be done at leading centres in India and Bangladesh, Glenmark Pharmaceuticals said in a statement.Commenting on the development Mr Glenn Saldanha, Chairman & MD, Glenmark Pharmaceuticals said, We are delighted to commence Phase III trials for Crofelemer in adult acute diarrhoea. Adult diarrhoea is a big concern around the world especially in emerging markets and globally millions of patients suffer from diarrhoea every year.Glenmark remains committed to the development of Crofelemer across various diarrhoea indications that it holds exclusive rights, the company said in a statement.Glenmark Pharmaceuticals has an exclusive license from Napo Pharmaceuticals,Inc. to distribute and commercialise Crofelemer in 140 emerging countries (restof world, or ROW territories) including India for indications related to HIV,use in acute adult and pediatric diarrhoea. Crofelemer is a novel, first-in-classanti-diarrhoeal agent that has a physiological and different mechanism ofaction from traditional anti-diarrhoeal agents. Besides its potential efficaciousrole in multiple diarrhoeal indications, Crofelemer controls diarrhoea with nodrug-drug interactions, minimal systemic adsorption and, unlike current antidiarrhoeals, no serious side effects.Although Napo has purported to terminate Glenmark's license, Glenmarkvehemently denies that Napo has any basis for terminating its license and isseeking a declaration from an arbitration panel that Napo's claims of breach areunfounded, Glenmark Pharma said in a statement.On a consolidated basis, Glenmark Pharmaceuticals' net profit fell 35.2% to Rs. 55.86 crore on 45.9% growth in net sales to Rs. 1055.45 crore in Q2 September 2011 over Q2 September 2010.Glenmark Pharmaceuticals (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is a leading player in the discovery of new molecules, both NCEs (new chemical entity) and NBEs (new biological entity). The company has eight molecules in various stages of clinical development and is primarily focused in the areas of Inflammation (asthma/COPD, rheumatoid arthritis etc) and Pain (neuropathic pain and inflammatory pain). The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has twelve manufacturing facilities in four countries and has five R&D centres.
The company made this announcement during trading hours today, 28 December 2011.Meanwhile, the BSE Sensex was down 175.85 points, or 1.11% to 15,698.10.On BSE, 12,000 shares were traded in the counter as against average daily volume of 51,684 shares in the past one quarter.The stock hit a high of Rs. 282.40 and a low of Rs. 278.05 so far during the day. The stock had hit a 52-week high of Rs. 372.10 on 6 January 2011. The stock had hit a 52-week low of Rs. 241.60 on 28 February 2011.The large-cap stock had underperformed the market over the past one month till 27 December 2011, falling 11.71% compared with Sensex's 1.14% rise. The scrip had also underperformed the market over the past one quarter, declining 13.82% as against Sensex's 3.93% fall.The company has an equity capital of Rs. 27.04 crore. Face value per share is Re 1.Glenmark Pharmaceuticals (GPL) said that post approval from the DCGI (India) for conducting the pivotal study of Crofelemer in acute watery diarrhoea patients, dosing in patients has also commenced. This is a randomized, double blinded, placebo controlled, parallel Group, three arm, multicenter and multinational pivotal study that is being carried out to assess the efficacy and safety of two dosage regimens of Crofelemer tablets in the treatment of moderate to severe Acute Watery Diarrhoea in adult patients including cholera. This phase III study will be done at leading centres in India and Bangladesh, Glenmark Pharmaceuticals said in a statement.Commenting on the development Mr Glenn Saldanha, Chairman & MD, Glenmark Pharmaceuticals said, We are delighted to commence Phase III trials for Crofelemer in adult acute diarrhoea. Adult diarrhoea is a big concern around the world especially in emerging markets and globally millions of patients suffer from diarrhoea every year.Glenmark remains committed to the development of Crofelemer across various diarrhoea indications that it holds exclusive rights, the company said in a statement.Glenmark Pharmaceuticals has an exclusive license from Napo Pharmaceuticals,Inc. to distribute and commercialise Crofelemer in 140 emerging countries (restof world, or ROW territories) including India for indications related to HIV,use in acute adult and pediatric diarrhoea. Crofelemer is a novel, first-in-classanti-diarrhoeal agent that has a physiological and different mechanism ofaction from traditional anti-diarrhoeal agents. Besides its potential efficaciousrole in multiple diarrhoeal indications, Crofelemer controls diarrhoea with nodrug-drug interactions, minimal systemic adsorption and, unlike current antidiarrhoeals, no serious side effects.Although Napo has purported to terminate Glenmark's license, Glenmarkvehemently denies that Napo has any basis for terminating its license and isseeking a declaration from an arbitration panel that Napo's claims of breach areunfounded, Glenmark Pharma said in a statement.On a consolidated basis, Glenmark Pharmaceuticals' net profit fell 35.2% to Rs. 55.86 crore on 45.9% growth in net sales to Rs. 1055.45 crore in Q2 September 2011 over Q2 September 2010.Glenmark Pharmaceuticals (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is a leading player in the discovery of new molecules, both NCEs (new chemical entity) and NBEs (new biological entity). The company has eight molecules in various stages of clinical development and is primarily focused in the areas of Inflammation (asthma/COPD, rheumatoid arthritis etc) and Pain (neuropathic pain and inflammatory pain). The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has twelve manufacturing facilities in four countries and has five R&D centres.
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