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“The Phase III trials of Crofelemer will be conducted on over 700 patients at leading medical centres in India and Bangladesh:” Glenmark Pharmaceuticals.
Glenmark Pharmaceuticals said it has received approval from Drug Controller General of India (DCGI) to conduct phase III trials for Crofelemer, aimed at treatment of acute diarrhoea in adults. The company, which is fighting an arbitration case over the drug with Napo Pharmaceuticals Inc, said the Phase III trials of Crofelemer will be conducted on over 700 patients at leading medical centres in India and Bangladesh.
"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," chairman and managing director, Glenmark Pharmaceuticals Glenn Saldanha said in a statement.
Phase III trials are randomised controlled multicenter trials on large patient groups (300-3,000 or more depending upon the disease/medical condition studied) and are aimed at a definitive assessment of the effectiveness of the drug.
The company said it has an exclusive license from Napo Pharmaceuticals Inc to distribute and commercialise Crofelemer in 140 emerging countries including India for indications related to HIV, use in acute adult and paediatric diarrhoea.
Napo Pharmaceuticals Inc, however, had recently claimed terminating an agreement signed in July 2005 with Glenmark regarding Crofelemer. Glenmark had countered it by saying, that Napo does not have any basis for terminating its license and "is seeking a declaration from an arbitration panel that Napo's claims of breach are unfounded". In August the company approached the American Arbitration Association over the issue and earlier this month, it asked the panel to issue an interim order directing Napo to comply with the collaboration agreement during the pendency of the arbitration.
Updating about the progress of the trials, Glenmark said post approval from the DCGI, the dosing in patients has also commenced. The primary objective of the study which is likely to be completed by fourth quarter of 2012 is to assess the efficacy of Crofelemer versus placebo in the treatment of moderate to severe acute watery diarrhoea in adult patients, it added.
In the late afternoon, Glenmark Pharmaceuticals was trading at around Rs280.30 per share on the Bombay Stock Exchange, 0.04% up from the previous close.
DLF said that "the company along with its joint venture partner Hubtown have sold 100% of their respective shareholding in DLF Ackruti Info Parks, Pune, for an aggregate consideration of Rs810 crore to an entity controlled by realty fund affiliated with Blackstone Group, BRE/Mauritius Investments II".
Realty giant DLF announced that the company, and its partner, has sold an IT SEZ in Pune to private equity firm Blackstone for Rs810 crore. DLF, the country's largest realty firm, is selling its non-core assets to reduce debt, which stood at Rs22,519 crore as on 30 September 2011.
In a filing to the Bombay Stock Exchange (BSE), DLF said that "the company along with its joint venture partner Hubtown have sold 100% of their respective shareholding in DLF Ackruti Info Parks [Pune] for an aggregate consideration of Rs810 crore to an entity controlled by realty fund affiliated with Blackstone Group, BRE/Mauritius Investments II".
DLF and Hubtown held 67% and 33% equity shares in DLF Ackruti SEZ, respectively. "The above transaction is in line with the DLF's objective of divesting its non-strategic assets," the BSE filing added.
DLF has so far raised Rs3,480 crore from sale of non-core assets and is planning to raise about Rs7,000 crore in the next 2-3 years.
In the late afternoon, DLF Ltd was trading at around Rs187 per share on the Bombay Stock Exchange, 2.91% down from the previous close.