Glenmark up on US FDA approval for migraine treatment drug
Glenmark shares gained further on Wednesday after the pharma major said its US generics arm has received US Food and Drug Administration approval to launch Rizatriptan Benzonate Tablets in 5mg and 10mg strength, a copy of Merck's Maxalt Tablets.
January 02, 2013 / 12:11 IST
Moneycontrol Bureau
Glenmark shares gained further on Wednesday after the pharma major said its US generics arm has received US Food and Drug Administration approval to launch Rizatriptan Benzonate Tablets in 5mg and 10mg strength, a copy of Merck's Maxalt Tablets.The medicine is used to treat migarines and Glenmark said it has started shipping it immediately post US FDA approval. Rizatriptan Benzonate tablets had US sales of USD 333 million for year-ending September 2012, Glenmark said, citing IMS Health data.Glenmark now has 82 products authorized for distribution in the US market and 46 ANDAs (abbreviated new drug applications) are pending approval with the drug regulator, the company said.Glenmark shares were up 0.7 percent at Rs 542.60 on NSE in morning trade.The stock had gained over 2 percent on Tuesday, following USFDA approval to Salix Pharmaceuticals for marketing anti-diarrheal drug Crofelemer.Glenmark is the sole API (active pharmaceutical ingredient) supplier to Salix for the US market. Glenmark had in-licensed Crofelemer, a novel anti-diarrheal agent, from Napo in July 2005, where it has exclusive right to distribute the formulations in 140 emerging market countries including India. It also has a commercial agreement to supply the API to Salix for the US market."We expect the API sales to Salix to commence sometime over the next six months, and peak revenues for Glenmark to be USD20-25 million per annum by FY18," Morgan Stanley analysts Sameer Baisiwala and Saniel Chandrawat said."While the USFDA approval is for HIV related diarrhea, clinical trials for adult acute diarrhea and cholera is currently under Phase III trials in India/Bangladesh and is expected to be completed sometime in FY14," they added.Morgan Stanley has a "overweight" rating on Glenmark. Nachiket Kelkar
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