Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF.PK) has has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ranitidine Syrup. Ranitidine in a generic version of GlaxoSmithKline plc's (NYSE; LSE:GSK) Zantac Syrup
Ranitidine syrup is a prescription product used for the treatment of ulcers, gastroesophageal reflux disease, or GERD, and other gastro-intestinal disorders.
GlaxoSmithKline's patent for Zantac Syrup expires in May 2009. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission. Taro cited industry sources that Zantac Syrup has annual US sales of $125 million. The expect other generic versions of Zantac Syrup to be launched when it receives final FDA approval of its ANDA.
Meanwhile, Taro is facing a fateful decision, whether to be sold to a strategic entity that will revamp the company, or find a financial partner to help rehabilitate it both financially and in the eyes of investors.
Taro has a current market cap of $265 million. Possible financial investors mentioned include Ofer Brothers through Ofer Hi Tech Ltd., Israel-Israel Cold Storage Supply Co. Ltd. (TASE: CDSS), by Roni Gat and Shlomo Rodav, and First Israel Mezzanine Investors Fund (FIMI), run by CEO Ishay Davi. Possible strategic investors include Perrigo Company (Nasdaq:PRGO; TASE:PRGO). Taro chairman and controlling shareholder Barry Levitt, the driving force in the company, will make the decision, reportedly in early March, after several postponements since the beginning of the year.
Published by Globes [online], Israel business news - www.globes.co.il - on February 27, 2007
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