HAWTHORNE, N.Y.--(BUSINESS WIRE)--Taro Pharmaceutical Industries Ltd. (“Taro,” the “Company,” Pink Sheets: TAROF) announced that it has begun Phase I clinical trials in Canada with T2007, the second in the Company’s class of proprietary non-sedating barbiturate compounds to be approved for studies in humans.
T2007 is the sodium salt of diphenylbarbituric acid (DPB). In previous Phase II studies conducted in Canada, T2000, a prodrug (precursor) of DPB, produced functional improvement in patients with essential tremor. The Company announced last week that the United States Food and Drug Administration (“FDA”), has granted an Investigational New Drug (“IND”) exemption to permit clinical studies on T2000 in the U.S. The Company expects that its experience with T2000 will facilitate its development of T2007.
Plans for T2007 are currently directed at its use as an antiepileptic agent. In animal models, DPB has efficacy comparable to phenobarbital, a long-established clinical treatment for epilepsy. Phenobarbital remains the most commonly prescribed antiepileptic drug throughout the world, although its use has always been limited by its sedating side effects and it has been largely replaced by newer agents in Europe and North America.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
For further information on Taro Pharmaceutical Industries Ltd., please visit the Company’s website at www.taro.com.
SAFE HARBOR STATEMENT
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s proprietary non-sedating barbiturate compounds, T2000 and T2007, and their use in essential tremor and epilepsy. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions; slower than anticipated completion of clinical studies and results of such studies; changes in the Company’s financial position; regulatory actions; and, other risks detailed from time to time in the Company’s SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.