HAWTHORNE, N.Y., Dec. 16, 2004 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. (Nasdaq:TARO) reported today that Taro Pharmaceuticals U.S.A., Inc. ("Taro USA"), its U.S. affiliate, has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Halobetasol Propionate Ointment, 0.05% ("halobetasol ointment"). In addition, Taro USA received tentative approval for its ANDA for Gabapentin Oral Solution, 250 mg/5 mL ("gabapentin solution").
Halobetasol Ointment Approval
Taro's halobetasol ointment is bioequivalent to Bristol-Myers Squibb's Ultravate(R) ointment. Halobetasol ointment is a super-high potency prescription topical corticosteroid product used primarily for the treatment of inflammatory skin conditions. According to industry sources, U.S. sales of Ultravate(R) ointment were approximately $30 million 2003.
Gabapentin Oral Solution Tentative Approval
Taro's gabapentin solution is intended to be marketed as a generic equivalent to Pfizer's Neurontin(R) oral solution. Gabapentin solution is used in treating postherpetic neuralgia in adults and epilepsy. According to industry sources, U.S. sales of Neurontin(R) oral solution were approximately $5 million in 2003.
The tentative approval for gabapentin solution is an FDA determination that Taro USA's ANDA submission for this product currently satisfies the substantive requirements for approval. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.
Taro USA submitted its ANDA for gabapentin solution to the FDA with what is commonly known as a "Paragraph IV" certification because there were patents listed by Pfizer in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"). Taro USA was not sued by Pfizer after submission of the ANDA. The FDA has informed Taro USA that another company has the right to an exclusive 180-day marketing period for the generic product, after which time, subject to FDA review, Taro USA expects to receive final approval from the FDA to market gabapentin solution.
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.
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 halobetasol ointment and gabapentin oral solution products. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking 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 penetration of new markets; physician, pharmacist or patient acceptance of Taro's halobetasol ointment or gabapentin solution products; receipt of final approval for the ANDA for gabapentin solution; 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 2003 Annual Report 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.