HAWTHORNE, N.Y., Dec. 6, 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 Mometasone Furoate Ointment, USP 0.1% ("mometasone ointment"). In addition, Taro USA received tentative approval for its ANDA for Mometasone Furoate Cream, USP 0.1% ("mometasone cream").
Taro's mometasone ointment and mometasone cream are prescription topical corticosteroid products used primarily for the relief of inflammatory skin conditions. The Taro products are generic versions of Schering-Plough's Elocon(r) ointment and cream. According to industry sources, in 2003, U.S. sales of mometasone ointment products were approximately $16 million and U.S. sales of Elocon(r) cream were approximately $54 million.
Mometasone Cream Tentative Approval
Taro USA submitted its ANDA for mometasone cream to the FDA with a certification stating the Company's belief that the product does not infringe Schering's listed patents on Elocon(r) cream, commonly known as a Paragraph IV certification. The FDA has informed Taro USA that another company has the right to an exclusive marketing period for the product, after which Taro USA expects to receive final approval from the FDA to market mometasone cream.
The tentative approval for mometasone cream is an FDA determination that Taro USA's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities, restrictions and any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.
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 mometasone furoate 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 mometasone furoate products; receipt of final approval from the FDA for the ANDA for mometasone cream; 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.