UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the month of October, 2005
Commission File Number 000-22286
Taro Pharmaceutical Industries Ltd.
(Translation of registrant's name into English)
14 Hakitor Street, Haifa Bay 26110, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F. Form 20-F |X| Form 40-F |_|
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1): _____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): _____
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes |_| No |X|
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-_____.
Taro to Initiate Phase III
Clinical Trial in the U.S. of Novel Ovide(R)
Formulation for Control of Head Lice
Business Editors/Health/Medical Writers
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Oct. 26, 2005--Taro
Pharmaceutical Industries Ltd. ("Taro," Nasdaq: TARO) reported today
that its U.S. affiliate will initiate a multi-center Phase III study
in the United States to evaluate a novel formulation of Ovide(R), a
prescription product for control of head lice (Pediculus humanus
capitis) in pediatric and adult subjects.
Taro Pharmaceuticals U.S.A., Inc. ("Taro USA") currently markets
Ovide(R) (malathion) Lotion, 0.5%. The Company expects that the new
formulation of Ovide(R) will maintain the efficacy of Ovide(R) Lotion
with shorter application time and greater ease of use, thus improving
patient compliance. There can be no assurance of the successful
completion of the study or of the eventual approval or successful
commercialization of the novel Ovide(R) product.
Approximately six to twelve million cases of head lice are
reported annually in the United States. The condition represents a
problem for school children and officials, and results in lost school
days for children and lost work days for parents. In addition, there
have been a significant number of reports of lice resistance to the
most commonly used over-the-counter treatments.
Taro has filed a patent application in the U.S. Patent and
Trademark Office with claims that cover this new, proprietary
formulation.
Taro 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 Taro's Phase III study to
evaluate a novel formulation of Ovide(R). 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 Taro's potential
inability to recruit volunteers for the Phase III study, to complete
the study successfully or to submit a New Drug Application for the
product, or U.S. FDA rejection of any such application; physician,
patient and pharmacist acceptance of the new product if it is
approved; and other risks detailed from time to time in Taro'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.
CONTACT: Taro Pharmaceutical Industries Ltd.
Daniel Saks, 914-345-9000 ext. 6208
or
Kevin Connelly, 914-345-9000 ext. 6338
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Date: October 28, 2005
TARO PHARMACEUTICAL INDUSTRIES LTD.
By: /s/ Kevin Connelly
------------------
Name: Kevin Connelly
Title: Senior Vice President and
Chief Financial Officer