SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of December 2002
Taro Pharmaceutical Industries Ltd.
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(Translation of registrant's name into English)
14 Hakitor Street, Haifa Bay 26110, Israel
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(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 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|
The following is included in this Report on Form 6-K:
1. Press release dated December 19, 2002.
TARO PHARMACEUTICAL INDUSTRIES LTD.
C/O TARO PHARMACEUTICALS U.S.A., INC.
Five Skyline Drive
Hawthorne, New York 10532
(Nasdaq/NMS: TARO)
AT THE COMPANY
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Daniel Saks Kevin Connelly
Vice President, Corporate Affairs Chief Financial Officer
(914) 345-9000 ext. 208 (914) 345-9000 ext. 338
FOR IMMEDIATE RELEASE
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THURSDAY, DECEMBER 19, 2002
TARO RECEIVES APPROVAL FOR KETOCONAZOLE CREAM, 2% ANDA
AMIODARONE TABLETS, 100 MG AND 400 MG ANDA ALSO APPROVED
HAWTHORNE, NY, DECEMBER 19, 2002 - Taro Pharmaceutical Industries Ltd.
(Nasdaq/NMS: TARO) reported today that the Company has received approval from
the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug
Application ("ANDA") for Ketoconazole Cream, 2% ("Ketoconazole Cream").
Taro's Ketoconazole Cream is bioequivalent to Nizoral(R) Cream, a product of
Janssen Pharmaceutica Products, L.P. Nizoral is a prescription pharmaceutical
product used primarily for the treatment of fungal infections of the skin.
According to industry sources, the annual U.S. market for Ketoconazole Cream is
approximately $54 million.
"Ketoconazole Cream is an important addition to Taro's line of antifungal
products and strengthens our leadership position in the U.S. topical
prescription market," said Barrie Levitt, M.D., Chairman of the Company.
- more -
Taro Pharmaceutical Industries Ltd.
Page 2 of 2
AMIODARONE HCL TABLETS, 100 MG AND 400 MG ANDA APPROVED
The Company has also received FDA approval for its ANDA for Amiodarone Tablets,
100 mg and 400 mg. Amiodarone is used in treating atrial fibrillation and other
cardiovascular conditions. While the 400 mg tablet is bioequivalent to
Upsher-Smith's Pacerone(R) Tablets, Taro believes it is currently the only
company with a 100 mg Amiodarone Tablet. In 2001, Taro received ANDA approval
for 200 mg Amiodarone Tablets.
"By offering the choice among 100 mg, 200 mg and 400 mg Amiodarone Tablets, Taro
hopes to enable physicians to simplify dosing regimens and more easily tailor
treatment to the needs of individual patients," Dr. Levitt stated.
Taro currently has 16 ANDAs on file with the FDA, including one tentative
approval. In addition, the Company has multiple regulatory filings in Canada,
Israel and other countries around the world.
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. 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, marketplace acceptance of Taro's generic
Ketoconazole Cream, 2% or Amiodarone Tablets, 100 mg, 200 mg and 400 mg, the
future size of the market for these four products, 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 2001 Annual Report on Form
20-F.
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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.
Taro Pharmaceutical Industries Ltd.
Date: January 6, 2003 By: /s/ Kevin Connelly
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Kevin Connelly
Senior Vice President and Chief
Financial Officer