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Biotech / Medical : Taro Pharmaceutical Ind. (NasdaqNM:TARO) -- Ignore unavailable to you. Want to Upgrade?


To: James Ling who wrote (12)4/21/2001 10:16:43 PM
From: Smartypts  Read Replies (2) | Respond to of 18
 
Taro Pharmaceuticals Announces Tentative ANDA Approval
Enalapril Maleate and Hydrochlorothiazide Tablets USP Receive Tentative FDA Approval
HAWTHORNE, N.Y., Apr 20, 2001 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO chart, msgs) today reported that the Company received notification from the U.S. Food and Drug Administration (FDA) for the tentative approval of its Abbreviated New Drug Application (ANDA) for Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg (Enalapril/HCTZ).

Enalapril/HCTZ is a cardiovascular drug used in the treatment of hypertension, with a diuretic component. Enalapril/HCTZ is bioequivalent to Merck's Vaseretic(R) Tablets. The U.S. market for the product is estimated by industry sources to be $57 million.

The tentative approval comes nearly one year before the patent and pediatric exclusivity on Vaseretic(R) expire on March 18, 2002. Taro currently expects to begin selling the product in the U.S. market at that time.

Growing Cardiovascular Line

"Taro has a growing number of cardiovascular products in the U.S. market," stated Barrie Levitt, M.D., FACC, Chairman of the Company. "Taro is committed to cardiology, and we expect to continue building our cardiovascular product line." The Company currently markets Warfarin Sodium Tablets and Acetazolamide Tablets, in addition to the more recent approvals for Amiodarone Hydrochloride Tablets, Enalapril Maleate Tablets and Enalapril/HCTZ.

Since 1996, Taro has introduced an increasing number of oral dosage form products in the U.S. market. Today, Taro has ANDA approvals for 14 oral dosage form products in 33 varying strengths. Taro plans to continue expanding its oral dosage form offering in the U.S.

In January 2001, Taro received approval from the FDA on its ANDA for Enalapril Maleate Tablets in strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, bioequivalent to Merck's Vasotec(R) Tablets. In March 2001, the Company received approval from the FDA on its ANDA for Amiodarone Hydrochloride Tablets 200 mg, bioequivalent to Wyeth-Ayerst Laboratories' Cordarone(R) Tablets.

Taro currently has 9 ANDAs submitted to the FDA (including the tentative approval for Enalapril Maleate/HCTZ), and multiple international filings with regulatory agencies 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., visit the Company's website at www.taropharma.com.

To receive additional information on Taro Pharmaceutical Industries Ltd., at no charge, dial 1-800-PRO-INFO and enter company code 104 or ticker symbol TARO.

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, 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 Report on Form 20-F for the last fiscal year ended December 31, 1999.
Contact:



To: James Ling who wrote (12)7/26/2001 6:09:22 AM
From: Dorine Essey  Respond to of 18
 
Taro Pharmaceutical Files Registration Statement With Respect to a Proposed Public Offering of Its Ordinary Shares
HAWTHORNE, N.Y., Jul 25, 2001 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. (NASDAQ: TARO chart, msgs) announced today that it has filed with the Securities and Exchange Commission a registration statement with respect to a proposed offering of up to 5,750,000 of its ordinary shares (after giving effect to the two-for-one stock split which Taro will consummate on July 26, 2001).

Taro proposes to sell 3,200,000 shares, the selling shareholders referred to below propose to sell an aggregate of 1,800,000 shares and up to 750,000 shares may be sold by Taro upon exercise of the underwriters' over-allotment option. Merrill Lynch & Co. will serve as the lead managing underwriter for the proposed offering and Bear, Stearns & Co. Inc., Banc of America Securities LLC and CIBC World Markets Corp. will also serve as managing underwriters.

The selling shareholders will be Barrie Levitt, M.D. (Taro's Chairman), Aaron Levitt (Taro's President) and Daniel Moros, M.D. (Taro's Vice-Chairman). They currently beneficially own in the aggregate approximately 29% of Taro's outstanding ordinary shares. Following their exercise of currently outstanding options and their sale of shares in the offering, the selling shareholders will beneficially own approximately 22% of Taro's then outstanding ordinary shares (assuming no exercise of the underwriters' over-allotment option). Dr. Levitt will also continue to beneficially own all of Taro's outstanding founders' shares. The selling shareholders intend to use a majority of the net proceeds from their sale of shares in the offering to pay the taxes, which they will incur by reason of the exercise of their options.

Taro develops, manufactures and markets generic and proprietary prescription and over-the-counter drug products, as well as active pharmaceutical ingredients, primarily in the United States, Canada and Israel.

When available, copies of the preliminary prospectus relating to this offering may be obtained from Merrill Lynch & Co. at 4 World Financial Center, North Tower, New York, N.Y. (212-449-1000); Bear, Stearns & Co. Inc. at 245 Park Avenue, New York, N.Y. (212-272-2000); Banc of America Securities LLC at 9 West 57th Street, New York, N.Y. (212-583-8900); or CIBC World Markets Corp. at 425 Lexington Avenue, New York, N.Y. (212-856-4000).

A registration statement relating to these securities has been filed with the Securities and Exchange Commission, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This announcement shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these shares in any state or other jurisdiction, in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction
Contact:

Taro Pharmaceutical Industries Ltd.
Kevin Connelly, (914) 345-9001
or
The Financial Relations Board/BSMG Worldwide
Daniel Saks, (310) 996-7466 (General Info.)
Judith Sylk-Siegel, (212) 661-8030 (Media Inquiries)