Forest Updates Status of Lercanidipine Regulatory Submission
Public Company Information:
Forest Laboratories Inc. (NYSE: FRX) announced today that the U.S. Food and Drug Administration will require the Company to conduct additional clinical trials in order to approve the dosing regimen of lercanidipine requested by the Company, which is the regimen currently approved in all 60 countries where lercanidipine is approved. Forest received an approvable letter for lercanidipine on August 1, 2002 in which the Agency requested additional information.
Forest officials met with the Agency on December 4, 2002 to review its proposed response to the approvable letter. Forest believed its prepared response was adequate to support the proposed dosing regimen of the product, but was unable to persuade the agency. During the meeting the Agency asked for this additional clinical data which Forest believes is likely to delay the potential approval and launch of lercanidipine by a minimum of two years or more. The current New Drug Application for lercanidipine retains its approvable status at the FDA. Forest remains committed to the commercialization of lercanidipine for the treatment of hypertension.
Lercanidipine is licensed to Forest Laboratories, Inc. (NYSE: FRX) from the Italian pharmaceutical company Recordati S.p.A. (Italian Stock Exchange, Reuters RECI.MI, Bloomberg REC IM), which developed lercanidipine. Lercanidipine is currently approved in 60 countries and actively marketed in 42 countries and, as of last June, its use cumulatively accounted for over 15 million patient months of experience.
About Forest Laboratories
Forest Laboratories develops, manufactures, and sells pharmaceutical products that are used for the treatment of a wide range of illnesses. Forest's growing line of products includes: Lexapro(TM), indicated as initial as well as maintenance treatment of major depressive disorder; Celexa(TM), also indicated for the treatment of depression; Tiazac(R), a once-daily diltiazem, which is indicated for the treatment of angina and hypertension; and Aerobid(R) an inhaled steroid indicated for the treatment of asthma. The Company has also entered into a co-promotion agreement with Sankyo of Japan for the marketing of Benicar(TM) for the treatment of hypertension.
Except for historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2002 and Quarterly Reports on Form 10-Q for the period ended June 30, 2002 and September 30, 2002. Actual results may differ materially from those projected.
Benicar is a registered trademark of Sankyo Pharma.