Forest Laboratories Updates Lercanidipine Development
November 02 2004 - 8:00AM
PR Newswire (US)
Forest Laboratories Updates Lercanidipine Development NEW YORK,
Nov. 2 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE:FRX), an international pharmaceutical manufacturer and
marketer reported on the development progress of lercanidipine, a
Calcium Channel Blocker (CCB) being investigated for the treatment
of hypertension. Forest has licensed U.S. rights for lercanidipine
from Recordati S.p.A of Milan, Italy. In August of 2002, Forest
received an approvable letter from the U.S. Food and Drug
Administration (FDA) seeking additional data related to the
proposed dosing regimen. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) In
response to the request for additional data Forest conducted an
eight week Phase II pilot study in which approximately 60 patients
were dosed once daily with lercanidipine in an experimental
modified release formulation. This study was conducted in order to
assess the clinical efficacy profile of lercanidipine in this new
modified-release formulation. The preliminary study results
indicated that this modified release version of lercanidipine was
associated with a clinically relevant reduction in blood pressure,
but did not meet all the stringent pre-set criteria for dose
response across the range of doses studied. Lercanidipine treatment
was well tolerated in this study. Forest is evaluating additional
alternative extended release formulations and will consider which
studies to conduct in the future. The development timeline of
lercanidipine would accordingly be somewhat delayed while the
Company assesses the appropriate next steps. About Lercanidipine
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 92 countries
and actively marketed in 66 countries and, as of June 30, 2004, its
use cumulatively accounted for over 40 million patient months of
experience. Except for the historical information contained herein,
this release contains forward looking statements that involve a
number of risks and uncertainties, including the difficulty of
predicting FDA approvals, acceptance and demand for new
pharmaceutical products, the impact of competitive products and
pricing, the timely development and launch of new products and the
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, 2004 and the quarterly report on Form 10-Q for
the period ended June 30, 2004.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Charles E. Triano, Vice
President - Investor Relations of Forest Laboratories, Inc.,
+1-212-224-6714, or Web site: http://www.frx.com/
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