Endo and Vernalis Provide Update on Frova
CHADDS FORD, Pa., and WINNERISH, England, Aug. 17, 2007 -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. and Vernalis pls today announced that the U.S. Food and Drug Administration has requested an extension of the August 19, 2007 review date in order to have more time to review the supplemental New Drug Application for Frova (Frovatriptan succinate) 2.5 mg tablets for the additional indication as short-term (six days) prevention of menstrual migraine.
The FDA indicated that it will provide a revised timeline to Endo and Vernalis, and the companies will make an announcement when appropriate. Until the companies receive further information from the FDA, they intend to continue with their existing commercial plan. The FDA has not currently requested any additional information or clinical trial data.
About Endo
Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain management products. Through its Endo Pharmaceuticals Inc. subsidiary, the company researches, develops, produces and markets a broad product offering of both branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available online at www.endo.com.
Endo Forward-Looking Statements
This press release contains forward-looking statements, within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, as amended, that are
based on management's beliefs and assumptions, current
expectations, estimates and projections. Statements that are not
historical facts, including statements which are preceded by,
followed by, or that include, the words "believes,"
"anticipates," "plans," "expects" or similar expressions and
statements are forward-looking statements. Endo's estimated
or anticipated future results, product performance or other
non-historical facts are forward-looking and reflect Endo's current
perspective on existing trends and information. Many of the factors
that will determine the Company's future results are beyond
the ability of the Company to control or predict. These statements
are subject to risks and uncertainties and, therefore, actual
results may differ materially from those expressed or implied by
these forward-looking statements. The reader should not rely on any
forward-looking statement. The Company undertakes no obligation to
update any forward-looking statements whether as a result of new
information, future events or otherwise. Several important factors,
in addition to the specific factors discussed in connection with
these forward-looking statements individually, could affect the
future results of Endo and could cause those results to differ
materially from those expressed in the forward-looking statements
contained in this press release. Important factors that may affect
future results include, but are not limited to: market acceptance
of the Company's products and the impact of competitive products
and pricing; dependence on sole source suppliers; the success of
the Company's product development activities and the timeliness
with which regulatory authorizations and product launches may be
achieved; successful compliance with extensive, costly, complex and
evolving governmental regulations and restrictions; the
availability on commercially reasonable terms of raw materials and
other third party manufactured products; exposure to product
liability and other lawsuits and contingencies; dependence on third
party suppliers, distributors and collaboration partners; the
ability to timely and cost effectively integrate acquisitions;
uncertainty associated with pre-clinical studies and clinical trials and regulatory approval;
uncertainty of market acceptance of new products; the difficulty of
predicting FDA approvals; risks with respect to technology and
product development; the effect of competing products and prices;
uncertainties regarding intellectual property protection; uncertainties as to the outcome of litigation; a
determination by a regulatory agency that we are engaging in
inappropriate sales or marketing activities, including promoting
the "off-label" use of our products; changes in operating results;
impact of competitive products and pricing; product development;
changes in laws and regulations; customer demand; possible future
litigation; availability of future financing and reimbursement
policies of government and private health insurers and others; and
other risks and uncertainties detailed in Endo's filings with the
Securities and Exchange Commission, including its Annual Report on
Form 10-K filed with the SEC on March 1, 2007. Readers should
evaluate any statement in light of these important factors.
About Vernalis
Vernalis is a speciality bio-pharmaceutical company focused on products marketed to specialist neurologists. The company has two marketed products, Frova and Apokyn, and a development pipeline focused on central nervous system disorders. The company has eight products in registration/clinical development and collaborations with leading, global pharmaceutical companies including Novartis, Biogen Idec and Serono. Vernalis has established a U.S. commercial operation to promote Apokyn and co-promote Frova alongside its North American licensing partner, Endo Pharmaceuticals, progressing the company towards its goal of becoming a sustainable, self-funding, R&D-driven, speciality bio-pharmaceutical company. For further information about Vernalis, please visit: www.vernalis.com
Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that
reflect the Company's current expectations regarding future events
including the clinical development and regulatory clearance of the
Company's products and including that of Frova for menstrual
migraine, the Company's ability to find partners for the
development and commercialisation of its products, the benefits of
re-acquiring Frova in North America and the partnership with
Endo on the Company's liquidity and results of operations, as well
as the Company's future capital raising activities..
Forward-looking statements involve risks and uncertainties. Actual
events could differ materially from those projected herein and
depend on a number of factors including the success of the
Company's research strategies, the applicability of the discoveries
made therein, the successful and timely completion of clinical
studies, including with respect to Frova and the Company's other
products, the uncertainties related to the regulatory process, the
ability of the Company to identify and agree beneficial terms with
suitable partners for the commercialisation and/or development of
Frova and other products, as well as the achievement of expected
synergies from such transactions, the acceptance of Frova and
other products by consumers and medical professionals, the
successful integration of completed mergers and acquisitions and
achievement of expected synergies from such transactions, and the
ability of the Company to identify and consummate suitable
strategic and business combination transactions.
Vernalis plc
+44 (0) 118 977 3133
Simon Sturge, Chief Executive Officer
Tony Weir, Chief Financial Officer
Endo Pharmaceuticals
Inc.
+1-610-558-9800
Bill Newbould, Vice President, Corporate Communications
GCI
Group
+1-404-260-3568
Katie Hogan
Brunswick
Group
+44 (0) 20 7404 5959
Jon Coles
Alex Tweed
Posted: August 2007
