Endo Pharmaceuticals and Vernalis plc Announce the Filing of the Supplemental NDA for Frova(R) for Short-Term Prevention of Men
20 July 2006 - 8:00AM
PR Newswire (US)
CHADDS FORD, Pa., and WINNERSH, England, July 19
/PRNewswire-FirstCall/ -- Endo Pharmaceuticals Holdings Inc.
(NASDAQ:ENDP) and Vernalis plc (LSE:VERLSE: Nasdaq:LSE:VNLS) today
announced that Endo has submitted to the U.S. Food and Drug
Administration (FDA) a supplemental New Drug Application (sNDA) for
Frova(R) (frovatriptan succinate) 2.5 mg tablets for the short-term
(six days per month) prevention of menstrual migraine (MM). This
submission contains data from previously reported pivotal Phase III
studies that met their primary efficacy endpoints of reduction in
incidence in MM. If the sNDA is approved by the FDA, Frova(R) will
be the only triptan indicated in the U.S. for the prevention of MM.
Currently, Frova(R) is FDA-approved for the acute treatment of
migraine attacks with or without aura in adults where a clear
diagnosis of migraine has been established. Approximately 21
million American women suffer from migraines. Of these female
migraineurs, approximately 60 percent, or 12 million women, are
estimated to suffer from menstrual migraines, a condition which can
have a serious and debilitating impact. Compared to non-menstrual
migraines, menstrual migraines can be more severe and are reported
to be longer in duration, often lasting up to three days. "Doctors
and patients need to understand that menstrual migraine differs
from other kinds of migraines. These differences need to be taken
into consideration in order for the condition to be treated
appropriately," said Stephen Silberstein, M.D., professor of
neurology at the Jefferson Medical College of Thomas Jefferson
University, director of the Jefferson Headache Center and lead
investigator of the initial efficacy study of Frova(R) for the
short-term prevention of menstrual migraine. "The predictable
nature of menstrual migraine supports the future use of
preventative therapy for this disabling condition." "Menstrual
migraines disrupt the lives of millions of women, but currently no
triptan is approved to prevent them," said Peter A. Lankau,
president and chief executive officer of Endo, which markets
Frova(R) in the U.S. "If approved, Frova(R) would provide a novel
treatment approach to address this unmet medical need. We are
pleased to be submitting this sNDA for Frova(R) to the FDA and will
work closely with the Agency throughout the review process." Simon
Sturge, chief executive officer of Vernalis, stated "The data
confirm the potential of Frova(R) for the prevention of menstrual
migraine. Short-term prevention could be a major benefit for women
who do not respond well to acute treatment. We continue to be
impressed by the therapeutic potential of Frova(R)." The sNDA for
Frova(R) is supported by data from four studies, including two
Phase III studies examining the efficacy and safety of once- and
twice-daily dose regimens of Frova(R) in the short-term prevention
of MM, a pharmacokinetics and tolerability study of once and
twice-daily dosing of Frova(R), and a 12-month open-label safety
study evaluating a six-day dosing regimen of Frova(R) in 525 women.
Important Information about Frova(R) Frova(R) was approved by the
FDA on November 8, 2001 for the acute treatment of migraine attacks
with or without aura (subjective symptoms at the onset of a
migraine headache) in adults. Frova(R) is generally well tolerated,
with a side-effect profile that is typical of the triptan class of
drugs. Frova(R) is indicated for the acute treatment of migraine
attacks with or without aura in adults where a clear diagnosis of
migraine has been established. Frova(R) is not intended for the
prophylactic therapy of migraine or for use in the management of
hemiplegic or basilar migraine. The safety and effectiveness of
Frova(R) have not been established for cluster headache, which is
present in an older, predominantly male population. Frova(R) should
not be given to patients with cerebrovascular syndromes, peripheral
vascular disease, uncontrolled hypertension, ischemic heart
disease, or to patients who have symptoms or findings consistent
with ischemic heart disease, coronary artery vasospasm, including
Prinzmetal's variant angina or other significant underlying
cardiovascular disease. Frova(R) should not be given to patients
within whom unrecognized coronary artery disease is predicted by
the presence of risk factors without a prior cardiovascular
evaluation. The most common adverse events (>/=4%) include
dizziness, fatigue, paresthesia, flushing, and headache. The
FDA-approved dosing for Frova(R) is one 2.5 mg tablet up to three
times within a 24-hour period. Frova(R) is not currently approved
by the FDA for any indications other than for the treatment of
acute migraine headaches, and its safety and efficacy in other
indications have not been established. Frova(R) is licensed for
this indication in the US. For other countries, check local
prescribing information. Not necessarily licensed for this
indication outside the US. Not for release in the UK. About
Menstrual Migraine Menstrual Migraine (MM) can have a serious
impact on women's lives because they last longer than non-menstrual
migraines, tend to be associated with severe pain and come back
more often. Patients with MM may suffer from migraines at any time,
although their migraine is frequently linked to their menstrual
cycle. Over 60 percent of migraines in women are associated with
menstruation. 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 http://www.endo.com/. About Vernalis Vernalis
is a speciality bio-pharmaceutical company focused on products
marketed to specialist neurologists. The company has two marketed
products, Frova(R) and Apokyn(R), and a development pipeline
focused on neurology and central nervous system disorders. The
company has seven products in clinical development and
collaborations with leading, global pharmaceutical companies
including Novartis, Biogen Idec and Serono. Vernalis has
established a US commercial operation to promote Apokyn(R) and
co-promote Frova(R) alongside its North American licensing partner,
Endo Pharmaceuticals, propelling 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 http://www.vernalis.com/. Enquiries: Endo
Pharmaceuticals Inc. +1-610-558-9800 Bill Newbould, Vice President,
Corporate Communications Vernalis plc +44 (0) 118 977 3133 Simon
Sturge, Chief Executive Officer John Hutchison, Development
Director Julia Wilson, Head of Corporate Communication GCI Group
+1-212-537-8297 Katie Hogan Brunswick Group +44 (0) 20 7404 5959
Jon Coles Justine McIlroy Endo Forward-Looking Statement 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;
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 Registration Statement on Form S-3 filed
with the SEC on March 21, 2006. Readers should evaluate any
statement in light of these important factors. 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(R) for menstrual migraine, the Company's
ability to find partners for the development and commercialisation
of its products, the benefits of re-acquiring Frova(R) 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(R) 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(R) and other
products, as well as the achievement of expected synergies from
such transactions, the acceptance of Frova(R) 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. DATASOURCE: Vernalis plc CONTACT: Bill Newbould, Vice
President, Corporate Communications, Endo Pharmaceuticals Inc.,
+1-610-558-9800; Simon Sturge, Chief Executive Officer, John
Hutchison, Development Director, or Julia Wilson, Head of Corporate
Communication, all of, Vernalis plc, +44-0-118-977-3133; Katie
Hogan, GCI Group, +1-212-537-8297; Jon Coles or Justine McIlroy,
both of Brunswick Group, +44-0-20-7404-5959 Web site:
http://www.vernalis.com/ http://www.endo.com/
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