Vernalis plc (LSE: VER, Nasdaq: VNLS) and Endo Pharmaceuticals Holdings
Inc. (Nasdaq: ENDP) today announced top-line data from the second Phase III
efficacy study of Frova(R) (frovatriptan succinate) 2.5 mg tablets for the
short-term (six-days per month) prevention of menstrual migraine (MM). The
data from this study corroborate the positive findings in a prior efficacy
study published in Neurology in July 2004 (ref: 2004, 63: 261-269). Endo
expects to file a supplemental New Drug Application (sNDA) with the U.S.
Food and Drug Administration (FDA) in the coming weeks to seek approval for
the additional indication of Frova(R) for the prevention of menstrual
migraine.
If approved, Frova(R) will be the only triptan indicated in the US for
the prevention of MM. 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.
"Menstrual migraines can have significant impact on a woman's life. The
preliminary results of this study are encouraging for women who suffer from
menstrual migraine and who have not responded well to acute treatment,"
said the lead investigator in the trial, Jan Lewis Brandes, M.D., of the
Nashville Neuroscience Group and of the Department of Neurology at
Vanderbilt University School of Medicine.
"There is an unmet need for a new treatment option that is
well-tolerated, effective and capable of preventing menstrual migraine from
occurring," stated 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.
"Menstrual migraine sufferers deserve a treatment tailored to their
condition."
Study Results
Patients in the study were treated for three peri-menstrual periods
(PMPs) and the primary endpoint was the number of menstrual migraine-free
PMPs. Both once and twice-daily dose regimens of Frova(R) demonstrated
efficacy, with statistical significance compared to placebo (p
Simon Sturge, chief executive officer of Vernalis, confirmed "We are
delighted to have achieved a positive outcome from this confirmatory
efficacy trial with Frova(R). The women in this study represent a
difficult-to-treat population, each having previously failed acute therapy.
These results underscore our belief in the potential of Frova(R)."
"We are excited about the outcome of this trial," said Peter A. Lankau,
president and chief executive officer of Endo, which markets Frova(R) in
the US. "Frova(R) may offer millions of women a promising therapy for their
monthly migraines. We look forward to working with the FDA to bring
Frova(R) to market as a preventive treatment for menstrual migraine." He
added that, if approved, Frova(R) would be the only triptan indicated for
the prevention of menstrual migraine in the US, with its unique dosing
regimen of six days per month.
Analyst Conference Call
Simon Sturge, Tony Weir and John Hutchison, CEO, CFO and Development
Director of Vernalis respectively, will today host an analyst / investor
presentation and conference call at 10:00 am BST to discuss the data. This
may be accessed by dialling: +44 1452 561 394, and quoting 'Vernalis
conference call.'
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 (greater than or equal to 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) has not been 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.
Previous Frova(R) Phase III Trials in Menstrual Migraine
Initial Efficacy Study: In October 2002, positive study data were first
presented from a study of more than 500 menstrual migraine sufferers in the
U.S., suggesting that six days treatment per month with Frova(R) (beginning
two days prior to the anticipated onset of menstrual migraine) was
effective in preventing migraine headaches triggered by menstruation. The
study was a crossover design covering three menstrual cycles in which
patients were administered each of placebo, once-daily and twice-daily
dosing with Frova(R) for one month. The data demonstrated a highly
statistically significant improvement in the numbers of patients who were
headache-free during their menstrual cycles for both once and twice-daily
dose regimens of Frova(R) compared to placebo (p < 0.0001). These data were
published in a leading journal, Neurology (2004, 63: 261-269).
Safety Study: In December 2005, data were announced from a long-term
safety study that investigated the higher dose regimen from the initial
efficacy study. Female patients were administered Frova(R) for six days
each month (2 x 2.5 mg twice-daily on day one, and 2.5 mg twice-daily for
five days) covering their menstrual cycles. The study results indicated
that Frova(R) was well-tolerated when used as a six-day dosing regimen for
up to 12 menstrual periods as preventive therapy for MM. Importantly, more
than 300 patients received 12 months of treatment, exceeding the study
objective of treating 100 patients for 12 menstrual cycles.
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
vernalis.
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
endo.
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
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.
Endo Pharmaceuticals Holdings Inc.
endo
vernalis
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