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Endo Licenses Rights from Vernalis to Market Acute Migraine
Treatment Frova(TM)
CHADDS FORD, Pa., July 14 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals,
Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc.
(NASDAQ:ENDP), and Vernalis plc (LSE:VERLSE:Nasdaq:LSE:VNLS) today announced
that they have entered into an agreement granting Endo the exclusive rights to
market Vernalis's Frova(TM) (frovatriptan) in North America. Launched in the
U.S. in June 2002, Frova(TM) is indicated for the acute treatment of migraine
headaches in adults. Net sales of Frova(TM) in the U.S. were $37.5 million in
2003.
"Frova(TM) has differentiating features from other migraine products, including
the longest half life in the triptan class and a very low reported recurrence
rate in its clinical program," said Peter A. Lankau, president and chief
operating officer. These distinct characteristics have yet to be fully
exploited in the North American market and we believe that we will be able to
capitalize on Frova's(TM) clinical benefits and commercial potential by
effectively leveraging the relationships and reputation that Endo has built
with the neurology community over the years in marketing our topical analgesic
patch Lidoderm(R). Further, Frova's(TM) potential future application for the
treatment of menstrually associated migraine makes it one of Endo's most
promising products."
One of a class of compounds known as triptans (selective serotonin receptor
agonists), Frova(TM) is also being studied as a potential prophylactic
treatment for Menstrually Associated Migraine (MAM). If approved for this
indication, the companies believe that Frova(TM) would be the first triptan to
be indicated for the prevention of any type of migraine. Vernalis anticipates
filing a supplemental New Drug Application (sNDA) for this indication following
the completion of the second of two Phase III clinical trials.
Under the terms of the agreement, Endo will pay Vernalis an upfront fee of $30
million, anniversary payments for the first two years at $15 million each year,
and a $40 million milestone payment upon U.S. Food and Drug Administration
(FDA) approval for the MAM indication. In addition, Vernalis will receive
one-time milestone payments for achievement of defined net sales targets in a
year. These sales milestone payments increase based on increasing net sales
targets ranging from a milestone of $10 million on $200 million in net sales to
a milestone of $75 million on $1.2 billion in net sales. These sales
milestones could total up to $255 million if all of the defined net sales
targets are achieved. Endo will also pay royalties to Vernalis on net sales of
Frova(TM).
On May 18, 2004, Vernalis completed the reacquisition of the North American
rights to Frova(TM) from Elan Corporation, plc for $50 million. Vernalis will
issue a five-year, $50 million, 5.0% note to Endo which will first be used to
repay all Vernalis' outstanding obligations to Elan.
"We are delighted to be able to add a proprietary brand such as Frova(TM) to
our portfolio, which is patent-protected until 2015, including a composition of
matter patent, and pleased to be partnering with Vernalis, a company dedicated
to the discovery and development of novel medicines to treat human disease,"
said Carol A. Ammon, chairman and chief executive officer. "We see Frova(TM),
our first branded neurology product, as an excellent strategic fit that will
reinforce our leadership position in pain management while expanding our
franchise into a complementary therapeutic area such as CNS (central nervous
system) disorders."
Ammon added that Endo expects to expand its primary and specialty sales force
in early 2005 by approximately one-third to ensure the commercial success of
Frova(TM) in the U.S., with the possibility for additional expansion in the
future based on the product's growth and the potential approval by the FDA for
the MAM indication.
Commenting on the agreement, Simon Sturge, CEO of Vernalis, said, "We are
delighted to be partnering Frova(TM) with Endo, who we believe will be an ideal
partner to fully exploit the potential of Frova(TM). As one of America's
leading pharmaceutical companies in the area of pain management, Endo's sales
force already has well-established relationships with the leading North
American neurologists and primary care physicians who prescribe pain
medications."
Overview of Frova(TM)
Frova(TM) 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. In April 2003 data were presented from an
initial clinical study into the efficacy of frovatriptan as a preventive
treatment for MAM, which affects roughly half of all women who suffer from
migraine. The data from this study demonstrated a highly statistically
significant improvement in the number of patients who were headache-free during
the perimenstrual period for both of the studied dose regimens of frovatriptan
compared to placebo (p