Vernalis (NASDAQ:VNLS)
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Vernalis Regains Control of North American Rights To Frovatriptan From Elan
LONDON, March 30 /PRNewswire-FirstCall/ --
Highlights
-- Vernalis reacquires the North American rights to frovatriptan from Elan
-- US sales in 2003 were US$37.5 million (Q4: US$13.7 million)
-- Vernalis sees significant potential in the prophylaxis of menstrually-
associated migraine (second Phase III ongoing)
-- Vernalis intends to seek a pharmaceutical partner capable of exploiting
the MAM potential
-- Elan to provide up to 12 months transitional services in order to
maintain product supply
-- The Company intends to raise further funds by way of a rights issue in
the next 12 months
Vernalis plc (NASDAQ:VNLS)(LSE:VER) announces today that it has entered into an
agreement to reacquire in their entirety the North American rights for
frovatriptan from Elan Pharma International Ltd (Elan) for a total of US$50
million payable over 21 months. Completion of the transaction is subject to the
approval of Vernalis' shareholders and, if required, US anti-trust clearance.
Vernalis intends to seek a major pharmaceutical partner to realise
frovatriptan's significant commercial potential, including the new proposed
menstrually-associated migraine indication (see below). Vernalis also intends
to seek additional funding by way of a rights issue to assist with the
reacquisition of frovatriptan.
Under the terms of the agreement, Vernalis will make an initial payment of US$5
million to Elan on completion. This will be followed by payments of US$20
million on 31 December 2004 and US$25 million on 31 December 2005. Vernalis
will also purchase certain inventory from Elan at an expected approximate cost
of US$5 million payable no later than 31 December 2004. On completion all rights
and all product information on frovatriptan currently held by Elan will revert
to Vernalis. The licence previously granted by Vernalis to Menarini
International in respect of Europe and Central America remains in place.
Vernalis Chief Executive Officer Simon Sturge said, "Regaining the rights to
frovatriptan in our most important market is an extremely exciting opportunity
for Vernalis and represents considerable potential. We look forward to realising
the very promising opportunities for frovatriptan as we continue to build value
for Vernalis shareholders."
Overview of frovatriptan
Frovatriptan was launched in the US in the second quarter 2002, where it is
marketed as Frova(TM) by Elan Corporation and UCB as an acute treatment for
migraine. US sales in 2003 were US$37.5 million and in Q4 2003 amounted to
US$13.7 million. Under the current US arrangements Vernalis receives a royalty
return of approximately 10 per cent linked to sales.
Frovatriptan is currently in Phase III development for the distinct label for
prophylaxis of menstrually-associated migraine (MAM) for which no existing
triptans are approved.
In April 2003 data were presented from an initial clinical study into the
efficacy of frovatriptan as a preventive treatment for MAM which affects around
50 per cent of all women who suffer migraine. The data demonstrated a highly
statistically significant improvement in the number of patients who were
headache-free during the peri-menstrual period for both the studied dose
regimens of frovatriptan compared to placebo (p