WINNERSH, U.K., March 12, 2007 (PRIME NEWSWIRE) -- Vernalis plc (LSE:VER) (Nasdaq:VNLS) today announces that its partner, Menarini, has received pricing and reimbursement for Frova(r) in France. Following launch in France planned for later this month, Menarini will market Frova(r) in all of the major European pharmaceutical markets.
Frova(r) (frovatriptan succinate tablets) is a selective 5-HT 1B/1D receptor agonist approved as an acute oral treatment for migraine headache and its associated symptoms. Frova(r) belongs to the triptan class of drugs and is distinguished from other triptans by its long half-life. As a result of this distinguishing feature, Frova(r) is also being developed for the short-term prevention of menstrual migraine (MM), a form of migraine that affects 12 million women in the U.S. alone.
Simon Sturge, CEO of Vernalis, commented:
"We are delighted that our partner Menarini has achieved pricing and reimbursement for Frova(r) in France, one of the major pharmaceutical markets. We are also looking forward to further potential opportunities to expand the label for the product to include prevention of menstrual migraine, both in Europe, where Menarini plans to file an application later in the year, and in the U.S., where we expect a decision about our Supplemental New Drug Application (sNDA) from the FDA in May."
Frova in U.S. and Europe
Vernalis co-promotes Frova(r) in the U.S. with its partner Endo Pharmaceuticals Inc. In Europe, frovatriptan is currently marketed in 13 countries by Menarini with a new launch expected in France in 1Q 2007. The drug was approved throughout the then 15 member states of the European Union via the mutual recognition procedure (MRP) in January 2002. In 2006, Menarini launched frovatriptan in Slovakia, Finland, Czech Republic, Slovenia, Portugal, Switzerland and all seven Central American countries. They received approval for the drug in Turkey, with a launch planned in 1Q 2007, and also applied for marketing authorisation in Russia, with approval expected 1H 2007.
Frova for intermittent, short-term prevention of Menstrual Migraine (MM)
Vernalis has completed a series of studies aimed at obtaining approval for Frova(r) for the intermittent, short-term prevention of MM and Vernalis' partner, Endo, filed a sNDA in the U.S. with the FDA in July 2006. The FDA has accepted this submission and has informed the companies that it will provide its response by 19 May 2007 (the PDUFA date) which is ten months after the sNDA submission date. If this application is successful, a $40 million milestone is due to Vernalis from Endo, though Endo reserves the right to pay $20 million in cash and retain the remaining $20 million as partial payment due on its outstanding loan to Vernalis. In 2H 2007 Menarini plans to submit an application to extend the current indication to include prevention of menstrual migraine throughout Europe under the mutual recognition procedure with France acting as the reference member state. If successful, it would lead to an extension of the existing indication for acute treatment in 25 EU countries.
Frova(r) is approved for the treatment of migraines in adults. The most common adverse events include dizziness, fatigue, paresthesia, flushing, and headache.
Notes to Editors
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 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(r) and co-promote Frova(r) 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
Phase Phase Phase Regis- Marketing
Product Indication I II III tration Market Rights
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Apokyn(r) Parkinson's North
Disease x America
-------- ----------- ---- ----- ----- ------- ------ ---------
U.S. mile-
stones &
Frova(r) Migraine x royalties
- Endo
(EU - roy-
alties)
-------- ----------- ---- ----- ----- ------- ------ ---------
U.S. mile-
Menstrual stones &
Frova(R) Migraine x royalties
Prevention - Endo
(EU -roy-
alties)
-------- ----------- ---- ----- ----- ------- ------ ---------
V1512 Parkinson's Worldwide
Disease x (excl. Italy)
-------- ----------- ---- ----- ----- ------- ------ ---------
V10153 Ischaemic Worldwide
stroke x
-------- ----------- ---- ----- ----- ------- ------ ---------
U.S. Profit
share
V1003 Acute Pain x Option
Reckitt
Benckiser
-------- ----------- ---- ----- ----- ------- ------ ---------
V3381 Neuropathic
Pain x Worldwide
-------- ----------- ---- ----- ----- ------- ------ ---------
V2006 Parkinson's U.S. Co-
Disease x promotion
Biogen Idec
-------- ----------- ---- ----- ----- ------- ------ ---------
MMPI Multiple Royalties
Sclerosis x - Serono
-------- ----------- ---- ----- ----- ------- ------ ---------
V24343 Obesity x Worldwide
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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 approval of the Company's products, the Company's ability to find partners for the development and commercialisation of its products, 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, 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 its products, as well as the achievement of expected synergies from such transactions, the acceptance of Frova(r) and Apokyn(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.