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Biotech / Medical : T/FIF, a New Plateau -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (872)	2/4/2002 5:40:12 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 2243

I've been watching the triptan. Maxalt is a true miracle for me. Tortured by headaches for my entire life, I just pop a Maxalt under my tongue and.... presto! On occasion, I get a rebound the next day. On those occasions, each headache costs me $8 (My copay is $25 for six 10 mg hits). I expect to see slow penetration, but it could eventually generate some decent revenue........ 09 November 2001 Vernalis Announces FDA Approval of Frovatriptan for Migraine Major Corporate Milestone for UK Biotech London, November 9, 2001 - Vernalis Group plc (‘Vernalis’ London Stock Exchange: VER) today announced that the US Food and Drug Administration (FDA) has approved frovatriptan for sale in the US for the acute treatment of migraine. "The FDA’s approval of frovatriptan is a major milestone in the history of our company," said Robert Mansfield, Chief Executive Officer of Vernalis. "Frovatriptan is the first approved product to emerge from our portfolio of new drug candidates for neurological disorders. I am extremely proud of the dedication and efforts of our entire company in obtaining approval for frovatriptan in the US. Our revenues from frovatriptan will be an important factor in Vernalis achieving profitability in the future." Controlled studies at the approved dose of 2.5 mg showed that frovatriptan has unique characteristics and benefits in the acute treatment of migraine. These studies demonstrated that frovatriptan has a prolonged presence in the bloodstream and that few migraine patients experienced a recurrence of headache within a 24-hour period of taking frovatriptan. In controlled clinical trials the drug was well tolerated and a single 2.5 mg tablet of frovatriptan was effective for the treatment of migraine attacks. Vernalis’ US marketing partner, Elan Corporation plc, who licensed exclusive North American sales and distribution rights for frovatriptan in October 1998, is currently in discussions with potential co-promotion partners and expects to conclude its launch plan this quarter. Elan intends to market the drug under the trademark FROVATM. The FDA approval of frovatriptan triggers an initial $15 million payment to Vernalis by Elan. Vernalis expects to receive further performance based milestones as well as royalties on Elan’s sales of the product. Approximately 10% of the population in the United States suffer from migraine. Worldwide sales of prescription medicines to treat migraine grew to an estimated $2 billion in 2000, from $500 million in 1995, and are expected to increase substantially over the next five years. Frovatriptan has already received approval from the French regulatory authorities, acting as the reference member state for the European Union regulatory review. The European mutual recognition process is underway with further regulatory approvals and first launches by Menarini, the company’s European marketing partner, anticipated in the first half of 2002. Notes to Editors Vernalis is an integrated European biopharmaceutical company focused on the discovery, development and commercialisation of new prescription medicines for the treatment of diseases and disorders related to the central nervous system and is internationally recognised for its expertise in neuroscience. The Company’s most advanced product is frovatriptan which has been approved in both the US and France for the treatment of acute migraine. Frovatriptan has been licensed to Elan and Menarini who will be responsible for marketing the product in North America and Europe respectively. Under the terms of its licencing deals, Vernalis expects to receive further performance related milestone payments, in additional to royalty revenues exceeding 20% of global sales of frovatripan. The Vernalis research and development portfolio includes potential medicines to treat obesity and related disorders, Parkinson’s disease, neuropathic pain, and sexual dysfunction in patients taking medication for clinical depression. Vernalis has a strong group of major pharmaceutical partners supporting its research and development efforts including Lilly, Roche, and Elan. Vernalis shares trade on the London Stock Exchange (VER). This press release contains forward-looking statements, including statements regarding Vernalis' strategy and prospects. Statements that are not historical facts are based on Vernalis' current expectations, beliefs, estimates and assumptions. Such statements are not guarantees of future performance and involve risks, uncertainties and other important factors that may cause Vernalis' actual results, performance or achievements to be materially different from those anticipated by such forward-looking statements. Important factors that may affect Vernalis' future operating results include the following: frovatriptan may not be accepted by the US market or elsewhere as quickly as expected or at all, Vernalis may not receive the milestone payments or royalty revenues it expects to receive based on sales of frovatriptan when expected or at all, Vernalis may not be permitted to use the labeling claims it wants to use to market frovatriptan in the US or elsewhere, frovatriptan may not receive further regulatory approvals in the European Union or elsewhere when anticipated or at all, frovatriptan may face later regulatory difficulties in the US and elsewhere, and other important factors described in the section titled "Risk Factors" in Vernalis' Registration Statement on Form 20-F filed with the US Securities and Exchange Commission. -ends- There will be a conference call on Monday 12th November at 1400 hrs UK time. Details of this will be announced on our website on Monday morning. For a copy of this press release or to learn more about Vernalis, visit its website at www.vernalis.com or you may visit Elan’s website at www.elancorp.com.