Parking a few Vernalis cut & pastes
"...SB has an interest in another triptan drug, frovatriptan, which is currently being developed by Vernalis Ltd. and which is scheduled for launch in the second half of 2001. The order required SB to assign all of its intellectual property rights and relinquish all options to regain control over frovatriptan to Vernalis Ltd."
"Under the terms of the agreement with Elan, we received an equity investment of £4.96 million and 50% of a total loan facility of £6.9 million (US$10 million). The remaining 50% will be drawn down at the end of March 2001. Elan may elect within 30 days of an NDA approval for frovatriptan to waive repayment of the US$10 million loan in return for a small reduction in the royalty due to Vernalis on sales of frovatriptan in North America. We will also receive additional milestone payments from Elan on NDA approval and when Elan achieves agreed sales levels for the drug. These payments to Vernalis could exceed US$45 million in total and are in addition to the royalties receivable from Elan.
The SB agreement provides for Vernalis to make a series of five annual $5 million payments, commencing within 90 days following NDA approval for frovatriptan. In return, SB has given up any right to receive royalties from Vernalis on sales of the product. Following this deal our net royalty income on worldwide sales of frovatriptan will increase by around 40%. Our projections indicate that within a few years of launch this deal will be substantially cash positive for Vernalis."
(FT - "Peter Worrall, finance director, said the move would lift Vernalis's royalties on the drug from 17 to 24 per cent, although it would have little effect over the first four years, because of the staged payments to SB. Frovatriptan sales are forecast to reach Dollars 250m...")
Release issued 13 Dec 2000
Vernalis Group plc ("Vernalis" LSE: VER) today announced plans for an expansion of its collaboration with Elan Corporation plc (Elan) on frovatriptan, Vernalis' 5HT1B/1D agonist for the acute treatment of migraine, for which Elan licensed North American marketing rights in October 1998, and for a further investment by Elan in Vernalis.
Vernalis will conduct a series of Phase IIIb / IV clinical studies with frovatriptan, which was granted "approvable " status by the US Food and Drug Administration ("FDA") in May 2000, to expand upon the distinctive characteristics of the drug that emerged during its clinical development programme. These studies are expected to involve around 6,500 migraine sufferers. Phase IIIb / IV clinical studies are typically carried out post-regulatory approval, and are designed to evaluate particular features of a drug's profile in a wider patient population.
Elan will make a non-convertible, interest bearing term loan of $10 million to Vernalis. At its option, Elan may elect, within 30 days following receipt of US marketing approval, to apply the full amount of the loan to buy out a proportion of the royalty due to Vernalis on North American sales of frovatriptan.
In addition, Elan will subscribe for two million new ordinary Vernalis shares, representing approximately 4.94% of Vernalis' current issued share capital, at a price of 248 pence per share. This new investment of £4.96 million will increase Elan's total holding in Vernalis to approximately 6.92% of the enlarged issued share capital. Elan will also pay certain additional post-approval milestones to Vernalis.
"Vanguard Medica Limited ("Vanguard") today announced that Menarini Group ("Menarini") will be its commercialisation partner for frovatriptan throughout Europe. Frovatriptan, a 5HT1B/1D agonist, is Vanguard’s most advanced compound, for the acute treatment of migraine.
Under the terms of the agreement Menarini will pay Vanguard royalties on sales and will purchase supplies of frovatriptan from Vanguard. Menarini has marketing rights throughout Europe.
Menarini Group is a privately owned Italian pharmaceutical company. It has established marketing operations in all major European markets allowing a broad coverage of the major migraine markets. Total sales in 1998 were over US$1 billion and the Group is one of the largest regional pharmaceutical companies in Europe with a sales force approaching 3,500.
Historically, Menarini has been involved in several extremely successful co-marketing collaborations starting with the launch of Glaxo’s ranitidine in Italy in the 1980’s. This success has made Menarini the license partner of choice for many of the leading R&D based multinational pharmaceutical companies. Menarini now has over 150 marketing collaborations and 19 of the top 20 pharma companies in the world currently have marketing agreements with Menarini..." |
