Vernalis Biotech Hipe

Die finanziellen Schwierigkeiten des Biotechunternehmens Vernalis (+93,7% auf 93,25p) haben vorläufig ein Ende gefunden. Der neue Vertriebspartner, das US-Unternehmen Endo Pharmaceuticals, wird Vernalis bis zu 400 Mio.$ überweisen. Endo darf dafür das Migränemedikament Frova in den USA vertreiben.

 

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VERNALIS AKTIE
Vernalis ist ein britisches Pharmaunternehmen, dass in der Forschung und Entwicklung von Behandlungen für Migräne, Übergewicht, sexuellen Störungen und die Parkinsonsche Krankheit tätig ist.
 
Das Unternehmen entstand im September 2003 durch die Fusion von British Biotech plc und der Vernalis Group plc.
 
Die Forschungs- und Entwicklungseinrichtungen des Unternehmens befinden sich in Reading und Cambridge. Vernalis entwickelt seine Therapien vollständig von der Forschung bis zur Registrierung der Produkte. Das fortschrittlichste Produkt des Unternehmens ist das Migräne-Medikament frovatriptan, das bereits in den USA und 15 europäischen Ländern zugelassen wurde.
 
Einige Programme arbeiten an der Entwicklung von Medikamenten für große potentielle Märkte - Thrombosekrankheiten, Schmerz und die Parkinsonsche Krankheit.
 
Die Aktien des Unternehmens notieren an der Londoner Börse und sind Teil des FTSE Techmark Index.  

Name: VERNALIS Telefon: +44 118 977 3133
Adresse: Fax: +44 118 989 9300
Oakdene Court, 613 Reading Road E-Mail: enquiries@vernalis.com
Winnersh RG41 5UA, Berkshire Internet: www.vernalis.com
Geschäftsjahresende: 31.12. Vorstandsvorsitzender:
Streubesitz: - Simon Sturge
Hauptaktionäre: Vorstand:
Invesco Perpetual UK 28.06% Apax Partners & Co Ltd 9.18% Aberforth Partners 5.76% Jupiter Asset Management Ltd 5.00% Hunter Hall Investment Management 3.82% Legal & General Investment Management Ltd 3.51% AXA SA 3.02% Peter Fellner, Anthony Weir, John Slater, Ian Clark, John Hutchison, George Kennedy, Carol Ferguson, Peter Read, Allan Baxter, Simon Sturge
Industrie: Gesundheitswesen Sektor: Pharmazeutische Industrie
 Subsektor: Pharmazeutische Industrie
 

Vernalis shares plunge on FDA rejection
3rd October 2007
By Sarah Routledge
Shares in UK biopharmaceutical company Vernalis have halved in value following the FDA's rejection of Frova for the prevention of menstrual migraine.  








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COMPANIES MENTIONEDCuraGen Corporation
Endo Pharmaceuticals Holdings Inc.
Vernalis Group PLC
WHITE PAPERS
No White Papers Available


The decision means a delay to a milestone payment Vernalis is due from US partner Endo Pharmaceuticals. The $40 million payment triggered by an approval would have gone some way to paying down the company's debt of $50 million to Endo.

The FDA has identified deficiencies and asked for additional information pertaining to Endo's supplemental new drug application (sNDA) for Frova (frovatriptan succinate) 2.5mg tablets in a "not approvable" letter, according to the company. Frova is already approved for the treatment of migraine with or without aura in adults where a clear diagnosis of migraine has been established.

While the FDA acknowledged that both pivotal efficacy trials that had been submitted as part of this sNDA met their primary endpoints in significantly improving the number of headache-free perimenstrual periods, it questioned whether the benefit demonstrated was clinically meaningful. The FDA also noted that even though serious vascular adverse events were not observed in this drug development program, an increased risk (compared to the approved acute use) could not be ruled out.

Simon Sturge, CEO of Vernalis, said: "We are surprised and disappointed by the FDA's response, as they had not engaged the companies in any dialogue during the extended review cycle as to FDA's interpretation of the data in the application."

Vernalis said that it had already been evaluating a number of options for its overall operations, which it would now review in light of the FDA decision.