Vernalis (NASDAQ:VNLS)
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Vernalis plc: Preliminary Results for the Eight Months Ended 31 December 2003
LONDON, March 30 /PRNewswire-FirstCall/ -- Vernalis plc today announces its
preliminary results for the eight months ended 31 December 2003 and the
reacquisition of rights for frovatriptan in North America from Elan (see
separate release).
Highlights
Frovatriptan
-- Vernalis agrees to reacquire rights to frovatriptan in North America
for $50 million, payable in installments up to 31 December 2005 (see
today's separate release)
-- Q4 2003 sales for frovatriptan of $13.7 million in North America
-- Initiation of a second Phase IIIb study with frovatriptan for
short-term prophylaxis of menstrually-associated migraine
Pipeline products and research
-- Announced today:
-- Positive data from Phase II clinical study of V10153 in acute
myocardial infarction patients and plans for a follow-up study in
stroke. The product showed similar efficacy to marketed thrombolytic
therapies and with no spontaneous bleeds.
-- Positive results from Phase I study of V2006 (Parkinson's disease).
The product was safe and well tolerated, achieving potentially
therapeutic concentrations at the lowest dose tested. It also
displayed a prolonged half-life consistent with once-daily dosing.
-- Successful initial Phase I studies with the novel analgesic V140.
-- Roche selects development candidate to treat obesity from 5HT(2C)
receptor agonist research programme, currently undergoing pre-clinical
studies by Roche.
-- New oncology research collaboration with Novartis Institutes for
BioMedical Research Inc. agreed in December 2003.
-- Integration of British Biotech, RiboTargets and Vernalis Group
completed in Q1 2004.
Financial
-- Revenue: 8.6 million pounds sterling (year ended April 2003 9.1 million
pounds)
-- Total operating loss: 29.4 million pounds (year ended April 2003 36.2
million pounds). Operatingloss before acquisitions: 17.3 million
pounds
-- Cash and short term investments of 24.2 million pounds at 31 December
2003
-- Restructuring to achieve full-year cost savings of 12.9 million pounds
completed; additional savings realised from further post-merger
restructuring which will reduce headcount to 110 during H1 2004.
Commenting on the results, Vernalis' Chief Executive Officer Simon Sturge said:
"In 2003 we embarked on a strategy of using M&A to create a sustainable,
R&D-driven biotechnology company. Restructuring and rationalisation of the
company's resources is now complete, and we have substantially reduced our cost
base. The outlook for the company is also greatly enhanced by the reacquisition
of the North American rights for frovatriptan and the positive results obtained
in our clinical studies with V10153 and V2006. Our strategy in the year ahead is
to continue to build Vernalis through the progression of our products and
research and through participationin further M&A in the biotech sector."
Enquiries:
Vernalis plc
Simon Sturge, Chief Executive Officer
Tony Weir, Chief Financial Officer
+44 (0) 118 977 3133
Brunswick Group (for analyst, financial media enquiries)
Jon Coles; Wendel Carson
+44 (0) 20 7404 5959
This document is not an offer of securities for sale in the United States of
America. Securities may not be offered or sold in the United States of America
absent registration or an exemption from registration.
Safe Harbour 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 clearance of the Company's
products, including thatof frovatriptan for menstrually-associated migraine,
the Company's ability to find partners for the development and commercialisation
of its products, including a new commercialisation partner (or partners) for
frovatriptan, as well as the terms of such partnership(s), the projected
benefits of reacquiring the rights to frovatriptan in North America and/or any
new partnership arrangement(s) on the Company's liquidity and results of
operations, as well as the Company's working capital requirements andfuture
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, and the
successful and timely completion of clinical studies, including with respect to
frovatriptan and the Company's other products, 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
frovatriptan and other products, as well as the achievement of expected
synergies from such transactions, the acceptance of frovatriptan and other
products by consumers and medical professionals, the ability of the Company to
obtain additional financing for its operations and the market conditions
affecting the availability and terms of such financing, 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 and the
risks described in our mostrecent annual report on Form 20-F filed with the
U.S. Securities and Exchange Commission (File No 0-20104).
1. Review of R&D operations
(i) Product Portfolio
Frovatriptan
-- Prescription data
Frovatriptan was launched in the US in the second quarter of 2002, where it is
marketed as Frova(TM) by Elan Corporation and UCB as an acute treatment for
migraine. Measured by prescriptions, Frova's annualised average share of the US
oral triptan migraine market in 2003 was 2.7 per cent, with a market share in
December 2003 of 3.1 per cent. Sales in the fourth quarter 2003 were $13.7
million, which resulted in sales for the eight months ended 31 December 2003 of
$25.0 million.
In Europe, frovatriptan is marketed by Menarini and has been launched in
Germany, Austria, Eire and the UK. In Germany, where frovatriptan is marketed as
Allegro(R), the drug's share of the overall triptan market at the end of 2003
was seven per cent. In January 2004 frovatriptan received marketing approval in
Switzerland and pricing approval in Italy. Further European launches are
expected during 2004.
-- Achieving a distinct label for prophylaxis of menstrually-associated
migraine
In April 2003 data were presented from an initial clinical study into the
efficacy of frovatriptan as a preventive treatment for menstrually associated
migraine, which affects around 50 per cent of all women who suffer migraine. The
data demonstrated a statistically highly significant improvement in the numbers
of patients who were headache-free during the peri-menstrual period for both the
studied dose regimens of frovatriptan compared to placebo (p