Vernalis plc: Research and Development Update

Vernalis plc (LSE: VER, NASDAQ: VNLS) is today providing to sector analysts a comprehensive update on in its R&D pipeline. Highlights include:

·         Frovatriptan

A Phase III long-term safety study has been initiated to support the extension of frovatriptan’s approved use to the prevention of menstrually-associated migraine. A confirmatory Phase III efficacy study will also begin in Q1 2004, with US and EU regulatory submissions planned in 2005.

·         BB-10153

This novel recombinant thrombolytic protein, targeted at stroke, has been assessed in an initial Phase II proof-of-concept ascending dose study in acute myocardial infarction (AMI), in 28 patients. The product met its initial efficacy end point, with full coronary blood flow restored in three out of seven patients at the 5mg/kg dose. Its safety profile was encouraging, with no bleeding observed. It is now being assessed in up to 35 further patients, with FDA approval to evaluate it up to a 10mg/kg dose.

·         5HT_2C receptor agonists

Roche has now selected a development candidate from this collaborative research programme for obesity, to progress into pre-clinical studies. Upon successful completion of pre-clinical testing, clinical studies will also be undertaken by Roche.

·         R140

This GABA_A agonist for the treatment of pain in cancer patients is being assessed in a Phase I clinical programme. Multiple doses were well tolerated, with no obvious signs of sedation. Phase IIa studies are planned to begin during 2004.

·         VR-2006

This adenosine A_2A receptor antagonist, a potential new treatment for Parkinson’s disease, has begun Phase I clinical studies.

Vernalis’ Chief Executive Officer, Simon Sturge, said: “At the beginning of October we announced that Vernalis would focus on its most competitive R&D pipeline products. Today’s announcement shows advances in all these key areas.”

Enquiries:

Vernalis plc

Simon Sturge, Chief Executive Officer

+44 (0)1223 895555

Tony Weir, Chief Financial Officer

+44 (0)118 936 7808

Brunswick Group

Jon Coles; Wendel Carson

+44 (0)20 7404 5959

Vernalis plc: R&D pipeline progress

Frovatriptan

·         Sales and prescription data

Frovatriptan was launched in the US in the second quarter of 2002, where it is marketed as a treatment for migraine by Elan Corporation and UCB. Frova™ generated sales of $9.1 million in Q3 2003 compared to $5.9 million in Q2 2003.

Prescription growth for Frova remained strong in Q3 2003, its share of the oral triptan migraine market reaching 3.2 per cent. In Germany, where frovatriptan is marketed as Allegro^Ò by Menarini, the drug’s share of the overall triptan market now stands at 7.25 per cent.

·         Development 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. These 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< 0.0001).

A long-term safety study is under way and a confirmatory efficacy trial will commence in the Q1 2004 to support extension of the existing frovatriptan label to include this novel indication. If the positive initial results are confirmed, these studies will lead to regulatory submissions in the US and Europe during 2005.

BB-10153

BB-10153 is a novel recombinant thrombolytic protein targeted at thrombotic disorders, in particular, stroke and peripheral artery occlusion. It is currently being evaluated by the TIMI Study Group in a Phase IIa ascending dose study to establish proof-of-concept (i.e. that it can dissolve clots and restore coronary bloodflow) in patients who have suffered acute myocardial infarction (AMI).

A total of 28 AMI patients have now been treated, in cohorts of seven per dose, with 1, 2, 3 and 5mg/kg doses of BB-10153. At the 5mg/kg dose level, the benchmark TIMI-3 bloodflow (i.e. full bloodflow restored within one hour of drug administration) was observed in three patients out of seven. To date, there have been no significant bleeding events in the trial and the drug appears to be well tolerated.

Having met the safety and efficacy criteria defined in the study protocol, treatment of a second cohort of seven patients at the 5mg/kg dose level is now under way. In addition, as a result of the encouraging safety data, an amendment to the study protocol has been approved by the FDA to allow evaluation of BB-10153 at doses up to 10mg/kg. Approximately 35 further patients will be evaluated, with results expected in Q2 2004.

5HT_2C receptor agonists

Vernalis’ 5HT_2C receptor agonist research programme for obesity is being undertaken in collaboration with Roche. Vernalis announces today that Roche has now selected a development candidate which Roche will progress into pre-clinical studies. Upon successful completion of pre-clinical testing, clinical studies will also be undertaken by Roche.

R140

R140 is a GABA_A agonist targeting the treatment of pain in cancer patients. It entered a Phase I clinical programme in September 2003 to evaluate its safety and pharmacokinetic properties in single and multiple dose studies.

The first elements of the Phase I programme, in which R140 has been administered to healthy volunteers both as a single dose and four times daily for five days, are now nearing completion. To date the drug has been well tolerated and there have been no obvious signs of sedation. Further safety and pharmacokinetic data are being evaluated.

The next stage in development will include a Phase Ic (proof of principle) study to investigate the analgesic properties of the compound in healthy volunteers and a Phase IIa (proof of concept) study in patients. The Phase I programme is expected to be completed in H1 2004.

VR-2006

VR-2006 is an adenosine A_2A receptor antagonist in development as a potential novel treatment for Parkinson's disease that is expected to possess advantages over current dopaminergic treatments. Recruitment of healthy volunteers has now started in the first Phase I study of VR-2006, designed to investigate the drug’s safety and pharmacokinetics. The Phase I clinical programme is expected to be completed by the end of 2004.

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Safe Harbour statement: this news release may contain forward-looking statements that reflect the Company’s current expectations regarding future events. 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 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.

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