Vernalis takes diabetes pain drug into phase II

pharmafile | August 15, 2006 | News story | Research and Development Vernalis 

UK biotech company Vernalis has started enrolment into a phase II trial of V3381, a drug designed for patients with neuropathic pain resulting from long-standing diabetes.

The trial is being conducted in the US and Canada and will include approximately 30 patients studied over a 12-month period.

Neuropathic pain resulting from diabetes affects around four million people in Europe and the US. Global trends towards obesity are increasing the number of diabetic patients, and the incidence of neuropathic pain associated with the illness is, therefore, also on the increase. V3381 is a novel drug candidate, and is believed to have dual mechanisms of targeting both the central and peripheral nervous systems.

Vernalis chief executive Simon Sturge said: “Neuropathic pain causes enormous suffering, and we are hopeful that V3381 may ultimately prove to be an effective treatment for this challenging condition.”

He added: “We are building our franchise in pain management and are pleased that we have progressed V3381 to the next stage in its development.”

Vernalis is one of the largest biotech companies in the UK, having been built through a merger of Vernalis and British Biotech in 2003.

The current, steady success of the company is a major turn-around from the huge losses it accrued  in 2002, when it needed a 16 million pound share offer to bail it out of financial crisis.

The company is one of the few remaining larger, independent UK biotech companies. Celltech was acquired by Belgian pharma company UCB in 2004 and Cambridge Antibody Technology was bought out by AstraZeneca earlier this year for 702m pounds ($1.32bn).

A Vernalis spokesman told Pharmafocus: “We are now one of the largest biotech companies in the UK, with a market capitalisation of more than 200 million pounds.”

He added: “We are cash rich – with good cash reserves and we have a very broad pipeline of promising products coming through.”

The company has two products already on the market  – Parkinson’s disease orphan drug Apokyn is on market, along with migraine treatment Frova, the latter being co-promoted with Endo Pharmaceuticals in the US.

Frova has also been filed in the US for the treatment of menstrual migraine, which will help boost its sales further. Vernalis currently has three other drugs in phase II development for Parkinson’s disease, thrombotic disorders and acute pain, and two in phase I, for Parkinson’s disease and multiple sclerosis.

Apokyn is expected to make profits $5 – 7.5 million in the US alone this year.  It is marketed in Europe by Brittania Pharmaceuticals.

The company is now expanding beyond its focus on Parkinson’s disease and pain, including the development of a new treatment for ischaemic stroke currently in phase II trials: V10153 is a protein drug that is inactive in the body until it comes into contact with a newly formed clot, which it then breaks up.

Vernalis is currently undertaking clinical trials to see if the post-stroke administration time of V10153 can be extended to nine hours to give it an advantage over existing drugs by providing doctors with a wider window of opportunity for treatment. 

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