BioWorld International Correspondent

LONDON - Vernalis plc acquired U.S. rights to Apokyn, a marketed orphan drug for treating late-stage symptoms of Parkinson's disease from Mylan Laboratories Inc., for $23 million, and agreed to collaborate on new formulations of the drug with its developer and owner, Britannia Pharmaceuticals Ltd.

The deal gives Vernalis another product for the specialist neurology sales team it is setting up in the U.S. to co-promote its migraine treatment, frovatriptan. The formation of the 25-strong sales force is partly financed by Vernalis' partner Endo Pharmaceuticals Inc., of Chadds Ford, PA.

Simon Sturge, CEO, said, "For us this is a substantial strategic step. Our strategy is to start to build a revenue stream because we want a company that is financially self-sustaining. Once the sales team is established and we bring in other products, revenues fall to the bottom line."

In effect, Vernalis is taking over the license agreement Mylan, of Morgantown, W.Va., has with Britannia. The $23 million payment buys all Mylan's interests in the drug; Vernalis will pay a royalty on sales to Britannia. Mylan will provide transitional services for up to 12 months including supply chain management and customer service. The company is selling Apokyn following the decision earlier this year to divest its Bertek Pharmaceuticals business.

Apokyn was approved by the FDA as an orphan drug in April 2004, launched in July 2004 and has market exclusivity until 2011. The product is a non-ergoline dopamine agonist, apomorphine, that is a generic product in Europe, but was not launched previously in the U.S. Mylan completed three U.S. clinical trials after acquiring the rights from Britannia. Apokyn is used as an adjunctive treatment with other Parkinson's disease medications and is the only registered drug for treating acute episodes of partial or complete loss of movement experienced by patients with advanced disease.

The orphan drug designation estimated there are 100,000 such patients in the U.S. Currently the product is administered by subcutaneous injection and can restore motor function in minutes.

London-based Vernalis estimates that sales of Apokyn in 2006 will be in the range of $6 million to $7.5 million. As part of the acquisition, Vernalis has committed to complete Phase IV studies, which means the product will not be profitable initially.

The acquisition extends Vernalis' Parkinson's disease franchise: The company has an internally developed product, V2006, being developed by Biogen Idec Inc., of Cambridge, Mass., on which it has retained co-promotion rights in the U.S.

At the same time, Vernalis announced a collaboration with Britannia, of Redhill, Surrey, to work on new formulations of apomorphine for the North American market. Britannia markets a pump system for continuous subcutaneous infusion of apomorphine in Europe. That product, for use by patients with frequent attacks of immobility who otherwise require several injections a day, will be developed for the U.S. market. Britannia also has a nasally administered powder formulation of the drug in Phase III development, and Vernalis has taken U.S. rights to that.