BioWorld International Correspondent
LONDON - Vernalis Group plc was forced to stop the clinical development of VR1065, an appetite suppressant being developed in collaboration with F. Hoffmann-La Roche Ltd., after it showed an unsatisfactory pharmacokinetic profile in Phase I. Shares in Vernalis fell by 25 percent to 93.5 pence last week when the news was announced.
The partners will now concentrate on moving other compounds from the collaboration along and have allocated additional resources to accelerate progress. However, Nick Staples, analyst at WestLB Panmure in London, said the failure of VR1065 was a major blow. "It could take up to two years for a new development candidate to enter the clinic, leaving Vernalis' clinical pipeline looking threadbare."
Staples added that the delay would put any successor 5-HT2c compound significantly behind two other 5HT2c compounds that are in development (PNU22394 from Pharmacia Corp. in Phase I and BVT 993 from Biovitrum AB, of Stockholm, Sweden, in Phase II).
Vernalis, based in Wokingham, Berkshire, said the pharmacokinetic data generated to date have provided valuable insights. John Hutchison, senior vice president of development at Vernalis, said both companies remain committed to the project. "We and our partner, Roche, are working closely together on this important program to progress one of our earlier [stage] compounds into the clinic as rapidly as possible."
A number of potential candidates already have been identified from the 5-HT2c library generated by the collaboration. VR1065 entered Phase I study in May, three months after Roche and Vernalis announced they were extending their obesity collaboration for a further two years.
The partners have two other research collaborations, one in diabetes announced in February, the second in anxiety and depression announced in May.
Vernalis, with a staff of 150, has a high cash burn of £20 million per annum and at present has enough money for 12 months. The company has a product on the market, the migraine treatment Frova, which was launched in the U.S. two months ago, but Staples said he does not believe Frova will generate sufficient sales to fund Vernalis' cash burn.