The UK’s Vernalis has posted a 60% rise in revenues and a 29% reduction in net loss for the first half of 2007 but the firm fears that it may be forced to look for additional funding to fund its clinical programmes.
Net loss was £13.2 million and revenues reached £10.6 million, driven by Apokyn (apomorphine hydrochloride injection) for Parkinson's disease and its acute migraine drug Frova (frovatriptan). However, Vernalis noted that recent changes in US Medicare rules have led to “a significant number of discontinuations” of Apokyn prescriptions, which is reflected in the lower-than-anticipated growth in the first half and in a revised sales estimate for the year of $8 million.
However most attention at the moment is on Vernalis’ bid to get Frova approved by the US Food and Drug Administration for a new indication, menstrual migraine. The agency has set September 30 as the date for when a decision will be made on the supplemental New Drug Application for Frova and if it is approved, Vernalis will be line to receive a $40 million milestone. “There has been no request for additional information and we remain as confident of approval as we did on the day of submission in July 2006,” Vernalis stated, but if the FDA does not look kindly on the drug, the company will need to make some difficult decisions.
Vernalis said that “existing cash balances are unlikely to be sufficient to fund its future planned net losses” and if the $40 million payment is not forthcoming, it has identified “a number of steps that could be taken to manage its cash resources and ensure that it can continue in operation for the foreseeable future”. These include “the delay or cancellation of planned future clinical and preclinical programmes,” job losses and further equity financing.
"Striking" results for obesity drug similar to Acomplia
One clinical programme Vernalis certainly will not want to discontinue involves its anti-obesity drug V24343. Indeed the financial results were overshadowed somewhat by data from a 66-patient Phase I trial of the treatment which demonstrated "striking weight loss over 16 days in overweight and mildly obese volunteers”.
Evidence of efficacy was demonstrated by clinically relevant reductions in body fat, energy intake and waist circumference, Vernalis noted, but the most exciting element of the trial was that V24343, a CB1 antagonist, demonstrated significant safety differences from the most well-known drug in that class, Sanofi-Aventis’ Acomplia (rimonabant). In July, the French drugmaker pulled its regulatory package from the USA for Acomplia/Zimulti after the FDA voted unanimously during a panel meeting not to recommend it for approval, due to the risk of psychiatric adverse effects.
Vernalis noted that V24343 has shown “a number of distinguishing features over rimonabant in pre-clinical studies” including “a markedly reduced propensity for neurological adverse events”. It is also less likely to induce nausea and gastrointestinal disturbance and has a better metabolic profile.