FDA Rejects Parkinson's Disease Drug Northera
Even with a revised proposal for Northera, to be used as a Parkison's disease treatment, Chelsea Therapeutics International Ltd will have to delay the release of its hypotension drug, due to insufficient information presented before the Food and Drug Administration (FDA).
Northera was created to treat symptomatic neurogenic orthostatic hypotension, or a chronic drop in blood pressure on standing up, that is most often linked to Parkinson's disease.
Chelsea, which does not have any approved products on the market, has experienced a decline in shares by 52 percent due to the rejection by the FDA.
Chelsea ended the quarter between January-March with $51.7 million in cash and cash equivalents. Lianna Moussatos, an analyst at Wedbush Securities, a securities firm and investment bank, anticipates this cash to run out by the end of Chelsea’s second quarter in 2013. This means that in order to produce a new trial, Chelsea would have to raise additional cash and find a partner to help with the financial woes.
Chelsea hoped to pitch a modified proposal using data from a present trial to support resubmission of its marketing application.
Moussatos estimates a new trial would push back Chelsea’s resubmission by a full two years. If Chelsea wants to save time it should modify the current trial and also propose a new trial to be conducted post-approval.
Compared to Moussatos, Scott Henry from Roth Capital Partners estimates differently. Henry expects Northera’s launch date won’t be until 2015, and he also believes the price target on the stock will be $2.25, a drop from its original target of $3.50.
Previously, Northera was rejected by the FDA in March. Chelsea's other drug in development, for rhemautoid arthrtis, had failed mid-trial in May.
Chelsea stated that it is currently evaluating several scenarios that may provide the FDA with the supportive information it is seeking.