Secret Flamel drug snubbed by FDA; shares drop
This article was originally published in Scrip
The new drug application (NDA) for a yet-to-be disclosed experimental medicine from French drug maker Flamel Technologies was rejected by the FDA, the company revealed on 29 April – news that had investors recoiling from the firm's shares.
The stock dropped 15% in morning trading, before closing the day at $11.91, down $1.19, or about 9%.
Flamel, which has been secretive about the drug – only disclosing it is the second NDA from the firm's Éclat portfolio – said the FDA issued a complete response letter (CRL) citing deficiencies found during a recent inspection of the manufacturing facility where the active pharmaceutical ingredient (API) is made by the firm's supplier.
"There were no other deficiencies in the CRL," Flamel insisted.
The company said it would need to satisfactorily resolve the facility deficiencies before the FDA would approve the NDA.
The company also said final agreement on the draft product labeling was pending.
"While we are disappointed by this delay, we believe that our application is sound and will work with the API supplier to resolve any open issues," said Flamel CEO Michael Anderson. "We will do everything in our power to submit the information sought by the FDA in order for them to reconsider our NDA as soon as possible."
He said the company could not yet estimate the timing of the NDA's resubmission to the FDA or when the agency would act on the application.
Mr Anderson said Flamel would communicate any updates on the status of the NDA to investors, "when appropriate."