Shares of Flamel Technologies (FLML +15.7%) pop on a 5x surge in volume representing a tidy 450% gain from the December 2012 low of $2.85. The fuel for the uptrend is the expectation that the FDA will issue a ruling that will favor Flamel's Bloxiverz (neostigmine methysulfate injection).
Neostigmine was first synthesized in 1931, making it eligible for grandfathering when the FDA was established. No company had an approved NDA for the product until Flamel's in July 2013. The regulator typically removes unapproved products within one year after it clears an NDA. Bloxiverz will enjoy a period of exclusivity as a result. Approximately 5M vials of neostigmine are sold in the U.S. each year.
The FDA sends Flamel Technologies (FLML -15%) a complete response letter (CRL) regarding its second NDA application from the Eclat portfolio. During an on-site inspection of a ingredient supplier's operations, some facility deficiencies were noted. These must be rectified before the agency will approve the application.
The company received the CRL on the PDUFA date. A new one will be established when the firm addresses the issues and resubmits its application.
Flamel Technologies (FLML +1.5%) bucks a weak tape today after saying it's signed a multi-year development partnership agreement with an undisclosed, large international pharmaceutical company. The development work, which will be done in Flamel's Bordeaux facility in France, is expected to generate revenue of over $4M over the next several years, and could be expanded.