Flamel Technologies (FLML) made quick work of turning around a Complete Response Letter from the FDA for one of the company’s undisclosed drug products. According to a press release on Monday, the company revised and resubmitted the New Drug Application in early June, and the FDA has set a PDUFA decision date for August 6, 2014. The resubmission received a Class 1 designation, meaning only minor changes to the original NDA were required, and indicating a 2-month decision goal.
Flamel is in the business of seeking approval for currently unapproved marketed drugs; for competitive reasons, the company does not disclose its product candidates. Unapproved drugs slipped through the cracks when the FDA tightened up safety and efficacy requirements in the middle of the last century. Between 1938 and 1962, some 4,000 drugs were approved based on safety, but not efficacy. To incentivize drugmakers to work towards replacing these unapproved but still marketed drugs, the Drug Efficacy Study Implementation (DESI) program allows FDA to remove competing/original products from the market if a company successfully completes the approval process for a drug that had been exempted.
The FDA approved the first of Flamel’s products, Bloxiverz (neostigmine methylsulfate) for reversal of the effects of non-polarizing neuromuscular blocking agents after surgery, in May of 2013; the product was launched in the third quarter of that year. Since, the FDA has slowly been moving to pull unapproved versions off of the market, and Flamel expects an open field by late 2014.
Now, the French company is less than two months away from potentially bringing another product to market. Flamel’s is an interesting approach to drug development, and one that few pharmaceutical companies have pursued aggressively. Given that this latest product is an unknown, August 6 could represent a significant value-driving event for FLML if the unapproved product to be replaced has significant revenue potential. Flamel is likely to increase the price of its own approved product multifold over the original.
