Today marks the day that the FDA would likely have sent Neurochem (Nasdaq: NRMX ) its third approvable letter for its lead drug Kiacta. Fortunately, investors don't have to worry about the FDA rejecting Kiacta a third time as a treatment for amyloid A amyloidosis (a rare inflammatory disease), since Neurochem pulled its marketing application with the FDA earlier this month.
Not wanting to scrap its Kiacta program (and preferring not to receive another FDA approvable letter, which was highly probable), Neurochem decided three weeks ago to run a second phase 3 study of the drug, a study the FDA has been asking for. Neurochem's hardheaded 19-month delay between its first approvable letter and its decision to start a new clinical trial for Kiacta trumps even drugmakers like Encysive Pharmaceuticals (Nasdaq: ENCY ) and Neurocrine Biosciences (Nasdaq: NBIX ) that ignored FDA calls for more clinical trial work on their compounds.
Without a doubt, there's no Nasdaq-listed drugmaker with more chutzpah than Neurochem. In Neurochem's newest transformation, it's changing its name to BELLUS Health and continuing on with its plans to market its Alzheimer's disease treatment, Alzhemed, as a food supplement rather than as a pharmaceutical drug after it failed in phase 3 testing. Anyone care to take a bet on how fast the FDA will pull Neurochem's Alzhemed food supplement off the market, like it does almost every week (here, for example) with other unauthorized drugs?
In another strange maneuver, Neurochem is also running a phase 2 study in Canada on a compound with the same active ingredient as Kiacta. This time, though, the company was testing it as a treatment for type 2 diabetes, much like how it tested Alzhemed in multiple indications (Alzheimer's disease and hemorrhagic stroke) in the hopes that something would stick.
For those keeping track, Neurochem's drug development activities have now swung from just targeting a rare inflammatory disease, hemorrhagic stroke, and Alzheimer's disease to producing food supplements and fighting diabetes. Drugmakers like Neurochem and BioSante (Nasdaq: BPAX ) that are able to continually reinvent themselves are the reasons why longtime pharma analysts often point out that it's possible for a money-losing drugmaker to exist for years no matter how far-fetched its drug programs may be.