For all of the trouble that biopharmaceutical company Medarex
In continuing to advance its drug programs, Medarex received news that the FDA granted fast-track designation to its lead cancer-fighting drug, MDX-10, as a potential treatment for melanoma. Shares rose more than 7% on the news yesterday. That spike was a little surprising, since the FDA hasn't made any sort of positive commentary on the drug's prospects in treating the disease. Instead, the designation acknowledges that good treatment opportunities currently don't exist for patients suffering from late-stage melanoma. The FDA fast-tracks any drug that meets an unmet medical need for such difficult-to-treat conditions.
Regardless, getting the fast-track designation for MDX-10 means that the drug will move through the FDA regulatory process more quickly. It will become eligible for rolling reviews, and also for the assumed six-month priority review that the drug will receive when Medarex files a biologics license application (BLA) for drug approval. The company is expected to submit a BLA next year, assuming favorable results from its open-label phase 3 trial.
MDX-10 is currently in two phase 3 trials for melanoma. It's also in multiple earlier-combination trials for the disease, and it's being tested in numerous other cancer indications and for multiple stages of those diseases. With a steady stream of clinical trial results expected to come in next year, lots of new information will be available to give us a better understanding of MDX-10's prospects as a treatment for these difficult diseases.
Making a pharmaceutical company investment-worthy requires success in the clinic and the laboratory, but it also mandates that companies handle their finances correctly. Even though Medarex is moving forward on the scientific front, its financial dealings have been terrible. Even though it's been stuck fixing its options backdating mess, and unable able to file a 10-Q for two quarters, it seems the company still has time to showcase itself at more than 10 investors' conferences. Medarex is showing its scientific acumen, but a little more focus on cleaning up its financial dealings may be in order.