From Feuerstein's Biotech Mailbag
thestreet.com
>Medarex keeps getting pushed to my back burner, and even here, I won't have a ton of space to comment fully, but I need to show Gil some love, so here's my quick take:
Medarex is another cancer immunotherapy story, so it basks in the Dendreon glow. The company has an impressive list of drugs in late-stage clinical testing and is tied up with some big-name Pharma partners, including Bristol Myers Squibb (BMY) and Pfizer (PFE) . It also owns a chunk of European biotech GenMab (GNMSF) .
Overall, I like the diversification because Medarex has multiple ways to win. No wonder the company is frequently mentioned as an acquisition target.
The primary focus at Medarex now is its anti-CTLA4 drug programs. In English, these are drugs (there are two of them) that switch a patient's immune system (specifically T cells) into hypersensitive mode so that it can more easily recognize and destroy cancer cells. Cancer cells are sneaky and often successfully hide from T cells, which is one reason why our immune systems don't normally rid us of cancerous cells.
Medarex and partner Bristol-Myers have multiple clinical trials ongoing with an anti-CTLA4 drug called MDX-010 (also known as ipilimumab). The most advanced of these are multiple phase III trials in first- and second-line melanoma, with data expected in the second half of this year.
Previous studies have shown some impressive efficacy out of MDX-010, and some nasty side effects. The toxicity is not necessarily bad because it's managed fairly well and may actually be a signal that the drug is working in patients.
But here's the rub: Melanoma is the cancer where otherwise good drugs go to die. It's a black hole of drug development. Now, there are some scientific reasons that an anti-CTLA4 drug and melanoma are a good fit and the efficacy hurdle might be low, but for me, melanoma drug trial equals big-time risk.
Another issue: A couple of these MDX-010 melanoma studies lack a control arm, which could make interpreting results a bit tricky for the FDA. Remember, the cancer folks at the FDA are real data-driven sticklers, and single-arm studies may not carry enough proof of efficacy. Still more worries: These single-arm studies use tumor response as the primary endpoint, but response rate has never been shown to correlate with survival in melanoma.
So, Gil. I think Medarex is an interesting stock to own, but at the right price and with the recognition that the upcoming trial data are high-risk. It looks like Medarex has been bid up lately, probably on the Dendreon happenings. Would a pullback make for a better entry point?< |
