Biotech's New Blockbusters -- Oh, Really?

FierceBiotech's Maureen Martino has produced a "special report" on four biotech drugs poised for approval later this year that could be "the next generation of biologic blockbusters" -- that is, treatments that not only pull in more than $1 billion in annual sales, but which "could offer real breakthroughs for patients" while "add[ing] significant cash" to companies' bottom lines.

Or that might be so much wishful thinking. Only two of these monoclonal-antibody drugs make any pretense of novelty -- the others are essentially updated, me-too versions of existing drugs that makers hope to milk the same way Amgen did with its anemia-drug franchise. Which, to be fair, earned Amgen and its shareholders a lot of money, at least until worries about side effects and company-promoted overuse of the drugs took their toll.

So here's my rundown of the FierceBiotech list, with some quick thoughts on each:

• Motavizumab (MedImmune/AstraZeneca) is the first retread. Like MedImmune's existing drug Synagis, motavizumab is intended for use in infants to prevent respiratory syncytial virus infection. Synagis is a certified blockbuster, and it's certainly conceivable that motavizumab could be as well, but for two things the WSJ pointed out back in April: Synagis costs $6,000 for five doses, and while it can lower the rate of RSV infection, it doesn't reduce deaths from the disease. Motavizumab -- tenatively scheduled to be marketed as Numax -- appears to be more effective than Synagis and so will almost certainly be even more expensive, yet it also hasn't demonstrated any survival advantage in two major studies. In today's more conservative drug climate, especially with drug costs emerging as a major issue with respect to expected benefits, blockbuster status may be a long shot.
• Denosumab is Amgen's main shot at getting back in the game by grabbing a chunk of the $7 billion osteoporosis market. Twice-yearly shots of "D-mab" have improved bone-mineral density, in one trial even beating out weekly doses of Merck's Fosamax in a head-to-head comparison. This is all good news, of course -- but Fosamax went generic earlier this year while D-mab isn't likely to be remotely cheap. Given the sorts of high copayments many patients must now pay for pricey biologics, this one is still a roll of the dice.
• Golimumab (J&J-Centocor/Schering-Plough) is only a quasi-retread, although not of J&J-Centocor's aging arthritis drug Remicade so much as of Abbott Labs' approved drug Humira. Both treatments are fully humanized antibodies against tumor-necrosis factor that should be useful treating rheumatoid arthritis, psoriasis and similar autoimmune disease. Golimumab's best selling point is extended dosing -- potentially once every four weeks compared to once every two weeks for Humira. Again, will that be enough to justify an entirely new molecule? Color me skeptical.
• Ipilimumab (Bristol-Myers Squibb/Medarex) is a novel cancer treatment of the sort that might have easily been a shoo-in blockbuster just a year or two ago. It takes on a new target -- CTLA-4, a immune-regulating receptor protein -- in a way that may promote immune-system attacks on tumors. If, that is, it really works, which is hard to say because the data to date has been decidedly mixed and ipilimumab hasn't yet completed any late-stage "phase III" trials so far as I can tell, meaning that BMS and Medarex are hoping for accelerated approval. Make that, were hoping, as in April the companies announced that they won't actually file for approval with the FDA until next year -- which in turn makes me wonder why the drug is on this list in the first place.