Alder Biopharmaceuticals caught a lucky break last week. The Bothell, WA-based biotech company saw its biggest competitor, Swiss drug giant Roche, get kneecapped by the FDA. The U.S. drug regulator delayed Roche’s application to sell a new rheumatoid arthritis drug, asking it to do more animal studies, which will probably keep the drug off the market at least one more year.
Roche is trying to win approval to sell its experimental drug, tocilizumab (Actemra), but it first needs to show it doesn’t harm fetal development or fertility, according to this Reuters report. The Roche drug is the first in its class, an antibody designed to block an inflammatory protein called IL-6 that hammers the joints of rheumatoid arthritis patients. This approach could offer doctors an alternative to the $10 billion-a-year class of drugs that block a different protein called TNF, like Amgen’s etanercept (Enbrel) and Abbott Laboratories’ adalimumab (Humira.) Analysts have predicted sales of the Roche drug could capture a tidy portion of this huge market, with sales of $2 billion a year.
So how does all this affect Alder? As I wrote back in September, Alder is angling to be a fast-follower behind Roche, with an improved antibody engineered to block the same IL-6 target. The Alder drug, ALD518, is designed to last longer in the bloodstream, so it can be given less frequently, possibly as little as three or four times a year instead of once a month, said Alder CEO Randy Schatzman. It is much more potent, so it can be given in one-tenth the dose, which is one reason it should be much cheaper to manufacture. The drug is also made to clip off a carbohydrate chain that typically hangs off other antibodies, which can sometimes provoke dangerous immune system reactions.
This concept still has a lot to prove in clinical trials, and it will take until 2013 to bring the Alder drug to the market, Schatzman said. So if Roche had gotten approval on time, that would have given it the first-mover advantage for at least four years. Now Roche’s lead will get narrower, because it is probably looking at more than a year of delay, Schatzman says.
“This will delay the Roche program 12-18 months, which is good for us,” Schatzman said in an e-mail on Friday.
Still, after the Roche news broke, Alder spent a day scrambling to get in touch with its clinical advisers to get the scoop on just how serious the FDA’s request was and what new hurdles it might pose for Alder. The answer is that the FDA wanted a full 4-part test of reproductive side effects in animals, while Roche performed just one part of the exam on embryonic-fetal development.
“Our advisors were very clear that there was nothing in the embryo-fetal toxicology that forced this issue, rather it was an increasingly conservative agency requiring a complete repro package,” Schatzman says. While there’s always a chance a conservative FDA could place new demands on Alder when it’s ready to turn in an application, that’s going to be a question for another day.