FDA Gives Cimzia the Thumbs Up in RA—At Last

UCB’s Cimzia deserved a break. After a troubled developmental and regulatory history (read about it here and here) the drug finally received FDA approval for RA today, earlier than most expected, and with a label that analysts describe as “the best possible.”

Brussels-based UCB received a complete response letter for the pegylated anti-TNF antibody in January, requesting a new safety update. That led most analysts to predict approval towards the end of this year at best—even though UCB had submitted its safety update at the end of April. Nor had anyone held much hope of approval with a pre-filled syringe and the option of dosing both fortnightly or once-monthly, since neither were tested in all Phase III trials. The approval grants both.

That’s lucky, since UCB will need all the tail-wind it can find to gain market share in a highly competitive market. Already on the market since last May for Crohn’s disease, Cimzia will be the fifth anti-TNF in RA, joining well-established incumbents including Abbott Laboratories’ twice-monthly Humira, which sold over $1 billion in the first quarter of this year, and Johnson & Johnson’s recently-approved once-monthly golimumab (Simponi). Humira’s pre-filled syringe formulation has already given it a huge lead over J&J/Schering-Plough’s Remicade, which is given by infusion. As such, “we have cautious expectations for Cimzia,” writes Piper Jaffray’s Richard Parkes, adding that the drug might eventually garner a 5% share of the RA biologics market, or about €593 million in peak sales.

But UCB is doing its damnedest to trump even Humira’s pre-filled syringe with a device, developed in conjunction with consumer products company OXO, that it describes as state-of-the-art. According to the press release, it’s ‘easy-to’ everything: open, grip, plunge, read….in sum, it’s a device designed to make self-injection as simple as pie for RA patients.

UCB isn’t solely banking on super-duper finger grips and easy-to-push syringe plungers to provide sufficient differentiation versus Simponi, and on a once-monthly dosing option to help it steal share from Humira, though. “We’ll sell it on efficacy,” a company spokesperson told The IN VIVO Blog, pointing to the drug’s fast-onset and long-lasting effects that result from its being the only pegylated anti-TNF. “I think it will go beyond $1 billion,” the spokesperson continues.

That would certainly be nice, since UCB faces a tough 2010, with its biggest-selling epilepsy drug levetiracetam (Keppra) facing generics in Europe (it’s already generic in the US), allergy drug levocetirizine (Xyzal) losing exclusivity in the US (and in the EU in 2011), and a loss of royalty income inherited from its 2004 acquisition of Celltech.

“You don’t have to be first to be best,” points out UCB, and that’s true. It’s also true that docs are calling for more choice in a market that’s growing, and where many patients don’t respond to existing drugs. But it will be an uphill battle for UCB even with a favorable label and a snazzy device—particularly now, when even Humira is suffering a growth slowdown as patients back away from pricey biologics.

UCB is desperate to prove the skeptics wrong. “I don’t blame them [the analysts] for their caution,” says the spokesperson, given Cimzia’s dodgy track record with FDA. But now that it’s through, UCB’s 150-strong US RA sales force is in place and the drug will go to its first patient within 24 hours, the company says. “We’ll prove we can get more than 5% market share,” the spokesperson says. “We’ll walk the talk.”

image of delirium tremens (belgian ale) by flickr user Nic Launceford used under a creative commons license