Biotech Values

[DewDiligence]

UCB Plans Cimzia-vs-Humira Phase-4 Trial in RA

[This will be the first consequential head-to-head trial of TNF-alpha drugs. Cimzia has been a commercial bust, so UCB figures it has little to lose. See #msg-48538855 for related info.]

http://www.reuters.com/article/2011/05/25/ucb-abbott-idUSLDE74O22O20110525

›May 25, 2011 1:27pm EDT
By Ben Hirschler

LONDON, May 25 (Reuters) - Belgium's UCB (UCB.BR) is to test its key rheumatoid arthritis drug Cimzia in a head-to-head clinical trial against Abbott's (ABT) Humira, in a bid to persuade doctors its fast-acting product has the edge.

Humira, which racked up global sales of $6.5 billion last year, has become the drug to beat in treating the crippling disease, with consensus forecasts suggesting its sales will reach $9.2 billion by 2014, according to Thomson Reuters Pharma.

Cimzia, with sales of 198 million euros ($279 million) last year and expected revenue of $1.2 billion by 2014, according to analysts, has a long way to go to catch up in an increasingly competitive market.

But Chief Executive Roch Doliveux told Reuters on Wednesday he was more confident than ever it would achieve peak sales of at least 1.5 billion euros ($2.1 billion).

Head-to-head clinical trials by drug companies are becoming more common as manufacturers strive to differentiate their products. They carry risks, however, since the results do not always come out as the company financing the test would like.

UCB believes the new trial will persuade doctors of the merits of its medicine, Doliveux said on the sidelines of the European League Against Rheumatisim (EULAR) annual meeting.

"We are not in the gambling business at all. We have some pretty firm hypotheses -- driven by science and clinical data and experience -- which makes us believe that Cimzia is well positioned," he said as the trial was unveiled.

In particular, UCB is banking on Cimzia's fast onset of action to help set it apart from the competition.

"Fast response is important because the earlier the response the more prolonged the response is," Doliveux said.

The study, which is expected to recruit hundreds of patients around the world, is the first industry sponsored head-to-head trial of two so-called anti-TNF drugs and will evaluate the two injectable products based upon clinical response after 12 weeks.

It will randomise patients to either Cimzia plus the older drug methotrexate (MTX) or Humira plus MTX, after which patients who respond will continue on their treatment whereas non-responders will switch to the alternative treatment arm until the study ends at 104 weeks.

It will assess patients with moderate-to-severe rheumatoid arthritis who have inadequately responded to MTX and who have not previously received anti-TNF treatment.

TNF inhibitors block a protein called tumour necrosis factor associated with inflammation. Other blockbuster drugs in the increasingly crowded category include Johnson & Johnson's (JNJ) Remicade and Amgen's (AMGN) Enbrel.

HOW DO YOU SPELL THAT?

UCB's medicine is a late arrival on the arthritis scene and has struggled to make inroads against the established brands. It currently has around 3 percent of the U.S. market, so even a few additional percentage points of market share could make a big difference to the company's sales line.

The modest uptake to date reflects a perception that Cimzia, which costs 7-10 percent less than other anti-TNFs, is little different to tried and tested products.

UCB has also had its job cut out to establish its name.

"We started three years ago in rheumatology in the U.S. and people didn't know how to spell UCB. They didn't know whether we were a stick to put in the computer -- people were talking about us as USB. It's something you overcome with time and persistence," Doliveux said.

Demand is, however, picking up week after week and he is upbeat that the drug will reach its long-term sales goal, despite the advent of a new competitors like Pfizer's (PFE) new pill tofacitinib.

"We have said that our peak sales estimate is at least 1.5 billion euros ($2.11 billion) and with what we see in terms of our development and the competitive development we feel even more confident in that," Doliveux said.‹