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Going head-to-head against a market leader is a gamble that does not always pay off, but pitting Actemra against Humira looks like a win for Roche (OTCQX:RHHBY). Top line data from a comparator trial showed its arthritis antibody beat the Abbott Laboratories (NYSE:ABT) blockbuster on all primary and secondary measures, an important triumph for a product that has struggled to carve out market share against the dominant anti-TNF therapies.

With data on a more convenient subcutaneous version of Actemra not due for a couple of years yet and the first oral RA therapy approaching the market, Roche needed this trial to succeed. The result will be used to persuade physicians that the product should be considered an earlier line therapy, although the full data will determine how loudly Roche and partner Chugai can shout that message. But coming after last week’s favourable guidance from the UK’s NICE, the prospects for Actemra are looking brighter.

Hitting home

Roche reported the success of the Adacta study Friday morning, a phase IV randomised, double blind, parallel group study designed to compare Actemra and Humira as monotherapies, in moderate to severe RA patients refractory to methotrexate.

The study was not huge, recruiting only 326 patients, but it was a first line study – no patient had previously received a biologic. After 24 weeks the Actemra patients had experienced significantly greater improvements on the DAS28 score, a combined index that measures disease activity and the primary endpoint of the study.

Statistical significance was also achieved on key secondary endpoints including DAS28 remission and low disease activity, as well as ACR20, 50 and 70 measures. Preliminary safety analyses showed adverse event rates were similar between the two groups, Roche said.

Superiority on all of these important measures of disease activity is a good result for Actemra although for this to really to hit home the full results, likely to come at the annual European rheumatology conference EULAR in June, need to show a clear win. Actemra remains at a disadvantage due to its intravenous administration versus subcutaneous for Humira and most other of the anti-TNFs. Just scraping statistical significance will weaken the message.

Winning the battle

It is also important to remember that this was a monotherapy trial and the anti-TNFs can often work better when used in combination with methotrexate; Actemra, an anti-IL6 antibody, appears to work equally as well as a single agent. As such, Humira was probably not shown in its best light.

Still, given the unpleasant side effects of methotrexate, evidence that Actemra is a stronger single agent therapy is no bad thing.

Roche needs to win every battle to make headway with Actemra, a slow starter that came late to an incredibly competitive field. Filed with the FDA at the end of 2007, the antibody failed to win approval until early 2010 and its use remains restricted in the US to moderate to severe patients who fail to respond to one or more anti-TNF therapies (Actemra approval masks historic disappointment, January 11, 2010).

Guidance in Europe is more favourable with use recommended in patients who have not responded to disease modifying anti-rheumatic drugs (DMARDs) or anti-TNFs. Only last week NICE in the UK updated its guidance to recommend use of the drug at an earlier stage. After DMARDs have failed, Actemra should be considered as the next treatment alongside anti-TNFs, the influential watchdog said.

Winning the war

As such the Adacta data are the second piece of good news for the product in as many weeks, in terms of Roche’s quest to win earlier stage patients.

Actemra brought in $698m for Roche and Chugai last year - analysts currently forecast worldwide sales of $2.30bn by 2016, with the Swiss pharma company booking $1.76bn of that, EvaluatePharma data show. Signs are those numbers could rise should full Adacta data impress. JP Morgan analysts wrote Friday morning that they see the potential to add SFr750m to their SFr3bn ($3.3bn) peak sales estimate; the bank is among the most optimistic on the drug’s potential.

To really level the playing field, the subcutaneous version of Actemra needs to succeed. Roche started phase III trials in 2010; two trials comparing it against the intravenous product and placebo should report in 2014. The oral RA therapies like Pfizer’s Tofacitinib are also a cloud on the horizon although ironically they will become more of a threat should Roche succeed in pulling Actemra forward – the orals are considered more likely to depose first line treatments.

The challenges ahead for the Roche product are huge. Top-selling anti-TNF Humira generated sales of more than $8bn last year, up to two-thirds estimated to come from RA. The TNFs as a class, across all indications, sold $25bn. Actemra needs to keep winning battles to even remain a contender in this war.

Source: Roche Scores Important Win With Actemra