ECTRIMS 2016: What Future For Merck KGaA’s Cladribine?
Executive Summary
With the EMA’s review of the latest MAA for cladribine ongoing, Merck KGaA is using ECTRIMS 2016 as the stage for numerous new presentations on the drug’s efficacy and safety. Data on this additional induction therapy are positive, but regulators and the market could prove difficult to persuade.
The 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2016) in London is bearing witness to the reappearance of Merck KGAA’s oral induction therapy cladribine, with an ample number of presentations covering the drug’s safety and efficacy. And while new safety data in particular might help the drug finally gain approval, the changes in the multiple sclerosis (MS) market in recent years mean higher commercial hurdles.
Most of the ECTRIMS presentations include analyses of data from already-known trials, namely the Phase III CLARITY, CLARITY Extension and ORACLE-MS studies, as well as the Phase II ONWARD study.
In addition, there is an integrated safety analysis from cladribine’s MS development program, which notably includes data from the ongoing PREMIERE registry and appears supportive of the drug’s risk-benefit profile, especially with regards to the risk of neoplasms.
As cladribine’s potential risk of malignancy was one of the chief reasons behind the European Medicines Agency’s (EMA’s) previous refusal to approve, the positive data presented at ECTRIMS 2016 are certainly promising. However, approval is far from a shoo-in, not least because of the ongoing lack of direct head-to-head trials involving cladribine versus other MS drugs.
If Merck does succeed in convincing European regulators this time around, cladribine could reach the market by October 2017.
However, it hardly seems positioned to claim a large share of the MS market.
The current competitive landscape is very different to the one that existed in 2010 at the time of cladribine’s initial rejection. Numerous drug approvals have occurred in MS in recent years – there are now three oral disease-modifying therapies (DMTs) available: Novartis AG /Mitsubishi Tanabe Pharma Corp.'s Gilenya (fingolimod), Biogen Inc.'s Tecfidera (dimethyl fumarate) and Sanofi's Aubagio (teriflunomide) – diminishing any novelty around cladribine’s oral formulation.
The recent approval of Sanofi/Bayer AG's Lemtrada (alemtuzumab) also means that there already is an effective induction therapy on the market, once again weakening another of cladribine’s key competitive advantages.
Finally, Roche’s Ocrevus (ocrelizumab) is poised to further revolutionize the treatment landscape in 2017 as a high-efficacy and well-tolerated B-cell-targeting drug that is effective across a range of MS subtypes.
The large number of disease-modifying competitors, coupled with the current low usage of induction treatment strategies, represents a serious constraint on cladribine’s commercial potential.
Ines Guerra is an analyst with Datamonitor Healthcare, your source for timely, in-depth, interactive research and expert analysis of the pharmaceutical and biotechnology industries. For more information on the research covered in this article, click here.