Germany’s Merck KGaA’s got its final kick-in-the-
teeth today when the EU panel confirmed its negative opinion on Multiple-Sclerosis drug Cladribine at the same time as it gave the green light to Novartis AG’s rival drug Gilenya.
Although not a surprise, the EU’s negative vote again underlines the company’s unenviable position in the MS market.
An EU rejection for Cladribine shouldn’t compromise growth in the pharma business, Merck said last year, but the truth is the company now lacks a key component of its MS product strategy. That makes for a gap it probably can’t close with revenue from its injectable MS drug Rebif, which itself is expected to come under pressure in the U.S. after the recent market launch of Gilenya.
The company refuses to abandon ship and remains committed to continuing and completing ongoing clinical trials on Cladribine, which until now was considered to have blockbuster potential with peak sales of more than €1 billion ($1.35 billion) annually. If results of these ongoing studies—due at the end of 2011 and in the first half of 2012—are positive, Merck can re-apply for approval in Europe.
However, should Merck continue to sink money into a project which seems to have such little chance of success?
Most analysts have already ceased estimating sales for Merck ‘s Cladribine, as they doubt the drug has much chance of being approved in the U.S. following the string of failures in Europe.
Last year Cladribine lost the race for approval in the U.S. when rival product Gilenya received marketing approval.
Yet, hope dies last. The U.S. Food and Drug Administration recently extended its review of Cladribine late last year. Some analysts saw that as a positive sign, saying there is still some chance that the medicine could be approved in the U.S.—the other key market for Merck next to Europe. But even so, it will certainly take Merck a long time to catch up in the MS market.