Merck scraps MS pill cladribine
pharmafile | June 23, 2011 | News story | Research and Development, Sales and Marketing | Cladribine, Merck KGaA, Movectro, multiple sclerosis
Merck KGaA has pulled all pending applications for its multiple sclerosis pill Movectro and will withdraw it from the markets in which it has been launched.
The move comes after regulators demanded extensive new clinical trial data on the drug, and gives Novartis’ rival oral MS treatment Gilenya a clear shot at the market.
Merck’s Movectro (cladribine) was approved in Russia and Australia last year for relapse and remitting MS, but the German firm was seeking approval in the more lucrative US and European markets.
This ambition was knocked back by both the FDA and EMA, who have now told Merck it would have to start a new clinical trial programme if it wants the drug to be re-considered for approval.
Merck has decided against this, saying it believes that data from ongoing clinical trials are “very unlikely” to address the regulators’ requirements, and would therefore not provide a basis for approval.
“Attempting to fulfill the FDA and the EMA requirements would necessitate the initiation of a new clinical trial programme, which would take several years to complete,” the company said in a statement.
This will be a bitter disappointment for Merck as analysts had predicted blockbuster sales for the drug, and it was relying on this revenue to help offset a relatively weak pipeline.
In a further blow, the company also said it would now withdraw Movectro from Australia and Russia, adding that it was working with the authorities on a timeline for this process.
To complete the disappointment, Merck will also have to pay an exceptional charge of 20 million euro ($28.8 million) in the second quarter.
Dr Stefan Oschmann, head of Merck’s pharma division, said: “We will continue our research and development activities and will actively pursue in-licensing opportunities to further strengthen our pipeline in multiple sclerosis.”
Oschmann added that Merck would continue to focus on its older injectable MS treatment Rebif.
Dr Bernhard Kirschbaum, head of R&D at Merck, said the company intends to complete its ongoing clinical trials of the drug, “in order to provide study participants with the opportunity to continue the trials and to add knowledge for the scientific community”.
But Merck’s woes will be a boost for Novartis, whose oral MS pill Gilenya (fingolimod), for relapsing forms of MS, will now have complete control over the market, and looks set to make good on its blockbuster predictions.
Gilenya was approved by the FDA in September last year and later by the EMA in March, to become the first oral MS pill to market.
Ben Adams
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