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Merck KGaA Stops Seeking Approval For MS Tablets After Regulatory Feedback

German drugmaker Merck KGaA (MKGAY.PK) Wednesday stated that it has decided not to pursue the global approval process of cladribine tablets for the treatment of relapsing-remitting multiple sclerosis, following feedbacks from the U.S. and European regulatory authorities. The company expects to incur a one-time charge of 20 million euros (about $28.8 million) in the second quarter in connection with this decision.

Multiple sclerosis or MS is a chronic, inflammatory condition of the central nervous system and is the most common disabling neurological disease in young adults. The relapsing forms of MS are the most common types of MS.

Merck KGaA, which had an end-of-review meeting with the U.S. Food and Drug Administration on the tablets' new drug application, believes that data from ongoing clinical trials are unlikely to address the FDA requirements and will not provide a basis for approval. The FDA's overall feedback was consistent with the feedback the company earlier received from the European Medicines Agency or EMA, it noted.

The company also stated that initiating a new clinical trial program to fulfill the requirements of both regulatory authorities would take several years to complete, and given the changing competitive landscape, it has decided to drop the bid.

It plans to, "focus resources on other projects bringing benefit to patients with multiple sclerosis," said Stefan Oschmann, member of the executive board and head of the Merck Serono division.

Merck KGaA said that it intends to complete the core 96-week treatment period of the CLARITY extension, ORACLE MS and ONWARD clinical trials. CLARITY is evaluating oral MS treatment with cladribine while ORACLE MS is studying cladribine in early MS. In ONWARD, oral cladribine is added on to interferon beta-1a in patients with active relapsing disease.

The company is in the process of informing regulatory agencies to ensure appropriate follow-up of patients.

In addition, Merck KGaA plans to withdraw its applications for regulatory review in a limited number of countries where procedures are ongoing. The company will withdraw the product from the markets of Australia and Russia, where cladribine tablets are approved and available under the trade name Movectro. The company will discuss the timelines and other details with the local regulatory agencies to determine the solutions for patients who are currently on Movectro therapy.

Meanwhile, the company will actively pursue in-licensing opportunities to further strengthen its MS pipeline. It will also continue its product enhancement and patient support activities around Rebif, a disease-modifying drug used to treat MS.

MKGAY.PK closed Tuesday's trading at $36.05.

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by RTT Staff Writer

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