In a so-called complete response letter, the U.S. drug regulator asked the German conglomerate to either provide additional analyses of study results that it had already submitted, or carry out new trials.

The regulator is expected to rule on the treatment in the fourth quarter, the Darmstadt-based maker of drugs and chemicals said in a statement on its website today.

“This approval for Cladribine Tablets means that people with relapsing-remitting multiple sclerosis in Russia will benefit soon from this effective oral treatment”, said Elmar Schnee, President of Merck Serono. “This is an important milestone reinforcing Merck Serono’s leadership position and ongoing commitment to fight against the devastating disease of multiple sclerosis. We expect other regulatory approvals in the near future.”

The German company’s US subsidiary EMD Serono has submitted a New Drug Application with the Food and Drug Administration for cladribine as a therapy for reducing relapses in people with MS. The drug was filed with the European Medicines Agency in July.

The filing is based on the two-year Phase III CLARITY trial, which revealed that 43% and 44% of patients with relapsing-remitting MS treated with cladribine, on a total dose of 3.5 mg/kg and 5.25 mg/kg respectively, had absence of disease activity, compared with 16% on placebo. Fereydoun Firouz, EMD Serono’s chief executive, said that if approved, short-course therapy with cladribine tablets “could transform the way people approach their treatment options, and meet an unmet need as an oral, disease-modifying drug”.

The company has not given any sales estimates for cladribine but analysts confidently predict blockbuster status for the compound which has been granted fast-track status by the FDA.

News of the filing came hours after Novartis had presented promising initial data from a two-year Phase III trial of its oral MS FTY720 (fingolimod). The Swiss company is planning regulatory submissions in the USA and Europe before the end of the year.

By Kevin Grogan

View full article here: http://www.pharmatimes.com/WorldNews/article.aspx?id=16669

by Matthew Dennis

Merck KGaA has decided to discontinue Phase II clinical trials of atacicept for the treatment of multiple sclerosis based on a recommendation from a data monitoring panel, according to ZymoGenetics. The panel observed an increase in disease activity in patients receiving the drug compared to those administered placebo in one study

Merck has global development and marketing rights for atacicept under a partnership agreement with ZymoGenetics. Two ongoing studies of the compound, one in rheumatoid arthritis and one in systemic lupus erythematosus, are continuing.

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These data show that over two years of study, 43% and 44% of patients treated with Cladribine Tablets (total dose of 3.5 mg/kg and 5.25 mg/kg respectively) had absence of disease activity, compared with 16% of patients who received placebo (p<0.001 for both Cladribine Tablets groups). Disease activity was assessed both clinically and radiologically and absence of disease activity was stringently defined as no relapses, no sustained disability progression, no T1 gadolinium-enhancing lesions and no active T2 lesions based on magnetic resonance imaging (MRI) during the study.
“Immune-mediated disorders such as relapsing forms of multiple sclerosis are characterized by periods of disease activity alternating with periods of remission, and a very important goal in treating such disorders is to help patients achieve and maintain disease remission for longer periods of time,” said Dr. Peter Rieckmann, Professor of Neurology, Director Department of Neurology, Bamberg Hospital, Germany, UBC Research Chair Vancouver/Canada and an investigator in the CLARITY study. “This CLARITY data analysis is very encouraging, based on the comparison between short-course oral treatment with Cladribine Tablets and placebo with respect to MS patients who had no disease activity, as assessed by both clinical and radiological measures over two years, with only 8-20 days of treatment in the first year of study and only 8-10 days of treatment in the second year of study.”

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Racing to beat Novartis to the world’s biggest drug markets with a new oral therapy for multiple sclerosis, Merck KGaA has filed for regulatory approval of cladribine in Europe and plans to file in the U.S. later this quarter.

The application brings Merck ”closer to the possibility of providing an oral short-course treatment to patients with multiple sclerosis,” Executive Vice President Roberto Gradnik said in a statement. Last spring researchers reported that cladribine cut the risk of relapse in half, though some patients also experienced a depletion of white blood cells needed to protect them from infections. The therapy works by blunting the human immune system.

Analysts say that cladribine is likely to achieve blockbuster status, with a billion dollars in annual sales. “A market entry in Europe beginning of 2010 seems feasible, as should be the case for the U.S.,” wrote analysts for DZ Bank AG.

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Merck KGaA on Wednesday presented detailed results from a previously announced Phase III study of investigational oral multiple sclerosis drug cladribine at the American Academy of Neurology annual conference. The findings demonstrated that annual short-course treatment with cladribine significantly reduced the rate of clinical relapses, disability progression and brain lesions in patients with relapsing-remitting MS, and also led to a significant increase in the proportion of patients who remained relapse-free, the drugmaker said.

The CLARITY study involved 1326 patients who were randomised to receive one of two doses of cladribine or placebo. Results showed that patients treated with the low-dose regimen of cladribine experienced a 58-percent relative reduction in annualised relapse rates, compared with placebo, while those in the high-dose regimen group experienced a relative reduction of 55 percent. The company also stated that, over the two-year course of the study, treatment with cladribine also led to a more than 30-percent reduction in the risk of disability progression relative to placebo.

Lead author Gavin Giovannoni noted that “our study shows that cladribine tablets prevent relapses and slow down the progression of the disease, making patients feel better. Importantly, it does so without the need for constant injections that are associated with unpleasant side effects.” He added that “we will continue to follow the patients in the trial to see how they fare in the long-term.” Meanwhile, Lee Dunster, head of research at the MS Society, commented that the drug’s oral formulation “will be a huge step forward for people with MS.”

Merck reiterated that it plans to submit the drug for approval by US and EU regulators in mid-2009.

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