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    You are here : Home » MS Research News » Drugs » ONO-4641

    ONO-4641

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    Ono’s experimental MS drug cuts brain lesions, study shows

    ONO-4641 An experimental drug to treat multiple sclerosis developed by Ono Pharmaceutical Co. reduced the number of lesions in the brain, a study to be presented at the American Academy of Neurology showed.

    Patients who took the ONO-4641 tablet were found to have as many as 92 percent fewer brain lesions, compared with a group that took a placebo, according to the study released today. Side effects from the once-a-day oral administration of the drug over a 26 week period appeared to be dose-related and included a slower heartbeat, blood pressure changes and liver enzyme elevation.

    The findings from the preliminary study move the drug a step closer to expanding the range of treatments for the debilitating condition that affects more than 2 million people worldwide. If approved, patients will have another treatment taken orally, in addition to Novartis AG’s Gilenya, the world’s first pill for MS.

    “In light of recent issues in the oral MS drug market, this is welcome news,” Timothy Vollmer, an author of the study from the University of Colorado in Denver and a fellow with the American Academy of Neurology, said in a statement.

    Ono Pharmaceutical, based in Osaka, Japan, funded the research.

    The study, the second stage of three clinical trials generally required for regulatory review, involved 407 patients age 18 to 55 with relapsing remitting MS, the most common form of the disease. They were randomly given placebo, 0.05 milligrams, 0.10 milligrams, or 0.15 milligrams of ONO-4641 for 26 weeks and had brain scans every four weeks after 10 weeks.

    Merck KGaA has the license to develop the medicine globally, excluding Japan, South Korea and Taiwan.

    MS Pill Development
    Biogen Idec Inc.’s experimental oral MS treatment BG-12 is ahead of ONO-4641 in development and in review by the U.S. Food and Drug Administration. Teva Pharmaceutical Industries Ltd.’s laquinimod pill is in the last stage of clinical testing.

    Multiple sclerosis causes the immune system to attack the myelin sheath, which surrounds and protects nerve cells, leading to symptoms including numbness, difficulty in coordination and memory loss, according to Medline Plus, a website of the U.S. National Institutes of Health. In its severest form, it can shorten life and, in rare cases, lead to death, according to the U.S. National Multiple Sclerosis Society’s website.

    MS afflicts more than 2.5 million people worldwide, according to the Multiple Sclerosis International Federation.

    The treatment will compete with therapies including Teva’s Copaxone, which generated $3.9 billion for the company in 2011, and Biogen’s Avonex, which sold $2.7 billion.

    The research is scheduled for presentation at the American Academy of Neurology meeting in New Orleans, April 21 to April 28.

    Source: Bloomberg COPYRIGHT 2012 BLOOMBERG L.P (17/04/12)

    Merck, Ono developing oral multiple sclerosis drug

    Oral MS DrugMerck KGaA said its Merck Serono unit will develop and market a pill for multiple sclerosis with Japan's Ono Pharmaceutical Co. to compete with a similar product made by Novartis AG.

    The experimental therapy, ONO-4641, is in the second of three stages of clinical trials usually required for regulatory approval, Merck said Tuesday.

    The companies will also collaborate in Japan on the development and marketing of Merck's Stimuvax, a cancer treatment in the final stage of trials, according to the statement.

    ONO-4641 is Merck's second attempt to develop a tablet for MS after it decided not to seek approval of its cladribine pill in June. Novartis' Gilenya, the first oral drug for MS, was approved last year, and Israel's Teva Pharmaceutical Industries Ltd. is developing a competing Laquinimod pill.

    "There's a huge unmet clinical need," said Gustav Ando, a London analyst at consulting company IHS Global Insight. With a pill, "the patient doesn't have to go to the hospital for monthly injections, which significantly impedes quality of life."

    Novartis has 13,000 patients on Gilenya, the company said in July. The drug may reach $1.2 billion in sales by 2013 and $2.1 billion by 2015, according to analysts' estimates compiled by Bloomberg.

    "It's a very lucrative market," Ando said.

    Source: SF Gate © 2011 Hearst Communications Inc.(05/10/11)

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