Medicinova (MNOV) Receives Positive CHMP Opinion on Ibudilast …
November 11, 2016 - als
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MediciNova, Inc. (Nasdaq: MNOV) announced that a European Medicines Agencyâ€™s (EMA) Committee for Orphan Medicinal Products (COMP) has released a certain opinion recommending waif medicinal product (orphan-drug) nomination for MN-166 (ibudilast) for a diagnosis of amyotrophic parallel sclerosis (ALS). Orphan-drug nomination offers intensity advantages including custom assistance, price waivers, and 10-year marketplace exclusivity once a medicine is on a marketplace in Europe.
This is a initial waif medicinal product nomination that MediciNova has perceived from a EMA. The routine compulsory a consummate systematic research including substantiating â€œsufficient justificationâ€� underneath a EMAâ€™s COMP criteria and that MN-166 (ibudilast) â€œwill be of poignant advantage to those influenced by a conditionâ€¦â€�
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are really gratified to accept a certain opinion recommending orphan-drug nomination for MN-166 for ALS in a European Union, a recommendation that complements a recently postulated orphan-drug nomination in a U.S. This is an critical miracle for a growth of a earnest new healing diagnosis for ALS, a life-threatening, singular illness for that riluzole is a customarily currently-approved diagnosis choice in a EU and U.S. Currently, we have dual ongoing clinical trials to weigh MN-166 in ALS in partnership with researchers during Carolinas HealthCare System’s (CHS) Neuromuscular/ALS-MDA Center and Massachusetts General Hospital. MN-166 (ibudilast) demonstrated certain trends in a halt efficiency information from a mid-study research of a CHS Neuromuscular/ALS-MDA Center study. This halt data, along with formerly reported certain ALS preclinical investigate data, was submitted to EMA COMP to residence a systematic motive for waif medicinal product nomination to settle a medical basement for a use of MN-166 (ibudilast) for ALS.”
About Amyotrophic Lateral Sclerosis
Amyotrophic parallel sclerosis (ALS), also famous as Lou Gehrig’s disease, is a on-going neurodegenerative illness that affects haughtiness cells in a mind and a spinal cord. The nerves remove a ability to trigger specific muscles, that causes a muscles to turn weak. As a result, ALS affects intentional transformation and patients in a after stages of a illness might turn totally paralyzed. Life outlook of an ALS studious is customarily 2-5 years. According to a ALS Association, there are approximately 20,000 ALS patients in a U.S. and approximately 6,000 people in a U.S. are diagnosed with ALS any year. Publications guess that there are approximately 29,000 ALS patients in a EU. Riluzole is a customarily curative diagnosis authorized for ALS in a U.S. and EU, though it has singular efficacy.
About Orphan Medicinal Product Designation
Orphan medicinal product nomination in a EU refers to pharmaceuticals that have been grown for a diagnosis of life-threatening or chronically debilitating singular diseases with reported superiority of fewer than 5 patients per 10,000 population. Orphan medicinal product nomination allows a some-more candid clinical growth trail for a drug and allows a unite to accept poignant intensity economic, scientific, and regulatory benefits, including reduced fees and taxes, entrance to giveaway custom assistance and systematic recommendation by a EMA, and a 10-year duration of selling exclusivity.
About MN-166 (ibudilast)
MN-166 (ibudilast) has been marketed in Japan and Korea given 1989 to yield post-stroke complications and bronchial asthma. MediciNova is building MN-166 for ALS and other neurological conditions such as on-going MS and drug use disorders. MN-166 (ibudilast) is a first-in-class, orally bioavailable, tiny proton phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage emigration inhibitory cause (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, that play a vital purpose in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical investigate formula and yield a motive for a healing application in neurodegenerative diseases (e.g., ALS and on-going MS), drug use disorders and ongoing neuropathic pain. MediciNova has a portfolio of patents that cover a use of MN-166 (ibudilast) to yield several diseases including ALS, on-going MS, and drug use disorders.