Emerald Health Pharmaceuticals Granted Orphan Designation in Europe for Huntington’s Disease
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Follows the success of obtaining Orphan Drug Designation for Huntington’s Disease in the US
SAN DIEGO, CA, Jan. 29, 2020 (GLOBE NEWSWIRE) -- Emerald Health Pharmaceuticals Inc. (EHP), a clinical-stage biotechnology company developing medicines based on cannabinoid science, announced today that the European Medicines Agency (EMA) has granted Orphan Designation for its product candidate, EHP-102, for the treatment of Huntington’s disease (HD).
“There is an urgent need for new, innovative treatments for patients with Huntington’s disease, a genetic disease which causes progressive degeneration of nerve cells in the brain and is associated with significant morbidity and mortality,” said Jim DeMesa, MD, President and CEO of EHP. “This EMA Orphan Designation adds to the previous granting of Orphan Drug Designation by the FDA, providing us additional global advantages by recognizing the unmet need with HD where EHP strives to transform lives by treating the disease with a unique therapy.”
The European Commission’s European Medicines Agency (EMA) plays a central role in facilitating the development and authorization of medicines for rare diseases, or “orphan medicines." To qualify for orphan designation in Europe, a medicine must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; the prevalence of the condition in the European Union must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development; and no satisfactory existing method of diagnosis, prevention or treatment of the condition concerned can be authorized or, if such a method exists, the new medicine must be of significant benefit to those affected by the condition.
Orphan Designation provides potential incentives from the EU to develop a medicine for a rare disease, including protocol assistance, reduced fees, funding from the European Commission for clinical trials, and protection from competition once the medicine is placed on the market, including ten years of market exclusivity.
EHP-102 is an oral formulation of a patented, synthetic new chemical entity (NCE) derived from cannabigerol (CBG), a cannabinoid that has been shown to be anti-inflammatory with evidence of neuroprotection. The NCE in EHP-102 has been modified to provide even more potent benefits compared to CBG by also affecting the peroxisome proliferator-activated receptor gamma (PPARγ), a key molecular target for the treatment of Huntington’s disease, as well as targeting other physiologic pathways involved in neuronal survival. EHP is developing this proprietary new drug product candidate initially for Huntington’s disease and Parkinson’s disease. EHP-102 received Orphan Drug Designation by the U.S. FDA for Huntington’s disease in February 2018.
About Huntington’s Disease
Huntington’s disease is a genetic disorder that causes progressive degeneration of nerve cells in the brain. It is a devastating and disabling disease that affects middle-aged people, with typical onset between the ages of 30 and 50. Symptomatic HD affects approximately 60,000 people in Europe and 35,000 people in the U.S., with another 200,000 people in the U.S. at-risk of inheriting the disease. There is a 50% chance that HD will be passed to an offspring. One of the characteristic signs and symptoms of HD is involuntary (choreaform) movements. Additional symptoms include difficulty swallowing, slurred speech and choking. Death is usually from secondary causes of the disease such as choking and infection. There is no curative treatment for HD. Treatment is mostly directed at symptomatic relief with suppression of the movement disorders.
About Emerald Health Pharmaceuticals Inc.
Emerald Health Pharmaceuticals is developing novel product candidates derived from cannabinoids for the treatment of CNS, autoimmune, fibrotic and other diseases. The Company has two families of new chemical entities, derived from synthetic cannabidiol (CBD) and cannabigerol (CBG), that it has modified through rational drug design to affect validated receptors and pathways pertinent to targeted diseases. Its first drug product candidate, EHP-101, has completed a Phase 1 clinical study and is entering Phase 2 studies focused initially on treating systemic sclerosis and multiple sclerosis. Its second product candidate, EHP-102, is in preclinical development and is focused initially on treating Huntington’s disease and Parkinson’s disease. EHP has received Orphan Drug Designation in the US and EU for systemic sclerosis (EHP-101) and Huntington’s disease (EHP-102). For more information, visit http://www.emeraldpharma.life or contact EHP at firstname.lastname@example.org.
To the extent statements contained in this news release are not descriptions of historical facts regarding Emerald Health Pharmaceuticals Inc. they should be considered "forward-looking statements," as described in the private securities litigation reform act of 1995, that reflect management's current beliefs and expectations. You can identify forward-looking statements by words such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "hope," "hypothesis," "intend," "may," "plan," "potential," "predict," "project," "should," "strategy," "will," "would," or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward-looking statements contained in this news release include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) the anticipated timing of clinical data availability; (v) our ability to meet our milestones; and (vi) our expectations regarding our ability to obtain and maintain intellectual property protection. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward-looking statements. Undue reliance should not be placed on forward-looking statements. We undertake no obligation to update any forward-looking statements. Emerald Health Pharmaceuticals' investigational drug products have not been approved or cleared by the FDA.
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