SAN DIEGO, CA / ACCESSWIRE / February 26, 2018 / Emerald Health Pharmaceuticals Inc. (EHP), which is developing medicines based on cannabinoid science, today announced that it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for its drug candidate, EHP-102, a patented cannabigerol (CBG) derivative, for the treatment of Huntington's disease (HD). HD is a fatal genetic disorder that causes the progressive breakdown of nerve cells in the brain.
'Having secured orphan designation for our lead product, EHP-101, a cannabidiol (CBD) derivative, for systemic scleroderma in the U.S. and Europe, we aim to repeat that accomplishment for EHP-102 for Huntington's disease. The FDA's granting of orphan designation for EHP-102 is a key step toward that goal,' said Jim DeMesa, MD, CEO of EHP. 'These are debilitating diseases that need new and more innovative treatments, and we look forward to getting our drug candidates into human studies.'
Huntington's disease typically appears in the 30 - 50 year age range. It deteriorates patients' physical and mental abilities to the extent that they are unable to care for themselves, and has no cure. A child of a parent with HD has a 50% chance of carrying the faulty gene. In the U.S., approximately 30,000 people are symptomatic and more than 200,000 are at risk of inheriting the disease (Huntington's Disease Society of America).
The FDA grants Orphan Drug Designation status to drugs and biologics that treat rare diseases, defined as those affecting fewer than 200,000 people in the U.S. The FDA Office of Orphan Products Development evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and support their scientific development.
Benefits associated with Orphan Drug Designation include seven-year marketing exclusivity against competition, tax credits for qualifying clinical trials, and federal grants. In addition, a marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.
About EHP-102
EHP-102 is derived from CBG, a natural cannabinoid that has been shown to be anti-inflammatory and shows evidence of neuroprotection. EHP-102 has been modified to provide even more potent benefits compared to CBG by also affecting peroxisome proliferator-activated receptors gamma, PPARy, a key molecular target for the treatment of Huntington's disease, as well as targeting other pathways involved in neural survival. EHP is developing this proprietary new drug candidate for Huntington's disease and Parkinson's disease. EHP aims to initiate a Phase I study of EHP-102 in 2019.
About Emerald Health Pharmaceuticals Inc.
Emerald Health Pharmaceuticals is developing product candidates derived from cannabinoids for the treatment of inflammatory, autoimmune, metabolic, neurodegenerative, and fibrotic diseases. The company has two families of new chemical entities, based on CBD and CBG, that it has modified through rational drug design to affect validated receptors pertinent to targeted diseases. Its first drug candidate, EHP-101, is focused on treating multiple sclerosis and scleroderma. Its second, EHP-102, is focused on treating Huntington's disease and Parkinson's disease. The company is advancing preclinical development with the intent to launch a Phase 1 clinical study in 2018 for EHP-101.
For more information, visit www.emeraldpharma.life or contact: info@emeraldpharma.life.
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 these presentations 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.
SOURCE: Emerald Health Pharmaceuticals Inc.
