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Emerald Health Pharmaceuticals Granted European Orphan Designation for Systemic Scleroderma

Thursday, February 15, 2018 8:00 AM
Emerald Health Pharmaceuticals Inc.

SAN DIEGO, CA / ACCESSWIRE / February 15, 2018 / Emerald Health Pharmaceuticals Inc. ("EHP"), which is developing medicines based on cannabinoid science, today announced that the European Medicines Agency ("EMA") has granted Orphan Designation for EHP's lead molecule, EHP-101, for the treatment of systemic scleroderma, also called systemic sclerosis ("scleroderma"). This chronic autoimmune disease causes severe fibrosis of the skin and internal organs and is associated with significant morbidity and mortality.

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.

"The EMA's granting of Orphan Designation for EHP-101 for scleroderma adds additional value when combined with the US FDA's recent granting to us of Orphan Drug Designation, giving us further incentive and opportunity to advance a possible solution for patients suffering from this terrible disease that has no cure," said Jim DeMesa, MD, CEO of EHP. "Since we are developing EHP-101 for multiple sclerosis as well as scleroderma, we now have indications for small patient populations at the same time that we plan our clinical studies for more prevalent diseases."

EHP's lead product candidate, EHP-101, is a patented new chemical entity derived from cannabidiol (CBD) that is being developed for the treatment of multiple sclerosis and scleroderma. The company plans to initiate a Phase 1 human clinical study in 2018 and potentially initiate Phase 2 studies for multiple sclerosis and scleroderma in 2019. EHP's second drug candidate, EHP-102, a cannabigerol (CBG) derivative, is being developed for Parkinson's disease and Huntington's disease.

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 EU 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 method of diagnosis, prevention or treatment of the condition concerned can be authorized or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

About EHP-101

EHP-101 is a patented new chemical entity derived from cannabidiol (CBD), which has been modified to enhance the therapeutic benefits of CBD by being a dual PPARγ and CB2 agonist that also affects the hypoxia inducible factor (HIF) pathway. There is evidence that these validated receptors may be beneficial in preventing neuroinflammation and demyelination in the central nervous system, and fibrogenesis in the periphery. Emerald is developing this drug candidate for multiple sclerosis and scleroderma.

About Systemic Scleroderma

Systemic scleroderma (or systemic sclerosis) is a rare and chronic autoimmune disease causing fibrosis of skin and internal organs and can also affect blood vessels, muscles, and joints. The tissues of involved organs become hard and fibrous, causing them to function less efficiently. While the symptoms of systemic scleroderma vary for each person, it can be life-threatening, depending on which parts of the body are affected and the extent of disease. The disease is more common in adults. Currently, there are no approved treatments specific to systemic scleroderma, and the current therapies for scleroderma are limited in efficacy and may contain toxicities. New treatments and early diagnosis will be critical to help reduce the symptoms of systemic scleroderma and prevent further damage to the body.1

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.

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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.

1Scleroderma Foundation. "What is Scleroderma?" Accessed February 13, 2018.

SOURCE: Emerald Health Pharmaceuticals Inc.

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