Patented new chemical entity derived from synthetic cannabidiol will initially target multiple sclerosis and scleroderma

End-to-end solution for process development and manufacturing of API and dosage form will facilitate the advancement of clinical development

Agreement will develop cGMP-standard drug product in formats that are easy for patients to take

San Diego, CA (USA) and Basel (CH) 13 February 2019 – Emerald Health Pharmaceuticals and Lonza have announced an agreement for the large-scale manufacturing of a new synthetic derivative of cannabidiol (CBD) and its oral drug product for the treatment of multiple sclerosis (MS) and systemic scleroderma, also known as systemic sclerosis (SSc). Under the terms of the agreement, Lonza Pharma & Biotech will synthesize the active pharmaceutical ingredient (API) / drug substance (VCE-004.8) and develop the drug product (EHP-101) as liquid-filled capsules.

“As Emerald Health Pharmaceuticals advances through clinical trials, we will be supporting them with an integrated API and specialized liquid encapsulation solution,” said Christian Dowdeswell, PhD, head of dosage forms & delivery systems, Lonza Pharma & Biotech. “Patients will benefit from cGMP-quality therapies in an accessible and efficient format.”

This manufacturing agreement enables the development and future commercialization of a novel cannabinoid-based medicine for therapeutic applications across a broad range of diseases with significant unmet medical needs. Emerald Health Pharmaceuticals has been at the forefront of cannabinoid-based drug research for the treatment of serious diseases, including MS, SSc, Huntington’s disease (HD) and Parkinson’s disease (PD).

“We firmly believe that novel cannabinoid-derived molecules with a unique combination of pharmacological properties have the potential to be developed into safe and effective prescription drugs that can be of great benefit in treating patients with life-threatening diseases that currently have no cure,” said Jim DeMesa, MD, CEO of Emerald Health Pharmaceuticals. “This agreement with Lonza will help us meet this vision.”

The development program will utilize Lonza’s global network: API (VCE-004.8) process development and cGMP manufacturing at Lonza’s Nansha (CN) site, which recently concluded a successful general U.S. FDA inspection; liquid-filled hard capsules at Lonza’s Edinburgh (UK) site; soft gel capsule drug product development and manufacturing at Lonza’s Ploermel (FR) site. A dedicated program manager will coordinate the activities at the three sites.