Zynerba Pharmaceuticals stands at the forefront of producing pharmaceutical-grade transdermal cannabinoid therapies specifically tailored for orphan neuropsychiatric disorders
Harmony Biosciences closes acquisition of Zynerba Pharmaceuticals. (Credit: Raman Oza from Pixabay)
Harmony Biosciences Holdings, a pharmaceutical company dedicated to the development and distribution of groundbreaking therapies for patients with rare neurological conditions, has finalised its acquisition of Zynerba Pharmaceuticals.
Zynerba Pharmaceuticals stands at the forefront of producing pharmaceutical-grade transdermal cannabinoid therapies specifically tailored for orphan neuropsychiatric disorders.
Harmony president and CEO Jeffrey Dayno has characterised their lead candidate, Zygel, as an all-encompassing solution with the potential to benefit approximately 80,000 patients diagnosed with Fragile X syndrome (FXS) and an additional 80,000 diagnosed with 22q deletion syndrome (22q) in the US.
Dayno said: “Zygel is a significant market opportunity that advances our long-term growth strategy of developing a diversified portfolio beyond sleep/wake therapies.
“This acquisition expands our pipeline with a product candidate in our area of expertise that could address high unmet medical needs for people living with rare neuropsychiatric disorders.”
Zygel represents a groundbreaking achievement as the first and only pharmaceutically manufactured synthetic cannabidiol. This non-euphoric cannabinoid is meticulously formulated as a patent-protected permeation-enhanced gel, facilitating transdermal delivery through the skin and into the circulatory system. Notably, Zygel is created via a synthetic process within a cGMP facility and is not derived from the cannabis plant.
Crucially, Zygel is devoid of THC, the compound responsible for the euphoric effects associated with cannabis use. This characteristic opens the door for Zygel to potentially become a non-scheduled product upon regulatory approval.
The active ingredient in Zygel, cannabidiol, has received orphan drug designation from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of Fragile X syndrome (FXS) and 22q.
Moreover, Zygel has been granted FDA Fast Track designation for addressing behavioural symptoms in FXS patients.
To complete the acquisition of all outstanding shares of Zynerba, Harmony extended a tender offer at a purchase price of $1.1059 per share in cash, totalling $60m collectively.
This offer also includes one non-tradeable contingent value right (CVR) per share, which entitles shareholders to potential additional payments, amounting to a maximum of $140m, or approximately $2.5444 in extra cash per share. These additional payments are contingent upon the achievement of specific clinical, regulatory, and sales milestones.