Pharmaceutical laboratory Pharma 5 announced on Thursday the launch of its first cannabis-based medicine. “It has been available across Morocco since November 9,” said Yasmine Lahlou Filali, the company’s CEO and responsible pharmacist. The oral solution, named Cannabidiol Pharma 5, received marketing authorization in September 2024. Its launch was initially expected in the first half of 2025, as previously reported by Le360.
The medicine is intended for patients with drug-resistant epilepsy, meaning those who have not responded to at least two conventional treatments. “We estimate that between 400,000 and 500,000 people in Morocco have epilepsy, around one-third of whom are drug-resistant. That means nearly 100,000 patients do not respond to conventional treatment,” said Professor Abdelmoumen Mahly, director of research and innovation. These so-called refractory forms of epilepsy mainly affect children and adolescents, who can sometimes experience dozens of seizures a day.
Cannabidiol Pharma 5 est le nom de code du médicament 100% marocain, à base de cannabis, pour le traitement de l’épilepsie rebelle qui sera bientôt sur le marché. (K.Essalak/Le360)
Cannabidiol Pharma 5 is a generic version of a reference medicine already marketed in Europe and the United States. “We are a generic drug manufacturer. For our first product on the market, we wanted to start with a generic medicine that has proven its effectiveness and is already an established reference worldwide,” Mia Lahlou Filali explained when asked why the company had chosen epilepsy as its first indication.
One consequence, acknowledged by the laboratory, is that “no specific clinical trial was conducted for the epilepsy indication, since, under international standards, we have to rely on the studies carried out for the original reference medicine on which the generic is based,” Abdelmoumen Mahly said. As with any generic drug, Pharma 5 submitted bioequivalence studies and uses the same indications and lists the same side effects as the original medicine.
The results cited by the company therefore come from international studies on cannabidiol. “In more than 50% of cases, we can achieve a very significant reduction in the number of seizures,” Abdelmoumen Mahly said, adding that “in 10% of cases, seizures disappear completely.”
The laboratory is also claiming a world first, based on its observations at a recent international pharmaceutical trade fair. “No one else is offering this generic medicine today,” Mia Lahlou Filali said.
The active ingredient is a cannabidiol (CBD) isolate purified to more than 98%, in line with the European Pharmacopoeia. “CBD is not a psychoactive substance. THC is the psychoactive substance and our product contains no THC,” Abdelmoumen Mahly stressed, noting that the medicine is largely intended for children. Dosages are adjusted according to the patient’s weight using graduated oral syringes.
The price, though, drew attention “Yes, it remains an expensive product,” Mia Lahlou Filali acknowledged, citing the cost of pharmaceutical-grade raw materials. “The original medicine costs between 10,000 and 15,000 dirhams elsewhere in the world, while ours costs 5,000. So we are at least 50% cheaper.”
The medicine is not currently covered by health insurance. “The reimbursement application is being reviewed by the National Health Insurance Agency (ANAM),” Yasmine Lahlou Filali said.
An integrated supply chain, from the Rif to the factory
Pharma 5 says it controls the entire production chain, from cultivation and extraction to purification and manufacturing. “This represents more than five years of research and development. We have invested more than 200 million dirhams, two-thirds of which has already been committed,” Mia Lahlou Filali said.
More than 40 hectares have been cultivated in the Rif in partnership with local cooperatives, and over 100 tonnes of biomass have been processed, a significant portion of which was used for trials. “We knew nothing about it. We had to learn alongside the farmers,” the CEO acknowledged. More than 70 families are involved in the project. Their income, she said, has increased “between fivefold and tenfold compared with what they used to earn from illicit activities.”
Cultivation has been GACP-certified since 2023, while extraction is carried out using supercritical CO2, without solvents. “This is the first time that an active pharmaceutical ingredient of plant origin has been produced entirely in Morocco,” Yasmine Lahlou Filali said. The documentation for this active ingredient has been approved by the Moroccan Agency for Medicines and Health Products (AMMPS).
The launch falls under the July 2021 law governing the legal uses of cannabis, overseen by the National Agency for the Regulation of Activities Related to Cannabis (ANRAC).
The laboratory is taking a cautious approach to exports. “Our priority is to serve Moroccan patients first,” Mia Lahlou Filali said, while acknowledging a production constraint: “Since the raw material comes from a plant, we cannot control from one year to the next how much we will produce.”
Pharma 5 is also preparing to extend the medicine’s indications to include pain, post-traumatic stress disorder and insomnia. “These are phase 3 clinical trials, with more than 300 to 400 patients enrolled in each study,” Abdelmoumen Mahly said.
Other cannabis-based medicines are also in development, notably for Parkinson’s disease, multiple sclerosis and endometriosis. “These will take more time,” the company’s management warned.
