We discuss with CEO Jan Storch CB21 Pharma’s approach to specialised cannabinoid therapies and their goals for the European market. He also talks about how EU GMP certification affects dronabinol production and outlines plans for clinical trials in gynaecology, urology, dentistry, and psychiatry.
In 2024, CB21 Pharma obtained an extension of its EU GMP Part II certification for dronabinol production. What plans do you have, and what impact do you anticipate on the Czech healthcare system?
Achieving certification places us among the select European producers of this substance. Nonetheless, our primary focus is on supplying markets with a stable regulatory framework, clear demand, and established pharmaceutical compounding. As such, all production is targeted at the German market, which is the largest and most developed in the EU. In the Czech Republic, while using dronabinol in IPLP is legally permissible, it is practically unfeasible. Patients would need to cover the full cost since it is not covered by insurance. Only a few pharmacies are authorised to handle Group N substances, and unlike in Germany, there are no standardised recipes. Additionally, the reimbursement policy favours herbal cannabis, further restricting the individual preparation of dronabinol. Consequently, the Czech Republic currently represents a zero market for dronabinol. However, future opportunities may arise in hospital pharmacies and specialised centres, where standardised active ingredients could enable more precise dosing and improved quality control compared to plant extracts.
How do you view the pressure on domestic drug production and the increasing regulation of cannabinoid therapies? Where do you see potential opportunities for CB21 Pharma?
There is increasing pressure for self-sufficiency, but we must consider the economic reality: producing new APIs under EU GMP is significantly more expensive than importing from India or China and requires substantial investment. If the EU aimed to bring API production back to Europe broadly, it would heavily strain public budgets and result in higher drug prices. Thus, it is practical to concentrate on highly specialised substances where traceability and quality are crucial. CB21 Pharma has long concentrated on this area. We not only produce APIs but also engage in clinical development and register final products as medical devices. This strategy enables quicker and more flexible innovation implementation. We see the greatest potential in gynaecology, urology, and dentistry, where well-tolerated, scientifically validated solutions are lacking.
What clinical studies are you preparing to initiate, and how will Czech university hospitals be involved?
Our R&D strategy targets areas with a strong demand for innovative treatments. In gynaecology, we are leveraging positive clinical results from CANNEFF® VAG SUP suppositories, noted for their quick effectiveness and the improvement of menopausal symptoms. This data offers a solid base for further research into other gynaecological conditions. In urology, we intend to expand on the promising pilot data for chronic abacterial prostatitis (CP/CPPS), in which CANNEFF® SUP rectal suppositories demonstrated positive effects in many patients. A multicentre study is in preparation to confirm these results on a larger scale and explore new options in a field where current therapies are often limited. In dentistry, we aim to advance research on CANNEFF® DNT GEL, which clinical studies have shown to support tissue regeneration and soothe gum inflammation and implant-related issues. The gel enhances current dental treatment standards and is part of the comprehensive CANNEFF® product line, including toothpaste and mouthwash for daily oral care. The fourth area is psychiatry, where we are developing a treatment for mild anxiety, tension, and sleep disorders. We are preparing a clinical study to determine the optimal use and to validate its effectiveness in daily practice. All these projects are being developed in collaboration with Czech university hospitals. These hospitals participate in clinical research and help integrate innovations into routine care, crucial for their broader application in the Czech Republic and across Europe.
