The long timelines and considerable risks involved in bringing a drug to market are well known, but the risks are even greater when a class of drug substance becomes effectively legal and unregulated overnight.
So for companies developing drugs containing cannabis-derived ingredients, the increasing legality of marijuana across the US and worldwide could be deemed a blow to heavy investment and years of R&D.
GW Pharmaceuticals, for example, is preparing for a commercial launch in the US and Europe of its potential epilepsy treatment Epidiolex – an oral solution of pure plant-derived cannabidiol (CBD) – which is the result of 18 years of research in the field of cannabinoid science.
But with increased access to ‘the raw ingredient’ – recreational marijuana is legal in California, Massachusetts, Nevada, Maine, Oregon, Colorado, Washington and DC, while medical marijuana is approved in 20 others – we asked whether cannabis-based therapeutics is still an appealing sector for pharma companies.
“There is more need for pharmaceutical cannabinoids then ever,” Jeffrey Korentur, CEO of Teewinot Life Sciences told in-Pharmatechnologist.com.
“While there is considerable anecdotal evidence that medical (and recreational) marijuana provide a non-quantified therapeutic effect, those effects are exceedingly difficult to standardize, and can vary widely from crop to crop, producer to producer, and state to state – even with the ‘same’ strain of cannabis.”
His firm manufactures synthesized cannabinoids including THCA, CBDA and CBCA from its facility in Tampa, Florida and last year licensed its cannabinoid quality analysis technology to AMRI.
“Those seeking reliable, safety tested, standardized, effective, homogenized, metered doses of medicine to address specific indications are reliant on pharmaceutical products,” Korentur told us.
“We contend that there is a difference between a therapeutic effect and a medical outcome. Properly formulated and tested pharmaceuticals offer the latter.”
Standardization and quality were also of concern to George Anastassov, CEO of Axim Biotechnologies, a firm whose pharmaceutical grade CBD and THC-containing chewing gum CanChew is being investigated for conditions including Multiple Sclerosis and irritable bowel syndrome.
“The so-called ‘medical’ marijuana today is of questionable quality, potency, provenance and effects on particular symptoms/ diseases,” he told us.
“The reports are at best anecdotal and no state or federal reimbursement program will consider these products. This is not the case with available pharma products.”
However, this may be changing and last month a facility in The Netherlands run by cannabis plant grower Bedrocan became the first to be granted GMP certification, representing “a major step” in bringing medical marijuana up to the same level of evidence-based medicines according to the firm.
Anastassov added the tightening up of regulations for CBD recently seen in the UK is likely to be replicated by the FDA and DEA in the US, presenting a greater market opportunity for pharma firms.
Last October, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) came to the opinion that products containing CBD used for medical purposes are a medicine and as such must have a marketing authorisation before they can be legally sold.
“Once this becomes reality in the US and elsewhere the patients will be seeking reliable, consistent, safe, efficient and strictly regulated products.”