04 Feb 2021
Posted in Pharma
Pharmaceutical manufacturers to benefit from Biden’s marijuana legalization plans, says GlobalData
President Joe Biden brings a significant likelihood of federal marijuana reform, one of his key campaign promises. Amidst the ongoing opioid crisis, legalizing cannabis at the federal level will lead many clinicians and patients to reduce their use of highly addictive opioids. The legalizing will also create significant business opportunities for pharmaceutical manufacturers of both pure cannabis (for medicinal purposes) and cannabis-derived pharmaceuticals, says GlobalData, a leading data and analytics company.
President Biden and Vice President Kamala Harris support the moderate drug rescheduling, federal medicinal legalization, allowing states to set their own laws, adult usage marijuana decriminalization and expunging the prior cannabis convictions.
Adam Bradbury, PharmSource Analyst at GlobalData, comments: “If cannabis were legalized and no longer a controlled substance, more manufacturers can be involved in its production. However, this increase in supply can also drive down profit margins for CMOs owning to expensive Schedule I facilities – currently the only sites approved for producing cannabis-derived pharmaceuticals.”
The FDA has not approved any marketing applications for cannabis. However, it has approved one cannabis-derived drug product, GW Pharmaceuticals’ (Cambridge, UK) Epidiolex (cannabidiol) and three synthetic cannabis-related drug products: AbbVie Inc’s (North Chicago, IL, US) Marinol (dronabinol), Benuvia Therapeutics Inc’s (Chandler, AZ, US) Syndros (dronabinol), and Bausch Health Companies Inc’s (Quebec, Canada) Cesamet (nabilone).
The dose manufacturing arrangements for FDA-approved cannabis-derived products are limited, and therefore only a few CMOs, such as Patheon (Durham, NC, US), Dechra Pharmaceuticals (Northwich, UK), Renaissance Lakewood LLC (Lakewood, NJ, US) and Bausch are involved in their manufacture.
Bradbury continues: “There is an indicator from the small number of approved cannabis-related drugs that there can be significant business opportunities for CMOs if these products were to become increasingly approved and used.”
The Drug Enforcement Administration’s (DEA’s) 2021 production quotas for cannabis (and its extract) are 1,700kg (increased from 444kg in 2018) and tetrahydrocannabinols are 1,000kg (increased from 385kg in 2018).
Bradbury concludes: “These increased quotas, released in August 2020—even before the Biden presidency – indicate that the federal government’s stance on the drug is becoming more liberal and that it will eventually legalize medical marijuana.”