The commercial landscape is shifting rapidly for Impression Healthcare (ASX: IHL), as the dental impression company continues its foray into medicinal cannabis.
Impression manufacturers a range of dental products (which remain a major focus) but over the past year, the company has made several sturdy steps into one of the highest growth markets in the world: medicinal cannabis.
The company’s latest move has been to execute an exclusive license agreement with Resolution Chemicals, to support the production, registration and commercialisation of generic drug Dronabinol in the US, Canada, Australia and New Zealand.
Dronabinol is the first-ever authorised cannabis medicine in the US and already has a proven safety profile.
Impression says it anticipates distributing Dronabinol under the Special Access Scheme and the Authorised Prescriber Scheme in Australia prior to pursuing wide-scale market authorisations in all other countries covered by the deal.
In addition, the licensing deal supplements Impression’s existing plans to become one of Australia’s first licensed distributors of medicinal cannabis products.
Why Dronabinol and why now?
Dronabinol comes in the form of pure delta-9 tetrahydrocannabinol (THC) capsules with the potential of treating a variety of ailments and diseases.
The first targets for Dronabinol are treating the loss of appetite in people with HIV/AIDS as well as nausea and vomiting caused by chemotherapy in people that have run out of options using existing anti-nausea medicines.
Impression has announced that it plans to execute a strategy that will ultimately expedite the achievement of marketing authorisations of 2.5mg; 5.0mg and 10.0mg generic Dronabinol capsules in the US, Canada, Australia and New Zealand.
Unsurprisingly, the very same markets that are currently undergoing across-the-board softening of existing legislation relating to medical cannabis use.
To achieve this, ResoChem has granted Impression the rights to all intellectual property (IP) associated with the production of a complete non-synthetic Dronabinol product to assist with commercialisation.
According to Impression, the IP it has licensed opens an opportunity for “significant international expansion into existing markets with patented and proven technology”.
Also, it furthers its overarching strategy to become a major player in the growing market for cannabinoid medicines and expands Impression’s growing cannabinoid product portfolio.
To ensure its market strategy is successful, Impression has employed the services of cannabis consulting firm Pharmout, to guide Impression towards market touchdown.
Impression has declared that Pharmout’s initial task will be to assess the intellectual property associated with Dronabinol and to suggest amendments to the materials and manufacturing process necessary to support either a synthetic or non-synthetic dronabinol product relevant to the current laws of each country.
Thereafter, Impression will manufacture and encapsulate a finished product as well as commission any further studies required to prove the regulatory-acceptable quality and stability of its capsules, including marketing authorisations in all the countries listed in the deal.
It is anticipated that Pharmout’s initial assessment prior to encapsulation will take up to 12 weeks.
Impression has said the deal has been set up to “avoid the heavy expense associated with drug development and trials,” and thereby puts the company in an advanced position to begin capitalising on growing demand for medical cannabis products in Western countries.
The exclusive licensing agreement gives Impression the rights to “use all associated materials” including a complete drug master file, otherwise known as an Abbreviated New Drug Application that has been previously assessed and rated “approvable” by the Food and Drug Administration (FDA) but not rescheduled by the Drug Enforcement Agency (DEA) to allow importation to the USA at that time it was rated “approvable”.
Interestingly, the DEA prevented the previous use of the drug due to the product being non-synthetic in nature – a verdict that has now been deemed subject to change given softening legislation regarding cannabis cultivation in the US.
Impression also stands to obtain a detailed manufacturing process, analytical methods and specifications for each manufacturing step and patents that detail a manufacturing process “similar to the manufacturing process approved by the FDA”.
Dronabinol was the first ever cannabinoid medicine permitted for patient use by the Drug Enforcement Agency (DEA) in the US. Additionally, a synthetic form of Dronabinol has been marketed under the trade name Marinol since in 1986, by US pharmaceutical giant Abbvie.
Any patents over Marinol have since expired which allows Impression to take advantage of this proven generic drug and could see Impression moving directly into commercialising an established medical cannabis product without having to commit extensive research and development spending.
Impression has said that “depending on legalities at the time”, it intends to move ahead either with a synthetic active pharmaceutical ingredient (API) or a botanically-grown non-synthetic alternative in each of the countries it has been licensed to do so.
For instance, synthetic dronabinol is legal in the US, but there has also been conjecture that the botanical version may be legal at some point in the future.
“The licensing deal with Resochem sets Impression apart from its Australian competitors that are pursuing high-cost R&D projects for the development of products that may or may not achieve commercial success. It also consistent with our collaboration with AXIM Biotechnologies,” said Mr Joel Latham, CEO of Impression Healthcare.
“Dronabinol has a long-recognised history of safe use and, by pursuing this market, we have the opportunity to create a generic Dronabinol product to grow revenues within new markets for which attitudes for the use of cannabinoid medicines has changed rapidly. Our objective now is to develop and manufacture relevant products for each country as quickly as possible and we have a number of options in relation to manufacturers,” said Mr Latham.