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07 September 2020

OCT - A Pharmaceutical Company Focused on Developing Cannabinoids to Pain

OCT is a pharmaceutical company founded on the concept of harnessing the medical potential of cannabinoids, and this has been at the heart of our motivation in the ensuing years. With this central mission of OCT in mind, we assessed the licensed medicines and unlicensed medical cannabis business models when we set out, to ensure that we took the path that would allow us to maximise the potential health benefits of cannabinoids while ensuring the highest degree of product safety and efficacy. There are some important differences between the two, which I set out below:

Types of Drug Products

Medical cannabis is either cannabis flower or cannabis extracts that are smoked, in the case of flower, vaped or orally ingested. The extracts may be in the form of a purified phytocannabinoid (e.g. CBD or THC) or a mixture thereof. These extracts may further contain other compounds from cannabis, such as terpenes and flavonoids.

Any of the above products can potentially be developed as a license medicine. In addition, improved versions of cannabinoids can be developed as a licensed medicine. Natural phytocannabinoids have some drawbacks, particularly when administered orally, that can be reduced or eliminated through medicinal chemistry. This offers the licensed medicine developer a vast array of possibilities that are not available to medical cannabis.

Market Exclusivity

A limited time of market exclusivity is necessary to allow drug maker to recoup the expense of development and provide a reasonable return on investment. Licensed drug makers can obtain market exclusivity through patents and regulatory exclusivity. Patents provide the owner with 20 years of market exclusivity. To obtain a patent, an invention such as a drug compound must be both novel and unobvious. New cannabinoid derivatives with improved drug-like properties may qualify for patent protection. Natural medical cannabis products, on the other hand, are generic by nature. Agencies that regulate medicines (e.g. FDA, MHRA and EMA) grant a limited period of exclusivity for new medicines. Regulatory exclusivity is also available for medicines that are developed for orphan indications. Since medical cannabis is not regulated by these agencies, regulatory exclusivity is unavailable.

Marketing

Licensed drug products can be indicated and marketed for approved indications. On the other hand, medical cannabis cannot make any claims to treating a disease or condition. This leaves both doctors and patients guessing as to whether a medical cannabis product is both safe and effective for their disease or condition.

By Prescription

Our aim as a pharmaceutical company is to develop prescription medicines for indications where there is a significant unmet medical need. These are indications where patients are diagnosed and treated by a physician. In the US, physicians are not permitted to prescribe unlicensed drug products, including medical cannabis. This leaves the patient to self-prescribe and dose a medical cannabis product that may be contraindicated for their condition or have drug-drug interactions with medicines prescribed by their doctor.

Reimbursement

Crucially, we wanted patients who could be treated with our medicines to be able to be reimbursed. While patients will usually have to pay out of their own pocket for medical cannabis, insurance companies will generally cover licensed medicines, allowing patients the peace of mind that their treatment will be paid for, so this ticked another box for us.

Legalisation of Cannabis

The ever-changing legal status of cannabis and cannabis-related products add a significant degree of uncertainty to medical cannabis producers. In the US, medical and adult use cannabis is regulated at the state level, with regulations varying from state to state.

Changes in cannabis-related legislation does not impact a licensed medicine business model as licensed medicines are regulated by FDA and other medicines regulatory agencies.

Regulation ensures Safety and Efficacy

When comparing the licensed medicines to unlicensed medical cannabis business models, it was abundantly clear which model OCT would follow. By far the most important reason for selecting the licensed medicines model was because of the higher regulatory standards imposed for licensed drug products. FDA and other regulatory agencies learned, often through tragic events, that the only definitive way of demonstrating a drug product is both safe and effective is through rigorous preclinical testing and randomised controlled clinical trials. We were adamant that physicians and patients must have assurance that our drug products are both safe and effective and produced in a quality and dose consistent manner.

We think you will see why it was obvious to us that the licensed medicines route to market was the right choice for OCT to take. If you are unsure though, the next time you open your medicine cabinet ask yourself: does it matter that my medicine has undergone rigorous preclinical testing and randomised controlled clinical trials to demonstrate that it is safe and effective?

 

Author: John Lucas

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