Biotech focus

AXIM Biotech Launches Marinol®-Bioequivalent Chewing Gum Program

The cannabinoid research and development space may be heating up billion dollar companies like GW Pharmaceuticals plc (NASDAQ: GWPH), but there have been approved cannabinoids on the market since the 1980s. Some companies are focusing their efforts on improving upon these already-vetted pharmaceuticals with new delivery systems designed to better address patient populations and reduce harmful and unwanted side-effects.

In this article, we will take a closer look at AXIM Biotechnologies Inc.’s (OTCQB: AXIM) recent move to develop a functional, controlled-release chewing gum product with synthetic THC as its active ingredient.

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Proven Pharmaceutical

AbbVie Inc.’s (NYSE: ABBV) Marinol® is a cannabinoid pharmaceutical that contains a man-made form of tetrahydrocannabinol (“THC”) called dronabinol. Marinol is approved to help manage loss of appetite associated with weight loss in patients with AIDS and for nausea and vomiting associated with cancer chemotherapy in patients that have failed to respond adequately to conventional treatment options.

In clinical trials, patients taking Marinol for AIDS-related anorexia had a greater increase in appetite than placebo at week four and six. These patients also experienced improvements in body weight and mood, as well as decreases in nausea symptoms. The antiemetic effect of Marinol was also observed in patients receiving chemotherapy with MOPP (Mustargen, Onvovin, procarbazine, and prednisone) for Hodgkin’s and non-Hodgkin’s lymphomas.

Marinol is notable because it was the first FDA-approved cannabinoid back in 1985 for nausea and vomiting and 1991 for AIDS-related weight loss. Since the patent expired, dronabinol has been included in four new drug applications (“NDAs”) by companies including SVC Pharmaceuticals and Insys Therapeutics Inc. (NASDAQ: INSY). The FDA-approved nature of the compound makes it particularly appealing in the cannabinoid space.

Improving Efficacy

AXIM Biotech has developed an innovative chewing gum delivery system that greatly improves the bioavailability of cannabinoids. On March 28, the company announced an agreement with a US API Company to develop a dronabinol functional, controlled-release chewing gum product that will be bioequivalent to Marinol® and help treat patients with chemotherapy-induced nausea and vomiting and AIDS patients experiencing appetite loss.

In its current form, Marinol® is delivered through a gel capsule where 90% of the dronabinol is metabolized into 11-OH-THC due to the first-pass metabolism effect in the liver. This causes significant side-effects for patients, such as impaired thinking and reactions. The company’s patented controlled-release chewing gum bypasses the first pass metabolism and results in decreased side-effects for patients using the drug.

“This is a substantial step forward to improving the current product offerings on the market for patients who are suffering these types of symptoms,” said AXIM Biotech CEO George E. Anastassov, MD, DDS, MBA. “Currently, there is a 40% drop out rate of patients who take Marinol. We are hopeful that our delivery methods will lead to decreased side effects and allow for a better quality of life for these patients.” 

Proof-of-Concept

AXIM Biotech’s move to reformulate an existing drug serves as a valuable proof-of-concept for future potential indications and partnership opportunities.

In some cases, new delivery mechanisms and reformulations can be a valuable way for large drug companies to partner and  extend the patent life of their drugs. New formulations that promote patient compliance or ease of use helps these companies defend against generics and protect market share. These new formulations also have the advantage of a shorter FDA approval route assuming they’re sufficiently similar to the approved drug.

In other cases, the company could decide to simply take a generic drug that has lost its patent protection and reformulate it on its own, as it’s doing with dronabinol. The many available generic drugs to choose from yield a significant number of opportunities for the company to apply its innovative delivery mechanism across all kinds of indications. The FDA approval process tend to be much shorter for these ANDAs since the drug properties are known.

The deal was highlighted in a Forbes article. In it, Dr. Anastassov discusses Marinol’s classification as a Schedule III drug and the implications for FDA approval of the new formulation. “It's essentially the bioequivalent, so we expect the same classification.” Anastassov said. “It is a short path to registration with the FDA. In 12 months it could be fully registered.” The doctor said that if it is Schedule III, it can be produced overseas with better supplies of cannabis. If it is classified as Schedule II, it will be produced in the U.S. “Best case scenario, the product could be on the shelf in a year,” said Dr. Anastassov.

Looking Ahead

AXIM Biotechnologies Inc. (OTCQB: AXIM) represents a compelling investment opportunity as it continues to grow its clinical portfolio and validate its chewing gum delivery method. With its recent agreement to develop a dronabinol formulation, the company could rapidly enter the market with a new formulation for a long-standing FDA approved drug designed to treat both appetite loss in AIDS patients and nausea and vomiting in chemotherapy patients.

For more information, visit the company’s website or investor presentation.