Acquisition of APIRx slide image

Acquisition of APIRx

For personal use only MedChew™ Rx (CBD and THC) for Pain and Spasticity in Multiple Sclerosis (MS) Problem Up to 84% of people suffering from MS also experience spasticity, which causes involuntary muscle stiffness and spasms. Pain is also a common symptom in MS, with up to two-thirds of people with MS reporting pain in worldwide studies. Solution MedChew™ Rx is absorbed through the oral mucosal membrane and bypasses the liver, and first pass metabolism. No cannabinoid-based drug approved for pain management in MS or other pain producing conditions. Although it targets oral mucosa, it has recently been suggested that the drug is partially washed away by saliva and absorbed in the GI tract. Patents 1) Granted: Chewing gum comprising cannabinoids. 2) Granted: Process to extract and purify delta-9-THC. Sativex (nabiximols, THC+CBD) Approved for use in Europe and Canada. Oromucosal spray approved in multiple jurisdictions in Europe and Canada (not U.S. currently) for treatment of spasticity associated with MS. Competitive Advantage MedChew™ Rx contains the same constituents as Sativex, however provides extended dosing, reducing the need to readminister, which for Sativex is up to 12 times per day, MedChew™ Rx does not contain alcohol, which Sativex does, and will not exacerbate the dry mouth that is ofter associated by MS pharmacotherapy. Incannex Administered too frequently - up to 12 times per day. Alcohol in formulation exacerbates dry mouth symptoms associated with MS pharmacotherapy. MedChew™ Rx (THC+CBD) MedChewTM Rx is absorbed in oral mucosa, bypassing first pass metabolism, increasing bioavailability. Increased bioavailability may also mean that MedChew™ Rx is effective at treating pain associated with MS, a claim that Sativex does not have in many regions. MedChewTM Rx provides extended dosing, reducing need to readminister frequently. Addressable Market US$ 62B* 50% Associated Total Global Direct Healthcare Costs in '21 Increase in Global MS Prevalence 2013 to 2020 The MedChew™M Rx formulation has been developed and patented by APIRx. MedChew™ Rx does not contain any alcohol. Pre-IND meetings completed with Swiss-Medic (Switzerland) and CBG-MEG (Netherlands). Lead Assets * Frost Sullivan Market Report as commissioned by APIRX, Oct. 2021 Next Steps: Step 1 - Potential fastrack to EMA drug approval with bioequivalent phase 1 bridging study* to bridge to Sativex CBD/THC oral spray safety and efficacy data. Step 2 - Additional late stage (phase 3 or 4) clinical trials to support extension of label claims to additional indications where THC+CBD is reported to have a therapeutic benefit. *a bridging study is a study designed to demonstrate that an investigational product is sufficiently similar to an approved product and establish a bridge to data, safety and/or efficacy, that is already accepted by the regulatory authority for the approved drug product Shareholder Presentation 17
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