Monetizing Medical Cannabis

+100 clinical indications:

• Multiple Sclerosis• Glaucoma• ALS• Peripheral Neuropathic Pain• Post Operative Pain• Spinal Cord Injury• Anxiety - PTSD• Parkinson’s Disease• Cachexia, Nausea& Vomiting - Cancer• Rheumatoid Arthritis• Inflammatory Bowel Diseases

Cannabis-based medicine: which molecules ?

Cannabinoids are molecules unique to the cannabis plant

Initial focus on two principal cannabinoids: THC (Tetrahydrocannabinol) and CBD (Cannabidiol)

• THC: Analgesic, Anti-spasmodic, Anti-tremor,Anti-inflammatory, Appetite stimulant, Anti-emetic

• CBD: Anti-inflammatory, Anti-convulsant, Anti-psychotic, Anti-oxidant, Neuroprotective, Immunomodulator

Cannabis-based medicine: clinical indications

• Compositions lacking harmful psychotropic components• Novel cannabis active compounds and derivatives• Novel cannabis compositions and formulations• Methods of Production• Novel drug delivery systems for cannabis• Novel dosages of cannabis• Novel medical applications and diseases to treat with cannabis• Plant breeders rights (PBR) for new cannabis varieties

Cannabis Industry: opportunities are there!

Cannabis Industry: Money is there too!

The market is estimated to become $6 billion dollars industry by 2018.

Cannabis Industry: ready, set, go for the gold rush !

Main companies

Want to join the race?

Think technology scouting, IP assesment…

Cannabis Industry: ready, set, go for the gold rush !

Number of granted patents Want to join the race?Think patent filing

Cannabis Industry: ready, set, go for the gold rush !

Intellectual Property issues are tricky. Cannabis IP rights are uniquely so.Navigating the cannabis-related IP issues requires extensive knowledge of the cannabis industry specificity. Getting cannabis IP counseling is a mandatory part in your drug development program and will guide you through:

• Patent driven competitive analysis• Patent filing and prosecution• Patent litigation and enforcement• Licensing agreements• Trade Secret Policy documentation and enforcement• Trade Marks registration and protection • Plant breeders rights (PBR) registration and enforcement

• Is it safe for patients?

• How does it work?

• Has it been proven to work in preclinical studies?

• Does the [proposed] mechanism or pathway through which the drug acts raise concerns about impact on normal organs/tissues?

Cannabis-based medicine drug development: ask the expert and meet the regulator!

• Cannabis is designated as a Schedule I drug (i.e., illegal with no current medical value)

• Cannabis-based therapeutics requires input from the U.S. Drug Enforcement Agency (DEA). (not favorable)

• Federally, a drug cannot be prescribed unless it has undergone clinical trials, yet many states legislation authorizes the use of medical marijuana without clinical trials and without identifying specific indications.

What the regulations says:

What the regulators wants to know:

Need to design your preclinical studies to be in compliance with the regulation

Designing the preclinical study: science and regulation hand in hand

Preclinical studies should be designed as pre-emptive strikes: address potential future regulatory concerns within the early stage preclinical development of your molecules, and with the first-in-man study in mind.

Preclinical design considerations:

• GLP vs non-GLP• Latest regulatory directives• Pre-IND/IDE meetings: understand what the

regulators wants• Safety (pharmacology, toxicology)• Efficacy ( in vivo efficacy)• Stability (formulation, absorption

reproducibility)• Non-biased design• Mimic clinical scenario

Designing the preclinical study: science and regulation hand in hand

Composition? THC/CBD others…?Stability?Mode of Administration?Dose?Which models?

What is the “API”? Unique pharmacology of cannabis-derived molecules [Bell Shape]- hard to translate

A perfectly tailored preclinical study design goes beyond science.It adds technological value to your IP rights. How? By understanding theunique pharmacology of your technology, and matching it with the most appropriate models, so it translates into clinical indications.

• Match models and technology• Balance mode of administration, dose and models• Translate models into clinical indications

Science & Regulatory, Clinical expertise Creativity” & ExperienceCommitment [ Financial]

Successful drug development: the perfect product arises from the perfect collaboration

Credit: collaboration by Michael Rojas, executive by Michael Wohlwend, Medical Marijuana by Blaise Sewell, Lawyer by Rflor from the Noun Project from the noun project

IP assets and protection, Licensing, Plant Breeders Rights…

Your ideas, your Molecule[ Financial]

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Pharmaseed is Israel's largest GLP-certified pre-clinical CRO specializing in translational and regenerative studies. From preclinical to first in man. We have extensive experiences in cannabis-based medicine drug development.Pharmaseedltd.com

We develop customized, targeted, and secure comprehensive strategies, focused on maximizing the benefits of new technologies and securing wide-ranging and cost-effective protection for our clients' inventions, discoveries and creations. bressler.co.il/ and so-law.co.il/

Successful drug development: the perfect product arises from the perfect collaboration