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OTC:AXIM

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Summary • AXIM Biotechnologies ( AXIM) holds the bookish acreage rights to the controlled-release, trans-mucosal (chewing gum) biologic commitment belvedere for medical cannabinoids. o The aggregation is advancing several indications: • Annoyed bowel affection (IBS) – Phase 2 • Affliction administering associated with assorted sclerosis (MS) – Phase 1 • Bioequivalence balloon against Marinol® (aka dronabinol)  • Alive leg affection (RLS) • In accession to the company’s proprietary trans-mucosal commitment system, AXIM is in the action of developing trademark-protected formulations with added methods of delivery: • contemporary balm for psoriasis/atopic dermatitis (ReneCann®) • suppositories for anarchic bowel ache (SuppoCann™) and  • ophthalmic solutions for glaucoma and dry eye (OphtoCann™ and CannBleph™) • Account on advancing and completed analytic studies should drive accretion broker assimilation in medical cannabinoid stocks in accustomed and AXIM in particular.  • AXIM Biotechnologies, a clinical-stage medical cannabinoid company, is focused on medical cannabinoids delivered by the company’s atypical biologic commitment systems, all of which are able-bodied positioned to account from the all-embracing medical cannabinoid beforehand theme.  • AXIM holds three patents (two accompanying to cannabinoid chewing gum and one for a cannabinoid ophthalmic solution), assorted filed IP -applications and 22 trademarks. • During 2018, AXIM is accustomed to accomplish cogent milestones. o Aural the aing 12-to-18 months, administering anticipates commutual several studies: • a Phase IIB balloon with CanChew 50 for IBS at the University of Wageningen • Phase I through Phase III trials with MedChew Rx for the analysis of abiding affliction and spasticity associated with assorted sclerosis • a bioequivalence abstraction of MedChew Dronabinol® chewing gum to Marinol® for the analysis of CINV and for HIV/AIDS patients experiencing accident of appetence and weight

The Bulk of Biologic Commitment Systems 

Novel biologic commitment systems (NDDS) can beforehand not alone a biologic efficacy, but additionally a patient’s affection of activity through assorted means, such as convalescent the ease-of-use by modifying the drug’s absolution contour or acceptable the dispensing method. Traditional methods of biologic commitment (standard articulate pills and injections) can be improved. In the case of an articulate us or tablet, the acceleration of access can be adapted from immediate-release to a controlled, abiding release, which stabilizes the bulk of biologic in the bloodstream (thereby convalescent efficacy) and additionally contributes to accommodating convenience, acquiescence and safety. Atypical biologic commitment platforms can adapt and beforehand the dispensing adjustment to beforehand assimilation and the bendability of release. Non-invasive routes of administering are preferred, namely, peroral (through the aperture aka PO), contemporary appliance (through the skin) and transmucosal (via nasal/inhalation, sublingual, ocular, belly and l routes). 

Drug commitment systems can be the disciplinarian for bulk conception of biologic companies. For example, ALZA Corporation developed pharmaceuticals by acceptable their ameliorative bulk through avant-garde commitment technologies. Initially developing transdermal commitment platforms (most conspicuously the NicoDerm patch), ALZA afterwards activated osmotic technology to ascendancy the bulk of absolution of articulate medications. This OROS controlled-release technology was the key to developing Procardia XL tablets for angina and hypertension and Glucotrol XL for the analysis of Type II diabetes. ALZA additionally developed biologic commitment systems employing implantable and liposomal technologies. Ultimately, Johnson & Johnson acquired ALZA in 2001 for $10.5 billion. Biologic Commitment Platforms in the Cannabinoid Space 

In the CBD space, several aerial contour biotechnology companies are advancing the development and commercialization of medical cannabinoid accessories with atypical biologic commitment systems to finer abode assertive medical conditions. Contempo studies beforehand that assertive compounds acquired from cannabis accept the abeyant to abate the cardinal and severity of epileptic seizures, abate the beef spasms accomplished by those with assorted sclerosis, apathetic the progression of Alzheimer’s and Parkinson’s’ diseases and accommodate all-overs abatement for those adversity with PTSD. Atypical biologic commitment systems can advice cautiously administrate and carriage a biologic admixture aural the anatomy to accomplish its adapted ameliorative effect.

AXIM Biotechnologies (AXIM) is a clinical-stage medical cannabinoid aggregation assimilation on the research, development and assembly of cannabis-based medical biologic products. AXIM is developing an bookish acreage (IP) portfolio comprised of several proprietary commitment systems that abode assorted medical indications. The company’s flagship medical cannabinoid accessories (CanChew 50™ and MedChew Rx™) bear CBD in a controlled absolution abode by actuality administered via chewing gum.  In addition, the aggregation is advancing the development and auction of cannabis-based nutraceutical (CanChew Plus™) and corrective products. 

AXIM’S CHEWING GUM DELIVERY SYSTEM

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AXIM Biotechnologies is actively affianced in administering analysis in adjustment to beforehand oral, trans-mucosal, controlled-release commitment systems (primarily CBD-infused chewing gum treatments) for a arrangement of indications. AXIM holds a apparent accoutrement the chewing gum commitment adjustment for cannabinoids through an exclusive, 50-year, accustomed bookish acreage licensing acceding with CanChew Biotechnologies, LLC.  AXIM has the advantage to acquirement the accountant bookish acreage alpha in 2020 for an bulk according to 50% of the anniversary ability fee paid, which is in the ambit of 2%-to-3% of gross sales acquired from accessories produced beneath the agreement. The aggregation is administering assorted preclinical and analytic studies for cannabinoid-based therapies on an arrangement of medical altitude with the trademarked accessories of CanChew ® and MedChew Rx®: 

AXIM’s Phase IIa Analytic Balloon for Annoyed Bowel Syndrome 

In 2016, AXIM Biotechnologies began analytic studies in patients with annoyed bowel affection (IBS) with its cannabinoid-infused CanChew 50™ gum (which contains 50 mg of CBD). This new conception offers bigger bioavailability over its predecessor, CanChew. By microencapsulating the alive ingredient, the articulate mucosal commitment arrangement was bigger by accretion the bioavailability of the CBD from beneath than 50% (after two hours of chewing) to 80% (after chewing for 30 minutes). The beforehand was due to the microencapsulation acceptable the solubility of the CBD, stering its able absolution into the bloodstream. Microencapsulation additionally helps assure the alive additive from blaze and degradation.

Irritable bowel affection is a accustomed abiding gastrointestinal ataxia that affects the ample intestine. Affection accommodate belly discomfort/pain, bloating, cramping, gas and diarrhea/constipation. The action impairs a patient’s affection of life, which increases the prevalence of affection disorders, such as abasement or anxiety.  Treatments accommodate attempting to abbreviate symptoms, decidedly belly discomfort/pain.

In 2017, AXIM began the company’s best avant-garde analytic trial: a 36-patient, 8-week Phase IIa abstraction (NCT03003260) for the analysis of annoyed bowel affection at the University of Wageningen in The Netherlands. The ambition was to admeasurement the all-embracing affliction abatement in patients adversity from affection of IBS.  

In November 2017, the Phase II pilot balloon was completed. AXIM’s mint-flavored CanChew 50™ was able-bodied acceptable by the patients as no cogent adverse ancillary furnishings were observed. All participants accomplished a abatement in their affliction score. The study’s trend ambit indicates that patients on CanChew accomplished a 50% college affliction abridgement than those on alive placebo. 

  AXIM affairs to extend this 8-week abstraction to one of best continuance with set dosing (50, 100, 200 and 300 mg CBD) at set intervals in adjustment to actuate the optimum dosage and dosing dieting through pharmacokinetics (PK) and pharmacodynamics (PD) studies.

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Treatment of Affliction and Spasticity Associated with Assorted Sclerosis

AXIM is advancing the use of MedChew Rx™ for the analysis of affliction and spasticity associated with assorted sclerosis (MS). MedChew Rx, a mint-flavored chewing gum, contains a aggregate of CBD and THC (5 mg of CBD and 5 mg of THC) that has been encapsulated for bigger efficacy. 

In January 2018, AXIM had an basic affair with the Dutch Medicines Evaluation Board apropos the company’s MedChew Rx analytic development affairs for affliction and spasticity associated with MS. AXIM accustomed advice from the Dutch Board and the all-important approvals to beforehand with a analytic development affairs for MedChew Rx.

Under the advice of the Dutch Medicines Evaluation Board, a 15-patient Phase I abstraction is planned to be conducted at QPS Netherlands’ ability in Groningen. Administering anticipates administering a Phase 1 PK/PD biocomparison analytic balloon comparing MedChew Rx with Sativex® (GW Biologic s’ THC/CBD oromucosal spray). Sativex is already registered for use in Europe, and the Dutch Medicines Evaluation Board has adumbrated it has accustomed the abstraction of MedChew Rx potentially actuality an accession advantage to an oral-mucosal aerosol product.

During the aing 18 months, administering anticipates commutual Phase I, Phase II and Phase III analytic trials paving the way for MedChew Rx to be registered and accustomed for the analysis of MS with the EMA (European Medicines Agency) and by the FDA (U.S. Food and Biologic Administration).  Bioequivalence to Marinol® (dronabinol)

AXIM’s administering is advancing a plan to complete a bioequivalence balloon to analyze the ameliorative adequation (both in acceding of ability and safety) of a new dronabinol-based, controlled-release chewing gum and the advertence listed biologic (RLD) Marinol® (aka dronabinol). The study, clearly blue-blooded A Two Part, Open Label, Randomized, Four Aeon Cross-over Abstraction to Analyze the Bioavailability of Two Different Dronabinol Formulations in Healthy Male and Female Volunteers, is advised as a 50-participant analytic trial, which is advancing to alpha in mid-2018.  If successful, AXIM and its controlled-substance API (Active Biologic Ingredient) accomplice will beforehand a dronabinol-based, controlled-release, chewing gum product, which should accept FDA approval in a bulk of months for the aforementioned break as Marinol, namely the analysis of:

• chemotherapy-induced nausea/ing (CINV) and • anorexia associated with weight accident (as an appetence stimulant), including anorexia in patients with blight or AIDS

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The all-around bazaar for dronabinol was $160 actor in 2016 and is accustomed to abound badly based on added biologic availability, a change in accessible assessment arise medical cannabis, new methods of biologic administering and the after-effects from new analytic trials. Competitors in the bazaar accommodate AbbVie (ABBV) with Marinol®, Akorn (AKRX) with dronabinol, PAR Biologic Companies/Endo International PLC /SVC Pharma LP (ENDP) with dronabinol and Insys Therapeutics (INSY), which in 2017 began to action SYNDROS™ (dronabinol in an orally-administered aqueous formulation). Akorn is in the action of actuality acquired by Fresenius Kabi AG, which is a allotment of Fresenius SE & Co. KGaA (DE:FRE), for about $4.3 billion. According to Insys Therapeutics, the accustomed anniversary bazaar for dronabinol is about 280,000 prescriptions with a abeyant addressable citizenry of almost 800,000 in CINV and 90,000 in AIDS anorexia.

In December 2017, AXIM completed a Pre-Investigational New Biologic Appliance (PIND) with the US Food and Biologic Administering (FDA) in adjustment to facilitate the approval process. The accessible basic altercation should advice AXIM accelerate the architecture of the bioequivalence abstraction amid Marinol and MedChew Dronabinol®. Administering anticipates administering a bioequivalence abstraction to analyze its dronabinol-based, controlled-release chewing gum to Marinol in chemotherapy patients with abhorrence & airsickness and in AIDS patients experiencing appetence and weight loss. Affliction Administering

The $58.6 billion all-around bazaar for affliction administering drugs is anticipation to abound to $77.1 billion by 2023. Opioids accept been the aloft beforehand disciplinarian due to their ability in managing astringent abiding pain. However, the added use of addictive opioid affliction relievers has spawned a accessible bloom crisis. The Council of Economic Advisers estimated that in 2015, the bulk of opioid abuse, addiction and accompanying deaths the U.S. was over $504 billion. And according to the Centers for Ache Control, calm biologic balance deaths added 22% in 2016 to over 60,000. 

New non-addictive affliction administering alternatives, such as medical cannabinoids, would arise to be a bigger solution. A contempo abstraction (Medical marijuana behavior and hospitalizations accompanying to marijuana and opioid affliction analgesic by Yuyan Shi, April 1, 2017) assured that these new accompaniment medical marijuana behavior are decidedly associated with bargain opioid-related hospitalizations. However, appropriately far, there is not yet an FDA-approved painkiller that is acquired from cannabis. 

In mid-2017, AXIM filed a apparent appliance (Serial No. 62/410,469) with the U.S. Apparent Office for chewing gum with controlled-release of cannabinoids, opioid agonists and/or opioid antagonists for the analysis of addiction and/or dependence. Aural the aing 18 months, administering affairs to alpha a proof-of-concept (POC) abstraction for the analysis of opioid addiction. 

Restless Leg Syndrome 

In July 2017, AXIM Biotechnologies entered into a Casework Acceding with an bearding Israel-based Contract Analysis Organization to activate a analytic proof-of-concept abstraction to amusement alive leg affection (RLS). The abstraction is accustomed to amusement about 30 participants with AXIM’s chewing gum artefact alloyed with both CBD and Gabapentin. Administering anticipates starting a proof-of-concept (POC) abstraction aural the aing 18 months.

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OTHER DRUG DELIVERY SYSTEMS 

Topical Commitment System 

AXIM’s AX-1602 topical, transdermal cannabinoid artefact (under the brand ReneCann®) is actuality evaluated for analysis of crawling and atopic dermatitis (eczema). A proof-of-concept balloon was completed at the Dermatological Center Maurits Clinic in The Netherlands during 2017; however, the aggregation is attempting to beforehand an bigger commitment belvedere for this contemporary system.  Ophthalmic Solutions

In October 2017, the United States Apparent and Brand Office accustomed a apparent (9,814,695) to AXIM for a cannabinoid ophthalmic band-aid developed for the analysis of glaucoma and appropriate abatement of conjunctivitis. Also, a Notice of Allowance (Serial Cardinal 15/728,283) was issued by the U.S. Apparent Office accustomed for the adjustment to use. The apparent arising and the Notice of Allowance for the adjustment to use set the date for the company’s analytic trials for AX-1603 and AX-1606 by Ora, Inc., a full-service Contract Analysis Organization (CRO) that helps accompany new ophthalmic accessories from abstraction to market. In March 2017, AXIM retained the casework of Ora to advice with the development of AXIM’s ophthalmic accessories accompanying to glaucoma and dry eye.

AXIM’s Analytic Development Affairs

Below is AXIM’s best afresh arise biologic activity graphic, advertisement the company’s abundant medical cannabinoid accessories and the date of development of anniversary one. One artefact (CanChew 50 for associated with IBS) has completed a Phase II pilot trial, and accession one (MedChew Rx for affliction associated with MS) has completed a Phase I for assurance and dose-finding purposes with abounding others in preclinical stages. An bigger commitment belvedere for the AXIM’s contemporary product, ReneCann® aka AX-1602, for analysis of crawling and atopic dermatitis is beneath development.

NUTRACEUTICAL PRODUCT

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The company’s flagship nutraceutical artefact is CanChew , a CBD-infused chewing gum. Arise in 2017, CanChew is accessible in all 50 states and can be purchased online at www.canchewgum.com. Anniversary allotment of CanChew gum contains 50 mg of CBD hemp oil and 10 mg of accustomed CBD (cannabidiol). 

On January 24, 2018, AXIM entered into a bounden non-exclusive 1-year administering acceding for CanChew for administering in Thailand. 

Conclusion

AXIM Biotechnologies is a alpha specialty biologic aggregation in the medical cannabinoid space. The aggregation is in the action of developing medical cannabinoid solutions for the analysis of abundant diseases utilizing several commitment systems. In accession to the altitude listed above, administering is targeting abounding added diseases, including anarchic bowel ache (IBD), ulcerative colitis, Crohn’s disease, Parkinson’s disease, Alzheimer’s disease, dementia, assimilation arrears hyperactivity ataxia (ADHD), PTSD and autism. Furthermore, the aggregation intends to admit a analytic balloon for affliction administering on opioid-dependent patients.

We apprehend AXIM to abide to aggrandize its medical cannabinoid artefact belvedere and beforehand a cardinal of added analytic programs. During the aing 18 months, the aggregation affairs to complete 1) a Phase IIB analytic balloon with CanChew 50 for IBS at the University of Wageningen, 2) Phase I, Phase II and Phase III analytic trials with MedChew Rx for the analysis of abiding affliction and spasticity associated with assorted sclerosis and 3) a bioequivalence abstraction to analyze its dronabinol-based, controlled-release chewing gum to Marinol in chemotherapy patients with abhorrence & airsickness and in AIDS patients experiencing appetence and weight loss.

The marijuana industry and medical cannabis amplitude currently are capacity of ample account breeze and broker interest. AXIM’s columnist releases on its analytic trials will accord to this accumulation of account coverage. If administering auspiciously executes on its focused action and attains its goals, the company’s banal appears to action cogent upside for investors. 

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