Executive Summary

izunpharmaceuticals

October 2015

OVERVIEW

Controlling inflammation and enhancing tissue repair are major medical challenges that impact upon a wide range of acute and chronic diseases such as atrophic vaginitis, ulcerative colitis, chronic wounds, skin disorders, periodontal disease and many others.  Izun has developed a patented portfolio of natural products that utilizes novel multi-modal technology to reduce inflammation and accelerate the body’s natural healing processes. Izun’s existing product line and advanced pipeline products provide exciting opportunities in the huge, underserved markets of oncology support, wound care, oral care, women’s health care, gastro-intestinal disease, and dermatological care (including cosmetic applications).  Izun’s products address both consumer (OTC) and prescription markets, utilizing a flexible regulatory pathway, which allows its products to reach markets rapidly with strong efficacy claims.

Existing topical products used to treat inflammation are primarily steroid-based, with the associated problems of significant side effects and local tissue damage. Furthermore, there is a lack of effective products in the tissue repair market. Izun’s botanically sourced platform provides products with excellent safety profiles to treat dermatologic and mucosal based inflammatory diseases while also enhancing tissue repair. Izun’s suite of novel and patented products allows it to capitalize on multi‑billion dollar market opportunities.

Izun’s unique model targets both prescription and consumer markets. Izun has launched three oral care products – two aimed at the professional market and one for the OTC market. Two newly developed hemorrhoid treatment products were introduced to the US OTC market in 2014. We have recently expanded our areas of interest to include the medical cannabis arena.  In addition to setting up an ISO 17025-certified service laboratory for the analysis of cannabis samples and cannabis-containing products, we are developing novel delivery systems and product formats that will cater to this rapidly expanding field.

 

Izun is a US corporation incorporated under the laws of Delaware, with a wholly-owned Israeli-based R&D subsidiary employing a staff of 17. In addition to an experienced and accomplished management team, Izun is supported by a world-class board of scientific advisors and opinion leaders.

The natural products market has been growing strongly for the last three decades and, while the market is expanding rapidly, there is a need for clinically proven natural products that will provide an improved and safe outcome compared to currently available products.

Izun combines the precision of analytical and pharmacological science with the safety of botanical extracts to produce breakthrough medical solutions. Izun has identified active plant compounds and specific biological targets. This is utilized to design highly effective therapeutic products. By focusing simultaneously on multiple physiologic receptors (multi-modal therapy), Izun provides products that are highly effective, while maintaining the safety of a natural extract.

 

PRODUCTS

Beta launch for PerioPatch®, Izun’s first Oral Care product, along with PeriActive™, occurred in Q4 2014.  In addition, Izun has established collaborative relationships with major pharmaceutical companies in the areas of Oncology Support, Wound Care, Women’s Health Care and Hemorrhoid Care. Presented below is our product line:

 

ORAL CARE

PerioPatch®

  • Focused high-dose, topical, anti-inflammatory patch system for the treatment of Periodontitis / Gingivitis.
  • First-in-class product, focusing on controlling the damage caused by Periodontitis and Gingivitis.
  • Data demonstrate rapid reduction in pocket depths and increased attachment levels, together with reduced clinical inflammation and inflammatory biomarkers in the gingiva within 24 hours.
  • Beta launch completed and full launch H2 2015.
  • Approved in USA and EU.
  • Product is targeted to address a significant need in the $18B periodontal market.

PeriActive™

  • Anti-inflammatory, antibacterial oral rinse to treat periodontitis and gingivitis.
  • Acute care and daily use.
  • Helps control inflammation while reducing infectious aspect of periodontitis & gingivitis.
  • Beta launch completed and full launch H2 2015.
  • Approved in USA and EU.
  • Global market of $3.6B.

Toothpaste

  • A novel concept in toothpaste with triple action – reduced inflammation, reduced plaque and enhanced repair of gums – that is designed to complement PeriActiveÔ rinse and PerioPatch®.
  • Global market $12.6B.
  • Unique product with potential line extensions.
  • Currently under formulation – anticipated launch 2017.

Soothe & Cure™

  • Topical micro-thin patch for aphthous ulcers.
  • Rapidly reduces pain (within 30 minutes) and initiates healing process.
  • Clinical trials demonstrated actual healing within the first day.
  • Approved EU.
  • Market opportunity estimated at $0.5B – $1B annually.

PeriGel

  • Injectable gel for reducing oral inflammation and infection for the professional market.
  • Complimentary (focused dose) product with PeriActive rinse and PerioPatch.
  • Ease of delivery and multiple site injectable.
  • Market opportunity estimated at $0.5 – $1B.
  • Proof of concept trial planned for 2016.

ONCOLOGY SUPPORT

 IZN-6N4

  • Oral Rinse for the prevention of Oral Mucositis, a common side effect of chemotherapy and radiation therapy.
  • In vivo data from animal model demonstrated 70% reduction of incidence and duration of stage III mucositis.
  • Phase II trial in process.
  • Market size estimated at $1-$2B.

WOUND CARE

Curasite™

  • Topical gel for the treatment of diabetic foot ulcer.
  • Phase I data demonstrated complete closure in 27% of lesions within 3 week treatment regimen and 100% transformation to healing tissue.
  • Phase II trial completed; results of trial due Q4 2015.
  • Market size estimated at $1.6B.

WOMEN’S HEALTH CARE

IZN-6N-AV

  • Unique non-hormonal solution to resolve dry vaginal tissue due to low hormonal levels.
  • Critically needed in both the post-menopausal and breast cancer patient.
  • Proof-of-concept trial commenced in Q3 2015 for Atrophic Vaginitis.
  • Market size estimated at $1.9B.

HEMORRHOID CARE

IZN-6N-HE

  • Relieves pain and bleeding.
  • No new products on the market for decades to compete with “old” brands.
  • Global market estimated at $5B.
  • Clinical trial commencing Q4 2015.

 

CannRx (newly formed subsidiary)

  • Developing high-quality pharmaceutical and analytical products utilizing the cannabis plant by leveraging the patented technology and established botanical expertise of Izun.
  • Filed two patents for a unique delivery system for cannabinoid compositions that can effectively capture and deliver all active components of the plant.
  • Initial focus on two therapeutic areas – Pain and Parkinson’s Disease.
  • Intent to initiate clinical trials Q2 2016.

 

DEVELOPMENT PLAN 2016

  • License and launch wound care product.
  • Manage and complete trials in progress.
  • Expand sales and markets of Oral Care products by developing additional distribution partnerships.
  • Expand CRM relationships for existing products.
  • Continue to expand Oral Care pipeline products.
  • Research & develop cannabis related pharmaceutical products.
  • Enter clinical trials with first cannabis product.
  • Complete development of delivery systems for cannabis products.
  • Expand and develop IP and patent base.