7/23/2014 9:04:23 AM
Health Canada Approves DispersinB(R) for Human Use
WINNIPEG, MANITOBA, Jul 22, 2014 (Marketwired via COMTEX) -- Kane Biotech Inc. , a biotechnology company engaged in the development and commercialization of products that prevent and remove microbial biofilms, is pleased to announce it has obtained Health Canada's Natural Health Products Directorate approval for the Company's dermatological care products, DispersinB skin cream and DispersinB shampoo. The approvals authorize the manufacturing and marketing of these products in Canada and more importantly allow for clinical studies to enhance the efficacy claims.
The DispersinB formulations are unique antibiofilm-antimicrobial and antibiotic free formulations that can be applied to the skin, scalp and hair. DispersinB skin care cream inhibits biofilm formation and also kills bacteria embedded in preformed microbial biofilm that cause recurring infections associated with atopic dermatitis including eczema, a chronic inflammatory condition of the skin that can affect individuals of all ages. It has both anti-inflammatory and anti-pruritic (anti-itching) effects. The skin cream can be used for relief of skin irritations associated redness, itching, dryness, scaling and redness due to eczema, insect bites, poison ivy, poison sumac, contact dermatitis, seborrheic dermatitis and psoriasis. DispersinB shampoo helps relieve itching and controls flaking caused by psoriasis or seborrhea, and dandruff. The global market for dermatology products is estimated at $4 billion per year.
The company continues to focus its resources and capital on the animal health sector at this time. The objective in animal health is to establish a portfolio of products and test market these products in order to build and strengthen our value proposition. Additional ongoing activities included in cementing this value proposition are pricing models, market messaging, manufacturing SOP's and the development of new applications. Establishing a value proposition is a critical step in the scale up of our business regardless of whether a distribution strategy or a licensing strategy is ultimately taken. The company continues to be in a licensing option agreement with a global health care company for certain company assets in the animal health market. At this time the due diligence surrounding the option continues.
The company has been successful in developing a portfolio of products across multiple markets and there are a number of market opportunities to pursue. Current Health Canada approvals include:
Animal Health - StrixNB(TM) liquid water additive, StrixNB powder sachet, StrixNB bulk powder, StrixNB oral spray and DispersinB topical spray.
Human Health - DispersinB skin cream and shampoo for dermatology.
KBI Hard Surface Disinfectant (KBI) - Ready-to-use formulation and concentrate formulation with antimicrobial label claims.
Additional projects to initiate include Health Canada Low Risk Veterinary Health Products Program approval for DispersinB shampoo and StrixNB oral foam in the animal health market, enhancing the efficacy claims for DispersinB in human dermatological market and KBI disinfectant label expansion to include biofilm claims.
About Kane Biotech Inc.
Kane Biotech is a biotechnology company engaged in the development and commercialization of products to prevent and remove biofilms. Biofilms are a major cause of a number of serious medical problems including chronic infections and medical device related infections. They develop on surfaces such as catheters, prosthetic implants, teeth, lungs and the urogenital tract. Biofilms are pervasive, costly to deal with and are involved in approximately 80% of all human bacterial infections. The healing of chronic wounds alone costs the United States health care system $20 billion per year.
Kane Biotech uses patent protected technologies based on molecular mechanisms of biofilm formation/dispersal and methods for finding compounds that inhibit or disrupt biofilms. The Company has evidence that these technologies have potential to significantly improve the ability to prevent and/or destroy biofilms in several medical and industrial applications.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Caution Regarding Forward-Looking Information
Certain statements contained in this press release constitute forward-looking information within the meaning of applicable Canadian provincial securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, including, without limitation, our anticipated future operating results, and can, in some cases, be identified by the use of words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
These statements reflect management's current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: Kane's early stage of development, lack of product revenues and history of operating losses, uncertainties related to clinical trials and product development, rapid technological change, uncertainties related to forecasts, competition, potential product liability, additional financing requirements and access to capital, unproven markets, supply of raw materials, income tax matters, management of growth, partnerships for development and commercialization of technology, effects of insurers' willingness to pay for products, system failures, dependence on key personnel, foreign currency risk, risks related to regulatory matters and risks related to intellectual property and other risks detailed from time to time in Kane's filings with Canadian securities regulatory authorities, as well as Kane's ability to anticipate and manage the risks associated with the foregoing. Kane cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on Kane's forward-looking statements to make decisions with respect to Kane, investors and others should carefully consider the foregoing factors and other uncertainties and potential events.
These risks and uncertainties should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, Kane cannot provide assurance that actual results will be consistent with these forward-looking statements. Kane undertakes no obligation to update or revise any forward-looking statement.
StrixNB(TM), DispersinB(R) and Aledex(R) are registered trademarks of Kane Biotech Inc. All Rights Reserved 2014
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