KANE Biotech, a Winnipeg biotech company that has been developing technologies and products to prevent and remove hard-to-address microbial biofilms, has received U.S. clearance on a wound-care product.
A month before this week’s U.S. Food and Drug Administration clearance for Coactiv+ Antimicrobial Wound Gel, Kane signed a U.S. distribution deal with ProgenaCare. The FDA approval triggered a $500,000 payment from ProgenaCare.
The FDA approval is a major advancement for the company, which had been making and selling a line of oral pet care using some of its patented antimicrobial technology. The pet care market does not have nearly the same hurdles to achieve regulatory approval.
The FDA approval and partnership with ProgenaCare are significant milestones for Kane, which has persisted in its research and development and commercialization for many years.
“This is the inflection point we have been working so hard for, for many, many years,” said company CEO Marc Edwards.
The company began its work addressing biofilm antimicrobials with the discovery of an enzyme called DispersinB. However, its efforts to further develop that into applications has hit many roadblocks, not the least of which is that it is an unknown entity to the FDA, even though it has been working with the U.S. Army and others on its development for several years.
Edwards said, “The brass ring we were always going for was a DispersinB-based gel. But funding has always been an issue. Publicly traded Canadian biotech companies have a tough go and being based in Winnipeg was an even bigger anomaly. It is a challenge.”
The company chose to focus on getting regulatory approval for Coactiv+, a patented combination of ingredients that are used in different products.
Edwards said the Coactiv+ will sell at a price within the U.S. medicare reimbursement rates and he believes it will become a more medically and cost-effective choice for treating things like foot ulcers caused by Type 2 diabetes. Edwards would not disclose its manufacturing arrangements but said it will be made in Canada and expects to be able to start shipping by the end of this year.
In addition to U.S. distribution, Kane signed a deal for distribution in some Central and South American countries and Edwards hopes the FDA approval will clear the way for potential distribution deals elsewhere.
Earlier this year, the company signed a licensing deal for its pet dental care products with Skout’s’ Honor Pet Supply Co., a major distributor to pet speciality stores in the U.S. Kane has had distribution in Canadian retail and with veterinary clinics for its product under the BlueStem brand. The deal with Skout’s Honor allows that company to sell it under Skout’s own brand name.
Edwards said, “When the Skout’s Honor product hits the shelves in November it will be in thousands of stores, much more retail presence for our product than we have today.”
The company has received funding from the U.S. Army and Canadian government to start Phase 1 clinical trials for DispersinB this year, something it has not been able to afford to do to date.
The company released its first-quarter results this week with revenue up 20 per cent to $677,617.
News source: Winnipeg Free Press