News Release
Date: February 15, 2006
Comvita announces it has signed a long-term exclusive licensing deal with US-based manufacturer and supplier of wound care products, Derma Sciences Inc.
The licensing deal, which includes patents and other intellectual property, covers the use of Comvita’s medical grade manuka honey-based products for chronic wounds, skin tears, post-operative wounds and burns.
Under the agreement, Derma Sciences will receive exclusive manufacturing and marketing rights to Comvita’s woundcare products throughout the Americas (North, Central and South).
In addition, and subject only to due diligence and final documentation Comvita will purchase US$500,000 (666,666 shares at US$0.75) of Derma Sciences stock when Derma receives FDA 510K approval for the manuka honey-based products. Funds from the purchase of Derma shares will be used exclusively to launch the manuka honey products in the Americas.
Comvita will also have the option to purchase an additional US$500,000 shares at the same price for one year from the signing of the license and an additional option to purchase two million shares three years from the signing of the agreement at US$3 per share.
Comvita CEO Brett Hewlett says his company is working to a precise step-by-step plan for entry into global markets and the evaluation and selection of Derma Sciences has been carefully planned.
“The US has always been part of our plan for growing our medical category and with its manufacturing capabilities and established distribution network, Derma Sciences is the perfect partner for Comvita’s entry into this large and growing advanced wound care market.
“Derma is ideally positioned to capture the commercialisation potential of Comvita’s range of patented products,’” he says.
Comvita now has the UK, US and Australasia covered for its wound care category, and rapidly growing sales in other new markets.
Hewlett says the value of the Derma Sciences agreement is significant for Comvita shareholders.
“The share options provide a pathway for more direct involvement in the US market through Derma. Operationally there will be excellent opportunities for knowledge sharing and learning between the organisations, benefiting both Comvita’s global wound care position and Derma’s sales and marketing efforts in the Americas.”
Barry Wolfenson, Director of Marketing for Derma Sciences says exclusive access to Comvita’s products greatly enhances Derma’s product portfolio as it fills an unmet need for combination wound healing/antimicrobial products for use in all phases of wound healing.
“Fifty percent of all non-traumatic leg amputations in the United States are due to infected diabetic ulcers, with a five-year mortality rate ranging from 39% - 68%. With other wounds and burns there is a growing concern over antibiotic resistant super-bugs such as MRSA. A significant percentage of these infections prove fatal.
“Medical grade manuka honey products will provide clinicians with additional resources to help reduce the risk of infection while providing optimal environments for wound healing from the onset of the wound through to closure.”
President and CEO of Derma Sciences, Edward J. Quilty says Comvita has a strong reputation for utilising raw materials from natural sources and is highly regarded in the natural health products industry.
“The unique qualities found in manuka honey have been shown in clinical studies to be effective in the management of leg ulcers, pressure sores and post-operative conditions. It’s capable of treating some of the more antibiotic resistant strains of bacteria, a significant and growing problem for hospitals.”
BackgroundFDA 510KManufacturers, distributors, or importers are required to get FDA clearance before marketing certain types of new medical devices in the United States. In most cases, this clearance is obtained by submitting a file, called a 510(k), for FDA review. The 510(k) must demonstrate that the new device is “Substantially Equivalent” to a named device (the “predicate”) that has already been legally marketed in the United States for the same purpose.
Web siteswww.dermasciences.comwww.comvita.com Derma Sciences IncDerma Sciences, Inc. is a fully integrated manufacturer, marketer and supplier of a complete line of products for wound and skin care. Its products can be broken down into five categories: Advanced Wound Care, Traditional Wound Care, Burn Care, Skin Care and Bathing, and Specialty Securement and Closure Devices. With three wholly owned and operated manufacturing facilities in St. Louis, Toronto, and China, Derma Sciences also offers contract manufacturing services for OEM or private label products.