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Bay of Plenty-based Comvita Ltd says its patented "advanced wound care dressing" has become the first using manuka honey for wounds and burns to receive marketing clearance from the US Food and Drug Administration (FDA).
The FDA approval heralded an important milestone for Comvita's wound care business, said the company's chief executive Brett Hewlett.
The global advanced wound care market is worth more than US$4 billion ($5.07 billion), of which the US makes up US$2.3 billion.
"An ageing population and increase in diabetes will continue to be strong drivers for this fast growing category," he said.
Some biologically active honey gathered from manuka contains the compound methylglyoxal, which helps it to battle bacteria causing stomach ulcers, and to promote wound healing.
Wound-care products using the honey have become increasingly valuable as they have also proven effective against some antibiotic-resistant strains of bacteria.
Mr Hewlett said the US approval meant revenues from a licensing agreement with Derma Sciences in the US will begin to come on stream later this year from a whole range of products that had been waiting in the pipeline.
Comvita has a 14 per cent stake (10 per cent fully diluted) in publicly owned Derma Sciences, a marketer of advanced wound care products.
Derma Sciences recently won clearance to sell Comvita's antimicrobial dressings with active manuka honey in Canada. Similar dressings are already approved as antimicrobials in Europe, Canada, Australia and New Zealand
Some health products require FDA approval before they can be sold in the USA. Comvita already had CE certification (the European Union equivalent of FDA approval) and said at one stage that it expected to have FDA approval by August 2006 in time to launch products in the US in September.
Comvita said in February 2006 after signing its deal with Derma Sciences that it would buy US$1 million worth of shares -- at US75c/share -- in the US company in two tranches, with an option to buy an additional 2 million shares at US$3/share in 2009, a cost of US$6 million ($7.6 million).
The deal, which includes patents and other intellectual property, gave Derma exclusive rights throughout North, Central and South America to Comvita's medical grade manuka honey products for chronic wounds, skin tears, post-operative wounds and burns.
According to Derma, the Comvita products fill an unmet need for combination wound healing/antimicrobial products for use in all phases of wound healing.
About 50 per cent 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 per cent to 68 per cent.
Other wounds and burns raise concern over antibiotic resistant super-bugs such as MRSA, in which a significant percentage of the infections kill patients.
Comvita -- which controls about 70 per cent of the biologically-active manuka honey harvest in New Zealand -- said today it had also completed its A$6 million ($6.68 million) takeover of Australian wound care specialist Medihoney.
"These two major events represent the culmination of a sustained strategy to secure a leadership position internationally in the honey-based wound care market," said Mr Hewlett.
Medihoney had an exceptional UK sales team which had successfully launched wound care lines into the $100 million UK antimicrobial market. Sales of MediHoney's products in the past 12 months were about $3 million and growing strongly.
"Acquisition of Medihoney with its coverage in UK and Europe -- plus the partnership with Derma Sciences in the US -- gives Comvita the ability to penetrate the world's two largest wound care markets," Mr Hewlett said.
Medihoney would provide Comvita with several patent filings, a number of CE-marked wound care products and therapeutic skincare products sold through existing hospital and pharmacy channels.
Comvita paid former owner, Capilano Honey Ltd for Medihoney with A$5 million in Comvita shares and A$500,000 cash, leaving Australia's largest honey manufacturer with an 8 per cent stake in Comvita.
- NZPA
