News Realease
July 23, 2007
A patented advanced wound care dressing by
Comvita Limited has become the first honey-based product for the management of wounds and burns to receive marketing clearance from the US Food and Drug Administration (FDA).
FDA approval comes at the same time as
Comvita wraps up the acquisition of Australian based
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.
Comvita’s US partner
Derma Sciences today announced it received the FDA clearance to market and sell the Comvita-owned API-MEDTM Active Manuka Honey Absorbent Dressing in the United States.
Comvita CEO Brett Hewlett says the FDA approval heralds an important milestone for Comvita’s burgeoning wound care business as it secures its place in a multi-billion dollar market.
“The global advanced wound care market is worth more than US$4 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 says.
“Derma Sciences’ US approval allows us to further confirm our leadership position in honey-based advanced wound care products. Our early investment in intellectual property, research and brand development will allow us to take a strong position in the rapidly growing antibacterial dressings category. What’s more, Derma Sciences has allowed Comvita to establish a distribution network in North America and to increase our sales prospects in that market.”
Mr Hewlett says FDA approval means
Comvita’s revenues from its licensing agreement with
Derma Sciences in the US will begin to come on stream later this year as they role out a whole range of new products that have been waiting in the pipeline for some time now.
“Our investment in our medical business has also stepped up accordingly as we seek to maximise long-term shareholder value from this success. Shareholders should expect to see the first positive contributions to earnings per share from the advanced woundcare part of our business in the 2008 financial year.”
Comvita has a 14 per cent stake (10 per cent fully diluted) in publicly owned Derma Sciences (code DSCI), a marketer of advanced wound care products. Active Manuka honey has an antibacterial effect that speeds up the healing process of wounds and burns1.
The FDA approval follows Derma Sciences’ recent clearance from Health Canada to market and sell Comvita’s line of API-MEDTM Antimicrobial Dressings with Active Manuka Honey in Canada. Active
Manuka Honey and other Leptospermum honey-based wound care products currently marketed under licence by Comvita are already approved as antimicrobials in Europe, Canada, Australia and New Zealand.
Derma Sciences CEO Ed Quilty says the company has secured its leadership position by being the first in North America with a honey-based wound care product.
“We should be assured the leadership position in this significant market thanks to
Comvita’s dominance in the procurement of Manuka honey, its advanced processing systems and patents for the use of honey in wound dressings, coupled with our exclusive US marketing rights. We are confident our non-toxic, naturally-derived product, with its large and growing evidence base, will be readily adopted by clinicians who are calling for easy and effective products to use in all phases of wound healing,” says Mr Quilty.
Comvita further cemented its strategy for the medical honey business with the successful acquisition of Australian wound care specialist Medihoney on July 1.
“
Medihoney will add to Comvita’s medical capability through its specialised team bringing considerable technical and regulatory expertise, existing networks and distribution channels. For example, Medihoney has an exceptional UK sales team which has successfully launched their leading wound care lines into the NZ$100 million UK antimicrobial market. Sales of MediHoney in the last 12 months were approximately $3 million and growing strongly,” says Mr Hewlett.
The majority of the world’s advanced wound care sales are attributed to the US and Europe. The 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.
Comvita will be able to accelerate its reach into lucrative new markets such as the UK and Germany through Medihoney’s existing distribution network. Furthermore, Medihoney is licensed as a Medical Device Manufacturer and audited to ISO 13485:2003 and complies with European MDD 93/42/EEC, enabling a faster product development pipeline.
Medihoney’s R&D programme is backed by a number of published clinical studies and will complement both Comvita’s scientific and clinical research programme using Manuka honey-based dressings and its proprietary IP around the application of honey in wound dressings. In addition, Medihoney will 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 is confident it will quickly reap the rewards of the Medihoney acquisition largely through the company’s strong offshore distribution channels and technical expertise.
“Medihoney’s distribution network and early commercialisation work in terms of regulatory approvals and IP will be of significant benefit to Comvita as we continue to grow our medical business internationally,” says Mr Hewlett.
Comvita’s $6 million purchase of Medihoney consists of AU$5.5 million in Comvita shares and AU$500,000 cash. Former owner, Capilano Honey Limited – Australia’s largest honey manufacturer - will have just over eight per cent shareholding in Comvita through the Medihoney sale.
Ends.
Visit these websites for more background on the companies referred to in this release:
www.dermasciences.comwww.medihoney.com www.capilano.com.au