WASHINGTON, CRESTVIEW HILLS, Ky. and DUBLIN, March 16 Ireland's Microbide Limited and LBR Regulatory & Clinical Consulting Services, Inc. ("LBR Regulatory") have entered into an agreement for LBR Regulatory to assess the potential for development of topical solutions to address fungal infections of the skin and nails. The companies will shortly initiate a technical evaluation of several Microbidex(TM) product formulations for their utility against human topical fungal infections.
The announcement was made in conjunction with a Trade and Investment Mission to Washington DC, led by Ireland's Prime Minister, Brian Cowen. The Mission was organized by Enterprise Ireland, the Irish state agency responsible for the development and promotion of Ireland's indigenous business sector.
Among the applications of particular interest is onychomycosis (toe nail fungus) a painful infection of the nail bed that discolors and deforms the protective nail of fingers and toes. This condition is estimated as affecting more than 35 million people in the U.S. Toe nail fungus is currently treated by either systemic or topical therapies. The current market for this indication is approximately $3.0 billion per year in the U.S. alone. Many of the current line of medications are either minimally effective or are complicated by the potential for liver toxicity. Other indications provided for under the agreement include tinea pedia (Athlete's Foot) and malassezi globosa (Dandruff).
"This alliance between Microbide Limited and LBR Regulatory will progress the ability to develop and commercialize meaningful products to meet the needs of patients with these issues, in the North American market, many of whom are on poly-therapies or otherwise unsuitable for oral medication," said Dr. Lois Rosenberger, President of LBR Regulatory & Clinical Consulting Services, Inc.
Once the evaluation period is complete, in approximately nine months time, the parties intend to enter into a formal agreement to pursue the development, regulatory approval, commercialization, marketing and distribution of these and other products throughout North America. No financial terms were disclosed.
Microbide Limited has an exclusive worldwide (ex-continental Africa) license to the stabilized aldehyde intellectual property of Antonietta P. Martin and The Martin Family Trust. The resultant stabilized aldehyde formulations show greater biocidal effect in laboratory tests than their corresponding native aldehydes with a significantly improved safety profile. The topical Microbidex(TM) formulations are all biodegradable and methanol free.
About Microbide Limited
Microbide Limited is developing novel stabilized aldehyde biocides for a number of market applications. Chief Executive Officer, Mary Skelly, recently completed the Dublin Institute of Technology's 16th Hothouse Venture Program and was awarded "Entrepreneur of the Year 2009."
About LBR Regulatory & Clinical Consulting Services
LBR Regulatory has addressed the regulatory and strategic drug development needs of numerous pharmaceutical companies since its inception ten years ago.
SOURCE Enterprise Ireland