FMI HOLDINGS LTD. 6-K 2005
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
For the month of August, 2005
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
This report on Form 6-K shall be deemed to be incorporated by reference in the prospectus included in Registration Statements on Form F-3 (File Nos. 333-110910 and 333-112619) filed with the Securities and Exchange Commission and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
A Life Sciences Company
Forbes Medi-Tech Submits IND Application for Cholesterol-Lowering Drug, FM-VP4
~Company Completes Major Milestone for US Phase II trial~
Vancouver, Canada Forbes Medi-Tech Inc. (TSX:FMI and NASDAQ:FMTI) today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a US Phase II clinical trial for its cholesterol-lowering drug, FM-VP4. The application provides the FDA with clinical and preclinical safety and manufacturing data in support of clinical evaluation of FM-VP4 in humans.
The IND represents the culmination of clinical and pre-clinical study results and our commitment to initiating an important human trial for FM-VP4, said Charles Butt, President and CEO of Forbes Medi-Tech. We are aggressively pursuing the further development of this drug to address the worlds largest pharmaceutical market, which is estimated to grow from $23 billion in 2005 to $40 billion by 2011.
The design of the upcoming US Phase II trial incorporates the knowledge gathered from both pre-clinical studies and a European proof of concept trial in humans. The planned US Phase II trial includes enhancements to the dosing regime, length of trial and patient population with an end target of 15% reduction in LDL-cholesterol. Further details will be available upon the trials initiation.
FM-VP4 is a cholesterol absorption inhibitor, a new class in cholesterol-lowering drugs. FM-VP4 has demonstrated significant cholesterol-lowering and anti-atherosclerotic properties in pre-clinical studies. The cardiovascular market represents a significant opportunity as industry-wide sales of cardiovascular pharmaceuticals are estimated to grow to over $40 billion by 2011. (Datamonitor, 2004)
About Forbes Medi-Tech Inc.
Forbes Medi-Tech Inc. is a life sciences company dedicated to the research, development and commercialization of innovative products for the prevention and treatment of cardiovascular disease. Our vision is to develop and market products along a treatment continuum that cardiovascular disease consumers, healthcare professionals and specialized cardiovascular disease research and healthcare institutions will identify, recommend and seek. Our business strategy is to develop and commercialize proprietary compounds to address the unmet needs of patients within the cardiovascular disease market.
ON BEHALF OF THE BOARD OF DIRECTORS OF FORBES MEDI-TECH INC.
Charles A. Butt
President & CEO
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For more information, please contact:
Manager, Investor Relations
Telephone: (604) 681-8976
NASDAQ and the Toronto Stock Exchange have not reviewed and do not accept responsibility for the adequacy or accuracy of the content of this News Release. This News Release contains forward-looking statements regarding the Company, its operations and future prospects, which statements can be identified by the use of forward-looking terminology such as vision, upcoming, will be, strategy, may have, provides, initiating, pursuing, planned, will be, or comparable terminology referring to future events or results or terminology referring to future dates. The Companys actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including uncertainty whether the U.S. Phase II trial of FM-VP4 will occur as planned or at all or will be successful; uncertainty whether FM-VP4 will be commercialized; uncertainty whether the Company will realize is strategies and vision; the need for additional clinical trials, the occurrence and success of which is not assured; intellectual property risks; the need for regulatory approvals, which are not assured and which may be denied or withdrawn; manufacturing risks and the need to manufacture to regulatory standards; product liability and insurance risks; the risk of unknown side effects; intellectual property risks; the effect of competition; and the Companys need for future funding; any of which could cause actual results to vary materially from current results or the Companys anticipated future results. See the Companys reports filed with the Canadian and U.S. securities regulatory authorities from time to time for cautionary statements identifying important factors with respect to such forward-looking statements, including certain risks and uncertainties, that could cause actual results to differ materially from results referred to in forward-looking statements. The Company assumes no obligation to update the information contained in this News Release.