FMI HOLDINGS LTD. 6-K 2005
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
For the month of June, 2005
Commission File Number
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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and Exchange Commission and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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
For Immediate Release:
June 27, 2005
Forbes Medi-Tech Completes FM-VP4 Toxicity Study
~Study Results to Provide Key Component for Phase II IND Submission~
Vancouver, Canada Forbes Medi-Tech Inc. (TSX:FMI and NASDAQ:FMTI) today announced that it has completed a 90-day toxicity study for its cholesterol-lowering drug, FM-VP4. The final results, expected in August, will be used for the Investigational New Drug (IND) application for the upcoming US Phase II trial. To date, there have not been any significant adverse events that would jeopardize the IND submission to the FDA, anticipated in the third quarter of 2005. The Company plans to initiate a US Phase II clinical trial pending the outcome of the FDA review of the IND.
FM-VP4 has consistently demonstrated a favorable safety profile through previous clinical and pre-clinical studies, said Charles Butt, President and CEO of Forbes Medi-Tech Inc. The incoming study results provide the opportunity to demonstrate FM-VP4s continued safety profile over a longer period of time than previous studies and to complete the IND application.
FM-VP4 is a cholesterol absorption inhibitor, a new class in cholesterol-lowering drugs. FM-VP4 has demonstrated dramatic cholesterol-lowering and anti-atherosclerotic properties in pre-clinical studies. The cardiovascular market represents a significant opportunity as 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.
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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 Companys toxicity study results, planned IND application and planned clinical trial, which statements can be identified by the use of forward-looking terminology such as expected, will be, upcoming, would, anticipated, plans, opportunity or comparable terminology referring to future events or results. The Companys actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including the risk that the toxicity study results will not be available as planned or scheduled or will contain unanticipated results; uncertainty whether the Company will file an IND as anticipated or at all or if filed, whether it will be approved; uncertainty whether the Company will undertake a Phase II clinical trial as planned or at all or if undertaken, whether such trial will be completed or successful; 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; 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, 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.