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Annual General Meeting of Shareholders - BELLUS Health provides updates on corporate and financial developments

^{Published on 2009-06-04 11:07:33, Last Modified on 2009-06-04 11:10:21 - Market Wire}
 

 LAVAL, QC, June 4 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU) (BELLUS Health or the Company) held its Annual General Meeting of Shareholders today, where management provided shareholders with updates on the status of eprodisate (KIACTA(TM)) and other products in the development pipeline, on VIVIMIND(TM)'s commercial activities and on the finances and operations of the Company. "Today, BELLUS Health is what I like to refer to as a 'virtual' biopharmaceutical company. By this, I mean that the organization has trimmed itself to focus on critical product programs, and now places greater reliance on external consultants and resources to maximize its internal expertise," said Dr. Francesco Bellini, BELLUS Health's Chairman, President and Chief Executive Officer. "It was vital that the Company restructure and re-invent itself," he added. BELLUS Health has successfully reduced its use of cash ('burn rate') to approximately CA$2 million per month. The measures taken by the Company to achieve this reduction included cutting expenses, streamlining operations to focus on critical product programs, reducing its workforce and outsourcing many support services. The Company also reorganized its corporate structure, restructured its existing debt to significantly reduce its levels, and raised new capital. Pharmaceutical Development Pipeline NRM8499 Prodrug Candidate In the last year, BELLUS Health conducted very important analyses on the data of its North American Phase III trial for tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease (AD). Outcomes of the subgroup analyses appear promising. Results obtained with an "adjusted by mixed effects repeated measures" model, looked at a subset of 474 patients that tested positive for the ApoE4 allele, a well-validated genetic marker for AD and a gene considered to increase the risk for the development of the disease and associated with more severe disease progression. Statistically significant differences between the placebo and tramiprosate-treated groups were observed over 18 months of treatment in favor of tramiprosate with respect to change in ADAS-Cog and CDR-SB, measures of cognitive function and global performance, respectively. Given their importance to advancing potential treatments in the field of AD, the Company will seek to publish these results as soon as possible. Consequently, BELLUS Health is forging ahead with the development of the NRM8499 prodrug candidate. The Company expects to complete the NRM8499 Phase I study by the end of 2009, and expects to initiate a Phase II study, in which the Company's intent will be to focus on ApoE4 positive patients, next year. BELLUS Health is confident that this will be a successful product and a high value addition in the arsenal for the treatment of AD. Eprodisate (KIACTA(TM)) BELLUS Health is currently in negotiations with several parties regarding a potential agreement for eprodisate (KIACTA(TM)) and is hopeful that it will sign a definite agreement in the coming months. As all the preparative work is already completed, once such an agreement is signed, the second Phase III confirmatory trial for eprodisate (KIACTA(TM)) will be initiated. The design of this confirmatory trial has been finalized, and the US Food and Drug Administration and the European Medicines Agency have already approved the protocol and planned statistical analysis. The study will involve approximately 190 patients recruited from over 35 sites and followed for 24 months. Eprodisate (KIACTA(TM)) is an investigational product candidate for the treatment of Amyloid A amyloidosis, a devastating and potentially fatal disease caused by the deposition of amyloid protein in major organs, causing malfunction and eventually failure. NC-503 NC-503 (eprodisate) is being studied for the treatment of Type II diabetes and certain features of metabolic syndrome. The Phase II clinical trial is ongoing in Canada and has advanced considerably. The primary objective of this clinical trial is to demonstrate that NC-503 is effective in controlling serum glucose levels either alone or as an add-on to other oral anti-diabetic drugs. Approximately 120 patients are currently randomized and interim results should be available early in the second half of 2009. Results from a validated rat model of diabetes and metabolic syndrome have demonstrated that, compared to the control group, NC-503 decreases glycemic levels in obese diabetic Zucker rats, while preserving 40% more pancreatic islet cells (insulin secreting cells), and have shown some protective effect on renal function. OVOS Natural Health - VIVIMIND(TM) OVOS Natural Health, BELLUS Health's wholly owned subsidiary, launched VIVIMIND(TM) (homotaurine) in September 2008. VIVIMIND(TM) is now available to Canadian consumers in 3,500 points of sales comprised of traditional food, drug and mass merchandise chains and natural health products stores. OVOS Natural Health continues to invest in the Canadian promotional and go-to-market strategy for VIVIMIND(TM) and continues to leverage this experience to develop worldwide commercialization opportunities for the brand. "Our immediate focus is to conclude one or more partnerships for VIVIMIND(TM). The key element to concluding these partnerships is regulatory approvals in various jurisdictions around the world, with a short-term focus on Canada, the United States, and the European Union. Needless to say, a great deal of effort is now being focused on obtaining these approvals hopefully in the next year," stated Mr. Gary Schmid, President and Chief Executive Officer of OVOS Natural Health Inc. VIVIMIND(TM) is a science-based natural health product that has been shown to protect memory function based on the naturally occurring ingredient, homotaurine, found in seaweed. Fifteen years of combined scientific research including clinical testing with over 2,000 individuals in Canada, the United States and Europe, along with millions of dollars invested, lie behind OVOS Natural Health's claim that VIVIMIND(TM) protects memory function. VIVIMIND(TM) targets healthy people aged 50 and over. Peer-reviewed Publications Four manuscripts describing the results of the North-American Phase III trial for tramiprosate on AD have been submitted for publication in peer-reviewed journals. To date, two manuscripts have already been accepted for publication, which is testimony to the credibility of the tramiprosate program. Financial Update BELLUS Health also announces the completion of the second and final tranche of its previously announced CA $20.5 million financing. BELLUS Health previously received gross proceeds of CA$10 million for the issuance of new convertible notes (CA$5 million from Vitus Investments III Private Limited and CA$5 million from Victoria Square Ventures Inc.). BELLUS Health has received a second tranche of CA$10.5 million (CA$5 million from Vitus Investments III Private Limited and CA$5.5 million from Victoria Square Ventures Inc.) and has issued subsequent notes in consideration for the aggregate principal amount of CA$10.5 million. The terms of the subsequent notes are identical to the terms of the notes issued by BELLUS Health on April 16, 2009. Board and Management Members In the context of the restructuring of the Company, the BELLUS Health Board of Directors was renewed. BELLUS Health welcomed Mr. Charles Cavell, Mr. Pierre Larochelle, Mr. Joseph Rus, and Mr. Roberto Bellini to the new Board and expressed its thanks and appreciation to members whose terms ended with the close of the Company's Annual General Meeting of Shareholders. Dr. Francesco Bellini also informed shareholders that following the signing of a partnership agreement for either eprodisate (KIACTA(TM)) or OVOS Natural Health, he will consider BELLUS Health to have begun a new cycle in its development. At that same time, he will ask the Board of Directors to actively begin looking for someone to replace him as President and Chief Executive Officer of the Company. About BELLUS Health BELLUS Health is a global health company focused on the development and commercialization of products to provide innovative health solutions to address critical unmet needs. To Contact BELLUS Health For additional information on BELLUS Health and its drug development programs, please call the Canada and United States toll-free number 1-877-680-4500 or visit the Web Site at [ www.bellushealth.com ]. Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond BELLUS Health Inc.'s (formerly known as BELLUS Health Inc.) control. Such risks include but are not limited to: the impact of general economic conditions, general conditions in the pharmaceutical and/or nutraceutical industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Group does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, that actual results may vary once the final and quality-controlled verification of data and analyses has been completed, as well as other risks disclosed in public filings of BELLUS Health Inc. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These statements speak only as of the date made and BELLUS Health Inc. is under no obligation and disavows any intention to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see the Annual Information Form of BELLUS Health Inc. for further risk factors that might affect the BELLUS Health Group and its business. 

For further information: Michelle Stein, Specialist, Corporate Communications, (450) 680-4573, [ mstein@bellushealth.com ]