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
"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
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.
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
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 (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.
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
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
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:
For further information: Michelle Stein, Specialist, Corporate
Communications, (450) 680-4573, firstname.lastname@example.org