Company Plans Expansion of Study to Japan
LAVAL, QC, Feb. 22, 2012 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU)
("BELLUS Health" or the "Company") reported today its financial results
for the year ended December 31, 2011, and provided an update on its
pipeline of products.
Japanese Pharmaceutical and Medical Device Agency (PMDA-Japan) has
accepted sponsor's proposal to expand the KIACTA™ phase 3 confirmatory
trial to Japan;
Continued enrolment of patients in the KIACTA™ phase 3 registration
Turned VIVIMIND™ business cash-flow positive in 2011;
Further expanded VIVIMIND™'s marketing and sales network through license
agreements in new markets;
Completed phase 1 trial of NRM8499: the compound was found to be safe
and well tolerated at the intended therapeutic dose;
Completed several strategic initiatives that reduced use of cash and
extended the Company's financial resources to mid-2013.
"During 2011, BELLUS Health continued to execute on its business plan,
making significant progress on several fronts," said Roberto Bellini,
President and Chief Executive Officer of BELLUS Health. "In particular,
the expansion of the KIACTA™ phase 3 registration trial to Japan is an
important milestone for the Company and now positions KIACTA™ for
marketing approval in the three major global pharma markets, the United
States, Europe and Japan, on completion of the phase 3 study," Mr.
KIACTA™ (eprodisate) for the treatment of AA amyloidosis - During 2011, BELLUS Health and its strategic partner Celtic Therapeutics
("Celtic") continued the patient recruitment for the global phase 3
confirmatory clinical trial for KIACTA™ (eprodisate). The trial is
designed to confirm the safety and efficacy of KIACTA™ in preventing
renal function decline in patients diagnosed with AA amyloidosis. The
international, randomized, double-blind, placebo-controlled,
event-driven study will involve approximately 230 patients diagnosed
with AA amyloidosis recruited from 83 sites in 28 countries worldwide,
including those in Japan. Thus far, a total of 72 clinical centers in
26 countries are actively recruiting patients. The Japanese portion of
the study is scheduled to enroll 10-20 patients in up to seven clinical
centers. These sites are expected to be activated in the second half of
2012 and will recruit patients for at least one year. Recruitment is
ongoing and is expected to be completed in the second half of 2013.
The phase 3 confirmatory study is an event-driven trial which will
conclude when 120 patients have reached worsening events linked to
deterioration of kidney function. Further to the expansion of the study
to Japan and the extension of the recruitment period, the completion of
the study is now expected in the second half of 2015.
There will be periodic data safety monitoring review boards that will
independently assess the safety of KIACTA™ (eprodisate) throughout the
study. The first such monitoring review board is scheduled to convene
in April 2012. No efficacy interim analysis will be performed.
KIACTA™ (eprodisate) has been granted Orphan Drug Designation in the
United States and received Orphan Medicinal Product designation in
Europe, which normally provide for market exclusivity of seven years
and ten years, respectively, once the drug is approved. KIACTA™
(eprodisate) has also received Orphan Drug Designation in Switzerland.
VIVIMIND™, a natural health product designed to protect memory function - Following the agreements entered into in 2010 relating to the
distribution of VIVIMIND™ in Italy with FB Health LLC ("FB Health"),
and the exclusive license and supply agreement for the distribution of
VIVIMIND™ in Canada with Advanced Orthomolecular Research Inc. ("AOR"),
the Company entered into an exclusive license and distribution
agreement with Agahan Ayandeye Pars Inc. ("Agahan Group") in 2011 for
the rights to VIVIMIND™ in Egypt, United Arab Emirates, Pakistan, Iran
and certain other Gulf states. The Agahan Group expects to launch
VIVIMIND™ in the first half of 2012. The Company also entered into an
exclusive license and distribution agreement with Integris Pharma Ltd.
(Integris) in 2011, who has secured the exclusive right to market and
sell VIVIMIND™ in Greece and Cyprus. Integris expects to launch
VIVIMIND™ in Greece and Cyprus in the middle of 2012.
The Company is actively pursuing additional partnerships in order to
further expand VIVIMIND™'s commercial footprint throughout the world.
NRM8499, a prodrug of tramiprosate for the treatment of Alzheimer's disease - In January 2011, BELLUS Health announced the results of the phase I
clinical trial for NRM8499, which investigated the safety, tolerability
and pharmacokinetic profile of NRM8499 as compared to tramiprosate in a
group of 67 young and elderly healthy subjects. The phase I clinical
trial data demonstrated that NRM8499 was safe and well tolerated at the
intended therapeutic dose. Moreover, the gastrointestinal tolerability
and pharmacokinetic profile of tramiprosate were meaningfully improved
with NRM8499. The Company is currently exploring strategic partnership
opportunities with the aim of further pursuing the development process
Strategic Cost Reduction Initiatives
Since the second quarter of 2010, the Company has been implementing
costs reduction initiatives to reduce its fixed-cost base and extend
its financial resources. These included the reduction of the Company's
head count by more than 75%; the early termination of the lease
agreement for the Company's Laval, Quebec premises; and the
reorganization of its international structure. As a result, the Company
has significantly reduced its required cash outflows.
In early 2011, the Company exercised its right to terminate the lease of
its Laval, Quebec premises as of April 7, 2011, as provided in the
amended lease agreement dated March 31, 2009, with A.R.E. Quebec No. 2,
Inc., the landlord of such premises. The early termination of the lease
resulted in annual savings of approximately $4.5 million for the
Company, representing a total of approximately $43 million in aggregate
savings over the remainder of the original lease term. The Company has
signed a new lease that began on April 8, 2011, at the same premises,
for less space.
In 2011, BELLUS Health completed a corporate reorganization whereby the
Company streamlined its international structure by liquidating its
subsidiaries in Europe and the United States. The reorganization
resulted in the repatriation of BELLUS Health's intellectual property
to Canada and the reduction of the Company's operating expenses by
approximately $1.4 million per year.
All currency figures reported in this press release, including
comparative figures, are in CDN dollars, unless otherwise specified.
For the year ended December 31, 2011, net income amounted to $3,424,000
($0.01 per share), compared to a net loss of $24,553,000 ($0.12 per
share) for the same period last year. For the fourth quarter ended
December 31, 2011, the Company recorded a net loss of $2,223,000 ($0.01
per share), compared to $12,739,000 ($0.06 per share) for the
corresponding quarter the previous year.
The increase in net income/decrease in net loss in the current periods,
compared to the corresponding periods the previous year, is partly due
to cost reduction initiatives implemented by the Company during the
past years, such as reducing its workforce, amending and early
terminating its lease agreement and streamlining its international
structure. In addition, net income for the year ended December 31,
2011, includes finance income of $13,105,000 recorded in relation to
the decrease in the fair value of the embedded conversion option
liability on the 2009 Notes, compared to finance costs of $5,904,000
for the corresponding period in 2010. Net loss for the fourth quarter
ended December 31, 2011, includes finance costs of $243,000 in relation
to the increase in the fair value of the embedded conversion option
liability on the 2009 Notes, compared to finance costs of $9,405,000
for the corresponding period in 2010.
As at December 31, 2011, the Company had available cash and cash
equivalents of $5,105,000, compared to $10,257,000 as at December 31,
2010. For the year ended December 31, 2011, net decrease in cash and
cash equivalents amounted to $5,152,000, compared to $3,760,000 for the
corresponding period the previous year. The net decrease in 2010 is net
of proceeds of $10.2 million received in relation to the KIACTA™ asset
sale and license agreement entered into with Celtic in 2010. Excluding
this cash inflow, net decrease in cash used compared to last year is
attributable to cost reduction initiatives implemented by the Company,
as discussed previously.
The Company's consolidated financial statements and accompanying
Management's Discussion and Analysis for the year ended December 31,
2011, will be available shortly on SEDAR at www.sedar.com and on the Company's web site at www.bellushealth.com.
As at December 31, 2011, based on current estimates, the Company's cash
and cash equivalents on hand and expected sources of funds are
considered, in management's view, to be sufficient to meet its
committed cash obligations and expected level of expenditures into the
third quarter of 2013. Beyond that, the ability of the Company to
continue as a going concern is dependent upon raising additional
financing through borrowings, share issuances, receiving funds through
sale of assets, supply agreements or product licensing agreements, and
from obtaining regulatory approval in various jurisdictions to market
and sell its product candidates and ultimately achieving future
profitable operations. The outcome of these matters is dependent on a
number of factors outside of the Company's control. This material
uncertainty may cast significant doubt about the Company's ability to
continue as a going concern beyond that period.
Management continues to pursue additional sources of funds including
through further arrangements relating to the distribution of VIVIMIND™
and a potential partnership for NRM8499. While the discussions could
lead to the signing of binding agreements in the future, there can be
no assurance whatsoever that any such transaction will be put in place.
About BELLUS Health
BELLUS Health is a development-focused health company concentrating on
the development of products that provide innovative health solutions
and address critical unmet medical needs. For further information on
BELLUS Health, please visit www.bellushealth.com.
Forward Looking Statements
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 control. Such risks include but are not
limited to: the ability to obtain financing immediately in current
markets, 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
Inc. does business, stock market volatility, fluctuations in costs, and
changes to the competitive environment due to consolidation,
achievement of forecasted burn rate, achievement of forecasted clinical
trial milestones, and that actual results may vary once the final and
quality-controlled verification of data and analyses has been
completed. 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
Company's public fillings including the Annual Information Form of
BELLUS Health Inc. for further risk factors that might affect the
Company and its business.
SOURCE BELLUS HEALTH INC.
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