- Also announces voting results from Annual Meeting of Shareholders
LAVAL, QC, May 7, 2014 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS
Health" or the "Company"), a drug development company focused on rare
diseases, today reported its financial and operating results for the
first quarter ended March 31, 2014.
Recruitment nearly completed for Phase III Confirmatory Study for
KIACTA™ for the treatment of AA amyloidosis, with 227 patients out of
230 recruited as of April 28, 2014;
KIACTA™ Phase III Confirmatory Study on track to conclude in 2016. As of
April 28, 2014, 55 patients out of 120 have experienced an event linked
to the deterioration of kidney function;
Recommendation of the Data and Safety Monitoring Board to continue
KIACTA™ Phase III Confirmatory Study as per protocol, based on last
review on April 15, 2014;
Initiated Shigamab™'s proof-of-concept testing for treatment of sHUS in
mouse and primate models;
Concluded the quarter with a cash position of $14.0 million, which
should enable the Company to finance its operations beyond the end of
the Phase III Confirmatory Study for KIACTA™.
Subsequent to quarter end, announced an amendment to the KIACTA™ asset
sale and license agreement in relation to the share of proceeds from a
potential divestiture of KIACTA™. In addition, BELLUS Health's clinical
development partner, Auven Therapeutics, hired Lazard as a financial
advisor to explore sale of KIACTA™. This new direction and amended
agreement provide more flexibility to divest KIACTA™ at the most
opportune moment for stakeholders, whether that proves to be this year
or after the conclusion of the KIACTA™ Phase III Confirmatory Study;
Subsequent to quarter end, announced that Auven Therapeutics entered
into a license agreement with Mount Sinai Hospital for the development
of KIACTA™ in sarcoidosis, a rare inflammatory condition that affects
"Recruitment for the Phase III study that is evaluating KIACTA™ as a
potentially safe and efficacious treatment for AA amyloidosis is almost
complete, and this rare disease asset is now also moving forward into a
Phase II study for sarcoidosis," said Roberto Bellini, President and
Chief Executive Officer of BELLUS Health. "In the coming quarters, we
will maintain our focus on advancing our pipeline of rare disease
projects towards greater shareholder value-creating events."
Phase III Confirmatory Study for KIACTA™
Recruitment for the KIACTA™ Phase III Confirmatory Study is on track
with target, and it is expected that it will be completed in the second
quarter of 2014. On April 28, 2014, Auven Therapeutics and Company
presented an update on the study's progress at the XIVth International Symposium on Amyloidosis in Indianapolis. It was
announced that as of that date, the Phase III Confirmatory Study had
enrolled 227 patients, and that 55 patients have had an event. Based on
the current recruitment and event rates, the KIACTA™ Phase III
Confirmatory Study is expected to conclude in 2016.
The study is designed to confirm the safety and efficacy of KIACTA™ in
preventing renal function decline in patients diagnosed with AA
amyloidosis. The Phase III Confirmatory Study is the last key step
before applications for regulatory approval for KIACTA™ can be filed.
The study is expected to enroll approximately 230 patients from more
than 70 sites and 30 countries worldwide.
The Phase III Confirmatory Study is an event-driven trial which will
conclude when 120 patients have experienced an event linked to
deterioration of kidney function. An event is counted when a patient's
kidney function has deteriorated as measured by a persistent 80 per
cent increase in serum creatinine, a persistent 40 percent decrease in
creatinine clearance or reaching end stage renal disease.
KIACTA™ is partnered with global private equity firm Auven Therapeutics.
Auven Therapeutics is conducting the KIACTA™ study and funding 100% of
the development costs of KIACTA™, including the Phase III Confirmatory
Study and other related activities, which total costs are currently
estimated to be in excess of US$50 million.
As part of the Phase III Confirmatory Study, there are periodic meetings
of the Data Safety Monitoring Board ("DSMB"), which independently
assesses the safety of KIACTA™ throughout the study. Based on its last
review on April 15, 2014, the DSMB recommended that the study continue
as per protocol.
Patients completing the Phase III Confirmatory Study will be offered to
continue in an extended program, for which the first patients are
expected to be enrolled in the coming weeks.
Amendment to the KIACTA™ asset sale and license agreement
Earlier today, Auven Therapeutics and BELLUS Health announced that they
have agreed upon modified terms to the KIACTA™ asset sale and license
agreement in relation to the share of proceeds from a potential
divestiture of KIACTA™, particularly in the now-envisaged scenario of a
KIACTA™ sale before the completion of its Phase III study. Assuming
that total divestiture transaction proceeds reach a pre-determined
threshold, the parties will share aggregate proceeds equally. Auven
Therapeutics retains certain preference rights on exit proceeds related
to Auven Therapeutics' aggregate investment in KIACTA™ up to the date
of the sale.
Engagement of financial advisor to explore the sale of KIACTA™
Earlier today, Auven Therapeutics and BELLUS Health announced that Auven
Therapeutics has engaged Lazard as financial advisor to explore the
sale of KIACTA™. As the Phase III KIACTA™ study in AA Amyloidosis nears
completion of its enrollment, it was determined that a potential sale
prior to the completion of the study would provide the acquirer with
the opportunity to have input into the regulatory process for approval
of KIACTA™ worldwide, and would facilitate the manufacturing, marketing
and sales preparations for a global launch of the drug.
License Agreement with Mount Sinai for KIACTATM in Sarcoidosis
On May 2, 2014, Auven Therapeutics and BELLUS Health announced that
Auven Therapeutics has entered into a license agreement with Icahn
School of Medicine at Mount Sinai Hospital, New York, under which Auven
Therapeutics obtained rights to develop KIACTA™ (eprodisate) as a
treatment for chronic sarcoidosis.
Auven Therapeutics intends to conduct a Phase II (proof-of-concept)
clinical trial to evaluate KIACTA™'s effectiveness and safety to treat
certain medical manifestations of sarcoidosis. Auven Therapeutics
expects to finalize a study protocol by mid-year and anticipates that
the trial will start dosing patients in the fourth quarter of 2014. The
Phase II trial is expected to be completed within approximately 18
months of the time the first patient is enrolled. All costs in relation
to the development of KIACTA™ in sarcoidosis will be borne by Auven
Therapeutics. Proceeds from potential future revenue of KIACTA™,
including the rights to KIACTA™ for sarcoidosis, are subject to the
proceeds sharing agreement between Auven Therapeutics and BELLUS
Sarcoidosis is a rare condition that causes small patches of red and
swollen tissue - called granulomas - that can develop in multiple
organs in the body, but mostly in the lungs and skin. The disease
affects approximately 120,000 patients in the US alone and
identification of an effective treatment is a major unmet medical need.
Most patients with sarcoidosis recover, but approximately 30% develop
chronic, debilitating disease. Mortality occurs in 1-5% of patients.
There is no cure for sarcoidosis, and treatment options are limited and
can have serious adverse effects. Obtaining the rights to move KIACTA™
into a second indication further expands its commercial potential and
may help patients with this sometimes debilitating chronic disease.
Shigamab™'s proof of concept testing for treatment of sHUS in mouse and
primate models is currently underway. Once completed, the Company then
intends to meet with regulators to agree on a development plan and seek
a partner to pursue the development of Shigamab™.
Shigamab™ is a monoclonal antibody therapy being developed for the
treatment of Hemolytic Uremic Syndrome related to Shiga toxin-producing
E. coli ("STEC") bacterial infections ("sHUS"), which principally
affects the kidneys and often leads to acute dialysis, and in certain
cases chronic kidney disease and death, primarily in children.
Summary of Financial Results
All currency figures reported in this press release are in Canadian
dollars, unless otherwise specified.
||Three months ended |
March 31, 2014
|Three months ended |
March 31, 2013
(in thousands of dollars, except per share data)
Research and development expenses
General and administrative expenses
Net loss attributable to owners of the Company
Basic and diluted loss per share
The Company's full consolidated financial statements and accompanying
management's discussion and analysis for the three-month period ended
March 31, 2014, will be available shortly on SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.
For the three-month period ended March 31, 2014, net loss attributable
to owners of the Company amounted to $680,000 ($0.01 per share),
compared to $537,000 ($0.01 per share) for the corresponding period the
previous year. The increase in net loss is primarily due lower revenue
recorded in the current quarter compared to the corresponding quarter
the previous year, mainly in relation to VIVIMIND™.
Research and development expenses amounted to $464,000 for the
three-month period ended March 31, 2014, compared to $395,000 for the
corresponding period the previous year. The increase is mainly
attributable to expenses incurred in relation to the development of
Shigamab™, which drug candidate was acquired through the acquisition of
Thallion Pharmaceuticals Inc. in August 2013.
General and administrative expenses amounted to $890,000 for the
three-month period ended March 31, 2014, compared to $966,000 for the
corresponding period the previous year. The decrease is mainly
attributable to an expense reduction in relation to VIVIMIND™
operations following its divestiture in October 2013.
As at March 31, 2014, the Company had available cash, cash equivalents
and short-term investments totalling $14,031,000, compared to
$15,297,000 as at December 31, 2013. Based on management's estimate,
the current cash position should enable the Company to finance its
operations beyond the end of the KIACTA™ Phase III Confirmatory Study.
BELLUS Health Announces Election of Directors and Independent Auditor at
Each director nominee listed in the Management Information Circular
dated March 18, 2014 was elected as Director of the Company during the
Annual Meeting of the Holders of Common Shares held today in Laval,
The details of the election are as follows:
Dr. Francesco Bellini, O.C.
|Franklin M. Berger||
HÉlÈne F. Fortin
Dr. Martin Tolar||
The results of the final votes regarding all matters subject to a vote
during the Annual Meeting that took place today will be made available
on SEDAR's site (www.sedar.com).
KPMG LLP, Chartered Accountants, have been appointed as the independent
auditor of the Company until the next Annual Meeting of Shareholders.
KPMG LLP has been the independent auditor of the Company since
BELLUS Health Announces Renewal of Stock Option Plan at Annual Meeting
In addition, all unallocated options under the Stock Option Plan of
BELLUS Health were approved, and the Company was granted the ability to
continue granting options under the Stock Option Plan until May 7,
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a drug development company focused on rare diseases. It
has a portfolio of rare disease projects including KIACTA™ in Phase III
for AA amyloidosis, KIACTA™ for sarcoidosis, clinical stage ShigamabTM for sHUS and a research-stage project for AL amyloidosis. The lead
program KIACTA™ is currently in a Phase III Confirmatory Study for the
treatment of AA amyloidosis, an orphan indication resulting in renal
dysfunction that often rapidly leads to dialysis and death. KIACTA™ is
partnered with global private equity firm Auven Therapeutics.
About AA Amyloidosis
AA amyloidosis is a deadly condition that progresses from chronic
inflammatory diseases such as rheumatoid arthritis. The disease causes
a protein called amyloid A to accumulate in major organs, particularly
the kidneys, which leads to organ dysfunction, failure, and eventually
There is currently no available treatment for AA amyloidosis. A recent
commercial assessment study conducted for Auven Therapeutics and BELLUS
Health indicated that there are approximately 13,000 diagnosed and
addressable patients with AA Amyloidosis worldwide, of which an
estimated 10,300 are in the U.S. and the EU5.
KIACTA™ has been granted Orphan Drug designation or its equivalent in
the United States, Europe and Japan, which provide seven, ten and ten
years of market exclusivity, respectively, once the drug is approved,
as well as a reduction in application and review fees.
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, the impact of general
economic conditions, general conditions in the pharmaceutical industry,
changes in the regulatory environment in the jurisdictions in which the
BELLUS Health Inc. does business, stock market volatility, fluctuations
in costs, changes to the competitive environment due to consolidation,
achievement of forecasted burn rate, potential payments in relation to
indemnity agreements, 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. In addition, the length of the KIACTATM Phase III Confirmatory Study is dependent upon many factors, including
clinical sites activation, patient enrollment rate, patient drop-out
rate and occurrence of clinical endpoint events, and the sharing of
proceeds between Auven Therapeutics and BELLUS Health Inc. from
potential future revenue of KIACTA™ is dependent upon a number of
factors, including the quantum of proceeds. 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 BELLUS Health Inc.'s public fillings
including the Annual Information Form for further risk factors that
might affect BELLUS Health Inc. and its business.
SOURCE BELLUS Health Inc.