LAVAL, QC, Nov. 5, 2013 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS
Health" or the "Company") today reported its financial and operational
results for the third quarter ended September 30, 2013.
Third Quarter 2013 Highlights
Acquired all outstanding common shares of Thallion Pharmaceuticals Inc.
The acquisition adds a clinical stage drug candidate in a rare disease
indication and strengthens the Company's cash position by more than
Continued recruitment for the Phase III Confirmatory Study for KIACTA™
for the treatment of AA amyloidosis. Based on the current recruitment
rate, it is expected that patient recruitment will be completed in the
first half of 2014;
KIACTA™ intellectual property further strengthened through the issuance
of a U.S. patent expiring in 2026;
KIACTA™ granted Orphan Disease Drug Status in Japan. Japanese drug
development grant also received for KIACTA™;
Concluded the quarter with a cash position of $16.0 million, enabling
the Company to finance its operations into 2018, beyond the end of
KIACTA™ Phase III Confirmatory Study;
Subsequent to quarter-end, recommendation of the Data and Safety
Monitoring Board to continue KIACTA™ Phase III Confirmatory Study as
per protocol, based on last review;
Subsequent to quarter-end, announced the divestiture of two non-core
assets: VIVIMIND™, a natural health product for memory protection, and
BLU8499, a drug candidate for the treatment of CNS diseases including
Subsequent to quarter-end, announced an agreement with AmorChem Holdings
Inc. to develop drug candidates for the treatment of AL amyloidosis.
"BELLUS Health has emerged as a significantly stronger and more focussed
company," said Roberto Bellini, President and Chief Executive Officer
of BELLUS Health. "We have greater financial resources to move our
promising pipeline of rare disease assets forward, and we now have the
opportunity to deploy all of our drug development expertise towards
this compelling therapeutic area."
Acquisition of Thallion Pharmaceuticals Inc.
On August 15, 2013, the Company acquired all of the issued and
outstanding common shares of Thallion Pharmaceuticals Inc.
("Thallion"), for a purchase price of $6.266 million or $0.1889 per
common share and the issuance of one contingent value right ("CVR") per
common share. The transaction was done by way of a court approved plan
Thallion is a biotechnology company developing pharmaceutical products
in the areas of infectious disease and oncology. Thallion's lead
clinical program Shigamabs™ is a monoclonal antibody therapy being
developed for the treatment of Hemolytic Uremic Syndrome ("HUS")
related to Shiga toxin-producing E. coli ("STEC") bacterial infections.
HUS principally affects the kidneys and often leads to acute dialysis,
and in certain cases chronic kidney disease and death, primarily in
children. Shigamabs™ has recently completed a Phase II clinical trial.
This transaction strengthens BELLUS Health's pipeline by adding a
clinical stage drug candidate in a rare renal indication and also
strengthens BELLUS Health's cash position by more than $1.1 million,
Thallion having cash, cash equivalents and short-term investments of
approximately $7.4 million on closing of the transaction.
Phase III Confirmatory Study for KIACTA™
During the third quarter of 2013, recruitment continued for the Phase
III Confirmatory Study for KIACTA™. The study is designed to confirm
the safety and efficacy of KIACTA™ in preventing renal function decline
in patients diagnosed with AA amyloidosis, an orphan indication
resulting in renal dysfunction that often rapidly leads to dialysis and
death. The study will involve approximately 230 patients enrolled from
more than 70 sites and 30 countries worldwide.
Based on the current recruitment rate, it is expected that patient
recruitment will be completed in the first half of 2014. The Phase III
Confirmatory Study is an event-driven clinical trial that will end when
120 events linked to deterioration of kidney function have occurred,
which is currently expected to be reached in 2017. BELLUS Health's
partner, Auven Therapeutics, is funding 100% of the development costs
of KIACTA™, including the Phase III Confirmatory Study and other
related activities, which are estimated to be in excess of US$50
million. Auven Therapeutics and BELLUS Health are expected to share the
overall proceeds from potential future revenue of KIACTA™ approximately
Patients completing the Phase III Confirmatory Study will be offered to
continue in an extended program. The first patients are expected to be
enrolled in the extended program in the fourth quarter of 2013.
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 October 21, 2013, the DSMB recommended that the study
continue as per protocol.
On July 23, 2013, the Company announced that KIACTA™ was granted Orphan
Disease Drug Status in Japan. As a result, KIACTA™ will receive
priority review from Japanese regulatory authorities as a New Drug
Application, once it is submitted. In addition, the drug will be
granted 10 years of market exclusivity as a treatment for patients with
AA amyloidosis. The Company also announced that a Japanese government
research organization had granted up to the equivalent of C$500,000
towards KIACTA™ clinical development expenses incurred in Japan. Five
clinical sites in Japan are currently participating in the global Phase
III Confirmatory Study for KIACTA™.
In July 2013, the U.S. Patent and Trademark Office ("USPTO") granted a
U.S. Patent offering strengthened intellectual property protection for
KIACTA™. The patent, which will expire in 2026 with a possible
extension available up to 2031, covers the dosing regimen of daily
administration of KIACTA™ relative to AA Amyloidosis patients' kidney
impairment. The patent has also been granted in Canada, Australia and
certain countries in Eurasia.
VIVIMIND™ and BLU8499 divestiture
On October 23, 2013, BELLUS Health announced the divestiture of two
non-core assets: VIVIMIND™, a natural health product for memory
protection, and BLU8499, a drug candidate for the treatment of central
nervous system diseases including Alzheimer's disease.
BELLUS Health licensed the worldwide rights to VIVIMIND™ to FB Health
S.p.A. ("FB Health") for a cash consideration of more than $2 million
to be paid over the next four years. FB Health is an Italy-based
distributor of specialty natural health and pharmaceutical products
targeting neurologists and geriatricians.
BELLUS Health also entered into a worldwide license agreement with FB
Health for BLU8499 and a family of analogs, along with an associated
platform of chemotypes and clinical datasets, in exchange for an equity
stake in FB Health. In turn, FB Health sub-licensed all its rights to
Alzheon Inc. ("Alzheon"), as part of an exclusive worldwide license,
excluding Italy. BELLUS Health will receive a portion of all future
payments received by Alzheon and royalties on net sales of BLU8499.
Alzheon is a clinical-stage biotechnology company focused on brain
health, memory and aging, developing the next generation of medicines
for Alzheimer's and other neurodegenerative diseases.
An independent committee of the BELLUS Health Board of Directors was put
in place to review and consider the transactions. They are considered
to be "related party transactions" under International Financial
Reporting Standards ("IFRS"). FB Health is controlled by Dr. Francesco
Bellini, the Chairman of the Board of Directors of BELLUS Health.
Alzheon is controlled by Dr. Martin Tolar, a member of the Board of
Directors of BELLUS Health. The independent committee was formed of
independent members of the BELLUS Health Board of Directors. It was
chaired by Mr. Charles Cavell and also included Mr. Donald Olds and Mr.
Pierre Larochelle. The independent committee found the transaction fair
and unanimously recommended its approval to the BELLUS Health Board of
Directors, which voted unanimously in favour of the transaction,
excluding Dr. Bellini and Dr. Tolar who declared their interest and
BELLUS Health also announced the termination of its agreement with
Asclepios Bioresearch (UK) Limited for the development of BLU8499.
Co-development agreement for AL amyloidosis
On October 28, 2013, BELLUS Health announced an agreement with AmorChem
Holdings Inc. ("AmorChem") to develop drug candidates for the treatment
of AL amyloidosis. As part of the co-development agreement, BELLUS
Health will provide proof-of-concept data, know-how and expertise.
AmorChem will fund the synthesis to be done at NuChem Therapeutics inc.
and the biological testing to confirm the compounds' potential in
established models of AL amyloidosis. Upon completion of the
co-development efforts, BELLUS Health will have an exclusive,
time-limited option to buy out AmorChem's rights in the project.
AL amyloidosis is a rare disease in which proteins build up in various
parts of the body, mainly the kidneys, heart, liver and peripheral
nerves. As these proteins accumulate, they disrupt the structure and
function of the affected tissues and organs leading to organ failure
and eventually, death. The median survival time of patients with AL
amyloidosis is one to two years from diagnosis. Currently, there is no
specific treatment for the disease; patients are treated with high dose
chemotherapy or stem cell transplant. AL amyloidosis affects
approximately 15,000 patients in the United States and Europe.
Summary of Financial Results
All currency figures reported in this press release are in Canadian
dollars, unless otherwise specified.
September 30, 2013
September 30, 2012
(in thousands of dollars, except per share data)
Research and development
General and administrative
Gain on acquisition
Net income (loss)
Net income (loss) attributable to
owners of the Company
Basic earnings (loss) per share
Diluted earnings (loss) per share
The Company's full consolidated financial statements and accompanying
management's discussion and analysis for the three and nine-month
periods ended September 30, 2013, 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 September 30, 2013, net income
attributable to owners of the Company amounted to $1,039,000 ($0.02 per
share), compared to a net loss of $256,000 ($0.01 per share) for the
corresponding period the previous year. The increase in net income is
primarily due to a gain of $1,672,000 in relation to the acquisition of
Thallion in August 2013.
General and administrative expenses amounted to $987,000 for the
three-month period ended September 30, 2013, compared to $768,000 for
the corresponding period the previous year. The increase is mainly due
to transaction costs incurred in relation to the acquisition of
Thallion as well as the transactions concluded in October 2013,
Gain on acquisition amounted to $1,672,000 for the three-month period
ended September 30, 2013, and is in relation to the acquisition of
Thallion in August 2013. The gain on acquisition represents the
difference between the fair value of the identifiable assets acquired
and liabilities assumed and the consideration transferred.
As at September 30, 2013, the Company had available cash, cash
equivalents and short-term investments totalling $16,004,000, compared
to $18,569,000 as at December 31, 2012. Based on management's estimate,
the current cash position should enable the Company to finance its
operations into 2018, beyond the end of KIACTA™ Phase III Confirmatory
About BELLUS Health
BELLUS Health is developing a portfolio of drugs for rare diseases
including KIACTA™ in Phase III for AA amyloidosis, clinical stage
Shigamabs™ for STEC-related Hemolytic Uremic Syndrome ("sHUS") and a
research-stage project for AL amyloidosis. The Company's 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 and it is
estimated that approximately 35,000 to 50,000 patients are living with
the disease in the United States, Europe and Japan. Independent
research conducted by the Frankel Group in 2009 estimates peak annual
revenues of $400 million to $600 million.
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
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, 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. The length of KIACTATM Phase III Confirmatory Study is dependent upon many factors including
clinical sites activation, patient enrolment rate, patient drop-out
rate and occurrence of clinical endpoint events. 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.
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