Auven Therapeutics & BELLUS Health Announce Engagement of Financial Advisor to Explore Sale of KIACTA™, an Experimental Dru...
May 07 2014 - 8:15AM
Business Wire
- Auven Therapeutics and BELLUS Health Amend
the KIACTA™ Asset Purchase and Licensing Agreement -
Auven Therapeutics, the global private equity company focused on
accelerated development of breakthrough therapeutic drugs and
BELLUS Health Inc. (TSX:BLU), a drug development company focused on
rare diseases, today announced that Lazard has been engaged as
financial advisors to explore the sale of KIACTA™, an orphan drug
nearing completion of its confirmatory Phase III trial as a
treatment for AA Amyloidosis. Auven and BELLUS Health also have
amended the asset purchase and license agreement related to KIACTA™
(eprodisate disodium) in order to facilitate a potential sale of
KIACTA™.
“We intended to complete the Phase III confirmatory study before
offering KIACTA™ for sale,” said Stephen Evans-Freke, co-founder
and Managing General Partner of Auven Therapeutics. “However, we
have received a number of indications of strong interest from
prospective buyers keen to have sufficient lead time to prepare for
a global launch. Therefore, it makes sense to facilitate this step
by modifying our agreement with BELLUS Health, and to appoint an
advisor to explore sale options.”
“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 registration trial,” said
Roberto Bellini, President and Chief Executive Officer of BELLUS
Health.
Auven Therapeutics acquired worldwide rights related to KIACTA™
from BELLUS Health in 2010 and assumed control of the KIACTA™
development program and related activities, including the
registrational Phase III clinical study in AA Amyloidosis. Auven
and BELLUS Health have now agreed upon modified terms to share the
proceeds from a divestiture of KIACTA™ particularly in the
now-envisaged scenario of a KIACTA™ sale before the completion of
its Phase III trial.
Assuming that total divestiture transaction proceeds reach a
pre-determined threshold, the parties will share aggregate proceeds
equally. Auven retains certain preference rights on exit proceeds
related to Auven’s aggregate investment in KIACTA™ up to the date
of the sale.
As the Phase III KIACTA™ trial in AA Amyloidosis nears
completion of its enrollment, Auven has determined that a potential
sale now 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.
KIACTA™ is an orally bioavailable small molecule that is being
developed for the treatment of AA amyloidosis, a rare disease
resulting from chronic inflammatory conditions that often rapidly
leads to renal failure, dialysis and death. The Phase III study is
designed to confirm the safety and efficacy of KIACTA™, previously
demonstrated in a phase II/III study, in preventing kidney function
decline in patients diagnosed with AA amyloidosis. A recent
commercial assessment study conducted for Auven 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. The incidence of AA
Amyloidosis is higher in the Middle East and certain other
countries where it is associated frequently with Familial
Mediterranean Fever.
“The data from the earlier Phase II/III trial prior to our
acquisition of KIACTA™ established with statistical significance
that it is both safe and effective in the treatment of this often
lethal disease, delaying AA amyloidosis disease progression based
on a composite endpoint of renal function deterioration and death,”
said Dr. Peter B. Corr, Co-Founder and Managing General Partner of
Auven Therapeutics. “This confirmatory and registrational Phase III
study is enrolling 230 patients at 70 sites in 30 countries around
the world, and we expect it to conclude within two years. We are
optimistic as we enter the final stages that the study will confirm
the prior results, so it is appropriate to explore a sale process
at this time.”
About KIACTA™ for AA Amyloidosis
KIACTA™(eprodisate disodium) is an orally bioavailable small
molecule intended for the treatment of AA amyloidosis, an orphan
indication that often rapidly leads to dialysis and death due to
end stage renal disease.
KIACTA™ is partnered with global private equity firm Auven
Therapeutics who is responsible for conducting and paying for the
currently ongoing Phase III Confirmatory Study. Patient recruitment
is ongoing and is expected to be completed in the second quarter of
2014. The Phase III Confirmatory Study is an event driven trial
that is expected to conclude in 2016. The study will be used to
confirm the positive safety and efficacy results shown in the Phase
II/III study previously conducted by BELLUS Health.
About Auven Therapeutics
(www.auventx.com)
Auven Therapeutics is a global private equity firm that acquires
and pursues accelerated development of breakthrough therapeutic
drugs prior to licensing them to commercial partners. Auven’s
in-house team of senior pharmaceutical development executives
establishes the clinical regulatory, manufacturing and commercial
strategies for all its products and oversees their execution. Auven
was founded in 2007 by Stephen Evans-Freke and Dr. Peter B. Corr,
and maintains operations in Lausanne, London, New York, Bermuda,
and the U.S. Virgin Islands.
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 STEC-related Hemolytic Uremic
Syndrome (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.
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 and Auven
Therapeutics’ 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. and Auven Therapeutics do 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. The length of
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. 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.
and Auven Therapeutics are under no obligation and disavow 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. public
fillings including the Annual Information Form for further risk
factors that might affect BELLUS and its business.
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Auven TherapeuticsMedia enquiries:Instinctif
PartnersSue Charles/Stefanie Bacher/Gemma HoweT: +44 (0)20 7866
7866auventx@instinctif.comorInvestor Relations:Kathy
ArmstrongT: +1 (212) 616 4042kathy.armstrong@auventx.comorBELLUS
HealthAdam PeelerTMX EquicomT: +1 416-815-0700 ext.
225apeeler@tmxequicom.com
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