Bristol-Myers Squibb Enters Agreement Providing Exclusive Right to Acquire Promedior, Inc. & its Novel PRM-151 in Development...
August 31 2015 - 8:30AM
Business Wire
Bristol-Myers Squibb Company (NYSE:BMY) and Promedior, Inc.
announced the companies have entered into an agreement that grants
Bristol-Myers Squibb an exclusive right to acquire Promedior and
gain worldwide rights to its lead asset PRM-151, a recombinant form
of human pentraxin-2 protein in Phase 2 development for the
treatment of idiopathic pulmonary fibrosis (IPF) and myelofibrosis
(MF). PRM-151 has been granted Fast Track designation in the U.S.
and Orphan designation in the U.S. and Europe for the treatment of
MF and Orphan Designation in the U.S. and Europe for the treatment
of IPF. Promedior is a clinical stage immunotherapy company
pioneering the development of targeted therapeutics to treat
fibrotic diseases. Total aggregate payments to Promedior under the
agreement have the potential to reach $1.25 billion, which includes
an upfront cash payment for the right to acquire Promedior, an
exercise fee payable if Bristol-Myers Squibb elects to exercise its
right to acquire the company, and subsequent clinical and
regulatory milestone payments.
“Bristol-Myers Squibb continues to invest in building a diverse
specialty portfolio, focusing on innovative approaches that can
transform the treatment landscape for patients with serious
diseases,” said Francis Cuss, MB BChir, FRCP, executive vice
president and chief scientific officer, Bristol-Myers Squibb.
“PRM-151 will complement our growing early-stage fibrosis
portfolio, and we are excited by its potential to address multiple
fibrotic diseases.”
“We are pleased that Bristol-Myers Squibb has recognized the
value of Promedior’s clinically validated approach to directly
address the underlying pathology of diseases involving fibrosis,”
said Suzanne L. Bruhn, Ph.D., President and Chief Executive Officer
of Promedior. “With the strong strategic fit between our companies,
we intend to continue to move PRM-151 forward rapidly as a new
treatment option to address the unmet needs of patients with
myelofibrosis, idiopathic pulmonary fibrosis, and other fibrotic
diseases.”
PRM-151 has been shown in multiple preclinical models to
regulate monocytes and macrophages at areas of tissue damage to
prevent and reverse fibrosis, including IPF, acute and chronic
nephropathy, liver fibrosis, and age-related macular
degeneration. Promedior has advanced PRM-151 into clinical
trials focused on two orphan fibrotic diseases (MF and IPF).
Bristol-Myers Squibb is developing an early stage fibrosis
portfolio that includes BMS-986020, a lysophosphatidic acid 1
(LPA1) receptor antagonist in Phase 2 development for the treatment
of idiopathic pulmonary fibrosis. Other areas of focus include
nonalcoholic steatohepatitis (NASH), systemic sclerosis, and
chronic kidney disease. Additionally, the company has executed a
series of agreements aimed at further advancing its fibrosis
development program, including an option to acquire Galecto Biotech
AB, a company with an inhaled inhibitor of galectin-3 in Phase 1
development for the treatment of idiopathic pulmonary fibrosis, a
research collaboration and license agreement with the California
Institute for Biomedical Research (Calibr), and a translational
research collaboration with The Medical University of South
Carolina.
Under the terms of the agreement, Bristol-Myers Squibb will make
payments aggregating up to $1.25 billion that includes an upfront
cash payment of $150 million as consideration for both the right to
acquire Promedior and as payment for services in support of the MF
and IPF Phase 2 clinical trials. The companies have agreed on a
development plan that will be executed by Promedior. It is
anticipated that the Phase 2 trials in MF and IPF will be initiated
in the coming weeks. Bristol-Myers Squibb can exercise its right to
acquire Promedior upon completion of either of these trials.
About Fibrosis
Fibrotic diseases are characterized by the formation of excess
fibrous connective tissue in an organ or tissue, compromising
function and ultimately leading to organ failure. Idiopathic
pulmonary fibrosis is a chronic, progressive form of lung disease
characterized by the scarring of lung tissue for which there are
limited treatment options. While estimates vary, it is believed
that IPF could affect approximately 130,000 patients in the
U.S. and approximately 76,000 patients in Europe.
Myelofibrosis is a serious, life-limiting blood cancer,
characterized by fibrosis of the bone marrow which prevents the
normal production of blood cells, leading to anemia, fatigue, and
increased risk of bleeding and infection. Myelofibrosis affects
18,000 people per year in the U.S., and available therapies have
minimal, if any, impact on the underlying fibrosis.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit www.bms.com or follow us on Twitter at
http://twitter.com/bmsnews.
About Promedior, Inc.
Promedior is a clinical stage immunotherapy company pioneering
the development of targeted therapeutics to treat diseases
involving fibrosis. Fibrosis occurs when healthy tissue is replaced
with excessive scar tissue, compromising function and ultimately
leading to organ failure. Fibrosis is a common feature of several
rare diseases as well as more prevalent illnesses such as age
related macular degeneration, diabetic nephropathy, nonalcoholic
steatohepatitis (NASH), and several types of solid tumors.
Promedior owns world-wide rights to PRM-151 and has a
significant intellectual property estate. Promedior is backed by
leading global healthcare investors, including Easton Capital
Investment Group, Fibrotec Ventures LLC, Forbion Capital Partners,
HealthCare Ventures, LLC, Morgenthaler Ventures, Polaris Partners,
BioMed Ventures, and Shire plc. For additional information about
Promedior, please visit www.promedior.com.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are
based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking
statement can be guaranteed. Among other risks, there can be
no guarantee that the investigational compounds discussed in this
release will be successfully developed or approved for any of the
indications described in this release or that Bristol-Myers Squibb
will exercise its option to acquire Promedior. Forward-looking
statements in this press release should be evaluated together with
the many uncertainties that affect Bristol-Myers Squibb's business,
particularly those identified in the cautionary factors discussion
in Bristol-Myers Squibb's Annual Report on Form 10-K for the year
ended December 31, 2014 in our Quarterly Reports on Form 10-Q and
our Current Reports on Form 8-K. Bristol-Myers Squibb
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise.
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Bristol-Myers SquibbMedia:Sarah Koenig,
609-252-4145sarah.koenig@bms.comorKen Dominski,
609-252-5251ken.dominski@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.comorPromediorMedia:The
Yates NetworkKathryn Morris,
845-635-9828kathryn@theyatesnetwork.comorInvestors:Stern
Investor Relations, Inc.Sarah McCabe,
212-362-1200sarah@sternir.com
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