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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