BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio) and Bayer today
announced a partnership wherein BridgeBio grants Bayer an exclusive
license to commercialize acoramidis for ATTR-CM in Europe. In
exchange, BridgeBio will receive up to $310 million USD comprising
of upfront and near-term milestone payments, as well as additional
undisclosed sales milestones. BridgeBio will also receive royalties
in a tiered structure beginning in the low-thirties percent on
sales of acoramidis in Europe.
Acoramidis is an investigational, next-generation,
orally-administered, highly potent small molecule stabilizer of
transthyretin (TTR). The US FDA has accepted BridgeBio’s NDA for
acoramidis for the treatment of ATTR-CM with a PDUFA action date of
November 29, 2024; additionally, the EMA has accepted the MAA for
acoramidis with potential EU approval in 2025.
“We are excited to have found a like-minded partner in Bayer
that shares our belief in the potential of acoramidis to ameliorate
the lives of ATTR-CM patients. We have a responsibility to the
ATTR-CM community to make acoramidis available to as many patients
as possible, as quickly as possible, and we believe that Bayer is
the right collaborator for us in this mission,” said Ananth
Sridhar, Senior Vice President of Corporate Development, BridgeBio
Cardiorenal. “This partnership leverages Bayer’s established
European cardiovascular infrastructure and enables us, via
substantial cost savings, to focus our resources on our
wholly-owned geographies for acoramidis, including preparing for
the US launch.”
In July 2023,
BridgeBio announced positive results
from ATTRibute-CM, reporting a highly statistically significant
result, demonstrated by a Win Ratio of 1.8 (p<0.0001) on the
primary endpoint (a hierarchical analysis prioritizing in order:
all-cause mortality, then frequency of cardiovascular
hospitalization, then change from baseline in N-terminal prohormone
of brain natriuretic peptide, then change from baseline in 6-minute
walk distance). Acoramidis was well-tolerated, with no safety
signals of potential clinical concern identified. BridgeBio has
also presented analyses from ATTRibute-CM at the European Society
of Cardiology Congress 2023 and at the American Heart Association
Scientific Sessions 2023. In February 2024, BridgeBio shared
positive results of a single-arm Phase 3 study of acoramidis in
Japanese patients with ATTR-CM, including no mortality reported in
the trial at 30 months.
“Bayer has a clear vision to transform cardiovascular care for
patients and acoramidis complements our portfolio in specialty
cardiology,” said Juergen Eckhardt, M.D., Member of the Executive
Committee of Bayer’s Pharmaceuticals Division and Head of Business
Development, Licensing & Open Innovation. “As a leading player
in the field of cardiovascular diseases, we will work to make this
new treatment available to patients as soon as possible, after a
positive decision by the European authorities."
About BridgeBio Pharma, Inc. BridgeBio
Pharma (BridgeBio) is a commercial-stage biopharmaceutical company
founded to discover, create, test and deliver transformative
medicines to treat patients who suffer from genetic diseases and
cancers with clear genetic drivers. BridgeBio’s pipeline of
development programs ranges from early science to advanced clinical
trials. BridgeBio was founded in 2015 and its team of experienced
drug discoverers, developers and innovators are committed to
applying advances in genetic medicine to help patients as quickly
as possible. For more information visit
bridgebio.com and follow us on
LinkedIn and Twitter.
BridgeBio Pharma, Inc. Forward-looking
Statements This press release contains
forward-looking statements. Statements in this press release may
include statements that are not historical facts and are considered
forward-looking within the meaning of Section 27A of the Securities
Act of 1933, as amended (the Securities Act), and Section 21E of
the Securities Exchange Act of 1934, as amended (the Exchange Act),
which are usually identified by the use of words such as
“anticipates,” “believes,” “continues,” “estimates,” “expects,”
“hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,”
“should,” “will,” and variations of such words or similar
expressions. We intend these forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 27A of the Securities Act and
Section 21E of the Exchange Act. These forward-looking statements,
including statements relating to expectations, plans, and prospects
regarding the success of our exclusive license granted to Bayer to
commercialize acoramidis as a treatment for patients with ATTR-CM
in Europe and the payments we are eligible to receive under the
license; the clinical, therapeutic and market potential of our
clinical development program for acoramidis, including the
statements in Mr. Sridhar’s and Dr. Eckhardt’s quotes
regarding the potential US launch of acoramidis (if approved by the
FDA) by us, the potential European launch of acoramidis (if
approved by the EMA) by Bayer, the potential benefits to us of the
partnership with Bayer, and the potential benefits of acoramidis to
ATTR-CM patients; the statements related to the FDA’s planned
actions regarding our NDA for acoramidis for the treatment of
ATTR-CM; and the potential outcomes and expected timing of
regulatory reviews by the FDA and the EMA, reflect our current
views about our plans, intentions, expectations and strategies,
which are based on the information currently available to us and on
assumptions we have made. Although we believe that our plans,
intentions, expectations and strategies as reflected in or
suggested by those forward-looking statements are reasonable, we
can give no assurance that the plans, intentions, expectations or
strategies will be attained or achieved. Furthermore, actual
results may differ materially from those described in the
forward-looking statements and will be affected by a number of
risks, uncertainties and assumptions, including, but not limited
to, initial and ongoing data from our preclinical studies and
clinical trials not being indicative of final data, the potential
size of the target patient populations our product candidates are
designed to treat not being as large as anticipated, the design and
success of ongoing and planned clinical trials, future regulatory
filings, approvals and/or sales, the FDA or such other regulatory
agencies not agreeing with our regulatory approval strategies,
components of our filings, such as clinical trial designs, conduct
and methodologies, or the sufficiency of data submitted, the
continuing success of our collaborations, the success of our
partnership with Bayer, our ability to obtain additional funding,
including through less dilutive sources of capital than equity
financings, potential volatility in our share price, uncertainty
regarding any impacts due to global health emergencies such as
COVID-19, including delays in regulatory review, manufacturing and
supply chain interruptions, adverse effects on healthcare systems
and disruption of the global economy, the impacts of current
macroeconomic and geopolitical events, including changing
conditions from hostilities in Ukraine and in Israel and the Gaza
Strip, increasing rates of inflation and rising interest rates, on
business operations and expectations, as well as those risks set
forth in the Risk Factors section of our most recent Annual Report
on Form 10-K and our other filings with the U.S. Securities and
Exchange Commission. Moreover, we operate in a very competitive and
rapidly changing environment in which new risks emerge from time to
time. These forward-looking statements are based upon the current
expectations and beliefs of our management as of the date of this
press release, and are subject to certain risks and uncertainties
that could cause actual results to differ materially from those
described in the forward-looking statements. Except as required by
applicable law, we assume no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
BridgeBio Contact:Vikram
Balicontact@bridgebio.com (650)-789-8220
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