- Adds flagship antibody-drug conjugate (ADC)
ELAHERE® (mirvetuximab soravtansine-gynx)
for folate receptor-alpha (FRα) positive platinum-resistant
ovarian cancer (PROC) to AbbVie's portfolio
- ImmunoGen's pipeline complements AbbVie's existing oncology
pipeline with potential to be transformative across multiple solid
tumors and hematologic malignancies
- ImmunoGen's late-stage development programs for ELAHERE
provide opportunity to expand into earlier lines of therapy and
additional patient populations
- AbbVie reaffirms previously issued 2024 full-year adjusted
diluted EPS guidance range of $11.05-$11.25 which
now includes a $0.42 per share
dilutive impact related to the ImmunoGen acquisition and the
pending Cerevel Therapeutics acquisition
- AbbVie updates previously issued 2024 first-quarter adjusted
diluted EPS guidance range from $2.30-$2.34 to
$2.26-$2.30 which now includes a $0.04 per share dilutive impact related to the
ImmunoGen acquisition
NORTH
CHICAGO, Ill., Feb. 12,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced
today that it has completed its acquisition of ImmunoGen (NASDAQ:
IMGN). With the completion of the acquisition, ImmunoGen is now
part of AbbVie.
"Together with ImmunoGen, we have the potential to continue
redefining the standard of care for those living with cancer," said
Robert A. Michael, president and
chief operating officer, AbbVie. "The addition of ImmunoGen's
treatment for ovarian cancer will accelerate our ability to help
patients today, expand our oncology pipeline and drive long-term
revenue growth well into the next decade. I want to thank ImmunoGen
for their efforts to advance science for patients and we look
forward to welcoming our new colleagues to AbbVie."
ELAHERE® (mirvetuximab soravtansine-gynx) is
the first and only antibody-drug conjugate (ADC) approved by the
U.S. Food and Drug Administration (FDA) in ovarian cancer. The FDA
granted accelerated approval for ELAHERE in folate receptor-alpha
(FRα) positive platinum-resistant ovarian cancer (PROC) patients
based on response data. Results from a confirmatory trial currently
under review by the FDA show that ELAHERE is the first targeted
agent to offer a survival benefit in PROC, with label
expansion opportunities across larger segments of the ovarian
cancer market.
ImmunoGen's follow-on pipeline of ADCs further builds on
AbbVie's existing solid tumor pipeline of novel targeted therapies
and next-generation immuno-oncology assets, which have the
potential to create new treatment possibilities across multiple
solid tumors and hematologic malignancies. Through focused R&D
efforts, AbbVie has developed novel ADC technology and has unique
strengths in antibody engineering, drug linker chemistry and toxin
research. AbbVie and ImmunoGen's combined capabilities represent an
opportunity to deliver potentially transformative ADC therapies to
patients.
ImmunoGen's investigational Phase 1 asset, IMGN-151, is a
next-generation FRα ADC for ovarian cancer with the potential
for expansion into other solid tumor indications.
Pivekimab sunirine, currently in Phase 2, is an investigational
anti-CD123 ADC targeting blastic plasmacytoid dendritic cell
neoplasm (BPDCN), a rare blood cancer, which was granted FDA
breakthrough therapy designation for the treatment of
relapsed/refractory BPDCN.
For additional background on the acquisition, please read the
announcement press release here and view AbbVie's investor
presentation here.
Financial Terms
AbbVie has acquired all outstanding ImmunoGen common stock for
$31.26 per share. It is expected that
ImmunoGen's common stock will cease to trade on the NASDAQ stock
exchange prior to market open on February
12, 2024. AbbVie expects its acquisition of ImmunoGen to be
accretive to AbbVie's diluted EPS beginning in 2027 and
significantly accretive over the long-term.
Full-Year 2024 Outlook
AbbVie is reaffirming its previously issued 2024 full-year
adjusted diluted EPS guidance range of $11.05-$11.25. This
guidance now includes a $0.42 per
share dilutive impact related to the completed ImmunoGen
acquisition, as well as the pending Cerevel Therapeutics
acquisition, which is anticipated to close in mid-2024. AbbVie's
2024 adjusted diluted EPS guidance excludes any impact from
acquired IPR&D and milestones that may be incurred during 2024,
as both cannot be reliably forecasted.
AbbVie is updating its previously issued 2024 first-quarter
adjusted diluted EPS guidance range from $2.30-$2.34 to
$2.26-$2.30. This guidance now includes a $0.04 per share dilutive impact related to the
ImmunoGen acquisition. AbbVie's 2024 first-quarter adjusted diluted
EPS guidance excludes any impact from acquired IPR&D and
milestones that may be incurred in the quarter, as both cannot be
reliably forecasted.
About ELAHERE (mirvetuximab soravtansine-gynx)
ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC
comprising a folate receptor alpha-binding antibody, cleavable
linker, and the maytansinoid payload DM4, a potent tubulin
inhibitor designed to kill the targeted cancer cells.
ELAHERE is indicated for the treatment of adult patients with
folate receptor-alpha (FRα) positive, platinum-resistant epithelial
ovarian, fallopian tube, or primary peritoneal cancer, who have
received one to three prior systemic treatment regimens. Select
patients for therapy based on an FDA-approved test. This indication
is approved under accelerated approval based on tumor response rate
and durability of response. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in a confirmatory trial.
The prescribing information includes a boxed warning. ELAHERE
can cause severe ocular toxicities, including visual impairment,
keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct
an ophthalmic exam including visual acuity and slit lamp exam prior
to initiation of ELAHERE, every other cycle for the first 8 cycles,
and as clinically indicated. Administer prophylactic artificial
tears and ophthalmic topical steroids. Withhold ELAHERE for ocular
toxicities until improvement and resume at the same or reduced
dose. Discontinue ELAHERE for Grade 4 ocular toxicities.
Serious adverse reactions occurred in 31% of patients. The most
common (≥2%) serious adverse reactions were intestinal obstruction
(8%), ascites (4%), infection (3%), and pleural effusion (3%).
Fatal adverse reactions occurred in 2% of patients, including small
intestinal obstruction (1%) and pneumonitis (1%).The most common
(≥20%) adverse reactions, including laboratory abnormalities, were
vision impairment, fatigue, increased aspartate aminotransferase,
nausea, increased alanine aminotransferase, keratopathy, abdominal
pain, decreased lymphocytes, peripheral neuropathy, diarrhea,
decreased albumin, constipation, increased alkaline phosphatase,
dry eye, decreased magnesium, decreased leukocytes, decreased
neutrophils, and decreased hemoglobin.
Please see full Prescribing Information, including Boxed
Warning for ELAHERE.
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care
for multiple blood cancers while advancing a dynamic pipeline of
investigational therapies across a range of cancer types. Our
dedicated and experienced team joins forces with innovative
partners to accelerate the delivery of potential breakthrough
medicines. We are evaluating more than 20 investigational medicines
in over 300 clinical trials across some of the world's most
widespread and debilitating cancers. As we work to have a
remarkable impact on people's lives, we are committed to exploring
solutions to help patients obtain access to our cancer medicines.
For more information, please
visit http://www.abbvie.com/oncology.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions that solve serious health issues today and address
the medical challenges of tomorrow. We strive to have a remarkable
impact on people's lives across several key therapeutic areas –
immunology, oncology, neuroscience, and eye care – and products and
services in our Allergan Aesthetics portfolio. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on
LinkedIn, Facebook, Instagram, X (formerly Twitter), and
YouTube.
Forward-Looking Statements
Some statements in this news release are, or may be
considered, forward-looking statements for purposes of the Private
Securities Litigation Reform Act of 1995. The words "believe,"
"expect," "anticipate," "project" and similar expressions and uses
of future or conditional verbs, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, risks related to the ability to realize the
anticipated benefits of the ImmunoGen acquisition on the
anticipated timeframe or at all, risks that the cost to consummate
the ImmunoGen acquisition or to obtain the anticipated benefits of
the acquisition could be greater than expected, the risk that the
ImmunoGen business will not be integrated successfully, disruption
from the ImmunoGen acquisition making it more difficult to maintain
business and operational relationships, the diversion of
management's attention from ongoing business operations and
opportunities, negative effects of the consummation of the
acquisition on business or employee relationships or the market
price of AbbVie's common stock and/or operating results,
significant transaction costs, the assumption of unknown
liabilities, the risk of litigation and/or regulatory actions
related to the acquisition or ImmunoGen's business, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission, as updated by its subsequent Quarterly Reports on Form
10-Q. AbbVie undertakes no obligation, and specifically declines,
to release publicly any revisions to forward-looking statements as
a result of subsequent events or developments, except as required
by law.
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SOURCE AbbVie
