ImmunoGen Announces Collaboration with Takeda to Develop and Commercialize ELAHERE® in Japan
28 Agosto 2023 - 7:30AM
Business Wire
ImmunoGen to Receive $34 Million1 in Upfront and Near-Term
Milestone Payments and is Eligible to Receive Potential Regulatory
and Commercial Milestone Payments as well as Double-Digit
Royalties
Collaboration Further Supports Strategy to Bring ELAHERE to
Eligible Patients with Folate Receptor Alpha (FRα)-Positive,
Platinum-Resistant Ovarian Cancer Globally
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced it has entered into an exclusive collaboration with
Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) to
develop and commercialize ELAHERE (mirvetuximab soravtansine-gynx)
in Japan.
"As a leader in the development and commercialization of novel
products in oncology for more than two decades and with a deep
heritage and presence in Japan, Takeda is the ideal partner to help
us deliver ELAHERE to eligible patients in this important market,"
said Mark Enyedy, ImmunoGen's President and Chief Executive
Officer. "Building upon our strong commercial launch in the US,
this partnership reinforces the continued excitement around
ELAHERE's practice-changing potential and our commitment to
bringing this biomarker-directed ADC to patients globally."
Under the terms of the collaboration and license agreement,
ImmunoGen will receive a one-time, upfront payment and an
additional payment upon conversion of US Food and Drug
Administration (FDA) accelerated approval of ELAHERE in
platinum-resistant ovarian cancer (PROC) to full approval. The
Company is eligible to receive additional payments if Takeda
achieves prespecified regulatory and commercial milestones, as well
as double-digit royalties on future net sales of ELAHERE in Japan.
Per the agreement, ImmunoGen has retained exclusive production
rights and will supply product for development and commercial use
in Japan. In exchange, Takeda will receive an exclusive license to
develop and commercialize ELAHERE in Japan and is responsible for
all regulatory filings and obligations.
“We are pleased to bring ELAHERE to Japan, where there is a
significant unmet need for patients with ovarian cancer,
particularly for those whose disease has become resistant to
platinum-based treatments,” said Teresa Bitetti, President of the
Global Oncology Business Unit at Takeda. “The data from the Phase 3
MIRASOL study demonstrate the potential for ELAHERE to become the
new standard of care for this devastating disease, and we are
confident this collaboration with ImmunoGen will bring significant
value to patients in Japan. This investment is reflective of
Takeda’s commitment to partnering with organizations that share our
passion for developing new medicines for cancers with limited or
ineffective treatment options and brings us one step closer to
achieving our aspiration to cure cancer.”
1 ¥5 billion (0.0068 exchange rate as of August 25, 2023)
ABOUT IMMUNOGEN ImmunoGen is developing the next
generation of antibody-drug conjugates (ADCs) to improve outcomes
for cancer patients. By generating targeted therapies with enhanced
anti-tumor activity and favorable tolerability profiles, we aim to
disrupt the progression of cancer and offer our patients more good
days. We call this our commitment to TARGET A BETTER NOW™.
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
ABOUT MIRVETUXIMAB SORAVTANSINE 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.
Eye problems are common with ELAHERE and can be severe. ELAHERE
also can cause severe or life-threatening inflammation of the lungs
that may lead to death and patients may develop nerve problems
called peripheral neuropathy during treatment. Please see full
Prescribing Information, including Boxed Warning, and Medication
Guide for ELAHERE.
FORWARD-LOOKING STATEMENTS This press release includes
forward-looking statements. These statements include, but are not
limited to, ImmunoGen's expectations related to the potential of
mirvetuximab to change the ovarian cancer treatment landscape; the
occurrence, timing and outcome of regulatory submissions for
mirvetuximab; the benefits and results that may be achieved through
ImmunoGen's collaboration and license agreement with Takeda; and
the payment of upfront and future milestones and royalties on
future sales of mirvetuximab in Japan. Various factors could cause
ImmunoGen's actual results to differ materially from those
discussed or implied in the forward-looking statements, and you are
cautioned not to place undue reliance on these forward-looking
statements, which are current only as of the date of this release.
Factors that could cause future results to differ materially from
such expectations include, but are not limited to: the successful
execution of the collaboration with Takeda and their development
and commercialization efforts; the timing and outcome of the
Company's clinical development processes; the difficulties inherent
in the development of novel pharmaceuticals, including
uncertainties as to the timing, expense, and results of clinical
trials and regulatory processes; the timing and outcome of
anticipated interactions with regulatory authorities; the risk that
the Company may not be able to obtain adequate price and
reimbursement for any approved products, including the potential
for delays or additional difficulties for ELAHERE in light of the
FDA granting accelerated approval; risks and uncertainties
associated with the scale and duration of the COVID-19 pandemic and
the resulting impact on ImmunoGen's industry and business; and
other factors as set forth in the Company's Annual Report on Form
10-K filed with the Securities and Exchange Commission on March 1,
2023, the Company's Quarterly Reports on Form 10-Q filed with the
Securities and Exchange Commission on April 28, 2023 and July 31,
2023, and other reports filed with the Securities and Exchange
Commission. The forward-looking statements in this press release
speak only as of the date of this press release. ImmunoGen
undertakes no obligation to update any forward-looking statement,
whether as a result of new information, future developments, or
otherwise, except as may be required by applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230828340387/en/
INVESTOR RELATIONS ImmunoGen Anabel Chan 781-895-0600
anabel.chan@immunogen.com
MEDIA ImmunoGen Courtney O'Konek 781-895-0600
courtney.okonek@immunogen.com
OR
FTI Consulting Robert Stanislaro 212-850-5657
robert.stanislaro@fticonsulting.com
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