Strengthens Jazz hematology/oncology portfolio with options
for innovative development candidates IMGN779 and IMGN632
ImmunoGen to receive a $75
million upfront payment, up to $100
million in research support, a co-commercialization option,
and potential future opt-in fees, milestones and royalties
ImmunoGen conference call to be held today at 8:00 AM EDT; Jazz conference call to be held
today at 4:30 PM EDT
DUBLIN and WALTHAM, Massachusetts, Aug. 29, 2017 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) and ImmunoGen, Inc. (Nasdaq:
IMGN) today announced that the companies have entered into a
collaboration and option agreement granting Jazz Pharmaceuticals
exclusive, worldwide rights to opt into development and
commercialization of two early-stage, hematology-related
antibody-drug conjugate (ADC) programs, as well as an additional
program to be designated during the term of the agreement.
The programs covered under the agreement include IMGN779, a
CD33-targeted ADC for the treatment of acute myeloid leukemia (AML)
in Phase 1 testing, and IMGN632, a CD123-targeted ADC for
hematological malignancies expected to enter clinical testing
before the end of the year.
Under the terms of the agreement, ImmunoGen will be responsible
for the development of the three ADC programs prior to any
potential opt-in by Jazz. Following any opt-in, Jazz would be
responsible for any further development as well as for potential
regulatory submissions and commercialization.
As part of the agreement, Jazz will pay ImmunoGen an upfront
payment of $75 million.
Additionally, Jazz will pay ImmunoGen up to $100 million in development funding over seven
years to support the three ADC programs. For each program,
Jazz may exercise its opt-in right at any time prior to a pivotal
study or any time prior to a biologics license application (BLA)
upon payment of an option exercise fee of mid-double digit millions
or low triple digit millions, respectively. For each program
to which Jazz elects to opt-in, ImmunoGen would be eligible to
receive milestone payments based on receiving regulatory approval
of the applicable product, plus tiered royalties as a percentage of
commercial sales by Jazz, which depending upon sales levels and the
stage of development at the time of opt-in, range from mid- to high
single digits in the lowest tier to low 10's to low 20's in the
highest tier. After opt-in, Jazz and ImmunoGen would share
costs associated with developing and obtaining regulatory approvals
of the applicable product in the United
States (U.S.) and the European Union. ImmunoGen has
the right to co-commercialize in the U.S. one product (or two
products, under certain limited circumstances) with U.S. profit
sharing in lieu of Jazz's payment of the U.S. milestone and
royalties to ImmunoGen.
"We are pleased to enter into this collaboration with ImmunoGen,
a well-known leader in the field of ADC technology, with
demonstrated success in creating ADC molecules, including the only
FDA-approved ADC product to treat metastatic breast cancer.
This investment supports our long-term commitment to expand our
hematology/oncology portfolio with the potential addition of
multiple innovative antibody drug conjugates," said Bruce Cozadd, chairman and chief executive
officer of Jazz Pharmaceuticals. "We look forward to the
advancement of these ADC programs and the potential synergy of
these compounds with our current products and pipeline, as new
therapeutic options for cancer patients are urgently needed."
"This strategic partnership with Jazz significantly advances our
goal of accelerating the development of our early-stage novel ADC
assets. This deal joins us with a global partner, provides us
with substantial funding to support these programs, and preserves
the right to co-commercialize one of these assets," said
Mark Enyedy, president and chief
executive officer of ImmunoGen. "Jazz has demonstrated the
ability to bring innovative compounds to patients and will make an
ideal partner to help develop and commercialize our novel ADC
assets targeting AML, and more broadly, in the area of
hematology/oncology. In addition, this partnership
significantly strengthens our financial position and moves us
closer to delivering upon our mission of bringing ADC therapies to
patients."
IMGN779 is a novel ADC that combines a high-affinity, humanized
anti-CD33 antibody, a cleavable disulfide linker, and one of
ImmunoGen's novel indolino-benzodiazepine payloads, called IGNs,
which alkylate DNA without crosslinking, resulting in potent
preclinical anti-leukemia activity with relative sparing of normal
hematopoietic progenitor cells1,2. IMGN779 is in
Phase 1 clinical testing for the treatment of AML. IMGN632 is
a preclinical stage humanized anti-CD123 antibody-based ADC that is
a potential treatment for AML, blastic plasmacytoid dendritic cell
neoplasm (BPDCN), myelodysplastic syndrome, B-cell acute
lymphocytic leukemia, and other CD123-positive malignancies.
IMGN632 uses a novel payload, linker, and antibody technology and
in AML xenograft models has demonstrated a large therapeutic
index3. ImmunoGen expects to file an
investigational new drug application (IND) for IMGN632 this quarter
and enroll the first patient in a Phase 1 study before the end of
the year.
Jazz Pharmaceuticals Conference Call Details
Jazz
Pharmaceuticals will host a conference call and live audio webcast
today at 4:30 p.m. EDT/9:30 p.m. IST to discuss this transaction.
Interested parties may access the live audio webcast and
slide presentation via the Investors section of the Jazz
Pharmaceuticals website at www.jazzpharmaceuticals.com.
Please connect to the website prior to the start of the
conference call to ensure adequate time for any software downloads
that may be necessary to listen to the webcast. A replay of
the webcast will be archived on the website for one week.
Jazz audio webcast/conference call:
U.S. Dial-In
Number: +1 855 353 7924
International Dial-In Number: +1 503 343 6056
Passcode: 76457218
A replay of the conference call will be available through
September 5, 2017 and accessible
through one of the following telephone numbers, using the passcode
below:
Replay U.S. Dial-In Number: +1 855 859 2056
Replay International Dial-In Number: +1 404 537 3406
Passcode: 76457218
ImmunoGen Conference Call Details
ImmunoGen will host
a conference call and live audio webcast today at 8am EDT to discuss this transaction. Interested
parties may access the live audio webcast via the Investors section
of the ImmunoGen website at www.immunogen.com. A replay of
the webcast will be archived on the website for approximately one
week.
ImmunoGen audio webcast/conference call:
Dial-In
Number: +1 719-457-2607
Passcode: 8332814
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc
(Nasdaq: JAZZ) is an international biopharmaceutical company
focused on improving patients' lives by identifying, developing and
commercializing meaningful products that address unmet medical
needs. The company has a diverse portfolio of products and
product candidates, with a focus in the areas of sleep and
hematology/oncology. In these areas, Jazz Pharmaceuticals markets
Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase
Erwinia chrysanthemi), Defitelio® (defibrotide sodium) and
Vyxeos™ (daunorubicin and cytarabine) liposome for injection in the
U.S. and markets Erwinase® and Defitelio® (defibrotide) in
countries outside the U.S. For more information, please visit
www.jazzpharmaceuticals.com.
About ImmunoGen
ImmunoGen is a clinical-stage
biotechnology company that develops targeted cancer therapeutics
using its proprietary antibody-drug conjugate (ADC) technology.
ImmunoGen's lead product candidate, mirvetuximab soravtansine, is
in a Phase 3 trial for FRα-positive platinum-resistant ovarian
cancer, and is in Phase 1b/2 testing in combination regimens for
earlier-stage disease. ImmunoGen's ADC technology is used in
Roche's marketed product, Kadcyla®, in other clinical-stage
ImmunoGen product candidates, and in programs in development by
Amgen, Bayer, Biotest, CytomX, Debiopharm, Lilly, Novartis, Sanofi
and Takeda. More information about the Company can be found
at www.immunogen.com.
Jazz Pharmaceuticals "Safe Harbor" Statement under the
Private Securities Litigation Reform Act of 1995
This press
release contains forward-looking statements, including, but not
limited to, statements related to the potential exercise by Jazz
Pharmaceuticals of its opt-in rights with respect to certain
early-stage product candidates covered by the collaboration and
option agreement, the potential benefits of such product candidates
and related development and regulatory activities, potential future
payments to ImmunoGen by Jazz Pharmaceuticals, the potential
exercise by ImmunoGen of its co-commercialization rights with
respect to such product candidates, Jazz Pharmaceuticals'
commitment to expand its hematology/oncology portfolio with the
potential addition of multiple innovative antibody drug conjugates,
the advancement of the ADC program covered by the collaboration and
option agreement and the potential synergy of these compounds with
Jazz Pharmaceuticals' current products and pipeline, the timing of
such events and activities, and other statements that are not
historical facts. These forward-looking statements are based
on the company's current plans, objectives, estimates, expectations
and intentions and inherently involve significant risks and
uncertainties. Actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with: whether Jazz Pharmaceuticals will exercise its opt-in rights
with respect to certain early-stage product candidates covered by
the collaboration and option agreement, and, if exercised, Jazz
Pharmaceuticals' ability to achieve the expected benefits
(commercial or otherwise) from the acquisition of rights to such
product candidates; whether ImmunoGen will exercise its
co-commercialization rights with respect to such product
candidates; pharmaceutical product development and clinical success
thereof; the regulatory approval process; and effectively
commercializing any product candidates acquired by Jazz
Pharmaceuticals under the collaboration and option agreement; and
other risks and uncertainties affecting the company and its
development programs, including those described from time to time
under the caption "Risk Factors" and elsewhere in Jazz
Pharmaceuticals plc's Securities and Exchange Commission filings
and reports (Commission File No. 001-33500), including the
company's Quarterly Report on Form 10-Q for the quarter ended
June 30, 2017 and future filings and
reports by the company. Other risks and uncertainties of
which the company is not currently aware may also affect the
company's forward-looking statements and may cause actual results
and the timing of events to differ materially from those
anticipated. The forward-looking statements herein are made
only as of the date hereof or as of the dates indicated in the
forward-looking statements, even if they are subsequently made
available by the company on its website or otherwise. The
company undertakes no obligation to update or supplement any
forward-looking statements to reflect actual results, new
information, future events, changes in its expectations or other
circumstances that exist after the date as of which the
forward-looking statements were made.
ImmunoGen "Safe Harbor" Statement under the Private
Securities Litigation Reform Act of 1995
This press release
includes forward-looking statements. For these statements,
ImmunoGen claims the protection of the safe harbor for
forward-looking statements provided by the Private Securities
Litigation Reform Act of 1995. It should be noted that there
are risks and uncertainties related to the development of novel
anticancer products, including IMGN779 and IMGN632, including risks
relating related to preclinical and clinical studies, their timing
and results. A review of these risks can be found in
ImmunoGen's Transition Report on Form 10-K for the six-month period
ended December 31, 2016 and other reports filed with
the Securities and Exchange Commission.
References:
1 S. Adams et al,
Abstract P526, Presented at the 22nd Congress of the
European Hematology Association, June 22-25,
2017.
2 Y. Kotvun et al. (2016) Blood 128:768.
3 S. Adams et al, Abstract 2832, Presented at the
American Society of Hematology, December
3-6, 2016.
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