Merrimack receives $100 million on closing, retains
commercialization rights in U.S.; Baxter gains exclusive
commercialization rights for all potential indications of MM-398 in all
other geographies outside Taiwan
Merrimack Conference Call Scheduled for 8:30 a.m. ET Today
DEERFIELD, Ill. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Baxter International Inc. (NYSE:BAX) and Merrimack Pharmaceuticals, Inc.
(Nasdaq:MACK) today jointly announced an exclusive license and
collaboration agreement for the development and commercialization of
MM-398 (nanoliposomal irinotecan injection), also known as ''nal-IRI.''
Through the agreement, Baxter gains exclusive commercialization rights
for all potential indications of MM-398 outside the United States and
Taiwan, and Merrimack retains commercialization rights in the United
States; the rights in Taiwan are held separately.
MM-398 is an investigational drug candidate for which Merrimack is
preparing a New Drug Application in the United States for the treatment
of patients with metastatic pancreatic cancer previously treated with a
gemcitabine-based therapy. Pancreatic cancer is a rare and deadly
disease that is difficult to diagnose and has limited treatment options
''Oncology represents an exciting new area and growth driver for our
biopharmaceutical business,'' said Ludwig Hantson, Ph.D., president of
Baxter BioScience. ''With this new collaboration with Merrimack on
MM-398, a promising new anti-cancer agent, we continue to augment our
growing pipeline focused on challenging diseases with significant unmet
needs, while capitalizing on our broad global reach.''
Under the terms of the agreement, Merrimack receives a $100 million
upfront payment from Baxter, which will be recorded by Baxter as a
special pre-tax in-process research and development charge in the third
quarter of 2014. Merrimack is also eligible to receive $120 million in
regulatory milestone payments related to the first pancreatic cancer
indication as these milestones are achieved, and $280 million in
development and regulatory milestone payments for a second pancreatic
Merrimack is also eligible to receive $220 million in future development
and regulatory milestone payments related to two additional indications.
Merrimack has the potential to receive $250 million in sales milestone
payments, as well as tiered royalties on net sales of MM-398 in the
''Baxter possesses the commercial and technical expertise, experience
and vision to obtain market approval and accelerate the global
commercialization of MM-398 in markets all over the world for patients
with metastatic pancreatic cancer who have few treatment options
following gemcitabine-based therapy,'' said Robert Mulroy, President and
CEO at Merrimack. ''This partnership also complements our strategy by
allowing us to develop our own commercial efforts in the United States
while aggressively pursuing the development of MM-398 across multiple
MM-398 is a novel encapsulation of irinotecan in a long-circulating
nanoliposomal formulation designed to increase drug deposition and
prolong cytotoxic effects, with the goal of improving its anti-cancer
properties. In May 2014, Merrimack announced that the Phase 3 trial,
known as NAPOLI-1, studying MM-398 in combination with 5-fluorouracil
(5-FU) and leucovorin achieved its primary and secondary endpoints for
patients with metastatic pancreatic cancer who were previously treated
with a gemcitabine-based therapy. In the study, the combination of
MM-398 with 5-FU and leucovorin demonstrated a statistically significant
improvement in overall survival, progression free survival and overall
response rate compared to the control arm of 5-FU and leucovorin alone.
This was the first positive global Phase 3 study in a post-gemcitabine
setting to show a survival benefit in this aggressive disease.
The U.S. Food and Drug Administration (FDA) and European Medicines
Agency have granted MM-398 orphan drug designation in metastatic
pancreatic cancer. Merrimack is planning to submit a New Drug
Application for MM-398 with the FDA in 2014. Baxter expects to submit
for regulatory approvals outside of the United States beginning in 2015.
Merrimack to Host Conference Call
Merrimack will host an investor conference call and webcast at 8:30
a.m., Eastern Time, today, September 24, where it will review the
details of the partnership. Investors and the general public are invited
to listen to the call by dialing (877) 564-1301 (domestic) or (224)
357-2394 (international) five minutes prior to the start of the call and
providing the passcode 8174452.
A listen-only webcast of the call can be accessed in the Investors
section of Merrimack's website, http://investors.merrimackpharma.com,
and a replay of the call will be archived there for six weeks.
MM-398 (irinotecan liposome injection), also known as "nal-IRI," is a
nanoliposomal encapsulation of the chemotherapeutic irinotecan. MM-398
has demonstrated extended circulation in comparison to free irinotecan
in the clinical setting. The activated form of irinotecan is SN-38,
which functions by inhibiting topoisomerase I (an essential enzyme
involved in DNA transcription and replication) and promoting cell death.
A Phase 1 clinical trial is assessing a potential companion diagnostic
for MM-398 in patients with multiple cancer types as a first step toward
determining which patients are most likely to benefit from treatment
with the drug.
NAPOLI-1 Trial Design
NAPOLI-1 (NAnoliPOsomaL Irinotecan) was a
randomized, open label Phase 3 study in patients with metastatic
pancreatic cancer who were previously treated with a gemcitabine-based
therapy. The study evaluated two MM-398 regimens, 80 mg/m2
combined with 5-FU and leucovorin every two weeks, and 120 mg/m2
as a monotherapy every three weeks. Each arm was compared to a control
arm of 5-FU and leucovorin. A total of 417 patients were randomized
across the three arms. Each MM-398 regimen was compared against the
control arm on the primary endpoint of overall survival. Patients were
enrolled at over 100 sites in North America, South America, Europe, Asia
About Pancreatic Cancer 1,2
Pancreatic cancer is rare and deadly, accounting for only three percent
of all cancer cases worldwide but is the fourth leading cause of cancer
death. An estimated 140,000 new cases are diagnosed every year around
the world, two-thirds of which are among people aged 65 or older. In the
United States alone, approximately 46,000 people are diagnosed with
pancreatic cancer and about 40,000 patients die annually.
Because the signs and symptoms of pancreatic cancer are non-specific and
may not appear until the disease has spread to other sites,
approximately 80% of patients are diagnosed with late stage disease and
are not candidates for surgery, instead receiving chemotherapy as the
mainstay of their therapy. As a result, the five year survival rate is
less than six percent; fewer than 20 percent of newly diagnosed patients
survive more than two years. There is no consensus on the standard of
care for patients with metastatic pancreatic cancer previously treated
with a gemcitabine-based therapy.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops,
manufactures and markets products that save and sustain the lives of
people with hemophilia, immune disorders, cancer, infectious diseases,
kidney disease, trauma and other chronic and acute medical conditions.
As a global, diversified healthcare company, Baxter applies a unique
combination of expertise in medical devices, pharmaceuticals and
biotechnology to create products that advance patient care worldwide.
About Merrimack Pharmaceuticals
Merrimack is a biopharmaceutical company discovering, developing and
preparing to commercialize innovative medicines paired with companion
diagnostics for the treatment of cancer. Merrimack seeks to gain a
deeper understanding of underlying cancer biology through its systems
biology-based approach and develop new insights, therapeutics and
diagnostics to improve outcomes for cancer patients. Merrimack currently
has six oncology therapeutics in clinical development and three
additional candidates in late stage preclinical development. Merrimack's
lead product candidate, MM-398, recently completed a Phase 3 trial in
post-gemcitabine pancreatic cancer. Based on the results of this trial,
Merrimack plans to submit a New Drug Application for MM-398 in 2014. For
more information, please visit Merrimack's website at www.merrimackpharma.com.
PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize
MM-398 in Taiwan under the terms of a 2011 agreement with Merrimack.
This release includes forward-looking statements concerning a license
and collaboration agreement between Baxter International Inc. and
Merrimack Pharmaceuticals, Inc., including expectations with regard to
the financial impact of such agreement on Baxter and Merrimack, as well
as future potential milestone payments and planned regulatory filings.
The statements are based on assumptions about many important factors,
including the following, which could cause actual results to differ
materially from those in the forward-looking statements: satisfaction of
regulatory and other requirements; actions of regulatory bodies and
other governmental authorities; clinical trial results; changes in laws
and regulations; product quality or patient safety issues; and other
risks identified in Baxter's and Merrimack's most recent filings on Form
10-K and other SEC filings. Neither Baxter nor Merrimack undertakes to
update their forward-looking statements.
1 American Cancer Society. Cancer Facts and Figures 2014. Atlanta:
American Cancer Society; 2014.
2 World Health Organization. GLOBOCAN 2012: Estimated Cancer Incidence,
Mortality and Prevalence Worldwide in 2012; Lyon, Fr.: International
Agency for Research on Cancer; 2012.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20140924005186/en/
Baxter Media Contact
Brian Kyhos, (224) 948-5353
Mary Kay Ladone, (224) 948-3371
Trachtman, (224) 948-3085
Merrimack Media Contact
Geoffrey Grande, CFA
Source: Baxter International Inc.
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