-- Lead Compound, Quizartinib, Will Further Build Daiichi
Sankyo Oncology Pipeline
TOKYO and SAN DIEGO, Sept. 29,
2014 /PRNewswire/ -- Daiichi Sankyo Company, Ltd.
(hereinafter Daiichi Sankyo) (TSE: 4568) and Ambit Biosciences
(NASDAQ: AMBI), jointly announced today that they have entered into
a definitive merger agreement under which Daiichi Sankyo will
acquire all of the outstanding common stock of Ambit Biosciences
for $15 per share in cash through a
tender offer followed by a merger with a subsidiary of Daiichi
Sankyo, or approximately $315 million
on a fully diluted basis. In addition to the upfront cash
payment, each Ambit Biosciences stockholder will receive one
Contingent Value Right (CVR), entitling the holder to receive an
additional cash payment of up to $4.50 for each share they own if certain
commercialization related milestones are achieved. The total
transaction is valued at up to $410
million on a fully diluted basis.
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Ambit Biosciences, a publicly traded, biopharmaceutical
company, is focused on the discovery and development of medicines
to treat unmet medical needs in oncology, autoimmune and
inflammatory diseases by inhibiting enzymes that are important
drivers for those diseases. The lead Ambit Biosciences drug
candidate, quizartinib, is currently in phase 3 clinical trials
among patients with acute myeloid leukemia (AML), who express a
genetic mutation in FLT3 and who are refractory to or relapsed
after first-line treatment with or without hematopoietic stem cell
transplantation (HSCT) consolidation. AML patients with the
FLT3 mutation tend to have a poorer prognosis than those whose
cancers are FLT3 negative.
"Daiichi Sankyo is the ideal organization to take quizartinib to
the next stage of development, and ultimately, to achieve our goal
of making it available as quickly as possible to help as many AML
patients as possible," said Michael A.
Martino, President and CEO, Ambit Biosciences. "This
attractive offer to shareholders, is a testament to the hard work
and dedication of the Ambit team to our mission of developing
innovative therapies for areas of high unmet medical need."
"The acquisition of Ambit Biosciences further builds our
presence in oncology to ensure we are delivering on our goal of
providing world-class, innovative pharmaceuticals in core areas of
unmet medical need," said Daiichi Sankyo Co., Ltd. President and
CEO, Joji Nakayama. "Long-term
success in oncology depends upon three pillars: fostering
development of our in-house molecules, exploring mutually
beneficial partnerships and executing strategic purchases, such as
Ambit Biosciences, which follows our acquisitions of U3 Pharma and
Plexxikon."
"Quizartinib will fit seamlessly into our already robust
oncology pipeline focused on targeted therapies with the potential
for personalizing the treatment of cancer," said Mahmoud Ghazzi, MD, PhD, Global Head of
Development for Daiichi Sankyo. "With the acquisition of
Ambit Biosciences, Daiichi Sankyo gains additional opportunities to
develop promising treatments for cancer, including the global
rights to quizartinib, currently being studied in patients with
refractory AML, a very serious condition for which no new therapies
have been approved for more than 30 years."
Ambit Biosciences board of directors has unanimously approved
the acquisition.
Closing of the tender offer and merger is subject to certain
conditions, including the tender of more than 50 percent of all
shares of Ambit Biosciences. Completion of the transaction is
also subject to clearance under the Hart-Scott-Rodino (HSR)
Antitrust Improvements Act and customary closing conditions.
The acquisition is expected to conclude promptly after
receipt of HSR clearance and the close of the tender period.
Centerview Partners acted as lead financial advisor to Ambit
Biosciences. Leerink Partners LLC also acted as financial
advisor to Ambit Biosciences. Cooley LLP acted as legal advisor to
Ambit Biosciences. Simpson Thacher & Bartlett LLP
acted as legal advisor to Daiichi Sankyo.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated
to the creation and supply of innovative pharmaceutical products to
address the diversified, unmet medical needs of patients in both
mature and emerging markets. While maintaining its portfolio of
marketed pharmaceuticals for hypertension, dyslipidemia and
bacterial infections used by patients around the world, the Group
has also launched treatments for thrombotic disorders and is
building new product franchises. Furthermore, Daiichi Sankyo
research and development is focused on bringing forth novel
therapies in oncology and cardiovascular-metabolic diseases,
including biologics. The Daiichi Sankyo Group has created a
"Hybrid Business Model," to respond to market and customer
diversity and optimize growth opportunities across the value chain.
For more information, please visit:
www.daiichisankyo.com.
The Daiichi Sankyo oncology portfolio continues to grow and
currently includes both small molecules and monoclonal antibodies
with novel targets in both solid and hematologic cancers.
About Ambit Biosciences
Ambit is a biopharmaceutical
company focused on the discovery, development and commercialization
of drugs to treat unmet medical needs in oncology, autoimmune and
inflammatory diseases by inhibiting kinases that are important
drivers for those diseases. Ambit's lead drug candidate,
quizartinib (AC220), is a once-daily, orally-administered potent
and selective, inhibitor of FMS-like tyrosine kinase-3 (FLT3) and
is currently in a registrational phase 3 clinical trial, referred
to as QUANTUM-R, in patients with relapsed/refractory FLT3-ITD
positive, acute myeloid leukemia (AML). Quizartinib is also being
studied in newly diagnosed patients in combination with
chemotherapy as well as maintenance following a hematopoietic stem
cell transplantation (HSCT). In addition to quizartinib, Ambit's
clinical pipeline includes AC410, an oral JAK2 inhibitor, and
CEP-32496, a BRAF inhibitor licensed to Teva Pharmaceutical
Industries Ltd. Ambit's preclinical portfolio includes a
proprietary CSF1R inhibitor program.
About AML
AML is the most common type of acute
leukemia in adults and is projected to account for approximately 36
percent of all new leukemia cases in 2014. AML results in
uncontrolled growth and accumulation of malignant white blood cells
which fail to function normally and interfere with the production
of normal blood cells.
According to the American Cancer Society, approximately 18,860
patients will be newly diagnosed with AML in 2014 in the United States and approximately 10,460 are
expected to die of the disease in 2014. AML is generally a disease
of older people and the median age of a patient at initial
diagnosis is 66 years. The five-year survival rate for all AML
patients, irrespective of age and FLT3-ITD status, is 23
percent.
The standard of care for AML has not changed appreciably for
decades. Treatment decisions for AML are typically based on the
patient's age (60 years of age being generally referred to as
"elderly" and used as a treatment indicator), overall health,
cytogenetics and molecular abnormalities such as FLT3-ITD status.
These factors determine the aggressiveness of the treatment
approach given the high toxicity associated with currently approved
treatment options for AML. Importantly, the National Comprehensive
Cancer Network recommends participation in clinical trials as a
treatment option for all AML patients.
The goal of treatment in AML is to reduce the blasts in the bone
marrow to below 5 percent and return the blood cell counts to
normal levels. A bone marrow transplant is generally recognized as
the only curative treatment option. Typically, patients who are
able to achieve a reduction in bone marrow blasts below 5% are more
suitable candidates for transplant and have an improved projected
outcome.
Important Additional Information
This press release is
for informational purposes only and is not an offer to buy or the
solicitation of an offer to sell any shares of Ambit Biosciences
common stock. The tender offer described herein has not yet been
commenced. On the commencement date of the tender offer, an offer
to purchase, a letter of transmittal and related documents will be
filed with the Securities and Exchange Commission (SEC). The
solicitation of offers to buy shares of Ambit Biosciences common
stock will only be made pursuant to the offer to purchase, the
letter of transmittal and related documents. Investors and Ambit
Biosciences securityholders are strongly advised to read both the
tender offer statement and the solicitation/recommendation
statement that will be filed by Ambit Biosciences regarding the
tender offer when they become available as they will contain
important information. Investors and securityholders may obtain
free copies of these statements (when available) and other
documents filed with respect to the tender offer at the SEC's
website at www.sec.gov. In addition, copies of the tender offer
statement and related materials (when available) may be obtained
for free by directing such requests to the information agent for
the tender offer or by directing such requests to the Daiichi
Sankyo Group investor relations at the e-mail address below. The
solicitation/recommendation statement and related documents (when
available) may be obtained by directing such requests to Ambit
Biosciences investor relations at the phone number or e-mail
address below.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements. Any
statements contained herein which do not describe historical facts,
including but not limited to, statements regarding: the proposed
transaction between Daiichi Sankyo and Ambit Biosciences; the
expected timetable for completing the transaction; strategic and
other potential benefits of the transaction; Ambit Biosciences'
product candidates, including regarding the therapeutic and
commercial potential of quizartinib; and any other statements
about Daiichi Sankyo or Ambit Biosciences managements' future
expectations, beliefs, goals, plans, or prospects, are
forward-looking statements which involve risks and uncertainties
that could cause actual results to differ materially from those
discussed in such forward-looking statements. Such risks and
uncertainties include: the possibility that certain closing
conditions to the transaction will not be satisfied; that required
regulatory approvals for the transaction may not be obtained in a
timely manner, if at all; the ability to timely consummate the
transaction and possibility that the transaction will not be
completed; the ability of Daiichi Sankyo to successfully integrate
Ambit Biosciences operations and employees; the anticipated
benefits of the transaction may not be realized; risks related to
drug development and commercialization; and those additional
factors discussed in Ambit Biosciences' most recent Quarterly and
Annual Reports on Forms 10-Q and 10-K filed with the Securities and
Exchange Commission. Daiichi Sankyo and Ambit Biosciences caution
investors not to place considerable reliance on the forward-looking
statements contained in this press release. These forward-looking
statements speak only as of the date of this document, and Daiichi
Sankyo and Ambit Biosciences undertake no obligation to update or
revise any of these statements.
