Transaction would add VYXEOS™, an investigational product in
development as a treatment for Acute Myeloid Leukemia (AML), to
Jazz Pharmaceuticals' portfolio
U.S. regulatory submission for VYXEOS planned by end of third
quarter 2016
Jazz Pharmaceuticals to host investor conference call today,
May 31, 2016 at 8:30 AM EDT (1:30 PM
IST)
DUBLIN and EWING, New Jersey, May
31, 2016 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq:
JAZZ) and Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today
announced that they have entered into a definitive agreement for
Jazz Pharmaceuticals to acquire Celator for $30.25 per share in cash, or approximately
$1.5 billion.
The transaction with Celator is well-suited to advance Jazz
Pharmaceuticals' growth strategy.
- VYXEOS is the first product
candidate to demonstrate a statistically significant
improvement in Overall Survival in patients with high-risk
(secondary) AML1
- U.S. FDA Breakthrough Therapy designation granted for
VYXEOS2
- U.S. FDA and European Commission Orphan
Drug designation for VYXEOS for the treatment of AML
- VYXEOS is an innovative product candidate based on the
Celator CombiPlex® platform
- Anticipated long-lived exclusivity for
VYXEOS
- Broadens Jazz Pharmaceuticals'
hematology/oncology portfolio
- Worldwide development and commercialization rights to
VYXEOS
- Synergies with Jazz
Pharmaceuticals' commercial expertise and
infrastructure
- Transaction expected to close in the third quarter of
2016
- Transaction expected to be accretive to Non-GAAP adjusted
EPS beginning in 2018 and beyond
1 Included secondary AML and de novo AML
with a karyotype characteristic of myelodysplastic syndrome
(MDS)
|
2 U.S. FDA Breakthrough Therapy
designation granted for VYXEOS for the treatment of adults with
therapy-related AML or AML with myelodysplasia-related
changes
|
"Celator Pharmaceuticals is a strong strategic fit with Jazz
Pharmaceuticals. VYXEOS will further diversify our product
portfolio and is complementary to our clinical and commercial
expertise in hematology/oncology," said Bruce Cozadd, chairman and chief executive
officer of Jazz Pharmaceuticals plc. "As Celator is currently
preparing a regulatory submission in the U.S. for VYXEOS, this
acquisition would add a new orphan product with the potential for
short- and long-term revenue generation and expansion of our
international commercial platform."
"The planned combination of Jazz and Celator is highly
complementary, as both companies are dedicated to bringing
differentiated therapies to patients who have high unmet medical
needs," said Scott Jackson, chief
executive officer of Celator Pharmaceuticals. "We believe that Jazz
Pharmaceuticals' clinical and commercial expertise in
hematology/oncology and existing international infrastructure will
help realize the value of VYXEOS as a treatment to patients with
AML. After thoroughly evaluating our strategic options, our board
of directors has unanimously determined that this all-cash
transaction is in the best interest of our stockholders."
Transaction Closing
The transaction is structured as
a tender offer and second step merger. The closing of the tender
offer is conditioned upon customary conditions, including the
tender of a majority of the outstanding shares of Celator common
stock and expiration or termination of the Hart Scott Rodino
waiting period. The transaction is expected to close in the third
quarter of 2016.
Certain stockholders of Celator holding approximately 18.4
percent of Celator's outstanding shares of common stock, including
executive officers, members of the Celator board of directors and
certain investment funds affiliated with the members of the board
of directors, have agreed to tender their shares in the tender
offer.
Financing
Jazz Pharmaceuticals expects to finance the
transaction with a combination of cash on hand and borrowings under
its senior secured credit facility.
Advisors
Jazz Pharmaceuticals' financial advisor for
the transaction is RBC Capital Markets, and its primary legal
advisor is Cooley LLP.
Celator Pharmaceuticals' financial advisor for the transaction
is MTS Health Partners, and its primary legal advisor is
Kirkland and Ellis LLP.
Conference Call Details
Jazz Pharmaceuticals will
host a conference call and live audio webcast today at 8:30 am EDT/1:30 pm
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.
Audio webcast/conference call:
U.S. Dial-In Number:
+1 503 343 6056
Outside the U.S. Dial-In Number: +1 855 353 7924
Passcode: 20942393
A replay of the conference call will be available through
June 7, 2016 and accessible through
one of the following telephone numbers and entering the
passcode:
Replay U.S. Dial-In Number: +1 404 537 3406
Replay Outside the U.S. Dial-In Number: +1 855 859
2056
Passcode: 20942393
About Jazz Pharmaceuticals plc
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) and Defitelio®
(defibrotide sodium) 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 Celator Pharmaceuticals, Inc.
Celator
Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is an oncology-focused
biopharmaceutical company that is transforming the science of
combination therapy, and developing products to improve patient
outcomes in cancer. Celator's proprietary technology platform,
CombiPlex®, enables the rational design and rapid evaluation of
optimized combinations of anti-cancer drugs, incorporating
traditional chemotherapies as well as molecularly targeted agents
to deliver enhanced anti-cancer activity. CombiPlex addresses
several fundamental shortcomings of conventional combination
regimens, as well as the challenges inherent in combination drug
development, by identifying the most effective synergistic molar
ratio of the drugs being combined in vitro, and fixing this
ratio in a nano-scale drug delivery complex to maintain the
optimized combination after administration and ensuring exposure of
this ratio to the tumor.
Celator's lead product is VYXEOS™ (also known as CPX-351), a
nano-scale liposomal formulation of cytarabine:daunorubicin that
has completed a Phase 3 trial for the treatment of acute myeloid
leukemia. Celator has also conducted clinical development on CPX-1,
a nano-scale liposomal formulation of irinotecan:floxuridine
studied in colorectal cancer; and have a preclinical stage product
candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle
formulation. More recently, Celator has advanced its CombiPlex
platform and broadened its application to include molecularly
targeted therapies. For more information, please visit Celator's
website at www.celatorpharma.com.
About VYXEOS
VYXEOS (cytarabine:daunorubicin)
Liposome for Injection, also known as CPX-351, is a nano-scale
liposomal co-formulation of cytarabine and daunorubicin at a
synergistic 5:1 molar ratio. VYXEOS represents a novel approach to
developing combinations of drugs in which molar ratios of two drugs
with synergistic anti-tumor activity are encapsulated in a
nanoscale liposome in order to maintain the desired ratio following
administration. The FDA granted Breakthrough Therapy designation to
VYXEOS for the treatment of adults with therapy-related AML (t-AML)
or AML with myelodysplasia-related changes (AML-MRC). VYXEOS was
granted orphan drug status for the treatment of AML by the FDA and
the European Commission. VYXEOS was also granted Fast Track
designation for the treatment of elderly patients with secondary
AML by the FDA.
In a Phase 3 trial in patients with high-risk (secondary) AML,
the median overall survival for patients treated with VYXEOS in the
study was 9.56 months compared to 5.95 months for patients
receiving the standard of care regimen of cytarabine and
daunorubicin known as 7+3, representing a 3.61-month improvement in
favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005), which
represents a 31% reduction in the risk of death versus 7+3. The
percentage of patients alive 12 months after randomization was
41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The
percentage of patients alive 24 months after randomization was
31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.
Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor
of patients treated with VYXEOS. No substantial difference in Grade
3 or higher adverse events was observed between VYXEOS and 7+3. In
the intent-to-treat population, Grade 3-5, hematologic adverse
events were similar for overall infections, febrile neutropenia,
and bleeding events. In the intent-to-treat population, Grade 3-5,
non-hematologic adverse events were similar across all organ
systems, including cardiac, gastrointestinal, general systems,
metabolic disorders, musculoskeletal, nervous system, respiratory,
skin and renal.
The final Phase 3 clinical trial data will be presented at the
American Society of Clinical Oncology on June 4, 2016 and at the European Hematology
Association Annual Congress on June 11,
2016.
"Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995
This press release
contains forward-looking statements regarding Jazz Pharmaceuticals
and Celator Pharmaceuticals, including, but not limited to,
statements related to the anticipated consummation of the tender
offer for Celator common stock and the timing and benefits thereof,
and estimated future financial results, regulatory submissions and
performance of VYXEOS, as well as other statements that are not
historical facts. These forward-looking statements are based on
each of the companies' current expectations 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 related to
Jazz Pharmaceuticals' ability to complete the tender offer on the
proposed terms and schedule, including risks and uncertainties
related to the satisfaction of closing conditions; the possibility
that competing offers will be made; risks associated with business
combination transactions, such as the risk that the acquired
business will not be integrated successfully or that such
integration may be more difficult, time-consuming or costly than
expected; risks related to future opportunities and plans for the
combined company, including uncertainty of the expected future
regulatory filings, financial performance and results of the
combined company following completion of the proposed transaction;
disruption from the proposed acquisition, making it more difficult
to conduct business as usual or maintain relationships with
customers, employees or suppliers; and the possibility that if Jazz
Pharmaceuticals does not achieve the perceived benefits of the
proposed acquisition as rapidly or to the extent anticipated by
financial analysts or investors, the market price of Jazz
Pharmaceuticals' ordinary shares could decline; and those other
risks detailed under the caption "Risk Factors" and elsewhere in
Jazz Pharmaceuticals' and Celator's U.S. Securities and Exchange
Commission ("SEC") filings and reports, including in Jazz
Pharmaceuticals' and Celator Pharmaceuticals' Quarterly Reports on
Form 10-Q for the quarter ended March 31,
2016, each of which is filed with the SEC, and future
filings and reports by either company. Neither Jazz Pharmaceuticals
nor Celator undertakes any duty or obligation to update any
forward-looking statements contained in this press release as a
result of new information, future events or changes in its
expectations.
Additional Information and Where to Find It
The
tender offer described in this communication (the "Offer") has not
yet commenced and this communication is neither an offer to
purchase nor a solicitation of an offer to sell shares of Celator
or other securities, nor is it a substitute for the tender offer
materials that Jazz Pharmaceuticals and its acquisition subsidiary
will file with the SEC upon commencement of the tender offer. At
the time the Offer is commenced, Jazz Pharmaceuticals and its
acquisition subsidiary will file tender offer materials on Schedule
TO, and Celator will file a Solicitation/Recommendation Statement
on Schedule 14D-9 with the SEC with respect to the Offer. The
tender offer materials (including an Offer to Purchase, a related
Letter of Transmittal and certain other tender offer documents) and
the Solicitation/Recommendation Statement, as they may be amended
from time to time, will contain important information. Holders of
Celator securities are urged to read these documents when they
become available because they will contain important information
that holders of Celator securities should consider before making
any decision regarding tendering their securities. The Offer to
Purchase, the related Letter of Transmittal and certain other
tender offer documents, as well as the Solicitation/Recommendation
Statement, will be made available to all holders of Celator
securities at no expense to them. Investors and security holders
may obtain free copies of these documents (when they are available)
and other related documents filed with the SEC at the SEC's web
site at http://www.sec.gov or by (i) directing a request to Jazz
Pharmaceuticals plc, c/o Jazz Pharmaceuticals, Inc., 3180 Porter
Drive, Palo Alto, California
94304, U.S.A., Attention: Investor
Relations, (ii) calling +353 1 634 7892 (Ireland) or + 1 650 496 2800 (U.S.) or (iii)
sending an email to investorinfo@jazzpharma.com. Investors and
security holders may also obtain free copies of the documents filed
with the SEC on Jazz Pharmaceuticals' website at
www.jazzpharmaceuticals.com under the heading "Investors" and then
under the heading "SEC Filings."
Logo -
http://photos.prnewswire.com/prnh/20150930/272253LOGO