JAZZ PHARMACEUTICALS AND CELATOR PHARMACEUTICALS ANNOUNCE
AGREEMENT FOR JAZZ PHARMACEUTICALS TO ACQUIRE CELATOR
FOR $30.25 PER SHARE
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, N.J., May 31, 2016 -- 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 nanoscale 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 nanoscale 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."
Contact Information
Jazz Pharmaceuticals plc
Investors, Kathee Littrell, Vice President, Investor Relations,
Jazz Pharmaceuticals plc, Ireland,
+ 353 1 634 7887, or U.S., + 1 650 496 2717; or Media, Laurie Hurley, Vice
President,
Corporate Affairs, Jazz Pharmaceuticals plc, Ireland, + 353 1 634 7894,
U.S., +1 650 496 2796
Celator Pharmaceuticals, Inc.
Investors, Peter Rahmer, The Trout Group, +1 646 378 2973,
prahmer@troutgroup.com; or
Media, Mike Beyer, Sam Brown, Inc., +1 312 961 2502,
mikebeyer@sambrown.com