87.9% of Cadence’s outstanding shares were
validly tendered, and subsequent merger has been completed
Addition of high-growth OFIRMEV®, a
differentiated pain product, will expand Mallinckrodt’s U.S.
hospitals channel
Mallinckrodt plc (NYSE:MNK), a leading global specialty
pharmaceuticals company, today announced the successful completion
of its acquisition of Cadence Pharmaceuticals, Inc. (NASDAQ:CADX)
for total consideration of approximately $1.4 billion. As
previously disclosed, Mallinckrodt expects that the acquisition
will be immediately accretive to its fiscal year 2014 adjusted
diluted earnings per share, and significantly accretive to its
fiscal year 2015 adjusted diluted earnings per share.
The transaction adds OFIRMEV® (acetaminophen) injection, a
high-growth, differentiated pain product, to Mallinckrodt’s growing
roster of brands and its robust Specialty Pharmaceuticals portfolio
of core controlled substance specialty generics. OFIRMEV also
provides Mallinckrodt with an expanded presence in the U.S.
hospital channel.
“We are excited by the opportunities provided by OFIRMEV, which
will significantly expand Mallinckrodt’s ability to serve U.S.
hospitals,” said Mark Trudeau, President and Chief Executive
Officer of Mallinckrodt. “As anticipated, the transaction was
straightforward, closed quickly, and we are planning for a rapid
and successful integration which we expect to be completed by the
beginning of September. We believe this accelerated integration
will provide greater clarity and direction for the employees
joining us, and ensure that the merger of OFIRMEV and the
transition of the hospital team into Mallinckrodt is smooth and
best serves our customers.”
The tender offer by a subsidiary of Mallinckrodt plc for all of
the outstanding shares of Cadence common stock expired as scheduled
at 12:00 midnight (EDT) on March 18, 2014. Excluding Cadence shares
tendered by notice of guaranteed delivery, a total of 78,396,180
shares of Cadence common stock, representing approximately 87.9% of
Cadence’s outstanding shares, were validly tendered into and not
validly withdrawn from the tender offer, according to the
depositary for the tender offer. As a result, Mallinckrodt and its
subsidiary have accepted for payment and will promptly pay for all
shares that were validly tendered and not validly withdrawn.
Following its acceptance of the shares tendered in the tender
offer, Mallinckrodt caused the merger of its subsidiary with and
into Cadence without a vote of Cadence’s other stockholders,
pursuant to Section 251(h) of the Delaware General Corporation Law.
As a result of the completed merger, Cadence became an indirect,
wholly owned subsidiary of Mallinckrodt. In connection with the
merger, all Cadence shares not validly tendered into the tender
offer have been cancelled and converted into the right to receive
$14.00 per share, the same price per share offered in the tender
offer. As a result of the acquisition, Cadence shares will cease to
be traded on NASDAQ.
Mallinckrodt’s financial advisor for the transaction is Deutsche
Bank Securities Inc., and its legal advisors are Wachtell, Lipton,
Rosen & Katz in the U.S., and Arthur Cox in Ireland.
ABOUT OFIRMEV® (ACETAMINOPHEN)
INJECTION
OFIRMEV (acetaminophen) injection (1000 mg / 100 mL, 10 mg / mL;
for intravenous use only), Cadence Pharmaceutical’s proprietary
intravenous formulation of acetaminophen, is indicated for the
management of mild to moderate pain, the management of moderate to
severe pain with adjunctive opioid analgesics and the reduction of
fever. The FDA approval of OFIRMEV was based on data from clinical
trials in approximately 1,020 adult and 355 pediatric patients.
These trials included two studies evaluating the safety and
effectiveness of OFIRMEV in the treatment of pain, and one study
evaluating OFIRMEV in the treatment of fever. The effectiveness of
OFIRMEV for the treatment of post-surgical acute pain and fever has
not been studied in pediatric patients less than two years of
age.
Important Safety Information
RISK OF MEDICATION ERRORS AND HEPATOTOXICITY
Take care when prescribing, preparing, and administering OFIRMEV
injection to avoid dosing errors which could result in accidental
overdose and death.
OFIRMEV contains acetaminophen. Acetaminophen has been
associated with cases of acute liver failure, at times resulting in
liver transplant and death. Most of the cases of liver injury are
associated with the use of acetaminophen at doses that exceed the
recommended maximum daily limits, and often involve more than one
acetaminophen-containing product.
OFIRMEV is contraindicated in patients with severe hepatic
impairment, severe active liver disease or with known
hypersensitivity to acetaminophen or to any of the excipients in
the formulation. Acetaminophen should be used with caution in
patients with the following conditions: hepatic impairment or
active hepatic disease, alcoholism, chronic malnutrition, severe
hypovolemia, or severe renal impairment. Rarely, acetaminophen may
cause serious skin reactions such as acute generalized
exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS),
and toxic epidermal necrolysis (TEN), which can be fatal.
Discontinue OFIRMEV immediately if symptoms associated with allergy
or hypersensitivity occur, or at the first appearance of skin rash.
Do not use in patients with acetaminophen allergy.
The most common adverse reactions in patients treated with
OFIRMEV were nausea, vomiting, headache, and insomnia in adult
patients and nausea, vomiting, constipation, pruritus, agitation,
and atelectasis in pediatric patients. The antipyretic effects of
OFIRMEV may mask fever in patients treated with postsurgical pain.
OFIRMEV is approved for use in patients ≥ 2 years of age. Do not
exceed the recommended maximum daily dose of OFIRMEV. OFIRMEV
should be administered only as a 15-minute infusion.
For more information, please see the full OFIRMEV Prescribing
Information, including the complete boxed warning, which is
available at www.OFIRMEV.com.
ABOUT MALLINCKRODT PLC
Mallinckrodt is a global specialty pharmaceutical and medical
imaging business that develops, manufactures, markets and
distributes specialty pharmaceutical products and medical imaging
agents. The company’s Specialty Pharmaceuticals segment includes
branded and specialty generic drugs and active pharmaceutical
ingredients, and the Global Medical Imaging segment includes
contrast media and nuclear imaging agents. Mallinckrodt has
approximately 5,500 employees worldwide and a commercial presence
in roughly 70 countries. The company’s fiscal 2013 revenue totaled
$2.2 billion. To learn more about Mallinckrodt, visit
www.mallinckrodt.com.
FORWARD-LOOKING STATEMENTS
Statements in this document that are not strictly historical,
including statements regarding the acquisition, future financial
and operating results, benefits and synergies of the transaction,
future opportunities for the combined businesses and any other
statements regarding events or developments that we believe or
anticipate will or may occur in the future, may be
“forward-looking” statements within the meaning of the federal
securities laws, and involve a number of risks and uncertainties.
There are a number of important factors that could cause actual
events to differ materially from those suggested or indicated by
such forward-looking statements and you should not place undue
reliance on any such forward-looking statements. These factors
include risks and uncertainties related to, among other things:
general economic conditions and conditions affecting the industries
in which we operate; the commercial success of OFIRMEV; our ability
to protect intellectual property rights; our ability to
successfully integrate Cadence’s operations and employees with our
existing business; the ability to realize anticipated growth,
synergies and cost savings; Mallinckrodt’s ability to receive
procurement and production quotas granted by the U.S. Drug
Enforcement Administration; Mallinckrodt’s ability to obtain and/or
timely transport molybdenum-99 to our technetium-99m generator
production facilities; customer concentration; cost-containment
efforts of customers, purchasing groups, third-party payors and
governmental organizations; Mallinckrodt’s ability to successfully
develop or commercialize new products; competition; Mallinckrodt’s
ability to integrate acquisitions of technology, products and
businesses generally; product liability losses and other litigation
liability; the reimbursement practices of a small number of large
public or private insurers; complex reporting and payment
obligation under healthcare rebate programs; changes in laws and
regulations; conducting business internationally; foreign exchange
rates; material health, safety and environmental liabilities;
litigation and violations; information technology infrastructure;
and restructuring activities. Additional information regarding the
factors that may cause actual results to differ materially from
these forward-looking statements is available in Mallinckrodt’s SEC
filings, including its Annual Report on Form 10-K for the fiscal
year ended September 27, 2013 and Quarterly Report on Form 10-Q for
the quarterly period ended December 27, 2013, as well as Cadence
Pharmaceuticals’ SEC filings, including its Annual Report on Form
10-K for the year ended December 31, 2013. The forward-looking
statements made herein speak only as of the date hereof and neither
Mallinckrodt nor any of our respective affiliates assumes any
obligation to update or revise any forward-looking statement,
whether as a result of new information, future events and
developments or otherwise, except as required by law.
Mallinckrodt plcJohn Moten, 314-654-6650Vice President, Investor
Relationsjohn.moten@mallinckrodt.comorKekst and CompanyJeffrey
Taufield, 212-521-4879jeffrey-taufield@kekst.comorDaniel Yunger,
212-521-4879daniel-yunger@kekst.comorMallinckrodt plcMeredith
Fischer, 314-654-3318Senior Vice President, Communications and
Public Affairsmeredith.fischer@mallinckrodt.com
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