DUBLIN, Aug. 14, 2014 /PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a leading global specialty pharmaceutical company,
today announced that it has completed its acquisition of Questcor
Pharmaceuticals, Inc. (NASDAQ: QCOR) in a cash and stock
transaction valued at approximately $5.8
billion. The acquisition is expected to be immediately
accretive to Mallinckrodt's fiscal 2014
adjusted diluted earnings per share and significantly accretive to
its adjusted diluted earnings per share in fiscal 2015.
The merger follows strong approval by both Mallinckrodt and Questcor shareholders at separate
special meetings held today. Under the terms of the merger
agreement, Questcor shareholders will receive $30.00 in cash and 0.897 of a Mallinckrodt ordinary share for each Questcor
share.
"We are pleased to complete this transformative transaction and
believe it will provide a strong, durable, well-diversified and
sustainable platform, capable of generating significant future
revenue and earnings growth for Mallinckrodt shareholders," said Mark Trudeau, President and Chief Executive
Officer of Mallinckrodt. "HP
Acthar® Gel has demonstrated success in treating
patients suffering from a variety of devastating and
difficult-to-treat autoimmune and inflammatory illnesses. We are
confident that Acthar will be a strong complement to Mallinckrodt's broadening portfolio of leading
specialty pharmaceutical brands, and we look forward to leveraging
our extensive manufacturing and scientific expertise, as well as
our experience with advocacy and payer communities, to capitalize
on the many opportunities it presents."
Mr. Trudeau added, "We are very pleased to welcome the Questcor
team to Mallinckrodt. We are excited
about our future prospects and the benefits that our collective
efforts will have for patients, our investors and the communities
that we serve."
As previously disclosed, commercial operations supporting HP
Acthar Gel will function as a separate business within Mallinckrodt's Specialty Pharmaceuticals segment
reporting to Mr. Trudeau. It will be known as the Autoimmune and
Rare Diseases business within Mallinckrodt.
Advisors
Mallinckrodt's
financial advisor for the transaction was Barclays, and its legal
advisors were Wachtell, Lipton, Rosen & Katz and Arthur Cox in Ireland.
Questcor Pharmaceuticals' financial advisor for the transaction
was Centerview Partners and its legal advisors were Latham &
Watkins LLP and Matheson in Ireland.
About H.P. Acthar® Gel
H.P. Acthar Gel
(repository corticotropin injection), is an injectable drug
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of 19 indications. Of these 19 indications, the product
currently generates substantially all of its net sales from the
following on-label indications: the treatment of proteinuria in the
nephrotic syndrome of the idiopathic type, or NS, the treatment of
acute exacerbations of multiple sclerosis, or MS, in adults, the
treatment of infantile spasms, or IS, in infants and children under
two years of age, and the treatment of certain rheumatology related
conditions, including the treatment of the rare and closely related
neuromuscular disorders dermatomyositis and polymyositis. With
respect to nephrotic syndrome, the FDA has approved Acthar to
"induce a diuresis or a remission of proteinuria in the nephrotic
syndrome without uremia of the idiopathic type or that due to lupus
erythematosus." The company is also exploring the possibility of
developing other on-label indications and the possibility of
pursuing FDA approval of additional indications not currently on
the Acthar label where there is high unmet medical need. For more
information about Acthar, please visit www.acthar.com.
IMPORTANT RISK INFORMATION
Indication
H.P. Acthar Gel is repository corticotropin
injection currently approved by the FDA for 19 indications in four
key, hard-to-treat areas: acute exacerbations of multiple
sclerosis; proteinuria in ideopathic types of nephrotic syndrome;
infantile spasms in children under two years' old; and
rheumatology-related conditions such as polymyositis and
dermatomyositis.
Important Safety Information
Contraindications
- Acthar should never be administered intravenously
- Administration of live or live attenuated vaccines is
contraindicated in patients receiving immunosuppressive doses of
Acthar
- Acthar is contraindicated where congenital infections are
suspected in infants
- Acthar is contraindicated in patients with scleroderma,
osteoporosis, systemic fungal infections, ocular herpes simplex,
recent surgery, history of or the presence of a peptic ulcer,
congestive heart failure, uncontrolled hypertension, primary
adrenocortical insufficiency, adrenocortical hyperfunction, or
sensitivity to proteins of porcine origins
Warning and Precautions
- The adverse effects of Acthar are related primarily to its
steroidogenic effects
- Acthar may increase susceptibility to new infection or
reactivation of latent infections
- Suppression of the hypothalamic‐pituitary‐axis (HPA) may occur
following prolonged therapy with the potential for adrenal
insufficiency after withdrawal of the medication. Adrenal
insufficiency may be minimized by tapering of the dose when
discontinuing treatment. During recovery of the adrenal gland
patients should be protected from the stress (e.g., trauma or
surgery) by the use of corticosteroids. Monitor patients for
effects of HPA suppression after stopping treatment
- Cushing's syndrome may occur during therapy but generally
resolves after therapy is stopped. Monitor patients for signs and
symptoms
- Acthar can cause elevation of blood pressure, salt and water
retention, and hypokalemia. Blood pressure, sodium and potassium
levels may need to be monitored
- Acthar often acts by masking symptoms of other
diseases/disorders. Monitor patients carefully during and for a
period following discontinuation of therapy
- Acthar can cause GI bleeding and gastric ulcer. There is also
an increased risk for perforation in patients with certain
gastrointestinal disorders. Monitor for signs of bleeding
- Acthar may be associated with central nervous system effects
ranging from euphoria, insomnia, irritability, mood swings,
personality changes, severe depression, and psychosis. Existing
conditions may be aggravated
- Patients with comorbid disease may have that disease worsened.
Caution should be used when prescribing Acthar in patients with
diabetes and myasthenia gravis
- Prolonged use of Acthar may produce cataracts, glaucoma and
secondary ocular infections. Monitor for signs and symptoms
- Acthar is immunogenic and prolonged administration of Acthar
may increase the risk of hypersensitivity reactions. Neutralizing
antibodies with chronic administration may lead to loss of
endogenous ACTH activity
- There is an enhanced effect in patients with hypothyroidism and
in those with cirrhosis of the liver
- Long‐term use may have negative effects on growth and physical
development in children. Monitor pediatric patients
- Decrease in bone density may occur. Bone density should be
monitored for patients on long-term therapy
- Pregnancy Class C: Acthar has been shown to have an embryocidal
effect and should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus
Adverse Reactions
- Common adverse reactions for Acthar are similar to those of
corticosteroids and include fluid retention, alteration in glucose
tolerance, elevation in blood pressure, behavioral and mood
changes, increased appetite, and weight gain
- Specific adverse reactions reported in IS clinical trials in
infants and children under 2 years of age included: infection,
hypertension, irritability, Cushingoid symptoms, constipation,
diarrhea, vomiting, pyrexia, weight gain, increased appetite,
decreased appetite, nasal congestion, acne, rash, and cardiac
hypertrophy. Convulsions were also reported, but these may actually
be occurring because some IS patients progress to other forms of
seizures and IS sometimes mask other seizures, which become visible
once the clinical spasms from IS resolve
Other adverse events reported are included in the full
Prescribing Information.
Please see full Prescribing
Information for additional important safety
information.
For parents and caregivers of IS patients, please also
see Medication Guide.
About Mallinckrodt
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 core strengths include the acquisition and
management of highly regulated raw materials; deep regulatory
expertise; and specialized chemistry, formulation and manufacturing
capabilities. 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 65 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 Questcor 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 Private Securities Litigation Reform Act
of 1995, 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
Mallinckrodt and Questcor operate; the commercial success
of Mallinckrodt's and Questcor's products, including H.P.
Acthar® Gel ("Acthar"); Mallinckrodt's and Questcor's
ability to protect intellectual property
rights; Mallinckrodt's ability to successfully integrate
Questcor's operations and employees
with Mallinckrodt's existing business; the ability to
realize anticipated growth, synergies and cost savings; Questcor's
performance and maintenance of important business relationships;
the lack of patent protection for Acthar, and the
possible United States Food and Drug
Administration ("FDA") approval and market introduction of
additional competitive products; Questcor's reliance on Acthar for
substantially all of its net sales and profits; Questcor's ability
to continue to generate revenue from sales of Acthar to treat
on-label indications associated with nephrotic syndrome, multiple
sclerosis, infantile spasms or rheumatology-related conditions, and
Questcor's ability to develop other therapeutic uses for Acthar;
volatility in Questcor's Acthar shipments, estimated channel
inventory, and end-user demand; an increase in the proportion of
Questcor's Acthar unit sales comprised of Medicaid-eligible
patients and government entities; Questcor's research and
development risks, including risks associated with Questcor's work
in the areas of nephrotic syndrome and lupus, and Questcor's
efforts to develop and obtain FDA approval of Synacthen™
Depot; 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 its 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 achieve
anticipated benefits of price
increases; 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 issuers; complex reporting and payment obligations 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
(i) Mallinckrodt's SEC filings, including its Annual
Report on Form 10-K for the fiscal year ended September 27,
2013 and its Quarterly Reports on Form 10-Q for the quarterly
periods ended December 27, 2013, March 28, 2014 and
June 27, 2014; (ii)
the SEC filings of Cadence Pharmaceuticals, Inc.,
which was acquired by Mallinckrodt on March 19,
2014, including its Annual Report on Form 10-K for the fiscal year
ended December 31, 2013; and (iii)
Questcor's SEC filings, including its Annual Report on
Form 10-K for the year ended December
31, 2013 (and the amendment thereto on Form 10-K/A),
its Quarterly Reports on Form 10-Q for the quarterly periods
ended March 31, 2014 and June 30, 2014, and its
Current Report on Form 8-K filed with
the SEC on July 10, 2014. The forward-looking
statements made herein speak only as of the date hereof and none
of Mallinckrodt, Questcor or any of their 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.
CONTACTS FOR MALLINCKRODT:
Investors
John Moten
Vice President, Investor Relations
314-654-6650
john.moten@mallinckrodt.com
Media
Jeffrey Taufield or Daniel Yunger
Kekst and Company
212-521-4879
jeffrey-taufield@kekst.com
daniel-yunger@kekst.com
Meredith Fischer
Senior Vice President, Communications and Public Affairs
314-654-3318
meredith.fischer@mallinckrodt.com
SOURCE Mallinckrodt plc