STAINES-UPON-THAMES, United
Kingdom, March 20, 2017
/PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading
specialty pharmaceutical company, announced today it has closed the
sale of its Intrathecal Therapy business to Piramal Enterprises
Limited's subsidiary in the U.K., Piramal Critical Care, for
approximately $203 million, including
fixed and contingent consideration. The company's Intrathecal
Therapy business markets products for the treatment of spasticity
via intrathecal drug delivery, including the key asset
Gablofen® (baclofen injection).
Mallinckrodt's divesture of this
business is aligned with the company's ongoing focus on driving
return on invested capital, and contributes to the strategic
transformation of the company.
"This action is another example of the strategic evolution of
our portfolio, and will free resources for investing in our growth
platforms in autoimmune and rare diseases and hospital therapies,"
said Mark Trudeau, President and
Chief Executive Officer of Mallinckrodt. "Our Intrathecal Therapy business
is an excellent fit for Piramal Critical Care, and is the best
solution to meet patient needs."
The approximately $203 million
transaction will consist of $171
million of fixed consideration of which 10%, or $17 million, will be paid at closing, and an
additional $154 million will be paid
on the first anniversary of the close date. The remaining total
consideration of up to $32 million is
contingent, based on the gross profit of the Gablofen products in
2018 and 2019.
Gablofen, a product approved by the U.S. Food and Drug
Administration (FDA) for use in management of severe spasticity of
cerebral or spinal origin in adult and pediatric patients age 4
years and above, is the only FDA-approved baclofen in prefilled
syringes and factory-sealed vials.
About Gablofen
Gablofen is indicated for use in
the management of severe spasticity of cerebral or spinal origin.
Approved by the FDA in late 2010, Gablofen is a branded, AP-rated
alternative for Lioresal® Intrathecal (baclofen
injection) and is listed in the FDA Orange Book: Approved Drug
Products with Therapeutic Equivalence Evaluations.
PLEASE SEE IMPORTANT RISK INFORMATION, INCLUDING BOXED
WARNING BELOW.
INDICATIONS AND USAGE
- Gablofen (baclofen injection) is a gamma-aminobutyric acid
(GABA) ergic agonist indicated for use in the management of severe
spasticity of cerebral or spinal origin in adult and pediatric
patients age 4 years and above.
- Gablofen should be reserved for patients unresponsive to oral
baclofen therapy, or those who experience intolerable central
nervous system side effects at effective doses.
- Patients should first respond to a screening dose of
intrathecal baclofen prior to consideration for long term infusion
via an implantable pump.
- Spasticity due to traumatic brain injury: wait at least one
year after injury before considering Gablofen therapy.
IMPORTANT RISK INFORMATION
WARNING: DO NOT
DISCONTINUE ABRUPTLY
Abrupt
discontinuation of intrathecal baclofen, regardless of the cause,
has resulted in sequelae that include high fever, altered mental
status, exaggerated rebound spasticity, and muscle rigidity, that
in rare cases has advanced to rhabdomyolysis, multiple organ-system
failure and death.
Prevention of
abrupt discontinuation of intrathecal baclofen requires careful
attention to programming and monitoring of the infusion system,
refill scheduling and procedures, and pump alarms. Patients and
caregivers should be advised of the importance of keeping scheduled
refill visits and should be educated on the early symptoms of
baclofen withdrawal. Special attention should be given to patients
at apparent risk (e.g., spinal cord injuries at T-6 or above
communication difficulties, history of withdrawal symptoms from
oral or intrathecal baclofen). Consult the technical manual of the
implantable infusion system for additional post-implant clinician
and patient information.
|
CONTRAINDICATIONS:
- Hypersensitivity to baclofen.
- Do not use Gablofen for intravenous, intramuscular,
subcutaneous or epidural administration.
WARNINGS AND PRECAUTIONS
- Risk of life-threatening overdose during pump refills. Use
extreme caution when filling the Medtronic SynchroMed®
II Programmable Pump which is equipped with an injection port that
allows direct access to the intrathecal catheter. Direct injection
into the catheter through the catheter access port may cause a
life-threatening overdose.
- Use only with Medtronic SynchroMed II Programmable Pump (or
other pumps labeled for intrathecal administration of Gablofen
(baclofen injection)).
- Potential for contamination due to non-sterile external surface
of prefilled syringe. Although the drug solution and pathway in the
Gablofen prefilled syringes are sterile, the external surface of
the prefilled syringes (all strengths, including the 50 mcg/mL
strength) are non-sterile and have the potential to lead to
contamination and consequent adverse reactions. The use of Gablofen
prefilled syringe in an aseptic setting (e.g., operating room) to
fill sterile intrathecal pumps prior to implantation in patients is
not recommended, unless the external surface of the prefilled
syringe is treated to ensure sterility. Gablofen supplied in vials
may be used with conventional aseptic technique to fill intrathecal
pumps prior to implantation.
- Resuscitative equipment and trained staff must be available
during screening dose, dose titration, and refills due to the
potential life-threatening CNS depression, cardiovascular collapse,
and/or respiratory failure.
- Overdose may cause drowsiness, lightheadedness, dizziness,
somnolence, respiratory depression, seizures, rostral progression
of hypotonia and loss of consciousness progressing to coma.
- Use with caution in patients with psychotic disorders,
schizophrenia or confusional states as it may exacerbate
condition(s).
- Fatalities have been reported with intrathecal baclofen
use.
- Caution should be used in patients with a history of autonomic
dysreflexia.
- Presence of infection may increase the risk of surgical
complication and complicate dosing of Gablofen.
- May cause drowsiness: use caution in operation of automobiles,
dangerous machinery and activity made hazardous by decreased
alertness. Other CNS depressants and alcohol may add to this
effect.
- Potential development of intrathecal mass formation. Clinicians
should monitor for signs and symptoms of new neurologic symptoms
including the use of imaging diagnostic modalities.
- Oral baclofen use has been associated with a dose-related
increase in incidence of ovarian cysts.
SERIOUS ADVERSE EVENTS:
- Sudden withdrawal of Gablofen can result in serious
complications that include high fever, confusion, muscle stiffness,
multiple organ-system failure, and death. Inform patients that
early symptoms of Gablofen withdrawal may include increased
spasticity, itching, and tingling of extremities. If Gablofen
withdrawal or a pump malfunction is suspected, patients should be
brought immediately to a hospital for assessment and
treatment.
- Gablofen overdose may occur suddenly or insidiously, and that
symptoms may include confusion, drowsiness, lightheadedness,
dizziness, slow or shallow breathing, seizures, loss of muscle
tone, loss of consciousness, and coma.
- Other serious adverse events may include: potential development
of intrathecal mass formation, drainage, infection, meningitis,
unmanageable trunk control, CSF leakage, coma and death.
COMMON ADVERSE EVENTS:
- The most common adverse reactions in patients with spasticity
of spinal origin were hypotonia (25.3%) somnolence (20.9%),
dizziness, nausea/vomiting, hypotension, headache, and
convulsions.
- The most common adverse reactions in patients with spasticity
of cerebral origin were hypotonia (34.7%), somnolence (18.7%),
headache (10.7%), agitation, constipation, leukocytosis, chills,
and urinary retention.
- Other common adverse events may include hypoventilation,
hypertonia, paresthesia, increased salivation, back pain, pruritus,
diarrhea, peripheral edema, asthenia, pain, confusion, speech
disorder, amblyopia, accidental injury and dry mouth.
For Full Prescribing Information about Gablofen, click
here.
About Mallinckrodt
Mallinckrodt is a global business that develops,
manufactures, markets and distributes specialty pharmaceutical
products and therapies. Areas of focus include autoimmune and rare
diseases in specialty areas like neurology, rheumatology,
nephrology, pulmonology and ophthalmology; immunotherapy and
neonatal respiratory critical care therapies; and analgesics and
hemostasis products. The company's core strengths include the
acquisition and management of highly regulated raw materials and
specialized chemistry, formulation and manufacturing capabilities.
The company's Specialty Brands segment includes branded medicines
and its Specialty Generics segment includes specialty generic
drugs, active pharmaceutical ingredients and external
manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a
channel of distribution of important company information, such as
press releases, investor presentations and other financial
information. It also uses its website to expedite public access to
time-critical information regarding the company in advance of or in
lieu of distributing a press release or a filing with the U.S.
Securities and Exchange Commission disclosing the same information.
Therefore, investors should look to the Investor Relations page of
the website for important and time-critical information. Visitors
to the website can also register to receive automatic e-mail and
other notifications alerting them when new information is made
available on the Investor Relations page of the website.
Cautionary Statements Related to Forward-Looking
Statements
Statements in this document that are not
strictly historical, including statements regarding future
financial condition and operating results, economic, business,
competitive and/or regulatory factors affecting Mallinckrodt's 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 operates; the
commercial success of Mallinckrodt's
products; Mallinckrodt's ability to
realize anticipated growth, synergies and cost savings from
acquisitions; conditions that could necessitate an evaluation of
Mallinckrodt's goodwill and/or
intangible assets for possible impairment; changes in laws and
regulations; Mallinckrodt's ability to
successfully integrate acquisitions of operations, technology,
products and businesses generally and to realize anticipated
growth, synergies and cost savings; Mallinckrodt's ability to successfully develop or
commercialize new products; Mallinckrodt's ability to protect intellectual
property rights; Mallinckrodt's ability
to receive procurement and production quotas granted by the U.S.
Drug Enforcement Administration; customer concentration;
Mallinckrodt's reliance on certain
individual products that are material to its financial performance;
cost containment efforts of customers, purchasing groups,
third-party payers and governmental organizations; the
reimbursement practices of a small number of public or private
insurers; pricing pressure on certain of Mallinckrodt's products due to legal changes or
changes in insurers' reimbursement practices resulting from recent
increased public scrutiny of healthcare and pharmaceutical costs;
limited clinical trial data for H.P. Acthar Gel; complex reporting
and payment obligations under healthcare rebate programs;
Mallinckrodt's ability to navigate
price fluctuations; future changes to U.S. and foreign tax laws;
Mallinckrodt's ability to achieve
expected benefits from restructuring activities; complex
manufacturing processes; competition; product liability losses and
other litigation liability; ongoing governmental investigations;
material health, safety and environmental liabilities; retention of
key personnel; conducting business internationally; the
effectiveness of information technology infrastructure; and
cybersecurity and data leakage risks.
These and other factors are identified and described in more
detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for the
fiscal year ended September 30, 2016.
The forward-looking statements made herein speak only as of the
date hereof and Mallinckrodt does not
assume 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
Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
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SOURCE Mallinckrodt plc