YASTEST
New Formulation of
ONCASPAR®
(pegaspargase) Receives Marketing Authorization in Europe for
Patients with Acute Lymphoblastic Leukemia (ALL)
Freeze-dried, or lyophilized, formulation aims to improve
supply management
by providing the same dosing regimen as liquid ONCASPAR,
but with a three-times longer shelf life of up to 24
months[1]
Zug, Switzerland - December
13, 2017 - Shire plc (LSE: SHP,
NASDAQ: SHPG), the global leader in rare diseases, today announced
that the European Commission (EC) granted Marketing Authorization
for lyophilized ONCASPAR (pegaspargase), as a component of
antineoplastic combination therapy in acute lymphoblastic leukemia
(ALL) in pediatric patients from birth to 18 years, and in adult
patients.[1] The
approval - which authorizes Shire to market lyophilized ONCASPAR in
the 28 member states of the European Union (EU), as well as
Iceland, Liechtenstein and Norway - follows a positive opinion
adopted by the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) on October 12.
"This approval underscores Shire's commitment to
patients with acute lymphoblastic leukemia through continued
research and evolution of asparaginase therapy," said Howard B.
Mayer, M.D., SVP and ad-interim Head, Global Research and
Development, Shire. "With this lyophilized formulation, we aim to
make pegylated asparaginase, part of the pediatric standard therapy
in acute lymphoblastic leukemia, available to patients in countries
where liquid ONCASPAR is not currently offered. Additionally, with
extended shelf life up to 24 months, treatment centers will have
flexibility in inventory management to help ensure continuous
treatment supply for patients."
Lyophilized ONCASPAR builds on more than a decade
of data and research with liquid ONCASPAR, a pegylated
asparaginase, and works the same way as the liquid formulation. By
depleting serum L-asparagine levels and thereby interfering with
protein synthesis, ONCASPAR deprives lymphoblasts of L-asparagine,
resulting in cell death.[2],[3],[4]
The new lyophilized formulation offers the same
dosing regimen as liquid ONCASPAR, but with a three-times longer
shelf life than the liquid formulation.[1]
Asparaginase is a critical component of the treatment regimen for
ALL patients as it is a proven approach to inducing leukemic cell
death.[2],[3],[4]
Shire expects lyophilized ONCASPAR to be available
in European markets beginning in the first half of 2018.
About Acute Lymphoblastic
Leukemia
Acute lymphoblastic leukemia (ALL) is a cancer of the white blood
cells and is characterized by an overproduction and accumulation of
lymphoblasts, immature white blood cells. ALL is the most common
type (~75%) of cancer among children diagnosed with
leukemia.[5] ALL can be
curable within certain pediatric patient populations, with a
five-year overall survival rate of 96% in children treated with
regimens including ONCASPAR.[6]
About ONCASPAR
In Europe, ONCASPAR is indicated as a component of antineoplastic
combination therapy in acute lymphoblastic leukemia (ALL) in
pediatric patients from birth to 18 years, and adult
patients.[1]
Safety Information in
Europe
ONCASPAR is contraindicated in patients with hypersensitivity to
the active substance or to any of the excipients, in patients with
severe hepatic impairment, and in patients with a history of
serious thrombosis, pancreatitis, or serious hemorrhagic events
with prior L-asparaginase therapy.
Anaphylaxis or serious allergic reactions can
occur; therefore, patients should be observed for 1 hour after
administration having resuscitation equipment ready. Discontinue
ONCASPAR in patients with serious allergic reactions. There have
been reports of adverse reactions of pancreatitis. If pancreatitis
is suspected ONCASPAR should be discontinued. ONCASPAR should also
be discontinued in patients with serious thrombotic events.
Combination therapy with ONCASPAR can result in
hepatic toxicity and central nervous system toxicity. In the
presence of symptoms of hyperammonemia (e.g. nausea, vomiting,
lethargy, irritation), ammonia levels should be monitored
closely.
Very common adverse reactions reported in clinical
trial data and the post-marketing experience of ONCASPAR in ALL
patients include: hyperglycemia, pancreatitis, diarrhea, abdominal
pain, nausea; hypersensitivity, urticaria, anaphylactic reactions;
weight decreased; decreased appetite; rash.
Common adverse reactions include: febrile
neutropenia, anemia, thrombosis; vomiting, stomatitis;
hepatotoxicity, fatty liver; infections, sepsis; amylase increased,
alanine aminotransferase increased, blood bilirubin increased,
blood albumin decreased, neutrophil count decreased, platelet count
decreased, activated partial thromboplastin time prolonged,
prothrombin time prolonged, hypofibrinogenemia;
hypertriglyceridemia, hyperlipidemia, hypercholesterolemia; pain in
extremities; seizure, peripheral motor neuropathy, syncope;
hypoxia; thrombosis.[1]
For further information please
contact:
Investor Relations |
|
|
Ian Karp |
ikarp@shire.com |
+1 781
482 9018 |
Robert Coates |
rcoates@shire.com |
+44 203
549 0874 |
Media |
|
|
Gwen Fisher |
gfisher@shire.com |
+1 781
482 9649 |
Annabel Cowper |
annabel.cowper@shire.com |
+41 44
878 6638 |
NOTES TO EDITORS
About Shire
Shire is the global leader in serving patients
with rare diseases. We strive to develop best-in-class therapies
across a core of rare disease areas including hematology,
immunology, genetic diseases, neuroscience, and internal medicine
with growing therapeutic areas in ophthalmics and oncology. Our
diversified capabilities enable us to reach patients in more than
100 countries who are struggling to live their lives to the
fullest.
We feel a strong sense of urgency to address unmet
medical needs and work tirelessly to improve people's lives with
medicines that have a meaningful impact on patients and all who
support them on their journey.
www.shire.com
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the actions of certain customers could affect
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Shire's products and product candidates face
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adverse outcomes in legal matters, tax audits
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inability to successfully compete for highly
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failure to achieve the strategic objectives,
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Shire incurred substantial additional
indebtedness to finance the Baxalta acquisition, which has
increased its borrowing costs may decrease its business
flexibility; and
a further list and description of risks,
uncertainties and other matters can be found in Shire's most recent
Annual Report on Form 10-K and in Shire's subsequent Quarterly
Reports on Form 10-Q, in each case including those risks outlined
in "ITEM 1A: Risk Factors", and in Shire's subsequent reports on
Form 8-K and other Securities and Exchange Commission filings, all
of which are available on Shire's website.
All forward-looking statements
attributable to us or any person acting on our behalf are expressly
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are cautioned not to place undue reliance on these forward-looking
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otherwise.
[1] Lyophilized
Oncaspar Summary of Product Characteristics. European Medicines
Agency.
[2] Oncaspar
(pegaspargase) Summary of Product Characteristics. (SmPC) EU
1/2016.
[3] Wilson GJ,
Bunpo P, Cundiff JK, et al. The eukaryotic initiation factor 2
kinase GCN2 protects against hepatotoxicity during asparaginase
treatment. Am J Physiol Endocrinol Metab.
2013;305:E1124-1133.
[4] Story MD,
Voehringer DW, Stephens LC, et al. L-Asparagainse kills lymphoma
cells by apoptosis. Cancer Chemother
Pharmacol. 1993;32:129-133.
[5] What is
Childhood Leukemia? American Cancer Society.
Available at:
https://www.cancer.org/cancer/leukemia-in-children/about/what-is-childhood-leukemia.html.
Accessed November 21, 2017.
[6] Place AE,
Stevenson KE, Vrooman LM, et. al. Intravenous pegylated
asparaginase versus intramuscular native Escherichia coli
L-asparaginase in newly diagnosed childhood acute lymphoblastic
leukaemia (DFCI 05-001): a randomised, open-label phase 3 trial.
Lancet Oncol. 2015;16:1677-90.
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
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The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Shire plc via Globenewswire
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