Shire plc : New Formulation of ONCASPAR® (pegaspargase) Receives Positive CHMP Opinion in Europe for Patients with Acute Lymphoblastic Leukemia (ALL)
(Thomson Reuters ONE) -
New Formulation of ONCASPAR(® )(pegaspargase) Receives Positive CHMP Opinion in
Europe for Patients with Acute Lymphoblastic Leukemia (ALL)
If approved, lyophilized formulation would offer three times longer shelf life
vs. liquid ONCASPAR, enabling better supply management and improved product
availability
Zug, Switzerland - October 13, 2017 - Shire plc (LSE: SHP, NASDAQ: SHPG), the
global leader in rare diseases, today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted
a positive opinion recommending the 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. Lyophilized ONCASPAR is a freeze-dried formulation of
ONCASPAR. The liquid form of ONCASPAR is currently approved for the same
indication in ALL, and is part of the pediatric standard therapy in ALL in many
European countries.[1] The CHMP's positive opinion will be submitted to the
European Commission (EC), which is responsible for granting marketing
authorizations for medicines in the EU.
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.[2] ALL can be curable within certain pediatric patient
populations, with a 5-year survival rate of more than 90% in children treated
with regimens including ONCASPAR.[3][4][5]
"Lyophilized ONCASPAR builds on more than a decade of data and research with
liquid ONCASPAR, and with no change in dosing regimen, it offers a three-times
longer shelf life," said Howard B. Mayer, M.D., SVP and ad-interim Head, Global
Research and Development, Shire. "Prolonging shelf life to 24 months for this
critically-important therapy facilitates management of product inventory by
enabling greater flexibility and longer-term planning. Once approved, with the
extended shelf life of lyophilized ONCASPAR, we also hope to improve access to
the medicine for ALL patients in countries currently not offering liquid
ONCASPAR."
Lyophilized ONCASPAR works the same way as the liquid formulation by rapidly
depleting serum L-asparagine levels and interfering with protein synthesis,
thereby depriving lymphoblasts of asparaginase and resulting in cell death. That
is why asparaginase is a critical component of the treatment regimen for ALL
patients as it is a proven approach to inducing leukemic cell
death.4[6][7][8][9][10][11]
About Lyophilized ONCASPAR
Lyophilized ONCASPAR builds on more than a decade of data and research with
liquid ONCASPAR, a pegylated asparaginase. The positive opinion is based on
analytical and nonclinical studies, which demonstrate that the lyophilized
formulation of ONCASPAR is comparable to the liquid formulation. Once
reconstituted, lyophilized ONCASPAR demonstrates similar pharmacokinetic
(PK)/pharmacodynamics (PD) to liquid ONCASPAR.(1) The new lyophilized
formulation offers no change in dosing regimen but a longer shelf life that is
three times that of the liquid formation.(1)
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.
ONCASPAR can be given by intramuscular injection or intravenous infusion. For
smaller volumes of ONCASPAR, the preferred route of administration is
intramuscular. When ONCASPAR is given by intramuscular injection the volume
injected at one site should not exceed 2 ml in children and adolescents and 3 ml
in adults. If higher volume is given, the dose should be divided and given at
several injection sites. Intravenous infusion of ONCASPAR is usually given over
a period of 1 to 2 hours in 100 ml sodium chloride 9 mg/ml (0.9%) solution for
injection or 5% glucose solution. The diluted solution of ONCASPAR can be given
together with an already-running infusion of either sodium chloride 9 mg/ml or
5% glucose. Do not infuse other medicinal products through the same intravenous
line during administration of ONCASPAR.
Safety Information
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 haemorrhagic 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. Appropriate monitoring should be performed for liver
impairment, blood and urine glucose levels as well as serum amylase for early
signs of inflammation of the pancreas.
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, vomiting, stomatitis,
hypersensitivity, urticaria, anaphylactic reaction, weight decreased, decreased
appetite, and rash.
Common adverse reactions include: febrile neutropenia, anemia, coagulopathy,
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, posterior reversible
leukoencephalopathy syndrome, hypoxia, and thrombosis.1
For Further Information, Please Contact
Investor Relations
Ian Karp ikarp(at)shire.com +1 781 482 9018
Robert Coates rcoates(at)shire.com +44 1256 894874
Media
Annabel Cowper annabel.cowper(at)shire.com +41 44 878 6638
Gwen Fisher gfisher(at)shire.com +1 781 482 9649
NOTES TO EDITOR
About Shire
Shire is the leading global biotechnology company focused on serving people with
rare diseases. We strive to develop best-in-class products, many of which are
available in more than 100 countries, across core therapeutic areas including
Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders,
Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and
a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and
deliver breakthrough therapies for the hundreds of millions of people in the
world affected by rare diseases and other high-need conditions, and who lack
effective therapies to live their lives to the fullest.
www.shire.com
Forward-Looking Statements
Statements included herein that are not historical facts, including without
limitation statements concerning future strategy, plans, objectives,
expectations and intentions, the anticipated timing of clinical trials and
approvals for, and the commercial potential of, inline or pipeline products, are
forward-looking statements. Such forward-looking statements involve a number of
risks and uncertainties and are subject to change at any time. In the event such
risks or uncertainties materialize, Shire's results could be materially
adversely affected. The risks and uncertainties include, but are not limited to,
the following:
* Shire's products may not be a commercial success;
* increased pricing pressures and limits on patient access as a result of
governmental regulations and market developments may affect Shire's future
revenues, financial condition and results of operations;
* Shire conducts its own manufacturing operations for certain of its products
and is reliant on third party contract manufacturers to manufacture other
products and to provide goods and services. Some of Shire's products or
ingredients are only available from a single approved source for
manufacture. Any disruption to the supply chain for any of Shire's products
may result in Shire being unable to continue marketing or developing a
product or may result in Shire being unable to do so on a commercially
viable basis for some period of time;
* the manufacture of Shire's products is subject to extensive oversight by
various regulatory agencies. Regulatory approvals or interventions
associated with changes to manufacturing sites, ingredients or manufacturing
processes could lead to, among other things, significant delays, an increase
in operating costs, lost product sales, an interruption of research
activities or the delay of new product launches;
* certain of Shire's therapies involve lengthy and complex processes, which
may prevent Shire from timely responding to market forces and effectively
managing its production capacity;
* Shire has a portfolio of products in various stages of research and
development. The successful development of these products is highly
uncertain and requires significant expenditures and time, and there is no
guarantee that these products will receive regulatory approval;
* the actions of certain customers could affect Shire's ability to sell or
market products profitably. Fluctuations in buying or distribution patterns
by such customers can adversely affect Shire's revenues, financial
conditions or results of operations;
* Shire's products and product candidates face substantial competition in the
product markets in which it operates, including competition from generics;
* adverse outcomes in legal matters, tax audits and other disputes, including
Shire's ability to enforce and defend patents and other intellectual
property rights required for its business, could have a material adverse
effect on the Company's revenues, financial condition or results of
operations;
* inability to successfully compete for highly qualified personnel from other
companies and organizations;
* failure to achieve the strategic objectives, including expected operating
efficiencies, cost savings, revenue enhancements, synergies or other
benefits at the time anticipated or at all with respect to Shire's
acquisitions, including NPS Pharmaceuticals Inc., Dyax Corp. or Baxalta
Incorporated may adversely affect Shire's financial condition and results of
operations;
* Shire's growth strategy depends in part upon its ability to expand its
product portfolio through external collaborations, which, if unsuccessful,
may adversely affect the development and sale of its products;
* a slowdown of global economic growth, or economic instability of countries
in which Shire does business, as well as changes in foreign currency
exchange rates and interest rates, that adversely impact the availability
and cost of credit and customer purchasing and payment patterns, including
the collectability of customer accounts receivable;
* failure of a marketed product to work effectively or if such a product is
the cause of adverse side effects could result in damage to Shire's
reputation, the withdrawal of the product and legal action against Shire;
* investigations or enforcement action by regulatory authorities or law
enforcement agencies relating to Shire's activities in the highly regulated
markets in which it operates may result in significant legal costs and the
payment of substantial compensation or fines;
* Shire is dependent on information technology and its systems and
infrastructure face certain risks, including from service disruptions, the
loss of sensitive or confidential information, cyber-attacks and other
security breaches or data leakages that could have a material adverse effect
on Shire's revenues, financial condition or results of operations;
* 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 qualified in their entirety by this cautionary statement.
Readers are cautioned not to place undue reliance on these forward-looking
statements that speak only as of the date hereof. Except to the extent otherwise
required by applicable law, we do not undertake any obligation to update or
revise forward-looking statements, whether as a result of new information,
future events or otherwise.
--------------------------------------------------------------------------------
[1] Lyophilized Oncaspar SMPC reference
[2] American Cancer Society. https://www.cancer.org/cancer/leukemia-in-
children/about/what-is-childhood-leukemia.html
[3] American Cancer Society.
http://www.cancer.org/cancer/leukemiainchildren/detailedguide/childhood-
leukemia-survival-rates
[4] Angiolillo AL, Schore RJ, Devidas M, et. al. Pharmacokinetic and
pharmacodynamic properties of calaspargase pegol Escherichia coli L-asparaginase
in the treatment of patients with acute lymphoblastic leukemia: results from
Children's Oncology Group Study AALL07P4. J Clin Oncol. 2014 Dec
1;32(34):3874-82. doi: 10.1200/JCO.2014.55.5763. Epub 2014 Oct 27.
[5] Place AE, et al. Lancet Oncol 2015; 16: 1677-1690 + appendix.
[6] Oncaspar (pegaspargase) Summary of Product Characteristics. (SmPC) EU
1/2016.
[7] Wilson GJ, et al. Am J Physiol Endocrinol Metab 2013; 305: E1124-1133.
[8] Story MD, et al. Cancer Chemother Pharmacol 1993; 32: 129-133.
[9] Avramis VA and Panosyan EH, Clin Pharmacokinet 2005; 44: 367-393.
[10] Schwarz JH, et al. Biochemistry 1966; 56: 1516-1519.
[11] Graham ML, Adv Drug Deliv Rev 2003; 55: 1293-302.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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
Datum: 13.10.2017 - 08:04 Uhr
Sprache: Deutsch
News-ID 563579
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