Shire Partner, Shionogi, Submits New Drug Application in Japan for ADHD Treatment for Children
Geschrieben am 10-02-2016
Lexington, Massachusetts (ots/PRNewswire) -
This press release is intended for U.S. and EU audiences only.
A separate press release has been prepared for use in Japan.
With submission, Shire continues to strengthen its presence in
Shire plc (LSE: SHP, NASDAQ: SHPG) and Shionogi & Co., Ltd.
recently announced that Shionogi submitted a New Drug Application
(NDA) for the manufacturing and marketing in Japan of S-877503
(guanfacine hydrochloride prolonged release tablets),* for the
treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in
children. The Japanese clinical studies were conducted in children 6
to 12 years old with this disorder.
Shire and Shionogi, under a co-development and commercialization
licensing contract signed in 2011, have been developing S-877503 as
an investigational pediatric ADHD candidate. Shionogi is a
Japan-based pharmaceutical company focused on the research and
development of treatments for various therapeutic areas, including
central nervous system disorders and infectious diseases.
"This NDA is significant for patients, Shire and Shionogi. If
approved, Shire will have another key product available in Japan,
increasing patient access to more of our medicines in a market
incredibly important on the world's stage," said Philip J. Vickers,
Ph.D., Head of Research & Development, Shire. "Fortunately, we have a
strong partner for our ADHD development and commercialization efforts
in Shionogi, who has been central to our growth in Japan. Shire has a
number of pipeline products, in addition to S-877503, intended for
Japan, so we're excited about the possibilities for addressing more
unmet patient needs in this country."
Shire Japan KK, Shire's local operating company (LOC), also has
investigational candidates in the pipeline for hereditary angioedema,
short-bowel syndrome, convulsive seizures and hypoparathyroidism. The
LOC offers two therapies of its own on the Japanese market - one for
Gaucher disease and the other for thrombocythemia - and partners with
several other companies to develop new products for the Japanese
New therapeutic options for ADHD are needed in Japan. Multiple
medicines for the disorder are approved and sold in the United States
and Europe. However, only two ADHD medicines have been approved in
Japan, where the anticipated regulatory review process for an NDA is
approximately 12 months.
The mode of action of S-877503 in ADHD is not fully established.
Preclinical research suggests S-877503 modulates signalling in the
prefrontal cortex and basal ganglia through direct modification of
synaptic noradrenalin transmission at the alpha2A-adrenergic
receptors. This proposed mode of action is different than the other
ADHD medicines currently available in Japan.
Guanfacine hydrochloride prolonged release tablets are marketed in
the United States, EU and Canada. For more information on the product
labelling in these markets, refer to the U.S. Prescribing
Information, EU Summary of Product Characteristics (SmPC) and
Canadian Product Monograph, respectively. In the United States,
generic versions of guanfacine hydrochloride prolonged release
tablets (or INTUNIV) are available for the treatment of ADHD.
*. U.S. and EU brand name: INTUNIV® (guanfacine extended-release
tablets in U.S.; guanfacine hydrochloride prolonged release tablets
in EU). Canadian brand name: INTUNIV XR® (guanfacine hydrochloride
About ADHD in children and adolescents
ADHD is a common psychiatric disorder in children and adolescents
and is recognized by the World Health Organization (WHO). The core
symptoms are inattention, hyperactivity and impulsivity. Worldwide,
prevalence of ADHD is estimated to be between 5.29% and 7.1%, and
just under 5% for children and adolescents (<18 years). While the
exact origin of ADHD is unknown, it is recognized that the disorder
may be caused by the interplay between genetic and environmental
About Shionogi & Co., Ltd.
Shionogi & Co., Ltd. is a major research-driven pharmaceutical
company dedicated to placing the highest value on patients based on
its corporate philosophy of "supply the best possible medicine to
protect the health and wellbeing of the patients we serve."
Shionogi's research and development currently targets two therapeutic
areas: infectious diseases and pain/CNS disorders. In addition,
Shionogi is engaged in new research areas such as obesity/geriatric
metabolic disease and oncology/immunology. Contributing to the health
and QOL of patients around the world through development in these
therapeutic areas is Shionogi's primary goal.
For more information, please visit http://www.shionogi.co.jp/en/.
Important Safety Information for United States and EU
- INTUNIV is contraindicated in patients with a history of a
hypersensitivity reaction to INTUNIV or its inactive ingredients.
Rash and pruritus have been reported.
- Treatment with INTUNIV can cause dose-dependent decreases in blood
pressure and heart rate. Orthostatic hypotension and syncope have
been reported. Measure heart rate and blood pressure prior to
initiation of therapy, following dose increases, and periodically
while on therapy. In patients with a history of syncope or a
condition that predisposes them to syncope, advise against becoming
dehydrated or overheated.
- Somnolence and sedation were commonly reported adverse reactions in
clinical studies. Caution patients against operating heavy
equipment or driving until they know how they respond to INTUNIV.
Advise patients to avoid use with alcohol.
- Cardiac Conduction Abnormalities: May worsen sinus node dysfunction
and atrioventricular (AV) block, especially in patients taking
other sympatholytic drugs.
- Side effects - very common (frequency >= 1/10): Somnolence,
headache, abdominal pain and fatigue. Please consult the U.S.
Prescribing Information or the EU SPC for additional information on
Please click here for the INTUNIV U.S. Prescribing Information
(http://pi.shirecontent.com/pi/pdfs/intuniv_usa_eng.pdf) or the EU
Summary of Product Characteristics (http://www.ema.europa.eu/docs/en_
In the U.S., INTUNIV (guanfacine extended-release tablets) is
available in 1 mg, 2 mg, 3 mg and 4 mg. The same strengths are
licensed in the EU.
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better
Our strategy is to focus on developing and marketing innovative
specialty medicines to meet significant unmet patient needs.
We focus on providing treatments in Rare Diseases, Neuroscience,
Gastrointestinal and Internal Medicine and we are developing
treatments for symptomatic conditions treated by specialist
physicians in other targeted therapeutic areas, such as Ophthalmics.
For more information, please visit http://www.shire.com. Follow
Shire on Social Media: @Shireplc (https://twitter.com/shireplc),
LinkedIn (https://www.linkedin.com/company/shire) and YouTube
Statements included herein that are not historical facts,
including without limitation statements concerning our proposed
business combination with Baxalta Incorporated ("Baxalta") and the
timing and financial and strategic benefits thereof, our 20x20
ambition that targets $20 billion in combined product sales by 2020,
as well as other targets for future financial results, capital
structure, performance and sustainability of the combined company,
the combined company's 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:
- the proposed combination with Baxalta may not be completed due to a
failure to satisfy certain closing conditions, including any
shareholder or regulatory approvals or the receipt of applicable
- disruption from the proposed transaction with Baxalta may make it
more difficult to conduct business as usual or maintain
relationships with patients, physicians, employees or suppliers;
- the combined company may not achieve some or all of the anticipated
benefits of Baxalta's spin-off from Baxter International, Inc.
("Baxter") and the proposed transaction may have an adverse impact
on Baxalta's existing arrangements with Baxter, including those
related to transition, manufacturing and supply services and tax
- the failure to achieve the strategic objectives with respect to the
proposed combination with Baxalta may adversely affect the combined
company's financial condition and results of operations;
- products and product candidates may not achieve commercial success;
- product sales from ADDERALL XR and INTUNIV are subject to generic
competition in the United States; this does not apply to markets
where the product is currently not licensed (i.e., Japan);
- the failure to obtain and maintain reimbursement, or an adequate
level of reimbursement, by third-party payers in a timely manner
for the combined company's products may affect future revenues,
financial condition and results of operations, particularly if
there is pressure on pricing of products to treat rare diseases;
- supply chain or manufacturing disruptions may result in declines in
revenue for affected products and commercial traction from
competitors; regulatory actions associated with product approvals
or changes to manufacturing sites, ingredients or manufacturing
processes could lead to significant delays, an increase in
operating costs, lost product sales, an interruption of research
activities or the delay of new product launches;
- the successful development of products in various stages of
research and development 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 the combined
company's ability to sell or market products profitably, and
fluctuations in buying or distribution patterns by such customers
can adversely affect the combined company's revenues, financial
condition or results of operations;
- investigations or enforcement action by regulatory authorities or
law enforcement agencies relating to the combined company'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;
- adverse outcomes in legal matters and other disputes, including the
combined company's ability to enforce and defend patents and other
intellectual property rights required for its business, could have
a material adverse effect on the combined company's revenues,
financial condition or results of operations;
- Shire is undergoing a corporate reorganization and was the subject
of an unsuccessful acquisition proposal and the consequent
uncertainty could adversely affect the combined company's ability
to attract and/or retain the highly skilled personnel needed to
meet its strategic objectives;
- failure to achieve the strategic objectives with respect to Shire's
acquisition of NPS Pharmaceuticals Inc. or Dyax Corp. ("Dyax") may
adversely affect the combined company's financial condition and
results of operations;
- the combined company will be 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 the combined
company's revenues, financial condition or results of operations;
- the combined company may be unable to retain and hire key personnel
and/or maintain its relationships with customers, suppliers and
other business partners;
- difficulties in integrating Dyax or Baxalta into Shire may lead to
the combined company not being able to realize the expected
operating efficiencies, cost savings, revenue enhancements,
synergies or other benefits at the time anticipated or at all; and
other risks and uncertainties detailed from time to time in
Shire's, Dyax's or Baxalta's filings with the Securities and Exchange
Commission ("SEC"), including those risks outlined in Baxalta's
current Registration Statement on Form S-1, as amended, and in "Item
1A: Risk Factors" in Shire's Annual Report on Form 10-K for the year
ended December 31, 2014.
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 republish
revised forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated
ots Originaltext: Shire Pharmaceuticals Group Plc
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