LEXINGTON, Massachusetts,
January 19, 2017 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food
and Drug Administration (FDA) has acknowledged receipt of the Class
2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed
amphetamine salts formulation. SHP465
is being evaluated as a potential once-daily treatment for
Attention-Deficit/Hyperactivity Disorder (ADHD). The FDA is
expected to provide a decision on or around June 20, 2017, the designated Prescription Drug
User Fee Act (PDUFA) action date. Shire resubmitted the NDA for
SHP465 in response to the Approvable
Letter from the FDA (May 18, 2007)
that requested additional clinical studies and classified the
response as a Class 2 resubmission with a review goal of six
months.
"Our progress with the SHP465
clinical development program underscores Shire's commitment to
supporting the needs of patients living with ADHD in the U.S.,"
said Philip Vickers, PhD, Global
Head of Research and Development, Shire. "Since our first
submission, our understanding of ADHD and adult patients' needs has
evolved, and we believe the additional studies in our filing
fulfill the request from the FDA. With the potential of once-daily
dosing, SHP465, if approved, could
help patients address the ongoing challenges of ADHD symptoms."
"As the medical community broadens its understanding of ADHD and
the ways it impacts people differently, it is important to expand
the long-acting treatment options available to health care
professionals to address patient needs," said Andrew J. Cutler, MD, Executive Vice President
and Chief Medical Officer at Meridien Research and an investigator
in the SHP465 clinical trials. "It's
encouraging to see that health care professionals and their
patients living with ADHD may have more options available to
them."
The NDA for SHP465 includes data
from a database of 16 clinical studies evaluating SHP465 in more than 1,600 subjects, including
data resulting from a U.S. FDA request to conduct a short-term
efficacy and safety study in pediatric patients with ADHD (aged
6-17). Positive top-line results from that study, SHP465-305, were reported in April 2016. The NDA also includes results from
SHP465-306, a short-term efficacy
study in adults, for which positive top-line results were announced
in June 2016.
In earlier adolescent and adult clinical studies, SHP465 demonstrated a statistically significant
difference versus placebo at 16 hours post-dosing, with onset of
action starting 2 or 4 hours post-dosing, as measured by the
Permanent Product Measure of Performance (PERMP). PERMP is an
objective, validated, skill-adjusted math test that measures
attention in ADHD. The most common adverse reactions in Phase 3
studies (incidence ≥5% and at a rate at least twice placebo) in
children, adolescents, and/or adults with ADHD were insomnia,
decreased appetite, dry mouth, decreased weight, increased heart
rate, anxiety, nausea, upper abdominal pain, irritability and
dizziness.
Protection for Shire's ADHD Franchise Extends
to 2029
There are patents supporting Shire's overall ADHD franchise in
the U.S. that extend to 2029. If approved, Shire expects that
SHP465 will have three years of
Hatch-Waxman exclusivity and at least three patents listed in the
FDA Orange Book expiring as late as May
2029. Launch is planned for the second half of 2017.
About ADHD
Attention-Deficit/Hyperactivity Disorder is a neurodevelopmental
disorder that manifests as a persistent pattern of inattention
and/or hyperactivity-impulsivity that interferes with functioning
or development and is inconsistent with developmental level.
An estimated 4.4 percent of adults have ADHD in the U.S. When
applied to the full U.S. adult population aged 18 and over,
approximately 10.5 million adults are estimated to have ADHD in the
U.S.
The specific etiology of ADHD is unknown. The diagnosis is made
utilizing criteria specified in the Diagnostic and Statistical
Manual of Mental Disorders, Fifth Edition,
(DSM-5®) or International
Classification of Diseases, 10th revision (ICD-10). Only
a trained health care professional can evaluate and diagnose
ADHD.
Although there is no cure for ADHD, there are accepted
treatments that have been demonstrated to improve symptoms.
Standard treatments include educational approaches, psychological
therapies which may include behavioral modification and/or
medication. Ongoing assessment and treatment may be necessary.
DSM-5® is a registered trademark of the
American Psychiatric Association.
NOTES TO EDITORS
About Shire
Shire is the leading global biotechnology company focused on
serving people with rare diseases and other highly specialized
conditions. 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.
http://www.shire.com
For further information please contact:
Investor Relations
Ian Karp
ikarp@shire.com
+1-781-482-9018
Robert Coates
rcoates@shire.com
+44-1256-894874
Media
Gwen Fisher
gfisher@shire.com
+1-781-482-9649
Clotilde Houzé
chouze0@shire.com
+1-781-266-3567
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
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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
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oversight by various regulatory agencies. Regulatory
approvals or interventions associated with 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;
- 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 combined 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 with respect to
Shire's acquisition of NPS Pharmaceuticals, Inc., Dyax Corp.
("Dyax") or Baxalta Inc. ("Baxalta") 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 the 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 may decrease its business
flexibility and increase borrowing costs;
- 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 filings with the Securities and Exchange Commission,
including those risks outlined in "ITEM 1A: Risk Factors" in
Shire's Quarterly Report on Form 10-Q for the quarter ended
June 30, 2016.
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.