LEXINGTON, Massachusetts,
February 19, 2013 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG), announces that the Lysosomal
Disease Network (LDN) presented Shire Human Genetic Therapies (HGT)
with the first ever Novel Treatment Award for VPRIV on February 14th, at its 9th Annual WORLD
Symposium. The LDN have launched this new award, which will be
presented annually, to recognize new drugs or therapies that have
made a considerable contribution in the area of lysosomal
diseases.
"Shire has demonstrated its commitment to developing new
therapies for the treatment of rare genetic diseases. We wanted to
recognize the contribution of VPRIV for the treatment of type 1
Gaucher disease by awarding Shire the first ever Novel Treatment
Award," said Chester Whitley,
University of Minnesota and Principal
Investigator, LDN. "As new treatments are developed, we want to be
sure that these huge efforts and accomplishments are recognized in
the hope of inspiring other young investigators and corporate
developers. We hope that this award is a way of demonstrating
this."
VPRIV is an enzyme replacement therapy (ERT) used for the
long-term treatment of patients with type 1 Gaucher disease. The
safety and efficacy of VPRIV was assessed in more than 100 patients
at 24 sites in 10 countries, representing the largest and most
comprehensive clinical data set to support registration for an ERT
for type 1 Gaucher disease. VPRIV is manufactured using a human
cell line with Shire's proprietary gene activation technology.
"As a leader in rare diseases, Shire is honored to be recognized
by LDN with its first Novel Treatment Award," said Dr. Philip J. Vickers, Global Head of Research and
Development, Shire HGT. "This award embodies the spirit of our
organization - every employee at Shire is dedicated to developing
and bringing forward new products, services and support offerings
which can make a positive impact on patients' lives. Shire is proud
to provide Gaucher patients with an effective treatment option and
continues to build upon a solid foundation, established by our
lysosomal enzyme replacement therapies, to further support rare
disease patients around the world."
As part of its ongoing commitment in type 1 Gaucher disease,
Shire continues to invest in further evaluating the safety and
efficacy of VPRIV through the generation of long-term clinical
trial data, additional pediatric data, as well as the long-term
observational data collected through the Gaucher Outcomes Survey.
About VPRIV (velaglucerase alfa)
VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme
indicated for long-term enzyme replacement therapy (ERT) for
pediatric and adult patients with type 1 Gaucher disease.
VPRIV has the exact human amino acid sequence as that found in
the naturally occurring human enzyme.
From September 2009, patients were
able to receive VPRIV via expanded access mechanisms. In parallel,
Shire worked in cooperation with regulatory agencies to expedite
the new drug application submissions and with priority reviews,
marketing authorization of VPRIV was granted by the US FDA on
26 February 2010, 18 months ahead of
anticipated timelines, and by the European Commission on
20 August 2010.
VPRIV is approved in 40 countries globally, including the US,
the European Union member states, and Israel, and is for patients previously treated
for type 1 Gaucher disease or those who are treatment-naive.
VPRIV Important Safety Information
The most serious adverse reactions seen with VPRIV were
hypersensitivity reactions. Infusion-related reactions were the
most commonly observed adverse reactions in patients treated with
VPRIV in clinical studies. The most commonly observed symptoms of
infusion-related reactions were: headache, dizziness, low or high
blood pressure, nausea, tiredness and weakness, and fever.
Generally the infusion-related reactions were mild and, in
treatment-naïve patients, onset occurred mostly during the first 6
months of treatment and tended to occur less frequently with
time.
All adult side effects of VPRIV are considered relevant to
children (ages 4 to 17 years). Side effects more commonly seen in
children compared with adult patients included: upper respiratory
tract infection, rash, aPTT prolonged, and fever. The safety of
VPRIV has not been established in patients younger than 4 years of
age.
VPRIV is not available in all countries and prescribing
information may differ between countries. Please consult your local
prescribing information. Full prescribing information for VPRIV in
the U.S. can be found at http://www.VPRIV.com.
NOTES TO EDITORS
Shire enables people with
life-altering conditions to lead better lives.
Through our deep understanding of patients' needs, we develop
and provide healthcare in the areas of:
- Behavioral Health and Gastro Intestinal conditions
- Rare Diseases
- Regenerative Medicine
as well as other symptomatic conditions treated by specialist
physicians.
We aspire to imagine and lead the future of healthcare, creating
value for patients, physicians, policymakers, payors and our
shareholders.
http://www.shire.com
FORWARD - LOOKING STATEMENTS - "SAFE
HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
Statements included in this announcement that are not historical
facts are forward-looking statements. 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, that:
- Shire's products may not be a commercial success;
- revenues from ADDERALL XR are subject to generic erosion;
- the failure to obtain and maintain reimbursement, or an
adequate level of reimbursement, by third-party payors in a timely
manner for Shire's products may impact future revenues and
earnings;
- Shire relies on a single source for manufacture of certain of
its products and a disruption to the supply chain for those
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;
- Shire uses third party manufacturers to manufacture many of its
products and is reliant upon third party contractors for certain
goods and services, and any inability of these third party
manufacturers to manufacture products, or any failure of these
third party contractors to provide these goods and services, in
each case in accordance with its respective contractual
obligations, could adversely affect Shire's ability to manage its
manufacturing processes or to operate its business;
- the development, approval and manufacturing of Shire's products
is subject to extensive oversight by various regulatory agencies
and regulatory approvals or interventions associated with changes
to manufacturing sites, ingredients or manufacturing processes
could lead to significant delays, increase in operating costs, lost
product sales, an interruption of research activities or the delay
of new product launches;
- the actions of certain customers could affect Shire 's ability
to sell or market products profitably and fluctuations in buying or
distribution patterns by such customers could adversely impact
Shire's revenues, financial conditions or results of
operations;
- 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 the
distraction of senior management, significant legal costs and the
payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including
Shire's ability to obtain, maintain, enforce and defend patents and
other intellectual property rights required for its business, could
have a material adverse effect on Shire's revenues, financial
condition or results of operations;
and other risks and uncertainties detailed from time to time in
Shire's filings with the U.S. Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K.
For further information please
contact:
Jessica Mann (Corporate)
jmann@shire.com
+44-1256-894-280
Jessica Cotrone (Human Genetic
Therapies)
jcotrone@shire.com
+1-781-482-9538
SOURCE Shire plc