LEXINGTON, Massachusetts,
March 12, 2013 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG), announces that it has
acquired Premacure AB of Uppsala, Sweden, a privately held biotechnology company
developing a protein replacement therapy, currently in Phase II
development, for the prevention of retinopathy of prematurity
(ROP). ROP is a rare and potentially blinding eye disorder that
primarily affects premature infants and is one of the most common
causes of visual loss in childhood. Currently, only symptomatic
treatment is available for ROP. Shire will purchase Premacure for
an upfront payment and certain contingent payments based on the
achievement of pre-specified development and commercial
milestones. This acquisition underscores and expands Shire's
commitment to bringing innovative therapies to patients with rare
disorders worldwide.
During normal gestation, the developing fetus is reliant on
certain growth factors from the maternal serum; full term babies
can produce these growth factors on their own. In preterm infants
(born before 31 weeks of gestation), the early separation from the
maternal circulation results in a loss of specific growth factors,
such as insulin-like growth factor 1 (IGF-1), that are believed to
result in lifelong complications, including ROP.
This acquisition allows Shire HGT to enter a new therapeutic
area - neonatology - while maintaining its focus on developing
novel therapies for the treatment of rare diseases with high unmet
medical need. With the acquisition of Premacure, Shire HGT will
continue the ongoing Phase II study, the primary goal of which is
to restore the IGF-1 levels in the preterm infant to those found
during normal in utero development.
"ROP is a devastating eye disorder that can severely impact
preterm infants for the rest of their lives," said Flemming
Ornskov, MD, CEO Designate, Shire. "This investigational protein
has the potential to provide a first-in-class treatment that may
minimize the development and impact of complications arising from
ROP. We will build on the work that Premacure has done and will
apply Shire's proven ability in developing protein replacement
therapies for rare disorders to bring this much needed therapy to
the market."
"The acquisition of Premacure by Shire further underscores the
potential to change the long-term outlook for preterm infants with
ROP and their families," said Jan
Borg, founding CEO of Premacure. "We are excited that this
program will become part of the innovative pipeline at Shire and
believe that their experience and resources may accelerate the
development of a product that seeks to prevent some of the
devastating long-term consequences of ROP."
Premacure AB is a private company launched in 2006 by
entrepreneurs and internationally recognized clinicians in the area
of neonatology.
About ROP
Retinopathy of Prematurity (ROP) is a potentially blinding eye
disorder that primarily affects premature infants weighing less
than 2 pounds (about 1kg) who are born before 31 weeks of gestation
(a full term pregnancy has a gestation of 38-42 weeks). The smaller
a baby is at birth, the more likely that baby is to develop ROP.
This disorder, which usually develops in both eyes, is one of the
most common causes of visual loss in childhood and can lead to
lifelong vision impairment and blindness.
In the US and EU, there are approximately 87,000 and 54,000
premature infants (born) born annually. Each year approximately
14,000-16,000 preterm infants in the US are affected by some degree
of ROP. In 1,100-1,500 of these infants the ROP is severe
enough to require medical treatment, and consequently 400-600
infants become legally blind.
About Insulin-Like Growth Factor 1
IGF-1 is primarily produced by the liver and supports normal
childhood growth and development. Administration of IGF-1 to
premature infants, as a substitute for the maternal and endogenous
source, allows for the establishment of a physiological level of
the hormone comparable to that present in utero. Such a treatment
is believed to promote normal development and thereby prevent the
development of complications of ROP.
Premacure initiated the clinical development of the preventative
treatment with a formulation of recombinant human IGF-1 combined
with a recombinant version of its naturally occurring binding
protein, insulin-like growth factor-1 binding protein-3
(IFGBP3).
A Phase I clinical trial was conducted and results showed that
the levels of IGF-1 were increased to within physiological levels
and that administration of the investigational protein to preterm
infants is generally well tolerated. A Phase II, safety and
efficacy multi-centre clinical trial has started in Sweden and is on-going.
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:
Investor Relations
Eric Rojas, erojas@shire.com, +1-781-482-0999
Sarah Elton-Farr, seltonfarr@shire.com, +44-1256-894-157
Media
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