LEXINGTON, Massachusetts,
March 25, 2013 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that it will
acquire SARcode Bioscience Inc., a privately held biopharmaceutical
company based in Brisbane,
California. This acquisition continues to build Shire's
presence in the ophthalmology therapeutic category and brings a new
phase 3 compound - LIFITEGRAST - currently under development for
the signs and symptoms of dry eye disease, into Shire's portfolio.
Shire anticipates launching LIFITEGRAST in the United States as early as 2016 pending a
positive outcome of the phase 3 clinical development program and
regulatory approvals. Shire is acquiring the global rights to
LIFITEGRAST and will evaluate an appropriate regulatory filing
strategy for markets outside of the
United States.
Some 25 million people in the United
States suffer from dry eye disease, and, of the approximate
9 million patients who are candidates for prescription drug
treatment, approximately 10% are treated with the only currently
approved prescription product for dry eye disease, indicated to
help increase the eyes' natural ability to produce tears, which may
be suppressed by inflammation due to chronic dry eye.
However, there is no approved treatment indication which
includes symptoms of dry eye (one of the most common complaints to
eye care specialists).
"The acquisition of SARcode is a demonstration of Shire's focus
on continuing to build our research and development pipeline with
innovative, well-differentiated assets that address significant
unmet patient need," said Flemming Ornskov, M.D., Shire's CEO
Designate. "This acquisition and our recent acquisition of
Premacure have the potential to provide the basis for an attractive
ophthalmology business for our company, given the significant
growth opportunities in this therapeutic area as well as Shire's
proven expertise in specialist markets."
The global ophthalmic pharmaceutical market, valued at
approximately $13 billion in 2012
with a compound annual growth rate of 4.5 percent, is consistent
with Shire's focus on the specialty market. There are approximately
42,000 office-based ophthalmologists, optometrists and retinal
specialists in the United
States.
Under the terms of agreement, Shire will make an upfront payment
of $160 million and SARcode
shareholders will be eligible to receive additional undisclosed
payments upon achievement of certain clinical, regulatory, and/or
commercial milestones. The transaction is expected to close in the
second quarter, subject to regulatory approval in the United States, and other customary closing
conditions.
The acquisition of SARcode will introduce a new late-stage phase
3 clinical program to Shire's research and development portfolio.
Shire is currently conducting a prioritization review of its
portfolio to accommodate this new expenditure in 2013.
Barclays acted as financial advisor to Shire and Davis Polk LLP
acted as legal counsel to Shire. J.P. Morgan Securities LLC
acted as financial advisor to SARCode and Wilson Sonsini Goodrich & Roasati acted as
legal counsel to Sarcode.
LIFITEGRAST and its Clinical
Development Program
LIFITEGRAST, a small-molecule integrin antagonist, is believed
to work by reducing inflammation through binding inhibition of the
proteins lymphocyte function - associated antigen 1 (LFA-1) and
intercellular adhesion molecule-1 (ICAM-1), influencing T-cell
activation and cytokine (protein) release. The interaction between
these two proteins plays a key role in the chronic inflammation
associated with dry eye. T-cells are important components of the
immune system that help control the body's response to a foreign or
harmful substance or stimuli. LIFITEGRAST is administered via a
preservative-free topical eye solution.
Three clinical trials - OPUS-1, OPUS-2 and SONATA - currently
make up the phase 3 clinical development program for LIFITEGRAST.
OPUS-1, a safety and efficacy study, concluded in 2012. In this
study the co-primary endpoint of reducing signs of dry eye was met.
Although the co-primary endpoint of reducing symptoms was not
achieved, this study was the basis of a positive meeting with the
FDA and for the continuation of the phase 3 clinical program,
including OPUS-2, a safety and efficacy study of both signs and
symptoms of dry eye disease, which is currently ongoing. In
addition to the OPUS-2 clinical efficacy study, SONATA, a
randomized, placebo-controlled safety study is also ongoing.
Shire is excited about the potential contribution of this
product to the treatment options for patients with dry eye
disease.
About Dry Eye Disease
Dry eye disease varies in severity and etiology, and symptoms
most commonly manifest as ocular discomfort, eye dryness, and tear
film instability due to decreased quality or quantity of tears. A
major contributing factor towards the development of dry eye is
inflammation caused by T-cell infiltration, proliferation and
inflammatory cytokine production that can lead to reduction in tear
film quality and ocular surface damage.
Some 25 million people are affected in the United States. This number is expected to
grow substantially in the next decade due to an aging population, a
contributor to higher rates of dry eye disease.
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, +44-1256-894157
Media:
Jessica Mann (Corporate),
jmann@shire.com, +44-1256-894-280
SOURCE Shire plc
