LEXINGTON, Massachusetts,
August 3, 2015 /PRNewswire/ --
FST-100, if approved, would be the first
to treat both bacterial and viral eye
infections, transforming treatment
of acute conjunctivitis
Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that it has
acquired New York-based, privately
held Foresight Biotherapeutics Inc. for $300
million. With the acquisition, Shire acquires the global
rights to FST-100 (topical ophthalmic drops combining 0.6% povidone
iodine (PVP-I) and 0.1% dexamethasone), a therapy in late-stage
development for the treatment of infectious conjunctivitis, an
ocular surface condition commonly referred to as pink eye. This
acquisition further strengthens Shire's late-stage pipeline, has a
clear strategic fit with lifitegrast, which is in late-stage
development for treatment of dry eye disease, another ocular
surface condition, and further demonstrates Shire's commitment to
building a leadership position in ophthalmics.
"With the acquisition of Foresight Biotherapeutics, Shire
demonstrates its commitment to eye care while advancing its
strategy of addressing high unmet medical need through
transformative treatments for rare diseases and specialty
medicines," said Flemming Ornskov, M.D., CEO, Shire. "Ophthalmics
is a highly-attractive growth area for Shire and this acquisition
allows us to strengthen our presence in this therapeutic area. It
is highly synergistic with the planned lifitegrast commercial
structure. FST-100 and lifitegrast, if approved, would address two
of the leading reasons people seek eye care treatment."
Michael Weiser, M.D., Ph.D.,
Director, Foresight Biotherapeutics, added: "We're excited about
the potential benefits of FST-100 for patients and the physicians
who care for them. In our discussions with experts in the field,
we've heard their enthusiasm for the possibility of a treatment
that could reduce inflammation while killing virus and bacteria
without the risk of unnecessary antibiotic use. We're pleased that
Shire has committed to moving this program forward in development,
so FST-100 might become an important treatment option for patients
with either viral or bacterial conjunctivitis."
Currently no therapy exists to resolve both clinical signs and
symptoms and eradicate adenovirus, which is the most common cause
of viral conjunctivitis. Approximately 50 percent of infectious
conjunctivitis cases have a viral etiology, and 65 to 90 percent of
these are caused by adenovirus. Viral conjunctivitis is highly
infectious and transmissible, causing lost work and school days as
well as increased healthcare costs and risks from unnecessary
antibiotic prescriptions.There are 5.9 million cases of infectious
conjunctivitis annually in the United
States and approximately 5.4 million cases in the EU
annually.
If approved by regulatory agencies, FST-100 has the potential to
become the first agent to treat both viral and bacterial
conjunctivitis. This is important as it is frequently difficult to
ascertain the etiology of the condition based on clinical
presentation.
"As a researcher and clinician, I know first-hand the
significant unmet patient need for an effective treatment for
infectious conjunctivitis as well as the challenges associated with
treating this condition, so I'm excited about the potential of
FST-100," said Edward Holland, M.D.,
Director, Cornea Services at the Cincinnati Eye Institute and
Professor of Ophthalmology at the University
of Cincinnati. "I'm also pleased to know that Shire, with
its research and commercial expertise, will further develop FST-100
with the goal of bringing it to market as a treatment option for
this significant clinical problem."
Shire has acquired the global rights to FST-100 and will
evaluate an appropriate regulatory filing strategy for additional
markets outside the United States.
Under the terms of the agreement, Shire will make a cash payment of
$300 million to complete the
acquisition of Foresight Biotherapeutics.
FST-100 and Its Clinical Development
Program
The phase 2 proof-of-concept efficacy and safety clinical trial
program for FST-100 involved two studies in adenoviral
conjunctivitis - one three-arm study and another two-arm pilot
study. While the two-arm study showed a trend toward efficacy,
there were too few subjects testing positive for a viral presence
for the study to deliver meaningful results, and it was not
statistically significant. In the three-arm study, patients were
randomized to receive FST-100, PVP-I or vehicle four times daily
for five days. Patients treated with FST-100 showed a statistically
significant improvement in rates of clinical cure and viral
eradication vs. vehicle at Day 6 (30.6% vs. 6.4%, p=0.0033). In the
same trial, there was a trend toward clinical significance for
FST-100 versus PVP-I (30.6% vs.18.0%, p=0.1432). The most common
treatment emergent adverse events were corneal infiltrates (19%),
punctate keratitis (22.4%) and eyelid edema (12.1%).
The phase 2 clinical data formed the basis of a meeting with the
FDA, in which Foresight Biotherapeutics discussed the path forward
to conduct a phase 3 clinical development program for FST-100 as a
potential treatment for adenoviral conjunctivitis. Upon close of
the transaction, Shire will take responsibility for the final
development and implementation for the phase 3 clinical program for
FST-100, to also include investigation for the treatment of
bacterial conjunctivitis. Foresight Biotherapeutics conducted
pre-clinical experiments evaluating bacterial killing speed of
FST-100 against pathogens that may cause bacterial conjunctivitis,
and the resulting data support further exploration.
Shire's Commitment to Ophthalmics
In May 2014, Shire established its
Ophthalmics Business Unit, solidifying its commitment to growing in
this therapeutic area. Shire's multi-faceted approach to discovery,
development, and delivery in both rare diseases and specialty
conditions includes our efforts to address unmet needs in eye
care.
Shire's growth in ophthalmics has been driven by a combination
of strategic acquisitions and organic growth. The Company is
focused on continuing to expand the ophthalmics portfolio to
include treatment options for rare diseases and those for anterior
and posterior eye conditions. Acquisitions in the last two years
include SARcode Bioscience, Premacure AB, and BIKAM
Pharmaceuticals, which has helped bolster Shire's early-, mid- and
late-stage ophthalmics pipeline. The Company currently has an
ophthalmics pipeline of investigational products in dry eye,
retinopathy of prematurity, autosomal dominant retinitis
pigmentosa, glaucoma, and now adenoviral and bacterial
conjunctivitis. The acquisition of Foresight Biotherapeutics
positions Shire to potentially become a leader in providing
treatments for ocular surface conditions, which encompass dry eye
disease and infectious conjunctivitis.
About Shire
Shire enables people with life-altering conditions to lead
better lives.
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 are developing
treatments for symptomatic conditions treated by specialist
physicians in other targeted therapeutic areas, such as
Ophthalmics.
http://www.shire.com
THE "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. 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, that:
- Shire's products may not be a commercial success;
- product sales from ADDERALL XR and INTUNIV are subject to
generic competition;
- the failure to obtain and maintain reimbursement, or an
adequate level of reimbursement, by third-party payers in a timely
manner for Shire's products may affect 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 the Shire's products or ingredients are only available from
a single approved source for manufacture. Any disruption to the
supply chain for any of the 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
basis for some period of time;
- the manufacture of Shire's products is subject to extensive
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;
- 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;
- 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;
- adverse outcomes in legal matters 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 Shire's revenues, financial condition
or results of operations;
- Shire faces intense competition for highly qualified personnel
from other companies and organizations. Shire is undergoing a
corporate reorganization and was the subject of an unsuccessful
acquisition proposal and the consequent uncertainty could adversely
affect Shire's ability to attract and/or retain the highly skilled
personnel needed for Shire to meet its strategic objectives;
- failure to achieve Shire's strategic objectives with respect to
the acquisition of NPS Pharmaceuticals, Inc. may adversely affect
Shire's financial condition and results of operations;
and other risks and uncertainties detailed from time to time in
Shire's filings with the US Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K.
For further information please contact:
Investor Relations
Sarah Elton-Farr
Seltonfarr@shire.com
+44(0)1256-894157
Media
Gwen Fisher
gfisher@shire.com
+1-484-595-9836