Shire announces submission of lifitegrast Marketing Authorization Application for treatment of dry eye disease in Europe
(Thomson Reuters ONE) -
Shire announces submission of lifitegrast Marketing Authorization Application
for treatment of dry eye disease in Europe
Lifitegrast, if approved, would be the first and only new class treatment to
address the signs and symptoms of dry eye disease in adults in Europe
Zug, Switzerland - 15 August - Shire plc (LSE: SHP, NASDAQ: SHPG) announces that
the Marketing Authorization Application (MAA) for lifitegrast, submitted on 07
August 2017, has been validated by the UK as the Reference Member State involved
in the Decentralized Procedure (DCP). If approved, lifitegrast would be the
first and only treatment in a new class of drugs
(LFA-1 antagonist) to address the signs and symptoms of dry eye disease in
adults in Europe. The disease is most commonly associated with eye dryness and
overall eye discomfort, as well as stinging, burning, and fluctuating blurry
vision.[1] Dry eye disease may significantly affect quality of life and may
impact activities such as reading and using computers.[2] It is one of the most
common conditions seen by ophthalmologists and eye care practitioners
worldwide.[3]
"This submission is another important milestone for lifitegrast and the millions
of patients living with dry eye disease, which can impact a person's vision-
related quality of life, affecting daily activities such as reading and using
computers," said Howard Mayer, M.D., Head of Clinical Development, R&D. "Shire
is committed to continued innovation in ophthalmics, where there are
opportunities to address unmet need and improve the lives of patients."
Shire's MAA for lifitegrast is supported by the largest development program to
date for an investigational-stage dry eye disease candidate, consisting of five
clinical trials with more than 2,500 patients.[4][5][6][7][8] In these studies,
the signs of dry eye disease were measured using corneal staining and the
symptoms by using patient reported eye dryness score (EDS).(4)(-8)
About the lifitegrast Marketing Authorization Application
The lifitegrast MAA was submitted via the Decentralized Procedure (DCP) to
Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France,
Italy, Portugal, Spain and Greece. The UK is the Reference Member State.
About Dry Eye Disease
The prevalence of dry eye disease, with and without symptoms, ranges from 5 to
50% in adults globally.[9] An eye care professional can diagnose dry eye disease
based on signs and symptoms and determine management options, which could
include the use of a prescription treatment. Dry eye disease is a multifactorial
disease of the ocular surface that is often chronic and may be progressive.(1)
The disease is most commonly associated with eye dryness and overall eye
discomfort, as well as stinging, burning, or fluctuating blurry vision.(1) Dry
eye disease may significantly affect quality of life and may impact activities
such as reading and using computers.(2)
Ophthalmologists and eye care professionals can diagnose dry eye disease based
on patient reported symptoms as well as signs which can be objectively evaluated
through various tests.(9)
Management options may include the use of non-prescription and prescription
treatments.[10]
Aging and gender are recognized as traditional risk factors of chronic dry eye
disease, while modern risk factors include prolonged digital/computer screen
time, contact lens wear and cataract or refractive surgery.[11](,)[12] Dry eye
is a common complaint to ophthalmologists and eye care professionals.(3)
About lifitegrast
Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist,
the first medication in a new class of drugs. Lifitegrast binds to the integrin
LFA-1, a cell surface protein found on leukocytes and blocks the interaction of
LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1), which
plays a prominent role in ocular surface inflammation.(6) ICAM-1 may be over-
expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1
interaction can contribute to formation of an immunological synapse resulting in
T-cell activation and migration to target tissues.[13] In vitro studies have
shown that lifitegrast may inhibit the recruitment of previously activated T
cells, the activation of newly recruited T cells, and the release of pro-
inflammatory cytokines-interrupting the perpetual cycle of
inflammation.[14](,)[15]
About lifitegrast in the U.S.A.
The U.S. Food and Drug Administration approved lifitegrast under the brand name
Xiidra(®) (lifitegrast ophthalmic solution) 5% for the treatment of signs and
symptoms of dry eye disease in July 2016.[16] For more information on the U.S.
prescribing information, click here.
About lifitegrast clinical studies
Shire's MAA for lifitegrast is supported by the largest development program to
date for an investigational-stage dry eye disease candidate, consisting of five
clinical trials with more than 2,500 patients.(4)(-8) In four safety and
efficacy studies, lifitegrast improved symptoms as measured by patient reported
eye dryness score (EDS), and in three of the four studies improved the objective
signs of dry eye disease (measured using corneal staining). A statistically
significant reduction in EDS favoring lifitegrast was seen in all four studies
at week six and week 12 (the week six analysis was a post-hoc analysis in three
studies). In two clinical trials, symptom improvement was noted at two, six and
12 weeks.(4)(-)(8) A long-term safety study randomized to either lifitegrast
(n=220) or placebo (n=111) over 360 days found lifitegrast to be generally well-
tolerated with no serious treatment-emergent ocular adverse events.
The most common adverse reactions reported in 5 to 25 percent of patients were
instillation site irritation, altered taste sensation (dysgeusia) and reduced
visual acuity.(4)(-8)
Shire's commitment to ophthalmology
Shire officially entered into ophthalmology with the acquisition of SARcode
Bioscience in 2013. Shire's multi-faceted approach to discovery, development,
and delivery in rare diseases and specialty conditions includes our efforts to
address unmet needs in eye care.
Shire's ophthalmology franchise has been driven by a combination of strategic
acquisitions and organic growth, and is focused on continuing to expand the
portfolio to include treatment options for anterior and posterior segment eye
conditions. In close to four years, acquisitions including SARcode followed by
Foresight Biotherapeutics helped bolster Shire's early-, mid- and late-stage
ophthalmology pipeline. As a result of a collaborative license agreement with
Parion Sciences Inc., Shire is developing SHP-659 (formerly P-321), another
investigational candidate for the treatment of dry eye disease in adults.
Shire's ophthalmology pipeline also includes investigational candidates in
infectious conjunctivitis and glaucoma.
For further information please contact:
Investor Relations
Ian Karp ikarp(at)shire.com +1 781 482 9018
Robert Coates rcoates(at)shire.com +44 1256 894874
Media
Gwen Fisher gfisher(at)shire.com +1 781 482 9649
Clotilde Houzé chouze0(at)shire.com +1 781 266 3567
NOTES TO EDITORS
About Shire
Shire is the leading global biotechnology company focused on serving people with
rare diseases. 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.
www.shire.com
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 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,
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 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, among other things, 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 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, including expected operating
efficiencies, cost savings, revenue enhancements, synergies or other
benefits at the time anticipated or at all with respect to Shire's
acquisitions, including NPS Pharmaceuticals Inc., Dyax Corp. or Baxalta
Incorporated 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 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 has increased its borrowing costs may decrease its
business flexibility; and a further list and description of risks,
uncertainties and other matters can be found in Shire's most recent Annual
Report on Form 10-K and in Shire's subsequent Quarterly Reports on Form 10-
Q, in each case including those risks outlined in "ITEM 1A: Risk Factors",
and in Shire's subsequent reports on Form 8-K and other Securities and
Exchange Commission filings, all of which are available on Shire's website.
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.
--------------------------------------------------------------------------------
[1] Gayton, J. (2009). "Etiology, prevalence, and treatment of dry eye disease".
Clinical Ophthalmology. 3: 405-412.
[2] Miljanovic, B. et al. (2007). "Impact of Dry Eye Syndrome on Vision-Related
Quality of Life". American Journal of Ophthalmology. 143(3): 409-415.
[3] O'Brien PD, Collum LM. (2004). "Dry eye: diagnosis and current treatment
strategies". Curr Allergy Asthma Rep. 4:314-319. Available at:
https://www.ncbi.nlm.nih.gov/pubmed/15175147 [Last accessed August 2017]
[4] Holland E J, Whitely WO, Sall Ke et al. (2016). "Lifitegrast clinical
efficacy for treatment of signs and symptoms of dry eye disease across three
randomized controlled trials". Current Medical Research and Opinion.
32(10): 1759-1765.
[5] Sheppard JD, Torkildsen GL, Lonsdale JD et al. (2014). "Lifitegrast
ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-
1 phase 3 study". Ophthalmology. 121(2): 475-83.
[6] Tauber J, Karpecki P, Latkany R et al. (2015). "Lifitegrast Ophthalmic
Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the
Randomized Phase III OPUS-2 Study". Ophthalmology. 122(12): 2423-2431.
[7] Holland E, Luchs J, Karpecki P et al. (2017). "Lifitegrast for the Treatment
of Dry Eye Disease Results of a Phase III, Randomized, Double-Masked, Placebo-
Controlled Trial (OPUS-3)". Ophthalmology. 124(1): 53-60.
[8] Donnenfeld E, Karpecki PM, Majmudar PA et al. (2016). "Safety of Lifitegrast
Ophthalmic Solution 5.0% in Patients with Dry Eye Disease: A 1-Year,
Multicenter, Randomized, Placebo-Controlled Study". Cornea. 35: 741-748.
[9] Nelson, J. Daniel et al. (2017). "TFOS DEWS II Introduction". The Ocular
Surface. 15(3): 269-275.
[10] Vickers LA, Preeya PK. The Future of Dry Eye Treatment: A Glance into the
Therapeutic Pipeline Ophthalmol Ther 2015 4:69-78
[11] Uchino M et al. (2013). "Dry Eye Disease: Impact on Quality of Life and
Vision". Curr Ophthalmol Rep. June; 1(2):51-57.
[12] Hovanesian JA, Shah SS, et al. (2001). "Symptoms of dry eye and recurrent
erosion syndrome after refractive surgery". J Cataract Refract Surg. 27:577-84.
[13] Pflugfelder, S. et al. (2017). "LFA-1/ICAM-1 Interaction as a Therapeutic
Target in Dry Eye Disease". Available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5240001/. [Last accessed July
2017].
[14] Shire. (2016). "HIGHLIGHTS OF PRESCRIBING INFORMATION". Available at:
http://www.shirecontent.com/PI/PDFs/Xiidra_USA_ENG.pdf. [Last accessed July
2017].
[15] DEWS Research Subcommittee. Research in dry eye: report of the Research
Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf.
2007;5(2):179-193.
[16] U.S. Food & Drug Administration. (2016). "FDA approves new medication for
dry eye disease". Available at:
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm510720.htm. [Last
accessed July 2017].
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Shire plc via GlobeNewswire
Datum: 15.08.2017 - 08:00 Uhr
Sprache: Deutsch
News-ID 556529
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