Shire Receives FDA Fast Track Designation for SHP607 for the Prevention of Chronic Lung Disease in Extremely Premature Infants
(Thomson Reuters ONE) -
Shire Receives FDA Fast Track Designation for SHP607 for the Prevention of
Chronic Lung Disease in Extremely Premature Infants
Cambridge, Mass. - September 12, 2017 - Shire plc (LSE: SHP, NASDAQ: SHPG), the
biotech leader in rare diseases, today announced that the United States Food and
Drug Administration (FDA) has granted Fast Track designation for SHP607 for the
prevention of chronic lung disease in extremely premature infants. SHP607,
currently in phase 2 clinical development, is a recombinant human version of the
naturally occurring protein complex of insulin-like growth factor 1 (IGF-1) and
its most abundant binding protein, IGF binding protein-3 (IGFBP-3). IGF-1 plays
an important role in the development of the fetus in the uterus.
The SHP607 Fast Track designation is supported by preclinical data and Phase 1
and 2 studies. The FDA's Fast Track process is designed to facilitate the
development, and expedite the review of drugs to treat serious conditions and
fill an unmet medical need. However, it does not guarantee that the FDA will
ultimately approve SHP607 or the timing of any such approval.
"We are pleased to achieve this regulatory milestone as we progress this very
important clinical development program," says Howard Mayer, M.D., Shire's Head
of Research and Development, ad interim. "There are no approved treatment
options for chronic lung disease for premature infants, and we are aiming to
change that. We are continuing to advance the SHP607 clinical program, which is
well aligned with Shire's focus on bringing innovative therapies to patients
with rare diseases worldwide."
About the SHP607 Clinical Development Program
Prior to Shire adding SHP607 to its clinical development pipeline in 2013 when
it acquired privately held Premacure AB, a Phase I clinical trial was conducted
and its results showed that the levels of IGF-1 were increased to within
physiological levels and that administration of the investigational protein to
preterm infants. Shire took over Premacure's Phase 2 clinical trial, reporting
topline results in June 2016, which did not meet the study's primary endpoint of
reducing the severity of retinopathy of prematurity (ROP), a rare eye condition.
The study, however, demonstrated clinically relevant effects in secondary
endpoints related to the development of severe bronchopulmonary dysplasia (BPD),
a chronic lung disease, and severe intraventricular hemorrhage (IVH), a type of
brain injury, both of which have lifelong negative implications for normal
development. There were no serious adverse events related to the investigational
medicinal product.
Following the phase 2 study results, Shire initiated discussions with regulatory
authorities in the United States, Europe and Japan to discuss an appropriate
regulatory review pathway for SHP607. As a result of those discussions, Shire is
in the process of developing a phase 2b/3 clinical trial SHP607 targeting a
primary endpoint focused on chronic lung disease in extremely premature infants.
Key secondary endpoints being explored include BPD and IVH.
Shire is currently conducting a five-year observational long-term outcomes study
of patients who had been enrolled in the phase 2 study.
About IGF-1 and Complications Related to Extremely Premature Infants
IGF-1 is supplied by the mother until about 30 weeks of gestation when the fetus
begins producing the growth factor on its own. Levels of IGF-1 dramatically
decrease in infants born extremely premature (before 28 weeks of gestation),
thereby increasing the risk for complications related to the lungs, brain, eyes,
and other organs.
Approximately 28,000 infants in the United States are born extremely premature -
before 28 weeks of gestation. Research suggests that 60% of extremely premature
infants experience one or more severe complications related to prematurity,
which include: IVH; BPD; or ROP. Severe complications can have life-long
implications for the developing infant.
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
Lisa Adler lisa.adler(at)shire.com +1 617 588 8607
Gwen Fisher gfisher(at)shire.com + 1 781 482 9649
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
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expectations and intentions, the anticipated timing of clinical trials and
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the following:
* Shire's products may not be a commercial success;
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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
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* 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
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* 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.
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: 12.09.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 559622
Anzahl Zeichen: 12991
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