TIDMSHP
Shire plc
18 April 2018
The Swiss Agency for Therapeutic Products (Swissmedic) Validates
Shire's Marketing Authorization Application (MAA) for
Investigational Hereditary Angioedema (HAE) Treatment
Lanadelumab
-- Lanadelumab, the first investigational monoclonal antibody in
HAE, is being evaluated for the prevention of angioedema attacks in
patients 12 years and older
-- Swissmedic validation shows continued regulatory progress for lanadelumab
-- HAE is a rare, genetic disorder that causes debilitating,
painful and sometimes life-threatening swelling in the body(1)
Dublin, Ireland - April 18, 2018 - Shire plc (LSE: SHP, NASDAQ:
SHPG), the leading global biotechnology company focused on rare
diseases, announced today that the Swiss Agency for Therapeutic
Products (Swissmedic) has validated the marketing authorization
application (MAA) for lanadelumab (SHP643). The validation of the
MAA confirms that the lanadelumab MAA submission is complete and
that the formal review process will begin. Lanadelumab is an
investigational treatment being evaluated for the prevention of
angioedema attacks in patients 12 years and older with hereditary
angioedema (HAE). Lanadelumab was also designated orphan drug
status by Swissmedic.
HAE is a rare, genetic disorder estimated to affect about 1 in
10,000 to 1 in 50,000 people worldwide.(1,2) The condition results
in recurring attacks of edema (swelling) in various parts of the
body, including the abdomen, face, feet, genitals, hands and throat
that can be can debilitating and painful.(1,3,4) Attacks that
obstruct the airways (asphyxiation) are potentially
life-threatening.(1,3,4)
Andreas Busch, Ph.D., Executive Vice President, Head of Research
and Development at Shire said, "Today's announcement represents
another important step forward as we continue our work to make
lanadelumab available to the global HAE community. For those living
with HAE, the recurring attacks of swelling can be debilitating.
Lanadelumab, if approved, has the potential to change the HAE
treatment landscape by directly targeting plasma kallikrein to
inhibit excessive bradykinin formation, which stops the blood
vessel permeability that causes these swelling attacks."
Lanadelumab Regulatory Status
- U.S. Food and Drug Administration (FDA) accepted Shire's
biologics license application (BLA) and granted priority review for
lanadelumab in February 2018. The FDA is expected to provide a
decision on lanadelumab by August 26, 2018, based on the
Prescription Drug User Fee Act V action date.
- European Medicines Agency (EMA) validated the marketing
authorization application for lanadelumab in March 2018. EMA had
previously granted lanadelumab an accelerated assessment reducing
the number of evaluation days required, from 210 to 150.
- Health Canada accepted the New Drug Submission (NDS) for
lanadelumab under Priority Review in March 2018 shortening the
review timeline from 300 to 180 days.
- Therapeutic Goods Administration in Australia granted
lanadelumab priority review and orphan drug designation in February
2018.
Regulatory filings are supported by data from four clinical
trials, including HELP(TM), the pivotal Phase 3 efficacy and safety
study, along with interim data from its ongoing extension study.
HELP, the largest prevention study in HAE conducted to date,
enrolled a total of 125 patients aged 12 years and over with type
I/II HAE. The HELP study demonstrated that subcutaneous
administration of 300 mg lanadelumab once every two weeks resulted
in an 87% reduction in the mean frequency of HAE attacks versus
placebo. In addition, an exploratory endpoint and post-hoc analysis
which would require confirmatory studies, showed that during the
steady state stage of the trial (day 70-182), a 91% attack
reduction was achieved versus placebo, and nearly 8 out of 10
patients reached an attack free state. In this study, no
treatment-related serious adverse events or deaths were reported.
The most commonly reported treatment-related adverse events in
patients treated with lanadelumab during the entire treatment
period were injection site pain (29.3% placebo vs. 42.9 % combined
lanadelumab arms), viral upper respiratory tract infection,
headache, injection site erythema, injection site bruising, and
dizziness. Most adverse events were mild to moderate in
severity.
About Lanadelumab
Lanadelumab is an investigational fully human monoclonal
antibody that specifically binds and inhibits plasma kallikrein(5)
and is being studied as a treatment for the prevention of
angioedema attacks in patients 12 years and older with HAE.
Lanadelumab is formulated for subcutaneous administration, and has
a half-life of approximately 14 days in patients with HAE.(6)
Shire's Commitment to Hereditary Angioedema
Shire is a dedicated, long-term partner to the HAE community
with nearly a decade of experience supporting patients. We believe
people living with HAE deserve a right-fit approach to treatment
and we are committed to ongoing innovation. Our existing portfolio
of products includes a number of therapy options to help meet the
needs of those living with the disease. Beyond our focus on
developing novel treatments, we provide specialized services and
support offerings tailored to the HAE community. Learn more at
shire.com.
For further information please contact:
Investor Relations
Christoph Brackmann christoph.brackmann@shire.com +41 795 432 359
Sun Kim sun.kim@shire.com +1 617 588 8175
Robert Coates rcoates@shire.com +44 203 549 0874
Media
Linda Calandra linda.calandra@shire.com +1 917 697 7543
NOTES TO EDITORS
About Shire
Shire is the global leader in serving patients with rare
diseases. We strive to develop best-in-class therapies across a
core of rare disease areas including hematology, immunology,
genetic diseases, neuroscience, and internal medicine with growing
therapeutic areas in ophthalmics and oncology. Our diversified
capabilities enable us to reach patients in more than 100 countries
who are struggling to live their lives to the fullest.
We feel a strong sense of urgency to address unmet medical needs
and work tirelessly to improve people's lives with medicines that
have a meaningful impact on patients and all who support them on
their journey.
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, projected revenues,
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 depends on third parties to supply certain inputs and
services critical to its operations including certain inputs,
services and ingredients critical to its manufacturing processes.
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;
-- the nature of producing plasma-based therapies 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;
-- failure to comply with laws and regulations governing the
sales and marketing of its products could materially impact Shire's
revenues and profitability;
-- Shire's products and product candidates face substantial
competition in the product markets in which it operates, including
competition from generics;
-- Shire's patented products are subject to significant 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 Shire's revenues,
financial condition or results of operations;
-- Shire may fail to obtain, maintain, enforce or defend the
intellectual property rights required to conduct its business;
-- Shire faces intense competition for highly qualified
personnel from other companies and organizations;
-- failure to successfully execute or attain strategic
objectives from Shire's acquisitions and growth strategy may
adversely affect the 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, could have negative
consequences for Shire's business and increase the risk of
non-payment by Shire's customers;
-- changes in foreign currency exchange rates and interest rates
could have a material adverse effect on Shire's operating results
and liquidity;
-- Shire is subject to evolving and complex tax laws, which may
result in additional liabilities that may adversely affect the
Shire's financial condition or results of operations;
-- if a marketed product fails to work effectively or causes
adverse side effects, this could result in damage to Shire's
reputation, the withdrawal of the product and legal action against
Shire;
-- 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 faces risks relating to the expected exit of the United
Kingdom from the European Union;
-- Shire incurred substantial additional indebtedness to finance
the Baxalta acquisition, which has increased its borrowing costs
and may decrease its business flexibility;
-- Shire's ongoing strategic review of its Neuroscience
franchise may distract management and employees and may not lead to
improved operating performance or financial results; there can be
no guarantee that, once completed, Shire's strategic review will
result in any additional strategic changes beyond those that have
already been announced;
-- the potential uncertainty resulting from the announcement by
Takeda Pharmaceutical Company Limited that it is considering making
an approach to Shire regarding a possible offer for Shire; 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 "ITEM1A: 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.
References:
(1) Cicardi M, Bork K, Caballero T, et al, on behalf of HAWK
(Hereditary Angioedema International Working Group). Evidence-based
recommendations for the therapeutic management of angioedema owing
to hereditary C1 inhibitor deficiency: consensus report of an
International Working Group. Allergy. 2012; 67(2):147-157.
(2) Longhurst HJ, Bork K. Hereditary angioedema: causes,
manifestations, and treatment. Br J Hosp Med.
2006;67(12):654-657.
(3) Zuraw BL. Hereditary angioedema. N Engl J Med.
2008;359(10):1027-1036.
(4) Banerji A. The burden of illness in patients with hereditary
angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.
(5) Kenniston JA et al. Inhibition of plasma kallikrein by a
highly specific active site blocking antibody. J. Biol. Chem.
2014;289(34):23596-23608.
(6) Banerji et al. Inhibiting plasma kallikrein for hereditary
angioedema prophylaxis. N Engl J Med. 2017; 376(8):717-728.
This information is provided by RNS
The company news service from the London Stock Exchange
END
NRAEAKLPFSXPEEF
(END) Dow Jones Newswires
April 18, 2018 03:00 ET (07:00 GMT)
Citi Fun 25 (LSE:AP79)
Historical Stock Chart
From May 2024 to Jun 2024
Citi Fun 25 (LSE:AP79)
Historical Stock Chart
From Jun 2023 to Jun 2024