TIDMCLIN
Clinigen Group plc
20 July 2021
20 July 2021
Clinigen and Horizon Therapeutics to launch Managed Access
Program
for UPLIZNA(R) (inebilizumab-cdon)
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global
pharmaceutical Products and Services company, and Horizon
Therapeutics Plc ('Horizon') announce that they have signed an
agreement to implement a Managed Access Program, being referred to
by Horizon as a Named Patient Use (NPU) Program, for UPLIZNA.
The UPLIZNA NPU Program is for adult patients with
anti-aquaporin-4 (AQP4) antibody positive NMOSD in countries where
UPLIZNA is not approved by the country's local regulatory
authority.
NMOSD is a unifying term for neuromyelitis optical (NMO) and
related syndromes. NMOSD is a rare, severe, relapsing,
neuroinflammatory autoimmune disease that attacks the optic nerve,
spinal cord and brain stem. 1,2 Approximately 80 percent of all
patients with NMOSD test positive for anti-AQP4 antibodies. 3
The program will provide an avenue for physicians - contingent
on meeting all eligibility criteria and receiving local health
approval - to potentially prescribe UPLIZNA for patients who live
in certain countries where it is not commercially available.
UPLIZNA is currently approved in the United States and Japan. In
Japan, UPLIZNA is marketed by Mitsubishi Tanabe Pharma
Corporation.
Pete Belden, Executive Vice President Services Division,
Clinigen said:
"We are pleased to be partnering with Horizon to make UPLINZA
available for patients with this rare autoimmune condition,
extending access to this valuable medicine where it is otherwise
unavailable. This aligns with our mission to ensure the right
patient gets the right medicine at the right time."
Healthcare professionals can obtain details about the accessing
UPLINZA by calling the Clinigen customer service team at +44 (0)
1932 824100 or emailing MedicineAccess@clinigengroup.com .
Patients seeking medical information should contact their
physician.
- Ends -
Contact details
Clinigen plc +44 (0) 1283 495010
Pete Belden, EVP Services Division investors@clinigengroup.com
Consilium Strategic Communications
Mary-Jane Elliott / Matthew Cole / Jessica Tel: +44 (0) 20 3709
Hodgson 5700 Clinigen@consiliumcomms.com
Notes to Editors
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global, specialist
pharmaceutical services and products platform focused on providing
ethical access to medicines. Its mission is to deliver the right
medicine to the right patient at the right time. The Group operates
from sites in North America, Europe, Africa and the Asia
Pacific.
Clinigen has more than 1,000 employees across five continents in
16 countries, with supply and distribution hubs and operational
centres of excellence in key long-term growth regions. The Group
works with 34 of the top 50 pharmaceutical companies; interacting
with over 5,000 hospitals across more than 115 countries.
For more information on Clinigen, please visit
http://www.clinigen.com
About Horizon Therapeutics
Horizon is focused on the discovery, development and
commercialization of medicines that address critical needs for
people impacted by rare, autoimmune and severe inflammatory
diseases. Our pipeline is purposeful: we apply scientific expertise
and courage to bring clinically meaningful therapies to patients.
We believe science and compassion must work together to transform
lives. For more information on how we go to incredible lengths to
impact lives, please visit www.horizontherapeutics.com and follow
us on Twitter, LinkedIn, Instagram and Facebook.
About UPLIZNA
UPLIZNA (inebilizumab-cdon) is indicated for the treatment of
neuromyelitis optica spectrum disorder (NMOSD) in adult patients
who are anti-aquaporin-4 (AQP4) antibody positive.
IMPORTANT SAFETY INFORMATION
UPLIZNA is contraindicated in patients with:
-- A history of life-threatening infusion reaction to UPLIZNA
-- Active hepatitis B infection
-- Active or untreated latent tuberculosis
WARNINGS AND PRECAUTIONS
Infusion Reactions: UPLIZNA can cause infusion reactions, which
can include headache, nausea, somnolence, dyspnea, fever, myalgia,
rash, or other symptoms. Infusion reactions were most common with
the first infusion but were also observed during subsequent
infusions. Administer pre-medication with a corticosteroid, an
antihistamine, and an anti-pyretic.
Infections: The most common infections reported by
UPLIZNA-treated patients in the randomized and open-label periods
included urinary tract infection (20%), nasopharyngitis (13%),
upper respiratory tract infection (8%), and influenza (7%). Delay
UPLIZNA administration in patients with an active infection until
the infection is resolved.
Increased immunosuppressive effects are possible if combining
UPLIZNA with another immunosuppressive therapy.
The risk of Hepatitis B Virus (HBV) reactivation has been
observed with other B-cell-depleting antibodies. Perform HBV
screening in all patients before initiation of treatment with
UPLIZNA. Do not administer to patients with active hepatitis.
Although no confirmed cases of Progressive Multifocal
Leukoencephalopathy (PML) were identified in UPLIZNA clinical
trials, JC virus infection resulting in PML has been observed in
patients treated with other B-cell-depleting antibodies and other
therapies that affect immune competence. At the first sign or
symptom suggestive of PML, withhold UPLIZNA and perform an
appropriate diagnostic evaluation.
Patients should be evaluated for tuberculosis risk factors and
tested for latent infection prior to initiating UPLIZNA.
Vaccination with live-attenuated or live vaccines is not
recommended during treatment and after discontinuation, until
B-cell repletion.
Reduction in Immunoglobulins: There may be a progressive and
prolonged hypogammaglobulinemia or decline in the levels of total
and individual immunoglobulins such as immunoglobulins G and M (IgG
and IgM) with continued UPLIZNA treatment. Monitor the level of
immunoglobulins at the beginning, during, and after discontinuation
of treatment with UPLIZNA until B-cell repletion especially in
patients with opportunistic or recurrent infections.
Fetal Risk: May cause fetal harm based on animal data. Advise
females of reproductive potential of the potential risk to a fetus
and to use an effective method of contraception during treatment
and for 6 months after stopping UPLIZNA.
Adverse Reactions: The most common adverse reactions (at least
10% of patients treated with UPLIZNA and greater than placebo) were
urinary tract infection and arthralgia.
For additional information on UPLIZNA, please see Prescribing
Information at www.UPLIZNA.com .
About NMOSD
Neuromyelitis optica spectrum disorder (NMOSD), also known as
Devic disease, is a chronic disorder of the brain and spinal cord
dominated by inflammation of the optic nerve (optic neuritis) and
inflammation of the spinal cord (myelitis). Classically, it was
felt to be a monophasic illness, consisting of episodes of
inflammation of one or both optic nerves and the spinal cord over a
short period of time (days or weeks) but, after the initial
episode, no recurrence. It is now recognized that most patients
satisfying current criteria for NMOSD experience repeated attacks
separated by periods of remission. The interval between attacks may
be weeks, months or years. In its early stages, NMOSD may be
confused with multiple sclerosis (MS). (4)
Horizon Forward Looking Statements
This release contains forward-looking statements, including, but
not limited to, statements related to the anticipated initiation of
the UPLIZNA NPU program and availability of UPLIZNA under the
program to patients outside of the United States and Japan; and
business and other statements that are not historical facts. These
forward-looking statements are based on Horizon's current
expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, the risk of future supply disruptions;
impacts of the COVID-19 pandemic and actions taken to slow its
spread; regulatory obligations and oversight, including any changes
in the legal and regulatory environment in which Horizon operates
and those risks detailed from time-to-time under the caption "Risk
Factors" and elsewhere in Horizon's filings and reports with the
SEC. Horizon undertakes no duty or obligation to update any
forward-looking statements contained in this release as a result of
new information.
References
1. Ajmera MR, Boscoe A, Mauskopf J, Candrilli SD, Levy M.
Evaluation of comorbidities and health care resource use among
patients with highly active neuromyelitis optica. J Neurol Sci.
2018; 384:96-103.
2. What is NMO? Guthyjacksonfoundation.org.
www.guthyjacksonfoundation.org/neuromyelitis-optica-nmo/ Accessed
April 15, 2021.
3. Layman's Guide to NMO. Sumairafoundation.org.
https://www.sumairafoundation.org/laymans-guide-to-nmo/ Accessed
March 9, 2020.
4. https://rarediseases .org/rare-diseases/neuromyelitis-optica/
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