SK Biopharmaceuticals is eligible to receive
milestones for future approval and commercialization in
Canada and Israel
PANGYO, South Korea, Aug. 9, 2022
/PRNewswire/ -- SK Biopharmaceuticals, Co., Ltd. announced that
Health Canada has accepted Paladin Labs Inc.'s filing of a New Drug
Submission (NDS) for cenobamate as an adjunctive therapy for the
management of partial-onset seizures in adults with epilepsy who
are not satisfactorily controlled with conventional therapy. If
Health Canada approves this NDS, Paladin Labs would be able to
launch cenobamate in Canada.
In December 2021, SK
Biopharmaceuticals entered into definitive agreements with Endo
International plc (Endo)'s subsidiary, Endo Ventures Limited, to
commercialize cenobamate in Canada. Under the agreements, Paladin Labs, a
Canada-based operating company of
Endo, is responsible for all commercial activities. SK
Biopharmaceuticals will receive milestone payments for future
approval and commercialization, as well as additional supply
benefits as a result of these agreements.
Dexcel Pharma, an Israeli partner of SK Biopharmaceuticals, has
also completed submission of its New Drug Application for
cenobamate, and has received filing acceptance from the Israel
Ministry of Health.
About Cenobamate
Cenobamate is an anti-seizure medication (ASM) discovered and
developed by SK Biopharmaceuticals and SK life science. While the
precise mechanism by which cenobamate exerts its therapeutic effect
is unknown, it is believed to reduce repetitive neuronal firing by
inhibiting voltage-gated sodium currents. It is also a positive
allosteric modulator of the γ-aminobutyric acid (GABAA) ion
channel.
Cenobamate is approved in the United
States for the treatment of partial-onset seizures in adults
and is available under the brand name XCOPRI®
(cenobamate tablets) CV. Cenobamate can be combined with other ASMs
or used alone. The recommended initial dosage of cenobamate is
12.5 mg once-daily, with titration every two weeks; it is available
in six tablet strengths for once-daily dosing: 12.5 mg, 25 mg, 50
mg, 100 mg, 150 mg and 200 mg.
Cenobamate is also approved in the European Union and the
United Kingdom for the adjunctive
treatment of focal-onset (partial-onset) seizures with or without
secondary generalization in adult patients with seizures that have
not been adequately controlled despite a history of treatment with
at least two anti-epileptic medicinal products and is marketed by
Angelini Pharma under the brand name ONTOZRY®.
Additionally, cenobamate is in clinical development in Asia. Ono Pharmaceutical and Ignis
Therapeutics have the rights to develop and commercialize
cenobamate in Japan and in the
Greater China region,
respectively.
IMPORTANT SAFETY INFORMATION AND
INDICATION FOR XCOPRI® (cenobamate tablets)
CV
DO NOT TAKE XCOPRI IF YOU:
- Are allergic to cenobamate or any of the other ingredients in
XCOPRI.
- Have a genetic problem (called Familial Short QT syndrome) that
affects the electrical system of the heart.
XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
Allergic reactions: XCOPRI can cause serious skin rash or
other serious allergic reactions which may affect organs and other
parts of your body like the liver or blood cells. You may
or may not have a rash with these types of reactions. Call your
healthcare provider right away and go to the nearest emergency room
if you have any of the following: swelling of your face, eyes,
lips, or tongue, trouble swallowing or breathing, a skin rash,
hives, fever, swollen glands, or sore throat that does not go away
or comes and goes, painful sores in the mouth or around your eyes,
yellowing of your skin or eyes, unusual bruising or bleeding,
severe fatigue or weakness, severe muscle pain, frequent
infections, or infections that do not go away. Take XCOPRI
exactly as your healthcare provider tells you to take it. It is
very important to increase your dose of XCOPRI slowly, as
instructed by your healthcare provider.
QT shortening: XCOPRI may cause problems with the electrical
system of the heart (QT shortening). Call your healthcare
provider if you have symptoms of QT shortening including fast
heartbeat (heart palpitations) that last a long time or
fainting.
Suicidal behavior and ideation: Antiepileptic drugs,
including XCOPRI, may cause suicidal thoughts or actions in a very
small number of people, about 1 in 500. Call your health care
provider right away if you have any of the following symptoms,
especially if they are new, worse, or worry you: thoughts about
suicide or dying; attempting to commit suicide; new or worse
depression, anxiety, or irritability; feeling agitated or restless;
panic attacks; trouble sleeping (insomnia); acting aggressive;
being angry or violent; acting on dangerous impulses; an extreme
increase in activity and talking (mania); or other unusual changes
in behavior or mood.
Nervous system problems: XCOPRI may cause problems
that affect your nervous system. Symptoms of nervous system
problems include: dizziness, trouble walking or with coordination,
feeling sleepy and tired, trouble concentrating, remembering, and
thinking clearly, and vision problems. Do not drive,
operate heavy machinery, or do other dangerous activities until you
know how XCOPRI affects you.
Do not drink alcohol or take other medicines that can make
you sleepy or dizzy while taking XCOPRI without first talking to
your healthcare provider.
DISCONTINUATION:
Do not stop taking XCOPRI without first talking to your
healthcare provider. Stopping XCOPRI suddenly can cause
serious problems. Stopping seizure medicine suddenly in a patient
who has epilepsy can cause seizures that will not stop (status
epilepticus).
DRUG INTERACTIONS:
XCOPRI may affect the way other medicines work, and other
medicines may affect how XCOPRI works. Do not start or stop
other medicines without talking to your healthcare
provider. Tell healthcare providers about all the
medicines you take, including prescription and over-the-counter
medicines, vitamins and herbal supplements.
PREGNANCY AND LACTATION:
XCOPRI may cause your birth control medicine to be less
effective. Talk to your health care provider about the best
birth control method to use.
Talk to your health care provider if you are pregnant or plan
to become pregnant. It is not known if XCOPRI will harm
your unborn baby. Tell your healthcare provider right away if you
become pregnant while taking XCOPRI. You and your healthcare
provider will decide if you should take XCOPRI while you are
pregnant. If you become pregnant while taking XCOPRI, talk to your
healthcare provider about registering with the North American
Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this
registry is to collect information about the safety of
antiepileptic medicine during pregnancy. You can enroll in this
registry by calling 1-888-233-2334 or go to
www.aedpregnancyregistry.org.
Talk to your health care provider if you are breastfeeding or
plan to breastfeed. It is not known if XCOPRI passes into
breastmilk. Talk to your healthcare provider about the best way to
feed your baby while taking XCOPRI.
COMMON SIDE EFFECTS:
The most common side effects in patients taking XCOPRI include
dizziness, sleepiness, headache, double vision, and feeling
tired.
These are not all the possible side effects of XCOPRI. Tell your
healthcare provider if you have any side effect that bothers you or
that does not go away. For more information, ask your healthcare
provider or pharmacist. Call your doctor for medical advice
about side effects. You may report side effects to FDA at
1-800-FDA-1088 or at www.fda.gov/medwatch.
DRUG ABUSE:
XCOPRI is a federally controlled substance (CV) because it
can be abused or lead to dependence. Keep XCOPRI in a safe
place to prevent misuse and abuse. Selling or giving away XCOPRI
may harm others and is against the law.
INDICATION:
XCOPRI is a prescription medicine used to treat partial-onset
seizures in adults 18 years of age and older. It is not known if
XCOPRI is safe and effective in children under 18 years of age.
Please see additional patient information in the Medication
Guide. This information does not take the place of talking with
your healthcare provider about your condition or your
treatment.
Please see full Prescribing Information.
About SK
Biopharmaceuticals
SK Biopharmaceuticals and its U.S. subsidiary SK life science
are global pharmaceutical companies focused on the research,
development and commercialization of treatments for disorders of
the central nervous system (CNS). The companies have a pipeline of
eight compounds in development for the treatment of CNS disorders,
including epilepsy. Additionally, SK Biopharmaceuticals is focused
on early research in oncology. For more information, visit SK
Biopharmaceuticals' website at www.skbp.com/eng and SK
life science's website at www.SKLifeScienceInc.com.
About Endo and Paladin
Labs
Endo (NASDAQ: ENDP) is a specialty pharmaceutical company
committed to helping everyone we serve live their best life through
the delivery of quality, life-enhancing therapies. Our decades of
proven success come from passionate team members around the globe
collaborating to bring the best treatments forward. Together, we
boldly transform insights into treatments benefiting those who need
them, when they need them. Learn more at www.endo.com or
connect with us on LinkedIn.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty
pharmaceutical company focused on acquiring or in-licensing
innovative pharmaceutical products for the Canadian market. Paladin
has a focused marketing and sales organization that has helped it
evolve into one of Canada's
leading specialty pharmaceutical companies. Paladin is an operating
company of Endo International plc. For more information
visit: www.endo.com or www.paladin-labs.com.
About Dexcel Pharma
Dexcel Pharma is an international specialty pharmaceutical
company that focuses on the development, manufacturing, and
marketing of innovative prescription, generics, and OTC
pharmaceutical products. Dexcel Pharma is Israel's largest private pharmaceutical
manufacturer. Founded in 1968, we develop, manufacture and market
value-added branded and generic pharmaceuticals. With a diverse
product portfolio that spans more than 85 branded and generic
products in over 175 dosage forms, our products are sold in the US,
the UK, Germany, Austria, and Singapore, via subsidiaries and through a
trusted network of partners in more than 30 countries
worldwide.
Media Inquiries
H. Park, Director
of Communications
h.p.comm@sk.com
Jaehee Kang, Communications
Manager
jaeheekang@sk.com
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SOURCE SK Biopharmaceuticals