SK Biopharmaceuticals Named Winner of CES 2023 Innovation Awards

SK Biopharmaceuticals is recognized in the digital health category for two wearable devices – Zero Glasses MT and wired zero MT – becoming the first Korean pharmaceutical company to win this distinction

PANGYO, South Korea, November 16, 2022 /PRNewswire/ — SK Biopharmaceuticals, an innovative global pharmaceutical company, announced that it has been named the winner of the CES® 2023 Innovation Awards for the outstanding design and engineering of two wearable devices: Zero GlassesMT and wired zeroMT.

SK Biopharmaceuticals will become the first Korean pharmaceutical company to receive such an honor in the digital health category. The announcement came ahead of CES 2023, the world’s most influential and important tech event to be held January 5-8 in Las Vegas, Nevada.

Zero Glasses, smart glasses and Zero Wired, a wired device connectable to cell phones, are integrated wearables that can detect and predict seizures by measuring biosignals of brain activity, heart rate and body movement.

They are compatible with the SK Biopharmaceuticals mobile application called Zero AppMT capable of recording and analyzing biosignal data in real time. Portable devices can be worn comfortably in business and private environments.

The wearable device names derive from SK Biopharmaceuticals’ key mission to achieve “zero seizure” potential for patients with cenobamate, an anti-epileptic drug (ASM) approved by the U.S. Food and Drug Administration for treatment of partial seizures. epileptic seizures (focal onset) in adults. It is commercially available in the United States under the brand name XCOPRI® (cenobamate tablets) CV. SK Biopharmaceuticals operates in the United States through SK Life Science, a subsidiary based in New Jersey.

SK Biopharmaceuticals will showcase the wearables and provide an on-site demonstration at CES 2023. The CES Innovation Awards program, owned and produced by the Consumer Technology Association (CTA)®, is an annual competition recognizing outstanding design and engineering in 28 technologies General public. product categories.

About SK Biopharmaceuticals

SK Biopharmaceuticals and its US subsidiary SK Life Science are global pharmaceutical companies focused on the research, development and commercialization of treatments for central nervous system (CNS) disorders. The companies have a pipeline of eight compounds in development for the treatment of CNS disorders, including epilepsy. Additionally, SK Biopharmaceuticals focuses on early research in oncology. For more information, visit the SK Biopharmaceuticals website at www.skbp.com/eng and the SK Life Science website at www.SKLifeScienceInc.com.

About Cenobamate

Cenobamate is an anti-epileptic drug (ASM) discovered and developed by SK Biopharmaceuticals and SK life science. Although the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, it is thought to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of γ-aminobutyric acid (GABAA) ion channel.

Cenobamate is approved in 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 starting dose of cenobamate is 12.5 mg once daily, titrated every two weeks; it is available in six tablet strengths for once-daily use: 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 (partial) epileptic seizures with or without secondary generalization in adult patients with inadequately controlled seizures despite a history of treatment with at least two antiepileptic drugs and is marketed by Angelini Pharma under the trademark ONTOZRY®.

In addition, 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. SK Biopharmaceuticals recently entered into an exclusive licensing agreement with Endo for cenobamate in Canada.

IMPORTANT SAFETY INFORMATION AND INSTRUCTIONS FOR XCOPRI®(cenobamate tablets) CV

DO NOT TAKE XCOPRI IF YOU:

  • are allergic to cenobamate or any of the other ingredients in XCOPRI.
  • Having 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 severe skin rashes or other severe allergic reactions that may affect organs and other parts of your body such as the liver or blood cells. You may or may not get 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 symptoms: swelling of your face, eyes, lips or tongue, difficulty swallowing or breathing, rash, hives, fever, swollen glands or sore throat that does not go away or comes and goes, painful sores in the mouth or around the eyes, yellowing of the skin or eyes, unusual bruising or bleeding, tiredness or severe weakness, severe muscle pain, frequent infections or infections that won’t go away.Take XCOPRI exactly as your healthcare provider has told you. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare professional.

Shortening of the QT interval: XCOPRI can cause problems with the electrical system of the heart (shortening of the QT interval). Call your healthcare provider if you have symptoms of QT interval shortening, including fast heartbeats (heart palpitations) that last a long time or fainting.

Suicidal behavior and thoughts: Antiepileptic drugs, including XCOPRI, can cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people. Call your healthcare provider right away if you have any of the following symptoms, especially if new, getting worse, or worrying you: suicidal or dying thoughts; attempted suicide; new or worsening depression, anxiety or irritability; feeling restless or restless; panic attacks; sleep disturbances (insomnia); act aggressively; be angry or violent; act on dangerous impulses; an extreme increase in activity and speech (mania); or other unusual changes in behavior or mood.

Nervous system problems: XCOPRI can cause problems affecting your nervous system. Symptoms of nervous system problems include: dizziness, difficulty walking or coordinating, feeling sleepy and tired, difficulty concentrating, remembering and thinking clearly, and vision problems.Do not drive, use heavy machinery or do other dangerous activities until you know how XCOPRI affects you .

Do not drink alcohol or take other medicines that may make you drowsy or dizzy while taking XCOPRI without first talking to your healthcare provider.

STOP:

Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Suddenly stopping seizure medication in a patient with epilepsy may cause seizures that will not stop (status epilepticus).

DRUGS INTERACTIONS :

XCOPRI can affect how other medicines work, and other medicines can affect how XCOPRI works.Do not start or stop other medications without talking to your healthcare provider.Tell healthcare professionals about all medications you are taking, including prescription and over-the-counter medications, vitamins, and herbal supplements.

PREGNANCY AND BREAST FEEDING:

XCOPRI may make your birth control medicine less effective.Talk to your health care provider about the best method of birth control to use.

Tell 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 health care provider right away if you become pregnant while taking XCOPRI. You and your healthcare professional will decide if you should take XCOPRI during your pregnancy. If you become pregnant while taking XCOPRI, talk to your healthcare provider about joining the North American Antiepileptic Drug Pregnancy Registry (NAAED). The purpose of this registry is to collect information on the safety of antiepileptic medicines during pregnancy. You can register for this registry by calling 1-888-233-2334 or by going to www.aedpregnancyregistry.org.

Tell your health care provider if you are breastfeeding or plan to breastfeed.It is not known if XCOPRI passes into breast milk. Discuss with your healthcare provider the best way to feed your baby while taking XCOPRI.

COMMON SIDE EFFECTS:

The most common side effects in patients taking XCOPRI include dizziness, drowsiness, 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 effects that bother you or that don’t go away. For more information, ask your health care provider or pharmacist.Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088or atwww.fda.gov/medwatch.

DRUG ABUSE:

XCOPRI is a Federally Controlled Substance (VC) because it can be abused or addictive.Store 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 replace a discussion with your healthcare provider about your condition or your treatment.

Please see fullPrescribing Information.

Media inquiries
SK Biopharmaceuticals
H. Park, communication manager
Hyunkyung Chodeputy communications manager
[email protected]

SOURCE SK Biopharmaceuticals Co.,Ltd

Luz W. German