Cenobamate

Pfizer and 3SBio's PD-1xVEGF deal, the FDA's first approval for an Alzheimer's disease blood test and Samsung Biologics' planned spinoff of Samsung Bioepis made our news this week. Pfizer is paying $1.25 billion to join the PD-(L1)xVEGF bispecific race. The FDA has granted its first official approval to a blood-based Alzheimer's disease test in a potential boon to anti-amyloid drugs. Samsung Biologics plans to spin off its biosimilars business. And more.1. Pfizer pays 3SBio $1.25B for PD-1xVEGF bispecific, joining red-hot race with BioNTech, MerckIn another major PD-(L)1xVEGF bispecific deal, Pfizer is shelling out $1.25 billion upfront for ex-China rights to 3SBio’s clinical candidate SSGJ-707. The deal includes up to $4.8 billion in milestones and a $100 million equity investment in the Chinese company. The drug is slated to enter phase 3 in China, with the first late-stage trial to test its mettle in first-line, PD-L1-positive non-small cell lung cancer.2. FDA clears its first blood test for diagnosing Alzheimer's disease, with Fujirebio's LumipulseFor Eisai and Biogen's Leqembi, first FDA-approved Alzheimer's blood test will take time to boost launch: analystThe FDA has issued the first approval for an Alzheimer’s disease blood test. The approval went to Fujirebio Diagnostics’ Lumipulse G pTau 217/beta-amyloid 1-42 plasma ratio test for the assessment of amyloid plaques. Eisai and Biogen have suggested that blood-based tests have the potential to boost the uptake of anti-amyloid antibodies such as Leqembi by replacing cumbersome PET scans or cerebrospinal fluid tests at least for some patients. But Mizuho analyst Salim Syed argued that payer reimbursement and physician user behavior remain key factors affecting how these tests could help Leqembi grow.3. CDMO Samsung Biologics telegraphs spinoff of biosim unitSamsung Biologics plans to spin off its biosimilars outfit Samsung Bioepis as the CDMO tries to allay concerns around potential conflicts of interest. Following the spinoff, Samsung Bio will focus on its contracting business, while Samsung Bioepis will continue to work on biosimilar products. The spinoff is planned for Oct. 1, subject to possible changes.4. Stars align for CRISPR Tx, Sirius as pair pens siRNA collab with a focus on thrombotic diseaseCRISPR Therapeutics is paying $25 million upfront in cash and $70 million in equity to work on multiple siRNA targets with Sino-American company Sirius Therapeutics. The initial focus is Sirius’ lead program, a long-acting, factor XI-inhibiting anticoagulant for thromboembolic disorders. Under the deal, CRISPR can pick up to two more siRNA targets.5. WuXi Biologics slims down again, handing off German plant to CDMO Terumo for $167MWuXi Biologics is shedding another facility, this time selling its site in Leverkusen, Germany, site to fellow CDMO Terumo for 150 million euros ($167 million). With the deal, WuXi Bio has finished its strategic review of all its sites, leaving the company to focus on building out its large Singapore site.6. With Illumina sequencers under an import ban, PacBio expands its footprint in ChinaAs Illumina faces a DNA sequencer ban in China, rival manufacturer PacBio is expanding a distribution agreement with local company Haorui Gene. Under the new deal, the Xi’an-based company will now distribute the recently launched Vego benchtop system, growing the reach of PacBio's hi-fi long-read sequencers.Other News of Note:7. After WHO loses its top donor in US, Novo Nordisk Foundation and China step up with large contributions8. Eisai mounts targeted TV ad push to raise awareness of Leqembi9. CDMO Bora Biologics expands operations in San Diego in wake of acquisition by Tanvex10. SK defeats Pfizer in Korean patent feud, opening new lines of business for pneumococcal vaccine11. SK Life Science starts TV ad campaign to drive patients to seizure drug Xcopri

PARAMUS, N.J., April 4, 2025 /PRNewswire/ -- SK Life Science, Inc., a global leader in developing treatments for central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals Co., Ltd., will present meaningful encore data on XCOPRI® (cenobamate tablets) CV, an anti-seizure medication, at the 77th American Academy of Neurology (AAN) Annual Meeting, taking place April 5-9, 2025, in San Diego, California. This presentation reinforces the growing body of clinical and real-world evidence supporting cenobamate's role in reducing seizure activity and optimizing epilepsy management. "Our goal at SK Life Science is to redefine seizure management by advancing research and education that translates into meaningful improvements for people living with epilepsy," said Louis Ferrari, BS, RPh, MBA, vice president, Medical Affairs at SK Life Science, Inc. "Seizure freedom remains an elusive, yet critical, objective for many patients, and this research offers valuable insights into how RNS data can be used as an objective measure to assess the efficacy of XCOPRI, and possibly other add-on anti-seizure medications." At AAN 2025, SK Life Science will highlight the impact of cenobamate on RNS epileptiform events. A retrospective, multicenter, observational, 24-week study among 37 patients with uncontrolled seizures showed a meaningful reduction in epileptiform events and clinically reported seizures during adjunctive cenobamate treatment. Results from this analysis support, through electrocorticographic data and observation of clinical seizures, the effectiveness of cenobamate in the treatment of focal seizures. Additional clinical and real-world data exploring cenobamate's efficacy, safety, and therapeutic potential in diverse patient populations will also be presented. Select SK Life Science posters presented at 2025 AAN include: Title: The Effect of Cenobamate on Responsive Neurostimulation Epileptiform Events (Aboumatar et al) Session: P5: Epilepsy/Clinical Neurophysiology (EEG): Neuromodulation Devices and Seizure Tracking Date/Time: Monday, April 7, from 8:00 a.m. – 9:00 a.m. PT Abstract Number: 2991 Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Cenobamate in Asian Patients With Focal Seizures, With Optional Open-Label Extension (Misra et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials Date/Time: Tuesday, April 8, from 8:00 a.m. – 9:00 a.m. PT Abstract Number: 1406 Title: Early Response Rates With Adjunctive Cenobamate in Uncontrolled Focal Seizures: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population (Pradhan et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials Date/Time: Tuesday, April 8, from 8:00 a.m. – 9:00 a.m. PT Abstract Number: 1404 Title: Efficacy of Adjunctive Cenobamate by Focal Seizure Subtypes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population (Ferrari et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials Date/Time: Tuesday, April 8, from 8:00 a.m. – 9:00 a.m. PT Abstract Number: 1408 Title: Clarification of the Mechanism of Action of Cenobamate (Sankar et al) Session: P9: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Mechanisms and Pharmacology Date/Time: Tuesday, April 8, from 11:45 a.m. – 12:45 p.m. PT Abstract Number: 1381 Title: Wide Range of Cenobamate Doses Associated With Initial Seizure Freedom in Patients With Uncontrolled Focal Seizures: Post-hoc Analysis of a Phase 3, Multicenter, Open-Label Study (Rosenfeld et al) Session: P12: Epilepsy/Clinical Neurophysiology (EEG): Retrospective Studies, Reviews, and Meta-analyses in Epilepsy Date/Time: Wednesday, April 9, from 11:45 a.m. – 12:45 p.m. PT Abstract Number: 158 A complete list of SK Life Science abstracts presented at AAN 2025 can be found here. In addition to these scientific presentations, SK Life Science, Inc. will host a booth (#223) in the Exhibit Hall, open from 11:30 a.m. PT on Sunday, April 6, 2025, until 4 p.m. PT on Wednesday, April 9, 2025. Attendees are encouraged to visit the booth to learn more about SK Life Science's commitment to epilepsy research and patient care. About SK Life Science, Inc. and SK Biopharmaceuticals Co., Ltd. SK Life Science, Inc., with headquarters in Paramus, New Jersey, is a U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a pioneering South Korean company in drug development and commercialization. Together, they are advancing innovative treatments for central nervous system (CNS) disorders and oncology, with eight compounds currently in development. Utilizing target-based drug discovery, high-throughput organic screening/high content screening, computer-aided drug design, and combinatorial chemistry, the companies drive R&D efforts in biology/discovery, medicinal chemistry, pharmacology, and clinical development. For more information, visit . SK Biopharmaceuticals Co., Ltd. is part of SK Group, South Korea's second-largest conglomerate. SK Group is a collection of global industry-leading companies driving innovations in energy, advanced materials, biopharmaceuticals and digital business. Based in Seoul, SK invests in building sustainable businesses around the world with a shared commitment to reducing global greenhouse gas emissions. SK companies combined have $151 billion in global annual revenue and employ more than 100,000 people worldwide. SK Group is one of TIME's 100 Most Influential Companies of 2023. SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Inc. is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information about SK Inc., visit . For more information about SK Biopharmaceuticals, visit . About XCOPRI® (cenobamate tablets) CV Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. Cenobamate reduces neuronal excitability through a unique dual mechanism of action, preferentially inhibiting the persistent sodium current and enhancing GABAergic inhibition at the type A γ-aminobutyric acid (GABAA) ion channel. The precise mechanism by which cenobamate exerts its therapeutic effect is unknown. Cenobamate is marketed under the brand name XCOPRI® in the U.S. by SK Life Science, Inc. Additionally, XCOPRI is commercialized in Canada and Israel by SK Biopharmaceuticals' partners, Paladin Labs Inc. and Dexcel Ltd. Cenobamate is marketed as ONTOZRY® by Angelini Pharma S.p.A. in Europe, the UK, and Switzerland. Cenobamate is also being developed for commercialization by SK Biopharmaceuticals' partners in many other countries to meet the needs of patients living with epilepsy, including Dong-A ST Co., Ltd., Eurofarma Laboratórios S.A., Hikma MENA FZE, Ignis Therapeutics, Inc. and ONO Pharmaceutical Co., Ltd. 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 1-888233-2334 or go to . 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 . 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 Epilepsy Epilepsy is the fourth most common neurological disorder. There are approximately 3.4 million people living with epilepsy in the United States, with 150,000 new cases each year in the country.1,2 Epilepsy is characterized by recurrent, unprovoked seizures. The seizures in epilepsy may be related to a brain injury or a family tendency, but often the cause is completely unknown. Having seizures and epilepsy can affect one's safety, relationships, work, driving, and much more.3,4 People with epilepsy are at risk for accidents and other health complications, including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).3,4 Despite the availability of many antiepileptic therapies, almost 40 percent of people with epilepsy are not able to achieve seizure freedom, meaning they have epilepsy that remains uncontrolled.5 XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals Co., Ltd. References Cleveland Clinic. Epilepsy. . Accessed April 2025. Epilepsy Foundation. Facts & Statistics About Epilepsy. . Accessed April 2025. Epilepsy Foundation. Staying Safe. . Accessed April 2025. Epilepsy Foundation. Complications and Risks. . Accessed April 2025. Chen Z, Brodie MJ, Liew D, Kwan P. Treatment outcomes in patients with newly diagnosed epilepsy treated with established and new antiepileptic drugs: a 30-year longitudinal cohort study. . Published online December 26, 2017. SOURCE SK Life Science, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED