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Category Archives: Neurology
French sales subsidiary of Japanese pharma firm Eisai divests rights of neurology drugs for 56.5 M – BSA bureau
Japan headquartered pharma company Eisai Co. has announced that its French sales subsidiary Eisai S.A.S. has entered into an agreement to transfer the rights in France, the French Overseas Territories and Algeria (the Territory for the antipsychotic, Loxapac (generic name: loxapine) and the Parkinson's disease treatment ParkinaneLP (generic name: trihexyphenidyl hydrochloride) to CNX Therapeutics, based in UK.
Following the signature of this agreement, a transition period had opened during which the required implementation steps will be carried out in order for CNX to become able to operate directly the business, including the regulatory steps for the transfer of the relevant marketing authorisations andexploitantstatus.
Under the terms of the agreement, Eisai S.A.S. will receive 56.5 million euro as a lump-sum contract payment upon completing the transaction. Eisai anticipates no changes to its consolidated financial forecast for the period ending March 31, 2024.
Eisai S.A.S. acquired the rights to both treatments in the Territory in July 2002 and has been marketing them since. With the conclusion of this agreement, Eisai believes that the value of both treatments in the Territory will be maximised based on CNXs ongoing commitment serving patients in to the fields of psychiatry and neurology.
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French sales subsidiary of Japanese pharma firm Eisai divests rights of neurology drugs for 56.5 M - BSA bureau
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Hackensack Meridian Neuroscience Institute at JFK University Medical Center Receives $2.2 Million Research Grant to … – Newswise
Hackensack Meridian Neuroscience Institute at JFK University Medical Center announced today that it has been awarded a major research grant from the National Institute of Neurological Disorders and Stroke, part of the U.S. National Institutes of Health, to study a novel approach on whether the blocking of formation of Neutrophil extracellular traps (NET) provides better outcomes after a Traumatic Brain Injury (TBI). The five-year award of $2,213,750 is part of the highly competitive NIH extramural grant application process that recognizes innovative scientific projects. NIH-funded research has led to scientific breakthroughs and new treatments that help people live longer, healthier lives.
The NIH grant will fund a project entitled Neutrophil Extracellular Traps And Associated Pathogenesis In TBI: A Novel Peptide Therapeutic Strategy proposed by Mohammed Abdul Muneer, MSc, PhD, Research Scientist & Principal Investigator, Hackensack Meridian Neuroscience Institute at JFK University Medical Center, and Associate Professor of Neurology at the Hackensack Meridian School of Medicine.
The work hypothesizes that inhibition of peptidyl arginine deiminase type 4 (PAD4), an enzyme required for NET formation, using PAD4 antagonistic peptide (PAP), will attenuate the formation of NET, NET-induced thrombosis, and will promote neovascularization and functional recovery after TBI.
We are honored to receive this prestigious NIH grant, said Gregory J. Przybylski, M.D., MBA, chairman, Hackensack Meridian Neuroscience Institute at JFK University Medical Center, and Professor of Neurosurgery at the Hackensack Meridian School of Medicine. I congratulate Dr. Muneer and his team for this incredible achievement. This is yet another research grant that he has received from the NIH. It is a testament to his hard work, dedication, and leadership in the neuroscience field.
The Muneer lab at the Hackensack Meridian Neuroscience Institute at JFK University Medical Center seeks to demonstrate a unique therapeutic strategy for TBI focusing on the activation of leukocytes, especially neutrophils that cause the release of nuclear and granular contents to form an extensive web-like structure of DNA called neutrophil extracellular traps (NET). In TBI, the mechanism of injury-induced formation of NET and its mechanistic regulatory role in thrombosis have remained elusive. Moreover, it is unclear whether blocking NET formation provides better outcomes after TBI. Therefore, Dr. Muneers novel research efforts to suppress the formation of NET will provide critical information potentially supporting a valuable new therapeutic strategy to enhance functional recovery following TBI.
My research team and I will study an approach to suppressing the formation of NET, which may be a valuable therapeutic strategy, and analyze the efficacy of the therapy in the functional recovery level after TBI, said Dr. Muneer.
The Neuroscience Institute at JFK University Medical Center has been in existence for over 30 years, said Gay Holstein, PhD, translation research, Neuroscience Institute at JFK University Medical Center. We are honored to receive this research grant and look forward to the findings.
TBI is such an omnipresent problem, its critical to have our talented researchers findings new ways to improve and lengthen lives for this significant patient population, said Ihor Sawczuk, M.D., FACS, president of Academics, Research, and Innovation at Hackensack MeridianHealth, founding chair of the Hackensack MeridianHealthResearch Institute, and associate dean of Clinical Integration and professor and chair emeritus of Urology at the Hackensack Meridian School of Medicine.
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SK Life Science Announces Data Presentations for XCOPRI (cenobamate tablets) CV at the 2024 American Academy … – InvestorsObserver
PARAMUS, N.J. , April 9, 2024 /PRNewswire/ -- SK Life Science, Inc. , a U.S. pharmaceutical company in pursuit of developing treatments that will change the future of central nervous system (CNS) disorders, today announced the schedule for two oral and six poster presentations at the American Academy of Neurology (AAN) Annual Meeting taking place April 1318, 2024, virtually and in-person in Denver, Colorado . The data includes a study examining the relative bioavailability of cenobamate as an intact or crushed tablet administered either orally or via nasogastric tube, and a retrospective claims-based analysis comparing the effectiveness of cenobamate in reducing hospitalizations among patients with focal-onset seizures.
"We are looking forward to sharing data on the use and administration of XCOPRI in adults with partial-onset (focal) seizures at this year's AAN meeting," said Louis Ferrari , RPh, MBA, vice president, Medical Affairs. "At SK Life Science we are continually conducting research that will help healthcare professionals and equip them with the information they need to care for patients living with the challenges of epilepsy. We continue to do this via ongoing research, relevant post-hoc analyses, and the publication of real-world data on the use of cenobamate in the U.S. and globally."
Abstracts are available online on the AAN meeting website here and on site at booth #1262. The schedule of oral and poster presentations is detailed below.
Oral Presentations
Title: Comparative Effectiveness of Cenobamate in Reducing Hospitalizations in Patients with Focal-Onset Seizures: A Retrospective Claims-Based Analysis (Urban et al) Session: S29: Epilepsy Diagnostics and Therapeutics Date: Wednesday, April 17 Time: 1:24 PM
Title: Relative Bioavailability of Cenobamate 200 mg Administered as a Crushed Tablet, Either Orally or via Nasogastric Tube, vs an Intact 200-mg Cenobamate Tablet (Vashi et al) Session: S29: Epilepsy Diagnostics and Therapeutics Date: Wednesday, April 17 Time: 1:36 PM
Poster Presentations
Title: Effectiveness Of Cenobamate in Pediatric Patients with Lennox-Gastaut Syndrome: A Retrospective Claims-based Analysis (Keough et al) Session: P1: Epilepsy/Clinical Neurophysiology (EEG): Pediatric Epilepsy 1 Date: Sunday, April 14 Time: 8:00 9:00 AM
Title: Effectiveness Of Cenobamate in Pediatric Patients with Intractable Focal Seizures: A Retrospective Claims-based Analysis (Labiner et al) Session: P2: Epilepsy/Clinical Neurophysiology (EEG): Pediatric Epilepsy 2 Date: Sunday, April 14 Time: 11:45 AM 12:45 PM
Title: Increased Incidence of Comorbidities in Patients with Uncontrolled Epilepsy (Faught et al) Session: P4: Epilepsy/Clinical Neurophysiology (EEG): Epilepsy Co-morbidities and Special Populations Date: Monday, April 15 Time: 11:45 AM 12:45 PM
Title: Effectiveness Of Cenobamate in Postsurgical Patients: A Retrospective Claims-based Analysis (Pellinen et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials and Outcomes Date: Tuesday: April 16 Time: 5:30 6:30 PM
Title: Cenobamate Use as Monotherapy: A Retrospective Claims-based Analysis (Becker et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials and Outcomes Date: Tuesday, April 16 Time: 5:30 6:30 PM
Title: Dose Reduction Timing for Concomitant Antiseizure Medications: Post-hoc Analysis of a Phase 3, Open-label Study Of Cenobamate For Treatment Of Uncontrolled Focal Seizures (Ferrari et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials and Outcomes Date: Tuesday, April 16 Time: 5:30 6:30 PM
AboutXCOPRI (cenobamatetablets) CV Cenobamateis an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. While theprecise mechanism by whichcenobamateexerts its therapeutic effect is unknown, it is believed toreduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the -aminobutyric acid (GABA A ) ion channel.
Cenobamateis approved in the United States for the treatment ofpartial-onset seizures inadults andis available under the brand name XCOPRI (cenobamatetablets) CV.Cenobamatecan be combined with other ASMs or used alone.The recommended initial dosage ofcenobamateis 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.
Cenobamateis also approved in the European Union and the United Kingdomfor the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with seizuresthathave not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinalproductsand is marketed by Angelini Pharma under the brand nameONTOZRY .
Additionally,cenobamateis in clinical development in Asia . Ono Pharmaceutical and Ignis Therapeutics have the rights to develop and commercializecenobamatein Japan and in the Greater China region, respectively.SK Biopharmaceuticals has recently entered into an exclusive licensing agreement with Endo for cenobamate in Canada .
IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI (cenobamate tablets) CV
DO NOT TAKE XCOPRI IF YOU:
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 http://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 http://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 Epilepsy
Epilepsy is the fourth most common neurological disorder. Approximately 3.4 million people are 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
About SK Biopharmaceuticals Co., Ltd. and SK Life Science, Inc.
SK Biopharmaceuticals and its U.S. subsidiary SK Life Science are pharmaceutical companies focused on the research, development, and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin its expansion into oncology through research and development efforts. The companies have a pipeline of eight compounds in development in both CNS disorders and oncology. Additionally, SK Biopharmaceuticals is focused on the discovery of new treatments in oncology. For more information, visit SK Biopharmaceuticals' website at http://www.skbp.com/eng and SK Life Science's website at http://www.SKLifeScienceInc.com .
Both SK Biopharmaceuticals and SK Life Science are part of SK Group, one of the largest conglomerates in Korea. 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.
References
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SK Life Science Announces Data Presentations for XCOPRI (cenobamate tablets) CV at the 2024 American Academy ... - InvestorsObserver
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This Week on NeurologyLive April 8, 2024 – Neurology Live
Every week, the NeurologyLive staff prepares this preview of what to expect from our coverage. This week on NeurologyLive, there are a number of hot topics that we will be posting on the website. As always, our weekly coverage extends beyond just these topics, so make sure to check out the rest of the site!
Click through the slides below to see what you can expect from our team this week. Click any slide to check out the content.
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This Week on NeurologyLive April 8, 2024 - Neurology Live
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Quality of Life in MG – Neurology Live
This is a video synopsis/summary of a panel discussion involving James Howard, MD; Nicholas Silvestri, MD, FAAN; Tuan Vu, MD; Ali Habib, MD; and Beth Stein, MD.
The discussion delves into the administration of treatments for myasthenia gravis (MG), emphasizing its impact on patients' quality of life. Traditionally, Intravenous immunoglobulin (IVIG) has been the go-to therapy for disease exacerbations, but this paradigm is shifting with the emergence of newer therapies, each with its own unique administration methods.
The insidious progression of MG often sets a new normal for patients, leading them to attribute symptoms to aging rather than disease progression. Physicians must engage patients in conversations about the risks and benefits of trying new treatments, challenging the notion that certain limitations are solely due to age.
Moreover, as MG symptoms are brought under control, it's crucial not to attribute every symptom to the disease itself. Patients may have other comorbidities contributing to their symptoms, requiring a comprehensive approach to management.
The term "refractory" is controversial, with physicians acknowledging that almost every patient responds to some degree of treatment. However, there's a push to redefine success in MG management, aiming for optimal control with minimal side effects.
Physicians note varying experiences with treatment efficacy, influenced by factors like patient demographics and practice settings. With the goal of achieving no symptoms and minimal adverse events, the consensus is that a significant portion of patients can achieve better outcomes with current therapies. Practice settings may influence success rates, with university-based practices potentially encountering more complex cases.
Overall, the conversation highlights the need for a patient-centered approach to MG management, with an emphasis on individualized treatment plans and realistic expectations for outcomes.
Video synopsis is AI-generated and reviewed by NeurologyLive editorial staff.
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Quality of Life in MG - Neurology Live
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