Biocodex To Present New Data at the American Epilepsy Society (AES) 2025 Annual Meeting

Biocodex, a global pharmaceutical company and long-time pioneer in the treatment of rare pediatric diseases, will present 12 studies at the upcoming AES 2025 Annual Meeting in Atlanta, Georgia, December 5-9. The studies focus on the use of stiripentol and its impact on patients with Dravet syndrome.

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Carla Schad, MD, Biocodex North American Medical Officer, previewed what providers can expect to see from Biocodex at AES this year.

“Biocodex USA is thrilled to be attending AES this year. We are dedicated to bringing new data to our healthcare providers and researchers; but most importantly, our AES attendance will highlight our partnerships with thought leaders and advocates. At Biocodex, our commitment and promise are to always keep the patient first.”

Key scientific and patient-focused data includes:

Poster Number Poster Title Poster on Display Author Present Time1.386 Real-World Use and Saturday December 6, Noon – 2 PM Effectiveness of Stiripentol Session 1, Noon – 6 in U.S. Patients With PM, Exhibit Hall B2 Dravet Syndrome: Results from the STIRUS Study1.39 Long-Term Effectiveness of Stiripentol in Reducing Seizure Burden and Status Epilepticus in Dravet Syndrome: Results From a 3-Year Japanese Post- Marketing Surveillance2.107 Evaluating Current Sunday December 7, Noon – 2 PM Practices and Session 2, 10 AM – 4 Communication PM, Exhibit Hall B2 Surrounding Sudden Unexpected Death in Epilepsy (SUDEP)2.426 Need for Reintroductionof Stiripentol After Weaning in Patients With Dravet Syndrome: A Multicenter Case Series2.436 Stiripentol Use in Dravet Syndrome Is Associated With Lower Mortality Rates in a Real-World Cohort2.444 Practical Consensus Recommendations for Rational Polytherapy Involving Stiripentol in Dravet Syndrome: Results of a US Cohort2.446 Underutilization of FDA- Approved Dravet Syndrome Specific Therapies: Findings From a US Multi-Center Survey and Advisory Board2.452 Real-World Utilization of Stiripentol (STP) by United States (US) Prescribers: A 3-Year Analysis Update3.374 Efficacy and Tolerability of Monday December 8, Noon – 1:45 PM Stiripentol Across Non- Session 3, 8 AM – 2 Dravet Developmental and PM, Poster Hall B3 Epileptic Encephalopathies: A Literature Review Including Genetic and Syndromic Epilepsies3.375 Real-World Utilization of Stiripentol in Children Aged Three Years and Younger: A US Perspective3.382 Practical Consensus Recommendations for Polytherapy Involving Stiripentol in Dravet Syndrome: A Nominal Group Approach3.436 Stiripentol Use in Lennox- Gastaut Syndrome: Results From a Phase 2 Clinical Trial

Symposia Programs atthe AES 2025 Annual Meeting

Biocodex will be hosting two informational symposia at this conference, focusing on the following:

Symposia Description Speaker Date, Time,Title LocationDiagnostic and In this fireside chat-style program, Julie Ziobro, MD, Saturday,Treatment recent data regarding the diagnostic PhD, December 6,Disparities in and treatment disparities in Dravet Assistant Professor 1:30 PM -Dravet syndrome will be examined. of Pediatrics 2:30 PM,Syndrome Recommended guidelines developed Division of Pediatric Georgia by leading epileptologists routinely Neurology, World treating Dravet will be shared with University of Congress the audience on how to accurately Michigan, Ann Arbor Center, diagnose and properly treat Dravet Mary Anne Meskis, Product syndrome for optimal outcomes. Chief Executive Theater 2, in Officer, the Exhibit Dravet Syndrome Hall Foundation Kelly Gwin, PharmD, Director, Field Medical Affairs, Biocodex Inc.Optimizing a An informative presentation that James W. Wheless, Saturday,Treatment discusses the impact of Dravet BScPharm, MD, December 6,Option for syndrome, signs and symptoms of FAAP, FACP, FAAN, 3:30 PM -Patients With the disease, as well as the FAES 4:30 PM,Dravet Syndrome importance of early intervention. Georgia Learn about an approved therapy for World patients with Dravet syndrome. Congress Center, Product Theater 2, in the Exhibit Hall

About Dravet Syndrome

Dravet syndrome is a rare and severe genetic epilepsy that most commonly begins before the age of one, when an otherwise normally developing child begins having frequent, prolonged seizures.1 These seizures can cause lasting damage, which over time can lead to developmental and cognitive delays affecting coordination, language, and behavior.2 Its incidence is estimated to be 1 in 16,000 births.3

About Biocodex

Founded in 1953, Biocodex is a French family-owned pharmaceutical company that leverages life sciences, placing health and its balance at the heart of its corporate initiatives, innovations, and development for the benefit of patients worldwide.

A pioneer and leader in human microbiota health by marketing the first probiotic strain, the global organization has developed its activities around three strategic areas: microbiota, women's health, and orphan diseases. It has also expanded its expertise by investing in other health areas, such as pain management; respiratory and ear, nose, and throat (ENT) pathways; and neurology.

Present in 115 countries through its subsidiaries and partners, Biocodex emphasizes its territorial roots, which are central to its corporate social responsibility, producing in France for over 50 years across most of its value chain.

The Biocodex global organization comprises 1,700 employees who share common values, embodied in their daily missions and rooted in the company's DNA.

To learn more about Biocodex visit: www.biocodex.us/en/

To learn more about DIACOMIT® (stiripentol) visit: www.diacomit.com

INDICATION

DIACOMIT (stiripentol) is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6months of age and older and weighing 7kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None

WARNINGS & PRECAUTIONS

Somnolence

DIACOMIT can cause somnolence. Monitor patients for somnolence, particularly when DIACOMIT is used concomitantly with other CNS depressants or clobazam, which is also known to cause somnolence.

Decreased Appetite and Decreased Weight

DIACOMIT can cause decreases in appetite and weight. The growth and weight of pediatric patients treated with DIACOMIT should be carefully monitored.

Neutropenia and Thrombocytopenia

DIACOMIT can cause significant declines in neutrophil and platelet counts. Hematologic testing should be obtained prior to starting treatment with DIACOMIT and then every 6 months.

Withdrawal Symptoms

As with most antiepileptic drugs (AEDs), DIACOMIT should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.

Risks in Patients with Phenylketonuria (PKU)

DIACOMIT for oral suspension contains phenylalanine, which can be harmful to patients with PKU. Before prescribing DIACOMIT for oral suspension to a patient with PKU, consider the total daily intake of phenylalanine from all sources, including DIACOMIT for oral suspension. DIACOMIT capsules do not contain phenylalanine.

Suicidal Behavior and Ideation

AEDs, including DIACOMIT, increase the risk of suicidal thoughts or behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

ADVERSE REACTIONS

The most common adverse reactions that occurred in at least 10% of DIACOMIT-treated patients and more frequently than on placebo were somnolence, decreased appetite, agitation, ataxia, decreased weight, hypotonia, nausea, tremor, dysarthria, and insomnia.

PREGNANCY

There are no adequate data on the developmental risks associated with the use of DIACOMIT in pregnant women. Based on animal data, DIACOMIT may cause fetal harm.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as DIACOMIT, during pregnancy. Physicians are advised to recommend that pregnant patients taking DIACOMIT enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (information at www.aedpregnancyregistry.org). This can be done by calling the toll-free number1-888-233-2334and must be done by patients themselves or their caregiver. To report suspected adverse reactions, contact Biocodex at1-866-330-3050or FDA at1-800-FDA-1088or www.fda.gov/medwatch.

Please see full DIACOMIT Prescribing Information at www.DIACOMIT.com.

References: 1. Dravet C. The core Dravet syndrome phenotype.Epilepsia. 2011;52 Suppl 2:3-9.doi:10.1111/j.1528-1167.2011.02994. 2. Genton P, Velizarova R, Dravet C. Dravet syndrome: the long-term outcome.Epilepsia. 2011;52 Suppl 2:44-49. doi:10.1111/j.1528-1167.2011.03001. 3. Wu YW, Sullivan J, McDaniel SS, et al. Incidence of Dravet Syndrome in a US Population.Pediatrics. 2015;136(5):e1310-e1315. doi:10.1542/peds.2015-1807

© 2025 Biocodex, Inc. All rights reserved. DIACOMIT® is a registered trademark of Biocodex, Inc.

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