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Zogenix To Present New FINTEPLA® (fenfluramine) Data at AES 2021

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  • ZGNX

Data add to the growing body of evidence supporting the efficacy and safety profile of FINTEPLA for the treatment of Dravet syndrome

EMERYVILLE, Calif., Dec. 02, 2021 (GLOBE NEWSWIRE) -- Zogenix (Nasdaq: ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that it will present new FINTEPLA® (fenfluramine) data from eight abstracts at the American Epilepsy Society (AES) Annual Meeting, taking place from December 3-7, 2021, in Chicago, IL. The Company will also have an additional four posters in a virtual scientific exhibition room and is sponsoring the Better Outcomes Through Diversity poster session during AES 2021.

“We continue to see positive safety and efficacy data of FINTEPLA for individuals with Dravet syndrome and Lenox-Gastaut syndrome,” said Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer, Zogenix. “As neurodevelopmental impairment is a major challenge for patients and caregivers of children with Dravet syndrome, the data highlighting the impact of FINTEPLA on executive function in preschool children could be particularly impactful for this community.”

Main Conference

Full data for the posters presented in the main conference will be available on the AES 2021 conference site beginning on Friday, December 3, 2021, at 9:00 AM Central Time, and will also be available following AES on the Zogenix Newsroom site. Authors will be available to discuss their data with attendees during the following times:

  • Fenfluramine (Fintepla®) Treatment Improves Everyday Executive Functioning in Preschool Children With Dravet Syndrome: Analysis From 2 Pooled Phase 3 Clinical Trials
    Bishop, Isquith, Gioia, et al.
    Poster # 2.413
    Authors available: Sunday, December 5, 2021, 12:00 – 2:00 PM CT

  • Fenfluramine (Fintepla®) Significantly Reduces Day-to-Day Seizure Burden by Increasing Seizure-Free Days: A Time-to-Event Analysis of a Phase 3 Study in Dravet Syndrome
    Sullivan, Specchio, Devinsky, et al.
    Poster # 3.280
    Authors available: Monday, December 6, 2021, 12:00 – 1:45 PM CT

  • Serial Echocardiographic Assessment of Patients with Dravet Syndrome Treated with Fenfluramine (Fintepla®) for up to 3 years: No incidence of Valvular Heart Disease or Pulmonary Artery Hypertension
    Agarwal, Farfel, Gammaitoni, et al.
    Poster # 3.415
    Authors available: Monday, December 6, 2021, 12:00 – 1:45 PM CT

  • Fenfluramine (Fintepla®) Provides Clinically Meaningful and Durable Improvement in Seizure Frequency in Patients With Dravet Syndrome Regardless of Age: “Real-World” Use in a European Early Access Program
    Guerrini, Specchio, Aledo-Serrano, et al.
    Poster # 1.298
    Authors available: Saturday, December 4, 2021, 12:00 – 2:00 PM CT

  • Fenfluramine Directly Inhibits Cortical Spreading Depolarization—A Pathophysiologic Process Linked to SUDEP
    Ning, Reeder, Noebels, et al.
    Poster # 3.394
    Authors available: Monday, December 6, 2021, 12:00 – 1:45 PM CT

  • Fenfluramine Exhibits Disease-Modifying Effects in a Mouse Model of Dravet Syndrome
    Reeder, Cha, Filatov, et al.
    Poster # 3.392
    Authors available: Monday, December 6, 2021, 12:00 – 1:45 PM CT

  • Dual Activity of Fenfluramine (Fintepla®) as a Serotonin Receptor Agonist and Positive Sigma-1 Receptor Modulator: Implication for Disease Modification in Developmental and Epileptic Encephalopathies
    Reeder, Martin, Sourbron, et al.
    Poster # 3.393
    Authors available: Monday, December 6, 2021, 12:00 – 1:45 PM CT

  • Sleep Disturbance in Parents of Individuals with Epileptic Encephalopathy
    Salem, Amtmann, Bamer, et al.
    Poster #2.371
    Authors available: Sunday, December 5, 2021, 12:00 – 2:00 PM CT

Scientific Exhibit Room

All eight posters from the main conference above, plus four additional Scientific Exhibit Room posters, will be available in the Zogenix Scientific Exhibit Room. Questions regarding data in the Scientific Exhibition Room will be answered during a live discussion on Sunday, December 5, 2021, 8:00 AM 1:00 PM Central Time.

  • Fenfluramine (Fintepla®) provides prolonged periods of seizure-free days in patients with Dravet syndrome: using a time-to-event analysis to measure treatment effect.
    Sullivan, Specchio, Devinksky, et al.

  • Fenfluramine (Fintepla®) provides clinically meaningful reduction in frequency of seizures resulting in a drop in patients with Lennox-Gastaut syndrome for up to 1 year: interim analysis of an open-label extension study.
    Knupp, Scheffer, Ceulemans, et al.

  • Fenfluramine (Fintepla®) Treatment Improves Everyday Executive Functioning in Patients With Lennox-Gastaut Syndrome: Analysis From a Phase 3 Clinical Trial.
    Bishop, Isquith, Gioia, et al.

  • Impact of Fenfluramine (Fintepla®) on the expected SUDEP mortality rates in patients with Dravet syndrome.
    Cross, Galer, Gil-Nagel, et al.

Zogenix is sponsoring the Better Outcomes Through Diversity poster session, which will be held on Sunday, December 5, 2021, from 5:15 p.m. to 6:15 p.m. Central Time. The event will feature 50 posters on research by and/or about individuals from underrepresented minority groups.

About Dravet Syndrome

Dravet syndrome is a rare, devastating and life-long form of epilepsy that generally begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of sudden unexpected death in epilepsy (SUDEP). Affecting one in 15,700 live births in the U.S. and approximately one in 20,000 to 40,000 live births in Europe, most patients follow a course of developmental delay with cognitive, motor, and behavioral deficits that persist into adulthood. Dravet syndrome severely impacts quality of life for patients, families, and caregivers due to the high physical, emotional, caregiving, and financial burden associated with the disease.

About Lennox-Gastaut Syndrome

Lennox-Gastaut Syndrome (LGS) is a rare and devastating lifelong childhood-onset epilepsy that can arise from multiple different causes. LGS is characterized by many different seizure types, including many that result in frequent falls and injuries and that often don't respond to currently available seizure medications. The intellectual and behavioral problems associated with LGS, as well as around-the-clock care requirements, add to the complexity of life with this disease.

About FINTEPLA® (fenfluramine) oral solution

FINTEPLA is approved by the FDA and European Commission for the treatment of seizures associated with Dravet syndrome and is in development in Japan for the treatment of seizures associated with Dravet syndrome. FINTEPLA is also being investigated as a potential treatment for Lennox-Gastaut syndrome (LGS) and other rare and severe childhood-onset epilepsy disorders.

United States

IMPORTANT SAFETY INFORMATION
Boxed WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION

  • There is an association between serotonergic drugs with 5HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension.

  • Echocardiogram assessments are required before, during, and after treatment with FINTEPLA.

  • FINTEPLA is available only through a restricted program called the FINTEPLA REMS.

Contraindications
FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use of, or within 14 days of the administration of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome.

WARNINGS AND PRECAUTIONS

Valvular Heart Disease and Pulmonary Arterial Hypertension (see boxed Warning)
Because of the association between serotonergic drugs with 5‑HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension, cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of this condition. In clinical trials of up to 3 years in duration, no patient receiving FINTEPLA developed valvular heart disease or pulmonary arterial hypertension.

Monitoring
Prior to starting treatment, patients must undergo an echocardiogram to evaluate for valvular heart disease and pulmonary arterial hypertension. Echocardiograms should be repeated every 6 months, and once 3-6 months post-treatment with FINTEPLA.

If valvular heart disease or pulmonary arterial hypertension is observed on an echocardiogram, the prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA.

FINTEPLA REMS Program (see boxed Warning)
In the United States, FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS program. Prescribers must be certified by enrolling in the FINTEPLA REMS program. Prescribers must Counsel patients receiving FINTEPLA about the risk of valvular heart disease and pulmonary arterial hypertension, how to recognize signs and symptoms of valvular heart disease and pulmonary arterial hypertension, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Patients must enroll in the REMS program and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the REMS program and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.

Decreased Appetite and Decreased Weight
FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Most patients resumed the expected measured increases in weight by the end of the open-label extension study. Weight should be monitored regularly during treatment with FINTEPLA and dose modifications should be considered if a decrease in weight is observed.

Somnolence, Sedation, and Lethargy
FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery.

Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.

Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Withdrawal of Antiepileptic Drugs
As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered.

Serotonin Syndrome
Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly with concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John’s Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA, dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started.

Increase in Blood Pressure
FINTEPLA can cause an increase in blood pressure. Significant elevation in blood pressure, including hypertensive crisis, has been reported rarely in adult patients treated with fenfluramine, including patients without a history of hypertension. Monitor blood pressure in patients treated with FINTEPLA. In clinical trials of up to 3 years in duration, no patient receiving FINTEPLA developed hypertensive crisis.

Glaucoma
Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain.

Adverse Reactions
The most common adverse reactions (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus.

Drug Interactions
Strong CYP1A2 and CYP2B6 Inducers: Coadministration with rifampin or a strong CYP1A2 and CYP2B6 inducer will decrease fenfluramine plasma concentrations.

Consider an increase in FINTEPLA dosage when coadministered with rifampin or a strong CYP1A2 and CYP2B6 inducer.

Use in Specific Populations
Administration to patients with moderate or severe renal impairment or to patients with hepatic impairment is not recommended.

Please see full Prescribing Information, including Boxed Warning, for additional important information on FINTEPLA.

About Zogenix
Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company’s first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The U.S. FDA recently accepted for filing Zogenix’s supplemental New Drug Application (sNDA) and granted Priority Review for the use of FINTEPLA for the treatment of seizures associated with an additional rare epilepsy, Lennox-Gastaut syndrome (LGS). Zogenix also plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies. The company has an additional late-stage development programs, MT-1621, in a mitochondrial disease called TK2 deficiency.

Forward Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed,” and similar expressions are intended to identify forward-looking statements. These statements include: the potential for FINTEPLA to improve executive function in preschool children; the expected timing of reporting data from clinical trials; Zogenix’s commercialization plans in the U.S. and Europe; and Zogenix’s plans with respect to its development programs. These statements are based on Zogenix’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: FINTEPLA may not achieve broad market acceptance as a treatment option of Dravet syndrome which would limit Zogenix’s ability to general revenues; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in the U.S. and Europe, including due to the costs and procedures related to the REMS certification process or controlled access program; the COVID-19 pandemic may continue to disrupt Zogenix’s business operations, impairing the ability to commercialize FINTEPLA in Europe and Zogenix's ability to generate product revenue in Europe and conduct its development programs; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine that could limit regulatory approval or commercialization, or that could result in recalls or product liability claims; later developments with FDA that may be inconsistent with the already completed meetings; additional data from Zogenix's ongoing studies may contradict or undermine the data previously reported; the potential for the FDA to delay timing of review of the sNDA due to the FDA's internal resource constraints or other reasons; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

CONTACTS:

Zogenix
corpcomms@zogenix.com

Investors
Brian Ritchie
Managing Director, LifeSci Advisors LLC
+1 (212) 915-2578 | britchie@lifesciadvisors.com

Media
Trish McCall, Porter Novelli
+1 (805) 390-3279 | trish.mccall@porternovelli.com



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