Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced the launch of its new global access program for FINTEPLA (fenfluramine) oral solution. FINTEPLA was approved in the U.S. and European Union in 2020 as an add-on therapy for the treatment of seizures associated with a debilitating rare epilepsy called Dravet syndrome in patients aged two years and older. The Zogenix Access Program expands access for physicians in other parts of the world, where local regulations allow, including European countries where reimbursement has not yet been established.
“Three randomized clinical studies have demonstrated FINTEPLA’s ability to provide transformational and durable seizure reduction for many Dravet syndrome patients whose seizures were not adequately controlled despite treatment with one or more other anti-epileptic medicines,” said Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer at Zogenix. “With these results and more than one thousand treated Dravet syndrome patients, physicians in many countries have expressed interest in FINTEPLA for their patients. We are pleased to be able to take this step to support their requests and help more patients in need.”
Zogenix has partnered with Uniphar to manage the Zogenix Access Program for FINTEPLA. Uniphar has extensive global experience providing, high-quality support while adhering to complex local requirements.
“We are delighted to be working in partnership with Zogenix on this important access program,” said Dan Piggott, Managing Director, Exclusive Access at Uniphar. “We look forward to helping facilitate broader access to FINTEPLA for patients with critical unmet medical needs.”
About the Zogenix Access Program
The Zogenix Access Program is for physicians who are interested in treating their patients with FINTEPLA in countries where it is not yet available commercially or through local access schemes. The program does not provide free-of-charge access to FINTEPLA and does not affect patients already taking FINTEPLA as part of a clinical study. Specifics of the program may vary by country based on local regulations.
In the U.S. and Europe, treatment with FINTEPLA is initiated and supervised by physicians with experience in the treatment of epilepsy under a Risk Evaluation Mitigation Strategy (REMS) program (U.S.) or Controlled Access Program (EU). Similarly, access through this program must be requested by the patient’s treating physician. Where local regulations allow, an initial registration process enables the program team to begin working with physicians on treatment and important safeguard planning.
Physicians can learn more about the Zogenix Access Program for FINTEPLA by sending an email inquiry to zogenixaccessprogram@zogenix.com.
About FINTEPLA®
Fintepla is a new treatment option that in clinical studies provided significant, well-tolerated, and lasting seizure reduction to many Dravet syndrome study patients. In 2020, FINTEPLA (fenfluramine) oral solution was approved by the U.S. Food & Drug Administration (FDA) and by the European Commission as an add on therapy to other anti-epileptic medicines for the treatment of seizures associated with Dravet syndrome in patients aged two years and older. In addition, Zogenix has reported positive results of a third Phase 3 study of FINTEPLA in Dravet syndrome to support planned registration in Japan, a study that corroborated the statistically significant and clinically meaningful convulsive seizure reductions seen in earlier multi-national Phase 3 studies. FINTEPLA is also being studied for the potential treatment of seizures associated with other rare epilepsies.
In the United States, please see important prescribing and safety information at www.Fintepla.com. In Europe, please see important prescribing and safety information at www.Fintepla.eu.
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 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. 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 company has two additional late-stage development programs, one in a rare epilepsy called Lennox-Gastaut syndrome and one in a mitochondrial disease called TK2 deficiency. Zogenix plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.
Uniphar Access
Uniphar’s access team prides itself on being experts in optimizing access, transforming lives and accelerating product development. We harness the capabilities, infrastructure and experience of Uniphar’s diversified pharmaceutical services, leveraging more than 55 years of building success with 200+ multinational clients.
Our highly experienced team deliver best-in-class access programs with a personal touch and true passion for patient outcomes. We leverage our extensive therapy area experience, local and global launch expertise to deliver pre-approval product access, while providing medical affairs strategies tailored to your market. Our commercial team launch assets, fully commercialize in-licensed therapies and manage established brands using innovative digital and in-person solutions to deliver success.
As part of Uniphar’s Pharma division, access, medical and commercial work together to unlock access to innovative therapies and optimize value while improving patient outcomes around the world.
We provide tailored specialist services and solutions for our clients’ changing needs throughout every stage of the product lifecycle. A publicly traded company with €2b revenue, 3,500 employees and active in more than 160 countries, Uniphar is dedicated to improving patient access to medicines worldwide.
CONTACTS:
Zogenix
Melinda Baker
Senior Director, Corporate Communications
+1 (510) 788-8732 | corpcomms@zogenix.com
Investors
Brian Ritchie
Managing Director, LifeSci Advisors LLC
+1 (212) 915-2578 | britchie@lifesciadvisors.com
Media
Stefanie Tuck, Vice President, Porter Novelli
+1 (978) 390-1394 | stefanie.tuck@porternovelli.com