Amzell, B.V., in Collaboration With Amring Pharmaceuticals Inc. Announce Their Lead Product Has Entered Phase III Clinical Trial in the U.S. for Treatment of Infantile Epileptic Disease

BERWYN, Pa.–(BUSINESS WIRE)–Amzell, B.V., a specialty pharmaceutical development company based in The Netherlands, and Amring Pharmaceuticals Inc. (Amring), a niche brand and generic pharmaceutical company based in Berwyn, PA, announced today that their lead product in the collaboration, AMZ002, has entered Phase III Clinical Trial in the U.S. for treatment of infantile epileptic disease. AMZ002, a purified synthetic polypeptide, offers an alternative to existing FDA-approved treatment for epileptic seizures. This product received both Rare Pediatric Disease and Orphan-Drug Designations.

This Phase III Clinical Trial is a randomized, open-label superiority study designed to evaluate the efficacy, and safety of AMZ002 in the treatment of infantile spasms (IS). In addition, this trial is one of the first to investigate co-primary endpoints assessing both the absence of spasms and resolution of hypsarrhythmia.

Dario Carrara, PhD, CEO of Amzell noted, “We are very excited that this important treatment has entered the Phase III stage in the U.S. We believe that these AMZ002 studies will provide needed clarity for future treatment strategies for IS, a severe epileptic encephalopathy that leads to neurodevelopmental delay and significant intellectual disability in young children. AMZ002 is the product of decades of hands-on technical and clinical experience with ACTH.”

“We are pleased that the Phase III program is underway, and that our collaboration with Amzell will produce significant benefits for young children and their parents in the U.S. and globally,” stated Daniel Carbery, President and CEO of Amring. “As the commercialization partner in the collaboration, we are very excited to soon be able to address the need for clinically-validated and cost-effective treatment alternatives for IS.”

About Amring Pharmaceuticals

Amring Pharmaceuticals is a privately held pharmaceutical company that provides niche generics and value-driven brands to the market. Amring is partnered with well-established global biopharmaceutical companies and is uniquely positioned to leverage its expertise in bringing biotechnology derived medicines, sterile manufacturing and other state of the art technologies to the marketplace.

About Amzell B.V.

Amzell B.V. is a specialist development pharmaceutical company which takes candidate drugs and devices either through to proof of efficacy or through to marketing authorization for further commercialization in partnership with leading niche-based commercial healthcare companies. The company, based in Hoofddorp, The Netherlands, was founded in 2016. Amzell has particular interest in developing well-characterized, active pharmaceutical ingredients using innovation platform drug delivery technologies to provide more effective drug delivery, increased efficacy, and improved safety and compliance.

Safe Harbor

This press release contains forward-looking statements, including, without limitation, statements related to Amring’s business developments and the implementation of Amring’s strategic initiatives. Because these statements reflect Amring’s current views, expectations, and beliefs concerning future events, these forward-looking statements involve risks and uncertainties that could cause actual developments and results to differ materially from Amring’s expectations. These factors include, but are not limited to, general market conditions, regulatory trends, changes in the financial conditions of third parties dealing with Amring, and other factors that could affect Amring’s business and financial performance. Amring does not assume any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Contacts

Amring Pharmaceuticals Inc.

Marina Volin, Esq.

VP, General Counsel

610-285-7137

[email protected]

Amzell B.V.

Dario Carrara, PhD

CEO

+31235560460

[email protected]