Amzell Ltd.

Specialist pharmaceutical development company Amzell B.V has acquired Bazell Pharma AG, a high-end clinical development and R&D laboratory facility based in Allschwil, Switzerland, to help to accelerate its development pipeline of late-stage novel drug candidates. Amzell specialises in developing well-characterized active substances through to proof-of-concept or registration for sale to commercial partners. Amzell’s innovative platforms and drug delivery technologies provide effective drug delivery, increased efficacy, and improved safety and compliance. Amzell’s CEO, Dario Carrara, comments, “We are very pleased to have finalised the acquisition of Bazell Pharma, as these lab facilities will be highly significant for the new candidates we have coming through our development pipeline. As our two lead candidates, AMZ001 for Osteoarthritis of the Knee, and AMZ002 for Infantile Epileptic Disease, have now reached Phase 3 trials, we are able to accelerate the development of some of our earlier stage candidates.” Alan Harris chairman of Amzell BV will also become chairman of Bazell Pharma AG while Dario Carrara will become CEO of Bazell Pharma AG. Amzell’s lead development candidate, AMZ001, is a novel non-invasive topical diclofenac formulation, containing 3.06% diclofenac sodium, which uses Amzell’s proprietary transdermal technology. This transdermal drug delivery platform delivers the drug substance beyond the skin and into the systemic circulation where it will be taken up and transported through the body to its site of action. Key benefits of this approach include greater bioavailability, excellent skin tolerability with no need for heat, microneedle, occlusion, or electrical current, and a skin-friendly gel carrier which is odourless, transparent, and preservative-free. Each dose of AMZ001 is accurately administered by an airless metered dose pump, and its higher drug strength combined with an efficient topical delivery system allows AMZ001 to improve localized pain with a single daily application (QD), resulting an efficient topical NSAID treatment. Results of a phase 2/3 multi-centre, randomized, double-blind trial of AMZ001, published in August 2020, found that it provides efficacy and safety results in the relief of pain associated with osteoarthritis of the knee (OA).

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.”

The specialist pharmaceutical development company, Amzell BV has appointed Dr Alan Harris, as Chairman and former Chief Scientific Officer, Dr Dario Carrara as CEO. Amzell BV specialises in developing well-characterized active substances, utilizing innovative drug delivery technology platforms and has a number of drug candidates in its late stage development pipeline. Dr Alan Harris, who will continue in his role as Senior VP in the Ferring Group’s R&D Management, has worked with the Ferring Group for more than 37 years, including leading the four BRIC R&D labs in Brazil, Russia, India, and China as part of Ferring’s pipeline expansion in these territories. Alan, who is located in Lausanne, Switzerland is a Board member of the Karolinska Institute spin-off company, Glucox Biopharma AB and a director of the Swiss based NGO, The ADEPT Foundation. Alan has a PhD in Biopharmaceutics from the Uppsala University, Sweden and an MBA from Ashridge Business School, UK. Dr Dario Carrara was General Manager at Ferring, Allschwil as well as Chief Scientific Officer of Amzell before taking over as CEO. He was also the co-founder and Head of R&D at Permatec Pharma and Managing Director of Antares Pharma AG. Dario has a dual master’s degree in Pharmacy and Biochemistry, and received his PhD in Pharmaceutical Technology from the University of Buenos Aires. He is the inventor of more than 30 patents related to pharmaceutical composition and drug delivery technology. Amzell CEO, Dario Carrara, comments, “We are delighted to have Alan join Amzell as Chairman. His extensive experience across research and development will be a huge asset for us, especially as we see a number of our product candidates approaching Phase 3 trials.” Amzell is a specialist pharmaceutical development company focused on developing well-characterized active substances through to proof-of-concept or marketing authorization for sale to commercial partners. Amzell’s innovative platforms and drug delivery technologies provide effective drug delivery, increased efficacy, and improved safety and compliance. The latest product in its portfolio to reach Phase 3 is AMZ002, an innovative new treatment for infantile epileptic disease.