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.”

Specialist development pharmaceutical company AMZELL B.V. and the FDA have reached an agreement on the protocol for the Phase 3 trial of its infantile epileptic disease therapy under an FDA Special Protocol Assessment (SPA). AMZELL is ready to initiate the trial and hopes to begin patient recruitment later this week. AMZ002 is a sterile injectable hormone that would offer a purified synthetic polypeptide as alternative to existing FDA-approved treatment for epileptic seizures. The >95% purity of the synthetic hormone allows high and reproducible product manufacturing quality. AMZ002 was developed as a low viscosity liquid formulation to facilitate the treatment administration and minimise medication errors. The Phase 3 trial will compare AMZ002 to another active treatment in a superiority study. Infantile epileptic disease can cause global neurodevelopmental delay, significant intellectual disability, and currently has limited treatment options and a poor prognosis. In most cases, the initial age of onset is between 3 and 12 months of age, and over 90% of cases begin before 12 months of age. Infantile epileptic disease is an orphan indication that affects fewer than 200,000 patients in the United States each year. The lack of treatment options for this devastating condition means that there is a considerable unmet need. Dario N. Carrara PhD, Chief Executive Officer commented: “We are delighted to have agreed with the FDA on our AMZ002 Phase 3 trial protocol. Our purified, synthetic injectable should provide a treatment option for epileptic seizures, suited to best meet the needs of a highly vulnerable patient population, and we look forward to initiating the trial in the coming months.” AMZ002 is the latest product to reach Phase 3 from AMZELL, which specialises in developing well-characterized active substances either through to proof-of-concept or registration for sale to commercial partners. AMZELL’s innovative platform drug delivery technologies provide effective drug delivery, good efficacy, and state of the art safety and compliance.