Amzell

What Amzell does

Amzell BV is a privately held, Netherlands-based specialty pharmaceutical development company founded in 2016 that operates under a lean, virtual development model. The company acquires and develops candidate drugs, repurposed drugs, medical devices, and combination drug-device products through to proof of concept or registration, then out-licenses these products to commercial healthcare companies for commercialization. Amzell is part of the Frederik Paulsen business interests, which encompasses Ferring Pharmaceuticals, providing it with privileged access to in-licensed assets, leadership overlap, and a stable capital base. The company maintains a headquarters in Hoofddorp, Netherlands and a wholly-owned R&D facility (Bazell Pharma AG) in Allschwil, Switzerland following a March 2021 acquisition.

The company's competitive differentiation rests on three proprietary drug delivery platforms: topical/transdermal, mucosal/transmucosal, and injectable technologies. Its portfolio includes AMZ001, a transdermal diclofenac sodium 3.06% formulation (in-licensed from Ferring) for osteoarthritis of the knee pain, delivered via airless metered dose dispenser and supported by a completed Phase 2/3 study in 440 patients across the U.S., Denmark, and Czech Republic; AMZ002, a >95% purity synthetic injectable hormone for infantile epileptic disease with FDA Orphan-Drug, Rare Pediatric Disease, and Special Protocol Assessment designations; and AMZ004, an odorless transdermal gel of a 5-HT3 receptor antagonist for severe nausea and vomiting in pregnancy and hyperemesis gravidarum. Amzell systematically applies 505(b)(2) and orphan drug regulatory pathways to compress development timelines.

Amzell monetizes through an asset-light B2B out-licensing model, generating revenue from licensing fees, milestone payments, and royalties rather than direct sales. Its lead commercial counterparties are Amring Pharmaceuticals (U.S. commercialization of AMZ002, announced November 2021) and Ferring Pharmaceuticals (originator of AMZ001). The company serves three distinct patient populations: elderly osteoarthritis sufferers, infants with catastrophic epileptic disease, and pregnant women with hyperemesis gravidarum, addressing indications where unmet medical need, regulatory exclusivity, and reformulation advantages justify premium positioning.

Name

Amzell

Legal name

Amzell Limited

Website

https://amzell.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

Amzell BV is a Netherlands-based specialty pharmaceutical development company that acquires and develops drug candidates through clinical proof-of-concept and out-licenses them to commercial partners. It leverages proprietary transdermal, transmucosal, and injectable drug delivery platforms across osteoarthritis, rare epilepsy, and pregnancy-related indications.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceutical Development

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industries

Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ), Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)

Keywords

• Pharmaceutical drug development
• Transdermal drug delivery
• Drug formulation services
• Out-licensing partnerships
• Specialty pharmaceuticals

Headquarters

HQ city

Hoofddorp

HQ country

Netherlands

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Out-licensing and commercialization partnerships: Amzell develops drug candidates through proof-of-concept or registration, then out-licenses products to commercial healthcare partners for sale. Revenue is generated through licensing fees, milestone payments, and royalties from commercialization partners.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels2 records

Core offering

Amzell acquires and develops candidate drugs, repurposed drugs, medical devices, and combination drug-device products through to proof of concept or registration. The company then out-licenses these products to commercial healthcare companies for commercialization, generating revenue through licensing fees, milestone payments, and royalties. Its core pipeline includes AMZ001 (transdermal diclofenac for osteoarthritis knee pain), AMZ002 (sterile injectable synthetic hormone for infantile epileptic disease), and AMZ004 (transdermal antiemetic gel for nausea and vomiting in pregnancy).

Product overview

Amzell BV is a specialist virtual pharmaceutical development company that acquires, develops, and advances candidate drugs, repurposed drugs, medical devices, and combination drug-device products through to proof of concept or registration for sale to commercial healthcare companies. The portfolio includes three named products: AMZ001 (a topical diclofenac gel for osteoarthritis of the knee using proprietary transdermal technology), AMZ002 (a purified synthetic injectable hormone for infantile epileptic disease), and AMZ004 (a transdermal gel formulation for nausea and vomiting in pregnancy). The company leverages innovative drug delivery technology platforms including topical/transdermal, mucosal/transmucosal, and injectable technologies. Amzell focuses on utilizing 505(b)(2) and orphan drug regulatory pathways to accelerate development.

Differentiator

Problem solved

Functional benefit

Products and services

• AMZ001 An easy-to-apply transdermal formulation of diclofenac sodium (3.06%) for the treatment of pain caused by osteoarthritis of the knee. Applied locally at the target area via an airless metered dose dispenser for rapid and long-lasting absorption through the skin. The formulation was in-licensed from Ferring Pharmaceuticals and uses Amzell's proprietary transdermal technology, developed as a combination drug-device product for adults and elderly populations with knee osteoarthritis.
• AMZ002 A highly purified sterile injectable product containing a synthetic hormone recognized as the gold standard for the treatment of catastrophic infantile epileptic disease, including infantile spasms. AMZ002 is a purified synthetic alternative to existing FDA-approved treatment, with greater than 95% purity enabling high and reproducible manufacturing quality. Developed as a low-viscosity liquid formulation to facilitate administration and minimize medication errors, and is being developed in collaboration with Amring Pharmaceuticals as commercialization partner.
• AMZ004 A discrete, odorless transdermal gel formulation of an FDA-approved potent antiemetic drug (serotonin 5-HT3 receptor antagonist) for the prevention and treatment of severe nausea and vomiting in pregnancy (NVP) and hyperemesis gravidarum (HG). Designed as a patient-friendly route of administration to address an unmet medical need where no FDA-approved pharmacologic treatment currently exists.

Quantifiable outcome

• Phase 2/3 efficacy study completed in 440 patients across US, Denmark, and Czech Republic
• +2 more outcomes

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• Amring Pharmaceuticals Inc.coreChannel Partner/ Reseller/ Distributor · 23 November 2021Amzell B.V. collaborates with Amring Pharmaceuticals Inc. for the development and commercialization of AMZ002 for infantile epileptic disease. Amring serves as the commercialization partner in the collaboration, providing clinical validation and cost-effective treatment alternatives for infantile spasms (IS). AMZ002 received both Rare Pediatric Disease and Orphan-Drug Designations.
• Bazell Pharma AGcoreOthers · 25 March 2021Amzell B.V. acquired Bazell Pharma AG, a high-end clinical development and R&D laboratory facility based in Allschwil, Switzerland. This acquisition was made to accelerate Amzell's development pipeline of late-stage novel drug candidates. Alan Harris (Chairman of Amzell BV) became Chairman of Bazell Pharma AG while Dario Carrara became CEO of Bazell Pharma AG.

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Emerging players

• Tapemark: Specialty transdermal drug delivery and contract manufacturer with proprietary patch and topical formulation technologies. Comparable to Amzell's platform model for in-licensed and reformulated assets.
• Nutriband: Specialty pharma developing abuse-deterrent transdermal delivery technologies. Smaller-scale player with overlapping transdermal platform technology relevant to Amzell's delivery stack.

Direct peers

• Noven Pharmaceuticals: Transdermal patch developer (now part of Viatris) commercializing products in women's health and CNS via proprietary skin-permeation technology, directly analogous to Amzell's topical/transdermal focus.
• Padagis: Specialty pharmaceutical company with a leading 505(b)(2) reformulation franchise. Highly comparable to Amzell's strategy of leveraging 505(b)(2) and orphan pathways to advance repurposed and reformulated products.
• Antares Pharma: Specialty pharmaceutical company focused on proprietary injectable and transdermal drug delivery platforms. Highly comparable to Amzell's injectable and topical delivery franchise; CEO Dr. Dario Carrara was previously Managing Director of Antares Pharma AG.
• Corium: Commercial-stage specialty pharma developing transdermal and transmucosal drug delivery systems for CNS and other indications. Closely aligned with Amzell's transdermal platform and CNS lead candidate.
• Lohmann Therapie-Systeme (LTS): Specialty CDMO and developer of transdermal therapeutic systems and oral thin-film drug delivery. Comparable as a delivery-platform company enabling reformulation and repurposing strategies similar to Amzell's.
• Osmotica Pharmaceuticals: Specialty pharma focused on modified-release and reformulated products across CNS and women's health, often using existing APIs in novel delivery formats. Aligns with Amzell's transdermal and CNS lead programs.

Broad incumbents

• 3M Drug Delivery Systems: Division of 3M offering transdermal patch design, development, and manufacturing services across multiple therapeutic categories. Overlaps with Amzell's transdermal delivery technology but operates across a much broader portfolio.

Others

• Ferring Pharmaceuticals: Parent-affiliated specialty pharma focused on reproductive health, gastroenterology, and urology. Functions as Amzell's strategic owner and out-license counterpart for AMZ001, providing both funding and pipeline assets.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/bazell-pharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Amzell