
Amarin Technologies S.A. ("AMARIN" or "The Company") is engaged in the development of innovative pharmaceutical products using its proprietary topical and transdermal drug delivery technology and know-how to offer improved formulations of established drugs. The Company is located in Buenos Aires, Argentina.
Amarin’s main product is a transdermal delivery system of Fentanyl (Fentanyl TDS), which is being commercialized by several partners in Germany, Hungary and Argentine, under different brand names (Fentadolon®, Dolforin®, Talnur®, among others). Fentanyl TDS is finalizing the Mutual Recognition Procedure in Europe and is in registration phase in latinamerican countries, other than Argentina, by Sandoz. Amarin has signed different marketing agreements of Fentanyl TDS with other companies in Europe and Latin America.
Other products developed by Amarin and marketed in different countries are:
- 1.16% and 5% diclofenac gels (OXA® Gel / OXA® Gel Plus)
- 1% Testosterone gel (Androlone® Gel)
- 0.06% Estradiol Gel (Trial® Gel)
- Estradiol TDS (Trial® SAT, Climaderm®)
- Estradiol/Norethindrone TDS (Trial® Gest, Trial® Combi)
Amarin pipeline includes: antidepressant TDS (Phase I); antipsychotic TDS (Phase I); second generation Diclofenac TDS (preclinical), narcotic analgesic TDS, and an antiAlzheimer TDS (preclinical).
AMARIN's research and development capabilities allow the company to perform and control all aspects of the product development process. An experienced team coordinates all of the company's research, project planning and product development programs. The company performs an exhaustive background analysis of the selected agent for a transdermal formulation before beginning the developments, including the search for documentation in databases and the evaluation of the patent status. In this field, specialized personnel of the company permanently consult services such as STN International, European Patent Office and United States Patent and Trademark Office. AMARIN possesses formulation and analytical laboratories, which follow GLP guidelines.
AMARIN designs and performs pre-clinical and clinical studies following GLP and GCP guidelines carrying out properly designed protocols in order to evaluate safety, bioavailability/bioequivalence and the efficacy/safety of the products under development. Clinical trials are performed according to cGCP standards and local regulations in hospitals and other health centers. The study protocols are presented to the local Ministry of Health for authorization, after being approved by either Institutional Review Boards (IRB) or Independent Ethics Committees (IEC). Qualified personnel closely supervise the trial execution, perform the statistical analyses and issues the final study report according ICH recommendations.
AMARIN has no direct marketing force and pursues a strategy of out-licensing its products to corporate partners. The company also enters into strategic alliances that provide for the development of pharmaceutical products in return for technology funding, milestone payments, royalties and other financial arrangements. The company's business opportunities are, amongst others, focused in four main areas: (a) Finding new partners for the existing projects or, (b) Developing new products on request or, (c) Developing early stage projects to be offered to pre- determined/selected candidates or (d) Technology transfer agreements. Among the existing commercial relationships, we can disclose those which cover our products with Merck KGaA (Germany), Zydus Cadila (India), Sandoz (Austria), Genericon Pharma Gesellschaft m.b.H. (Austria)Helm Pharmaceuticals (Germany), Laboratorios Beta S.A. (Argentina), Wyeth (U.S.A.), Eurofarma (Brazil), Unimed (Korea), Ranbaxy (India), Mega Pharma (Uruguay), TAD Pharma GmbH (Germany), Riemser Arzneimittel AgG (Germany), Gedeon RichterLtd (Hungary), Esparma GmbH (Germany), Biogaran (France), Bowmed Ltd (England), Mibe GmbH (Germany), Krewel Meuselbach GmbH (Germany), Generis Farmaceutica S.A.(Portugal), (Kwizda Pharma GmbH (Austria), Laboratorios Cinfa S.A.(Spain), Laboratorios Normon S.A. (Spain), Kern Pharma S.A. (Spain), Heumann Pharma GmbH (Germany), Adcock Ingram Healthcare (Pty) Ltd. (South Africa), Algol Pharma OY (Finland),Gry Pharma GmbH (Germany), Drossapharma AG (Switzerland),P N Gerolymatos S.A. (Greece), Demos S.A. (Greece), Aliud Pharma GmbH (Germany), BioPro Pharmaceuticals Inc (USA).