Amarin is engaged in the development of innovative pharmaceutical products using its proprietary topical and transdermal drug delivery technologies and know-how.
Profile
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 technologies and know-how to offer improved
formulations of established drugs. The Company is located in
Buenos Aires, Argentina.
Several transdermal systems containing different substances
(homones, diclofenac, etc) have reached the markets. The
latest products were a high permeation diclofenac gel (OXA®
GEL PLUS) and a testosterone gel (Androlone® Gel), both
commercilized by Laboratorios Beta SA in Argentina. A
Fentanyl TDS is presently in its registration phase in Latin
America and Europe while was launched by Sandoz in
Argentina. Amarin has signed different development and
marketing agreements with other companies in Europe and
Latin America.
Research and Development
AMARIN performs pre-clinical and clinical studies following
GLP and GCP guidelines carrying out properly designed
protocols in order to evaluate safety, PK and the efficacy
of the products under development.
AMARIN's research and development capabilities, allow the
company to perform and control all aspects of the product
development process. An experienced team coordinates and
manages 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 online services such as STN
International, European Patent Office and United States
Patent and Trademark Office.
AMARIN possesses modern formulation and analytical
laboratories, which follow GLP guidelines. The company
currently designs the protocols and carries out pre-clinical
as well as clinical investigations in order to evaluate the
safety, pharmacokinetics and efficacy of its products.
The pre-clinical studies (e.g. primary irritation,
sensitization and pharmacokinetics in animals) are carried
out by the clinical research section in qualified
third-party facilities.
Clinical trials are performed according to cGCP rules and
local regulations in hospitals and other health centers. The
protocols designed by its clinical research section are
presented to the local Ministry of Health for authorization,
after being approved by either the Institutional Review
Boards (IRB) or Independent Ethics Committees (IEC).
Qualified personnel closely supervise pharmacokinetic
studies and clinical trials.
Partnering strategy/interests
· 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 agreements, we can disclose those which
cover products with Wyeth (U.S.A.), Merck KGaA (Germany),
Zydus Cadila (India), Ranbaxy (India), Sandoz (Austria),
Helm Pharmaceuticals (Germany), Laboratorios Beta S.A.
(Argentina) and Mega Pharma (Uruguay).