FT. LEE, N.J.--(Business Wire)--
Amarin Corp. (NASDAQ: AMRN), a clinical stage pharmaceutical company with R&D
operations based in Mystic, Conn., has joined SAFE-BioPharma Association, the
non-profit association that created and manages the global SAFE-BioPharma
digital identity and signature standard for the pharmaceutical and healthcare
industries.
SAFE-BioPharma digital signatures provide superior antiforgery and legal
protection to electronic documents than conventional electronic signatures. The
SAFE-BioPharma standard also is used extensively for digital identity management
and facilitates interoperability across different information systems.
Amarin, which is scheduled to soon commence two Phase 3 clinical trials, joined
SAFE-BioPharma in order to sign documents digitally, thus minimizing the paper
associated with drug development.
"Being able to apply digital signatures allows us to eliminate paper and helps
us accelerate the drug development process. We decided to join SAFE-BioPharma so
we can minimize our reliance on paper records and the associated hidden costs of
handling, storing and accessing paper. Making the change now will improve our
efficiency and our bottom line," explained Declan Doogan, M.D., interim CEO,
Amarin Corporation.
Amarin will equip most of its employees with SAFE-BioPharma roaming digital
certificates, allowing them to apply signatures digitally and securely to
electronic documents from any location with Internet access. SAFE-BioPharma
digital certificates also simplify identity management and give their users
trusted access to a vast and growing network within the biopharmaceutical and
other industries and US government agencies.
"Amarin is at a point in its development where it decided that membership in
SAFE-BioPharma would be an important investment in the company`s paperless
future. Most organizations are aware of inherent problems with keeping paper
records but postpone taking action to eliminate paper," said Mollie
Shields-Uehling, president and CEO, SAFE-BioPharma Association. Contributing to
the decision of the company, which is headquartered in Ireland, is the legal and
regulatory acceptance of SAFE-BioPharma in the US and throughout the European
Union.
Amarin, with 20 employees, is the first small pharmaceutical company to join
SAFE-BioPharma, under the association`s new membership pricing.
About Amarin (www.amarincorp.com) Amarin is a clinical-stage biopharmaceutical
company focused on cardiovascular disease. The Company`s lead candidate is
AMR101, a prescription grade omega-3 product comprising not less than 96%
ultra-pure ethyl eicosapentaenoic acid (EPA-E). Amarin is preparing to commence
two Phase 3 clinical trials for AMR101 targeting the treatment of
hypertriglyceridemia. These trials will be conducted under Special Protocol
Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). It
is estimated that as many as 28 million people in the U.S. alone have elevated
blood triglyceride levels, a major risk factor for cardiovascular morbidity and
mortality. In addition, Amarin has potential next-generation lipid candidates
under evaluation for preclinical development. Amarin recently established its
research and development headquarters in Mystic, Connecticut, USA and engaged
Medpace as CRO for the Phase 3 trials. In addition to its cardiovascular
development focus, Amarin has non-core programs available for partnering in the
area of central nervous system (CNS) disorders, including Huntington`s disease,
myasthenia gravis and Parkinson`s disease. Additional information about Amarin
is available at www.amarincorp.com.
About SAFE-BioPharma Association (www.safe-biopharma.org) SAFE-BioPharma
Association is the non-profit association that created and manages the
SAFE-BioPharma digital identity and signature standard for the pharmaceutical
and healthcare industries.
The SAFE-BioPharma industry standard is used to mitigate legal, regulatory and
other business risk associated with business-to-business and
business-to-regulator electronic transactions. It facilitates interoperability
by providing a secure, enforceable, and regulatory-compliant way to verify
identities of parties involved in electronic transactions. Because the standard
is linked to the Federal Bridge PKI Architecture through the 4BF
(http://www.the4bf.com), a SAFE-BioPharma digital identity can be trusted by any
Federal agency. SAFE-BioPharma`s vision is to be a catalyst in transforming the
biopharmaceutical and healthcare communities to a fully electronic business
environment by 2012.
The Association`s members include:
* Abbott (NYSE: ABT)
* Amarin (NASDAQ: AMRN)
* Amgen (NASDAQ: AMGN)
* AstraZeneca (NYSE: AZN)
* Bristol-Myers Squibb (NYSE: BMY)
* GlaxoSmithKline (NYSE: GSK)
* Johnson & Johnson (NYSE: JNJ)
* Eli Lilly (NYSE: LLY)
* McDougall Scientific
* Merck (NYSE: MRK)
* National Notary Association
* Novartis
* Pfizer (NYSE: PFE)
* Premier Inc.
* Roche
* Sanofi-Aventis (NYSE: SNY)
* ScheringPlough-Organon (NYSE: SGP)
* SNAP Diagnostics
SAFE-BioPharma is a trademark of SAFE-BioPharma Association. Any use of this
trademark requires approval from SAFE-BioPharma Association.
Jon Weisberg
SAFE-BioPharma Association
M 801-860-9977
O 801-359-9977
Jon.weisberg@safe-biopharma.org
Copyright Business Wire 2009
