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
- Pfizer (NYSE: PFE)
- Premier Inc.
- 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.