Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company focused on improving the treatment of cardiovascular disease, today issued a special letter to its shareholders. The text of the letter, written by Dr. Declan Doogan, Amarin's Interim CEO, follows:
Dear Shareholders:
With 2010 now underway, I want to provide you with a brief review of Amarin's accomplishments in 2009 and outline our strategy for 2010 and beyond. During 2009, we underwent significant change within the Company and I am pleased to report we have already made excellent progress towards our goal of becoming a successful biopharmaceutical company developing effective new treatments for cardiovascular diseases.
The key events during 2009 include: successfully raising $70 million to fund the Phase 3 clinical development of AMR101 in cardiovascular indications; the appointment of a new senior management team to supplement our recently assembled but highly experienced R&D team; and reaching formal agreements with the U.S. Food and Drug Administration (FDA) for two pivotal Phase 3 clinical trials using the Special Protocol Assessment (SPA) process regarding study design.
Solidified our focus on drug development for cardiovascular disease
During 2009, Amarin focused on repositioning its business towards developing a new improved treatment for cardiovascular diseases that capitalize on our lipid science expertise and the potential therapeutic benefits of AMR101, our lead product candidate.
AMR101 is prescription grade, ultra-pure form of eicosapentaenoic acid (ethyl-EPA; an omega-3 compound) that is being positioned as a best-in-class prescription medicine for treating patients with very high triglycerides (hypertriglyceridemia). In addition, AMR101 is being evaluated to treat high triglycerides in patients with mixed dyslipidemia (high triglycerides and high LDL cholesterol) who are also being treated with statins. Earlier this month, we announced that the first patients were enrolled into these studies.
Our highest priority is the late-stage development of AMR101, which we believe has great potential for treating high triglyceride levels, an independent cardiac risk factor, The treatment of high triglyceride levels represent a major commercial opportunity targeting a potential billion dollar market. It is estimated that over 40 million adults in the US have elevated triglyceride levels, which can be associated with increased risk of developing coronary artery disease as well as being a component of certain other metabolic disorders, such as diabetes and obesity.
New investment of $70 million allows Amarin to complete the Phase 3 development of AMR101 and submit and NDA
We were pleased in October to complete a $70 million fundraising, particularly given the difficult economic environment in the capital markets. This substantial new financing secures Amarin's near term requirements and provides the resources necessary for us to progress our two Phase 3 clinical trials with AMR101 to an NDA filing. We are confident in the high value potential of AMR101 and were pleased to retain the support of our existing investors and the participation of new and well-recognised investors, including Abingworth, APG Asset Management, Great Point Partners, Tavistock Life Sciences Company and RA Capital.
Strengthened our management team and consolidated our operations
To implement our strategy, we also made personnel changes to ensure that we have the necessary operational capabilities and expertise to execute. In particular, Joseph Zakrzewski joined as Executive Chairman and John Thero joined as Chief Financial Officer. These individuals bring significant operational and business experience to Amarin and complement our R&D strengths. Notably, Mr. Zakrzewski was previously the Chief Operating Officer of Reliant Pharmaceuticals, the company that introduced the blockbuster Omega-3 product Lovaza® (Omacor® in Europe; now marketed by GlaxoSmithKline) to the market.
In addition, we have centralized all of our R&D operations and many of our business functions in Mystic, Connecticut, USA. As a result of these changes, we believe that Amarin is now positioned better than ever.
Added significant experience and investor representation to our Board of Directors
In addition to Mr. Zakrzewski, we were pleased to welcome Dr. Joseph Anderson, a partner at Abingworth, and Dr. Manus Rogan, a Managing Director at Fountain Healthcare Partners, as non-executive directors to our Board. Drs. Anderson and Rogan both have significant experience in helping life science companies grow and have already made a valuable contribution to Amarin's strategic direction.
Positioned AMR101 clinical and regulatory programs for success, including SPA agreements
As mentioned earlier, Amarin's primary objective is to take AMR101 to NDA filing through the two Phase 3 clinical trials, the MARINE and ANCHOR studies.
In brief, the MARINE study is a pivotal 240-patient Phase 3 registration trial designed to evaluate the efficacy and safety of two doses of AMR101 in patients with very high triglycerides (over 500mg/dl). The ANCHOR study is a pivotal 650-patient US multi-center, placebo-controlled, randomized, double-blind, 12-week study to evaluate the efficacy and safety of two doses of AMR101 in patients with mixed dyslipidemia (high triglyceride levels of 200-500 mg/dL who are on statin therapy).
In mid-2009, we reached formal agreements with the FDA for both the MARINE and ANCHOR studies using the SPA process which enables clear agreement to be documented with the FDA on study design. We welcomed renowned physicians, Harold Bays, M.D., Medical Director Louisville Metabolic and Atherosclerosis Research Center, Kentucky and Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, Texas, as Principal Investigators for our Phase 3 trials.
We also engaged Medpace, a leading global clinical research organization, to help us manage the clinical trials in multiple countries and we began enrolling clinical sites and patients, the first of which was announced in early 2010.
Strategy and opportunities
Amarin's primary focus is to develop AMR101 through Phase 3 trials for hypertriglyceridemia and related cardiovascular disease indications for international commercialization.
There are multiple potential follow-on indications for AMR101, including its potential use in a broader population for cardiovascular disease prevention and its potential combination with other drugs such as statins. However, these and other opportunities will be pursued only after we make further progress in the clinical trials for the two indications which we are currently advancing.
With respect to the indications that we are pursuing, the MARINE study is targeting an indication for which only one other Omega-3 based drug is approved in the US. That drug, Lovaza, has worldwide revenues which have been growing rapidly and have now reached nearly $1 billion per year. The ANCHOR study is targeting an indication for which there is currently no prescription omega-3 drug approved in the US. By some estimates, the patient population for this indication is many times larger than the patient population being targeted by the MARINE study.
We believe that AMR101 has the potential to be a best-in-class medicine. In addition to seeking approval for the second indication for use as targeted by the ANCHOR study, we seek to show that AMR101 has meaningful differential properties from its closest competitor, including reduced pill burden (e.g. two versus four capsules per day) and the absence of an elevating effect on LDL cholesterol as well as other potential consumer preference differences. These factors, we believe give our product potential significant competitive advantage subject to regulatory approval.
Looking ahead: focus on execution
Our priorities for 2010 and 2011 include: