Amarin reviews 2009 accomplishments; outlines strategy for 2010 and beyond
October 15, 2017
Execute the Phase 3 clinical trial program for both the MARINE and ANCHOR studies
We aim to rapidly recruit patients into both pivotal studies during 2010 and complete the studies in 2011.
For the MARINE study, regulatory and ethics approvals have been received for the US, Finland, Germany, the Netherlands, Russia, and South Africa. Approvals in most of the remaining countries are expected in the coming weeks. Patient screening has started in the US, and will commence this fiscal quarter in Denmark, Finland, South Africa, Germany, Russia, India, The Netherlands, Ukraine and shortly thereafter in Mexico and Italy. All the centers for the ANCHOR study are in the US.
In the US, an Investigator meeting, combined for sites from the US and Mexico in the MARINE study and for all US sites in the ANCHOR study, was held in Atlanta in mid-January 2010. A meeting for the remaining investigators in the MARINE study from sites outside the US is planned to be held in Barcelona at the end of January. These meetings represent the final training phase for many of the clinical sites participating in the trials.
Consider potential partnering opportunities for commercialization of AMR101While AMR101 could be launched with a specialty sales force, we believe that the best approach for commercialization of AMR101 is through partnering with a larger pharmaceutical company. There has already been some expression of interest regarding AMR101 from potential big Pharma licensees. During 2010 we will ramp-up business development activities to support this interest. We believe that potential partners will be attracted to AMR101 as a significant commercial opportunity initially as a standalone product and there is some discussion of also pursuing it as a potential combination product with other drugs marketed by such companies.
Our strengthened financial position both as a result of the fundraising in October (our unaudited cash balance as of December 31, 2009 was approximately $52 million) and having no debt, means that we can develop AMR101 through NDA on our own. Our partnering strategy is to secure a partner with significant experience in the cardiovascular area and with commercial operations that will help maximize global sales of AMR101. While it is difficult to predict when this might happen, optimal timing would be prior to the release of Phase 3 results in order to enable Amarin and its partner(s) sufficient time to prepare for product launch pending approval.
Expanded investor communicationsWe are committed to making our story better known and to providing regular updates to stakeholders on our progress.
To this end, in 2010 we will begin filing our financial regulatory documents with the SEC as a domestic rather than foreign filer. This should result in broader and more frequent disclosure.
We will be presenting more frequently at investor conferences and meeting more frequently with investors. We recently kicked off this process with presentations to investors in San Francisco in connection with the JPMorgan Healthcare Conference. We are also schedule to present in New York City on February 8, 2010 at the BIO CEO Investor Conference.
To enhance our stakeholder outreach, we retained The Trout Group, an experienced international investor relations firm, and Citigate Dewe Rogerson, an experienced international public relations firm.
In closing to our shareholders, I would like to thank you for your commitment to supporting the company through this period of transformation. We will push hard to execute the clinical program in 2010, complete our pivotal studies in 2011 and submit an NDA in 2012. Our aim is to significantly increasing the value of the company as well as delivering a truly safe and effective product to patients.
Sincerely,
/s/ Declan Doogan
Declan Doogan, M.D.
Interim Chief Executive Officer
SOURCE Amarin Corporation plc