Amarin Corporation plc has announced that the Company has:
- Signed an agreement to acquire Ester Neurosciences Limited ("Ester"), a private research and development company based in Israel. The initial consideration is $15 million, plus up to $17 million in contingent payments. Ester's core assets include (i) a platform messenger RNA (mRNA) silencing technology which targets the cholinergic pathway; (ii) EN101, a Phase II compound with promising efficacy data for the treatment of myasthenia gravis ("MG") utilizing this technology; and (iii) a preclinical program in neurodegenerative and inflammatory diseases.
- Received financing commitments for approximately $8.1 million in gross proceeds in connection with public offerings of equity, three-year convertible debt and warrants. Directors and officers committed $1.7 million. The financing is expected to close this week.
- Resolved to hold a General Meeting in January 2008 at which the Company's shareholders will be asked to approve a 1-for-10 reverse stock split, which is part of Amarin's definitive plan to regain and sustain compliance with Nasdaq listing requirements.
Rick Stewart, Chief Executive Officer of Amarin, commented, "We are delighted to announce the signing of the Ester acquisition, which is an excellent strategic fit for Amarin. This acquisition allows Amarin to gain access to a unique mRNA platform technology based on breakthrough discoveries in cholinergic neuromodulation. The validation of the platform via the promising clinical data from a Phase II study in myasthenia gravis adds substantial value to Amarin's neuroscience portfolio."
Eli Hazum, Chief Executive Officer of Ester and a partner at Medica Venture Partners, the company founders, commented, "Amarin's experience with neurological disorders and strong management team will be of considerable benefit in advancing our Phase II clinical program in myasthenia gravis and further developing our novel technology platform. We are very excited about the Phase II program as the interim results have demonstrated superior efficacy over MestinonTM, the current standard of care for this disease."
Ester's lead product candidate, EN101, is in Phase IIa clinical development as a treatment for MG, a chronic autoimmune neuromuscular disease characterized by progressive muscle weakness. EN101 has demonstrated safety and efficacy in a Phase Ib clinical study and in interim results from an ongoing Phase IIa clinical study.
The ongoing Phase IIa clinical study is currently evaluating the safety and efficacy of three different, once-daily oral doses of EN101 in patients with MG compared with Mestinon. An interim analysis of this study has shown that each of the three doses of EN101 showed a statistically significant improvement over baseline quantitative MG ("QMG") score.
The QMG score is used in MG studies and measures the strength of 13 different muscle groups. The interim data suggest EN101 may have efficacy, longer duration of action, a favorable side effect profile and dosing regimen, as compared with Mestinon.
EN101 has been granted orphan drug status for the treatment of MG by the U.S. Food and Drug Administration and by the European Medicines Agency. Amarin's focus will be on completing the ongoing Phase IIa clinical study and other non-clinical studies in preparation for commencing a Phase IIb or Phase II/III study.