$8.1 Million Financing in Connection With Acquisition
Reverse Stock Split Planned for January 2008
- Signed an agreement to acquire Ester Neurosciences Limited ('Ester'), a
private research and development company based in
- Received financing commitments for approximately
- Resolved to hold a General Meeting in
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.'
Nava Swersky Sofer, President and Chief Executive Officer of Yissum, the
Hebrew University of Jerusalem's technology transfer company, from which
Ester licensed the technology, commented, 'This technology, developed by
EN101 in Phase IIa for Myasthenia Gravis
Ester's lead product candidate, EN101, is in Phase IIa clinical development as a treatment for MG, a chronic autoimmune neuromuscular disease characterised 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 superior efficacy, longer duration of action, a more 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.
EN101 in Preclinical Development for Neurodegeneration and for Inflammation-based Diseases
Preclinical studies have shown that EN101 may have potential application in other peripheral nervous system disorders, such as amyotrophic lateral sclerosis. In addition to its known anti-cholinergic effect, EN101 also possesses anti-inflammatory properties not associated with neuronal or neuromuscular degeneration. In preclinical animal studies, EN101 led to the amelioration of the symptoms associated with inflammatory bowel disease ('IBD'), an inflammatory gastrointestinal tract disorder. The efficacy of EN101 was shown to be highly significant and comparable to that achieved by dexamethasone, a routine steroidal treatment for IBD.
Intellectual Property
Ester's patent estate protects its novel technology platform with both
issued patents and pending patent applications. EN101 is protected by an
issued composition of matter patent in the
Technology Platform
Ester's therapeutic platform is based on novel and proprietary
discoveries in the field of acetylcholinesterase ('AChE'), developed by
Ester's technology platform also exhibits anti-inflammatory effects, including an indirect inhibitory effect on key pro-inflammatory cytokines via modulation of AChE-R, as well as a direct anti-inflammatory effect via modulation of macrophage activity mediated by interaction with the toll-like receptor or TLR signalling pathway.
Ester Integration
Preparations for the integration of Ester and Amarin have already begun.
Amarin is not acquiring any facilities or office space in
Acquisition Consideration
Under the terms of the acquisition agreement, Amarin will acquire 100% of
the issued share capital of Ester for initial consideration of
- Two milestones aggregating
- ADSs valued at
- ADSs valued at
- One milestone of
Amarin has assumed an obligation to pay a royalty to Yissum equal to 7% of net product sales of EN101, or of any other product commercialised from Ester's licensed intellectual property. In addition, should Amarin partner EN101 for applications other than MG, Ester shareholders will be entitled to receive 10% of any license fees, milestone payments, royalties and/or other related income arising therefrom in the five years from closing.
Financing Transactions
Amarin also announced today that it has received commitments for the
purchase of ADSs, convertible debt and warrants. These public offerings are
expected to result in gross proceeds to the Company of approximately
In the first of the offerings, Amarin received commitments of
In the second of the offerings, Amarin received commitments to purchase
Rodman & Renshaw LLC, a subsidiary of Rodman & Renshaw Capital Group Inc
(NASDAQ: RODM), served as placement agent for the offerings in the
A registration statement relating to these securities has been filed with
and declared effective by the Securities and Exchange Commission. The
offerings may be made only by means of a prospectus supplement and the
accompanying prospectus. Copies of the prospectus supplement and the
accompanying prospectus may be obtained directly from the Company or by
sending a request to Rodman & Renshaw. Application is being made to list
16,290,900 ordinary shares on the AIM and IEX, in respect of the above
financings, respectively. Application is also being made to list 25,000,000
ordinary shares on AIM and IEX in respect of the consideration shares due to
Ester. Admission is expected to occur on
This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, any of the securities, nor shall there be any sale of these securities, in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities of each state.
Reverse Stock Split and Nasdaq Capital Market Listing Requirements
Amarin intends to send to its shareholders a notice of a General Meeting
at which Amarin will seek approval for a 1-for-10 reverse stock split of the
Company's ordinary shares. It is expected that the General Meeting will take
place in
Amarin received a notice on
This press release does not constitute a solicitation of proxies for any meeting of shareholders, which can only be made by way of a properly filed meeting notice and related proxy form.
For further information regarding the financial impact of the Ester acquisition on Amarin's historical financial statements, please see the unaudited historical pro forma condensed combined financial statements filed with the SEC in a Report of Foreign Issuer on Form 6-K and available on our website; www.amarincorp.com.
Myasthenia Gravis - An Unmet Medical Need
MG is the most common primary disorder of neuromuscular transmission. It is a chronic autoimmune neuromuscular disease characterized by varying degrees of weakness of the skeletal (voluntary) muscles of the body. About 10% of MG patients develop a life threatening weakness of the respiratory muscles needed for breathing, a condition called myasthenic crisis. MG occurs in all races, both genders, and at all ages.
Existing therapies for MG include cholinesterase inhibitors, immunosuppressants and corticosteroids, plasma exchange and intravenous immune globulin and surgical treatment (thymectomy). Cholinesterase inhibitors are used to treat the symptoms of MG but are often accompanied by side effects such as nausea, diarrhea, hypersalivation, bronchorrhea, headache and involuntary muscle twitching.
According to the Myasthenia Gravis Foundation of America, the prevalence
of MG is estimated at 14 to 20 per 100,000 population, with up to 60,000
cases in the
About Amarin
Amarin is committed to improving the lives of patients suffering from central nervous system and cardiovascular diseases. Our goal is to be a leader in the research, development and commercialization of novel drugs that address unmet patient needs.
Amarin's CNS development pipeline includes the recently acquired myasthenia gravis clinical program and preclinical programs in neuromuscular, neuronal degenerative and inflammatory diseases; Miraxion for Huntington's disease; two programs in Parkinson's disease; one in epilepsy; and one in memory and cognition. Amarin is initiating a series of cardiovascular preclinical and clinical programs to capitalize on the known therapeutic benefits of essential fatty acids in cardiovascular disease. Amarin also has a proprietary lipid-based technology platform for the targeted transport of molecules through the liver and/or to the brain that can be leveraged in a wide range of disease applications for its own product pipeline or with potential partners.
Amarin has its primary stock market listing in the U.S. on the NASDAQ
Capital Market ('AMRN') and secondary listings in the U.K. and
About Yissum
Yissum was founded in 1964 to protect the Hebrew University's
intellectual property and commercialise it.
Disclosure Notice
The information contained in this document is as of
SOURCE Amarin Corporation Plc
