RNS Number:2359J
Amarin Corporation Plc
05 December 2007
AMARIN SIGNS AGREEMENT TO ACQUIRE ESTER NEUROSCIENCES
Adds Promising Phase II Neurology Candidate
$8.1 Million Financing in Connection with Acquisition
Reverse Stock Split Planned for January 2008
LONDON, United Kingdom, December 5, 2007 - Amarin Corporation plc (NASDAQ: AMRN)
today announced that the Company has:
- Signed an agreement to acquire Ester Neurosciences Limited ("Ester"), a
private research and development company based in Israel. The acquisition is
expected to close tomorrow. 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") utilising 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."
Alan Cooke, President and Chief Financial Officer of Amarin, added, "The Ester
acquisition achieves our stated objective of adding one more clinical stage
program with efficacy data to our pipeline with the additional benefit of the
valuable underlying technology platform. The concurrent financing enables the
Company to make the initial $5 million cash payment to Ester shareholders
without utilizing the Company's existing cash reserves and provides additional
working capital to invest in integrating and advancing Ester's programs along
with our existing development pipeline in neurology and cardiovascular disease."
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 Professor Hermona
Soreq, has the potential to aid numerous patients around the world suffering
from debilitating chronic diseases. Ester has developed the technology over the
past ten years, and we are delighted that Amarin has decided to take it to the
next level using its considerable strengths and excellent team."
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 United States that runs to 2022, and has
patent protection pending in a number of other jurisdictions around the world,
including Europe.
Technology Platform
Ester's therapeutic platform is based on novel and proprietary discoveries in
the field of acetylcholinesterase ("AChE"), developed by Professor Hermona Soreq
of the Hebrew University of Jerusalem. AChE is a degrading enzyme of the
neurotransmitter acetylcholine, the imbalance of which plays a central role in a
range of currently incurable and highly debilitating neurodegenerative
conditions. The basic premise of Ester's therapeutic paradigm is the modulation
of the "read-through" isoform of acetylcholinesterase ("AChE-R"), an excess of
which plays a fundamental detrimental role in the CNS and inflammatory
processes.
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 Israel. The management of
Ester's programs and research and development activity is being transitioned to
Amarin's research and development team in Oxford, England. To facilitate this
transition to Amarin, Eli Hazum, Chief Executive Officer of Ester, will act as a
consultant to Amarin for a period of at least six months.
Acquisition Consideration
Under the terms of the acquisition agreement, Amarin will acquire 100% of the
issued share capital of Ester for initial consideration of $15 million, of which
$5.0 million is payable in cash and $10 million is payable through the issuance
of 25 million Amarin ordinary shares, each ordinary share represented by one
American Depositary Share ("ADS"), representing approximately 20% of the
outstanding ADSs of Amarin (excluding the issuance of ADSs in the financing).
Additional contingent payments, valued at an aggregate of $17 million, will be
payable to Ester in the event that certain development-based milestones are
successfully completed. The additional contingent consideration consists of:
- Two milestones aggregating $11 million, payable, at Amarin's option, in
cash or in ordinary shares valued at $0.38 per share, the volume weighted
average closing price of Amarin's ADSs for the 10 days ending on December 4,
2007 (subject to an adjustment reducing the number of shares payable to former
Ester shareholders if Amarin's ADS closing price on such milestone date is
higher than $0.76 per share). These milestones consist of:
* ADSs valued at $5 million payable no earlier than April 5, 2008, on
the achievement of certain efficacy data on completion of the ongoing Phase IIa
study; and
* ADSs valued at $6 million due on successful completion of the Phase
II program, supporting progression to Phase III in the United States.
- One milestone of $6 million payable in cash on successful completion of
the Phase III program in the United States.
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 $8.1 million and are
due to close this week.
In the first of the offerings, Amarin received commitments of $5.4 million from
institutional and other accredited investors, including certain directors and
executive officers of Amarin, to purchase 16.3 million Amarin ADSs at a purchase
price of $0.33 per ADS. This price represents a discount of 10% to Amarin's
5-day volume weighted average closing price on December 3, 2007. In addition,
investors will receive five-year warrants exercisable to purchase 8.1 million
Amarin ADSs at an exercise price of $0.48, which is a 30% premium to the 5-day
volume weighted average closing price of Amarin ADSs on December 3, 2007.
In the second of the offerings, Amarin received commitments to purchase $2.7
million in aggregate principal amount of three-year convertible notes from
institutional and other accredited investors, including certain directors and
officers of Amarin. The notes may be converted into 5.7 million Amarin ADSs
commencing four months after the date of closing at a conversion price of $0.48
per Amarin ADS, which is a 30% premium to the 5-day volume weighted average
closing price of Amarin ADSs on December 3, 2007. The notes will bear interest
at a rate of 8% per annum, payable quarterly in arrears. In addition, the note
holders will also receive five-year warrants exercisable to purchase 2.3 million
Amarin ADSs at an exercise price of $0.48. The convertible notes will be
required to be repaid from the proceeds of, and the holders of the convertible
notes will have the right to participate in, future financings of the Company,
with certain exceptions.
Rodman & Renshaw LLC, a subsidiary of Rodman & Renshaw Capital Group Inc
(NASDAQ: RODM), served as placement agent for the offerings in the United
States. ProSeed Capital Holdings CVA served as financial advisor to Amarin in
connection with the Ester acquisition and financing transactions.
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 December
10, 2007.
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 January 2008. Pursuant to Nasdaq Marketplace Rule 4320(e)(2)(E)(ii), in
order to maintain its listing on The Nasdaq Capital Market, Amarin must maintain
a minimum bid price of $1.00. In affecting the 1-for-10 reverse stock split,
Amarin expects the bid price of its ADSs to greatly exceed the minimum bid price
of $1.00 and thus to regain and sustain compliance with this requirement.
Amarin received a notice on December 4, 2007 from The Nasdaq Stock Market
indicating that the Company is not in compliance with the $1.00 minimum bid
requirement for continued listing and, as a result, the Company's ADSs are
subject to delisting, unless the Company requests a hearing by December 11, 2007
in accordance with the Nasdaq Marketplace Rules. The Company intends to request
an appeal hearing prior to December 11, 2007 with the Nasdaq Listing
Qualification Panel to review the delisting determination. There can be no
assurance that the Panel will grant the Company's request for continued listing.
If the Panel denies the request, the Company's ADSs will be delisted. The
hearing date will be determined by Nasdaq and should occur within 45 calendar
days from the request for hearing. Amarin's hearing request will 'stay' the
delisting of the Company's ADSs pending the Panel's decision. At the hearing,
the Company will be required to provide a plan to regain compliance with the
minimum bid price requirement, which will include the Company's plan to seek
shareholder approval for the reverse stock split in order to exceed the minimum
bid price requirement.
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
United States.
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 Ireland on AIM ("AMRN")
and IEX ("H2E"), respectively.
About Yissum
Yissum was founded in 1964 to protect the Hebrew University's intellectual
property and commercialise it. $1 billion in annual sales are generated by
products based on Hebrew University technologies licensed out by Yissum. Ranked
among the top technology transfer companies in the world, Yissum has registered
5,000 patents covering 1,400 inventions; licensed out 400 technologies and spun
out 60 companies. Yissum's business partners span the globe and include
companies such as Novartis, Microsoft, Johnson & Johnson, Merck, Intel and Teva.
Contacts:
Amarin +44 (0) 207 907 2442
Rick Stewart Chief Executive Officer
Alan Cooke President and Chief Financial Officer
investor.relations@amarincorp.com
Investors:
Lippert/Heilshorn & Associates, Inc.
Anne Marie Fields +1 212 838 3777
Bruce Voss +1 310 691 7100
Media:
Powerscourt +44 (0) 207 250 1446
Rory Godson
Sarah Daly
Davy: +353 (0)1 679 6363
Ivan Murphy
Fergal Meegan
Disclosure Notice
The information contained in this document is as of December 5, 2007. Amarin
assumes no obligation to update any forward-looking statements contained in this
document as a result of new information or future events or developments. This
document contains forward-looking statements about Amarin's financial condition,
results of operations, business prospects and products in research that involve
substantial risks and uncertainties. You can identify these statements by the
fact that they use words such as "will", "anticipate", "estimate", "expect",
"project", "forecast", "intend", "plan", "believe" and other words and terms of
similar meaning in connection with any discussion of future operating or
financial performance or events. Among the factors that could cause actual
results to differ materially from those described or projected herein are the
following: risks relating to the Company's ability to maintain its Nasdaq
listing (including the risk that the Company may not successfully appeal a
Nasdaq delisting determination); the Company's ability to close the equity,
convertible debt and warrant financings; the Company's ability to successfully
integrate the Ester acquisition; Amarin's ability to maintain sufficient cash
and other liquid resources to meet its operating requirements; the success of
Amarin's research and development activities, including its planned clinical
trials in cardiovascular disease and; decisions by regulatory authorities
regarding whether and when to approve Amarin's drug applications, as well as
their decisions regarding labeling and other matters that could affect the
commercial potential of Amarin's products; the speed with which regulatory
authorizations, pricing approvals and product launches may be achieved; the
success with which developed products may be commercialized; competitive
developments affecting Amarin's products under development; the effect of
possible domestic and foreign legislation or regulatory action affecting, among
other things, pharmaceutical pricing and reimbursement, including under Medicaid
and Medicare in the United States, and involuntary approval of prescription
medicines for over-the-counter use; Amarin's ability to protect its patents and
other intellectual property; claims and concerns that may arise regarding the
safety or efficacy of Amarin's product candidates; governmental laws and
regulations affecting Amarin's operations, including those affecting taxation;
general changes in International and US generally accepted accounting
principles; and growth in costs and expenses. A further list and description of
these risks, uncertainties and other matters can be found in Amarin's Form 20-F
for the fiscal year ended December 31, 2006, filed with the SEC on March 5,
2007, Amarin's statutory annual report for the year ended 31 December, 2006
furnished on a Form 6-K to the SEC on May 9, 2007 and in its Reports of Foreign
Issuer on Form 6-K furnished to the SEC.
Ends
# # #
This information is provided by RNS
The company news service from the London Stock Exchange
END
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