Amarin Expands Neurology Pipeline With Epilepsy Product Candidate
March 06 2007 - 11:20AM
PR Newswire (US)
Acquires Global License to Novel Nasal Lorazepam Formulation
LONDON, March 6 /PRNewswire-FirstCall/ -- Amarin Corporation plc
(NASDAQ:AMRN) today announced the acquisition of a global license
to develop and market a novel, nasal lorazepam formulation for the
out-patient treatment of emergency seizures in epilepsy patients,
specifically status epilepticus (SE) and acute repetitive seizures
(ARS). This formulation utilises the patent protected
NanoCrystal(R) Technology from Elan Corporation, plc ("Elan", NYSE:
ELN). SE and ARS have an estimated annual incidence in the United
States of 150,000 cases and up to 400,000 patients, respectively.
There are approximately 40,000 deaths in the United States each
year associated with such emergency seizures. Rick Stewart, Chief
Executive Officer of Amarin, commented, "The potential of this
nasal lorazepam opportunity is significant in addressing this unmet
medical need. A nasal product for seizure emergencies in the
out-patient setting for epilepsy patients would represent an
important treatment option. We believe the potential annual sales
for such a product could be up to $300 million in the United
States. We are very excited about this opportunity as it fits
neatly into Amarin's neurology focused strategy." Paul Breen,
Executive Vice President and Head Elan Drug Technologies stated,
"We are very pleased to execute this agreement with Amarin. This
agreement continues to validate the robustness and flexibility of
our proprietary NanoCrystal technology. We look forward to working
with Amarin and assisting them in their efforts to develop a nasal
formulation of lorazepam that will significantly benefit patients".
Diazepam rectal gel is the only treatment currently approved by the
U.S. Food and Drug Administration ("FDA") for seizure emergencies
in the out- patient setting. Diazepam gel's use is limited by its
rectal route of administration. Consequently, an opportunity exists
for the development of a product with a more convenient route of
administration permitting broader out- patient treatment of SE and
ARS in both children and adults. Intravenous lorazepam is a first
line of treatment for SE and ARS in hospital emergency rooms in the
United States. Development Programme Formulation of a NanoCrystal
nasal lorazepam commenced in early 2006. Amarin plans to initiate a
pharmacokinetic trial later this year with the objective of
commencing efficacy trials in 2008. Elan will be responsible for
completing the development of the NanoCrystal formulation, plus the
manufacturing of clinical and commercial supplies. Amarin is
responsible for completing the final nasal formulation work, the
clinical development programme, the regulatory approval process and
commercialisation. NanoCrystal Technology and Patent Protection
Amarin has obtained a global licence for a number of Elan's patents
and know-how relating to Elan's proven NanoCrystal technology,
including six issued patents that expire in 2019 and 2020, and two
pending patents that expire in 2021 and 2026, respectively.
Strategic Fit Amarin's strategy is to commercialise novel neurology
products for the treatment of unmet medical needs for small,
focused physician audiences. A successfully developed nasal
lorazepam will be promoted to a focused group of approximately 500
neurologists and epileptologists. Transaction Terms In
consideration of the grant of the license and ultimately commercial
supply, Amarin will pay Elan success-based development, filing and
approval milestones totalling $5.2 million plus royalties on net
sales. There is no initial license payment. In connection with this
transaction, Amarin will also pay a third party, Neurostat
Pharmaceuticals, Inc. ("Neurostat"), a finder's fee and similar
payments comprising upfront and contingent milestones totalling
$0.6 million plus warrants to purchase 175,000 Amarin shares with
an exercise price of $1.79 per share. Unmet Medical Need - Status
Epilepticus and Acute Repetitive Seizures A seizure emergency is a
prolonged seizure or continuous state of frequently occurring
seizures. One common type of seizure emergency is called status
epilepticus (SE). SE may be defined as a prolonged seizure lasting
anywhere between 10 and 30 minutes. SE is also defined by a series
of repeated seizures without the return of consciousness between
seizures. SE has an annual incidence estimated at approximately
150,000 cases in the United States alone with approximately 40,000
deaths per year. Another type of seizure emergency is acute
repetitive seizures (ARS), which is a bout or cluster of seizures
over a short period of time in which the patient regains
consciousness between seizures. It is estimated that up to 400,000
people in the United States suffer from ARS. Epilepsy is a very
common disorder affecting approximately 0.5% of the population and
is characterized by seizures, which may vary from the briefest
lapses of attention to muscle jerks to severe and prolonged
convulsions. They may also vary in frequency, from less than one a
year to several per day. About Amarin Amarin is committed to
improving the lives of patients suffering from diseases of the
central nervous system. Our goal is to be a leader in the research,
development and commercialization of novel drugs that address unmet
patient needs. Amarin has a late-stage drug development pipeline.
Miraxon, Amarin's lead development compound, is in Phase III
development for Huntington's disease ("HD"), Phase II development
for depressive disorders and is entering Phase IIa development for
Parkinson's disease. Amarin's core development pipeline also
includes the global rights to a novel oral formulation of
apomorphine for treating patients with advanced Parkinson's disease
and a nasal formulation of lorazepam for treating emergency
seizures. Miraxion for HD is being developed under a Special
Protocol Assessment agreed with the U.S. Food and Drug
Administration ("FDA"), has been granted Fast Track designation by
the FDA and has received Orphan Drug designation in the U.S. and
Europe. Amarin has its primary stock market listing in the US on
NASDAQ ("AMRN") and secondary listings in the UK and Ireland on AIM
("AMRN") and IEX ("H2E"), respectively. For press releases and
other corporate information, visit the Amarin website at
http://www.amarincorp.com/. Information on our website does not
form part of this press release. NanoCrystal(R) Technology is a
registered trademark of Elan Pharma International Limited, Ireland.
For more information on Elan's NanoCrystal(R) Technology, please
visit http://www.elan.com/EDT. Disclosure Notice The information
contained in this document is as of March 6, 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: the success of Amarin's research and development
activities, including the Phase III trials with Miraxion in
Huntington's disease; 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; Amarin's ability to maintain sufficient cash
and other liquid resources to meet its operating requirements;
general changes in UK and US generally accepted accounting
principles; growth in costs and expenses; and the impact of
acquisitions, divestitures and other unusual items, including
Amarin's ability to integrate its acquisition of Amarin
Neuroscience Limited. A further list and description of these
risks, uncertainties and other matters can be found in Amarin's
Annual Report on Form 20-F for the fiscal year ended December 31,
2006, and in its Reports of Foreign Issuer on Form 6-K furnished to
the SEC. DATASOURCE: Amarin Corporation plc CONTACT: Rick Stewart,
Chief Executive Officer, or Alan Cooke, Chief Financial Officer of
Amarin, +44 (0) 207 907 2442, or ; Investors, Anne Marie Fields of
Lippert-Heilshorn & Associates, Inc., +1-212-838-3777; or
Media, Rory Godson or Victoria Brough of Powerscourt, +44 (0) 207
236 5615 Web site: http://www.amarincorp.com/
http://www.elan.com/EDT
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