Amarin Corp PLC/UK – ‘6-K’ for 7/13/04

On:  Tuesday, 7/13/04, at 3:18pm ET   ·   For:  7/13/04   ·   Accession #:  1159554-4-19   ·   File #:  0-21392

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Report of a Foreign Private Issuer   —   Form 6-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 6-K         Report of a Foreign Private Issuer                     6±    22K 


SECURITIES AND EXCHANGE COMMISSION  
  Washington, D.C. 20549

    FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUERS PURSUANT TO RULE    
13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT    
OF 1934     

Dated: July 13, 2004                                  

Commission file number 0-21392    

AMARIN CORPORATION PLC  
(Exact name of Registrant as Specified in its Charter)  

ENGLAND   
(Jurisdiction of Incorporation or   
organization of Issuer) 

7 Curzon Street 
 London W1J 5HG, England
    (Address of Principal Executive Offices)

Indicate by check mark whether the registrant files                   
or will file annual reports under cover of Form 20-F or                         
Form 40-F.                                                                      

[X] Form 20-F            [ ] Form 40-F                  

Indicate by check mark whether the registrant by                      
furnishing the information contained in this Form is                            
also thereby furnishing the information to the                                  
Commission pursuant to Rule 12g3-2(b) under the                                 
Securities Exchange Act of 1934.                                                

[ ] Yes                  [X] No                         

Attachment:                                                                     

Material Events                                                                 

(a) AMARIN CORPORATION ANNOUNCES DEFINITIVE AGREEMENT TO                        
ACQUIRE LAXDALE LTD.                                                    

This report on Form 6-K is hereby incorporated by                     
reference in (a) the registration statement on Form F-3                         
(Registration No. 333-104748) of Amarin Corporation plc and                     
in the prospectus contained therein, (b) the registration                       
statement on Form F-3 (Registration No. 333-13200) of                           
Amarin Corporation plc and in the prospectus contained                          
therein and (c) the registration statement on Form F-3                          
(Registration No. 333-12642) of Amarin Corporation plc                          
and in the prospectus contained therein, and this report                        
on Form 6-K shall be deemed a part of each such registration                    
statement from the date on which this report is filed, to the                   
extent not superseded by documents or reports subsequently                      
filed or furnished by Amarin Corporation plc under the                          
Securities Act of 1933 or the Securities Exchange                               
Act of 1934.                                                                    

Pursuant to the requirements of the Securities                        
Exchange Act of 1934, the registrant has duly caused                            
this report to be signed on its behalf by the                                   
undersigned, thereunto duly authorized.                                         

AMARIN CORPORATION PLC              

By:/s/Richard A B Stewart             
Richard A B Stewart               
Chief Executive Officer           

Date: July 13, 2004                                                             

          Index to
Exhibits                                                                        

Exhibit Item                  Sequentially Numbered Page                        

(a) Material Event description-             4                                   

         Exhibit (a)

Contact:                                                                        
Rick Stewart                                                                    
Chief Executive Officer                                                         
Amarin Corporation plc                                                          
Phone: +44 (0) 207 907 2442                                                     
investor.relations@amarincorp.com                                               

Alan Cooke                                                                      
Chief Financial Officer                                                         
Amarin Corporation plc                                                          

AMARIN CORPORATION ANNOUNCES DEFINITIVE AGREEMENT           
TO ACQUIRE LAXDALE LTD.       

Combined Company to Lead in Development and Commercialization of                
Neuroscience Compounds                                                          

LONDON, United Kingdom, July 12, 2004 - Amarin Corporation plc                  
(NASDAQ: AMRN) today announced that it has signed a definitive                  
agreement to acquire Laxdale Limited, a privately owned, neuroscience           
development company based in Stirling, Scotland.  Laxdale's                     
development pipeline includes programs in Huntington's disease,                 
treatment unresponsive depression and other neurological disorders.             
Amarin previously licensed the U.S. rights to Miraxion TM (formerly             
referred to as LAX-101) for Huntington's disease in November 2000.              

The purchase price comprises an initial consideration of 3.5 million            
Amarin American Depositary Shares.  Other success related milestones            
payable on product approvals are as follows:                                    

-       On receipt of a marketing approval for Miraxion in Huntington's         
disease in the U.S. and Europe, a stock or cash payment of 7.5                  
million pound sterling for each approval                                        

-       On receipt of a marketing approval for any other indication             
or product using Laxdale intellectual property, a stock or cash                 
payment of 5 million pound sterling for each of the first two marketing         
approvals.                                                                      

The transaction is contingent upon Amarin shareholder approval,                 
completion by Amarin of a $15 million financing and other customary             
conditions. Amarin has agreed a loan facility of up to 950,000 pound            
sterling to Laxdale. This loan facility is secured by a floating charge         
against Laxdale's assets.                                                       

In conjunction with the acquisition of Laxdale, Amarin will execute             
cross-licensing agreements with Scarista Limited at closing providing           
Amarin with rights to specified intellectual property covering                  
North America, the E.U. and Japan for the payment of 500,000 pound sterling.    

Rick Stewart, chief executive officer of Amarin Corporation,                    
commented, "Our long-term collaboration with Laxdale on the                     
development of Miraxion for Huntington's disease has given Amarin               
a great appreciation of the scientific capabilities, competencies               
and depth of the development pipeline in central nervous system                 
diseases at Laxdale. We have been particularly encouraged by                    
additional clinical data analysis from the initial pivotal clinical             
trial in Huntington's disease which identified a sub-group                      
of Huntington's disease patients which responded positively                     
to Miraxion."                                                                   

Sherri Clarkson, managing director of Laxdale, commented, "Laxdale              
enjoys a proud reputation for scientific excellence in central                  
nervous system disorders. A combination with Amarin, our U.S. marketing         
partner, makes tremendous strategic sense to progress the Phase III             
development program for Miraxion."                                              

Key benefits to Amarin                                                          

-       Improvement in Amarin's share of Miraxion's economics by                
reducing Amarin's royalty obligations on U.S. sales from an effective           
rate of 40% previously to 5% post acquisition                                   
-     E.U. and Japanese rights to Miraxion for Huntington's disease plus        
existing licensee relationships for the major European markets and Japan        
-       North American, E.U. and Japanese rights to Miraxion in all             
other central nervous system disorders, including treatment unresponsive        
depression                                                                      
-       Leading neuroscience development capability which can be                
further leveraged through in-licensing and acquiring rights to additional       
programs                                                                        
-     A development pipeline beyond Miraxion consisting of additional           
neuroscience programs at earlier stages of development.                         

Development Pipeline                                                            

Amarin's late-stage development pipeline will consist of the following key      
programs:                                                                       

Program          Indication               Development Status                    

Miraxion         Huntingdon's disease     Filed (EMEA)                          
(E.U.)                                                                          

Miraxion         Huntingdon's disease     Phase III studies to commence         
(U.S.)                                    early next year                       

Miraxion         Treatment unresponsive   Phase II to commence next year        
Depression               (to be partnered)    

Miraxion for Huntington's Disease  - Recent Progress                            

Miraxion has been granted Fast Track designation by FDA as well as              
having received Orphan Drug designation both in the U.S. and in                 
Europe.  Laxdale recently met with the Food and Drug Administration             
(FDA) regarding the clinical trial protocol for Miraxion in additional          
Phase III clinical studies in Huntington's disease.  As a result of             
those discussions with the FDA, revisions have been made to the protocol        
to include two six-month studies totaling approximately 400 patients.           
It is anticipated that the studies will start early next year subject           
to finalization of the protocol.  Miraxion was submitted for regulatory         
approval in Europe in June 2003 based on the initial Pivotal                    
clinical data.                                                                  

The initial Pivotal clinical trial in 135 Huntington's disease patients         
did not achieve statistical significance in the "Intent to Treat"               
group of patients primarily due to a high number of patients who did            
not comply with the protocol.  However, in those patients that complied         
with the protocol ("per protocol"), a trend to statistical significance         
was observed.                                                                   

Recent additional analysis of the clinical data from the initial                
study also identified a sub-set of Huntington's patients (with a                
specific gene variant) that responded to Miraxion with statistical              
significance at 6 months and at 12 months.  The per protocol analysis           
and the additional clinical data in this patient sub-group provides             
Amarin with valuable information with which to design our planned               
Phase III studies.                                                              

Huntington's Disease is an autosomal-dominant genetic disease that              
has been diagnosed in approximately 30,000 patients in the U.S.                 
with a similar number in Europe. Additionally, over 200,000                     
persons are genetically "at risk" of developing the disease in                  
the U.S. alone.  Huntington's disease is a neurodegenerative                    
disease characterized by movement disorder, dementia and                        
psychiatric disturbance.  Onset of symptoms is typically between                
40-45 years of age with a typical life expectancy from diagnosis                
of 15-25 years. Huntington's disease is believed to be caused                   
by a genetic mutation of the cytosine, adenosine and guanine                    
(CAG) polymorphic trinucleotide repeat.  Patients with late                     
stage disease require continuous nursing care, often in nursing                 
homes, with an estimated annual cost to the U.S. economy of                     
up to $2.5 billion.                                                             

Miraxion for Treatment Unresponsive Depression                                  

Two Phase II clinical trials have been conducted with Miraxion                  
in treatment unresponsive depression that concluded with                        
statistical significance that a 1-gram per day dose of Miraxion                 
was effective in treating depression in patients who remained                   
depressed despite receiving standard therapy.  The results of                   
these trials were published in the Archives of General Psychiatry               
in October 2002 and the American Journal of Psychiatry in March 2002.           

As a result of the encouraging clinical trial results in treatment              
unresponsive depression, Amarin intend to further evaluate the                  
clinical benefits of Miraxion in this indication and will seek a                
development and marketing partner to accelerate the program.                    

Clinical depression is one of the most common mental illnesses,                 
affecting more than 19 million people in the U.S. alone each year.              
In 2003, U.S. sales of antidepressants were approximately $12 billion.          
Miraxion is being developed as an adjunctive therapy to treat those             
who do not respond to current treatments.                                       

Corporate Strategy                                                              

Amarin's goal is to capitalize on its strong reputation and strategic           
position in neuroscience and to become a leader in the development and          
commercialization of novel drugs which address unmet medical needs.             

Amarin will develop its late-stage development pipeline initially               
Focusing on Huntington's disease and treatment unresponsive                     
depression, for which a development partner will be sought. Amarin              
will seek to directly commercialize its neurology products in the U.S.          
and out-license or partner its rights in Europe and Japan.  Amarin              
will also out-license or partner its pipeline globally for indications          
outside neurology.                                                              

Amarin also intends to leverage its development capabilities by                 
supplementing its internal development pipeline through acquiring               
and/or in-licensing products for direct marketing by Amarin in                  
its core U.S. market and selected field of neuroscience.                        

Amarin's Short-Term Objectives                                                  

* To successfully complete Phase III studies with Miraxion in Huntington's      
disease by the end of next year                                                 
* To commence Phase II or Phase III studies during 2005 with at least two other 
products either from Amarin's internal pipeline or from in-licensing activities.

About Amarin Corporation                                                        

Amarin Corporation plc is a neuroscience company focused on the                 
development and commercialisation of novel drugs for the treatment              
of neurological disorders affecting the central nervous system.                 

For press releases and other corporate information, visit our website at        
http://www.amarincorp.com.                                                      

Statements in this press release that are not historical facts are forward-     
looking statements that involve risks and uncertainties which may cause the     
Company's actual results in future periods to be materially different from any  
performance suggested herein.  Such risks and uncertainties include, without    
limitation, the uncertainty of entering into and consummating a definitive      
agreement on terms acceptable to the parties, the inherent uncertainty of       
pharmaceutical research, product development and commercialisation, the impact  
of competitive products and patents, as well as other risks and uncertainties   
detailed from time to time in periodic reports.  For more information, please   
refer to Amarin Corporation's Annual Report for 2003 on Form 20-F and its Form  
6-Ks as filed with the U.S. Securities and Exchange Commission.  The company    
assumes no obligation to update information on its expectations.                

Dates Referenced Herein

This ‘6-K’ Filing		Date		Other Filings
Filed on / For Period End:		7/13/04		None on these Dates
		7/12/04
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