A neuroscience company focused on developing novel drugs for the treatment of CNS disorders, Amarin’s lead product, Miraxion TM, is in development for Huntington’s disease and treatment-unresponsive depression

Amarin is a neuroscience company focused on developing novel drugs for the treatment of central nervous system (CNS) disorders. Amarin’s leading pipeline product, Miraxion™, is in development for a number of therapeutic indications including Huntington’s disease (HD) and treatment-unresponsive depression. Amarin is listed on the Nasdaq small cap market (ticker: AMRN), and has headquarters in London and a research and development facility in Stirling, Scotland.

Amarin’s goal is to capitalize on its strong reputation 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 HD and depression. The company plans to partner any products outside the therapeutic areas of neurology, and partner all products outside the geographic area of the USA. In October 2004, the company completed a $12.75 million private placement of shares, allowing it to further develop its pipeline particularly its lead product, Miraxion (LAX 101).

“Neurology in the US is a key area for Amarin, a therapeutic sector with a great unmet medical need. What makes this particularly attractive for a company of our size is that among the approximately 7,200 neurologists across the US, about 1,000 are movement disorder specialists. These specialists can be targeted with a modest size sales force to great effect. Having divested our US neurology focused business in early 2004 it is our intention to reestablish an infrastructure in time for the launch of Miraxion, or sooner if the opportunity arises.” Darren Cunningham, Executive Vice President of Strategic Development at Amarin explained to Partnering Focus.

Miraxion, a phospholipid-based TLA2 inhibitor, is a semi-synthetic, highly (96%) purified derivative of eicosapentaenoic acid. The product, which is believed to act by reducing the destruction of mitochondria and so stabilizing neurons, is also known to have neuro-anti-inflammatory effects.

Amarin originally licensed US rights for Miraxion in Huntington’s disease from Laxdale in November 2000. However, Amarin acquired Laxdale in October 2004, gaining North American, EU and Japan rights for all CNS indications and reducing the effective royalty rate in the USA from 40% to 5%. Prior to the acquisition, Laxdale had partners for Huntington’s disease in Europe and Japan, and these agreements will remain in place.

In Huntington’s disease, one phase III trial with Miraxion has been completed. Although Miraxion did not have a significant effect in the intent to treat (ITT) group, the drug had a significant effect in a subgroup with CAG repeat length of less than 45 (less severe patients). CAG repeat length can be identified with a simple genetic test. Two follow up phase III trials are planned to commence in the first half of 2005 and will incorporate the valuable information obtained from this initial phase III trial. Miraxion is a very safe compound, with no side effects of note seen so far in clinical trials.

Huntington’s disease is a genetic neurodegenerative disease characterized by movement disorder, dementia and psychiatric disturbance. It has been diagnosed in approximately 30,000 patients in the US and a similar number in Europe. Additionally over 200,000 people in the US alone are genetically at risk to developing the disease. The potential Huntington’s disease market in North America and Europe is estimated to be greater than $500 million.

Miraxion has also been studied in five phase II trials in depressive disorders with positive results. The focus of development will be as an adjunctive therapy in unresponsive depression, a large indication with approximately 60% of patients either not responding or only partially responding to existing treatments. Amarin is likely to outlicense this indication to accelerate this program.

“Amarin’s key short term objective is to commence phase III studies with Miraxion in the first half of 2005, and to progress at least two other in-house or licensed compounds to phase II or III,” Mr Cunningham explained

Amarin Pipeline

Details at http://pharmalicensing.com/company/dispcompany/3756

To make any comments on this article, or to ask a question of the author, please contact the publisher. If you would like to submit an article please subscribe to our PL Intelligence service.

The opinions expressed in the articles published in this section do not necessarily reflect those of Pharmalicensing or UTEK Corporation. No actions including proposals to or agreements with other companies should be taken by any reader without obtaining specific business or legal advice. Neither the publisher nor the authors accept any liability for any actions or activities undertaken by any reader or other third party as a consequence of these articles or for any errors or omissions therein.