Amarin Corporation plc has signed a definitive agreement to acquire Laxdale Limited, a privately owned, neuroscience development company based in Stirling, Scotland, according to a company release.
Laxdale's development pipeline includes programmes in Huntington's disease, treatment unresponsive depression and other neurological disorders. Amarin previously licensed the US rights to Miraxion (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. 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 Stg£950,000 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 EU and Japan for the payment of Stg£500,000, the release says.
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 US marketing partner, makes tremendous strategic sense to progress the Phase III development programme for Miraxion."
Miraxion has been granted Fast Track designation by FDA as well as having received Orphan Drug designation both in the US 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 totalling 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 US with a similar number in Europe.