NeuroSearch regains global rights to ACR16

NeuroSearch regains global rights to ACR16     
02 Mar 2009 
NeuroSearch announces that the company has regained the global rights to ACR16, a dopaminergic stabiliser in Phase III development as a novel treatment for Huntington's disease

Ballerup; Denmark | March 2, 2009 | NeuroSearch announces that the company has regained the global rights to ACR16, a dopaminergic stabiliser in Phase III development as a novel treatment for Huntington's disease.

Under a license agreement between NeuroSearch and Astellas Pharma Inc. (Astellas), Astellas has held worldwide rights to ACR16 for all indications, except in North America, EU, Norway and Switzerland, in which territories NeuroSearch retained the rights to develop and commercialise the drug for Huntington's disease. The license agreement was originally made between former Carlsson Research AB (now NeuroSearch) and former Fujisawa (now Astellas).

Under the now terminated licence agreement Astellas has been evaluating ACR16 in Phase I studies with a view to developing the drug as a novel treatment for schizophrenia. Based on a strategic assessment including consideration of the commercial and developmental challenges in this indication, Astellas has now decided to discontinue development of ACR16 in schizophrenia and to return all territorial and commercialisation rights to the compound to NeuroSearch. Astellas' decision does not relate to any technical or developmental issues of relevance for NeuroSearch's ongoing clinical programme with ACR16 or for the drug's potential in the treatment of Huntington's disease.

In relation to the return of rights, NeuroSearch has ensured the manufacturing of ACR16 and also the future delivery of the drug for commercialisation. The discontinuation of the license agreement with Astellas will not affect the overall budget, the timing of the development programme, the production or the estimated profitability of ACR16 going forward.

Flemming Pedersen, CEO of NeuroSearch comments;

"Vi har haft et meget vellykket samarbejde med Astellas om at evaluere den samme lægemiddelkandidat inden for to forskellige sygdomsområder. Idet ACR16 nu er i sin sidste udviklingsfase til Huntingtons sygdom, anser vi det dog for meget værdifuldt for NeuroSearch at eje de globale rettigheder til produktet. Vi er meget dedikerede til vores Huntingtons-program, og det er vores mål at afslutte det igangværende fase III-studie senere på året."

As a consequence of Astellas' decision to discontinue the development of ACR16 in schizophrenia, a potential milestone consideration of SEK 125 million (DKK 83.1 million/EUR 11,2 million) to the sellers of Carlsson Research following NeuroSearch's acquisition of the company in 2006, will not become due and the corresponding debt obligation has therefore been taken off NeuroSearch's balance sheet. The transaction has no impact on the company's financial results.

NeuroSearch will disclose financial guidance for 2009 in connection with the company's 2008 full year announcement on 4 March 2009.