Announcement
26.05.2011
- NeuroSearch has received written feedback from both the FDA and EMA concerning the clinical development programme for tesofensine for the treatment of overweight and obesity
- NeuroSearch has concluded that a Phase III programme is to include two obesity studies of one year’s duration each with weight loss as the primary endpoint
- The Phase III programme must also comprise a study of more than two years’ duration to establish the compound’s cardiovascular safety profile
- NeuroSearch considers tesofensine to be an efficient drug candidate for the treatment of overweight and obesity, and clarity about the Phase III programme has now been provided for a potential partner
Today, NeuroSearch (NEUR) reports on the conclusions based on the scientific advice received from the FDA and EMA.
In a previous six months’ Phase III study, tesofensine demonstrated an approx. 10% placebo-adjusted weight loss but also a modest increase in blood pressure and pulse at therapeutic doses. As a consequence, NeuroSearch decided to seek scientific advice from the FDA and EMA. Based on these interactions, a Phase III programme has been designed to comprise two obesity studies of one year’s duration and a cardiovascular outcome study of more than two years’ duration. The latter requires 5-7,000 patients.
NeuroSearch is satisfied that a development programme to prepare for registration has now been decided upon.
NeuroSearch will not invest further in the programme in-house but seeks a partner for the continued development and commercialisation of tesofensine.
Patrik Dahlen, CEO of NeuroSearch, comments:
"Tesofensine has demonstrated a considerable weight reducing effect and, based on our assesment, also a favourable safety profile. For a long time, we – and potential partners – have been aware of the uncertain regulatory climate, and it is therefore encouraging that NeuroSearch has been able to obtain clear indications of the requirements from both the American and the European authorities to take tesofensine through to market registration. Thereby, potential partners have also gained a better understanding of a future development path”.
NeuroSearch maintains the company's financial expectations for the full financial year 2011 of an expected loss before financials and other shares of result in the region of DKK 325 million.
Patrik Dahlen
CEO
Contact persons:
Patrik Dahlen, CEO, telephone:+45 4460 8214 or +45 2629 7296
René Schneider, EVP & CFO, telephone: +45 4460 8700 or +45 2911 2097
About NeuroSearch
NeuroSearch A/S is a European based biopharmaceutical company, specialising in CNS diseases, and listed on NASDAQ OMX Copenhagen A/S (NEUR). The company has a pipeline of speciality CNS drugs, including Huntexil® (pridopidine), a unique orphan drug in Phase III for the treatment of Huntington’s disease. NeuroSearch is building commercial competences with a view to commercialising Huntexil® through an in-house marketing and sales organisation.
NeuroSearch has a well-established drug discovery division, NsDiscovery, with unique capabilities in the field of ion channels and CNS diseases. The company has strategic drug discovery and development alliances with Janssen Pharmaceutica and Eli Lilly as well as a licence collaboration with Abbott. NeuroSearch also has equity interests in a number of unlisted companies in the Life Science industry.
