Milan, Italy – September 10, 2009 - Newron Pharmaceuticals S.p.A. (“Newron”, SIX:NWRN), a research and development company focused on novel CNS and pain therapies, today announced its financial results for the half year ended June 30, 2009.
Highlights
• In a phase III pivotal trial, safinamide significantly improved motor fluctuations and motor function in patients with advanced Parkinson’s disease
o Results presented at the Movement Disorder Society’s 13th International Congress in Paris in June
• The SETTLE safinamide study was initiated
o A six month trial involving over 450 patients with mid- to late-stage PD is to evaluate the efficacy and safety of a 50-100 mg once daily dose range of safinamide as add-on therapy to a stable dose of levodopa compared to placebo
• First patients randomized to treatment with ralfinamide in a potentially pivotal phase IIb/III study (SERENA study) in patients with moderate Neuropathic Low Back Pain (NLBP)
o The study will evaluate the safety and efficacy of two dose regimens of ralfinamide compared to placebo. The EMEA has approved the plans for the NLBP indication, the study design, diagnostic criteria, outcome measures, and statistical analysis plan
• Newron, in its aim to become an integrated biopharmaceutical company, has continued to carefully control costs and has a stable financial base to pursue the longer term clinical development of its key product candidates as they near commercialization.
Luca Benatti, CEO, commented: “Our key product candidates have passed important development milestones on their way to commercialization. Alongside we have tightly controlled costs whilst investing prudently in our broad pipeline. As a result, Newron has continued to deliver on its objectives of becoming a leading CNS biopharmaceutical company and we believe that we are strongly positioned for further growth.”
Safinamide: one phase III trial successfully completed, one initiated to support an application for marketing authorization In June 2009, Newron and its partner Merck Serono presented the results from detailed analysis of the first phase III clinical trial (Study 016) of safinamide in advanced Parkinson’s disease (PD) at the Movement Disorder Society’s 13th International Congress in Paris. In the study, safinamide at doses of 50 mg and 100 mg a day, when used as add-on to a stable dose of levodopa and other anti-Parkinsonian treatments for 24 weeks in patients with mid- to late-stage PD, significantly increased total daily “ON” time without increasing troublesome dyskinesia, indicating that safinamide improved motor fluctuations. The study had a high completion rate (89%) and of the 669 patients enrolled, 544 (81 %) continued into the 18-month extension study (Study 018) to specifically assess the effect on dyskinesias as the primary endpoint.
In May 2009, Newron and Merck Serono announced the initiation of the SETTLE study, a six month trial involving over 450 patients with mid- to late-stage idiopathic PD, who have motor fluctuations with more than one and a half hours of “OFF” time during the day. This study will evaluate the efficacy and safety of a dose range of safinamide (50-100 mg once daily) as add-on therapy to a stable dose of levodopa compared to placebo. The primary endpoint of the trial is the change in daily “ON” time, as assessed by the recordings of diary cards maintained by patients after prior training, from baseline to week 24. Secondary endpoints include changes in measures of activities of daily living, global clinical status and health-related quality of life.
Three major studies are currently ongoing for safinamide. Two of them, the SETTLE and MOTION studies, are phase III trials designed to support an application for marketing authorization as discussed with the regulatory authorities.
Ralfinamide – start of one of two possible pivotal studies for approval in NLBP
In March 2009, the first patients were randomized to treatment with ralfinamide in the first phase IIb/III study in patients with moderate Neuropathic Low Back Pain (NLBP). The SERENA study – a 12-week, randomized, double-blind, international (Europe and Asia) phase IIb/III trial in 400 patients – will evaluate the safety and efficacy of two dose regimens of ralfinamide compared to placebo. It could be one of the two pivotal studies required for an approval in NLBP, an indication with a prevalence of about 8% of the population with no approved treatments available. Newron expects to report top-line data from the SERENA study in the first half of 2010.
NW-3509 – undergoing IND-enabling studies
NW-3509 is currently undergoing IND-enabling studies. NW-3509 is an innovative new chemical entity which, similarly to ralfinamide, originates from Newron’s Ion Channel program. NW-3509, acting by a different mechanism from current antipsychotics, has the potential to address unmet medical needs in schizophrenia such as cognitive symptoms, negative symptoms, mood disorders, partial responders, suicidality and co-morbidities such as anxiety and depression. Furthermore, NW-3509 has the potential to treat the manic as well as the depressive phase of bipolar disorders without inducing sedation.
HF0220, the lead compound from Newron’s 2008 acquisition of Hunter-Fleming, is being evaluated for further development.
Financial Highlights
In the first six months of 2009, Newron has increased its investments into development projects to EUR 6.5m from EUR 5.2m in 2008. These R&D expenses are net of reimbursements by Merck Serono for the development costs for safinamide incurred by Newron, as well as Italian and European government grants and Italian and UK tax credits. The gross R&D expense for the reporting period was EUR 11.2m compared to EUR 10.9m in 2008. The increase mainly reflects the progress of the phase IIb/III SERENA trial in Neuropathic Low Back Pain. Newron reduced the G&A expenses to EUR 4.1m compared to EUR 5.2m in the previous year, mostly due to the reduction in legal fees and the one-time restructuring cost following the Hunter-Fleming acquisition in 2008. License income relates to the down-payment received from Merck Serono in 2006, which is being recognized over the estimated period of collaboration. Interest income has reduced, due mainly to Newron’s policy to invest only in short term funds, as well as a reduced cash and short term investment position of EUR 29.7m as per June 30, 2009. The cash used in operating activities of EUR 11.7m is lower than the previous year (EUR 12.7m) and fully in line with the guidance given at the beginning of the year (EUR 25m for all 2009).
