Hamburg, Germany - 30 June 2015: Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) was updated today by its partner Roche (SIX: RO, ROG; OTCQX: RHHBY) on the initial results of the Phase IIb trial with Sembragiline (RG1577, EVT302), a MAO-B inhibitor for the treatment of Alzheimer's disease ("AD"). In this study, Sembragiline failed to demonstrate benefit on the primary endpoint (Alzheimer's Disease Assessment Scale - Cognitive Behaviour Subscale, ADAS-cog-11) after 52 weeks of treatment. Preliminary safety analyses showed that Sembragiline was well tolerated with no safety signals identified. Roche has initiated a process to evaluate all secondary endpoint read-outs on Sembragiline and to consider all further development options. The multicentre, randomised, double-blind, parallel-group, placebo-controlled Phase IIb study was undertaken to evaluate the efficacy and safety of Sembragiline in patients with moderate severity Alzheimer's disease added on background of AD standard therapy.
Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "Clearly disappointing news that Sembragiline didn't reach its primary endpoint but Alzheimer's is one of the biggest medical challenges of our times, and will remain a priority for Evotec and our partners. Strategically, this programme represents one out of more than 70 product opportunities within our portfolio in the fields of CNS and pain, metabolic diseases, oncology and anti-infectives."
Today's news has no impact on Evotec's financial guidance. In 2015, total Group revenues excluding milestones, upfronts and licences are expected to increase more than 35%. Evotec's Group EBITDA before changes in contingent considerations is expected to be positive. Evotec expects research and development (R&D) expenses to grow to EUR 15 m - EUR 20 m. Liquidity is expected to be well in excess of EUR 100 m at 31 December 2015.