HAMBURG, Germany, June 30, 2015 (GLOBE NEWSWIRE) -- Evotec AG (Frankfurt:EVT) (TecDAX) (ISIN:DE0005664809) was updated today by its partner Roche (SIX:RO) (SIX: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 € 15 m – € 20 m. Liquidity is expected to be well in excess of € 100 m at 31 December 2015.
The compound was originally licensed from Roche to Evotec in 2006, and initially developed in another indication. In 2011, Evotec and Roche entered into an exclusive worldwide agreement for the development and commercialization in patients with Alzheimer's disease. Under the terms of the agreement, Roche paid Evotec an upfront fee of $10 m. Roche is responsible for all costs, clinical development, manufacturing and commercialisation activities.
Sembragiline (RG1577, EVT 302) is a novel, potent inhibitor of monoamine oxidase type B (MAO-B), an enzyme that breaks down the chemical messenger dopamine in the brain and contributes to the production of free radicals. Free radicals are known to cause oxidative stress which may contribute to pathogenesis of AD as demonstrated by the up-regulation of MAO-B expression in the brain of AD patients. For these reasons, the selective MAO-B inhibitor is targeted to treat AD symptoms and potentially slow disease progression.
About Evotec AG
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide providing the highest quality stand-alone and integrated drug discovery solutions, covering all activities from target-to-clinic. The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuroscience, pain, metabolic diseases as well as oncology, inflammation and infectious diseases. Evotec has long-term discovery alliances with partners including Bayer, Boehringer Ingelheim, CHDI, Genentech, Janssen Pharmaceuticals, MedImmune/AstraZeneca, Roche and UCB. In addition, the Company has existing development partnerships and product candidates both in clinical and pre-clinical development. These include partnerships with Boehringer Ingelheim and MedImmune in the field of diabetes, with Janssen Pharmaceuticals in the field of depression and with Roche in the field of Alzheimer's disease. For additional information please go to www.evotec.com.
FORWARD LOOKING STATEMENTS — Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this report. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.
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