Corporate | 30 June 2015 20:52
DGAP-News: Evotec AG / Key word(s): Miscellaneous
2015-06-30 / 20:52
---------------------------------------------------------------------
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.
About Sembragiline
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.
Contact Evotec AG:
Gabriele Hansen, VP Corporate Communications & Investor Relations, Phone:
+49.(0)40.56081-255, gabriele.hansen@evotec.com
---------------------------------------------------------------------
2015-06-30 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
Language: English
Company: Evotec AG
Manfred Eigen Campus / Essener Bogen 7
22419 Hamburg
Germany
Phone: +49 (0)40 560 81-0
Fax: +49 (0)40 560 81-222
E-mail: info@evotec.com
Internet: www.evotec.com
ISIN: DE0005664809
WKN: 566480
Indices: TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart
End of News DGAP News-Service
---------------------------------------------------------------------
373949 2015-06-30