DGAP-News: Evotec announces NMDA antagonist license agreement
(firmenpresse) - DGAP-News: Evotec AG / Key word(s): Alliance
Evotec announces NMDA antagonist license agreement
17.12.2012 / 09:11
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Hamburg, Germany - 17 December 2012: Evotec AG (Frankfurt Stock Exchange:
EVT, TecDAX) today announced that it has entered into a license agreement
with Janssen Pharmaceuticals, Inc. ('Janssen') regarding its NR2B subtype
selective NMDA-antagonist portfolio for development against diseases in the
field of depression.
Under the terms of this agreement Janssen has been granted an exclusive,
worldwide license to a series of small molecule drug candidates. Janssen
has the exclusive right to further develop the compounds and market the
resulting products. Janssen Research&Development, LLC, an affiliate of
Janssen Pharmaceuticals, Inc., will conduct the clinical development work
under the agreement.
Evotec will receive an upfront payment of USD 2 million with an additional
USD 6 million to be paid upon confirmation of certain pre-clinical
properties of the candidates. Evotec is eligible to receive additional
milestone payments from Janssen upon the successful completion of certain
clinical, regulatory and launch events for a first product, which may total
up to USD 67 million, as well as additional, reduced milestone payments
upon successful completion of certain events for additional indications
and/or compounds. Evotec shall be entitled to receive an additional USD 100
million in commercial milestones depending and upon meeting certain sales
thresholds and royalties which could be as high as double-digit on certain
future sales of royalty bearing products. Evotec will share portions of the
payments with F. Hoffmann-La Roche Ltd., which originally discovered the
molecules.
The compounds in the portfolio are orally active NR2B subtype selective
NMDA-antagonists which were developed from discovery stages through to
clinical studies by Evotec. In 2009 Roche entered into an agreement with
Evotec for Phase II clinical development of the portfolio compounds in
patients with treatment-resistant depression; this collaboration was
terminated in 2011. The rights licensed hereunder are those that Evotec
retained to the portfolio of compounds.
Dr. Mario Polywka, Chief Operating Officer of Evotec, commented: 'Evotec
has worked towards tackling the significant need for an effective treatment
approach against depression. The now sealed collaboration with Janssen
reflects not only the value attributable to our past development efforts
but, more importantly, also enhances the hopes of many patients to gain
access to a first-in-class relief of their suffering. We are happy to team
with Janssen Pharmaceuticals, one of the leaders in the field for the
further development of our NMDA antagonists.'
The Janssen Pharmaceutical Companies leverage world-class discovery and
development expertise and operational excellence to bring to market
innovative, effective treatments in five therapeutic areas: cardiovascular
and metabolism, immunology, infectious diseases and vaccines, neuroscience,
and oncology. For more than 50 years Janssen has been a leader in
neuroscience with many innovative products in psychiatry, neurology and
pain.
Background Information
About NMDA (N-methyl-d-aspartate) antagonists
Apart from their normal physiological role in nerve-to-nerve cell
communication NMDA receptors are important players in certain pathological
disease states such as Alzheimer's disease, Parkinson's disease,
neuropathic pain and epilepsy. The hypothesis is that when NMDA receptor
over-activation is reduced in these conditions with an 'antagonist',
disease symptoms are reduced. Extensive studies over the last 20 years have
indicated a potential for NMDA receptor antagonists in the treatment of
these diseases. However, the clinical development of non-selective
antagonists has been limited by unfavourable side-effects, such as
hallucinations. In the early 1990's it was found that multiple NMDA
receptor subtypes exist which contain different NR2(A-D) subunits.
Compounds selectively targeting NR2B subunit-containing receptors retain
many of the beneficial effects of earlier non-selective compounds but have
much improved side effect profiles. Separating side effects from beneficial
effects by selectively targeting the NR2B-subunit allows higher dosing and
hence the potential to increase efficacy of the drug.
NMDA receptors are involved in the pathology of depression and other CNS
diseases. The proof of concept Phase II study with the most advanced NR2B
subtype selective NMDA-antagonist of the portfolio was designed as a
double-blind, placebo-controlled, randomized study performed with
approximately 100 patients suffering from treatment-resistant depression.
Treatment-resistance of patients was to be confirmed in a 6-week
prospective antidepressant treatment phase preceding the actual
double-blind treatment, which lasted 4 weeks. The main endpoints of the
study were safety, tolerability, and efficacy.
The antidepressant effect was assessed using the Montgomery-Asberg
Depression Rating Scale (MADRS) and other rating scales. This study was
discontinued early in the patient enrollment process.
About Major depressive disorders
It is estimated that over 120 m people suffer from depression and that
about one-third of patients treated for major depressive disorder (MDD) do
not respond satisfactorily to the first antidepressant pharmacotherapy.
There is a need for new treatments and NR2B subtype selective
NMDA-antagonists represents one of the few new approaches in clinical
development for depression.
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. 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 and inflammation. Evotec has
long-term discovery alliances with partners including Bayer, Boehringer
Ingelheim, CHDI, Genentech, Medimmune/Astra Zeneca, and Ono Pharmaceutical.
In addition, the Company has existing development partnerships and product
candidates both in clinical and pre-clinical development. These include
partnerships with Boehringer Ingelheim, MedImmune and Andromeda (Teva) in
the field of diabetes, 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 anychange in events, conditions or circumstances on which any such
statement is based.
Contact Evotec AG:
Dr Mario Polywka, Chief Operating Officer, Phone: +44.(0)1235.441676,
mario.polywka(at)evotec.com
End of Corporate News
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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(at)evotec.com
Internet: www.evotec.com
ISIN: DE0005664809
WKN: 566480
Indices: TecDAX
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, Hannover,
München, Stuttgart
End of News DGAP News-Service
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