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.
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.
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.