Hamburg, Germany – 5 September 2011: Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) and Roche AG (SIX: RO, ROG; OTCQX: RHHBY) announced today that they have entered into an exclusive worldwide agreement for the development and commercialization of Evotec’s MAO-B inhibitor in patients with Alzheimer’s disease (AD).
Under the terms of the agreement, Roche will pay Evotec an upfront fee of $10 million. Evotec could receive further development and commercial milestone payments of up to $820 million as well as tiered double-digit royalties on sales. Roche will initiate studies in 2012 to demonstrate proof of concept and will be responsible for all clinical development, manufacturing and commercialization activities.
Evotec’s compound (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.
The compound, which will be entering clinical studies in AD, was originally licensed from Roche to Evotec in 2006, and initially developed in another indication.
Commenting on the deal, Jean-Jacques Garaud, Head of Roche Pharma Research & Early Development, said: “Roche is committed to bringing innovative treatments to patients suffering from devastating neurodegenerative diseases, and is developing a number of approaches to tackle Alzheimer’s. The addition of EVT-302 to our CNS pipeline complements other approaches we are investigating including tau- and amyloid- targeted therapies.”
Dr Werner Lanthaler, CEO of Evotec said: “We are delighted to have Roche as our strategic partner to fight Alzheimer’s disease. Their outstanding commitment to pharmaceutical innovation makes Roche the ideal partner to fight one of the biggest healthcare problems of our times.”
Alzheimer’s disease is the most common cause of dementia and, according to the World Health Organisation is affecting around 35 million people worldwide. During the course of the disease, protein plaques appear in the brain, leading to the death of brain cells. No single factor has been identified as the cause for Alzheimer’s disease.
Evotec changes its revenue guidance for 2011 from € 70-72 m to € 77-79 m and increases its 2011 year-end liquidity target to above € 60 m.
MAO-B inhibition and Alzheimer’s Disease
Evotec’s MAO-B inhibitor programme (EVT 302) is an orally active, selective and reversible inhibitor of monoamine oxidase-B (MAO-B). It has favourable preclinical profiles, was well tolerated and showed excellent pharmacokinetic properties in Phase I studies. Evotec has demonstrated in a clinical study that the very high selectivity of this compound for MAO-B avoids the potential adverse interaction with dietary tyramine that is associated with less selective compounds. MAO-B activity results in the production of free radicals causing oxidative stress which may contribute to the pathogenesis of AD where its expression is strongly up-regulated. Evotec in-licensed the compound from Roche in January 2006 when it had completed a first Phase I study. Evotec initiated the regulatory process in the treatment of Alzheimer’s disease based on the clinical progress and a very favourable safety profile in 2009.
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 stateof-
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 Boehringer Ingelheim, CHDI, Genentech, Medimmune/Astra
Zeneca, Ono Pharmaceutical. In addition, the Company has existing
development partnerships and product candidates both in clinical and preclinical
development. These include partnerships with Boehringer Ingelheim,
MedImmune and with Andromeda (Teva) in the field of diabetes. For additional
information please go to www.evotec.com.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche
is the world’s largest biotech company with truly differentiated medicines in
oncology, virology, inflammation, metabolism and CNS. Roche is also the world
leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in
diabetes management. Roche’s personalised healthcare strategy aims at
providing medicines and diagnostic tools that enable tangible improvements in
the health, quality of life and survival of patients. In 2010, Roche had over
80.000 employees worldwide and invested over 9 billion Swiss francs in R&D.
The Group posted sales of 47.5 billion Swiss francs. Genentech, United States,
is a wholly owned member of the Roche Group. Roche has a majority stake in
Chugai Pharmaceutical, Japan. For more information: www.roche.com.