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.
Evotec invites you to join a conference call announcing the license agreement to Roche.
Details of the Conference Call:
Tuesday 6 September 2011 at
1.00 p.m. CET
12.00 p.m. BST
4.00 a.m. PDT / 7.00 a.m. EDT
+49 69 58 999 0805 (Germany)
Pass Code: 4470251
A simultaneous slide presentation for participants dialing in via phone is available at www.equitystory.com, password:
evotec060911. You can also listen to the conference call via audio webcast including presentation slides at www.evotec.com.
If you are unable to attend, a recording will be available for 24 hours after the call at the following phone numbers: +49 69 58 99 90 568 (Germany), +44 207 154 2833 (UK), +1 303 590 3030 (US). The access code is 4470251#. The on-demand version of the webcast will be available on our website: http://www.evotec.com - Investors/Events/Financial Calendar.
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.