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Evotec and Roche to Develop EVT 101 for Treatment-Resistant Depression


Hamburg, Germany and Basel, Switzerland - Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ: EVTC) and Roche (SWX: RO, ROG; OTCQX: RHHBY) announced today that they have entered into an agreement for Phase II clinical development of EVT 101 in patients with treatment-resistant depression. The potential value of this transaction exceeds USD 300 million.

Evotec will be responsible for conducting Phase II studies for EVT 101, a compound originally discovered by Roche and developed from discovery stages through clinical studies by Evotec.

Eugene Tierney, Head of CNS at Roche, said: “Our aim is to alleviate the suffering of the many patients with treatment-resistant depression. As many as one in three depressed patients are not adequately treated by currently available medicines. We believe that EVT 101 has the potential to become an effective new therapy for the high unmet need of these patients.”

Evotec will also conduct Phase I safety and tolerability studies for EVT 103, a next generation compound to EVT 101. Roche will fully fund these development programs. In addition, for the option to buy back rights to the entire EVT 100 family of compounds, Roche has agreed to pay Evotec an upfront fee of USD 10 million.

Dr Klaus Maleck, Chief Financial Officer of Evotec, said: “This product development agreement with Roche is clear evidence of the value Evotec has created with the EVT 100 compound family over the past few years, benefiting patients and, ultimately, shareholders. We are delighted to enter into this partnership with Roche, providing obvious benefits to both parties.”

Terms of the Agreement

This agreement covers possible development of the entire EVT 100 family of compounds, with a total potential deal value exceeding USD 300 million.

Roche has committed to fund clinical development of EVT 101, as well as EVT 103, the follow-on compound to EVT 101.

If Roche exercises its buy-back option after the completion of the Phase II study, Evotec will receive a USD 65 million lump-sum payment from Roche in exchange for returning the asset, as well as the entire EVT 100 family to Roche. Evotec would be eligible for further development, sales performance, and scalable double-digit commercial payments.

In the event that Roche decides not to exercise its buy-back option, Evotec will be granted exclusive worldwide rights to the entire EVT 100 family of compounds. Evotec will then get rights to all indications under revised terms from the original contract signed between Evotec and Roche at the end of 2003.

Background Information

About Treatment-Resistant Depression
More than 120 million people are estimated to suffer from depression globally. According to the National Institute for Mental Health, some of the symptoms include persistent sad, anxious or “empty” mood, feelings of hopelessness or pessimism, feelings of guilt, worthlessness or helplessness, or loss of interest or pleasure in hobbies and activities that were once enjoyed.
According to European Neuropsychopharmacology (D. Souery, 1999) it has been recognized that about one third of patients treated for major depression disorder do not respond satisfactorily to the first antidepressant pharmacotherapy. Treatment-resistant depression is a term used in clinical psychiatry to describe cases of major depressive disorder that do not respond to adequate courses of at least two antidepressants. There is currently no specific therapy approved for treatment-resistant depression, and there are few new mechanisms 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. Such forward-looking statements include, but are not limited to, statements about our expectations and assumptions concerning regulatory, clinical and business strategies, the progress of our clinical development programs and timing of the results of our clinical trials, strategic collaborations and management’s plans, objectives and strategies. These 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. In particular, the risks and uncertainties include, among other things: risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured; risks relating to our ability to advance the development of product candidates currently in the pipeline or in clinical trials; our inability to further identify, develop and achieve commercial success for new products and technologies; competing products may be more successful; our inability to interest potential partners in our technologies and products; our inability to achieve commercial success for our products and technologies; our inability to protect our intellectual property and the cost of enforcing or defending our intellectual property rights; our failure to comply with regulations relating to our products and product candidates, including FDA requirements; the risk that the FDA may interpret the results of our studies differently than we have; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully secure regulatory approval of and market our drug candidates; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally.

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