Bayer HealthCare and Juvaris BioTherapeutics Announce Major Licensing Agreement

PLEASANTON, Calif., March 4 /PRNewswire/ -- The Animal Health Division of Bayer HealthCare AG and Juvaris BioTherapeutics, Inc. jointly announced today that the companies have executed a broad-based licensing agreement. Under the terms of the agreement, Bayer HealthCare will have complete access in the veterinary field to the Juvaris mono-immunotherapy and vaccine technology, which is being developed by Juvaris for human health care. The companies will evaluate and execute product development programs directed at immune stimulation and disease prevention in a variety of animal species.

In addition, the agreement anticipates that Bayer Animal Health will help financially support Juvaris’ research, product formulation, development and GMP manufacturing activities to support its alliance obligations. The license is worldwide in scope. The financial terms of the deal have not been disclosed.

In commenting on the transaction, Lykele van der Broek, President of Bayer’s Animal Health Division and Member of the Executive Committee of Bayer HealthCare AG said, “We are excited about the opportunities the Juvaris technology offers us. The beauty about this cooperation is, that it is not just about one single product. It serves as a platform technology that helps us develop a wide range of applications in several species for numerous indications in preventing infectious diseases. This technology in combination with our in-house expertise dramatically expands our ability to develop new and innovative products that promote immune stimulation and disease prevention.”

In commenting on behalf of Juvaris, Martin D. Cleary, Co-Founder and Chairman of the Board of Juvaris, said, “We are delighted to put this agreement in place with an established veterinary franchise such as Bayer Animal Health. The world’s animal health marketplace is basically underserved and to have a company willing to develop products, for which there are currently no approved human counterparts, is truly unusual in this space. We look forward to a long and productive relationship with Bayer Animal Health.”

Kimberlee Gonzaga, Chief Financial Officer of Juvaris said, “Although human health is our intended market, this relationship offers Juvaris an opportunity to generate non-dilutive cash flows that will be used to support this deal, to further develop our product portfolio and most importantly to support human clinical trials. Our organization has an opportunity to genuinely impact the prevention and treatment of infectious diseases and cancer. This helps Juvaris to advance to the next step in this effort.”

The companies have created a joint steering committee made up of Bayer Animal Health and Juvaris BioTherapeutics executives to ensure the required tasks are properly understood and executed.

About Juvaris BioTherapeutics

Juvaris BioTherapeutics was created in 2003 to develop an immunotherapeutic product platform for the treatment of infectious diseases and cancers using lipid-DNA complexes. Cationic lipids are formulated with non-coding DNA (plasmid) to create the JuvImmune (JVRS-100) Immunostimulant, a lipid-DNA complex, which as a single product will have utility in multiple infectious disease and cancer applications. The JuvImmune product has been shown to be at least 50-times more potent at triggering innate immune activation and interferon release than current immune stimulants.

When combined with disease-specific antigens, the technology creates JuvaVax vaccines capable of activating substantial antibody- and cell-mediated immune responses, particularly induction of cytotoxic T lymphocytes (CTL). Immunological responses elicited by the lipid-DNA complexes have been successfully demonstrated in both prophylactic and therapeutic settings in a variety of mammals including rodents, rabbits, cats, dogs and non-human primates. This platform provides the opportunity to develop many disease-specific immunotherapy products, for which there are significant unmet medical needs.

The Company recently completed a Series A financing with Kleiner Perkins Caufield & Byers as the sole investor. It plans to start up to four clinical studies in 2008. The first will be a prophylactic vaccine for Influenza A, the second for chronic Hepatitis C, the third for Acute Myelogenous Leukemia (AML), and a fourth therapy for chronic Hepatitis B. The Company encourages partnering inquiries and can be reached at its website at http://www.juvaris.com.

About Bayer HealthCare

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading innovative companies in the health care and medical products industry. The company combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The company’s pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide.

With sales of EUR 956 million (2007) the Animal Health Division is one of the world’s leading manufacturers of veterinary drugs. The division manufactures and markets approximately 100 different veterinary drugs and care products for food-supplying animals and companion animals.

Company Contact: Martin D. Cleary Juvaris BioTherapeutics, Inc. 925.399.6200 mdcleary@juvaris.com

Source: Juvaris BioTherapeutics, Inc.

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