Cytos Biotechnology Enters Exclusive License Agreement With Novartis Corporation (NVS) to Develop, Manufacture and Commercialize Novel Vaccine for Treatment of Nicotine Addiction; Cytos May Receive up to CHF 600 Million
ZURICH , Switzerland, April 25 -- Cytos Biotechnology announced today that it has entered into an exclusive global commercial license agreement with Novartis to develop, manufacture and commercialize CYT002-NicQb, a therapeutic vaccine in phase II clinical development for the treatment of nicotine addiction.
Under the terms of the agreement, Novartis is granted world-wide exclusive rights for CYT002-NicQb and is responsible for late stage clinical development, manufacturing, and commercialization of the vaccine. In return, Cytos Biotechnology is eligible to receive up to CHF 600 million in upfront and potential development, regulatory approval and sales milestone payments based on the successful development and commercialization of CYT002-NicQb. The upfront payment by Novartis will be CHF 35 million. In addition, Cytos Biotechnology will receive royalty payments on net sales of products. The agreement announced today is subject to customary regulatory approvals such as clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
"The vaccine market, including therapeutic vaccines, represents an increasingly attractive segment of the healthcare market and is an additional source of growth for large pharmaceutical companies. Licensing our phase II product candidate to Novartis, a top-tier healthcare company with strong inhouse vaccines' expertise, maximizes the opportunity to build CYT002-NicQb as a first-in-class product to treat nicotine addiction", comments Dr Mark Dyer, EVP Business Development of Cytos Biotechnology.
About CYT002-NicQb
CYT002-NicQb is a therapeutic vaccine in development for the treatment of nicotine addiction. It is based on Cytos Biotechnology's Immunodrug(TM) platform. Vaccination with CYT002-NicQb has been shown to induce nicotine- specific antibodies that bind nicotine in the bloodstream. As the complex of nicotine attached to an antibody is too large to cross the blood-brain barrier, nicotine uptake into the brain and the subsequent stimulation of nicotine-responsive nerve cells is believed to be significantly reduced. In this way, the reward-inducing and addiction-driving stimulus of nicotine should be minimized and abstinence from smoking more easily achieved and maintained. A phase I and a phase II clinical trial have demonstrated that CYT002-NicQb has a favorable safety profile and is generally well tolerated and that it promoted and sustained long-term abstinence from smoking, when high antibody levels have been achieved upon vaccination.
About nicotine addiction
Worldwide, there are 1.3 billion smokers and with 4.9 million tobacco- related deaths per year, tobacco use is the leading cause of preventable death in the world today (WHO; Facts about smoking and health, 2006). Smoking harms nearly every organ of the body, resulting in life-threatening diseases like cancer, chronic obstructive pulmonary disease (COPD), stroke, and circulation disease. Nicotine is a plant-derived alkaloid and the principal addictive component of tobacco. Upon inhalation of cigarette smoke, nicotine passes into the bloodstream and, within seconds, crosses the blood-brain barrier to enter the brain where it stimulates specific nerve cells. Stimulation of these nerve cells leads to the release of messenger molecules, which give rise to an almost immediate reward and feeling of pleasure. This sensory stimulus is critical to the addictive properties of nicotine and causes a high relapse rate after quitting attempts. Although nearly 75% of smokers in the U.S. report that they want to stop smoking, less than 5% of those who make an attempt are able to stay tobacco-free for 3 to 12 months (CDC, USA; Surgeon General's Report, 2004).
About Cytos Biotechnology AG
Cytos Biotechnology AG is a public Swiss biotechnology company that specializes in the discovery, development and commercialization of a new class of biopharmaceutical products - the ImmunodrugsTM. ImmunodrugsTM are intended for use in the treatment and prevention of common chronic diseases, which afflict millions of people worldwide. ImmunodrugsTM are designed to instruct the patient's immune system to produce desired therapeutic antibody or T-cell responses that modulate chronic disease processes. Taking advantage of the high flexibility of its ImmunodrugTM platform, Cytos Biotechnology has built a pipeline of different ImmunodrugTM candidates in various disease areas, of which six are currently in clinical development. The Immunodrug(TM) candidates are developed both in-house and together with Novartis and Pfizer Animal Health. Founded in 1995 as a spin-off from the Swiss Federal Institute of Technology (ETH) in Zurich, the company is located in Schlieren (Zurich). Currently, the company has 129 employees. Cytos Biotechnology AG has been listed on the SWX Swiss Exchange (SWX:CYTN - News) since October 2002.
This foregoing press release may contain forward-looking statements that include words or phrases such as "may", "potential", "will", "maximize the opportunity", "believe", "should", "intend", "designed", or other similar expressions. These forward-looking statements are subject to a variety of significant uncertainties, including scientific, business, economic and financial factors, and therefore actual results may differ significantly from those presented. There can be no assurance that any other therapeutic entities will enter clinical trials, that clinical trial results will be predictive for future results, that therapeutic entities will be the subject of filings for regulatory approval, that any drug candidates will receive marketing approval from the U.S. Food and Drug Administration or equivalent regulatory authorities, or that drugs will be marketed successfully. Against the background of these uncertainties readers should not rely on forward- looking statements. The company assumes no responsibility to update forward- looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of Cytos Biotechnology AG.