December 28, 2006
First human study with vasopharm's trauma compound VAS203
Wuerzburg, Germany – December 28, 2006
vasopharm GmbH, a pharmaceutical company dedicated to the discovery and development of novel therapeutics for the treatment of cerebro- and cardiovascular diseases, announced today that the company has received a positive ethics vote from the Landesärztekammer Baden-Württemberg, Stuttgart, Germany and the necessary approval from the Federal Institute for Drugs and Medical Devices, Germany (BfArM) for the first study in humans of VAS203.
The goal of the upcoming phase I study which will start in January 2007 is to demonstrate safety, tolerability and pharmacokinetics of ascending single intravenous administrations of VAS203 in healthy volunteers. Provided that the enrolment of the volunteers proceeds as intended the results of the study are expected in June 2007. The single dose administration study will then be followed by a multiple dose study which is currently planned for July 2007.
Facts about Traumatic Brain Injury
Traumatic brain injury (TBI) is a major cause of disability and death and generates significant economic costs to the society. In 1995 direct medical costs and indirect cost such as lost productivity totalled an estimated $ 56.3 billion in the United States alone. Currently there is no pharmacological approach available to treat this condition. Of the annual 1.4 million people in the United States who sustain a traumatic brain injury 235,000 are hospitalised and 50,000 patients die. The incidence rate in Europe is similar, although with fewer penetrating head injuries. Severe TBI is often associated with permanent functional and cognitive disorders, learning disabilities and a range of behavioural and emotional problems. The occurrence of TBI is highest among young and elderly people. The leading causes of TBI are motor vehicle accidents, assaults and accidental falls.
September 05, 2006
European Commission Grants Orphan Medicinal Product Designation for vasopharm's drug candidate VAS203
Wuerzburg, Germany – September 2006
vasopharm GmbH, a pharmaceutical company dedicated to the discovery and development of novel therapeutics for the treatment of cerebro- and cardiovascular diseases, announced today that the European Commission has granted orphan medicinal product status for its drug candidate VAS203 for the treatment of traumatic brain injury. This designation is based on a recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA). VAS203, a NO Synthase modulator, is developed exclusively for the acute indication of closed head injury.
The Orphan Medicinal Product Designation (OMPD) will significantly facilitate the registration of VAS203 by providing access to the EMEA centralised procedure for the application for marketing authorisation. Additionally, vasopharm will benefit from market exclusivity within the European Community with respect to similar products for 10 years after the grant of a marketing authorization of VAS203. Furthermore, vasopharm can expect fee reductions with regard to all centralised activities of the EMEA, as well as scientific advice / protocol assistance to optimise development and guidance on preparing a dossier that will meet the European regulatory requirements. Finally, vasopharm will be eligible for grants from the European Community and Member State programs and other incentives.
vasopharm plans to conduct a clinical phase I in Q/IV 2006. On May 24, 2006, vasopharm and the European Brain Injury Consortium (EBIC) signed a Memorandum of Understanding with regard to the clinical development program of VAS203 (phase IIa). vasopharm thereby has secured a strong and independent clinical perspective from European opinion leaders for the evaluation of VAS203.
January 30, 2006
vasopharm BIOTECH Closes € 9.7 Million
Series B Investment
Würzburg, Germany – January 2006
vasopharm BIOTECH GmbH (vasopharm) today announced the successful completion of its Series B financing amounting to € 9.7 million ($ 11.8 million). The investment is led by EMBL Ventures, Heidelberg, Germany.
Additional new investors participating in this round were Bayern Kapital, Landshut and KfW, Frankfurt a. M., both from Germany. Existing shareholders Future Capital AG, Frankfurt a. M., Entrepreneurs Fund, Amsterdam, 3i Group Investments LP, London, and several private investors also participated. Dr Christof Antz, managing partner of EMBL Ventures, will join vasopharm’s board of directors as chairman. This Series B financing will support the further clinical development of vasopharm’s compound VAS 203, a nitric oxide synthase (NOS) inhibitor for the treatment of closed head injury (CHI).
VAS 203 has shown high efficacy and safety in pre-clinical studies and is expected to begin clinical testing in the third quarter of 2006. “Up to date there is no effective treatment option for acute CHI, a condition that affects more than 300.000 patients worldwide often leading to death or persistent disabilities. Due to the company’s exclusive approach, its impressive achievements to date and its excellent management and know-how, vasopharm is in a prime position to become the leading biotech company focussing on CHI treatment and other nitric oxide (NO)-related diseases”, says Dr Christof Antz of EMBL Ventures. “vasopharm has a unique portfolio of early and mid-stage projects centred on endothelial health and the NO-pathway. In addition to VAS 203, the company’s early stage NAD(P)H oxidase (NOX) inhibitors provide excellent partnering opportunities and shareholder value”, says Christian Leikert, CEO of Future Capital.
Christian Wandersee, CEO of vasopharm BIOTECH: "We are thrilled to announce this significant round of funding which enables us to carry our core project VAS 203 through the completion of proof-of-concept in man. The addition of three new investors and the explicit commitment by all previous investors is a strong sign of the importance of our product portfolio and clearly acknowledges our great recent progress in development.

