Distribution of company announcements to the professional platforms, finance portals and syndication of important corporate news to a wide variety of news aggregators and financial news systems.
Speedel Holding AG Active participation with numerous scientific and medical contributions to ISH/ESH in Berlin, Germany
Basel/Switzerland and Bridgewater NJ/USA, 16 June 2008
Speedel Holding Ltd. (SWX: SPPN) highlighted today that it is actively participating in Hypertension 2008, a joint meeting of the International Society of Hypertension (ISH) and the European Society of Hypertension (ESH), held from 14-19 June 2008 in Berlin, Germany. At the meeting, which is expected to attract over 7000 senior scientists and physicians from around the world, researchers from Speedel and academia will be presenting pre-clinical and clinical data relating to the company's product candidates SPP635 (a second generation renin inhibitor in development for patients with diabetes)[2],[3] and SPP301 (an endothelin receptor A antagonist in development for diabetic kidney disease)[4],[5],[6].
Six years after the last joint meeting of ISH and ESH, Hypertension 2008 aims to present a comprehensive update on hypertension and its links to other cardiovascular diseases and diabetes. According to the World Health Organisation, hypertension and cardiovascular diseases remain the leading causes of death worldwide despite recent scientific advances[7]. Primary and secondary prevention of cardiovascular diseases require an in-depth understanding of the mechanisms leading to hypertension and adequate medical treatments.
Dr. Alice Huxley, CEO stated: "Speedel is a research-driven company directed to innovation: we focus on cardiovascular and metabolic diseases with the aim of bringing effective new medicines to patients and doctors. I am personally proud that Speedel scientists and co-workers are participating in this very significant medical meeting on hypertension and related diseases at which they will be presenting data on SPP635, one of our next generation of renin inhibitors, and SPP301 (avosentan), and that a lot of attention during the meeting will be given to SPP100/aliskiren, the flagship of the renin inhibitor class."
The renin-angiotensin-aldosterone system is a significant regulatory mechanism in the control of blood pressure. For decades, it has been a major target in the development of antihypertensives. Several classes of drugs have been introduced like angiotensin converting enzyme inhibitors (ACE-Is) and angiotensin receptor blockers (ARBs). Renin inhibitors are the latest addition to the treatment armamentarium. Speedel's first successful development, SPP100/aliskiren (marketed by Novartis as Rasilez/Tekturna[1]), is the first-in-class direct oral renin inhibitor available to patients. A symposium held on 14 June 2008 and organized by the President of Hypertension 2008, Professor Detlev Ganten, dealt with the "Renin-Angiotensin-Aldosterone-System - Past, Present, Future". As part of this event, Professor Hans R. Brunner, Medical Advisor to Speedel gave a presentation on "New Renin Inhibitors" currently in development.
Hans R. Brunner is a Professor emeritus of Medicine at the University of Lausanne, Switzerland. He has been at the forefront of research on the role of renin and angiotensin in blood pressure regulation and has been involved in the development of drugs such as ACE-Is and ARBs and their introduction into clinical practice. Professor Brunner has been a medical advisor to Speedel since the early days of the company.
At Hypertension 2008, Speedel is also present with a company booth. This is an additional opportunity to meet with the company and to discuss renin inhibition as well as other developmental activities for cardiovascular and metabolic diseases.
About Speedel
Speedel is a public biopharmaceutical company that seeks to create value for patients, partners and investors by developing innovative therapies for cardiovascular and metabolic diseases. Speedel is a world leader in renin inhibition, a promising new approach with significant potential for treating cardiovascular diseases. Our lead compound SPP100, Aliskiren (Tekturna/Rasilez[1])the first-in-class direct renin inhibitor, was in-licensed from Novartis in 1999 and licensed-back to Novartis Pharma in 2002 for further development and commercialisation; SPP100 was approved by the FDA in the US in March 2007, and by the EMEA in the EU in August 2007. Our pipeline covers four different modes of action, and in addition to SPP100, includes SPP301 (an endothelin A receptor antagonist) in Phase II, SPP200 (a direct thrombin inhibitor) in Phase II, the next generation renin inhibitors SPP635 (in Phase Il), SPP1148 and SPP676 (both in Phase I) and several pre-clinical projects, including SPP2475 (an aldosterone synthase inhibitor). Speedel develops novel product candidates through focused innovation and smart drug development from lead identification to the end of Phase II. We either partner with big pharma for Phase III and commercialisation in primary-care indications, or we may ourselves complete Phase III development in specialist indications. Candidate compounds for development and the company's intellectual property come from our late-stage research unit Speedel Experimenta and from in-licensing. Our team of approximately 80 employees, including over 30 experienced pharmaceutical scientists, is located at our headquarters and laboratories in Basel, Switzerland and at offices in New Jersey, USA and Tokyo, Japan. Speedel was founded in 1998 as a private company. In September 2005 the company's shares were listed on the SWX Swiss Exchange under the symbol SPPN. Further information is available at www.speedel.com.
Forward looking statements This press release includes forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements are based on our current expectations and projections about future events. All statements, other than statements of historical facts, regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The word "may" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations described in these forward-looking statements and you should not place undue reliance on them. There can be no assurance that actual results of our research and development activities and our results of operations will not differ materially from these expectations. Factors that could cause actual results to differ from expectations include, among others: our or our partners' ability to develop safe and efficacious products; our or our partners' ability to achieve positive results in clinical trials; our or our partners' ability to obtain marketing approval and market acceptance for our product candidates; our ability to enter into future collaboration and licensing agreements; the impact of competition and technological change; existing and future regulations affecting our business; changes in governmental oversight of pharmaceutical product development; the future scope of our patent coverage or that of third parties; the effects of any future litigation; general economic and business conditions, both internationally and within our industry, including exchange rate variations; and our future financing plans.
-- Ends --
[1] Rasilez/Tekturna® are Novartis trademarks. [2] Hengelage T, Herold P, Jensen C, Baltatu OC. Efficacy and safety of the oral renin inhibitor SPP635 once daily in patients with mild to moderate hypertension. [3] Zaugg CE, Louie P, Dembowsky K, Jensen C, Baltatu OC. Preclinical pharmacokinetic and pharmacodynamic characterization of SPP635, a new direct renin inhibitor. [4] Baltatu OC, Zaugg CE, Bader M, Dembowsky K. Additive kidney protective effects of an angiotensin receptor antagonist combined with the endothelin type A receptor antagonist SPP301 in a rat model of malignant hypertension. [5] Maillard MP, Wang Q, Baltatu OC, Burnier M. Do endothelin receptor antagonists induce edema through an extravasation of fluids? Evidence from an experiment in bi-nephrectomized rats. [6] Jandeleit-Dahm K, Watson A, SoroPaavonen A, Allen T, Thomas M, Schumacher C, Cooper M. The novel endothelin receptor A (eT-A) antagonist SPP 301 attenuates albuminuria and renal structural injury in streptozotocin- induced diabetic apoE knockout mice. [7] WHO Factsheet, February 2007.
For further information please contact:
Dr. Harald F. Schaefer Director Communications & Investor Relations Speedel Hirschgässlein 11 CH - 4051 Basel Switzerland
T +41 (0) 61 206 40 00 D +41 (0) 61 206 40 14 F +41 (0) 61 206 40 01 M +41 (0) 79 629 76 71 E harald.schaefer@speedel.com www.speedel.com
Frank LaSaracina Managing Director Speedel Pharmaceuticals Inc 1661 Route 22 West P.O. Box 6532 Bridgewater, NJ 08807 United States of America
T +1 732 537 2290 F +1 732 537 2292 M +1 908 338 0501 E frank.lasaracina@speedel.com www.speedel.com
