BASEL, Switzerland and BRIDGEWATER, N.J., Oct. 28 /PRNewswire/ -- Speedel announced today that data from its Phase IIb study of SPP301 in the treatment of diabetic nephropathy will be presented at the 38th Annual Meeting of the American Society of Nephrology (ASN) in Philadelphia, Pennsylvania, USA on 11 November 2005.
Professor Rene Wenzel, Head of Internal Medicine, Zell am See Hospital, Austria, and Principal Investigator in the Phase IIb study, will make an oral presentation of the study on 11 November between 4:00 - 6:00 PM EST during the session entitled “Novel Clinical Markers and Therapy in Diabetes.”
SPP301 has successfully completed Phase II clinical trials in the indication of diabetic nephropathy (diabetic kidney disease) and entered Phase III in July this year.
About SPP301
SPP301 is a once daily oral endothelin A receptor antagonist that Speedel licensed from Roche in October 2000. SPP301, a second generation ERA, was developed out of Roche’s endothelin research and drug discovery program, and was specifically optimized for improved liver safety. Speedel took the compound through a number of Phase I and exploratory Phase IIa clinical trials before selecting the novel indication of diabetic nephropathy for a Phase IIb clinical trial, the headline results for which were announced in March 2005. A Phase III study began in July 2005. Speedel has exclusive worldwide development and commercialization rights under the licensing agreement with Roche.
About Diabetic Nephropathy
Diabetic Nephropathy is a new indication for this class of compound, and the positive Phase II results for SPP301 indicate considerable additional benefit on top of current therapies taken by patients suffering from this chronic disease. Current therapies include -- amongst others -- drugs that work on the renin-angiotensin system such as ACE inhibitors and ARBs, which have an antihypertensive effect as well as a renoprotective effect and have been shown to slow disease progression. However, 20-40% of patients with markers of early disease still progress to advanced kidney damage and eventually End Stage Renal Disease and death(1).
Definition: Diabetic nephropathy refers to any deleterious effect on kidney structure and/or function caused by diabetes mellitus. More specifically, diabetic nephropathy is thought of in stages, the first being that characterized by microalbuminuria (30-300 mg urinary albumin per 24 hours). This may progress to overt nephropathy or macroalbuminuria (>300 mg urinary albumin per 24 hours). Later still, progressive renal functional decline is characterized by significant decreases in glomerular filtration rate accompanied by rises in serum creatinine, the final result of which is End Stage Renal Disease.
Prevalence: According to the WHO in 2000, some 177 million people around the world had some form of diabetes, including undiagnosed cases. About 20-40% of patients with type 1 or type 2 diabetes develop nephropathy(2). Current treatments (primarily antihypertensive treatment and inhibition of the renin angiotensin system) slow progression of DN, but it remains an unmet medical need, with a high mortality rate.
About Endothelin Receptor Antagonists
Pharmacological blockade of the endothelin system constitutes a relatively new concept for modulating haemodynamic and cellular functions. Substantial evidence from animal testing and clinical studies suggest that endothelin plays a pivotal role in several diseases such as hypertension, chronic heart failure, and chronic nephropathies. Endothelin triggers renal vasoconstriction, decreases glomerular filtration rate and modulates sodium excretion and water balance at the level of the proximal tubule and medullary collecting ducts, by mechanisms that are still unclear. Endothelin also stimulates the renin angiotensin system and atrial natriuretic peptide release and inhibits vasopressin-mediated water re-absorption in the collecting duct. In preclinical testing, chronic administration of Endothelin Receptor Antagonists protected animals, including those with induced diabetes, from developing renal injury.
About Speedel
Speedel is a 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), the first-in-class renin inhibitor, is partnered with Novartis for Phase III development and commercialization in hypertension with filing for registration expected in 2006. Our pipeline covers three different modes of action, and in addition to SPP100, includes SPP301 in Phase III, SPP200 in Phase II, SPP635 in Phase I, and several pre-clinical projects.
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 commercialization 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 70 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. Since being founded in 1998, we have raised gross proceeds of CHF 239 million (approximately EUR 154 million or USD 191 million) from private placements of equity securities and two convertible loans and we have had total revenues, principally from milestone payments, of CHF 57.7 million (approximately EUR 37 million or USD 46 million). The company’s shares were listed on the SWX Swiss Exchange under the symbol SPPN on 08 September 2005.
(1) Diabetes Care, American Diabetes Association 2004 (2) Diabetes Care, American Diabetes Association 2004 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.
Speedel Pharmaceuticals, Inc
CONTACT: Nick Miles, Director Communications & Investor Relations, T:+41-61-206-40-00, D: +41-61-206-40-14, F: +41-61-206-40-01, M:+41-79-446-25-21, nick.miles@speedel.com; Frank LaSaracina, ManagingDirector, T: +1-732-537-2290, F: +1-732-537-2292, M: +1-908-338-0501,frank.lasaracina@speedel.com, both of Speedel Pharmaceuticals Inc.
Web site: http://www.speedel.com/
