SOURCE: Speedel Holding AG

October 04, 2007 01:00 ET

SPEEDEL'S THIRD RENIN INHIBITOR ADVANCES TO THE CLINIC

BASEL, SWITZERLAND--(Marketwire - October 4, 2007) -


- STRATEGY ON TRACK FOR BUILDING FAMILY OF NEXT GENERATION COMPOUNDS

Basel/Switzerland and Bridgewater NJ/USA, 4 October 2007

Speedel Holding Ltd (SWX: SPPN), today unveiled SPP676 as a new renin inhibitor with the announcement that the promising new compound is beginning Phase I clinical trials. SPP676 is from the SPP600 series of renin inhibitors for the treatment of hypertension and related end-organ diseases. The Phase I trial will test the safety and tolerability of single and multiple oral doses in healthy volunteers and first results are expected in 2008. SPP676 is one of several novel compounds developed by Speedel Experimenta, the company's late-stage research unit.

Dr. Alice Huxley, CEO, commented: "Our strategy is on track for building a family of next generation compounds, and this important milestone further strengthens Speedel's position as a world leader in renin inhibition. SPP676 is the third compound developed by our in-house laboratory to enter clinical trials, following SPP635 in Phase II and SPP1148 in Phase I. We believe that renin inhibition will become the gold standard in the treatment of cardiovascular diseases, the largest segment in the pharmaceutical industry and Speedel intends to be a significant player in this huge market."

The Phase I trial of SPP676 is a double-blind, randomised, placebo-controlled study in healthy male volunteers designed to evaluate clinical safety and tolerability following single and multiple oral doses. In addition, the pharmacokinetics and pharmacodynamics of the compound will be assessed. Testing of the single doses has started in October 2007, and the multiple-dose phase of the study is planned to start in 2008.

Speedel's first renin inhibitor SPP100 (Tekturna/Rasilez)[1] was approved by the FDA in the US in March 2007, and by the EMEA in the EU in August 2007, and is marketed by Novartis in these markets. Both Speedel and Novartis recently won the Wall Street Journal Gold Award for Technology Innovation, which was given to the companies for their work in discovering and developing SPP100 as a novel therapy for hypertension. Speedel is developing a number of series of next generation renin inhibitors, including the SPP600, SPP800 and SPP1100 series.

About SPP600 series

In June 2007 Speedel reported promising Phase IIa results with SPP635 in hypertensive patients. SPP635 is the most advanced compound of the SPP600 series of renin inhibitors being developed by Speedel. The company has made significant progress in the optimisation and development of this series of newly synthesised compounds by using rational drug design, including computer assisted molecular modelling techniques, state-of-the art preclinical disease models and human microdosing.

In December 2001, Speedel acquired a worldwide exclusive license from Roche covering its entire programme in renin inhibition. This license allows Speedel to use the acquired know-how for lead optimisation of its own compounds designated as the SPP600 series. Speedel holds full development and commercialisation rights for these product candidates under the license agreement with Roche. If Speedel decides to offer rights to any Speedel compound from the series to a third party, Roche has a right of first negotiation with respect to such rights. If Roche has not expressed its interest in acquiring such rights within a defined period of time, or the parties have not reached an agreement on the terms of such rights, Speedel is free to grant such rights to any third party.

About Hypertension

Hypertension is a common disorder in which blood pressure is abnormally high, placing undue stress on the heart, blood vessels and other organs such as the kidney and the brain. Blood pressure is determined in two phases as the heart contracts and relaxes. Systolic blood pressure represents the force that blood exerts on the walls of arteries as the heart contracts to pump out blood. Diastolic blood pressure represents the force as the heart relaxes to allow the blood to flow into the heart.

Due to its wide prevalence and impact on cardiovascular health, hypertension is a major cause of disease and death in Europe and North America. More than one in three Europeans and North Americans over the age of 35 suffers from hypertension - but for the vast majority of patients who undergo hypertension treatment, the causes of high blood pressure are unknown. More than 40 % of patients undergoing treatment with current therapies do not reach targeted blood pressure levels, and so there is a considerable unmet medical need.

The latest potential therapeutic agents for hypertension are renin inhibitors. Renin is an enzyme produced in the kidneys in response to reduced renal perfusion. Through a cascade of biological events, renin acts to bring about sodium retention, an increase in blood pressure, and restoration of renal perfusion, which shuts off the signal for renin release. For hypertensive individuals, renin inhibitors are currently being investigated as a therapy that may provide benefits over current therapies to reduce blood pressure, decrease salt retention and may protect end organs such as the kidney, heart and brain.

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 (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 three different modes of action, and in addition to SPP100, includes SPP301 in Phase III (on hold), SPP200 in Phase II, SPP635 in Phase Il, SPP1148 and SPP676 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 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 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.

In January 2007 the company raised gross proceeds of CHF 55.5 million (approximately EUR 34.3 million or USD 44.5 million) through a convertible bond issue. In March 2006 the company raised gross proceeds of CHF 83.95 million (approximately EUR 53m or USD 64m) through the public offering of 500,000 treasury shares. Previously, as a private company, we raised gross proceeds of CHF 255 million (approximately EUR 157 million or USD 204 million) from private placements of equity securities and two convertible loans including the conversion premiums. We have had total revenues, principally from milestone payments, of CHF 57.7 million (approximately EUR 37 million or USD 44 million). The company's shares were listed in September 2005 on the SWX Swiss Exchange under the symbol SPPN.


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] Tekturna/Rasilez® are Novartis trademarks


For further information please contact

Nick Miles
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) 79 446 25 21
E nick.miles@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




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