Speedel Group Announces A New Series Of Renin Inhibitors

Published: Feb 16, 2006

- Speedel Selects Compounds for Toxicology Testing from its Latest SPP1100 Series -

BASEL, Switzerland and BRIDGEWATER, N.J., Feb. 16 /PRNewswire-FirstCall/ -- Speedel Holding Ltd , a world leader in renin inhibition, announced today that it has reached late-stage preclinical profiling of a new series of renin inhibitors designated as the SPP1100 series. Speedel has applied its extensive experience in the development of renin inhibitors for the treatment of hypertension, and specifically designed these new compounds for higher bioavailability and increased end-organ protection, while endeavoring to maintain the excellent safety and tolerability profiles of previously developed renin inhibitors. The compounds incorporate Speedel's intellectual property and are the subject of several filed patent applications. Depending upon the results of toxicology testing, the first compound of this SPP1100 series could potentially enter into clinical Phase I testing by the end of 2006 or early 2007.

Dr. Alice Huxley, Chief Executive Officer, commented: "This is another significant milestone for Speedel Experimenta, our late-stage research unit, as this new SPP1100 series of proprietary compounds adds yet another member to the Speedel family of renin inhibitors. We believe that we are well positioned to maintain and build our world leadership in the development of this novel class of drugs for the treatment of cardiovascular diseases. Our lead compound SPP100 (Rasilez) is on track for filing by Novartis in the US in Q1 2006. We are developing our proprietary second renin inhibitor SPP635 in Phase I."

Dr. Chris Jensen, Director of Pharmacology, added: "Our unique expertise gained from the development of three different chemical classes of renin inhibitors has led to the discovery, synthesis and promising preclinical results of this new chemical series. We have selected the two most promising compounds for toxicology testing. The results to date show that these compounds meet or surpass our stringent requirements for selectivity, potency, bioavailability, and once-a-day dosing. In addition, it is expected that these compounds should provide renal protection equal to or better than any other renin inhibitor we have tested to date."

Speedel's most advanced renin inhibitor SPP100 (Rasilez ) is currently in Phase III clinical trials with our partner Novartis; it is expected that Novartis will file SPP100 (Rasilez) for regulatory approval with the FDA in the US in Q1 2006 for the treatment of hypertension. Speedel has previously announced progress with two series of next generation renin inhibitors: the SPP600 series and SPP800 series. In October 2005 SPP635 started Phase I tolerability and safety trials and results are expected in 2H 2006.

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 (Rasilez ), the first-in- class renin inhibitor, is partnered with Novartis for Phase III development and commercialisation 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 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. Since being founded in 1998, we have raised gross proceeds of CHF 239 million (approximately EUR 154 million or USD 183 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 44 million). The company's shares were listed on the SWX Swiss Exchange under the symbol SPPN on 08 September 2005.

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.

Rasilez (SPP100, aliskiren) is a trade name pending regulatory approval

Speedel Pharmaceuticals Inc.

CONTACT: Nick Miles, Director Communications & Investor Relations ofSpeedel, +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, or nick.miles@speedel.com, or Frank LaSaracina,Managing Director of Speedel Pharmaceuticals Inc., T +1-732-537-2290, F+1-732-537-2292, M +1-908-338-0501, frank.lasaracina@speedel.com

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