Healthcare Industry News:  angiotensin II 

Biopharmaceuticals

 News Release - April 20, 2006

Filing for U.S. Approval of Renin Inhibitor SPP100 (Rasilez) in Treatment of Hypertension by Novartis

Major milestone for Speedel in its goal to develop renin inhibitors as gold standard therapy over the next decade

BASEL, Switzerland and BRIDGEWATER N.J., April 20 (HSMN NewsFeed) -- Speedel (SWX: SPPN ) achieved a major milestone today as Novartis announced the first regulatory submission of SPP100 (aliskiren, Rasilez(1)). The U.S. Food and Drug Administration (FDA) have accepted for review Novartis' new drug application (NDA) for SPP100 as a treatment for hypertension both as monotherapy and in co-administration with other anti-hypertensives. The NDA includes data from more than 6,000 patients with high blood pressure treated with SPP100 in 34 clinical trials. SPP100 is the first-in-class once daily oral renin inhibitor that Speedel successfully developed through Phase I and II clinical trials before Novartis exercised its license-back option in 2002. Novartis also reconfirmed today that it is on track for regulatory submission of SPP100 in the EU during 2006.

Dr. Alice Huxley, Chief Executive Officer said: "Today marks a significant step towards SPP100 becoming available as the first of a new generation of anti-hypertensives for the rapidly growing number of patients who suffer from hypertension and other cardiovascular diseases. Speedel is at the forefront of research & development of renin inhibitors, and we are well on our way to our goal of building a Speedel family of renin inhibitors as the gold standard therapy over the next decade."

Mr. Ben Tan, Head of Business Development & Licensing said: "We are delighted that our first product, the first-in-class renin inhibitor SPP100, is being so extensively profiled by Novartis, a company with the world's leading franchise in hypertension treatment. Hypertension is the largest indication for prescription pharmaceuticals worldwide and remains an area of high unmet medical need. Speedel is developing a series of innovative new compounds each of which is expected to have different and improved properties offering incremental protection from the harm caused by high blood pressure."

Speedel believes that SPP100 has a five year lead over the next generation of renin inhibitors being developed in the industry. Speedel's own family of renin inhibitors includes SPP635 currently in Phase I with results due in the second half of 2006, followed by the SPP1100 series currently in toxicology testing with a compound due for entry into man before the end of 2006, and the SPP800 series currently in late-stage pre-clinical profiling.

About SPP100 (aliskiren, Rasilez(2))

SPP100 (aliskiren, Rasilez) is the first-in-class oral renin inhibitor. The development of SPP100 is the result of over 20 years of research on renin. Renin is the key enzyme at the top of the Renin Angiotensin System (RAS), one of the key regulators of blood pressure. The RAS is a cascade, starting with renin, leading to angiotensin I and finally to angiotensin II. Angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin II receptor antagonists (ARBs) have been developed to block this system "down stream" and have shown clinical efficacy in patients with hypertension and other cardiovascular diseases.

Inhibition of renin, articulated as Plasma Renin Activity (PRA) is believed to be very important in end-organ protection (e.g. heart and kidney). PRA is an independent and direct surrogate marker for several cardio-renal diseases, such as myocardial infarction and chronic renal disease. It is only a Renin Inhibitor that lowers PRA efficiently whereas most current leading anti-hypertensive drug classes such as ACE-Is and ARBs increase PRA levels.

Speedel in-licensed SPP100 from Novartis in 1999, and successfully completed 18 clinical trials through Phase I and II in about 500 patients and healthy volunteers. Based on the results generated during this programme, Novartis exercised a license-back option in 2002, and in March 2004 Novartis started trials with SPP100 in Phase III as monotherapy for hypertension and in Phase IIb as combination therapy. Phase III trials are ongoing in the US, EU, and Japan, with first regulatory submission in the US already filed in Q1 2006 and planned in the EU during 2006.

Speedel believes that it is the first company to establish successfully a clinical proof of concept in Phase II and to have developed and filed for patent protection a commercially viable manufacturing process for a renin inhibitor, an area of industry research for over 20 years. In a Phase II study of 200 patients conducted by Speedel, it was demonstrated that SPP100 achieves dose-dependent blood pressure reduction. The study also showed that 150mg and 300mg SPP100 once daily were comparable to Losartan 100mg, which is double the starting dose of this ARB (Stanton, Jensen, Nussberger, O'Brien, Hypertension.2003; 42: 1137-1143).

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(3)), the first-in-class renin inhibitor, is partnered with Novartis for Phase III development and commercialisation in hypertension. 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. In March 2006 the company raised gross proceeds of CHF83.95 million (approximately EUR 53m or USD 64m) through the sale of 500,000 treasury shares. As a private company, we have previously 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.

(1) Rasilez (SPP100, aliskiren) is a Novartis trade name pending regulatory, including FDA, approval. (2) Rasilez (SPP100, aliskiren) is a Novartis trade name pending regulatory, including FDA, approval. (3) Rasilez (SPP100, aliskiren) is a Novartis trade name pending regulatory, including FDA, approval.


Source: Speedel Pharmaceuticals

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