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Novartis' (NVS) Latest Phase III And II Data With SPP100 (Aliskiren) Reconfirm Speedel's Previous Clinical Studies For The Treatment Of Hypertension

10/19/2005 5:12:31 PM

BASEL, Switzerland, and BRIDGEWATER N.J., Jan. 21 /PRNewswire/ -- Speedel welcomes the positive Phase III and Phase II clinical results in hypertension released yesterday by Novartis on SPP100 (Aliskiren) as a monotherapy and in combination with Diovan, and also welcomes the news that Novartis is on track for its first regulatory submission in early 2006. These latest results reconfirm the previous findings from clinical studies conducted by Speedel. SPP100 (Aliskiren) is the first-in-class renin inhibitor being developed for the treatment of hypertension. Speedel successfully developed SPP100 (Aliskiren) through Phase I and II before licensing the compound to Novartis in 2002.

Dr. Alice Huxley, Speedel CEO, stated: "Speedel is at the forefront of research and development for novel therapies to treat cardiovascular diseases. The continued successful development of SPP100 should lead to the filing of a regulatory submission in 2006, and when launched, provide a royalty stream to Speedel."

On January 20, 2005 at its annual financial results meeting, Novartis disclosed first results of its Phase III clinical study (study no. 2203) in 1064 hypertensive patients. This data reconfirmed the blood pressure lowering effect and safety profile of SPP100 as a monotherapy compared to placebo and to Diovan (angiotensin receptor blocker ARB - Valsartan). The data are consistent with a previous Phase II study in 650 patients conducted by Novartis comparing SPP100 with another ARB - Irbesartan - and are also consistent with the original Phase II study in 200 patients conducted by Speedel comparing SPP100 with yet another ARB - Losartan. In contrast to other hypertensive agents, SPP100 lowers renin enzyme activity in the bloodstream, so it may have the potential to better protect against heart attacks (myocardial infarction) and kidney disease.

Novartis also released Phase II results from the same study (study no. 2203) that treated patients with a combination of SPP100 and Diovan. This data suggests there is a trend towards additive benefits with a dose response for the combinations that are to be confirmed in a follow up study. Speedel notes that this combination data builds on Speedel's clinical findings about the benefits of combination therapy shown in 2001 and 2002 in pilot clinical studies with SPP100 in combination with an ARB, as well as with an ACE-I (angiotensin converting enzyme inhibitor) or a diuretic. All three studies showed the potential for beneficial effects of SPP100 with these three different classes of blood pressure modulators while maintaining the promising safety profile of SPP100.

Dr. Jessica Mann, MD, PhD, Speedel Medical Director, commented: "We are delighted that these latest data from Novartis confirm the benefits we observed in Speedel's clinical studies. SPP100 appears to be safe, well tolerated and efficacious for patients in the studies conducted so far, and is on track to be the first new treatment for hypertension since 1994."

About SPP100 (Aliskiren)

SPP100 (Aliskiren) 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 (ACE) inhibitors 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 ACEIs 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 additional Phase III data expected in Q3 2005, and first regulatory submission is planned for early 2006.

Speedel 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 Speedel's combination studies

The three pilot clinical studies conducted by Speedel in 2001 and 2002 investigated the safety and efficacy of SPP100 in combination with the ACE-inhibitor (ramipril), the diuretic (hydrochlorothiazide - HCTZ) and the ARB (irbesartan), in hypertensive patients. All three studies were open label and blood pressure effects were assessed by 24-hour Ambulatory Blood Pressure Monitoring.

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 50% 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 biopharmaceutical company that creates value for patients, partners and investors by developing innovative therapies for cardiovascular and metabolic diseases. Speedel is a world leader in renin inhibition, an exciting new approach to treating cardiovascular diseases. Our lead compound SPP100 (Aliskiren), a first-in-class renin inhibitor, is partnered with Novartis for Phase III development and commercialisation in hypertension and other cardiovascular diseases. Our pipeline covers three different modes of action, and in addition to SPP100, it includes two compounds in Phase II plus three pre-clinical projects.

Speedel develops novel therapies 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 of primary-care indications, or we may ourselves complete Phase III for 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 sixty experienced pharmaceutical scientists and managers 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 as a private company, we have secured CHF 180 million (USD 140m approx.) for investment in our pipeline through operating revenues, equity and a convertible loan.

Forward looking statements

This press release contains certain forward looking statements that can be identified by the use of forward-looking terminology such as "envisaged", "potentially", and "should", "could" or "may" etc. There are no guarantees that such future events or results will actually be realized, and in particular that the aforementioned licensing agreements or approaches will result in the development of a new drug for cardiovascular indications or any subsequent commercialisation of any product in any market. Any such commercial success can be affected by, among other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other intellectual property protection and competition in general. Any of these and other factors can cause the actual results to differ materially from the expected or predicted results.

Speedel Pharmaceuticals Inc.

CONTACT: Nick Miles, Director Communications & Investor Relations ofSpeedel, T: +41-61-206-40-00, D: +41-61-206-40-14, F: +41-61-206-40-01,M: +41-79-446-25-21,; or Frank LaSaracina, ManagingDirector of Speedel Pharmaceuticals Inc., T: +1-732-537-2290,F: +1-732-537-2292, M: +1-908-338-0501,

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