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Speedel Group Release: Successful Outcome Of Aliskiren, The First-In-Class Renin Inhibitor, Vs. Irbesartan, In A 650 Patient Hypertension Study, Recently Completed By Novartis (NVS)


10/19/2005 5:10:49 PM

BASEL, Switzerland, Nov. 19 /PRNewswire/ -- The Speedel Group, a privately held pharmaceutical company focused on cardiovascular and metabolic drug development, today welcomed the positive clinical results released by Novartis on the first-in-class renin inhibitor Aliskiren. Speedel successfully developed Aliskiren, (SPP100) through Phase I and II before Novartis licensed-back the molecule in 2002.

Novartis today presented at their R&D Day in New York the outcome of a randomized, double blind, placebo controlled, parallel study of Aliskiren versus Irbesartan, a potent angiotensin receptor blocker, covering 650 patients over a period of 8 weeks. The study results indicate that Aliskiren, the first of a new class of antihypertensives, significantly reduced blood pressure in patients with essential hypertension at all doses tested and was either as good as or statistically better than Irbesartan in lowering Diastolic Blood Pressure. Furthermore, preclinical data demonstrating a synergistic effect of Aliskiren with Valsartan were also presented. Based on these results, Novartis announced to start Phase III development in 2004, with an NDA submission scheduled for the end of 2005. This entitles Speedel to receive the next milestone payment.

"The excellent clinical results of Aliskiren, presented today by Novartis, have important strategic implications for Speedel and highlight the value creation of Speedel's business model", states Dr. Alice Huxley, CEO and President. "We are extremely pleased that the high potential of this innovative antihypertensive drug was confirmed through a major clinical study against one of the most potent angiotensin receptor blockers available. These results follow Speedel's completion of clinical proof-of-concept studies in hypertension versus Losartan and Speedel's design of an alternative synthesis process, as well as the rapid transition of Aliskiren into Novartis' advanced development program."

"The positive outcome of the study performed by Novartis underscores the good tolerability and clinical efficacy of this first orally-active and first-in-class renin inhibitor in essential hypertension", comments Dr. Jessica Mann, Medical Director of Speedel. "These results are in line with Speedel's earlier Phase I and II clinical studies. Aliskiren is now well positioned to become the first renin inhibitor to reach the market, delivering antihypertensive efficacy as well as good tolerability, while having a potential for improved end-organ protection."

The blockade of the renin-angiotensin system has been shown to deliver not only antihypertensive efficacy but also end-organ protection for the heart (congestive heart failure) and for the kidney (chronic renal disease). Renin inhibitors are a new class of compounds that effectively block the renin-angotensin system cascade at the very top of the cascade. Speedel has established itself as the worldwide leader in renin inhibition through several research and development projects starting with Aliskiren (SPP100), which was developed through Phase II (2002), followed by projects SPP500 and SPP600, preclinical renin inhibitors licensed in from Hoffmann- La Roche in 2002, which form the basis for Speedel's lead optimization program, and by Speedel's own lead identification project (SPP800) initiated in 2003 by Speedel Experimenta in collaboration with Locus Pharmaceuticals Inc.

Cardiovascular diseases, including hypertension, are the leading cause of death in the Western world. Experts estimate that only 25% of all patients with high blood pressure are adequately controlled with current drugs and therefore physicians and patients need additional therapeutic options. Global antihypertensive drugs sales are forecasted by Datamonitor to grow from USD 35 billion in 2001 to USD 52 billion by 2007.

About Speedel

The Speedel Group, based in Basel, Switzerland, is a pharmaceutical company with a core competence in drug development, focusing on early proof-of-concept in man in cardiovascular and metabolic diseases, both of which are main causes of death in the industrialized world and represent the largest pharmaceutical market segments worldwide. A privately owned company formed in 1998, Speedel employs a team of over forty experienced pharmaceutical scientists and managers in Europe and the United States. Speedel in-licenses innovative drug candidates at late preclinical or early clinical development stages and upon completion of Phase II development, partners with leading pharmaceutical companies for Phase III development and commercialization. In addition, Speedel is a leader in the area of renin inhibitors and through its research unit Speedel Experimenta AG, which encompasses medicinal chemistry as well as preclinical pharmacology and galenical formulations, generates novel drug candidates. For additional information see http://www.speedelgroup.com/

This press release contains certain forward looking statements that can be identified by the use of forward-looking terminology such as "envisaged", "potentially", and "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 commercialization 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.

Contact address: Dr. Jessica Mann Nick Miles Medical Director Director of Communication and IR Speedel Group Speedel Group CH-4051 Basel, Switzerland CH-4051 Basel, Switzerland Tel. +41 61 206 40 00 Tel. +41 61 206 40 00 Jessica.mann@speedelgroup.comNick.miles@Speedelgroup.com

The Speedel Group

CONTACT: Dr. Jessica Mann, Medical Director, +41-61-206-40-00,Jessica.mann@speedelgroup.com, or Nick Miles, Director of Communication andIR, +41-61-206-40-00, Nick.miles@Speedelgroup.com, both of The Speedel Group


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