SOURCE: Speedel Holding AG

March 06, 2007 08:39 ET


BASEL, SWITZERLAND -- (MARKET WIRE) -- March 6, 2007 --



Basel/Switzerland and Bridgewater NJ/USA, 06 March 2007

Speedel (SWX: SPPN) welcomes today's announcement by Novartis that the US Food and Drug Administration (FDA) has approved SPP100 (aliskiren, Tekturna[1]) to treat hypertension both as monotherapy and in combination with other anti-hypertensives. The approval was based on data from more than 6,400 patients with high blood pressure in numerous clinical trials. SPP100 is the first-in-class once daily oral direct renin inhibitor that Speedel successfully developed through Phase I and II clinical trials before Novartis exercised its license-back option in 2002.

Dr. Alice Huxley, CEO, commented: "We are delighted that SPP100 has been approved in the US as the first in a new class of medicines for high blood pressure in over a decade. This is a wonderful example of a win-win partnership between big pharma and small biotech, and we are confident that Novartis will ensure the market success of Tekturna given the drug's profile and Novartis' position as the global leader in cardiovascular therapies."

Dr. Huxley continued: "This approval validates Speedel's long standing commitment to renin inhibition as the potential gold standard therapy for treatment of hypertension and other related disorders. Hypertension is a leading cause of cardiovascular disease, the world's No. 1 killer. Speedel remains at the forefront of research and clinical development of next generation renin inhibitors with SPP635 in Phase IIa and SPP1148 in Phase I."

In clinical trials, SPP100 produced double-digit reductions in blood pressure sustained for a full 24 hours, reaching its maximum lowering effect within 2 weeks. It was generally well tolerated at the approved doses of 150mg and 300 mg once daily.

Clinical trials have also shown that SPP100 further reduced blood pressure when used in combination with many common high blood pressure therapies, including angiotensin converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs) or the diuretic hydrochlorothiazide (HCTZ).

Novartis is also conducting a large outcome trial programme to evaluate the potential long-term effects of SPP100 and direct renin inhibition beyond high blood pressure.

In September 2006, SPP100 was also submitted by Novartis to the European Medicines Agency (EMEA) for review in the European Union. The proposed brand name for SPP100 outside the US is Rasilez[1].

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 IIa with results due in the second half of 2007, followed by SPP1148 which started Phase I in Q12007, and the SPP800 series currently in late-stage pre-clinical profiling.

About SPP100 (aliskiren, Tekturna)

SPP100 (aliskiren, Tekturna) 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.

By inhibiting renin at the top of the RAS, SPP100 decreases the system's activity, as measured by 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. Renin inhibitors lower PRA 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. Regulatory approval was given by the US FDA in March 2007 and a regulatory submission was made by Novartis in the EU during Q3 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 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 (aliskiren, Tekturna[1]), the first-in-class 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 filed by Novartis with the EMEA in the EU in Q3 2006. 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 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 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 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.


Nick Miles
Director Communications & Investor Relations
Hirschgässlein 11
CH - 4051 Basel

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

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

[1] Tekturna® is a Novartis trademark

[1] Rasilez® is a Novartis trademark

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