Healthcare Industry News:  aliskiren 

Biopharmaceuticals FDA

 News Release - January 21, 2008

US Approval for SPP100 Combined with Diuretic to Treat Hypertension

Single tablet "combo" therapies well accepted by prescribers and patients

BASEL, SWITZERLAND--(Healthcare Sales & Marketing Network)--Jan 21, 2008 -- Speedel Holding Ltd (Swiss:SPPN.SW ) today announced that it is delighted by the FDA approval of a second product containing SPP100 (aliskiren) in the USA for the treatment of hypertension. The approval was announced by Novartis who is responsible for commercialisation of this first in class direct renin inhibitor.

Tekturna HCT® [1] (aliskiren and hydrochlorothiazide) has been approved by the US Food and Drug Administration as a single-tablet combination of two high blood pressure medicines - Tekturna® [2] (aliskiren), the first new type of high blood pressure medicine in more than a decade, and the diuretic hydrochlorothiazide (HCT)[3].

This is the first regulatory approval of a single-tablet combination therapy involving Tekturna®, known as Rasilez® [4] outside the US, which has been shown to consistently lower blood pressure for 24 hours and beyond[5].[6] HCT, sometimes called a "water pill", is one of the most commonly-used high blood pressure medicines[7].

Dr Chris Jensen, Head of Scientific Affairs, commented: "Hypertension is still a poorly treated disease despite current therapies. This combination of a new mode of action such as the first direct renin inhibitor with a traditional diuretic should give a significant new treatment option for patients and improve their compliance."

Alice Huxley, CEO, stated: "This approval is an important step forward for the growing acceptance of aliskiren in the market. One third of antihypertensive prescriptions in the US are written for HCT as a combination or as monotherapy. This is the second approved product containing our lead compound SPP100 and we expect more combination products to be developed."

The two medicines in this single-tablet combination work together in complementary ways to lower blood pressure, with clinical data showing that the combination of Tekturna and HCT offers greater blood pressure reductions than either component alone[8].

Single-tablet combinations such as Tekturna HCT simplify high blood pressure management by reducing the number of pills people take daily[9].Tekturna HCT is approved for patients not controlled by either medicine alone[10].

The US approval of Tekturna HCT was based on clinical trials involving more than 2,700 patients treated with Tekturna and HCT[11].

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. Among them, Speedel conducted the first successful pilot clinical trial with the combination of aliskiren and HCT. Based on the results generated during this programme, Novartis exercised a license-back option in 2002. Regulatory approval of Tekurna, known as Rasilez outside the US, was given by the US FDA in March 2007 and by the EU in August 2007.

Speedel next generation renin inhibitors

With three new renin inhibitors in clinical development, Speedel continues to build its mature pipeline by leveraging its expertise and experience in renin inhibition. This novel mode of action has been validated by the 2007 approval of SPP100 (Tekturna/Rasilez) in the US, EU and Switzerland where it is marketed by Novartis in these markets. Both Speedel and Novartis recently won the Wall Street Journal Gold Award for Technology Innovation, which was given to the companies for their work in discovering and developing SPP100 as an innovative therapy for hypertension. Speedel is developing a family of next generation direct renin inhibitors, and now has three compounds in the clinic: SPP635 in Phase IIa, SPP676 in Phase I and SPP1148 in Phase I.

Growing global health risks of high blood pressure

The Lancet published an editorial on 17 August 2007 which stated: "The risk of becoming hypertensive during lifetime exceeds a staggering 90% for a person in a developed country." The editorial also observed that: "The increasingly common combination and interaction of obesity, diabetes, hyperlipidaemia and high blood pressure, if left untreated for too long, leads to cardiovascular disease, stroke, renal failure, dementia, and ultimately death. Worldwide, the estimated number of adults with hypertension was 972 million in 2000; 639 million live in developing countries. By 2025, the total number is expected to increase to 1.56 billion." [12]

About SPP100 (aliskiren, Tekturna/Rasilez[13])

SPP100 (aliskiren, Tekturna/Rasilez) is the first-in-class oral direct renin inhibitor. The development of SPP100 is the result of over 20 years of research on renin. Renin is the rate-limiting 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). Lowering PRA is believed to be very important in end-organ protection (e.g. heart and kidney). PRA is an independent risk factor and direct surrogate marker for several cardio-renal diseases, such as myocardial infarction and chronic renal disease. Direct renin inhibitors lower PRA whereas most current leading anti-hypertensive drug classes such as ACE-Is and ARBs increase PRA levels.

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 usual 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 (Tekturna/Rasilez[14] ), the first-in-class direct 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 by the EMEA in the EU in August 2007. Our pipeline covers three different modes of action, and in addition to SPP100, includes SPP301 in Phase II, SPP200 in Phase II, SPP635 in Phase Il, SPP1148 and SPP676 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 80 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 255 million (approximately EUR 157 million or USD 204 million) from private placements of equity securities and two convertible loans including the conversion premiums. 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.

[1] Tekturna HCT® is a Novartis trademark

[2] Tekturna/Rasilez® are Novartis trademarks

[3] Tekturna HCT US Prescribing Information

[4] Tekturna/Rasilez® are Novartis trademarks

[5] Oh BH, Mitchell J, Herron JR, et al. aliskiren, an oral renin
inhibitor, provides dose-dependent efficacy and sustained 24-hour
blood pressure control in patients with hypertension. J Am Coll
Cardiol 2007;49:1157-1163.

[6] Sica D, Gradman AH, Lederballe O, et al. aliskiren, a novel renin
inhibitor, is well tolerated and has sustained BP-lowering effects
alone or in combination with HCTZ during long-term (52 weeks)
treatment of hypertension. Eur Heart J 2006;27(Suppl):121 P-797

[7] Chobanian AV, Bakris GL, Black HR et al. and the National High
Blood Pressure Education Program Coordinating Committee. The seventh
report of the Joint National Committee on prevention, detection,
evaluation, and treatment of high blood pressure. Hypertension 2003;

[8] Villamil A, et al. Renin inhibition with aliskiren provides
additive antihypertensive efficacy when used in combination
with hydrochlorothiazide. Journal of Hypertension 2007, 25: 217-226

[9] Boolell M, Glasspool J. Cardiovascular Disease Health Burden,
Treatment Benefits and Challenges: Need for Partnership. Health
& Productivity Management Vol 5, No 4 December 2006, p 11-14.

[10] Tekturna HCT US Prescribing Information

[11] Tekturna HCT US Prescribing Information

[12] The Lancet: 2007; 370:539

[13] Tekturna/Rasilez® are Novartis trademarks

[14] Tekturna/Rasilez® are Novartis trademarks

Source: Speedel

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