BASEL, Switzerland and BRIDGEWATER, N.J., Dec. 14, 2006 (PRIME NEWSWIRE) -- Speedel (SWX:SPPN) notes today's announcement by Novartis that the U.S. regulatory review period has been extended by up to 3 months for SPP100 (aliskiren, Tekturna(1)) which was submitted for approval by Novartis during the first quarter of 2006.
The extension will provide the U.S. Food and Drug Administration (FDA) with time to consider additional clinical data submitted by Novartis in early December. These data come from a study involving 30 healthy volunteers who received SPP100 at the proposed 300 mg once-daily dose for eight weeks to study potential changes of the colonic mucosa. Analysis of the data indicated that SPP100 did not induce any changes in the mucosal lining of the colon, as evaluated by colonoscopy and biopsies.
Dr. Alice Huxley, CEO, commented: "We understand that Novartis is confident that providing this additional information to the FDA will help secure approval for SPP100 in the U.S. and allow this important therapy to be offered to patients seeking to gain control of high blood pressure."
The extension provides the FDA time to review this new clinical data supporting the safety profile of SPP100 which has been studied in more than 6,000 people to date. SPP100 is potentially the first in a new class of therapies for high blood pressure -- renin inhibitors -- to be made available to patients for more than a decade.
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.
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 U.S., EU, and Japan, with regulatory submissions already filed in the U.S. in Q1 2006 and 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, is partnered with Novartis for development and commercialisation in hypertension; SPP100 was filed with the FDA in the U.S. in Q1 2006 and 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, SPP200 in Phase II, SPP635 in Phase Il, 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 CHF 83.95 million (approximately EUR 53m or US$64m) through the public offering of 500,000 treasury shares. As a private company, we have previously raised gross proceeds of CHF 239 million (approximately EUR 154 million or US$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 US$44 million). The company's shares were listed in September 2005 on the SWX Swiss Exchange under the symbol SPPN.
(1) Tekturna (SPP100, aliskiren) is a Novartis trade name
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