Speedel Receives First Cost-of-Goods Savings for SPP100
-Novartis confirms it is using Speedel's manufacturing process forSPP100-
BASEL, Switzerland and BRIDGEWATER, NJ/USA, Nov. 29, 2007-Speedel Holding Ltd (SWX: SPPN) today announced it has received from Novartis the revenue report regarding SPP100 (Tekturna/Rasilez) for the three months ending 30 September 2007. Consequently Speedel has updated its revenues and now confirms that it has earned a total of CHF 621,000 for the third quarter 2007 compared to management's best estimate of CHF 571,000 previously announced with its financial results.
After publishing its results on 14 November and in line with the licensing agreement, Speedel has received from Novartis the revenue report regarding SPP100 for the third quarter. This report includes details on the royalties due to Speedel from Novartis reported net sales of USD 9 million for SPP100 in the US and Europe. This report also includes for the first time details on the cost-of-goods savings which Novartis has achieved for product sold during the third quarter, using the chemical synthesis route developed by Speedel and licensed to Novartis in 2002. A small portion of the product sold by Novartis in the third quarter was reported to be eligible for the savings on cost-of-goods stipulated in the licensing agreement.
Alice Huxley, CEO, stated: "We are glad that Novartis have now confirmed their use of the manufacturing process developed by Speedel for SPP100. It is encouraging to see the first fruits of our major technical breakthrough which enabled the first renin inhibitor to come to market. We look forward to being in a position to report to the investment community every quarter an increasing revenue stream attributable to this component of our agreement with Novartis, as one may expect the manufacturing efficiencies for SPP100 to further improve going forward."
Although Novartis has provided Speedel with a revenue report for Q3 which includes details on the cost-of-goods component for that period, no comparable data for the first and second quarters of 2007 is yet available to us. Furthermore, Novartis have now indicated their willingness to discuss the terms and conditions of Speedel'saudit of data supplied by Novartis with the quarterly revenue reports pertaining to the cost-of-goods component under the licensing agreement signed in January 2000. On this basis, Speedel remains confident that these two items will be resolved amicably in due course.
Speedel will update its financial results for the first nine months when the company reports its full year 2007 results on 07 March 2008.
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), 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 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 II, SPP200 in Phase II, SPP635 in Phase Il, SPP1148 in Phase I, 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.
 Tekturna/ Rasilez ® are Novartis trademarks
For further information please contact
Director Communications & Investor Relations
CH - 4051 Basel
Speedel Pharmaceuticals Inc
1661 Route 22 West
P.O. Box 6532
Bridgewater, NJ 08807
United States of America
Posted: November 2007
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