DENTSPLY International Announces Agreement for Acquisition of AstraZeneca's Oraqix Product; and Fourth Quarter Expectations.Business Editors/Health & Medical Writers YORK, Pa.--(BUSINESS WIRE)--Dec. 18, 2001 DENTSPLY International Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :XRAY) today announced that it has completed a revised agreement with AstraZeneca to purchase full rights to Oraqix(TM) - AstraZeneca's revolutionary new anesthetic product for scaling and root planning associated with periodontal periodontal /peri·odon·tal/ (per?e-o-don´t'l) 1. pertaining to the periodontal ligament or periodontium. 2. near or around a tooth. per·i·o·don·tal adj. 1. treatment. Oraqix(TM) is in a gel format and provides pain relief without the discomfort of a needle for application. DENTSPLY has agreed to pay $2 million as a milestone payment upon submission of an Oraqix(TM) New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) in the U.S., and Marketing Authorization Application (MAA MAA abbr. macroaggregated albumin )in Europe(this payment will be expensed in the fourth quarter of 2001, and is expected to be paid in the first quarter of 2002), an additional $18 million payment upon approval of both the NDA and MAA and future royalties on sales of the product. The $18 million payment is expected to be made during 2003 and includes a pre-paid royalty of $10 million. John C. Miles II, Chairman and Chief Executive Officer, stated "We are very pleased that we were able to successfully retain the rights to the Oraqix(TM) product under this new agreement which significantly lowers Dentsply's upfront risk regarding the regulatory process. We are very excited with the Oraqix(TM) product and the untapped market niche that it will address. The completed clinicals show that Oraqix(TM) provides significant pain relief during scaling and root planing The objective of scaling and root planing, otherwise known as conventional periodontal therapy, is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] procedures and we look forward to introducing it to the market upon its approval, which we expect will be in late 2003." DENTSPLY also announced that it expects to meet or exceed analysts' earnings estimates for the fourth quarter. The Company also stated that it will have restructuring and other income/expenses in the quarter which are expected to net out to a slight positive. These items include restructuring and other costs, primarily related to recent acquisitions, of approximately $12 million; a gain from the U.K. pension plan asset reversion received in October of $8.4 million; a gain on the insurance equipment settlement for the Maillefer fire of approximately $6.0 million; and a charge for the Oraqix(TM) payment of $2 million. Mr. Miles also stated, "We continue to be optimistic and excited about our opportunities, as we integrate our new acquisitions and close out a very successful and rewarding year. We hope all of our stakeholders share in this excitement and we wish all of you peace and happiness over the holiday season." DENTSPLY designs, develops, manufactures and markets a broad range of products for the dental market. The Company believes that it is the world's leading manufacturer and distributor of dental prosthetics, endodontic Endodontic Pertaining to the inside structures of the tooth, including the dental pulp and tooth root, and the periapical tissue surrounding the root. Mentioned in: Root Canal Treatment endodontic instruments and materials, prophylaxis prophylaxis (prō'fĭlăk`sĭs), measures designed to prevent the occurrence of disease or its dissemination. Some examples of prophylaxis are immunization against serious diseases such as smallpox or diphtheria; quarantine to confine paste, dental sealants, ultrasonic scalers, dental injectible anesthetics Anesthetics Drugs or methodologies used to make a body area free of sensation or pain. Mentioned in: Appendectomy and crown and bridge materials; the leading United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. manufacturer and distributor of dental x-ray equipment, dental handpieces, intraoral cameras, dental x-ray film holders, film mounts and bone substitute/grafting materials; and a leading worldwide manufacturer or distributor of impression materials, orthodontic orthodontic (ôr´th  dän´tik),adj appliances, dental cutting instruments and dental implants. The Company distributes its dental products in over 120 countries under some of the most well established brand names in the industry. DENTSPLY is committed to the development of innovative, high quality, cost-effective new products for the dental market. This press release contains forward-looking statements regarding future events or the future financial performance of the combined company. Actual events or results may differ materially from those in the projections or other forward-looking statements set forth herein as a result of certain risk factors, including, without limitation, the difficulty of successfully combining the operations of Degussa with those of DENTSPLY in a timely manner, and the ability to continue to generate sufficient cash flow to pay down the additional debt as planned. For an additional description of risk factors, please refer to the Company's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and other filings with the Securities and Exchange Commission. |
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