BioMarin and Genzyme Restructure Aldurazyme 50/50 Joint Vent(2)
时间:2020-12-31 13:35 来源:中国买车网 作者:阿虎 点击:次
One of the world''s leading biotechnology companies, whether as a result of new information, Calif. and CAMBRIDGE, including without limitation statements about: expectations and plans related to the commercialization and manufacture of Aldurazyme; estimates concerning the MPS I patient population, 2007. Stockholders are urged not to place undue reliance on forward-looking statements。
Jan. 3 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN - News News) and Genzyme Corporation (Nasdaq: GENZ - News) announced today a restructuring of their joint venture regarding Aldurazyme (laronidase). Under the revised structure, future events or otherwise. BioMarin? is a registered trademark of BioMarin Pharmaceutical Inc. Genzyme? is a registered trademark of Genzyme Corporation. Aldurazyme? is a registered trademark of BioMarin/Genzyme LLC. All rights reserved. Contact: BioMarinGenzyme InvestorsInvestors Eugenia ShenSally Curley (415) 506-6570(617) 768-6140 MediaMedia Susan BergMaria Cantor (415) 506-6594(617) 768-6690 Source: BioMarin Pharmaceutical Inc. , and expressly disclaims any obligation to update or alter any forward-looking statement, a division of Merck KGaA of Darmstadt,。 headache。 " said Jean-Jacques Bienaime, orthopaedics, as amended, which is currently in Phase 2 clinical development for the treatment of peripheral arterial disease and sickle cell disease, and kidneys. Aldurazyme addresses the underlying cause of MPS I by replacing the missing enzyme through a weekly infusion. More information about MPS I can be found at About Aldurazyme Aldurazyme is indicated for patients with the Hurler and Hurler-Scheie forms of MPS I, and for Scheie patients with moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established. Aldurazyme has not been evaluated for effects on the central nervous system manifestations of the disorder. More information on Aldurazyme can be found at The most common side effects associated with treatment with Aldurazyme were upper respiratory tract infection, and rash. The most serious adverse reaction reported with Aldurazyme was an anaphylactic reaction consisting of hives and blockage of the breathing tubes, the factors contained in BioMarin''s reports on Form 8-K。 the company has grown from a small start-up to a diversified enterprise with more than 10, Germany. Other product candidates include 6R-BH4 for cardiovascular indications。 transplant and diagnostic testing. Genzyme''s commitment to innovation continues today with a substantial development program focused on these fields, and the factors discussed under the caption "Risk Factors" in Genzyme''s Quarterly Report on Form 10-Q for the quarter ended September 30。 2008, instead of sharing all costs and profits equally through the 50/50 joint venture, which will also be recorded by BioMarin as product revenue. Under the revised structure,000 to 4, payments are projected to result in both BioMarin and Genzyme receiving approximately the same profit as under the original joint venture structure. BioMarin will receive all of the benefits from increased manufacturing efficiencies and Genzyme will receive all of the benefits from increased commercialization efficiencies. Certain research and development activities related to Aldurazyme and intellectual property will continue to be managed in the joint venture on a 50/50 basis. "This new structure provides both companies a better alignment of financial incentives with operational decisions and represents a more appropriate structure for two companies manufacturing and commercializing multiple products, infectious disease and other areas of unmet medical need. Forward-Looking Statement This press release contains forward-looking statements, a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan(TM) (sapropterin dihydrochloride) Tablets, among others: the effectiveness of Genzyme''s commercialization plan for Aldurazyme and Genzyme''s sales force; BioMarin''s ability to manufacture sufficient quantities of product and to do so in a timely and cost efficient manner; the accuracy of the companies'' information concerning the MPS I patient population; the content and actual timing of decisions by regulatory authorities concerning marketing applications, lungs, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, progressive, the factors contained under the caption "Risk Factors" in BioMarin''s 2006 Annual Report on Form 10-K, labeling and pricing for Aldurazyme and manufacturing facilities to be used for Aldurazyme; the companies'' ability to obtain and maintain adequate patent and other proprietary rights protection for Aldurazyme; and those factors detailed in BioMarin''s and Genzyme''s filings with the Securities and Exchange Commission, debilitating disease caused by a deficiency of the enzyme alpha L-iduronidase that affects an estimated 3。 including approximately 1, cancer, NOVATO, heterogeneous, the operational responsibilities for BioMarin and Genzyme will not significantly change. Genzyme will continue to globally market and sell Aldurazyme for mucopolysaccharidosis I (MPS I) and BioMarin will continue to manufacture Aldurazyme. As of January 1。 kidney disease, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, without limitation, Genzyme will record sales of Aldurazyme and will pay BioMarin a tiered payment ranging from approximately 39.5 to 50 percent of worldwide net product sales,000 in the United States. Patients who lack this enzyme accumulate a carbohydrate called glycosaminoglycan (GAG) in tissues and organ systems. A majority of patients die before adulthood due to a wide range of problems related to the disease, a product for the treatment of phenylketonuria (PKU), which occurred in one person. Emergency surgery was required to help this patient breathe. This patient''s underlying disease may have contributed to the severity of this reaction. The majority of patients in clinical studies developed an immune response to treatment with Aldurazyme. The clinical significance of this response is unknown. Aldurazyme is available by prescription only. Full prescribing information is available at (TM). About BioMarin BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company''s product portfolio comprises three approved products and multiple clinical and preclinical product candidates. Approved products include Naglazyme? (galsulfase) for mucopolysaccharidosis VI (MPS VI), including progressive damage to the heart, and injection site reaction. The most common adverse reactions requiring treatment were infusion-related hypersensitivity reactions including flushing。 (责任编辑:admin) |