3M To Manufacture Xopenex HFA Metered-dosed Inhaler.Business Editors & Health/Medical Writers ST. PAUL St. Paul as a missionary he fearlessly confronts the “perils of waters, of robbers, in the city, in the wilderness.” [N.T.: II Cor. 11:26] See : Bravery , Minn. & MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jan. 7, 2002 3M Drug Delivery Systems (DDS (1) (Digital Data Storage) See DAT. (2) (Data Dictionary System) See QuickBuild and OpenDDS. (3) (Dataphone Digital S ) Division and Sepracor Inc. today announced initiation of a scale-up and manufacturing collaboration for a Xopenex (levalbuterol tartrate tartrate /tar·trate/ (tahr´trat) a salt of tartaric acid. tar·trate n. A salt or ester of tartaric acid. tartrate a salt of tartaric acid. ) hydrofluoroalkane (HFA HFA Harvard Film Archive (Harvard University) HFA Harry Fox Agency, Inc. HFA Housing Finance Agency (District of Columbia government) HFA Hyogo Framework for Action HFA High-Functioning Autism ) metered-dose inhaler metered-dose inhaler Pharmacology A device used to deliver a specified number of doses of a therapeutic inhalant–eg, β-agonist for asthma (MDI (1) (Multiple Document Interface) A Windows function that allows an application to display and lets the user work with more than one document at the same time. ). The collaboration will combine Sepracor's short-acting beta-agonist, Xopenex, and 3M's expertise in manufacturing MDIs, the device most commonly used by patients for the treatment of asthma and chronic obstructive pulmonary disease chronic obstructive pulmonary disease n. Abbr. COPD A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced. , using HFA technology. Sepracor currently is conducting large-scale clinical studies for levalbuterol in an HFA MDI in children, adolescents and adults. Short- and long-acting beta-agonist MDI sales in the 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. in 2001 were approximately $1.1 billion with a combined annual growth rate of approximately 20 percent, according to IMS Health information. "The Xopenex MDI will expand our franchise to a greater number of adult asthmatics who use MDI therapy. The MDI delivery system will allow pediatric patients who currently are benefiting from nebulizer nebulizer /neb·u·liz·er/ (neb´u-li?zer) atomizer; a device for throwing a spray. neb·u·liz·er n. therapy with Xopenex inhalation solution to continue to use Xopenex when they are old enough to use a hand-held device," stated Paul D. Rubin, M.D., executive vice president, Drug Development and Research at Sepracor Inc. "We are pleased to announce this important collaboration agreement with Sepracor," said John Sampson, general manager, 3M DDS. "Sepracor's Xopenex inhalation solution is an established and competitive product that continues to gain share in the unit-dose vial market. We are looking forward to working with Sepracor to optimize the Xopenex franchise with this new delivery system." Sepracor currently markets Xopenex (levalbuterol HCl) inhalation solution in dosage strengths of 0.63 mg and 1.25 mg for nebulizer use. Xopenex inhalation solution is indicated for the treatment or prevention of bronchospasm bronchospasm /bron·cho·spasm/ (brong´ko-spazm) bronchial spasm; spasmodic contraction of the smooth muscle of the bronchi, as in asthma. bron·cho·spasm n. in patients 12 years of age and older with reversible obstructive airway disease, such as asthma. A Supplemental New Drug Application (sNDA) seeking clearance to market Xopenex inhalation solution at lower dosage strengths for the treatment or prevention of bronchospasm in pediatric patients is under review at the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). About 3M DDS 3M Drug Delivery Systems Division is a global leader in the development of inhalation and transdermal technologies. As the creator of the first metered-dose inhaler (MDI), the division has a 45-year history of medical innovation, including introduction of the world's first HFA inhalers. Today, 3M DDS components and services are used in over 50 percent of all global MDI devices. Likewise, the company also pioneered the 3M Latitude Transdermal Drug Delivery System, a drug-in-adhesive platform that can be customized for a variety of therapeutic agents while delivering medication through a patient's skin for up to a week. Over 80 percent of transdermal systems in the United States contain at least one 3M DDS component. About 3M 3M is a $17 billion diversified technology company with leading positions in health care, safety, electronics, telecommunications, industrial, consumer and office, and other markets. Headquartered in St. Paul, Minnesota, the company has operations in more than 60 countries and serves customers in nearly 200 countries. 3M businesses share technologies, manufacturing operations, brands, marketing channels and other important resources. 3M is one of the 30 stocks that make up the Dow Jones Industrial Average Dow Jones Industrial Average The best known U.S. index of stocks. A price-weighted average of 30 actively traded blue-chip stocks, primarily industrials including stocks that trade on the New York Stock Exchange. and also is a component of the Standard & Poor's 500 Index. For more information about 3M go to www.3M.com or www.3M.com/profile/pressbox/index.jhtml About Sepracor Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded an extensive portfolio of pharmaceutical candidates that are focused on the treatment of respiratory, urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. and central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency . Sepracor's corporate headquarters are located in Marlborough, Massachusetts. This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy, potential benefits and successful development of the company's pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the submission, acceptance and approval of regulatory filings; the results of clinical trials with respect to products under development; the scope of the company's patent protection with respect to such product candidates; the commercial success of Sepracor's products; the ability of the company to attract and retain qualified personnel; the performance of Sepracor's licensees; the availability of sufficient funds to continue research and development efforts; and certain other factors that may affect future operating results and are detailed in the company's periodic reports filed with the Securities and Exchange Commission. Xopenex is a registered trademark of Sepracor Inc. 3M is a trademark of 3M company. Latitude is a trademark of 3M. |
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