Catalytica Pharmaceuticals Adds Clinical Trial Packaging Services and Expands Pilot Plant Scale-Up Capabilities; Reports Unchanged Outlook for Glaxo Wellcome Business.MOUNTAIN VIEW, Calif.--(BW HealthWire)--Dec. 8, 1999-- Catalytica Pharmaceuticals, Inc., a subsidiary of Catalytica, Inc. (Nasdaq:CTAL CTAL Confederacion de Trabajadores de America Latina (Confederation of Latin American Workers) CTAL Canadian Tire Acceptance Limited CTAL Computer Technology Application Lab, Inc. CTAL Confidentially Typed Assembly Language ) announced today that it is expanding its service capabilities to include clinical trial material packaging and labeling for its customers. In addition, it has completed plans to expand its chemical pilot plant scale-up facilities to accommodate growing customer demand for its services. Catalytica currently manufactures clinical trial products for several of its customers and now intends to package and label these products to increase the efficiency and speed with which customers can bring them to physicians and patients. The Company currently expects facility modifications and validation See validate. validation - The stage in the software life-cycle at the end of the development process where software is evaluated to ensure that it complies with the requirements. for the packaging business to be completed by April 2000. The Company currently operates pilot plant scale-up facilities in both Greenville, North Carolina
Greenville, one of the fastest growing cities in North Carolina, is the county seat of Pitt County, and is the principal city of the Greenville, North Carolina Metropolitan Statistical Area. and South Haven, Michigan South Haven is a city in the U.S. state of Michigan. Most of the city is in Van Buren County, although a small portion extends into Allegan County. The population was 5,021 at the 2000 census. . It plans to expand these capabilities through a capital investment of approximately $6 million for improvements at its Greenville facility, and increased reactor Reactor (electricity) A device for introducing an inductive reactance into a circuit. Inductive reactance x is a function of the product of frequency f and inductance L; thus, x = 2πfL. capacity as well as additional small "We continue to strengthen our abilities to partner with pharmaceutical and biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. companies to further serve their needs. By adding clinical trial packaging services and expanding our pilot plant scale-up capabilities, we address more completely and for more customers their needs in the early stages of the drug development process. We believe that our customers value the comprehensive capabilities that we can offer and we continue to draw new customers to our facility. Just this quarter, we have already signed four new contracts in the research and development side of our business. We have also received clinical trial sample orders from two customers that have worked with us for chemical process development of these two compounds. Most of these customers have agreed to also use Catalytica as a source to manufacture the products from these research and development efforts if successful development of the product leads to an approved drug In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo an extensive FDA approval process. This process involves first testing the drug on animals or in medical labs. ." Catalytica also stated that its current expectation for Glaxo Wellcome business remains unchangedA re-inspection of our Greenville chemical faci Inc., provides the pharmaceutical and biotech industries with comprehensive skills and demonstrated commercial experience in a broad spectrum of areas extending from process development through drug development, formulation, manufacturing and packaging. Since the acquisition of the Greenville Facility from Glaxo Wellcome in 1997, Catalytica has entered into over 45 new agreements for the development and manufacture of products for various pharmaceutical and biotech companies. In anticipation of additional business, it has expanded its chemical manufacturing facility and is currently expanding its sterile sterile /ster·ile/ (ster´il) 1. unable to produce offspring. 2. aseptic. ster·ile adj. 1. Not producing or incapable of producing offspring. 2. facility. It is the largest independent, fully integrated drug development and manufacturing supplinced Technologies, Inc. serves as the incubator incubator, apparatus for the maintenance of controlled conditions in which eggs can be hatched artificially. Incubator houses with double walls of mud, a fireroom, and several compartments each holding about 6,000 hens' eggs were developed in ancient times; the for new catalytic cat·a·lyt·ic adj. Of, involving, or acting as a catalyst: "Deregulation's catalytic power . . . is still reshaping the banking, communications, and transportation industries" Ellyn E. technologies for industrial applications. Catalytica, Inc. employs over 1,600 people and had 1998 revenues of $406 million. Find Catalytica on the World Wide Web at http//www.catalytica-inc.com. This news release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. regarding Catalytica's outlook for Glaxo Wellcome business, its working relationship wustomers and from additional services, revenue expectations from Glaxo Wellcome, the ability to transition new customers and business into the Greenville facility, the ability to complete the facility modifications for clinical trial packaging, the planned construction of additional pilot plant scale-up capabilities, Catalytica's competitive position in its markets, and Catalytica's compliance with curreo perform cost effectively and in a timely manner, product development delays, changes in the company's competitive position, and the impact of 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. and other regulations on pharmaceutical and biotech manufacturing. Catalytica undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this release or to reflect the incurrence of unanticipated events. Investors are encouraged to review Catalytica's Form 10K for the year ending December 31, 1998, Form 10Qs for the periods ending March 31, 1999, June 30, 1999, and September 30, 1999, and Form S4/A dated August 19, 1999, for a discussion of additional factors that could affect Catalytica's future performance. |
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