Catalytica Pharmaceuticals Announces New Clinical Trial Packaging Services.Business Editors/Health &Medical Writers MOUNTAIN VIEW, Calif.--(BW HealthWire)--Jan. 19, 2000 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 will expand its outsourcing services to offer clinical trial material packaging and labeling for its pharmaceutical customers. Catalytica will complete facility modifications and testing for the launch of this business in April 2000. Concurrently, Catalytica Pharmaceuticals also announced it has named Shumena B. Horton to the position of senior development scientist to oversee clinical trial packaging. &uot;We manufacture many clinical study materials for our customers,&uot; said Dr. Gabriel Cipau, Catalytica Pharmaceuticals' president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . &uot;Our ability to now package and label clinical materials increases the efficiency and speed with which our customers can bring their products to physicians and patients. This expansion of our business reinforces our position as a world leader in pharmaceutical development and manufacturing for our customers.&uot; Catalytica's new services will include packaging and labeling bottles, vials, blister blister, puffy swelling of the outer skin (epidermis) caused by burn, friction, or irritants like poison ivy. A response of the body to protect deeper tissue, blisters generally contain serum, the liquid component of blood. packs and other materials for use in clinical studies. Technicians at the company's 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. site are trained in the complex processes of packaging for different study designs, reading randomization randomization (ranˈ·d prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. customer needs. &uot;Our expert scientists are trained to read and understand complex study protocols, eliminating the need for a customer to explain the details of a specific order,&uot; said Dr. Cipau. &uot;Our customers will simply provide us with the protocol and we will package the material as specified by the trial design -- randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , crossover Crossover The point on a stock chart when a security and an indicator intersect. Crossovers are used by technical analysts to aid in forecasting the future movements in the price of a stock. In most technical analysis models, a crossover is a signal to either buy or sell. , or whatever the customer requires.&uot; Ms. Horton will manage the clinical trial material packaging and labeling operation for Catalytica. She joined Catalytica in 1999 as senior development scientist. Prior to joining Catalytica, Ms. Horton most recently served as a clinical supply supervisor for Rhone-Poulenc Rorer in Collegeville, Pennsylvania Collegeville is a borough in Montgomery County, Pennsylvania, 25 miles (40 km) northwest of Philadelphia on the Perkiomen Creek. Collegeville was incorporated in 1895. It is the seat of Ursinus College, opened in 1869. Population in 1910, 621. . She brings 15 years of pharmaceutical experience to Catalytica, with expertise in the areas of clinical labeling and packaging, microbiology microbiology: see biology. microbiology Scientific study of microorganisms, a diverse group of simple life-forms including protozoans, algae, molds, bacteria, and viruses. and clinical research. As a clinical supply supervisor for Rhone-Poulenc Rorer, she supervised label technicians to generate clinical labels for blinded and open label clinical trials. Her work required close involvement with the company's regulatory and medical affairs functions, and production management to meet packaging schedules. Prior to joining Rhone-Poulenc in 1992, Ms. Horton worked for eight years at Procter and Gamble in its microbiological laboratory and package testing department. In her new role at Catalytica, Ms. Horton will work with customers to provide packaging specific to study protocols and ensure the processes meet all customer and Food &Drug Administration requirements. She received a bachelor's degree in biology from North Carolina Central University History NCCU was chartered in 1909 and opened in 1910 as the National Religious Training School and Chautauqua under the leadership of President James E. Shepard. in Durham, North Carolina Durham is a city in the U.S. state of North Carolina. It is the county seat of Durham CountyGR6 and is the fourth-largest city in the state by population. . &uot;We believe Shumena's expertise will enable successful implementation of our clinical trial packaging services,&uot; said Mike Renn, director of pharmaceutical research &development. &uot;Her expertise in clinical study design along with her expert knowledge of clinical trial materials will ensure we structure our packaging business in a way that strengthens Catalytica's position as the leader in pharmaceutical development and manufacturing services for the pharmaceutical industry.&uot; Catalytica Pharmaceuticals, Inc., a subsidiary of Catalytica, Inc., provides the pharmaceutical and biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. 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 facility. It is the largest independent, fully integrated drug development and manufacturing supplier in the world. Catalytica, Inc. builds businesses in high growth industries where the Company's technologies optimize manufacturing and solve environmental problems. Catalytica Pharmaceuticals, Inc. provides drug development and manufacturing products and services to the pharmaceutical industry; Catalytica Combustion Systems, Inc. has developed and is producing XONON Cool Combustion for pollution prevention in gas turbines for power production and mechanical drive applications; and Catalytica Advanced 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 technologies for industrial applications. Catalytica employs over 1600 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 ability to market the Company's manufacturing, clinical trial packaging, and other services to current and prospective clients, the amount and timing of additional revenues, if any, from other customers and from additional services, the ability to transition new customers and business into the Greenville facility, the ability to complete the facility modifications for clinical trial packaging and labeling, Catalytica's competitive position in its markets. Actual results may differ from these statements and such differences may be material. These statements involve risks and uncertainties, including without limitation, the ability to operate the manufacturing and development facilities efficiently, the ability to 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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