West Pharmaceutical Services Initiates U.S. Clinical Trials of Novel Site-Specific Oral Therapy for Gastrointestinal Disorders
Proprietary Oral Delivery System, TARGIT-Budesonide, to Potentially Improve Effectiveness and Reduce Side-Effects for Treatment of Inflammatory Bowel Diseases, Ulcerative Colitis and Crohn's DiseaseWest Pharmaceutical Services, Inc. (NYSE: WST) announced today that it is launching Phase I U.S. clinical trials for TARGIT(R)-budesonide, a product with the potential to improve the treatment of inflammatory bowel disease (IBD), ulcerative colitis and Crohn's disease. TARGIT is West Pharmaceutical Services' proprietary technology for delivering drugs to the lower GIT (gastrointestinal tract).
West Pharmaceutical Services' TARGIT delivery system is based on a combination of proprietary polymer coatings and starch capsules. The polymer formulation and thickness allows the targeting of budesonide directly to the terminal ileum or colon in the GIT. If this initial trial shows that the drug is safe enough to advance to Phase II, West Pharmaceutical Services will then begin to evaluate targeting the drug directly to the site of the disease, using dual principles of pH and time to enhance product efficacy and reduce systemic side effects.
"The initiation of these clinical trials is consistent with our strategy to develop drug delivery technologies that ultimately enhance and improve the effectiveness of our customers' drug products," said Dr. Donald E. Morel, Jr., president and chief operating officer of West Pharmaceutical Services. "The potential to deliver accurate doses of drug compounds, proteins and peptides and possibly vaccines to the large intestine makes the TARGIT platform quite attractive for treating a range of diseases. Our initial trial with budesonide is aimed at evaluating the safety of the product and ultimately addressing the need for induction and possible maintenance of remission of Crohn's disease and ulcerative colitis. The study is also aimed at testing the technology so that it can be used to treat other site-specific diseases of the GIT."
The trial, which follows an Investigational New Drug (IND) Application that passed the FDA's 30-day comment period earlier in 2001, is expected to be completed by the end of 2001.
About West Pharmaceutical Services
West Pharmaceutical Services, Inc. (NYSE: WST) supports global pharmaceutical and healthcare markets with products and services that enhance the effective administration of pharmaceutical and healthcare products. West Pharmaceutical Services' technologies include drug formulation research and development, clinical research and laboratory services and the design, development and manufacture of components and systems for dispensing and delivering pharmaceutical, healthcare and consumer products. For more information, visit West Pharmaceutical Services at www.westdrugdelivery.com and www.westpharma.com.
Statements concerning forecasted financial results, which are contained in the above material, constitute forward looking statements as the term is used in the Private Securities Litigation Reform Act of 1995. The Company's actual results may differ materially from those expressed in any forward looking statements and are dependent on a number of factors including but not limited to, sales demand, timing of customers' projects, competitive pressures, the strength or weakness of the U.S. dollar, inflation, the cost of raw materials and successful continuance of cost-improvement programs.
Contact: West Pharmaceutical Services, Inc. Dr. Donald E. Morel, Jr. President and Chief Operating Officer 610-594-3075 Morgen-Walke Associates Theresa Vogt 212-850-5631 firstname.lastname@example.org Schwartz Communications Shoba Vaitheeswaran 781-684-0770 email@example.comSOURCE West Pharmaceutical Services, Inc.