West Pharmaceutical Services to Commence Phase I Clinical Trials for Nasal Morphine for Pain
LIONVILLE, Pa., Jan. 18 /PRNewswire/ -- West Pharmaceutical Services, Incorporated (NYSE: WST) announced today that its December 1999 IND (Investigational New Drug) application for a nasally administered formulation of morphine has now passed the FDA 30 day comment period, clearing the way for Phase I trials to begin in the U.S.
The nasal formulation, indicated for the treatment of pain, is based on West's proprietary technology. Nasal morphine achieves rapid pain relief and has a pharmacologic profile similar to that exhibited by intravenous morphine, but with enhanced ease of administration. Potential indications include breakthrough pain for cancer patients, post surgical analgesia, trauma pain, and post MI-analgesia.
Phase I U.S. trials are expected to begin in early February and will be conducted by West's Clinical Services Group.
Internationally, clinical testing is already underway in the United Kingdom, with trials scheduled for completion in early March. European studies being conducted in cancer patients demonstrate that West's proprietary morphine formulation can be delivered via the nasal route safely with onset of pain relief within five minutes.
Dr. Donald Morel, President of West's Drug Delivery Division, commented, "The successful filing of this IND is a milestone in the execution of our corporate strategy. The formulation research was completed in our Nottingham, U.K. research center with final product development performed in our corporate laboratories. The stability and clinical trial samples were manufactured by West's contract manufacturing group and Phase I clinical trials will be conducted through our Clinical Services Division.
"The results obtained in the U.K. clinical studies with nasal morphine provide encouraging data about the effectiveness of our nasal delivery technology. We anticipate completing U.S. Phase I trials early in the third quarter and moving to a pivotal Phase II/III trial in the fourth quarter. We continue to evaluate potential licensees' applications as we progress through early stage clinical trials."
West Pharmaceutical Services applies value-added technologies to the process of bringing new drug therapies and healthcare products to global markets. West's technologies include the design and manufacture of packaging components for pharmaceutical, healthcare and consumer products; research and development of drug delivery systems; contract laboratory services; clinical services; and other services that support the manufacturing, filling and packaging of pharmaceutical and healthcare products. For more information, visit the West Pharmaceutical Services website at http://www.westpharma.com.
Statements concerning forecasted financial results, which are contained in the above material constitutes 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.
SOURCE West Pharmaceutical Services, Incorporated
CONTACT: Steven A. Ellers, Senior Vice President and Chief Financial Officer of West Pharmaceutical Services, 610) 594-3375; Investor Relations: Jill Zames, Dory Lombardo, or Press: Stacey Nield, all of Morgen-Walke Associates, 212-850-5600, for West Pharmaceutical Services/