West Pharmaceutical Services Files IND Application For Nasal Leuprolide For The Treatment Of Endometriosis
LIONVILLE, Pa., Jan. 31 /PRNewswire/ -- West Pharmaceutical Services, Incorporated (NYSE: WST) announced today that it completed filling of an Investigational New Drug (IND) application covering a nasally administered formulation of leuprolide for the treatment of endometriosis and other selected indications. The product is based on West's patented delivery technology and will be the second product entering clinical trials this year.
Patient recruitment for Phase I trials in the US will begin in February. As with the Phase I trial planned for its nasal morphine product, West plans to conduct the trials through its Clinical Service Group in Evansville, Indiana. Very encouraging results have been obtained in a proof-of-concept study in healthy human volunteers conducted in the UK utilizing the system.
Dr. Donald Morel, President, West's Drug Delivery Division stated, "There are a number of exciting market opportunities for nasally administered leuprolide and West plans to vigorously pursue a dual registration strategy for this product. In the United States the primary indication will be for the treatment of endometriosis. In Europe we intend to pursue license partner for endometriosis and other applications. We are currently in the process of preparing our European regulatory filings which are scheduled for submission in the second quarter."
"The patient-friendly nasal route of administration was well tolerated during the UK trial" commented Dr. Morel. "As a result there is a significant level of interest expressed by a number of our customers in securing a license agreement."
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 results, financial or otherwise, which are contained in the above material constitute "forward-looking statements" as the term is used under 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, Inc.
CONTACT: Stephen M. Heumann, Vice President and Treasurer of West Pharmaceutical Services, Inc., 610-594-3346; or Investor Relations - Jill Zames, or Dory Lombardo, or Press - Stacey Nield of Morgen-Walke Associates, 212-850-5600/