West Pharmaceutical Services Secures U.S. Marketing Rights for Novel Single Dose Drug Reconstitution System
LIONVILLE, Pa., July 17 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST) announced the first significant commercial milestone in its new initiative to manufacture and market an advanced single dose delivery drug reconstitution system.
Debiopharm, S.A., a Swiss-based pharmaceutical development company, last week obtained FDA approval to use the delivery system under the brand name DebioClip(TM) in the administration of Trelstar(TM), a treatment for advanced stage prostate cancer that is currently marketed in more than 80 countries.
West Pharmaceutical Services recently acquired worldwide exclusive rights to manufacture and market the delivery system from Debiotech, S.A., a medical device subsidiary of the Debio Group. The delivery system provides a faster and easier method to reconstitute dry powder or lyophilized drugs. West Pharmaceutical Services will market and manufacture the system for a broad range of therapeutic delivery applications under the name Clip'n'Ject(TM).
West Pharmaceutical Services will manufacture the Clip'n'Ject system at its FDA-registered facility in Montgomery, Pennsylvania.
Products requiring point-of-care reconstitution include, but are not limited to, interferons, oncology therapies, vaccines, growth hormones and plasma derivatives. The market is expected to grow as a result of new products developed from complex biotechnological processes and genetic engineering. The delivery system can be applied to standard vials with stoppers and overseals, allowing pharmaceutical manufacturers to incorporate it into existing product lines.
Debiopharm will market the system with a controlled release formulation of Trelstar (luteinizing hormone releasing hormone [LHRH] agonist, triptorelin pamoate). In this application, the Debioclip single dose delivery system will consist of a vial containing triptorelin pamoate and the diluent in a 2 mL prefilled syringe.
"We are pleased that the FDA recognizes the utility of this important new drug delivery initiative for which West Pharmaceutical Services owns long- term, exclusive worldwide rights," said William G. Little, chairman and CEO of West Pharmaceutical Services. "The therapeutic category opportunities for this product are vast, and patients and healthcare workers alike will benefit from delivery systems that are safe, effective and easy to use."
"Regulatory approval of this advanced delivery system for use with a major prostate cancer treatment is an important step in our development activity and commitment to our licensee West Pharmaceutical Services," said Dr. Frederic Neftel, CEO of Debiotech, S.A. "We believe Trelstar is only the first of a long series of pharmaceutical and biotechnology treatments that will be improved by this innovative, safe and easy-to-use reconstitution system. We value our relationship with West Pharmaceutical Services, which is obviously in the best position to manufacture and market this product worldwide."
About Debiotech, S.A.
Debiotech, S.A. (http://www.debiotech.com) specializes in the research and development of innovative medical devices in the field of drug reconstitution and syringes, flow control, electronic infusion systems, dialysis, diagnostics, implantable drug delivery systems and micro-systems for insulin and peptide drug delivery.
About West Pharmaceutical Services
West Pharmaceutical Services supports global pharmaceutical and healthcare markets with products and services that enhance the effectiveness of drug delivery and product dispensing. 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 results, financial or otherwise, which are contained in the above material, constitute "forward looking statements" that involve risks and uncertainties. The Company's actual results may differ materially from those expressed in any forward looking statement 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, successful continuance of cost-improvement programs and statutory tax rates.
West Pharmaceutical Services Morgen-Walke Associates William F. O'Dell Theresa Vogt Vice President, 212-850-5631 Global Marketing email@example.com
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SOURCE West Pharmaceutical Services, Incorporated
CONTACT: William F. O'Dell, Vice President West Pharmaceutical Services of Global Marketing, 610-594-3365, Bill_O'Dell@westpharma.com; or Theresa Vogt of Morgen-Walke Associates, 212-850-5631, firstname.lastname@example.org; Shoba Vaitheeswaran of Schwartz Communications, 781-684-0770, email@example.com/