Debiotech and West Pharmaceutical Services have closed a license agreement regarding Debiotech's reconstitutions systems Debioclip^TM and Debioject^TM.

link : West Pharmaceutical Services website

License agreement injects West into a new market

West Pharmaceutical Services has acquired the global rights to market and manufacture the Debioclip^TM and Debioject^TM systems. These systems were developed by Debiotech, part of the Debio Groupe, Lausanne, Switzerland. The company performs research and development on medical devices, with expertise in microtechnology, micromechanics and microelectronics.

Theses novel systems allow easy, safe, and cost-effective reconstitution of lyophilized and dry powder injectable drug products. The system is based on a plastic transfer mechanism that links to a standard vial and allows a closed reconstitution of the drug using a prefilled syringe containing a diluent. This eliminates the many steps necessary during a traditional reconstitution using a vial or ampoule of diluent in conjunction with various needles and syringes.

With an increase in the number of lyophilized drugs in the market, primarily from the biotechnology industry, there is an increasing need for improved ways to reconstitute these products. The Debiotech systems have been shown to have significant benefits over other systems on the market.

" This product fits perfectly into West’s overall strategy, " said Bill O’Dell, vice president, global marketing. " We can offer a complete package to our costumers, including product development, manufacture, assembly and packaging, as well as support through the validation and regulatory process. It provides a tremendous opportunity to offer our costumers a novel product, while generating significant revenues for the company. "

The sales campaign to launch the Debiotech systems is planned for the third quarter of 2001.

" By the third quarter, we should have the necessary  samples, support documentation and market strategies in place, " said Mr. O’Dell. " In keeping with our sales campaign strategy, we will actively promote products only when we can approach the targeted market with all of our resources ready. This provides is with the maximum opportunity to drive sales for our products. "

West will mold and assemble the plastic components in Montgomery, Pa. The components will be combined with prefilled syringe that is already approved by the Food and Drug Administration for Water For Injection in 1 milliliter and 3 milliliter versions. A 5 milliliter version is also available.

The assembled unit will be packaged in a blister and outer carton and sent for ethylene oxide (ETO) sterilization. West will supply the complete packaged unit to the customer, with or without the drug vial in place. Production will be scaled up during 2001.

The products will be marketed for the delivery of lyophilized or dry powder drugs in the oncology and biotech areas and particularly for home healthcare administred products.