West World's article - fourth quarter 2000 issue.
License agreement injects
West into a new market
West Pharmaceutical Services has acquired the global
rights to market and manufacture the DebioclipTM and
DebiojectTM 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.
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
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.