Javelin Pharmaceuticals Signs Commercial Supply Agreement With Precision Pharma Services
Javelin Pharmaceuticals, Inc. (AMEX: JAV), a leading developer of novel products for pain control, today announced it has signed a Commercial Supply Agreement with Precision Pharma Services, Inc. Under the Agreement, Precision will manufacture vials of Javelin's injectable Dyloject product (diclofenac sodium 75mg / 2mL) for use in Javelin's anticipated European markets pending regulatory approval. The Agreement has a two-year, renewable term and sets forth minimum purchase and production requirements.
"This agreement is an important step forward in growing Javelin's manufacturing infrastructure in anticipation of initial product sales later this year in Europe," said Michael Moshman, Javelin's Vice President for Clinical and Commercial Manufacturing. "Working with Precision Pharma will enable us to marshal the resources to meet future demand for Dyloject as we begin commercializing this promising analgesic with its launch in the UK in 2007."
About Javelin Pharmaceuticals, Inc.
With US corporate headquarters in Cambridge, MA, and a European office
in Cambridge, UK, Javelin applies innovative proprietary technologies to
develop new drugs and improved formulations of existing drugs to target
unmet and underserved medical needs in the pain management market. For
additional information, please visit the Web site at www.javelinpharmaceuticals.com.
About Precision Pharma Services, Inc.
Precision Pharma's manufacturing facility in Melville, New York, has
been licensed by the FDA for more than 20 years and offers development,
manufacturing, packaging and testing services spanning clinical,
small-scale and commercial-stage products. Operating 24 hours per day, 7
days per week, the facility meets all current standards for Good
Manufacturing Practice. For additional information, please visit the
Web site at www.precisionpharma.com. Precision is a subsidiary of
Talecris Biotherapeutics, a global biotechnology company that discovers,
develops and produces critical care treatments for people with
life-threatening disorders in a variety of therapeutic areas including
immunology, pulmonology, and hemostasis.
About Dyloject
Dyloject - injectable diclofenac sodium - is presently under review
for marketing approval in the UK for the treatment of acute
moderate-to-severe pain. Subsequent approval in other European countries
is anticipated through a regulatory strategy following the Mutual
Recognition Process. In the US, Dyloject is in Phase 3 clinical trials
for the same indication. Earlier studies demonstrated Dyloject to be
safe and well tolerated (including evidence for a lower incidence and
severity of vein irritation than Voltarol, the currently marketed
European formulation of injectable diclofenac). Prior studies have shown
Dyloject to have a more rapid onset of action than Voltarol when both
drugs were evaluated in patients with moderate-to-severe postoperative
pain, and a more rapid onset of action than ketorolac in the molar
extraction model of postsurgical pain. The latter study also indicated
that Dyloject had half the incidence of surgical site bleeding compared
with ketorolac.
Source: Talecris Biotherapeutics, Inc.