Javelin Pharmaceuticals Signs Commercial Supply Agreement with Precision Pharma Services New York-Based Contract Manufacturer to Supply Dyloject(TM) for Launch in Europe
CAMBRIDGE, Mass., Feb 26, 2007 (BUSINESS WIRE) -- 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(TM) 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."
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 website at .
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 website at 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.
Dyloject(TM) - 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.
This press release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
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Javelin Pharmaceuticals Signs Commercial Supply Agreement with Precision Pharma