Healthcare Industry News:  analgesia 


 News Release - December 11, 2007

Javelin Pharmaceuticals Launches Dyloject(R) in UK

Announces NHS Pricing for Dyloject

CAMBRIDGE, Mass.--(HSMN NewsFeed)--Javelin Pharmaceuticals, Inc. (AMEX:JAV ) today announced that it has received and published its UK pricing for Dyloject® (diclofenac sodium solution for injection). Pricing was received from the Department of Health Pharmaceutical Price Regulation Scheme (“PPRS”). PPRS accepted Javelin’s proposal that the National Health Service (NHS) Tariff Price for Dyloject be GBP 48.00 per pack (10 x 75mg/2ml vials).

“Today is a watershed in Javelin’s evolution from a development company to a revenue-generating organization,” said Dr. Daniel Carr, CEO/CMO. “Pricing publication marks the UK launch of Dyloject, our proprietary injectable NSAID for the treatment of acute moderate-to-severe pain. The Javelin sales force is now fully engaging hospital formulary decision makers in making the product available to prescribers within the hospital setting.”

“This decision is a very positive outcome for Javelin in the UK, coming as it does at a time of increasing price pressures. Based upon such pricing, we believe that Dyloject provides significant clinical and cost savings benefits to patients, healthcare providers and the National Health Service,” said Derek Gallacher, Javelin’s European Managing Director.

Javelin intends to file additional marketing applications through the mutual recognition process in a number of European Union ("EU") member countries, including Germany, Europe's largest market for prescription injectable pain medications.

About Dyloject:

In its pivotal UK registration trial, Dyloject's efficacy and safety were superior to those of the currently marketed IV formulation of diclofenac. Each dose of the latter product requires buffering, dilution and slow infusion. Dyloject comes ready to use for immediate IV bolus administration, works faster, and according to a recent study, has potential to save the UK NHS up to GBP 50 per postoperative patient compared to the currently marketed formulation. This pharmacoeconomic benefit coupled with Dyloject's superior clinical attributes differentiates Dyloject from the currently marketed IV formulation of diclofenac sodium, which holds approximately 60 (sixty) percent of the market for UK injectable nonsteroidal anti-inflammatory drugs (NSAIDs). Dyloject employs a proprietary solubilizing agent that is significantly less irritating to veins than the organic solvents used in the currently marketed IV diclofenac formulation.

According to IMS Health, a well-known pharmaceutical market intelligence provider, the original formulation of diclofenac sodium is the most widely prescribed injectable NSAID in the UK and is sold in numerous countries throughout the world. IMS estimates over seventy million injectable NSAID units are prescribed annually in the G5 countries alone.

Dyloject's UK label includes two routes of administration, intramuscular (IM) injection and rapid (IV bolus) injection. IM is effective for acute forms of pain, including renal colic, exacerbations of osteo- and rheumatoid arthritis, and acute flare-ups of back pain or gout. Dyloject's IV bolus application is for the treatment or prevention of post-operative pain in supervised healthcare settings. With Dyloject, Javelin Pharmaceuticals is the first company to create a formulation for rapid IV bolus or low volume IM diclofenac injections. Javelin was recently awarded European Patent 1,574,221, extending patent protection on Dyloject through 2024. A corresponding patent application is pending in the United States.

In the United States, Javelin has completed patient accrual in the first of its two Phase 3 pivotal trials, and is now enrolling patients in the second of two Phase 3 pivotal trials for Dyloject. Javelin plans to file a New Drug Application (NDA) for FDA approval in the first half of 2009.

NSAIDs such as Dyloject can be used postoperatively with opioids, e.g., morphine, to reduce opioid doses by as much as thirty to fifty percent, and thereby decrease morphine-related side effects. Combining different types of pain medicines (called "multimodal analgesia") is the most commonly advocated approach to acute postoperative pain management worldwide. A number of studies of multimodal analgesia have shown that when patients are given an NSAID along with an opioid, dose requirements and adverse effects of the latter are reduced. Opioid side effects that are reduced by this dose-sparing approach include nausea, vomiting, and inadequate breathing.

About Javelin Pharmaceuticals, Inc.:

Javelin is a specialty pharmaceutical company that applies proprietary technologies to develop new drugs and improved formulations of existing drugs for pain management. Specialty pharmaceutical analysts from six investment firms cover Javelin Pharmaceuticals, Inc. Javelin's headquarters are located in Cambridge, Massachusetts with European offices in Cambridge, England and Cologne, Germany. For additional information, visit

Forward Looking Statement

This news 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.

Source: Javelin Pharmaceuticals

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