Market Potential for Dyloject Expands in UK

Today Javelin Pharmaceuticals Inc. (AMEX: JAV - News) announced that Dyloject® (diclofenac sodium solution for injection) has been accepted by the Scottish Medicines Consortium (SMC) for use within the National Health Service (NHS) Scotland, for the treatment or prevention of postoperative pain by intravenous injection, in supervised healthcare settings at the NHS Tariff Price of £48 per pack (10 x 75mg/2ml vials).

“This is a significant decision” said Derek Gallacher, European Managing Director for Javelin. “Not only is Javelin now able to commercialize Dyloject in Scotland which represents approximately eight percent of the UK market, but the SMC assessment is viewed extremely favorably by other Health Technology assessment bodies throughout Europe. Achieving a positive SMC assessment speaks to the strong clinical profile and cost-saving benefits Dyloject brings to the treatment or prevention of postoperative pain.”

"The opioid sparing effect of Dyloject, coupled with the ease of simple IV bolus delivery represents a major contribution to the multimodal management of acute postoperative pain. It will be a very useful addition to our postoperative drug portfolio in Scotland" said Dr. Graeme McLeod, Consultant Anaesthetist at Ninewells Hospital, Dundee, Scotland.

Dyloject is being marketed by Javelin’s UK sales force in a convenient ready-to-use injectable formulation that can be administered quickly as an IV bolus at considerable cost savings (up to £50 per treated patient) compared to the current branded diclofenac formulation that requires buffering, dilution and slow infusion over at least 30 minutes.

About The Scottish Medicines Consortium and Its Advice for Dyloject

The SMC provides advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of newly licensed medicines, new formulations of existing medicines, and new indications for established products. Favorable SMC advice facilitates the introduction of beneficial treatments like Dyloject throughout Scotland.

The SMC advice is as follows:

“following a full submission diclofenac (Dyloject) is accepted for restricted use within NHS Scotland for the treatment or prevention of post-operative pain by intravenous injection, in supervised healthcare settings.

When given as an intravenous bolus, it showed non-inferiority to a comparator non-steroidal anti-inflammatory drug infusion at providing pain relief over an initial 4 hour period and caused less thrombophlebitis.

The manufacturer’s submission related only to intravenous use of diclofenac (Dyloject) in the post-operative setting. SMC cannot recommend its use by the intramuscular route.”

About Dyloject

Dyloject is an injectable NSAID with analgesic, anti-inflammatory and antipyretic activity. Diclofenac, the same active ingredient in Dyloject, Voltaren®, Cataflam® and Voltarol®, is a leading analgesic for the treatment of moderate-to-severe postsurgical pain and has a demonstrated history of efficacy and safety since its approval in 1981. Historically, diclofenac has been used to treat pain from inflammatory and degenerative forms of osteoarthritis, musculoskeletal conditions, acute attacks of gout, kidney stones, and after surgical operations or trauma.

In October of 2007, Dyloject received Marketing Authorization Application (MAA) approval and favorable pricing in the UK, where it is also being sold. In its pivotal UK registration trial, Dyloject's efficacy and safety were superior to those of the IV formulation of diclofenac currently marketed in the UK. 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 £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.

About Javelin Pharmaceuticals, Inc.

With corporate headquarters in Cambridge, MA, 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. The Company has three drug candidates in US Phase 3 clinical development. One of these US Phase 3 drug candidates, Dyloject(TM), has received Marketing Authorization Application (MAA) approval and favorable pricing in the UK, where it is now being sold. Previous clinical trials have demonstrated its safety and rapid onset of action. For additional information about Javelin, please visit the company's website at http://www.javelinpharmaceuticals.com.

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.