Empresas y finanzas

Javelin Pharmaceuticals Launches Dyloject(R) in UK



    Javelin Pharmaceuticals, Inc. (AMEX:JAV) today announced that it
    has received and published its UK pricing for Dyloject(R) (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
    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.

    JAV-G