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