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Javelin Pharmaceuticals Expands Patent Protection for PMI-150 in Canada
Tuesday, January 22, 2008
Cambridge, MA -- Javelin Pharmaceuticals Inc. (AMEX: JAV) today announced that it recently received notification that it had been granted a commercially important Canadian patent with broad claims, enabling greater protection of Javelin's PMI-150 (intranasal ketamine). Canadian Patent Number 2,184,007 entitled: "Nasal and Ocular Administration of ketamine to manage Pain and for Detoxification" provides protection covering Javelin's intranasal ketamine drug into 2015.
Generally, Javelin’s Canadian ketamine patent covers the use of nasally administered ketamine to treat chronic pain, as well as devices used to treat pain by nasal administration of ketamine. "The device claims are significant," said David Bernstein, Javelin’s General Counsel and Chief Intellectual Property Counsel, "because they offer broad protection for the idea of using ketamine intranasally to treat pain, while also providing a readily enforceable focus on a device for controlling pain rather than a method."
"This new patent, directed to Javelin's anticipated commercial formulations of PMI-150, encompasses a broad range of claims that enhance our intellectual property portfolio and commercial protections for PMI-150 in Canada," said Dr. Daniel Carr Javelin’s CEO/CMO. "We believe that upon approval, PMI-150 will be the only intranasal ketamine product offering physicians and patients a non-opioid alternative for treatment of moderate to severe pain," Dr. Carr added.
Ketamine, a non-opioid, is an N-methyl-D-aspartate (NMDA) receptor antagonist that has been in clinical use for over 30 years. Since its approval by the FDA, ketamine has been safely used as an anesthetic in tens of thousands of patients. NMDA receptors are located in the central nervous system and play a role in the perception of acute and chronic pain. Ketamine, at lower doses than those approved for anesthetic use, has been reported in the medical literature to be an effective analgesic for post operative settings, nerve injury pain, and pain during medical procedures, such as burn dressing changes.
About PMI-150 (Intranasal Ketamine)
The Company is developing PMI-150, a proprietary nasal formulation of ketamine, for several intended indications. Javelin believes that PMI-150 is optimized for use as a pain medication and may offer a safe, non-opioid alternative for the treatment of acute moderate-to-severe pain. Prior randomized, double-blinded, placebo-controlled phase II clinical studies of PMI-150 have demonstrated rapid, statistically significant relief of moderate to severe postoperative and breakthrough pain. The Company is now planning a Pivotal Phase 3 postoperative acute pain study for this product candidate.
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, 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.
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