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Nautilus Neurosciences, Inc. and Tribute Pharmaceuticals Announce Exclusive Canadian License for CAMBIA(TM) (diclofenac potassium for oral solution) for the Acute Treatment of Migraine


11/16/2010 6:43:12 AM

BEDMINSTER, N.J., and MILTON, Canada, Nov. 16, 2010 /PRNewswire/ -- Nautilus Neurosciences, Inc., a neurology-focused specialty pharmaceutical company, and Tribute Pharmaceuticals, a privately-held Canadian specialty pharmaceutical company, announced today their exclusive license agreement for the commercialization of CAMBIA (diclofenac potassium for oral solution) in Canada. CAMBIA is approved in the United States for the acute treatment of migraine with or without aura and was launched in the United States in June 2010.

"Canada is an important pharmaceutical market and opportunity for CAMBIA," said James Fares, Chairman and CEO, of Nautilus Neurosciences. "The management team at Tribute Pharmaceuticals has a wealth of experience in developing, launching and successfully commercializing new products in Canada. This partnership along with recent developments in the US has significantly enhanced our ability to market CAMBIA to the broader North American market and reach more people suffering from acute migraine headaches. We look forward to completing the expansion of our efforts through the addition of a partner for the family practice market in the United States in 2011."

Rob Harris, President & CEO of Tribute Pharmaceuticals points out that, "According to IMS, the prescription drug market in Canada for treating migraine headaches is valued at approximately one hundred and fifty million dollars." Many Canadians who suffer from migraines are dissatisfied with their current medication and hope for a better treatment. "Tribute Pharmaceuticals is very excited about the potential for CAMBIA in Canada and we look forward to building a strong partnership with Nautilus Neurosciences."

According to a survey published in the Journal of the American Board of Family Medicine, many people still hope to find a better treatment for their migraines, with more than a quarter dissatisfied with their treatment and fewer than a fifth of people who suffer migraines describing themselves as "very satisfied" with their treatment.

A novel, water-soluble, buffered diclofenac potassium powder, CAMBIA is the only prescription non - steroidal anti-inflammatory drug (NSAID) available for the acute treatment of migraine. Engineered using Dynamic Buffering Technology (DBT), a patented absorption-enhancing technology developed by APR Applied Pharma Research S.A., CAMBIA is specifically designed for fast, effective relief from the symptoms of migraine. CAMBIA enters the bloodstream quickly and readily achieves peak plasma concentrations, providing pain relief in fifteen minutes for some patients.

About Nautilus Neurosciences, Inc.

Nautilus Neurosciences is a neurology-focused specialty pharmaceutical company committed to providing the health care community with medically relevant products and services that directly benefit those affected by neurologic disorders. Nautilus is backed by Tailwind Capital and Galen Partners.

For more information, please visit www.nautilusneurosciences.com.

About Tribute Pharmaceuticals, Inc.

Tribute Pharmaceuticals is a specialty pharmaceutical company engaged in the acquisition, licensing and management of pharmaceuticals products in Canada. Tribute is committed to providing patients and physicians with clinically proven pharmaceuticals products that treat recognized medical conditions and diseases. Tribute Pharma is a privately held Canadian company. For more information please visit http://www.tributepharma.ca.

Unites States Indication

CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older.

CAMBIA is not indicated for prophylactic therapy or for cluster headache.

Important Safety Information (United States)

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS NSAIDs, including CAMBIA, may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use or in patients with CV disease or risk factors for CV disease. CAMBIA is contraindicated for peri-operative pain in coronary artery bypass graft surgery. NSAIDs increase the risk of gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk.

Use the lowest effective dose for the shortest possible duration. Long-term administration of NSAIDs can result in serious and potentially fatal events, including CV thrombotic events or GI reactions.

CAMBIA is contraindicated in patients with hypersensitivity to diclofenac or other NSAIDs, and in patients with preexisting asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic-like reactions have been reported in such patients. Anaphylactic reactions may also occur in patients with the aspirin triad or in patients without prior exposure to CAMBIA. CAMBIA is contraindicated in patients with the aspirin triad. Discontinue immediately if an anaphylactic reaction occurs.

Renal papillary necrosis and other renal injury may occur with long-term use of NSAIDs. Use CAMBIA with caution in patients at risk, including the elderly, those taking diuretics or ACE inhibitors, those with renal impairment, heart failure, or liver impairment. CAMBIA is not recommended in patients with advanced renal disease.

Use caution when prescribing CAMBIA with drugs known to be hepatotoxic (eg, acetaminophen, certain antibiotics, antiepileptics). Warn patients to avoid acetaminophen containing products while taking CAMBIA. The liver metabolizes almost 100% of diclofenac, and there is insufficient information to support dosing recommendations in patients with hepatic insufficiency. Hepatic effects range from transaminase elevations to liver failure. Discontinue CAMBIA immediately if abnormal liver tests persist or worsen.

NSAIDs can lead to new onset or worsening of preexisting hypertension. Monitor blood pressure closely during therapy. Patients taking ACE inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs. Note that fluid retention and edema have been observed in some patients taking NSAIDs. Use CAMBIA with caution in patients with fluid retention or heart failure.

Using CAMBIA with other NSAIDs (eg, aspirin) or with anticoagulants (eg, warfarin) is not advised due to increased risk of serious adverse events, such as GI bleeding. Use with caution in patients with a history of ulcers or GI bleeding. Anemia may occur in patients on NSAIDs. In patients on long-term therapy, check hemoglobin or hematocrit upon any sign or symptom of anemia or blood loss.

NSAIDs, including CAMBIA, can cause serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. Discontinue use immediately if rash or other signs of local skin reaction occur.

CAMBIA can harm fetuses. Starting at 30 weeks' gestation, pregnant women should avoid CAMBIA and other NSAIDs as premature closure of the ductus arteriosus in the fetus may occur. Use with caution in nursing mothers as it is not known if diclofenac is excreted in human milk.

The most common adverse events in clinical trials with CAMBIA were nausea and dizziness.

SOURCE Nautilus Neurosciences, Inc.


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