MONTREAL, CANADA (January 14, 2009) – Paladin Labs Inc. (TSX: PLB), a leading Canadian specialty pharmaceutical company, today announced that it has entered into a distribution agreement under which Mission Pharmacal Company has granted Paladin the exclusive Canadian rights to market and sell Urocit®-K. Urocit®-K 540 mg strength is approved for sale in Canada and is indicated for the treatment of calcium and uric acid kidney stones. Financial terms of the deal were not disclosed.
According to the Canadian Urological Association, approximately one in ten Canadians develop kidney stones. Data suggests that 50% of stone formers will develop a second stone within 10 years and 75% of stone formers will develop a second stone within 20 years. Urocit®-K is a slow-release formulation of potassium citrate clinically proven to inhibit the formation of most kidney stones in over 90% of patients. In the United States, Urocit®-K is available in 540 mg and 1080 mg strengths. The U.S. potassium citrate market for 2008 is estimated to be USD$30 million.
"We intend to launch Urocit®-K 540 mg and submit the 1080 mg formulation for approval in 2009. Urocit®-K complements our broad urology franchise which includes Testim® for the treatment of male hypogonadism and Trelstar® for the treatment of prostate cancer," said Jonathan Ross Goodman, President and Chief Executive Officer of Paladin Labs Inc. "We expect Urocit®-K to fulfill an unmet need for kidney stone patients in Canada."
"Paladin's dynamic portfolio in the urology space and their demonstrated success introducing specialty pharmaceutical products in Canada makes them the ideal partner for Urocit®-K and Mission" said Neill B. Walsdorf Jr. President, Mission Pharmacal. "We look forward to building a long and successful relationship with Paladin that will benefit Canadian patients and their healthcare providers."
About Urocit®-K and Nephrolithiasis
Urocit®-K is a slow release formulation of potassium citrate for treatment of nephrolithiasis in patients with renal tubular acidosis (RTA) with calcium stones, hypocitraturic calcium oxalate of any etiology, and uric acid lithiasis, with and without uric acid stones. Urocit®-K corrects the pH of the urine and elevates a naturally occurring urinary inhibitor. In addition, Urocit®-K lowers saturation of calcium oxalate. This helps control the formation of new stones.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. For more information, please visit the Company's website at www.paladinlabs.com.
Forward-Looking Statements
This news release may contain forward-looking statements and predictions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Paladin Labs Inc. (the "Company") considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the Company and its subsidiaries may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report as well as in the Company's Annual Information Form for the year ended December 31, 2007. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether a result of new information, future events, or except as required by law. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other fillings found on SEDAR at www.sedar.com
For further information:
Paladin Labs
Samira Sakhia
Chief Financial Officer
(514) 340-5067, (514) 344-4675 (FAX)
info@paladin-labs.com
Urocit®-K is a prescription form of potassium citrate. It helps restore the chemicals in urine that stop crystals from forming, and reduces the formation of the two most common types of kidney stones: calcium oxalate and uric acid stones.
Important Safety Information
Urocit®-K is not for everyone. It has not been tested on children, pregnant women, or women who are breastfeeding, and it is unknown whether Urocit®-K can affect reproductive capacity, unborn children, or breast milk content. You should not take Urocit®-K if you are pregnant, may become pregnant, or are currently breastfeeding, unless your doctor has discussed the risks with you and determined that it is necessary.
Certain drugs can interact with Urocit®-K and lead to increased gastrointestinal (GI) irritation. Drug interactions can also lead to hyperkalemia, an excess of potassium in your blood that could lead to cardiac arrest or death. These serious and possibly fatal conditions can develop rapidly with no noticeable symptoms. Always talk to your doctor about any medications you are taking before starting a prescription of Urocit®-K.
If you have hyperkalemia, or any condition that puts you at risk for the condition or prevents your body from processing potassium normally, do not take Urocit®-K because it could lead to cardiac arrest. Conditions that may put you at risk include kidney failure, uncontrolled diabetes, severe dehydration, strenuous physical exercise if you're unconditioned, extensive tissue breakdown, or adrenal insufficiency (when your adrenal glands do not produce the correct amount of chemicals needed to regulate the function of your organs).
Do not take Urocit®-K if you have an active urinary tract infection, peptic ulcer disease, or conditions that slow or prevent the tablet from passing through your GI tract, such as compression of the esophagus, delayed gastric emptying, or narrowing or blockage of your intestines.
Take Urocit®-K only as directed. Do not crush, chew, or suck on the tablets, and check with your doctor if you experience any trouble swallowing tablets or if they seem to get stuck in your throat.
To ensure your safety during your prescription, your doctor may perform regular blood tests and EKGs (which analyze the electrical activity in your heart).
Some patients taking Urocit®-K may develop minor GI side effects such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. To reduce these effects, take each dose of Urocit®-K with meals or snacks, or talk to your doctor about reducing the amount of your dosage.
If you experience severe vomiting, abdominal pain, tarry stools, or other signs of intestinal bleeding, stop taking Urocit®-K and see your doctor right away. These could be signs of a serious condition such as a perforated or blocked bowel.
To report negative side effects, contact Mission Pharmacal Company at 1-800-298-1087 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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