CNS/Pain Specialty Infrastructure - End-User Sales of $20 Million in 2009
DUBLIN, March 11 /CNW/ - Azur Pharma Limited ("Azur") today announced it has signed a definitive agreement with Elan Pharmaceuticals, Inc. (a subsidiary of Elan Corporation, plc) (NYSE: ELN) ("Elan") to acquire the analgesic therapy, PRIALT(R) (ziconotide intrathecal infusion).
PRIALT is indicated in the United States for the management of severe chronic pain in patients for whom intrathecal ("IT") therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine. PRIALT was approved by the U.S. Food and Drug Administration ("FDA") in December 2004 and launched in January 2005.
Azur has agreed to acquire worldwide rights (other than Europe) to PRIALT. Azur will offer employment to a 34 person specialty pharmaceutical infrastructure, which is currently supporting the product at Elan. End-user sales of PRIALT in the U.S. were approximately $20 million and $18 million in 2009 and 2008, respectively.
Mr. Seamus Mulligan, Chairman and Chief Executive of Azur Pharma, stated "We are pleased to add PRIALT, an important therapeutic for the management of severe chronic pain, to our portfolio. We look forward to welcoming the PRIALT team to our organisation and to their continued support for this product. We believe PRIALT will grow with continued investment in the brand. The patents covering PRIALT run through December 2016. Our business will have 170 employees at closing and had revenues of approximately $100 million for 2009. We expect to add other products and development projects to both our CNS and Women's Health businesses during the course of 2010 and look forward to the continued growth of our business."
The acquisition is expected to close in the second quarter of 2010. Financial terms are not disclosed. Azur will utilise its existing cash resources to finance the transaction. The acquisition will be EBITDA positive from Closing.
About Azur Pharma
Azur is a privately held pharmaceutical company dedicated to enhancing patients' lives by developing and marketing pharmaceutical products in specialist therapeutic areas. Azur's strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development and approved pharmaceutical products. (Website: http://www.azurpharma.com)
About PRIALT(R) (ziconotide intrathecal infusion)
On December 28, 2004, the FDA approved PRIALT for the management of severe chronic pain in patients for whom IT therapy is warranted, and who are intolerant of or refractory to other treatments, such as systemic analgesics, adjunctive therapies, or IT morphine. PRIALT is approved for use only in the Medtronic SynchroMed(R) EL, SynchroMed(R) II Infusion System and the CADD-Micro(R) ambulatory infusion pump.
Mechanism of Action
PRIALT is in a class of non-opioid analgesics known as N-type calcium channel blockers (NCCBs). PRIALT is the synthetic equivalent of a naturally-occurring conopeptide found in a marine snail known as Conus magus. Research in animals suggests that the mechanism of action of PRIALT works by targeting and blocking N-type calcium channels on nerves in the spinal cord that ordinarily transmit pain signals.
Dosing and Administration
PRIALT is administered through microinfusion devices (pumps) delivering the drug into the fluid surrounding the spinal cord. Typically, these pumps are implantable, programmable, variable rate microinfusion devices, but external pumps may be used for initial or shorter-term treatment. The current dosing and titration schedule for PRIALT was optimized based on the final phase III pivotal trial. In the slow titration study, the initial dosing was lowered and the rate of titration was reduced in both frequency and dosage increments compared with previous clinical trials. Treatment should be initiated at a delivery rate of 2.4 mcg/d (0.1 mcg/h) or less. Titration increments should be 2.4 mcg/d or less, and increases should be made 1, 2, or no more than 3 times per week. FDA approval of PRIALT was based on the treatment of more than 1,200 patients included in the 3 phase III trials, which evaluated the efficacy and safety of PRIALT in patients with severe chronic pain that was not adequately managed with a regimen of systemic and/or IT analgesic and other drugs. These trials involved a variety of patient populations, including patients with pain related to failed back surgery, cancer, AIDS, and non-malignant causes.
PRIALT has been evaluated as an IT infusion in more than 1,200 patients participating in chronic pain trials.
Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Patients with a pre-existing history of psychosis should not be treated with PRIALT. All patients should be monitored frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. PRIALT therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurological or psychiatric signs or symptoms.
Because PRIALT is a non-opioid, it does not react with opiate receptors and does not potentiate opiate-induced respiratory depression. Dosage titration can be tailored to patient needs without the risk of dependency or tolerance. The most frequently reported adverse events (greater-than-or-equal-to 25%) in clinical trials (N=1,254) were dizziness, nausea, confusional state and nystagmus.
Information about PRIALT, including prescribing information and comprehensive support services, is available through a toll-free number, 1-888-PRIALT-1, and at http://www.PRIALT.com.
Please see full prescribing information including boxed warning at http://www.PRIALT.com/Images/product_information_tcm7-25115.pdf.
PRIALT(R) is a registered trademark and is a trademark of Elan Pharmaceuticals Inc. SynchroMed(R) is a registered trademark of Medtronic, Inc. CADD-Micro(R) is a registered trademark of the Smiths Medical family of companies.
SOURCE AZUR PHARMA LIMITED
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