Carolyn Logan, President and Chief Executive Officer, stated, “XIFAXAN continues to grow sequentially, with prescriptions, on a milligram basis, increasing 5.4% for the first quarter of 2012 compared to the fourth quarter of 2011. APRISO also continued to exceed the Company’s expectations during the quarter. APRISO prescriptions increased 6.3% during the first quarter of 2012 compared to the fourth quarter of 2011. RELISTOR prescriptions increased 22.3% during the first quarter of 2012 compared to the fourth quarter of 2011.
“Salix continued to execute its plan and to progress in the commercial and product development arenas during the first quarter of 2012. A commercial milestone for the period was the March launch of SOLESTA ® and DEFLUX ® by the Salix sales force. SOLESTA is a first-in-class, biocompatible tissue bulking agent for the treatment of fecal incontinence. Fecal incontinence is estimated to affect approximately 15% of people in the United States over the age of 50 and is the leading reason for admission to assisted living facilities in the United States. In December 2011 the Company submitted an application to the Centers for Medicare and Medicaid Services (CMS) to secure a Healthcare Common Procedure Coding, or HCPC code, for reimbursement purposes for SOLESTA. DEFLUX is the only FDA-approved alternative to major ureteral reimplantation surgery for the treatment of children with vesicoureteral reflux (VUR) grades II-IV. VUR is a malformation of the urinary bladder that can result in severe infections of the kidneys and irreversible kidney damage.
“On February 3, 2012 the FDA granted marketing approval for GIAZO (balsalazide disodium) tablets, 1.1 gm for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. The availability of GIAZO will provide an additional aminosalicylate-based option for treating ulcerative colitis.
“During the first quarter we continued to broaden, strengthen and expand our rifaximin intellectual property portfolio. Two additional patents relating to rifaximin - U.S. Patent No. 8,158,644 and U.S. Patent No. 8, 158,781 - issued by the U.S. Patent and Trademark Office in April provide further protection relating to a previously-issued patent that covers several physical states, or polymorphous forms, of rifaximin. These patents should provide protection until June 2024. Salix has an exclusive license to patents 8,158,644 and 8,158,781 from Alfa Wassermann S.p.A. to use, sell, have sold and import licensed rifaximin products, which the Company markets in the United States under the trade names XIFAXAN ® (200mg) and XIFAXAN550 ™ (550mg). These two patents provide protection for all indications currently marketed and being assessed.“On April 25, 2012 the FDA notified the Company that it requires additional time for review of the supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain and has extended the April 27, 2012 goal date by three months. The extended user fee goal date is July 27, 2012. We look forward to working with the FDA to complete the review of the NDA by the extended PDUFA goal date. RELISTOR is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. We believe RELISTOR, if approved, should be a welcomed option for physicians and their patients who experience the often debilitating gastrointestinal consequences of the use of opioid analgesics to manage chronic pain.
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