“In June results of a 36-month trial to evaluate the long-term safety of SOLESTA for the treatment of fecal incontinence were presented at the American Society of Colon and Rectal Surgeons. The statistically significant results of the study demonstrate SOLESTA provides safe and effective long-term, out to three years, treatment of fecal incontinence.
“In July we continued to strengthen our intellectual property relating to rifaximin and RELISTOR. We secured the issuance of U.S. Patent No. 8,227,482; which relates to several novel polymorphic forms of rifaximin. This patent should provide protection until February 2032. With respect to RELISTOR, we received an Issue Notification from the USPTO stating that U.S. Patent No. 8,247,425 will issue August 21, 2012. Salix intends to list this patent in the Orange Book for the RELISTOR prefilled syringe upon issuance. This patent will provide protection until December 2030.
“We recently received a paragraph IV notification from Lupin Limited stating that Lupin had filed an ANDA application to seek approval to market a generic version of APRISO. The notification letter asserted non-infringement and invalidity of the Company’s Orange Book-listed U.S. Patent No. 6,551,620. Salix is evaluating the notification letter, continues to have full confidence in its intellectual property protecting APRISO, and intends to vigorously enforce its intellectual property rights within the 45-day response period of the Hatch-Waxman Act. In addition, there are pending patent applications and other IP related to APRISO being pursued and, if issued, will be evaluated for use in our ANDA defense strategy. We are also evaluating our issued process patent covering APRISO as well as other mesalamine formulation patents for inclusion in our defense against this ANDA filing.
“Salix is built on a tremendous history of success – including the approval of eight New Drug Applications, the acquisition/licensing of 16 products and the establishment of a top-ranked specialty sales force since 2000. Our core business remains strong and growing. Our portfolio of marketed products is complemented by our impressive pipeline of product candidates in development that should drive additional revenue growth over the long term as they are commercialized. Additionally, the Company continues to actively pursue additional product opportunities to expand and broaden our product portfolio. We are extremely pleased with the success we have achieved to date and we believe the Company is well-positioned to continue to succeed in our mission of being the leading specialty pharmaceutical company licensing, developing and marketing innovative products to healthcare professionals to prevent or treat gastrointestinal disorders.”
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