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News Breaks
February 27, 2013
09:23 EDTAUXLAuxilium shares poised to advance, says RBC Capital
RBC Capital expects Auxilium's stock to rise closer to approval of the company's Peyronies treatment, which the firm believes is likely to occur in September. Increases in the volumes of the company's Testim treatment should also move the stock higher, added RBC ,which maintained an Outperform rating on the shares.
News For AUXL From The Last 14 Days
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December 22, 2014
16:06 EDTAUXLBioSpecifics announces positive CHMP opinion for XIAPEX
BioSpecifics Technologies (BSTC) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion for the use of XIAPEX for the treatment of adult men with Peyronie's disease with a palpable plaque and a curvature deformity of at least 30 degrees at the start of therapy. Swedish Orphan Biovitrum AB is the Marketing Authorization Holder for XIAPEX in 28 EU member countries, as well as Norway and Iceland, and holds the exclusive rights from BioSpecifics' strategic partner Auxilium Pharmaceuticals (AUXL) to commercialize XIAPEX for Dupuytren's contracture and Peyronie's disease indications subject to applicable regulatory approvals.
07:04 EDTAUXLXobi's Xiapex receives positive opinion by CHMP
Swedish Orphan Biovitrum AB and partner Auxilium announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the use of Xiapex for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. The use of Xiapex in men with Peyronie's disease is supported by positive safety and efficacy outcome data from two double-blind placebo-controlled studies IMPRESS I and II.
December 16, 2014
16:53 EDTAUXLAuxilium updates court findings in Actavis testosterone gel patent suit
Auxilium (AUXL) disclosed in a filing that as previously disclosed, on May 23 , Auxilium Pharmaceuticals, and FCB I LLC, as licensor of Testim, filed a lawsuit in the U.S. District Court for the District of New Jersey against Actavis (ACT) for infringement of FCBís 10 patents listed in the Orange Book as covering Testim testosterone gel. The lawsuit was filed in response to a notice letter, dated April 12, 2012, sent by Actavis Laboratories, regarding its filing with the U.S. Food and Drug Administration of an Abbreviated New Drug Application for a generic 1% testosterone gel product. This letter also stated that the ANDA contained Paragraph IV certifications with respect to the nine patents listed in the Orange Book on that date as covering Testim. The companyís lawsuit filed against Actavis initially involved those nine patents, as well as a 10th patent covering Testim that was issued on May 15, 2012 and is listed in the Orange Book. By the time that the trial commenced in September 2014, the parties had agreed to remove all but one of those patents from the litigation, with the trial focused solely on claim 3 of U.S. Patent # 7,608,607 . The trial commenced in September 2014 and closing arguments occurred in November 2014. On December 16 , the company learned that Judge Linares held that claim 3 of the Ď607 patent is invalid for obviousness. The Judge also found claim 3 invalid for derivation and improper inventorship, but he declined to rule on whether correction of inventorship would be appropriate because it would be futile in light of his ruling on obviousness. Auxilium believes that Actavis is now free to enter the market with its testosterone gel product once it obtains approval from the FDA. At this time, Auxilium is not aware of Actavis having received tentative approval or final approval from the FDA for its testosterone gel product. Auxilium is analyzing the District Courtís opinion and will explore its available options with regard to this matter.
08:58 EDTAUXLEndo a top pick for 2015, says Sterne Agee
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