FDA Panel recommends approval of Probuphine. ENTA IPO. ALIM NDA refiling due this month + updates for ANAC AEZS KYTH

Mar 22, 2013 No Comments by
 Titan Pharmaceuticals, Inc. (OTCBB:TTNP) announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) members voted for approval (10 positive votes, 4 negative votes and 1 abstention) of Probuphine for the maintenance treatment of adult patients with opioid dependence. The PDUFA date is April 30, 2013.
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Alimera Sciences, Inc. (NASDAQ: ALIM) maintained previous guidance that it intends to resubmit its New Drug Application for ILUVIEN to the U.S. Food and Drug Administration (FDA) by the end of March 2013.
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KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) provided an update noting that it expects to report topline results in mid-2013 from its Phase 3 trial of ATX-101 for the reduction of submental fat.
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Aeterna Zentaris Inc. (NASDAQ: AEZS) provided an update noting that in 2013 it intends to submit a NDA filing of AEZS-130 as an oral diagnostic test for adult growth hormone deficiency (AGHD).
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Anacor Pharmaceuticals (NASDAQ:ANAC) announced positive results from a Phase 2 dose-ranging trial (AN2728-AD-204) of its topical boron-based phosphodiesterase-4 (PDE-4) inhibitor, AN2728 in adolescents with mild-to-moderate atopic dermatitis. Lesions treated with AN2728 ointment, twice daily for 28 days achieved a 71% improvement from baseline in their Atopic Dermatitis Severity Index (ADSI) score, with 66% of lesions in this treatment group achieving total or partial clearance. AN2728 was generally safe and well-tolerated. Most adverse events were mild and largely unrelated to study drug. According to previous guidance, a Phase 3 trial is expected to be initiated in mid-2013.
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Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) Phase 2 CVac CAN-003 final progression-free survival data is due 4Q 2013.
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Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA) announced the pricing of its initial public offering of 4,000,000 shares of its common stock at a price to the public of $14.00 per share and subsequently commenced its IPO. Its main product candidate is ABT-450 for HCV and is currently involved in three Phase 2 and three Phase 3 trials.
Abbott reported the start of three Phase 3 clinical trials in October 2012 in genotype 1-infected adults that will use a combination of ABT-450/r (protease inhibitor), ABT-267 (NS5A inhibitor), ABT-333 (non-nucleoside polymerase inhibitor) and ribavirin, and announced that it expected regulatory filings in 2014. The first of these reported trials, Turquoise II, which is in patients with compensated cirrhosis, will include two co-formulated tablets of ABT-450/r and ABT-267, or ABT-450/r/ABT-267, once daily, plus ABT-333 in one tablet twice daily, plus ribavirin. The other two trials, Sapphire I and Sapphire II, will be double-blind, placebo-controlled trials of the same co-formulation of ABT-450/r/ABT-267, plus ABT-333, co-administered with ribavirin. Sapphire I is in treatment-naïve patients and Sapphire II is in patients who have had prior treatment with interferon plus ribavirin.
The Phase 2 “Co-Pilot” study, which began in May 2011, consisted of HCV genotype 1, non-cirrhotic patients enrolled in an open-label trial of a 12-week interferon-free regimen consisting of ABT-450/r once daily plus ABT-333 (Abbott’s non-nucleoside polymerase inhibitor) 400 mg twice daily plus weight-based ribavirin twice daily (1000-1200 mg total daily dose).
The Phase 2b “Aviator” study, which began in October 2011, consisted of HCV genotype 1 non-cirrhotic patients enrolled in an open-label trial of a 12-week interferon-free regimen consisting of three direct acting antivirals, or DAAs, with and without ribavirin.
The Phase 2 “Navigator” study, which began in September 2011, is evaluating ABT-450/r with Abbott’s NS5A inhibitor ABT-267 with and without ribavirin
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Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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