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  • There Is Still Too Much Uncertainty Surrounding Aegerion Pharmaceuticals [View article]
    The big elephant in the room is almost a 50% dropout rate. Sales growth was basically flat when the price increase of 30k is taken into account. Something unseemly about ratcheting up the already very expensive drug to counter the very high dropout rate. Results from a large ISIS/Genzyme (Sanofi) outcome trial is due out around mid year. Positive results will add another headwind for AEGR.
    May 7, 2015. 12:12 PM | 1 Like Like |Link to Comment
  • Aegerion Pharmaceuticals beats by $0.32, beats on revenue [View news story]
    Lost .55 per share,consensus was .28. Need to retract.
    May 4, 2015. 11:02 PM | Likes Like |Link to Comment
  • Alnylam Strengthens Its Clinical Case Once Again [View article]
    It s hard to explain why the analysts have glossed over something so important. Maybe it's a stone they prefer not to turn over as it would conflict with their long time bullish thesis. I believe most analysts that cover ALNY derive the bulk of ALNY"s valuation from Patisiran, so that's reflected in the stock price already just as the author alludes. Therefore if Patisiran is not that successful and it needs to be very successful, ALNY is overvalued and significantly, at least until much more value can be accorded to the rest of the pipeline, that will take a long time and is far from a sure thing.
    Apr 23, 2015. 11:48 PM | 2 Likes Like |Link to Comment
  • Alnylam Strengthens Its Clinical Case Once Again [View article]
    The difference is marginal and maybe meaningless and overkill. ISIS drug 78% median vs ALNY's 84% mean. Due to the long half life of ISIS drug the knockdown numbers should in fact go higher.
    There is no comparison regarding ease of use and total cost, ISIS TTRrx wins easily. SubQ at home, versus hours as an outpatient.
    But worst of all, the ALNY drug requires heavy doses of steroids for life. Basically substituting one chronic disease for others, like osteoporosis, weight gain, hip fractures and that's not all.

    The ALNY "Premedication Regimen" section below is from pages 37 and 38 of 72 of the TTR02 protocol section, which can be accessed via this open access link to the protocol (which was part of the "Safety and Efficacy of RNAi Therapy for Transthyretin Amyloidosis" publication from Aug 29, 2013 in NEJM)

    8.2 Dosage and Administration

    8.2.1 ALN-TTR02 or Placebo

    Following a standard breakfast (given at approximately 30 minutes prior to the start of infusion) subjects will receive a single dose of ALN-TTR02 or placebo by IV infusion over 60 minutes by a controlled infusion device. The infusion time may be extended up to 3 hours in the event of an acute infusion reaction. The subjects will be in a supine position during the IV infusion.

    Four subjects will be dosed per group (3 subjects on ALN-TTR02 and 1 subject on placebo) using a sentinel dosing strategy as described in Section 7.1.1. The planned dosing schedule is as follows:
     Group 1: 10 μg/kg ALN-TTR02 or placebo;
     Group 2: 50 μg/kg ALN-TTR02 or placebo;
     Group 3: 150 μg/kg ALN-TTR02 or placebo;
     Group 4: 300 μg/kg ALN-TTR02 or placebo;
     Group 5: 500 μg/kg ALN-TTR02 or placebo.
    Subjects ≥105 kg in body weight will receive ALN-TTR02 dosing based on an assumption of a body weight of 104 kg.

    8.2.2 Premedication Regimen

    All subjects will be premedicated prior to dosing with ALN-TTR02 or placebo to reduce the potential for an infusion reaction. Premedication will be administered as follows:
     Oral 8 mg dexamethasone administered the evening before dosing and 20 mg 30 to 60 minutes prior to start of infusion of ALN-TTR02 or placebo;
     Oral 500 mg paracetamol the evening before dosing and 30 to 60 minutes prior to the start of infusion of ALN-TTR02 or placebo;
     Oral H2 blocker (i.e., ranitidine 150 mg or famotidine 20 mg or equivalent other H2 blocker dose) the evening before dosing and 30 to 60 minutes prior to start of infusion of ALN-TTR02 or placebo;
     Oral H1 blocker, 10 mg cetirizine (hydroxyzine 25 mg or fexofenadine may be substituted if subject does not tolerate cetirizine) the evening before dosing and 30 to 60 minutes prior to start of infusion of ALN-TTR02 or placebo;
    Apr 23, 2015. 11:44 AM | 8 Likes Like |Link to Comment
  • Celladon: CUPID-2 Is Likely To Fail [View article]
    Past performance in analyzing risky biotechs is an important consideration in rating an author's expertise. After all money follows success. From what you say your track record isn't too shabby. Even at 30% success probably makes this a good entry point or good price to add. One can take some profits before a binary event.
    Apr 23, 2015. 10:38 AM | Likes Like |Link to Comment
  • Celladon: CUPID-2 Is Likely To Fail [View article]
    Patrick had been negative on ISIS for longer than I can remember. He blocked me on Twitter after too many smackdowns. Very chummy with another ISIS bear Adam F. Approx triple since last May low. Stellar trial results out after close yesterday.
    Apr 23, 2015. 09:46 AM | Likes Like |Link to Comment
  • Aegerion Pharmaceuticals Expects Little Growth In 2015 [View article]
    Stick a fork in it.
    Mar 15, 2015. 09:46 PM | Likes Like |Link to Comment
  • What To Make Of The Chaos At Acadia [View article]
    Worst management ever? Lots of bad management in biotech history, but should be nominated. No excuse for what happened including the delay in reporting after saying everything was hunky dory a month ago. Will trade at a lack of credibility discount for a long time.
    StockNews @StockNews_ · 12h 12 hours ago
    $ACAD - Harwood Feffer LLP Announces Investigation of Acadia Pharmaceuticals Inc.
    Mar 13, 2015. 08:18 AM | Likes Like |Link to Comment
  • Sarepta Is Suffering From Overreaction [View article]
    I think Golabki hit the nail on the head. Extended and larger trials are most likely.
    Jan 15, 2015. 12:04 PM | Likes Like |Link to Comment
  • Update: Richmont Is Betting On Its Island Gold Mine - And It Will Very Likely Pay Off [View article]
    Thanks for the update. This one looked like it going sub zero last year when it crashed.
    New found money!
    Jan 9, 2015. 01:51 PM | Likes Like |Link to Comment
  • The 2015 Calendar Of NASH Trial Catalysts: Gilead Adds To Its NASH Arsenal [View article]
    ISIS also has an early stage drug for NASH. Never count them out. And a NASH partnership.

    Isis Pharmaceuticals shares rise 2.8% after company raises outlook

    (7:18 AM ET) NEW YORK (MarketWatch) -- Isis Pharmacueticals Inc. ISIS, +2.27% said Thursday it expects to "significantly" improve on its 2014 guidance, ending the year with a pro forma net operating loss in the mid to high teens and more than $725 million cash. That is a nearly 70% improvement over its original guidance of a pro forma loss in the low $50 million range. The improvement is due to the maturation of its drug pipeline "and the growing validation of antisense as a viable, efficient and effective drug discovery technology," the company said in a statement. Isis' pipeline comprises 33 drugs to treat a range of diseases with a focus on cardiovascular, metabolic, severe and rare diseases, including neurological disorders, and cancer. Shares rose 2.8% in premarket trade, and have gained 75.3% in the last three months, while the S&P 500 has gained 2.9%.
    Jan 8, 2015. 10:03 AM | 1 Like Like |Link to Comment
  • Isis - Addressing Some Of The Bull Arguments To My Short Thesis [View article]
    Market doc has never been heard from since. His career as a financial writer ended appropriately with this specious article. He deserves all the blame and ignominy that befalls him.

    ISIS hit an all time high today.
    Dec 11, 2014. 10:05 PM | 1 Like Like |Link to Comment
  • Isis - Addressing Some Of The Bull Arguments To My Short Thesis [View article]
    Hope no one listened to this pretend doctor. ISIS up almost 100% since this non scientifically based short hack job.
    Dec 11, 2014. 09:58 AM | 3 Likes Like |Link to Comment
  • Regulus To See Further Declines [View article]
    This is not the only drug in development as you stated. I would not want to be short when the next data point comes out (multi dosing at higher dose). One dose of the Regulus drug versus how many for Harvoni? 84! Double that with cirrhosis. Not a very fair comparison. Insurance companies would love the cheaper drug.
    Nov 19, 2014. 08:27 PM | 1 Like Like |Link to Comment
  • Regulus To See Further Declines [View article]
    Characterization of the in vitro antiviral activity and the preclinical and clinical resistance profile of miravirsen, a novel anti-HCV therapeutic targeting the human factor miR-122.
    Ottosen S1, Parsley TB2, Yang L2, Zeh K3, van Doorn LJ4, van der Veer E4, Raney AK3, Hodges MR3, Patick AK5.
    Author information
    Miravirsen is a β-D-oxy-Locked Nucleic Acid modified phosphorothioate antisense oligonucleotide targeting the liver-specific microRNA-122 (miR-122). Miravirsen demonstrated antiviral activity against HCV genotype 1b replicons with a mean 50% effective concentration (EC50) of 0.67 μM. No cytotoxicity was observed up to the highest concentration tested (>320 μM) in different cell culture models yielding a therapeutic index of ≥297. Combination studies of miravirsen with interferon-α2b, ribavirin, non-nucleoside (VX-222) and nucleoside (2' -methylcytidine) inhibitors of NS5B, NS5A (BMS-790052), or NS3 (telaprevir) indicated additive interactions. Miravirsen demonstrated broad antiviral activity when tested against HCV replicons resistant to NS3, NS5A and NS5B inhibitors with less than 2-fold reductions in susceptibility. In serial passage studies, an A4C nucleotide change was observed in the 5' HCV UTR from cells passaged in the presence of up to 20 μM (40-fold the miravirsen EC50 concentration) at day 72 of passage but not at earlier time points (up to 39 days of passage). Likewise, a C3U nucleotide change was observed in the HCV 5' UTR from subjects with viral rebound after the completion of therapy in a miravirsen Phase 2 clinical trial. An HCV variant constructed to contain the A4C change was fully susceptible to miravirsen. A C3U HCV variant demonstrated overall reductions in susceptibility to miravirsen but was fully susceptible to all other anti-HCV agents tested. In summary, miravirsen has demonstrated broad antiviral activity and a relatively high genetic barrier to resistance. Identification of nucleotides changes associated with miravirsen resistance should help further elucidate the biology of miR-122 interactions with HCV. (The clinical trial study has been registered at under registration no. NCT01200420).

    Copyright © 2014, American Society for Microbiology. All Rights Reserved.
    Nov 19, 2014. 07:57 PM | Likes Like |Link to Comment