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  • Buy Human Genome Sciences, The Benefit May Outweigh The Risk [View article]
    Breaking news after the close Friday, 7-6-2012, HGSI up in after hours trading

    http://reut.rs/PthOBa
    Jul 6 11:47 PM | Likes Like |Link to Comment
  • Today's Pharma Buzz: Avon Files Interesting 8k, Amarin And Vivus Approach FDA Approvals [View article]
    There was an extension on the Viagra patent.

    http://bit.ly/M9laT2
    Jul 6 04:29 PM | Likes Like |Link to Comment
  • Amarin Is A Hold [View article]
    Gary,
    more info - recent article reviewing most trials to date and is their meta analysis of placebo controlled trials (as opposed to open label such as Jelis and GISSI-Prevenzione trials). The reduce it will be double blind.

    http://bit.ly/N5yM47
    Jul 6 03:34 PM | Likes Like |Link to Comment
  • Amarin Is A Hold [View article]
    Agreed, the JELIS trial does provide evidence that EPA reduces events. Quick summary, (the abstract is enclosed below) in patients with a history of coronary artery disease, EPA reduced events (significant), in patients without a history of coronary artery disease, EPA reduced events (non -significant). Sudden cardiac death and coronary death did not differ between groups.

    The Lancet

    Volume 369, Issue 9567, 31 March–6 April 2007, Pages 1090–1098
    Cover image
    Articles
    Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis

    Dr Mitsuhiro Yokoyama, MDa, Corresponding author contact information, E-mail the corresponding author,

    Available online 29 March 2007.





    Summary
    Background

    Epidemiological and clinical evidence suggests that an increased intake of long-chain n-3 fatty acids protects against mortality from coronary artery disease. We aimed to test the hypothesis that long-term use of eicosapentaenoic acid (EPA) is effective for prevention of major coronary events in hypercholesterolaemic patients in Japan who consume a large amount of fish.
    Methods

    18 645 patients with a total cholesterol of 6·5 mmol/L or greater were recruited from local physicians throughout Japan between 1996 and 1999. Patients were randomly assigned to receive either 1800 mg of EPA daily with statin (EPA group; n=9326) or statin only (controls; n=9319) with a 5-year follow-up. The primary endpoint was any major coronary event, including sudden cardiac death, fatal and non-fatal myocardial infarction, and other non-fatal events including unstable angina pectoris, angioplasty, stenting, or coronary artery bypass grafting. Analysis was by intention-to-treat. The study was registered at ClinicalTrials.gov, number NCT00231738.
    Findings

    At mean follow-up of 4·6 years, we detected the primary endpoint in 262 (2·8%) patients in the EPA group and 324 (3·5%) in controls—a 19% relative reduction in major coronary events (p=0·011). Post-treatment LDL cholesterol concentrations decreased 25%, from 4·7 mmol/L in both groups. Serum LDL cholesterol was not a significant factor in a reduction of risk for major coronary events. Unstable angina and non-fatal coronary events were also significantly reduced in the EPA group. Sudden cardiac death and coronary death did not differ between groups. In patients with a history of coronary artery disease who were given EPA treatment, major coronary events were reduced by 19% (secondary prevention subgroup: 158 [8·7%] in the EPA group vs 197 [10·7%] in the control group; p=0·048). In patients with no history of coronary artery disease, EPA treatment reduced major coronary events by 18%, but this finding was not significant (104 [1·4%] in the EPA group vs 127 [1·7%] in the control group; p=0·132).
    Interpretation

    EPA is a promising treatment for prevention of major coronary events, and especially non-fatal coronary events, in Japanese hypercholesterolaemic patients.
    Jul 6 12:01 PM | Likes Like |Link to Comment
  • Idenix: New HCV Drug Could Be A Blockbuster [View article]
    Vertex's Incivek was approved May 23, 2011. Might have mentioned that in your article dated July 3, 2012 rather than "the recent problems that Vertex has had in respect of its data on Incivek do not take away from the effectiveness of the treatment", for one of many references see http://on.wsj.com/Ob1rD8. Were you refering to the misleading promotion?, see http://bit.ly/N04azn. The truly remarkable aspect of both these new Hepatitis C protease inhibitors, from Merck and Vertex, is that cure rates are up and treatment time is reduced dramatically. Albeit fantastic, how did you come up with a $100 billion market by 2012? Interesting article though, Take care.
    Jul 5 07:14 PM | Likes Like |Link to Comment
  • Orexigen: When To Buy? [View article]
    Thanks for the information on insider selling after the spike in Orexigen share price after Arena's Locarserin approval.
    Jul 2 11:56 AM | Likes Like |Link to Comment
  • Sell Avanir: Stellar Quarterly Growth, But A Small Revenue Stream [View article]
    Correct, the safety trial for Orexigen's Contrave trial will not end in 2014 (unless there's a total surprise on cardiovascular outcomes - look to the glucose control arm of ACCORDtrial for an example of that - http://wapo.st/MO4xwV). But From the Orexigen 2011 annual report regarding Contrave, "An interim analysis and NDA resubmission is planned once at least 87 MACE events have occurred, which is anticipated to be less than two years from the start of the trial. " So the plan is a 2014 to seek approval in 2014 for Contrave.
    Jul 2 11:52 AM | Likes Like |Link to Comment
  • Sell Avanir: Stellar Quarterly Growth, But A Small Revenue Stream [View article]
    AMLN news - presumably AMLN will open up at near $31 per share Monday 7-2-2012

    http://reut.rs/LWSqwJ
    Jun 30 03:19 PM | Likes Like |Link to Comment
  • Sell Avanir: Stellar Quarterly Growth, But A Small Revenue Stream [View article]
    I would encourage investors to look at the revenue and operating expense (in the article) themselves and read the earnings report transcript. Difficult questions to answer are whether revenue growth rate will increase or decrease. Operating expenses seem likely to increase. Today,a new trial of Neudexta for agitation in Alzheimers patients was announced (http://yhoo.it/LKHiIP). Of course, that has long term potential for a new indication for Neudexta and revenue for Avanir.
    Jun 29 09:53 PM | Likes Like |Link to Comment
  • MannKind: If You Buy, When? [View article]
    Yes, thanks!
    Jun 27 03:17 PM | Likes Like |Link to Comment
  • MannKind: If You Buy, When? [View article]
    Thanks, I agree, there is mention of other ways of financing in the annual report, but whether you sell shares or borrow, it seems it would still impact future earnings per share. Also, it still needs to be considered until that financing is in place to see Mannkind through the next approval decision. Thanks, I think your point is important.
    Jun 27 11:18 AM | Likes Like |Link to Comment
  • The Obesity Race: Update, Part 2 [View article]
    Your point is well taken, and I think the trials excluded MAOIs and SSRIs, but some allowed dextromorphan. SSRIs and MAOIs need to be a contraindication in the FDA labeling, IF Lorcaserin is approved.

    There was information in the bloom trial consent form indicating, from animal studies, that serotonin syndrome was not likely with lorcaserin monotherapy. "As with any drug that activates the serotonin system, there is a risk of developing
    “serotonin syndrome.” .... Studies in animals appear to show that the drug does not cause an increase in serotonin in the brain.
    However, the effects of lorcaserin in humans are not fully known."

    Some of the trials allowed dextromorphan and there was at least one incidence of possible serotonin syndrome in combination with dextromorphan.

    Definitely potential for serious drug drug interactions, but so is eating cheese and taking MAOIs :)
    Jun 26 02:26 PM | Likes Like |Link to Comment
  • If Arena's Lorcaserin Is Approved, Buy Vivus [View article]
    Yes, for Qnexa, the average heart rate on the population increased slightly and also from the briefing doucment "The incidence of TEAEs in the cardiac arrhythmia subclass was higher in the QNEXA Top-dose group (4.7%) and Mid-dose group (4.2%) than in the placebo group (1.8%). Palpitations, increased heart rate, and tachycardia represented 36 of the 41 cardiac arrhythmia TEAEs in the
    1-year cohort. Palpitations and increased heart rate are expected and dose-related side effects of phentermine and phentermine-containing products. The cardiac arrhythmia TEAEs were
    primarily mild or moderate in severity and were serious for 4 (0.3%) subjects in the placebo group, 2 (0.4%) subjects in the Mid-dose group, and 2 (0.1%) subjects in the Top-dose group."

    And yes, see my response to the first post, on 90% / Eisai issue.
    Jun 26 01:14 PM | Likes Like |Link to Comment
  • If Arena's Lorcaserin Is Approved, Buy Vivus [View article]
    Thank you, I've submitted a correction to Seeking Alpha. Your information would impact the potential profitability of Arena and Eisai.

    From a Form 8-K, 90% of the post-development expense would be Eisai’s responsibility, “With respect to the United States, if the FDA requires development work following approval of the lorcaserin NDA, Eisai will bear 90% and Arena GmbH will bear 10% of the expenses for such work, except that the parties will share equally the costs of certain pediatric or adolescent studies”.

    and the link to the Form 8-K

    http://bit.ly/LdFNhu

    Again, thank you.
    Jun 26 01:02 PM | Likes Like |Link to Comment
  • Vivus: A Window For Buying Or Is Approval Already Priced In? [View article]
    You are a woman with an astute grasp of the importance of phamacokinetics - it is the most rapid onset of the four approved PDE5 inhibitors, Tadalafil (Cialis) having the longest half-life.
    Jun 20 03:25 PM | Likes Like |Link to Comment
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