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Arena Pharmaceuticals, Inc. Message Board

jeremiahthirtythreeone 1515 posts  |  Last Activity: Jul 10, 2014 3:54 PM Member since: Feb 16, 2010
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  • jeremiahthirtythreeone jeremiahthirtythreeone Jul 10, 2014 3:54 PM Flag

    This study was based on the BLOOM DM findings.
    Nearly twice as many patients with diabetes in the lorcaserin group achieved hemoglobin levels of less than 7% compared with the placebo group (50.4% vs. 26.3%), even if they did not lose weight, the researchers found.

    This important and should continue to be emphasized by Eisai.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 30, 2014 2:31 PM Flag

    JD things are still pretty busy. Will email you this weekend to catch up.
    Danny

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 30, 2014 2:28 PM Flag

    Thanks hedge. I also appreciate your input since it seems clear to me you have a sound understanding of the financial market. This helps me understand things better.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 30, 2014 12:04 PM Flag

    dio
    This is an extremely point that none of the articles bring up and relevant to the discussion of efficacy between the two. I know of very few other than yourself that has recognized this big discrepancy in the efficacy of V. Very important to always bring to the forefront.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 30, 2014 11:35 AM Flag

    None that I know of!!! Now there are some that are being introduced that combine two antihypoglycemics for the treatment of type 2 DM but I can think of no others but this usually combines one new drug with a generic. It is hard two understand why two generics would not be preferred over an expensive formulation with two generics. Go figure! All I know is that our medical group always prefers generics whenever its possible.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 30, 2014 11:31 AM Flag

    VJ
    Yes, I will continue to post relevant information. I hope the importance of increasing exposure in the medical literature is appreciated and especially when the it is presented in a positive light.
    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 30, 2014 11:23 AM Flag

    Norrie this is becoming too obvious. It is incredible all the nonsensical information that is allowed. Nevertheless, after having the second article deleted as a stand alone post I was able to post the reference on my original post.

    Norrie thanks for all that you do to try to ward off the falsehoods on this board.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 30, 2014 11:19 AM Flag

    YMB deleted the second article but it pretty much says the same thing. Here is the reference

    New centrally acting agents for appetite control: from biological mechanisms to clinical efficacy.
    Catoira NP, Viale L, Di Girolamo G, Gonzalez C - Curr Med Res Opin - Jun 2014; 30(6); 961-9

    CONCLUSION:

    Conclusion: With differences in efficacy (higher for the topiramate-phent combination), both preparations are active in reducing appetite and body weight, as well as in improving comorbidities. Additional information will be collected from Phase IV surveillance. Focus on cardiovascular, neuropsychiatric (for both introductions) and embrio-fetal safety (especially for topiramate) is expected.

    Sentiment: Strong Buy

  • Nothing new in these articles. The significance is that Belviq will continue to get more and more exposure in the medical literature

    New pharmacological treatments for the management of obesity.
    Hurt RT, Edakkanambeth Varayil J, Ebbert JO - Curr Gastroenterol Rep - Jun 2014; 16(6); 394

    Abstract
    Obesity is quickly becoming the leading preventable cause of death in the USA. Over 60 obesity-related comorbidities exist which increase the complexity and cost of medical care in obese patients. Even a moderate weight loss of 5 % can reduce morbidity associated with these conditions. Lifestyle modification through caloric restriction and enhanced exercise and physical activity remain the first line treatment for obesity. The development of pharmacologic agents for the treatment of obesity has been challenged by both lack of efficacy and serious adverse side effects leading to their removal from market. Two new agents were recently approved by the US Food and Drug Administration to complement lifestyle modification in obese and overweight patients and one obesity-related comorbidity). Lorcaserin is a novel serotonin 5-HT2C selective agonist which has been shown in three phase III studies to significantly reduce weight and cardiovascular risk factors such as diabetes. Phent/topiramate extended release (ER) is a novel combination of two agents which have individually been shown to significantly reduce weight. The combination agent phent/topiramate ER has been shown to reduce weight in overweight and obese subjects in a number of studies. This article reviews the pharmacology, clinical efficacy, and safety of these new agents compared to past and other presently available medications for the treatment of obesity.

    NOTE: "Lorcaserin....shown to significantly reduce weight and cardiovascular risk factors such as diabetes."

    This is a factual statement that will continue to increase in its dissemination...because the science will prevail.

    CONTINUED

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 26, 2014 8:06 PM Flag

    “It’s much easier to write [the prescription] instead of spending five minutes explaining why a different drug is better than what’s on the market,” says Jeffrey Lobosky, MD, an associate clinical professor in the department of neurological surgery at the University of California-San Francisco.
    Molly Cooke, MD, immediate past president of the American College of Physicians, says that while advertising is described as patient education, “the commitment to education” is not uniform across medications. For example, she says there is not much emphasis on common drugs. Instead, the companies stress newer, more expensive drugs still covered by patents. “This is a genie that’s notv going to get put back in the bottle,” Cooke says

    AFFORDABLE CARE ACT impact
    The ACA likely will bring new patients into practices who haven’t been getting care, and medication questions related to advertising may become more frequent as physicians begin treating these patients. Physicians need to ensure that these medication inquiries are not a distraction from more critical topics.
    The challenge is that answering these inquires takes time—the most precious resource the patient has when he or she is in your practice, says the ACP’s Cooke. Spending five minutes of a 15-minute patient encounter explaining why a new weight loss medication may not be right for them “is five minutes I can’t spend on something else.”

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone by jeremiahthirtythreeone May 26, 2014 7:58 PM Flag

    Direct-to-consumer advertising of prescriptions impacts patient requests

    Publish date: MAY 23, 2014

    Published on Medical Economics (medicaleconomics.modernmedicineDOTcom)
    By: Keith Griffin

    The influx of new patients under the Affordable Care Act (ACA) may exacerbate an ongoing challenge for physicians: Responding to patient inquiries and requests for prescriptions in the wake of large-scale, direct-to-consumer pharmaceutical advertising campaigns. Physician experts say there are strategies practices can use to talk with patients about medication choices.
    On one side of the direct-to-consumer advertising debate are doctors, who can be overwhelmed by patient demands for specific medications while trying to communicate effectively with a patient during a short encounter. On the other side is the pharmaceutical industry trying to educate patients, build awareness, and drive sales in a tightly-regulated and competitve industry.
    Since 1997, when the U.S. Food and Drug Administration issued guidance to enable pharmaceutical companies to more easily advertise to the public on television, companies have spent billions annually on these consumer marketing efforts. As a November 2013 article in the American Medical Association Journal of Ethics concluded: “Drug advertisements remain pervasive and therefore exert an undeniable influence on the way the public learns about available therapies and how patients and physicians communicate.”
    One-third of individuals who see a direct-to-consumer television ad, if it’s relevant to their condition, will ask doctors to prescribe that drug, and more than one-half of physicians will prescribe it, according to a national survey by USA Today, the Kaiser Family Foundation and the Harvard School of Public Health published in 2008.

    CONTINUED
    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone by jeremiahthirtythreeone May 20, 2014 11:51 AM Flag

    Obesity appears to increase the risk of breast cancer–related deaths by about one-third in premenopausal but, surprisingly, not postmenopausal women with estrogen receptor–positive disease, investigators report.
    An analysis of pooled data on 80,000 patients enrolled in 70 clinical trials showed that among 60,000 patients with estrogen receptor (ER)-positive disease, body mass index (BMI) was associated with risk for breast cancer mortality in both pre- and perimenopausal women.
    But after adjustment for patient factors and tumor characteristics, the association remained significant only for premenopausal women with ER-positive tumors, who had a 34% higher risk of dying from breast cancer, said Dr. Hongchao Pan, on behalf of colleagues in the Early Breast Cancer Trialists’ Collaborative Group.
    “To our surprise, we found little independent adverse effects of obesity in the 40,000 postmenopausal women with ER-positive disease,” Dr. Pan said at a media briefing highlighting research to be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, from May 30 through June 3.
    “The bottom line, of course, remains that obesity is overall a negative prognostic feature, and something that we will need to address at a societal level,” he said.
    Dr. Yu comoderated the briefing, but was not involved in the study.
    The other moderator, Dr. Clifford Hudis, president of ASCO and chief of the breast cancer service at Memorial Sloan Kettering Cancer Center, New York, commented that both overweight and obesity are known to contribute to risk for postmenopausal, ER-positive breast cancer
    A comparison of obese women (BMI, 30 kg/m2 or greater) with those of normal weight (BMI, 20-25) showed 10-year death rates of 21.5% and 16.6%, respectively. The absolute difference at 10 years was 5%, Dr. Pan said.
    The study was funded by Cancer Research UK, the Medical Research Council, and and the British Heart Foundation.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 10, 2014 5:35 PM Flag

    No coverage yet. We r very slow in getting new drugs approved. However since we r in the California Exchange it will likely be sooner than it would usually take.
    Daniel
    UCLA

    Sentiment: Strong Buy

  • Reply to

    Symphony Wk ended 5/2

    by sharonconk May 9, 2014 1:43 PM
    jeremiahthirtythreeone jeremiahthirtythreeone May 9, 2014 2:19 PM Flag

    Thank you Sharon. You are truly an asset to this board.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 9, 2014 1:35 PM Flag

    Thanks Dio. What is important on this study is actually looking at the combination of lorcasern with LLLT and not only a comparison!!! If found to be effective then one the most important uses will be for metabolic syndrome.

    As I have always stated, the science will prevail and is prevailing.
    I would rather have management that has sound science and patient business practices than management that is nothing but hype, or as you once called them 'used car salesmen,' ie VVUS

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 9, 2014 12:57 PM Flag

    KEY: " effectiveness of the combination of LLLT and lorcaserin for reducing abdominal subcutaneous fat in overweight/obese individuals"

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone May 9, 2014 12:56 PM Flag

    Continued:

    Lorcaserin was approved by the FDA on June 2012 for weight management in people with a BMI of 27 kg/m2 (overweight) when accompanied by a weigh-related condition such as type 2 diabetes or high blood pressure or in people with a BMI 30 kg/m2 (obese). The purpose of this pilot study is to obtain preliminary data on: 1) effectiveness of the combination of LLLT and lorcaserin for reducing abdominal subcutaneous fat in overweight/obese individuals; 2) impact of LLLT on inflammatory biomarkers, blood sugar, and cholesterol.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone by jeremiahthirtythreeone May 9, 2014 12:55 PM Flag

    I know someone posted this before but some details are important to understand the significance of this study:

    First we must review some important findings in the randomized, placebo controlled trial of Belviq (then called lorcaserin), the BLOOM trial, that were reported in the New England Journal of Medicine in July of 2010 (N Engl J Med 2010; 363:245-56). This trial provides information on the possible benefits Belviq may have as an adjunct therapeutic option in the treatment of metabolic syndrome. Thus, in year 1, lorcaserin use was associated with a significant decrease in waist circumference (baseline 109.6 cm) of 6.8 cm versus a decrease of 3.9 cm in the placebo arm and a decrease in BMI of 2.09 versus 0.78.
    Both obesity and body fat distribution play a role here. Independent of total body fat, people with a large abdominal circumference are more insulin resistant and more likely to develop diabetes. Of note is that the BLOOM study showed that Belviq caused a significant decrease in abdominal circumference.

    LLLT and Lorcaserin for Weight Managment Study
    Purpose
    Currently in the United States about 97 million adults are considered obese, accounting for about 33% of the American adult population (compared to 22.9% in 1988). Obesity, defined as a body mass index of 30.0 or higher, is accountable for 44% of the diabetes, 23% of the ischemic heart disease and between 7% and 41% of certain cancers. The Erchonia Zerona2.0 Laser (which will be used in this study) has been approved by the FDA (K123237) as a non-invasive dermatological aesthetic treatment which can be used by individuals intending to reduce circumference of hips, waist, and thighs. Lorcaserin is a selective serotonin 2C (5-HT(2C)) receptor agonist. The exact mechanism of action is not known, but lorcaserin is believed to promote satiety and decrease food intake by activating 5-HT(2C) receptors on anorexigenic pro-opiomelanocortin neurons in the hypothalamus.
    Continued

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • Arena's CB2 agonist will likely get fast tracked for approval by the FDA once the trials are completed.
    From this weeks NEJM editorial:

    Chronic Pain, Addiction, and Zohydro
    Yngvild Olsen, M.D., M.P.H., and Joshua M. Sharfstein, M.D.
    April 23, 2014DOI: 10.1056 NEJM1404181

    Chronic pain, which affects tens of millions of people in the United States, is associated with functional loss and disability, reduced quality of life, high health care costs, and premature death. U.S. physicians are now more likely to recognize and treat chronic pain than they have been historically, with the number of prescriptions written for opioids having increased 10-fold since 1990.
    Over the same period, however, the rate of overdose deaths in the United States has more than tripled.
    =========================
    The following two statements are key for Arena for both belviq and CB2 agonists:
    It is also time for the FDA to address the intertwining of chronic pain and addiction farther upstream in the drug-development cycle (fast tracking of CB2 agonist)
    The agency might consider creating a pathway for development and review of new products and indications for simultaneous treatment of chronic pain and opioid-use disorder. (Lorcaserin has demonstrated potential for treatment of substance abuse).

    Just food for thought – however, these are very real possibilities because the basic science has been mastered by Arena and now we await the completion of making this science work for the benefit of our patients.
    The huge potential of CB2 agonists in the treatment of chronic pain has not been fully appreciated.
    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • The valvulopathy issue is a NON issue but Arena continues to provide evidence to refute the falsehoods produced by the paid charlatans.

    EFFECTS OF LORCASERIN ON PREEXISTING VALVULOPATHY IN TWO PHASE 3 LORCASERIN TRIALS: A POOLED ANALYSIS
    Neil J. Weissman, et al
    JACC (Journal of the American College of Cardiology), 2014-04-01, Volume 63, Issue 12, Supplement , Pages A1945-A1945
    2014 American College of Cardiology Foundation
    Background
    Lorcaserin (lor) is a selective 5-HT2C receptor agonist indicated for chronic weight management as an adjunct to lifestyle modification. Valvulopathy has been associated with nonselective serotonergic agonists; however, the phase 3 trials showed no significant increase in valvulopathy in patients (pts) on lor (relative risk ∼1.1, lor vs placebo; P=0.47). This analysis of the phase 3 studies sought to evaluate the effect of lor on pts with valvulopathy prior to taking lor.
    Methods
    Serial echocardiographs were performed at baseline (BL) and every 6 months in BLOSSOM (4,008 pts without type 2 diabetes [T2D] and BMI 30-45 kg/m2 or 27-29.9 kg/m2 with ≥1 weight-related comorbidity) and BLOOM-DM (604 pts with T2D and BMI 27-45 kg/m2). Echocardiographs were performed over 1 year (W52) in 168 pts with BL valvulopathy. American Society of Echocardiography criteria were used by an independent core lab with 2 blinded cardiologists. The primary endpoint is change in regurgitation from BL to W52 (last observation carried forward).
    Results
    The majority of shifts from BL to W52 were single-grade changes (Figure), with more pts demonstrating a decrease in regurgitation than an increase. At W52, 57.8% and 52.9% of lor and placebo pts with BL valvulopathy no longer met these criteria, using FDA criteria.
    Conclusions
    Lor pts with preexisting valvulopathy did not show progression of valve disease up to 1 year. Most showed regression of ttheir regurgitation, which was comparable to the placebo group.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

ARNA
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