Dr. Lawrence Ginsberg MD

GLG News by Dr. Lawrence Ginsberg MD, President

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Vanda"s Iloperidone: Lemonade or Lemon

October 11, 2007

Analysis of:Vanda Pharmaceuticals Submits Iloperidone New Drug Application | www.pipelinereview.com

1. Iloperidone has demonstrated efficacy in treating positive and negative symptoms of schizophrenia and also has a favorable safety profile. 2. Vanda has utilized pharmacogenetic studies to identify a group of schizophrenic patients that will benefit from this agent that binds to a number of serotonin and dopamine receptors. 3. Two out of three previous Novartis Iloperidone trials were failed trials but they utilized low to medium doses of Iloperidone.

DOV 21,947: A Triple Reuptake Inhibitor With a Favorable Metabolic Profile

October 8, 2007

Analysis of:DOV 21,947 Demonstrates Significant Body Weight and BMI Reductions in Drug Compliant Subjects in Phase Ib Clinical Study | www.medicalnewstoday.com

1. DOV 21,947 in a phase Ib study produced a statistically significant reduction in plasma triglyceride levels, body weight, and Body Mass Index (BMI). 2. This compound is believed to not only manage depression but also impact weight gain. 3. A phase II study of DOV 21,947 is being delayed until the first quarter of 2008 to allow for sufficient capital to conduct the study and to further evaluate the protocol design. 4. Phase I studies of DOV 21,947 have shown that the compound was safe and well tolerated with a low incidence of adverse events.

Shire Takes Proactive Stance Regarding Daytrana Skin Patches

September 18, 2007

Analysis of:Shire withdraws some ADHD skin patches | www.reuters.com

1. Shire has withdrawn patches that had defective patch liners. 2. This defect is not related to safety or efficacy issues. 3. The cost to Shire is less than $10 million.

New Potentially Effective Antidepressants to be Marketed by a Potentially Effective Alliance

September 12, 2007

Analysis of:Lundbeck and Takeda form Alliance to Develop and Commercialize a Portfolio of Novel Compounds in the US and Japan for the Treatment of Mood and Anxiety Disorders | www.pipelinereview.com

1. Lu AA21004 and Lu AA24530 are two compounds with a great deal of potential and will be co-marketed jointly by Takeda and Lundbeck. 2. Lu AA21004 is the more advanced of the compounds and is currently in phase II development for the treatment of major depression. 3. The compounds potentially address some unmet needs as they have fast onset of effect and increased efficacy.

LY2140023: An Antipsychotic With A New Mechanism of Action

September 11, 2007

Analysis of:Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medicine Finds | www.pipelinereview.com

1. LY2140023 is an antipsychotic agent that is a metabotropic glutamate 2/3 receptor agonist. This agent has a new mechanism of action that is efficacious in treating schizophrenia and potentially other neuropsychiatric conditions. 2. LY2140023 in addition to separating from placebo in a statistically significant manner demonstrated a safety and tolerability profile that lacked many of the problems of atypical antipsychotic agents. 3. This has great significance for Eli Lilly who manufactures Zyprexa. This compound despite having a great deal of efficacy in treating schizophrenia and bipolar disorders has been associated with metabolic side effects including hyperglycemia. (Lilly has recently settled Zyprexa class action suits.)

Actelion Has A Non-Sedative-Hypnotic Sleep Aid That Appears Effective and Safe

September 10, 2007

Analysis of:Actelion Sleep Aid Does Well | online.wsj.com

1. The Actelion agent (ACT-078573) is not a sedative-hypnotic but is an orexin receptor antagonist. 2. This agent may have a safety and tolerability profile that is better than the sedative-hypnotics. 3. The above implications would make Actelion a prime acquisition for a big-pharma company with a less than desired CNS pipeline.

Bipolar Disorder in Children: Higher Incidence or More Accurate Diagnosis

September 10, 2007

Analysis of:Bipolar Disorder Among Kids in U.S. Rising, Study Suggests | online.wsj.com

1. A recent psychiatric journal reported a higher incidence of bipolar disorders in the pediatric population and a subsequent increase in antipsychotic medication use in children. 2. Assessment tools (bipolar disorder questionnaires) have significantly increased awareness of bipolar disorder symptomatology and have increased diagnostic accuracy. 3. Other studies in the past have demonstrated the lack of correct bipolar disorder diagnoses. 4. There is a great deal of comorbidity in child psychiatry-having one diagnosis does not necessarily eliminate the possibility of a second diagnosis. (Almost 40% comorbidity between ADHD and Bipolar Disorders in children.)

Vyvanse: Pros and cons

September 4, 2007

Analysis of:Shire's New ADHD medication, VYVANSE(TM) (lisdexamfetamine dimesylate) Now Available in U.S. Pharmacies Nationwide | www.eurekalert.org

I am a psychiatrist in private practice in a major metropolitan area that has a diverse population. I offer the following observations based on my clinical post-marketing experience. I have already prescribed Vyvanse to a few hundred patients. My observations: 1. Duration of action: This is a huge issue. Clinical studies have shown significant efficacy of Vyvanse even at the 12-hour mark; this is the only stimulant medication on the market that is able to consistently demonstrate such efficacy. 2. Predictability: Compared with other agents there is a very narrow window of time to maximum concentration  (Tmax) -less than 2 hours from the mean, and duration of action. This is in contrast to Adderall XR, which had been the gold standard but has a great amount of interpatient variability (7 hours) . Vyvanse should not wear off prematurely. 3. Abuse Potential: Patients who "like" stimulants usually subjectively prefer shorter acting agents & Adderall XR.

Bifeprunox: A Drug Not Approved By The FDA Because It Lacks Efficacy

September 3, 2007

Analysis of:Wyeth's Schizophrenia Pill Is Rejected by U.S. FDA | www.bloomberg.com

1. This agent despite a favorable side effect profile lacks efficacy as compared to other antipsychotic agents already approved by the FDA. 2. This is a temporary setback for Wyeth. 3. This in the long run is to Wyeth's advantage as such an agent would have done poorly in a competitive atypical antipsychotic market. 4. Putting this product on the market would have tarnished Wyeth's reputation/credibility and would have indirectly hurt the promotion of the hopefully soon to be approved desvenlafaxine.

DOV 21,947: Is The Antidepressant That We Have Been Waiting For?

August 30, 2007

Analysis of:DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947 | www.pipelinereview.com

1. Most currently marketed oral antidepressants replenish only norepinephrine or serotonin and result in remission in less than 45% of patients over 8 weeks. A triple reuptake inhibitor such as DOV 21,947 has the potential to effect a remission in a higher percentage of patients. 2. Most of the antidepressants currently being used have at least a moderate amount of side effects. It is refreshing that this drug has a favorable metabolic profile. 3. It is not reasonable to predict that this agent will be an effective agent to treat ADHD or to facilitate weight loss unless future studies that specifically examine these issues demonstrate efficacy.

Biolinerx: Issues to Consider

August 28, 2007

Analysis of:BIOLINERX STARTS PHASE II TRIAL OF BL-1020 FOR SCHIZOPHRENIA. | www.therapeuticsdaily.com

1. An antipsychotic with a novel mechanism of action is highly desirable as currently available atypical antipsychotic agents lack efficacy or cause undesirable side effects (metabolic, extrapyramidal, increased prolactin.) 2. If this agent demonstrated significant efficacy and safety it could be a big factor in the multi-billion dollar antipsychotic market (for schizophrenia, schizoaffective disorders, mood disorders, autism, and even anxiety.) 3. The trial design was open label and a sequential cohort. Open label studies are not as helpful as placebo-controlled trials. With sequential cohorts there could be a positive bias; if a subject was already exposed to a given dose of medication for more than a few days there could be some physiologic adjustments which could minimize perceived side effects. A placebo-controlled fixed-dose multiple dose armed trial with some sites in the U.S. (vs. Eastern Europe) would be an important future step.

Review of INTUNIV Extended Release for treatment of ADHD:

June 26, 2007

Analysis of:Shire Receives Approvable Letter from FDA for INTUNIV(TM) (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD | www.pipelinereview.com

Review of INTUNIV Extended Release for treatment of ADHD: This is still another ADHD Shire drug that is efficacious and has an excellent tolerability profile. I have utilized this agent (as a principal investigator) in several clinical trials and can't wait until I am able to prescribe this agent in my clinic (non-research) patients either as a monotherapeutic or as an adjunctive agent. I have been very successful with immediate release guanfacine in my pediatric ADHD patients. Some patients also report an alleviation of anxiety not seen with stimulants. I can foresee many patients being switched from the immediate release to the extended release version as well as many new prescription starts. Submitted by Lawrence D. Ginsberg, M.D. C.E.O. Red Oak Psychiatry Assoc., Houston, TX

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