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  1. 1. MM Presentations Seroquel By, Shilpa C
  2. 2. <ul><li>■ Client: Edelman </li></ul><ul><li>■ End Client: AstraZeneca </li></ul>Brand Name : Seroquel <ul><li>■ Industry: Pharma (Neuroscience) </li></ul>
  3. 3. <ul><li>Schizophrenia is a chronic, severe and disabling brain disease. </li></ul><ul><li>In the U.S., approximately 2.2 million adults, or about 1.1 percent of the population age 18 and older in a given year, have schizophrenia. </li></ul><ul><li>Approximately 1 % of the population develops schizophrenia. </li></ul><ul><li>Schizophrenia ranks among the top 10 causes of disability in developed countries worldwide. </li></ul>What Is Schizophrenia & Bipolar Disorder? <ul><li>Bipolar disorder is a serious lifelong condition that affects 2 million people in the U.S. </li></ul><ul><li>Bipolar disorder experience a vicious cycle of dangerous highs called &quot;mania“ and debilitating lows known as &quot;depression.&quot; </li></ul>
  4. 4. Signs & Symptoms of Schizophrenia <ul><li>Problems in focusing attention and concentration </li></ul><ul><li>Suicidal thoughts </li></ul><ul><li>Inattention </li></ul><ul><li>Delusions </li></ul><ul><li>Weakened/restricted emotional expressiveness </li></ul><ul><li>Hallucinations </li></ul><ul><li>Apathy & Anhedonia </li></ul><ul><li>Distorted perceptions of reality (illusions) & thinking disturbances </li></ul>Negative symptoms Positive symptoms
  5. 7. Signs & Symptoms of Bipolar Disorder <ul><li>Depressive phase/Clinical depression: It is characterized by a persistent lowering of mood, loss of interest in usual activities and diminished ability to experience pleasure. It is also called as major depressive disorder/unipolar depression. </li></ul><ul><li>Manic Phase/Mania: It refers to an elevated, expansive or irritable mood state. Mania is a severe medical condition characterized by extremely elevated mood,energy, hypersexuality & unusual thought patterns. </li></ul><ul><li>Hypomania: It is a mood state characterized by persistent & pervasive elated or irritable mood, and thoughts and behaviors that are consistent with such a mood state. It is distinguished from mania by the absence of psychotic symptoms & by its lower degree of impact on functioning. </li></ul><ul><li>Mixed episode: It is a condition during which symptoms of mania & clinical depression occur simultaneously. </li></ul>
  6. 8. Bipolar Disorder
  7. 9. <ul><li>Seroquel is an atypical antipsychotic drug. </li></ul><ul><li>Seroquel has been approved for the treatment of schizophrenia since 1997 and for the treatment of acute manic episodes associated with bipolar disorder since 2003. </li></ul><ul><li>Seroquel is available in over 80 countries worldwide, including the US and across Europe. In October 2006 the U.S. Food and Drug Administration (FDA) approved Seroquel for the treatment of patients with depressive episodes associated with bipolar disorder. </li></ul><ul><li>Seroquel is now the first and only single medication approved by the FDA to treat both depressive and manic episodes associated with bipolar disorder. </li></ul>Seroquel – An Introduction
  8. 10. <ul><li>The U.S. FDA approved Seroquel XR, a sustained release version of quetiapine, for the treatment of schizophrenia on May 18, 2007. </li></ul><ul><li>AstraZeneca will retain the exclusive right to market Seroquel XR until year 2017. However, AstraZeneca’s patent for Seroquel expires September 2011. </li></ul><ul><li>Seroquel XR is not yet available for purchase in pharmacies across the U.S., nor has AstraZeneca begun advertising for the drug as of October 2007. The delay in launch of Seroquel XR is not yet provided by the company. </li></ul><ul><li>AstraZeneca is planning to file NDA for the use of Seroquel to treat generalized anxiety disorder & major depressive disorder soon. </li></ul>
  9. 11. <ul><li>Seroquel is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. </li></ul>Oral Administration:
  11. 13. Mechanism of Action of Seroquel
  12. 14. <ul><li>Common side effects: </li></ul><ul><li>Constipation </li></ul><ul><li>Drowsiness/sedation </li></ul><ul><li>Dry Mouth </li></ul><ul><li>Indigestion </li></ul><ul><li>Head ache </li></ul><ul><li>Stomach pain/upset (incomplete or infrequent bowel movements) </li></ul><ul><li>Dizziness </li></ul><ul><li>Weight Gain (mild) </li></ul>
  13. 15. Major Competitors:                               <ul><li>Risperdal (risperidone) is indicated for the treatment of schizophrenia & for the short-term treatment of acute, manic or mixed episodes associated with bipolar I disorder. Risperdal is available in form of tablets, oral solution & long acting injection. </li></ul><ul><li>Zyprexa (olanzapine) is approved by the FDA for treating the symptoms of schizophrenia, acute mixed or manic episodes of bipolar I disorder and for maintenance treatment in bipolar disorder. Zyprexa tablets & Orally disintegrating tablets are available. </li></ul>
  14. 16. Major Competitors: <ul><li>Abilify (aripiprazole) is indicated for the treatment of schizophrenia & the treatment of acute, manic and mixed episodes associated with bipolar I disorder. Abilify comes as tablets, oral solution, orally disintegrating Tablets & intramuscular injection. </li></ul><ul><li>Invega (paliperidone) is an extended release formulation of paliperidone that allows for easy once-daily dosing. It is approved for the treatment of schizophrenia. </li></ul>
  15. 17. <ul><li>On August 29, 2007 AstraZeneca announced that the Netherlands regulatory authority MEB (Medicines Evaluation Board) has approved Seroquel XR Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients. </li></ul><ul><li>On August 22, 2007 the FDA approved Risperdal for the treatment of schizophrenia in adolescents (Age: 13 to 17yr), and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents (Age: 10 to 17yr). </li></ul><ul><li>Johnson & Johnson submitted a ‘New Drug Application’ to the U.S. FDA for intramuscular injection of Invega for the treatment of schizophrenia on October 29, 2007. </li></ul>Recent Issues: