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Attention Deficit Hyperactivity Disorder (ADHD) Disease PowerPoint Presentation

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  • Slide 1 - GLGi: Attention Deficit Hyperactivity Disorder (ADHD) Louis Sanfilippo, MD January 22, 2008 Chicago
  • Slide 2 - © 2007 Gerson Lehrman Group Inc., All Rights Reserved Council Member Biography Louis Sanfilippo, MD, is an Assistant Clinical Professor of Psychiatry at Yale School of Medicine and is also in private practice. He is a Managing Partner of Cenestra Health, a biotech company focused on developing empirically validated nutraceutical products. Dr. Sanfilippo teaches on Psychopharmacology to Yale Psychiatry residents with a focus on antidepressants, mood stabilizers, antipsychotics, and psychostimulants. His clinical expertise is in the treatment of anxiety, depression, ADHD, and bipolar disorder in adults, college students, athletes and executives. Dr. Sanfilippo has published articles, chapters, and books across a wide range of topics, including psychotic disorders, principles of psychopharmacology in young adults, mood disorders and suicide, forensic and ethical issues in psychiatry, the philosophy of mind, as well as a review of psychiatry for medical students. He has presented on sports psychiatry and has been a fellow with American Psychoanalytic Association.
  • Slide 3 - © 2007 Gerson Lehrman Group Inc., All Rights Reserved Topics Recent developments in the treatment protocol for attention deficit hyperactivity disorder (ADHD) Prescribing patterns, reimbursement, and generic competition  for stimulants Novel therapeutics in clinical development
  • Slide 4 - © 2007 Gerson Lehrman Group Inc., All Rights Reserved About GLG Institute GLG Institute (GLGiSM) is a professional organization focused on educating business and investment professionals through in-person meetings. It is designed to revolutionize the professional education market by putting the power of programming into the hands of the GLG community. GLGi hosts hundreds of Seminars worldwide each year. GLGi clients receive two seats to all Seminars in all Practice Areas. GLGi’s website enables clients to: Propose Seminar topics, agenda items and locations View and RSVP to scheduled and proposed Seminars Receive a daily briefing with new posts on your favorite tickers, subject areas and from trusted Council Members Share Seminar details with colleagues or friends
  • Slide 5 - © 2007 Gerson Lehrman Group Inc., All Rights Reserved Gerson Lehrman Group Contacts Craig Cinquina, PhD Vice President, Healthcare Gerson Lehrman Group 850 Third Avenue, 9th Floor New York, NY 10022 + 1 212 984 3640 ccinquina@glgroup.com Aaron Liberman Managing Director, Sales and Marketing Gerson Lehrman Group 850 Third Avenue, 9th Floor New York, NY 10022 212-984-3684 aliberman@glgroup.com Carly Pisarri Process Manager Gerson Lehrman Group 850 Third Avenue, 9th Floor New York, NY 10022 212-750-1435 cpisarri@glgroup.com
  • Slide 6 - © 2007 Gerson Lehrman Group Inc., All Rights Reserved IMPORTANT GLG INSTITUTE DISCLAIMER – By making contact with this/these Council Members and participating in this event, you specifically acknowledge, understand and agree that you must not seek out material non-public or confidential information from Council Members. You understand and agree that the information and material provided by Council Members is provided for your own insight and educational purposes and may not be redistributed or displayed in any form without the prior written consent of Gerson Lehrman Group. You agree to keep the material provided by Council Members for this event and the business information of Gerson Lehrman Group, including information about Council Members, confidential until such information becomes known to the public generally and except to the extent that disclosure may be required by law, regulation or legal process. You must respect any agreements they may have and understand the Council Members may be constrained by obligations or agreements in their ability to consult on certain topics and answer certain questions. Please note that Council Members do not provide investment advice, nor do they provide professional opinions. Council Members who are lawyers do not provide legal advice and no attorney-client relationship is established from their participation in this project. You acknowledge and agree that Gerson Lehrman Group does not screen and is not responsible for the content of materials produced by Council Members. You understand and agree that you will not hold Council Members or Gerson Lehrman Group liable for the accuracy or completeness of the information provided to you by the Council Members. You acknowledge and agree that Gerson Lehrman Group shall have no liability whatsoever arising from your attendance at the event or the actions or omissions of Council Members including, but not limited to claims by third parties relating to the actions or omissions of Council Members, and you agree to release Gerson Lehrman Group from any and all claims for lost profits and liabilities that result from your participation in this event or the information provided by Council Members, regardless of whether or not such liability arises is based in tort, contract, strict liability or otherwise. You acknowledge and agree that Gerson Lehrman Group shall not be liable for any incidental, consequential, punitive or special damages, or any other indirect damages, even if advised of the possibility of such damages arising from your attendance at the event or use of the information provided at this event.
  • Slide 7 - Diagnosis & Assessment of ADHD Clinical Diagnosis of ADHD Inattention Symptoms (at least 6 of 9 symptoms) or Hyperactivity/Impulsivity Symptoms (at least 6 of 9) Symptoms present for 6 months Some symptoms before 7 years of age Symptoms cause impairment in 2 or more settings Spectrum of Severity Collateral History Neuropsychological Testing Assessment of Comorbid Disorders (Different for Children & Adults) Learning/Communication Oppositional Defiant Anxiety Mood (Depression & Bipolar) Substance Abuse Disorders
  • Slide 8 - Prevalence of ADHD in the U.S. Population Percent(%) Millions * Mental health in the United States: Prevalence of diagnosis and medication treatment for attention-deficit hyperactivity disorder, United States, 2003. MMWR, September 2, 2005; 54(34):842-847. ** Kessler RC, et. al. The prevalence and correlates of adult ADHD in the United States from the National Comorbidity Survey Replication. Am J Psychiatry. 2006; 163:716-723. ***US Census Bureau, Statistical Abstract of the United States, 2006. Numbers derived from 2004 data. At http://www.census.gov/prod/2005pubs/06statab/pop.pdf Prevalence of ADHD (in percentages) Prevalence of ADHD (in millions)
  • Slide 9 - ADHD: Trends in Medication Treatment
  • Slide 10 - Overview: Medication Treatments for ADHD FDA-Approved Treatments Stimulants Schedule II Drugs Potentiate dopamine/norepinephrine neurotransmission Atomoxetine (Strattera; Eli Lilly) Non-stimulant Norepinephrine reuptake inhibitor Off-Label Treatments Modafanil (Provigil; Cephalon) – arousal-promoting Guanfacine - alpha-2 agonist Clonidine - alpha-2 agonist Bupropion (Wellbutrin family) – norepinephrine/dopamine reuptake inhibitor Tricyclic Antidepressants
  • Slide 11 - ADHD Prevalence vs. Medication Treatment, U.S. *Kessler RC, et. al.; The prevalence and correlates of adult ADHD in the United States from the National Comorbidity Survey Replication. Am J Psychiatry. 2006; 163:716.723. **Castle, L, et. al.; Trends in Medication Treatment for ADHD. Journal of Attention Disorders. 2007; 335-342.
  • Slide 12 - ADHD Medication Treatment Trends, Ages 0-19 (2000-2005)* % Children & Adolescents Treated Late 2002, Strattera With Medication introduced ANNUAL GROWTH RATE = 9.5% (2000-2005) *Castle, L, et. al.; Trends in Medication Treatment for ADHD. Journal of Attention Disorders. 2007; 335-342.
  • Slide 13 - ADHD Medication Treatment Trends, Ages 20+ (2000-2005)* % Adults Treated with Medication Late 2002, Strattera introduced ANNUAL GRWOTH RATE = 15.3% (2000-2005) *Castle, L, et. al.; Trends in Medication Treatment for ADHD. Journal of Attention Disorders. 2007; 335-342.
  • Slide 14 - Trends: ADHD Diagnosis & Medication Treatment Up to 65% children with ADHD will continue to have symptoms into adulthood * Pharmacologic treatment of Adult ADHD doubled between 2000-2005** Marketing New Drug Treatments May Increase Public & Clinician Awareness Most Rapid Rate of Growth in Pharmacologic Treatment (2000-2005)** Children ages 0-9 Adults ages 20-64 Medication Patterns (in 2005)** Children & Adolescents (Extended Release Formulations account for 68.3%) Amphetamine mix, 32.4% (does not include dextroamphetamine products) Methylphenidate, 46.9% (does not include dexmethylphenidate products) Atomoxetine, 16.7% Adults (Extended Release Formulations account for 43.7%) Amphetamine mix, 43.4% Methylphenidate, 34.5% Atomoxetine, 13.7% *American Academy of Child & Adolescent Psychiatry. Practice Parameters for the assesment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder, J Am Acad Child Adolesc Psychiatr. 1997; 36 (10 Suppl); 85S-121S. **Castle, L, et. al.; Trends in Medication Treatment for ADHD. Journal of Attention Disorders. 2007; 335-342.
  • Slide 15 - AN OVERVIEW:Clinical Decision-Making in ADHD Pharmacotherapy The Stimulant Landscape: Drugs & Companies Pharmacotherapy Approaches: Choosing the Initial Type of Drug Stimulant vs. Non-Stimulant Comorbidities Treatment with Stimulants: Which One to Choose? Practical Concepts in ADHD Medication Treatment Which Class: Amphetamine or Methylphenidate? Which Form: Immediate-Release, Intermediate-Release, or Extended Release? VYVANSE (lisdexamfetamine) Clinical Practice
  • Slide 16 - The Stimulant Landscape: Drugs & Companies Amphetamine Line Extended Release Formulations (up to 12 hours) –once daily Vyvanse capsules (Shire) – lisdexamfetamine, d-amphetamine/L-lysine prodrug; approved 2/07, launched 2nd quarter 2007 Adderall XR capsules (Shire) – mixed amphetamine salts of dextroamphetamine & racemic d/l-amphetamine Dexedrine SR spansules (GlaxoSmithKline) & generic versions of Dexedrine SR - dextroamphetamine Immediate Release Formulations (3-6 hours) – 2-3 times daily Adderall tablets (Barr/Duramed-Shire Deal) Generic versions of Adderall (ie, “mixed amphetamine salts”) Dexedrine tablets (GlaxoSmithKline) -dextroamphetamine Generic versions of Dexedrine Methylphenidate Line Extended Release Formulations (up to 12 hours) – once daily Concerta tablets (McNeil Pediatrics) - methylphenidate Focalin XR capsules (Novartis) - dexmethylphenidate Daytrana Transdermal Patch (Shire) - methylphenidate Intermediate-Release Formulations, Second-Generation (6-8 hours) – 1-2x daily Ritalin LA capsules (Novartis; Celgene); ANDA filed for generics 11/2007 with Paragraph IV certification Metadate CD Capsules (UCB) -methylphenidate +metadate ER Intermediate-Release Formulations, First-Generation (3-6 hours) – 1-2x daily Ritalin SR tablets (Novartis) & generic versions - methylphenidate Metadate ER tablets & generic versions – methylphenidate Immediate Release Formulations (2-4 hours), 2-4x daily Ritalin tablets (Novartis) & generic versions – methylphenidate Focalin tablets (Novartis) & generic versions (approved 2/07) - dexmethylphenidate
  • Slide 17 - ADHD Pharmacotherapy: Choosing the Initial Type of Drug Stimulants: 1st Line Treatments for ADHD (without comorbidities)* Texas Algorithm for Children: if one stimulant trial fails, use drug from alternative stimulant class (ie, if amphetamine first, then try methylphenidate product)* Efficacious and generally well-tolerated High Effect Size ~60-70% respond favorably to stimulant medication initially and over time more significant with stimulants (0.95 long-acting; 0.91 short-acting) than with atomoxetine (0.62)** When might stimulants not be considered1st or 2nd Line? Comorbid Tic Disorders Strattera Stimulant, with alpha-agonist or atypical antipsychotic Anxiety Disorders Strattera Stimulant, with SSRI for anxiety Substance Abuse Disorders Stattera Long-Acting Stimulant Other clinical conditions in which most severe comorbidity should be treated first (ie, depression, aggression) *Pliska SR, et al. The Texas Children’s Medication Algorithm Project: revision of the algorithm for pharmacotherapy of attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006; 45:642-657. **Farone SV, Biederman J, et al. Comparing the efficacy of medications for ADHD using metaanalysis. MedGenMed.2006;8:4.
  • Slide 18 - Practical Concepts in ADHD Stimulant Treatment
  • Slide 19 - One Drug May Not Fit All …but are some better? ADHD pharmacotherapy should be tailored to each patient Drug dose-response curves are unique for each patient Patients may respond better to one drug class than another Other clinical factors (ie, lifestyle, comorbidities, abuse liabilities) Be clinically rational, accept trial & error Patients/parents have preferences Extended-release formulations are easy with once daily dosing offer continuous effect through much of the day decrease concern medication will wear off too early or at an important time Immediate-release formulations offer flexibility of dosing achieve faster, higher peak levels; may optimize performance situations help avoid “feeling on” all day Clinicians have preferences
  • Slide 20 - Stimulant Treatment Often Involves A Combination Drug Strategy Combining different formulations may help optimize efficacy and is common practice ER form in the morning, IR form (“booster”) in the afternoon Concerta in the am, IR-methylphenidate in mid-late afternoon Adderall XR in the am, Adderall in late afternoon Concerta + IR-methylphenidate booster in the am, with IR- methylphenidate in afternoon Other variations on the theme Combination Rx is typically within the same drug class (ie, amphetamine: Adderall XR with its IR form) but not always Vyvanse: ER form in the am + IR form in the pm, all-in-one?
  • Slide 21 - Which Class: Methylphenidate or Amphetamine? More important than the class of stimulant is which time-release formulation is chosen and its associated properties Patient and/or clinician factors that may influence the use of one class of stimulant over the other Family history (ie, positive or negative response) Patient preference/bias Clinician preference/bias Clinical relevance of the type of encapsulation or delivery Sprinkles for food (able with Adderall XR; not with Concerta) Patch (Daytrana) only with methylphenidate Insurance Factors (covered later) Dextroamphetamine & dexmethylphenidate much less commonly used
  • Slide 22 - Which Form: Immediate, Intermediate, or Extended Release? Extended-Release Formulations Generally Favored Easier, for parents and patients No need for in-school dosing Stability of effect for most of day Improved treatment adherence Less abuse/misuse potential Better profile for patients at risk for subtance abuse Short-Acting For patient seeking flexible dosing options Useful as boosters Higher peak levels may be better for some patients Very low dose titrations may be better for very young children Intermediate-Acting
  • Slide 23 - VYVANSE (LDX:lisdexamfetamine dimesylate)
  • Slide 24 - OVERVIEW: How Does/Will VYVANSE Fit Into the Stimulant & ADHD Treatment Landscape? Efficacy Data Distinguishing Clinical Features Current Clinical Trials Practice Patterns: What Am I Doing? What Are Colleagues Doing? Other (Clinical & Non-Clinical) Factors That May Affect Prescribing Patterns
  • Slide 25 - VYVANSE: Efficacy Data for ADHD It Works: Results from Phase II, III Studies, High Effect Sizes Study NRP-104-201 (Phase II)* Vyvanse & Adderall XR vs. placebo Children ages 6-12, n=52 Significant results vs. placebo on primary efficacy measure: SKAMP-DS Rating Scale (attention/deportment), analog classroom (p<0.001) Significant results vs. placebo on secondary measures: PERMP, Clinical Global Impression (p<0.001) Study NRP-104-301 (Phase III)** Children ages 6-12, n=290 Significant results vs. placebo on primary efficacy measure ADHD-RS-IV (50-59% decrease in ADHD-RS scores vs. 15% decrease for placebo, p<0.001) Study NRP-104-302*** Long-term open-label study Significant improvement (>60%) from baseline in the ADHD-RS at endpoint Pivotal Adult Phase III ADHD Trial**** sNDA before FDA Adults 18-55, n=414 “Significant reduction” in ADHD-RS-IV scores; 57-61% improved/very imprv (similar to MAS SR trials) Conclusions Children: Effect Sizes very high, dose-related (? better than other stimulants) Adults: looks efficacious *Biederman J et al (2007). Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry 62:970-976. **Biederman J et. al (2007). Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a Phase III, multi-center, randomized, double-blind, forced-dose, parallel-group study. Clin Therapeutics 29: 450-463. ***Findling RL, el al. Long-term efficacy and safety of lisdexamfetamine in school-age children with attention-deficit/hyperactivity disorder. Poser presented at the annual meeting of the American Pscyhiatric Association; 2007 May 23; San Diego, CA. ****From Press Release, Results of VYVANSE pivotal trial in adult ADHD presented at major scientific meeting. At http://www.shire.com/shire/uploads/press/shire/LDX1238.pdf
  • Slide 26 - VYVANSE:Distinguishing Clinical Features
  • Slide 27 - The Prodrug Concept Lisdexamfetamine dimesylate is a therapeutically inactive prodrug The active ingredient d-amphetamine is covalently linked to the amino acid l-lyine The active ingredient d-amphetamine is released during the enzymatic breakdown of the prodrug in the gut and liver Saturation kinetics govern the breakdown into the active d-amphetamine form (unlike other stimulants) Pharmacokinetic properties associated with the prodrug mechanism of action confer unique clinical and safety properties First-in-class prodrug stimulant
  • Slide 28 - Does Vyvanse offer efficacy soon enough in the day? How does it measure up with other long-acting stimulants? VYVANSE: Distinguishing Clinical Features
  • Slide 29 - VYVANSE: Time to Efficacy, Peak Levels How soon to work in the day? reach peak levels? (T-max = time to reach maximum drug concentration) Likely fairly consistent given saturation kinetics Significant improvement SKAMP-DS at 2 hours** Mean T-max=3.7 hours* Mean T-max=4.5 hours; Range of T-max=4.5-6 hours** (n=8 Vyvanse; 70 mg) How does this compare to Adderall XR? Adderall XR carries higher variability; influenced by stomach pH/food content Significant improvement of SKAMP-DS at 3 hours** Mean T-max=6 hours; Range of T-max=3.00-12 hours** (n=9 Adderall XR; 30 mg) How might this compare to Concerta? Mean T-max=6.8 hours*** Clinical Practice Good. In the range of other ER formulations Booster IR-amphetamine can be used in the am if an issue Conclusions & Implications Vyvanse works soon enough May provide a more consistent T-max. More data needed T-max may be between Adderall-IR and Adderall XR *Krishnan S (2006): A multiple-dose single-arm pharmacokinetics study of oral lisdexamfetamine dimesylate (LDX; NRP-104) in healthy adult volunteers. Abstract presented at the New Clinical Drug Evaluation Unit 46th Annual Meeting; June 12-15, 2006; Boca Raton, Florida. **Biederman J, et al (2007). Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry 62:970-976. ***Concerta Package Insert. At: http://www.concerta.net/concerta/pages/full.jsp.
  • Slide 30 - What is Vyvanse’s duration of effect in a given day? How does this compare to other ER stimulants? Implications, Pros & Cons? VYVANSE: Distinguishing Clinical Features
  • Slide 31 - VYVANSE: Duration of Action Duration of Action Efficacy on attention and deportment at 12 hours* Efficacy on inattention and hyperactivity at 6 pm (dosed b/w 7:30-8:00 am)** Comparison to Adderall XR** Small trial; not an active comparison trial Vyvanse & Adderall XR both with significant effect on attention & deportment at 12 hours Change in math scores (PERMP) most favorable for Vyvanse (49 for LDX; 22 for Adderall XR; -24 for placebo) Clinical Practice Conclusions & Implications May offer greater efficacy in late afternoon/evening than other ER forms Avoidance of booster doses Mostly a positive Possibly a negative some patients prefer flexibility of dosing with other formulations sleep *Biederman J et al (2007). Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry 62:970-976. **Biederman J et. al (2007). Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a Phase III, multi-center, randomized, double-blind, forced-dose, parallel-group study. Clin Therapeutics 29: 450-463.
  • Slide 32 - Does Vyvanse offer more stable, consistent drug delivery than other (ER) stimulants? Implications for patients? Implications for clinicians? VYVANSE: Distinguishing Clinical Features
  • Slide 33 - VYVANSE: A More Consistent Drug Delivery System? Phase II Trial with Vyvanse, Adderall XR, and placebo arms (n=52)* Coefficient of variance (%CV) Measure of inter-patient variability of pharmacokinetic parameters Lower numbers reflect less inter-patient variability T-max (Time to max. concentration) Vyvanse - 15.33 Adderall XR - 52.77 C-max (Max. observed concentration) Vyvanse - 20.34 Aderrall XR - 43.96 Clinical Practice Implications Patients Clinicians Marketing *Biederman J et al (2007). Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry 62:970-976.
  • Slide 34 - Does Vyvanse offer a better safety profile among stimulants? Better alternative for patients at risk, or with a prior history of substance abuse? Other safety or side effect issues? How significant? VYVANSE: Distinguishing Clinical Features
  • Slide 35 - VYVANSE: Safety Profile, Overdose Toxicity1, 2 LD-50 Amount of drug expected to cause death of 50% of the animal population (ie, rats) LD-50 of Vyvanse greater than 1000 mg/kg LD-50 of amphetamine about 100 mg/kg Vyvanse carries significantly reduced toxicity compared with amphetamine Higher doses of Vyvanse lead to attenuated plasma concentrations (saturation kinetics) compared with amphetamine 1Krishnan S, et al. Determination of the acute oral toxicity of lisdexamfetamine dimesylate in rats [poster]. Presented at the 2007 Society of Biological Psychiatry; May 17-19, 2007; San Diego, California. 2Jasinski D, et al. Pharamacokinetics of oral lisdexamfetamine (LDXl NRP104) vs. d-amphetamine in healthy adults with a history of stimulant abuse [poster]. Presented at the 2006 U.S. Psychiatric & Mental Health Congress; November 17, 2006; New Orleans, LA.
  • Slide 36 - VYVANSE: Safety Profile, Misuse/Abuse Liabilities Schedule II: High Abuse Potential, Severe Dependence Liability Decreased Misuse/Abuse Liability? IR formulations: greatest risk, recreational use/misuse on college campuses ER formulations: less risk, can be crushed Vyvanse - oral ingestion required; no crushing, sniffing, etc…. Shire study: Vyvanse vs. amphetamine in patients with a history of drug abuse Drug-liking events (DLE) significantly less than amphetamine Implications Clinical Practice Marketing
  • Slide 37 - VYVANSE: Safety Profile, Substance Abuse Comorbidities Comorbidity of ADHD & Substance Use Disorders (SUD) Complicated & Extremely Signficant Clinical Area 30% adults: ADHD-SUD comorbidity* Stimulant treatment of ADHD reduces risk of SUD in adolescents** (contrary to what many may think) Clinical Practice A role for Vyvanse? When? “Wear-off” effects, drug re-enforcing behavior Clinical Trials Pilot study of Vyvanse in ADHD Adolescents at Risk for Substance Abuse (at clinicaltrials.gov) Sponsored by Columbia University; study start date January 2008 *Biederman J. Attention-deficit/hyperactivity disorder: a selective overview. Biol Psychiatry 2005; 57:1215-1220.\ **Biederman J, et al. Pharmacotherapy of attention-deficit/hyperactivity disorder reduces risk of substance abuse disorder. Pediatrics 1999; 104:e20.
  • Slide 38 - VYVANSE: Safety Profile, Side Effects Cardiovascular Profile/Side Effects Historical Background Canada, 2005: Adderall XR pulled from market ~ 6 mos based on 20 int’l reports of sudden death US FDA, 2006: Drug Safety/Risk Mgmt Comt. rec’d black box on CV risk; Pediatric Advisory Comt. against Stimulants in General* Retrospective cohort study (n=55,383; children/adolescents), Pediatrics, 12/07 20% increased hazard of cardiac ED/office visits, use v. non-use (low overall) Rates of serious or fatal manifestations of heart disease small and comparable to national background rates Vyvanse FDA and Agency for Health Research and Quality (AHRQ) Study most comprehensive study to date of potential CV risks and ADHD medications Completion ~2009/2010, n=500,000 children and adults Other Side Effects/Issues Distinctions from other ER stimulants *Winterstein AD, el al. Cardiac safety of central nervous system stimulants in children and adolescents with attention-deficit/hyperactivity disorder. Pediatrics. 2007; 120; 1494-1501.
  • Slide 39 - VYVANSE: Current Clinical Trials* Clinicaltrials.gov (as of 1/2/08) 9 registered clinical trials mostly for trials completed, or nearing completion, as basis of Shire’s FDA drug applications (children and adults) Shire sponsored trials (at clinicaltrials.gov) Classroom study to assess time of onset in children ages 6-12 with ADHD (study completed December 2007) Dose-optimization study in children ages 6-12 with ADHD study estimated close to completion dosing beginning with 20 mg, and up to 70 mg Columbia Study: Pilot Study of Vyvanse in ADHD Adolescents at Risk for Substance Abuse Open-label feasibility study, estimated start January 2008 Aim: develop method to approach and treat high risk youth before they develop substance abuse Safety Studies Across ADHD Drug Treatments (AHRQ Study) Implications *A listing currently registered Vyvanse clinical trials can be found at:http://clinicaltrials.gov by searching the term “Vyvanse”
  • Slide 40 - Practice Patterns: What Am I Doing? Colleagues? History IR Formulations Concerta vs. Adderall XR, Canada Vyvanse Initiating Stimulant Treatments Favoring ER formulations When Vyvanse? When Concerta or Adderall XR? Switching Stimulant Treatments “if it ain’t broke, don’t fix it”, changing views? Switching to Vyvanse Switching off Vyvanse Future
  • Slide 41 - Other (Clinical & Non-Clinical) Factors that May Affect Stimulant Prescribing Patterns
  • Slide 42 - Generic Incursion: The Landscape Ahead Adderall XR* Shire Pharmaceuticals/Barr Laboratories patent litigation settled Deal to allow Barr’s launch of generic Adderall XR as early as April 1, 2009, followed by 180 days market exclusivity of the generic Time delays? Concerta** Concerta patent expired 2004 Two parties have filed generic ANDAs, pending approval Ritalin LA*** November 2007, Barr Pharmaceuticals filed ANDA with Paragraph IV certifications for generic Ritalin LA Celgene & Novartis filed suit 30 month stay before FDA will accept ANDA *Shire/Barr: excitement levels rise on Adderall deal. At http://www.pharmaceutical-business-review.com/article_feature.asp?guid=28EC938C-683A-4E5F-90BC-770D38F4D471 **Johnson & Johnson 10-Q quarterly report, August 2007. At http://64.233.169.104/search?q=cache:-Q_PMr2NaFcJ:biz.yahoo.com/e/070808/jnj10-q.html+10-+and+Johnson+and+anda+and+concerta&hl=en&ct=clnk&cd=1&gl=us&ie=UTF-8 ***Barr sued over Ritalin LA patent challenge. FDA-News. At http://fdanews.com/newsletter/article?issueId=10988&articleId=100965
  • Slide 43 - How Will the Use of Vyvanse Be Affected by a Generic Adderall XR? Adderall XR & its generic equivalent(s) will NOT be the generic equivalent of Vyvanse Continuing Vyvanse Prescriptions. Clinically (and in my view, from a managed care quality of care standpoint) it will be problematic for patients taking Vyvanse to be pressured to take a “non-generic ‘generic’ alternative” of Vyvanse Initiating or Switching to Vyvanse Prescriptions. Formularies may revise their step-therapy protocols for initiating or switching to new Vyvanse prescriptions once a generic version of Adderall XR or Concerta is out Step-therapy may be bypassed by pre-certification How willing would clinicians be to take on pre-certs, other advocacy roles? Will Vyvanse be compelling enough clinically if such measures are required? When could a generic form of Vyvanse be available?
  • Slide 44 - VYVANSE: Insurance Coverage, Pricing Structure, & Positioning for Formulary Coverage
  • Slide 45 - 3-Tiered Formulary Models Three Tiers Tier 1 - Generics, least expensive co-pay Tier 2 - Preferred brand, middle co-pay Tier 3 - Non-preferred brand or generic, highest co-pay (Tiers 4, 5) – For self-injectables Step-Therapy Model If step-therapy is not followed, then the drug claim may be rejected Physician may bypass or override step-therapy by acquiring pre-certification (“medical exception”) for the drug Assessed on a case-by-case basis Typically can be done prior to or after the prescription is filled Formularies are dynamically evolving based on economic and medical factors
  • Slide 46 - 2008 Aetna Preferred Drug Guide,3,4, & 5 Tier Open Formulary Plans* * 2008 Aetna Preferred Drug Guide, 3,4 & 5 Tier Open Formulary Plans. At http://www.aetna.com/FSE/planType.do
  • Slide 47 - VYVANSE: Insurance, Price Structure & Positioning Where does Vyvanse stand in other prescription formularies/plans? Anthem Medco Others How will Shire’s pricing structure of Vyvanse (vs. Adderall XR, Concerta) position it for inclusion and coverage? Assumptions (wholesale, retail pricing) Selected retail data
  • Slide 48 - PRICING: Vyvanse, Adderall XR, and Concerta Chain Pharmacy in CT, December 2007 Vyvanse (#30 capsules/1 month supply) 30 mg daily dose - $134.99 50 mg daily dose - $134.99 70 mg daily dose - $134.99 Adderall XR (#30 capsules/1 month supply) 10 mg daily dose - $167.99 20 mg daily dose - $167.99 30 mg daily dose - $167.99 Concerta (#30/1 month supply) 18 mg daily dose - $132.99 27 mg daily dose - $140.99 36 mg daily dose - $138.99 54 mg daily dose - $157.99
  • Slide 49 - PRICING: Adderall, Branded & Generic Chain Pharmacy in CT, December 2007 (con’d) Amphetamine Line/Immediate Release Drugs Adderall (Branded Version) - #60 tabs 5 mg tabs - $86.99 10 mg tabs - $77.99 20 mg tabs - $77.99 Generic mixed amphetamine combo - #60 tabs 5 mg tabs - $25.39 10 mg tabs - $32.39 20 mg tabs - $39.59
  • Slide 50 - PRICING: Vyvanse, Adderall XR, & Concerta HMO Pharmacy in CT, December 2007 Vyvanse (#30 capsules/1 month supply) 30 mg daily dose - $125.63 50 mg daily dose - " 70 mg daily dose - " Adderall XR (#30 capsules/1 month supply) 5 mg daily dose - $125.63 10 mg daily dose - $ " 15 mg daily dose - $ " 20 mg daily dose - $ " 25 mg daily dose - $ " 30 mg daily dose - $ " Concerta (#30/1 month supply) 18 mg daily dose - $119.33 27 mg daily dose - $121.68 36 mg daily dose - $124.69 54 mg daily dose - $142.38
  • Slide 51 - PRICING: Adderall & Ritalin, Branded & Generics HMO Pharmacy in CT, December 2007 (con’d) Amphetamine Adderall (Branded Version) 5 mg tabs (#30 - $90.27; #60 - $163.53) 10 mg tabs (#30 - " ; #60 - $ " ) 20 mg tabs (#30 - " ; #60 - $ " ) Generic mixed amphetamine combo 5 mg tabs (#30 - $19.93; #60 - $24.41) 10 mg tabs (#30 - $24.69; #60 - $31.59) 20 mg tabs (#30 - $19.93; #60 - $24.21) Methylphenidate Ritalin #30 10 mg tabs - $33.88 #30 20 mg tabs - $47.33 Generic methylphenidate #30 10 mg tabs - $10.99 #30 20 mg tabs - $14.83
  • Slide 52 - Yet Other Factors that May Influence Rx Patterns…. Clinician Factors New clinical data, observable benefit, and tolerability The New-Drug-On-The-Market Phenomenon Who’s treating the ADHD? Patient Factors Perception of the drug Marketing & Public Awareness (ADHD, Vyvanse, Rx treatments) Adult ADHD Indication Greater Dosing Flexibility Will Novartis chose to market Focalin XR? New ADHD Drugs on the Market
  • Slide 53 - OVERVIEW: ADHD Drugs in The Pipeline The Problem with New Treatments Emerging Non-Stimulant Classes Alpha-2 agonists Neuronal Nicotinic Acetylcholine Receptor (NNR) agonists CV Safety The Adult ADHD Market Failures
  • Slide 54 - ADHD Drugs in the Pipeline “APPROVABLE”, now awaiting final FDA decisions SPD-465 (Shire) “Extended-release Adderall XR”, up to 16 hr effect Shire’s plans INTUNIV (Shire) Extended release guanfacine Non-stimulant, alpha-2 agonist Efficacy data & side effect profile Phase III CLONICEL (Sciele Pharma/Addrenex) First Phase III Trial, Children & Adolescents, initiated October 2007 Extended release clonidine Non-stimulant, alpha-2 agonist
  • Slide 55 - ADHD Drugs in the Pipeline Phase II ABT-089 (Abbott Labs) Children & Adults, ADHD Neuronal Nicotinic Acetylcholine Receptor (NNR) partial agonist (alpha4beta2) Published clinical data (n=11) ABT-894 (Abbott Labs/Neurosearch) Adult ADHD, initiated March 2007 Neuronal Nicotinic Acetylcholine Receptor (NNR) agonist (alpha4beta2) MK0249 (Merck) Adult ADHD, study start date July 2007 GTS21 (CoMentis) Adult ADHD ? Status (per CoMentis website, Phase II expected Q4 2007; per clinicaltrials.gov, Phase II/I “not yet open”, last updated January 2007) Neuronal Nicotinic Acetylcholine Receptor (NNR) agonist (alpha7) PF-03654746 (Pfizer) Adult ADHD (not yet enrolling, clinicaltrials.gov) ? Novel Mechanism of Action (in a decongestant study) JNJ-31001074 (Alza) Adult ADHD (not yet open for recruitment) Info last updated Dec 2007, clinicaltrials.gov Phase I & Pre-Clinical

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