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Ensuring Remoxy success

Ensuring Remoxy success






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    Ensuring Remoxy success Ensuring Remoxy success Presentation Transcript

    • “Make  the  World  a  Be/er  Place”   Ensuring  REMOXY  Success  Timothy R. Roe!82 Sherry LaneKensington, CT 06037(860) 829-6688 Home(860) 518-5571 Cellt.roe@m2details.com Emailwww.m2details.com Web Confidenal  
    • Contents  Page   3   Objec3ves  and  Limita3ons   6   About  the  Launch   9   Background  Informa3on   23   Compe33ve  Look   33   REMOXY  In  Vivo   44   Market  Development  and  Projec3ons   47   Strategic  Approach   61   Research  and  Backup  Slides   2   Confidenal  
    • OBJECTIVES  AND  LIMITATIONS   3   Confidenal  
    • ObjecCves  of  PresentaCon  •  Thorough  understanding  of  the   marketplace,  REMOXY  and  the   commercial  environment  •  Depict  ability  to  think   strategically   4   Confidenal  
    • LimitaCons  •  Only  publically  available  informa3on  was   u3lized  •  Some  data  could  not  be  adequately   referenced,  thus  valida3on  maybe  suspect.  •  Some  public  informa3on  maybe  dated  or   inaccurate.  •  Conclusions  or  plans  based  on  this  work   represents  only  one  strategic  direc3on  and   is  without  the  benefit  of  team  input   (Marke3ng,  Managed  Markets,  Tech  Ops,   Finance,  Medical,  Legal,  Regulatory  and   Compliance,  to  name  a  few).  •  Time  –  The  deck  is  long.    I  will  breeze   through  some  parts  that  are  well-­‐ understood.    Some  slides  are  incomplete   but  the  thought  process  is  present.   5   Confidenal  
    • ABOUT  THE  LAUNCH   6   Confidenal  
    • One  Shot  To  Get  It  Right!!  •  The  World  is  Watching…Wai3ng  •  King  absolutely  needs  this   success  •  Tireless  pre-­‐launch  effort  •  Address  Unmet  Needs  in  Opioid-­‐ based  Pain  Management  •  Not  an  incremental  step  toward   abuse-­‐resistance  –  Must  ensure   percep3ons  are  managed   consistently  across  all  channels   and  targeted  segments     7   Confidenal  
    • REMOXY   “Making  the  World  a  Be1er  Place”   Im Gonna Make A Change,! For Once In My Life!Its Gonna Feel Real Good,! Gonna Make A Difference! Gonna Make It Right . . .!…Im Starting With The Man In! The Mirror! Im Asking Him To Change! His Ways! And No Message Could Have! Been Any Clearer! If You Wanna Make The World! A Better Place! (If You Wanna Make The! World A Better Place)! Take A Look At Yourself, And! Then Make A Change! 8   Confidenal  
    • BACKGROUND  INFORMATION   9   Confidenal  
    • /   (The  Deal)  •  Ini6al  Terms     –  Big  upfront  –  $150  million   –  Significant  milestones  –  up  to  $150  million   –  Royales  15-­‐20%   –  King  to  fund,  but  PTI  to  control  development  through  Phase  II,  joint  control  through  Phase  III  •  Complica6ons     –  PTI  license  to  Durect  Technology   •  King  to  meet  all  PTI  obligaons  to  Durect  (due  diligence,  etc.)     –  Inial  Legal  Hurdles   •  Limited  to  Durect  technology  applied  to  certain  opioids     •  Possible  compeon  from  other  Pain  (non-­‐Durect)  products     •  Considered  limited  “Right  of  First  Offer”  •  CommercializaCon  Due  Diligence   –  Agreed  on  detailed  ini3al  budget  for  King   –  Couldn’t  agree  on  detailed  full  budget  at  3me  of  signing,  so  agreed  on  minimum  and  maximum  level   of  spending  over  several  years  with  JDC  to  determine  specifics   Source:  Wilson  Sonsini  Goodrich  &  Rosa3  Post-­‐Contract  Presenta3on   10   Confidenal  
    • Chronic  Pain  Prevalence   •  Up  to  56  million  American  adults   (28%  of  the  adult  popula3on)   experience  chronic  pain.     –  16  million  experience  low-­‐back  pain   –  48  million  have  arthri3s—a  disease   associated  with  chronic  pain   –  25  million  have  migraine  pain   –  20  million  have  jaw  and  lower-­‐facial   pain   –  4  million  have  neuropathic  pain   •  Many  people  have  lived  with  pain   for  >5  years  and  experience  it   almost  six  days/week   •  Younger  people  are  as  likely  to   experience  chronic  pain  as  are   older  people   •  One-­‐third  of  Americans  lose  20   hours  of  sleep  a  month  because  of   pain  Source:  PainBalance.org  (Funded  by  and  data  provided  by  King  Pharmaceu3cals)   11   Confidenal  
    • Burden  of     Moderate-­‐Severe  Chronic  Pain  •  Total  U.S.  direct  and  indirect  cost  of  chronic  pain  is  between  $50  &  $90  billion  per  year   –  $4  billion  of  lost  income  and  produc3vity,  as  well  as  healthcare  costs,  associated  with  arthri3s   pain   –  People  with  headache  pain  spend  $4  billion  on  medica3ons  according  to  a  2007  study  •  Chronic  pain  is  associated  with  millions  of  days  of  lost  work   –  Chronic  pain  brings  a  burden  of  depression,  anxiety,  frustra3on,  fa3gue,  isola3on,  and  lowered   self-­‐esteem.    It  shaoers  produc3ve  lives.   –  “Presenteeism”:  75%  of  the  lost  Produc3vity  is  due  to  Reduced  performance  while  on  the  job  –   not  work  absences.   –  25%  of  people  in  industrialized  countries  lose  work  because  of  chronic  pain   –  People  with  low-­‐back  pain  lose  93  million  days  of  work  according  to  a  2007  study   –  People  with  headaches  and  migraine  headaches  lose  157  million  days  of  work  according  to  a  2007   study  •  The  American  Board  of  Pain  Medicine  has  taken  the  lead  in  educa3ng  and  creden3aling   pain  medicine  specialists.       –  So  far,  the  board  has  cer3fied  just  1,700  doctors  as  pain  specialists.  Thats  about   one  pain  specialist  for  every  23,500  people  who  need  care.   –  With  specialists  so  rare,  many  pa3ents  are  cared  for  by  doctors  who  lack  training   and  experience  in  the  appropriate  use  of  pain  therapies.  Source:  Chronic  Pain  Organiza3on  Web  Site  May  7,  2010    Stewart,  WF  et  al.  JAMA,  2003;290:2443-­‐2454    PainBalance.org  (Funded  by  and  data  provided  by  King  Pharmaceu3cals)   12   Confidenal  
    • Under-­‐Treatment  •  Only  25%  of  those  suffering  from  chronic  pain  receive   appropriate  treatment   –  Postopera3ve,  cancer,  and  chronic  pain  are  unlikely  to  be  treated   adequately   –  Elderly,  children,  minori3es,  and  substance  abusers  are  unlikely  to   receive  adequate  pain  care   –  Doctor  visits  for  pain-­‐related  illnesses  were  the  primary  reason  for  66.16   million  visits—7.3%  of  all  visits—in  the  United  States  in  2003   –  Drugs  for  the  relief  of  pain  were  prescribed  during  all  pa3ent  visits  more   oten  than  any  other  therapeu3c  class  •  Reasons  for  Under-­‐treatment   –  Failure  of  healthcare  professionals  to  properly  assess  pain     –  Pa3ent  factors  such  as  financial  barriers  and  poor  adherence     –  Mispercep3ons  among  healthcare  professionals  about  the   consequences  of  opioid  use     –  40%  of  people  with  chronic  non-­‐cancer  pain  are  not  currently  under  a   healthcare  professional’s  care          •  Many  non-­‐unified  pain  assessments  and  treatment  algorithms  Source:  PainBalance.org  (Funded  by  and  data  provided  by  King  Pharmaceu3cals)   13   Confidenal  
    • Major  Barriers  to  NarcoCc  Use  •  PaCent  and  Physician  PercepCons   •  Supply  Issues   –  Ease  of  abuse   –  FDA   –  Addic3on  poten3al   •  Stops  several  manufacturers  from  produc3on   un3l  passing  modern  approval  process   –  Concern  of  stereotyping/s3gma   •  Under  higher  scru3ny  ater  Cox-­‐2  Crisis  –  more  •  Physician  Issues  (Opiophobia)   stringent  rules  for  new  and  safer  drug  op3ons   –  Rx  matching,  regulatory  scru3ny   –  Pharmacy  Boolenecks   •  Blame  distribu3on  issues   –  Abuse  poten3al   –  Distribu3on  System   –  Subop3mal  knowledge  of  pain  and  poor   •  Security  (Loss  Preven3on  &  Training)   assessment  tools   •  Refrigera3on  requirements   –  Fear  of  Robbery   •  Short-­‐dated  product   –  PCPs  manage  50%  of  all  pa3ents  with  pain   •  Manufacturer  supply  factors   –  Pa3ent  non-­‐compliance  with  script   •  Cost  and  Coverage   –  50%  of  pa3ents  found  it  necessary  to  change   –  Manufacturer  Price/Rebate  Structure   physicians,  primarily  because  of  inadequate   pain  management   –  Independent  Insurance/Payer  Coverage,   Treatment  Protocols  &  Guidance  and  Tier   –  Oten  relegated  for  terminally  ill  pa3ents   Structure   leaving  less  supply  for  others   –  Addi3ve  cost  for  abuse  and  dependency   –  Overdose  with  lethal  consequences   treatments   •  The  number  of  fatal  poisonings  involving  opioid   analgesics  more  than  tripled  from  4,000  in  1999   –  Diversion  and  Overseas  Counterfei3ng     to  13,800  in  2006,  according  to  the  Centers  for   Disease  Control  and  Preven3on   ly   Supp   ician Phys ns   ep3o Perc Needs  Treatment   14   Confidenal  
    • FiZh  Vital  Sign   Pain  is  recognized  as  the  “Fith  Vital  Sign”  by  the   Joint  Commission  on  Accredita3on  of  Healthcare   Organiza3ons,  the  American  Pain  Society,  and   the  Veterans  Health  Administra3on.  Research  shows  that  when  pa3ent’s  acute  pain  is  managed  around  the  clock  and  the  pain  level  is  kept  from  becoming  severe,  the  total  amount  of  opioid  needed  is  reduced.     1.  Body  temperature        2.  Pulse  rate  (or  heart  rate)        3.  Blood  pressure        4.  Respiratory  rate   5.  Pain     15   Confidenal  
    • Failure  to  Adequately     Treat  and  Manage  Chronic  Pain   Tradi3onal  Approach:   Most  Chronic  Pain   PT  with  Unmanaged   cannot  be  treated  like   Chronic  Pain   acute  pain.    It  cannot  be   cured,  it  must  be   Healthcare  Costs  Rise,   managed.   Seen  by  PCP  or   MCO’s  Restrict  Access   Specialists   Further  In  a  2008  APS  study,  nearly  50%  of   PT  has  difficulty  pa3ents  found  it  necessary  to  change   func3oning  produc3vely,   Majority  Treated  Under  physicians  at  least  twice,  primarily   misses  work,  develops   Acute  Pain  Algorithms  because  of  inadequate  pain   secondary  depression    management.  70%  who  received  treatment   Seen  by  PCP  #2,  3…  Due  con3nued  to  report  pain.   To  Non-­‐Relief   Modern  Approach:    Neurobehavioral  Model   Chronic  Pain   PCP/ • Assessed   Pain  Under  Control   PT   • Ini3al  Treatment   PT   Presenta3on   Spec   • Managed   for  Long-­‐Term   Gallagher,  RM,  Med  Clin  Noth  Amer,  1999,  83  555-­‐583;  Gallagher,  RM,  AmJ  Phys  Med  Rehab  2005,  B4  (Suppl)  s64-­‐s76   16   Confidenal  
    • Opioids: Advantages and Disadvantages •  Advantages   –  Effec3ve  against  moderate  to  severe  pain,   par3cularly  nocicep3ve  pain   –  No  dose  ceiling   –  No  end-­‐organ  toxicity   •  Disadvantages   –  Poten3ally  addic3ve  Class  II  controlled  substances   •  Pose  risk  of  abuse,  misuse,  and  diversion   –  Dosage  limita3ons  due  to  side  effects—especially   cons3pa3on,  nausea,  and  somnolence—may  be   necessary   –  Can  cause  respiratory  depression  and  should  be   used  with  cau3on  in  pa3ents  with  impaired   ven3la3on  Source:  PainBalance.org  (Funded  by  and  data  provided  by  King  Pharmaceu3cals)   17   Confidenal  
    • Side-­‐Effects  of  Oxycodone  IM   Side  Bar   Worldwide  Produc3on  Growth  11.5  tons  in  1998  75.2  tons  in  2007  (U.S.  accounts  for  82%  or  51.6  tons  in  2007)   That’s  3  trucks  or  1  C-­‐5  Galaxy   American  Society  of  Health-­‐System  Pharmacists  (2009-­‐03-­‐23).  "Oxycodone".      U.S.  Na3onal  Library  of  Medicine,   MedlinePlus.  hop://www.nlm.nih.gov/medlineplus/druginfo/meds/a682132.html.  Retrieved  2009-­‐03-­‐27.   18   Confidenal  
    • Common  Opiate  Methods  of  Abuse     by  Brand   Source:  Budman    et  al.  Harm  Reduc3on  Journal  2009  6:8   19   Confidenal  
    • REMOXY  ADF   Crushed  REMOXY   Crushed  OxyCon3n   No  Rapid  Release     Euphoria   of  Oxycodone   20   Confidenal  
    • REMOXY  Design    •  ORADUR  Technology  (SABER)   –  Gel  cap  sustained  release   –  Novel,  long-­‐ac3ng  formula3on   –  U3lizes  a  high-­‐viscosity  base  for  controlled  release   of  ac3ve  over  12  to  24  hour  period   –  Less  prone  to  abuse   –  Manufactured  by  a  simple  process  using   conven3onal,  scalable  methods   –  Lower  CoGS  than  most  compe33on  yields  higher   profit  margins   21   Confidenal  
    • REMOXY  as  a  Recognized  Name     “Pre-­‐CommercializaCon”   22   Confidenal  
    • Current  and  Horizon    COMPETITIVE  LOOK   23   Confidenal  
    • CompeCCon/OxyConCn  Approval  •  The  new  formula3on  will  most  likely  result  in  less   abuse  by  inhaling  or  injec3on,  but  it  s3ll  can  be   “Hillbilly  Heroin”   abused  or  misused  by  inges3ng  larger  doses  than  are   recommended,  the  F.D.A.  said.    •  With  the  previous  formula3on,  those  intent  on   abusing  the  drug  could  release  high  levels  of   oxycodone  all  at  once  by  tampering  with  the  pills.    •  “Although  this  new  formula3on  of  OxyCon3n  may   provide  only  an  incremental  advantage  over  the   current  version  of  the  drug,  it  is  s3ll  a  step  in  the  right   direc3on,”  Bob  Rappaport,  the  F.D.A.’s  director  of  the   Division  of  Anesthesia  and  Analgesia  Products,  said  in   a  statement.     Approved:  April  5,  2010   24   Confidenal  
    • REMOXY  Needs  a  Respectable  Piece   of  The  Pie   50M  US  Chronic  Pain  Sufferers   25   Confidenal  
    • CompeCCve  Oxycodone  ERs  in   Development  Morphine  in  Phase  II,  Oxycodone  in  Phase  I   26   Confidenal  
    • CompeCCve  Oxycodone  ERs  in   Development   27   Confidenal  
    • Egalet  CompeCCve  Deterrent   28   Confidenal  
    • Egalet  Compared  to  Others  Including   REMOXY   29   Confidenal  
    • CompeCCve  Oxycodone  ERs  in   Development  Resists  Typical  Methods  of  Abuse:  •  When  crushed  or  ground  and  taken  orally,  releases  drug  comparably  to   INTELLITABs  delivery  mechanisms  maintain  the  controlled-­‐release   an  intact  tablet,  and  significantly  less  than  compe3ng  technologies   proper3es  of  a  drug  even  if  the  tablet  is  broken,  crushed  or  consumed  with  •  When  crushed  or  ground  and  snorted,  releases  significantly  less  drug   alcohol.    Addi3onally  if  crushed  and  added  to  water,  alcohol  or  other   than  an  intact  tablet,  and  significantly  less  than  compe3ng  technologies   solvents,  form  a  solid  matrix  that  will  prevent  intravenous  injec3on  or  •  When  crushed  or  ground,  cannot  be  injected   insuffla3on  (snor3ng).  •  When  placed  in  alcohol,  will  not  dose  dump   30   Confidenal  
    • Other  ADFs  •  OxyCon3n  –  oxycodone  CR  (Purdue)   –  Not  permioed  to  market  the  tablet  as  tamper  resistant.   –  New  tablet  will  be  marketed  as  a  switch-­‐out  for  the  old  tablet   "so  both  will  not  be  sold,”  there  are  no  labeling  changes.   –  Is  marginal  improvement  so  granted  approval.  •  Acurox  –  oxycodone  IR  (Acura/King)   –  “Among  the  weakest  and  most  fundamentally  flawed  of  the  ADF   formula3ons  currently  in  development.”   –  ADF  defeated  with  325mg  Aspirin.    Niacin  flushing  will  simply   drive  pa3ents  to  other  physicians  the  Rx  of  a  non  ADF  IR  agent.   –  Could  get  “ Tamper  Resistant”  label  resul3ng  in  a  marginal   improvement  and  be  approved   –  Will  add  several  years  to  development  3meline.    Company  only   has  $33  million  cash.   31   Confidenal  
    • Other  ADFs  •  Embeda  –  (King)  •  COL-­‐003  &  COL-­‐172  –  DETERx  Technology   (Collegium)  •  ATLP-­‐0001  –  Smart/Script  (Atlan3c)  •  OxyTrex  (PTI)  •  Rexista  (IntelliPharm)   32   Confidenal  
    • Watch  for  Transdermal  Opioids   •  Delay  in  onset  of  plasma  levels   •  Appears  to  be  efficient  route  for  chronic  pain   condi3ons  (Small  Compound  Molecule)   •  Examples     •  Fentanyl  (Duragesic,  IonSys)   •  Sufentanil  (Endo,  In  Development)   •  Buprenorphine  (Europe,  Australia)   •  Hydromorphone  (Altea,  In  development)   Source:    Pamela  P.  Palmer,  MD     Professor  and  Director,  UCSF  PainCARE        Chief  Medical  Officer,  AcelRx  Pharmaceu3cals,  Inc.   33   Confidenal  
    • REMOXY  IN  VIVO   34   Confidenal  
    • REMOXY  IN  VIVO  RESULTS  Summary  Four  robust  in  vivo  studies  have  shown  that  under  certain  physical  and  chemical  challenges  the  controlled-­‐release  formulaon  of  REMOXY  is  not  defeated  and  that  these  challenges  do  not  result  in  a  rapid  release  or  dose  dumping  of  oxycodone.    Moreover,  a[er  mechanical  and/or  chemical  manipulaon,  the  rate  of  rise  of  oxycodone  plasma  concentraons  from  REMOXY  is  less  and  the  Tmax  is  longer  than  a[er  an  oral  oxycodone  soluon  or  OxyConn.  The  a]racon  of  drugs  such  as  oxycodone  for  abuse  purposes  requires  an  effect  that  is  both  rapid  and  intense.    The  Abuse  Quoent  (AQ),  a  measure  of  a]racveness  of  a  formulaon  for  abuse,  for  REMOXY  a[er  physical  and/or  mechanical  manipulaon  remained  far  below  that  of  OxyConn  when  manipulated  in  a  similar  manner,  or  a[er  an  immediate  release  oral  soluon  of  oxycodone.  The5  4  3  2  1  0REMOXY  +4%  EtOH  :  REMOXY  +  Water  REMOXY  +  20%  EtOH  :  REMOXY  +  Water  REMOXY  +  40%  EtOH  :  REMOXY  +  Water0  10  20  30  Subject57  of  60Cmax  RaoNDA  22-­‐324  -­‐  REMOXY®  Advisory  Commi]ee  BriefingAvailable  for  Public  Releasecombined  data  from  these  studies  suggest  that  REMOXY  a[er  certain  physical  and  chemical  challenges  may  offer  less  appeal  for  abuse  than  its  comparators.   (Detailed  Slides  in  Backup  Sec3on)   35   Confidenal  
    • REMOXY  –  Efficacy  Success     in  Phase  III  Trial   36   Confidenal  
    • REMOXY  –  Efficacy  Success     in  Phase  III  Trial   37   Confidenal  
    • REMOXY:  AnC-­‐Abuse  Crushing  Results   (N  =  10)   38   Confidenal  
    • REMOXY  Pivotal  Phase  III  Study   Design   39   Confidenal  
    • REMOXY  In  Vivo  Results  1  •  PTI-­‐821-­‐CZ   –  The  controlled-­‐release  mechanism  of  the  formula3on   was  not  defeated  ater  crushing  and  extrac3ng  with   40%  ethanol.   –  Tmax  for  REMOXY  ater  tamper  was  significantly  greater   than  and  twice  as  long  as  that  of  OxyCon3n.  Cmax   –  Although  the  rate  of  absorp3on  was  increased  ater   tamper,  it  remained  well  below  that  of  OxyCon3n  and   for  the  comparator  immediate  release  solu3on.   40   Confidenal  
    • REMOXY  In  Vivo  Results  2  •  PTI-­‐821-­‐C04   –  Early  Exposure  (AUC)  to  oxycodone  ater  chewing  REMOXY  was  much   lower  than  ater  an  oral  solu3on,  suppor3ng  the  premise  that  the   controlled  release  formula3on  was  maintained.   –  A  decrease  in  Tmax  and  an  increase  in  Cmax  were  observed  ater   rigorous  chewing  of  REMOXY.  However,  the  data  indicated  that  the   controlled-­‐release  mechanism  of  the  REMOXY  formula3on  was  not   defeated,  as  was  evident  from  the  lack  of  dose  dumping  and  plasma   concentra3on  profiles  which  retained  a  broad  plateau,  from  a  Tmax   which  remained  approximately  2.5-­‐fold  longer  than  ater  an  oral   oxycodone  solu3on,  and  a  Cmax  which  was  lower  than  ater  an  oral   solu3on.     –  The  data  taken  together  demonstrate  that  although  mas3ca3on  of   REMOXY  does  increase  the  rate  of  absorp3on  of  oxycodone  and  peak   exposure  compared  to  REMOXY  swallowed  whole,  it  does  not   approach  that  observed  with  an  immediate  release  oxycodone  oral   solu3on.   41   Confidenal  
    • REMOXY  In  Vivo  Results  3  •  PTI-­‐821-­‐CU   –  Results  from  this  study  show  that  buccal   administra3on  of  REMOXY  resulted  in  an  increase   in  the  rate  of  oxycodone  exposure,  but  one  that   was  much  lower  than  ater  an  oxycodone  oral   solu3on.     42   Confidenal  
    • REMOXY  In  Vivo  Results  4  •  PTI-­‐821-­‐CS   –  Ater  co-­‐inges3on  of  REMOXY  with  ethanol  from  4-­‐40%  the   plasma  concentra3on  profiles  were  similar  to  those  ater   inges3on  with  water  and  con3nued  to  display  typical   controlled  release  proper3es,  consistent  with  maintenance   of  the  controlled-­‐release  characteris3cs  of  the  formula3on   and  without  any  evidence  of  dose  dumping.     –  There  were  no  significant  effects  on  the  rate  or  extent  of   absorp3on  of  oxycodone  ater  administra3on  of  REMOXY   with  4%  or  20%  ethanol  and  overall  exposure  was  not   affected.     –  There  was  a  minor  increase  in  Cmax  (10%)  and  exposure   ater  co-­‐inges3on  with  40%  ethanol.  Tmax  was  not  affected   by  co-­‐inges3on  of  REMOXY  with  ethanol  from  4-­‐40%   43   Confidenal  
    • Opioid  Market  Development  1  Share  Point  =  77  Million  USD   45   Confidenal  
    • REMOXY  Capture  ProjecCons   Confidenal   46  
    • STRATEGIC  APPROACH…   47   Confidenal  
    • Strategy  Under  My  Tutelage:   Strategic Optimization Model PEQ322 Input Customer Data HereThe  strategic  plan  must  be     •  Op3mized   •  From  the  customer’s   perspec3ve   •  Include  Posi3oning  Analysis   from  “R”  to  “2B”   •  Non-­‐issues  based   •  Allow  for  tac3cal  curve-­‐fi}ng   •  Fully-­‐developed  and  approved   48   Confidenal  
    • OpCmizaCon  An  op3mized  strategic  plan  is...   •  Simply  a  roadmap.    It  tells  us  where  we  “R”    today  and  where  we  need  “2B”  in  the  minds   of  our  customers  in  order  to  meet  internal  objec3ves.    It  is  always  an  external  view,   never  internally  focused.       •  Based  on  customer  (both  Rx’er  and  end-­‐user)  percep3ons  at  3me  points  “R”  and  “2B”   •  Customer  percep3ons  should  be  measured  across  several  meaningful  aoributes  rela3ve   to  product  profile,  customer  expecta3ons,  and  compe33ve  profiles  –  it  is  that  easy!   •  Percep3ons  are  80%  reality  (Peter  Drucker  -­‐  modified  Pareto’s  Principle)   •  Remember  the  marke3ng  adage    form  product  launches  “You  are  not  actually  launched   unless  your  customers  can  recognize  and  tell  you  that  you  are”   •  Never  issues-­‐based!      An  issues-­‐based  plan  is  never  op3mized.    In  an  op3mized  plan,   issues  are  nothing  more  than  a  bump  in  the  road.    Planning  for  issues  that  may  or  may   never  occur  waste  planning  3me  and  resources.    If  an  issue  is  large-­‐enough  to  be   included  in  the  plan,  then  it  is  not  an  issue,  rather  a  cri3cal  success  factor  to  overcome   •  Simple  to  understand  and  communicate       49   Confidenal  
    • Sample  PercepCon  Analysis…  Example:  Along  2  Aoributes:  Sa3sfac3on  and  Loyalty   Example:  Along  5  Geographic  Aoributes   50   Confidenal  
    • Mapping  Stakeholders  Interests  vs.   REMOXY  Pain  PosiCon  REMOXY  Has  Each  Stakeholder  Covered  Stakeholders  •  Pa3ents   –  BID  Pain  Coverage  with  no   breakthrough  pain   –  Less  side-­‐effects  (no  dose   dumping)  •  Physicians   –  Safety  (no  dose  dumping)   –  Avoid  diversion  •  FDA   –  Promotes  general  safety  to   the  popula3on  •  Payers   –  Stops  PT  doc-­‐seeking  cycle   thus  reducing  total  medical   costs   –  Avoid  fraud  and  diversion   51   Confidenal  
    • P.E.S.T.   (PoliCcal,  Economic,  Social,  and  Technological  Analysis)   •  Should  be  Included  as  part  of  planning   •  Helps  define  cri3cal  success  pathways  The  PEST  factors  can  be  classified  as  opportuni3es  and  threats  in  the  S.W.O.T.   52   Confidenal  
    • S.W.O.T.  -­‐  IniCal  Look   Internal  Factors   •  Controlled  release  mechanism   intact  ater  40%  Ethanol   Weaknesses  Strengths   •  Tmax  Significantly  greater  and  2X   •  Slight  rate  of  absorp3on  increase   as  long  as  OxyCon3n   •  Small  increase  in  Cmax  ater  co-­‐ •  Rate  of  absorp3on  with  40%   inges3on  with  ethanol   ethanol  id  similar  to  that  of  water   •  High  bioavailability   External  Factors  Opportuni3es   •  First  true  XRT  oxycodone  to   market   •  FDA  –  stability  issues   Threats   •  Physicians  will  feel  more   •  Unmo3vated  or  uninterested   comfortable  prescribing   sales  force   •  Managed  Markets  should  provide   coverage  immediately   53   Confidenal  
    • One  Last  Word  On  Strategy  Development     Most  organiza3ons,  independent  of  industry,  spend  very  liole   resources  on  strategy  development     •  Brand  Engineers  es3mates  that  less  than  1%  of  budget  dollars  go  toward  strategy  and   posi3oning.  “ The  irony  in  this  is  that  these  are  the  marke3ng  aspects  that  ul3mately   drive  the  vast  majority  of  your  spend.  Even  if  you  allocated  2%  or  3%  to  ensuring   appropriate  strategic  and  posi3oning  insight,  would  that  s3ll  be  enough?”   Ill-­‐Strategic  planning  leads  to  poorly  op3mized  tac3cal  plans   and  can  actually  do  more  harm  over  the  log-­‐term   •  Example:  Quiznos  Creatures  Campaign   Bad  Tac3cal  Ideas*:    The  Quiznos  creatures  Superimposed  over  a  Quiznos  sub   shop  were  two  disturbing,  singing  rat-­‐like  creatures.  No  one  wanted  to  eat  in  a   place  associated  with  disease-­‐ridden  rats.     Fortunately,  the  shop  got  wise  and  ditched  them  ater  public  outcry.  But  it’s  an   image  that  stays  with  you.    Quiznos  is  s3ll  recovering.   Go  ahead,  look  them  up  on  YouTube–but  don’t  say  you  weren’t  warned.    They  are   all  too  reminiscent  of  the  sort  of  guys  who  hang  outside  a  Quiznos  and  ask  for   your  change!   *Entrepreneur  Magazine,  Ten  Best  and  Worst  Campaigns  Ever,  January  29,  2009   54   Confidenal  
    • “TACDEVEX”  •  TAC3cal  DEVelopmental   EXercises  are  not  new   concepts  •  There  are  countless   exercises  to  prepare  a   team  for  posi3ve,   crea3ve  and  enjoyable   tac3cal  planning.     55   Confidenal  
    • TacCcal  Curve-­‐Fikng  •  Will  fast,  inexpensive  “buses”,  or  large,  preoy-­‐ to-­‐look-­‐at,  slow-­‐moving  “yachts”  to  take  you   where  you  need  to  go  on  3me?  •  Not  all  tac3cal  ideas  are  appropriate  just   because     •  everyone  is  doing  it     •  it  has  been  done  this  way  for  years   •  it  is  easy   •  it  is  proven  to  work  •  This  is  where  team  crea3vity  comes  in...   56   Confidenal  
    • Aktude  of  Team  Before  Exercises   •  Kioen  vs.  Baby  Monkey  A}tude*   •  Kioen  in  Danger  or  Confused  -­‐  meows  and  waits  for  mother   •  Baby  Monkey  -­‐  runs  to  mother,  jumps  on  her  back  and  hangs  on   for  itself.   •  These  exercises  are  for  monkeys!     •  Control  Your  “FUDs”   •  Nothing  is  more  harmful  to  posi3ve  crea3ve  a}tude  than  fears,   uncertain3es  and  doubt  (FUDs).    When  you  are  depressed,  your   thoughts  are  quite  different  from  when  you  are  happy.    When   you  feel  rich  and  successful,  your  thoughts  are  different  from   when  you  feel  poor  and  inhibited.*   *  Michael  Michalko,  Thinkertoys,  10-­‐Speed  Press,  1991   57   Confidenal  
    • Human  Need  for  Consistency   •  If  thoughts  are  inconsistent  with   other,  stronger  ideas,  then  the   mind  will  reject  them.   •  Example:  Most  people  immediately   see  only  one  way  to  cut  “13”  in   half.   *  Michael  Michalko,  Cracking  Crea3vity,p2,  10-­‐Speed  Press,  1991   58   Confidenal  
    • Need  a  Partner  in  Sales!!  Find  a  way  to  mo3vate  the  troops  while  op3mizing  the  por‚olio.    It  may  translate  into  changes  for  the  beoer.  Do  we  have  enough  SOV?   59   Confidenal  
    • Timothy R. Roe! 82 Sherry Lane Kensington, CT 06037 (860) 829-6688 Home (860) 518-5571 Cell t.roe@m2details.com Email www.m2details.com WebTogether,  we  can  make  the  “World  a  Beoer  Place”  THANK  YOU!   60   Confidenal  
    • Personal  Research  RESEARCH  AND  OTHER  BACKUP  SLIDES   61   Confidenal  
    • SEVERE  PAIN  HAS  A  MAJOR  NEGATIVE  IMPACT  ON   EMOTIONAL  WELL-­‐BEING   WHETHER  OR  NOT  PAIN  IS  UNDER  CONTROL     Husband  describes  wife’s  pain  as  “almost  being   a  third  person  in  our  marriage”.  Source:    American  Society  Web  Site  May  7,  2010   62   Confidenal  
    • SEVERE  PAIN  HAS  A  MAJOR  NEGATIVE  IMPACT  ON   QUALITY  OF  LIFE   WHETHER  OR  NOT  PAIN  IS  UNDER  CONTROL    Source:    American  Society  Web  Site  May  7,  2010   63   Confidenal  
    • Quality  of  Life  Improvement  on   NarcoCc  Pain  Reliever   THE  QUALITY  OF  LIFE  HAS  IMPROVED  SIGNIFICANTLY  AMONG  THOSE  WHO   HAVE  THEIR  PAIN  UNDER  CONTROL.  Source:    American  Society  Web  Site  May  7,  2010   64   Confidenal  
    • EMPLOYERS  ARE  NOT  AS  SUPPORTIVE  AS  CLOSE   FAMILY  AND  FRIENDS  OR  DOCTORS  Source:    American  Society  Web  Site  May  7,  2010   65   Confidenal  
    • PercepCon  of  Pain  Relief  by  Drug  Type   ALMOST  75%  OF  CHRONIC  PAIN  SUFFERERS  PERCEIVE  OTCs  AS  BEING  EFFECTIVE  IN  RELIEVING  MODERATE  TO   SEVERE  PAIN   A  MAJORITY  ALSO  BELIEVE  NARCOTIC  PAIN  RELIEVERS  AND  Rx  NSAIDS  WOULD  PROVIDE  EFFECTIVE  RELIEF   Source:    American  Society  Web  Site  May  7,  2010   66   Confidenal  
    • Current  Pain  Relief  MedicaCon  Usage   THOSE  WITH  VERY  SEVERE  PAIN  ARE  MORE  LIKELY  TO  USE  ANTI-­‐DEPRESSANTS  AND  ANTI-­‐SEIZURE  DRUGS   Source:    American  Society  Web  Site  May  7,  2010   67   Confidenal  
    • Severity  of  Pain  for  NarcoCc  Users   Source:    American  Society  Web  Site  May  7,  2010   69   Confidenal  
    • NarcoCc  User    -­‐  SCgma  Measurement     AMONG  THOSE  WHO  HEAR  CONCERNS  FROM  OTHERS  IT  IS  LIKELY  TO  BE  A  FAMILY   MEMBER  OR  THEIR  DOCTOR  Source:    American  Society  Web  Site  May  7,  2010   70   Confidenal  
    • Risk  EvaluaCon  and  MiCgaCon   Strategy  Risk  evalua3on  and  mi3ga3on  strategies  (REMS)  formerly  known  as  Risk  Minimiza3on  Ac3on  Plans  (RiskMAPs)  are  a  regulatory  technique  for  dealing  with  an3cipated  risks  of  medica3ons  and  are  especially  important  for  new  drugs  with  abuse  poten3al.   71   Confidenal