Presentation is loading. Please wait.

Presentation is loading. Please wait.

The Lifecycle of a Drug: Pharmaceutical Advertising, Patent Extension, & Me-Too Drugs ©PharmedOut 2013 Georgetown University Medical Center Part of the.

Similar presentations


Presentation on theme: "The Lifecycle of a Drug: Pharmaceutical Advertising, Patent Extension, & Me-Too Drugs ©PharmedOut 2013 Georgetown University Medical Center Part of the."— Presentation transcript:

1 The Lifecycle of a Drug: Pharmaceutical Advertising, Patent Extension, & Me-Too Drugs ©PharmedOut 2013 Georgetown University Medical Center Part of the Drug Ads Exercise Presentation Series

2 Disclaimer: Intellectual Property In this presentation, you will notice that we use images of many registered trademarks, many branded drug trade names, and many copyrighted advertisements -- from many different business concerns -- including drug companies, marketing consultants and medical journals. All of the intellectual property contained therein is, and remains, the exclusive intellectual property of the respective owners. Each image is used for the purpose of educational, and critical, analysis. No endorsement of any position articulated in this presentation should be inferred from the appearance of any brand, trademark, trade name or ad copy herein. This presentation has been designed with the intent to qualify for the doctrine of "fair use" -- as to these pieces of intellectual property -- under the law of the United States.

3 Pharmaceutical Advertising

4 Marketing Timeline 1.Pre-Launch Ads and Disease/Mechanism Mongering 2.Launch 3.Active Marketing

5 Marketing Timeline 1. 1.Pre-Launch Ads and Disease/Mechanism Mongering 2.Launch 3.Active Marketing

6 Pre-Launch: “Coming Soon” Pre-launch ads: Pique interest in a new product Pique interest in a new product Introduce logos and color schemes Introduce logos and color schemes Introduce the brand name Introduce the brand nameLAUNCH ACTIVE MARKETING  PRE-LAUNCH 

7

8

9

10

11 Marketing Timeline 1.Pre-Launch Ads and Disease/Mechanism Mongering 2. 2.Launch 3.Active Marketing

12 LAUNCH  ACTIVE MARKETING  PRE-LAUNCH Launch Launch: Announcement of availability Announcement of availability

13

14

15 Marketing Timeline 1.Pre-Launch Ads and Disease/Mechanism Mongering 2.Launch 3. 3.Active Marketing

16 ACTIVE MARKETING LAUNCH  PRE-LAUNCH  Active Marketing Ads now include: Brand name Brand name Generic name Generic name Use/indications Use/indications Summary of side effects Summary of side effects Contraindications Contraindications Effectiveness Effectiveness

17

18 Patent Extension

19 Strategies for Patent Extension Delayed-release preparationsDelayed-release preparations Minor changes in dosingMinor changes in dosing Fixed-dose combinationsFixed-dose combinations EnantiomersEnantiomers Metabolites, prodrugs, analogsMetabolites, prodrugs, analogs RenamingRenaming

20 Strategies for Patent Extension Delayed-release preparations Minor changes in dosingMinor changes in dosing Fixed-dose combinationsFixed-dose combinations EnantiomersEnantiomers Metabolites, prodrugs, analogsMetabolites, prodrugs, analogs RenamingRenaming

21 Delayed-Release Preparations Controlled-release (CR)Controlled-release (CR) Sustained-release (SR)Sustained-release (SR) Extended-release (XL)Extended-release (XL) Long-acting (LA)Long-acting (LA)

22 Ambien CR (Controlled-Release)

23 Strategies for Patent Extension Delayed-release preparationsDelayed-release preparations Minor changes in dosing Fixed-dose combinationsFixed-dose combinations EnantiomersEnantiomers Metabolites, prodrugs, analogsMetabolites, prodrugs, analogs RenamingRenaming

24 Patient extension may be granted for minor changes in dosing. Examples: Yasmin (ethinyl estradiol Yasmin (ethinyl estradiol 30 mcg / drospirenone 3 mg) Yaz (ethinyl estradiol Yaz (ethinyl estradiol 20 mcg / drospirenone 3 mg) Androgel (topical testosterone Androgel (topical testosterone 1% vs. 1.62%)

25 Aricept (for Alzheimer’s Disease) To extend patent life on Aricept, the manufacturer developed a 23 mg version. To extend patent life on Aricept, the manufacturer developed a 23 mg version. Aricept 23 mg failed to show a statistically significant improvement over the previously approved Aricept 10 mg formulation in both primary and secondary outcome measures. Aricept 23 mg failed to show a statistically significant improvement over the previously approved Aricept 10 mg formulation in both primary and secondary outcome measures. Aricept 23 mg demonstrated a higher incidence of adverse events such as nausea, vomiting, diarrhea, anorexia, and fatigue. Aricept 23 mg demonstrated a higher incidence of adverse events such as nausea, vomiting, diarrhea, anorexia, and fatigue.

26 Aricept 23 mg: Approval Granted Aricept 23 mg was approved, despite a lack in superiority over Aricept 10 mg and recommendations of non-approval by two FDA medical reviewers.

27 Aricept 23 mg: Approval Granted Justification of FDA approval: “The 23 mg dose is clearly superior to the 10 mg dose on the cognitive measure. In my view, this strongly argues for a conclusion that ” “The 23 mg dose is clearly superior to the 10 mg dose on the cognitive measure. In my view, this strongly argues for a conclusion that the 23 mg dose is very likely to also have an effect on overall functioning, despite this not having been demonstrated directly in this study.” - Dr. Russell Katz, Division Director, Neurology Products

28 “Aricept 23 mg… did not show improvement on overall patient functioning. In the study, more people who took Aricept 23 mg experienced increased side effects.”

29 Strategies for Patent Extension Delayed-release preparationsDelayed-release preparations Minor changes in dosingMinor changes in dosing Fixed-dose combinations EnantiomersEnantiomers Metabolites, prodrugs, analogsMetabolites, prodrugs, analogs RenamingRenaming

30 Fixed-Dose Combinations : two or more drugs in one pill. Fixed-dose combination: two or more drugs in one pill. Fixed-dose combinations: Fixed-dose combinations: Are often more expensive than their components. Are often more expensive than their components. Provide less flexibility in dosing options. Provide less flexibility in dosing options.

31 Fixed-Dose Combination: Example Fosamax plus D (Vitamin D), a bisphosphonate, is patent- protected and costs six times as much as its generic, alendronate. Fosamax plus D (Vitamin D), a bisphosphonate, is patent- protected and costs six times as much as its generic, alendronate. Bisphosphonates must be taken with a calcium Bisphosphonates must be taken with a calcium supplement. However, calcium supplements are often formulated with Vitamin D. Since a patient must still take additional calcium with Fosamax plus D, the total tablet burden remains the same. Therefore, the “plus D” component is of no use beyond marketing the product.

32 Strategies for Patent Extension Delayed-release preparationsDelayed-release preparations Minor changes in dosingMinor changes in dosing Fixed-dose combinationsFixed-dose combinations Enantiomers Metabolites, prodrugs, analogsMetabolites, prodrugs, analogs RenamingRenaming

33 Enantiomers: Definition Many drugs are a racemic mixture, containing equal parts of the left-handed and right-handed enantiomer.Many drugs are a racemic mixture, containing equal parts of the left-handed and right-handed enantiomer. Receptors may only accept one enantiomer. Effectively one-half of the drug molecules in a racemic drug are active and the other half are inactive.Receptors may only accept one enantiomer. Effectively one-half of the drug molecules in a racemic drug are active and the other half are inactive. Left-handed enantiomers of drugs useLeft-handed enantiomers of drugs use the prefix “” or “” the prefix “es” or “levo” Right-handed enantiomers of drugs useRight-handed enantiomers of drugs use the prefix “” or “” the prefix “ar” or “dextro”

34 Enantiomers: Definition 1.It has become common practice to introduce a drug as a racemic mixture. 2.Then, when the patent is close to expiring, the company releases the active enantiomer as a “new, improved” product. Why is the racemic mixture marketed first when it was technically possible to market the active enantiomer initially? Ask yourself: Why is the racemic mixture marketed first when it was technically possible to market the active enantiomer initially?

35 Omeprazole (Patient Care, 2000) omeprazole Esomeprazole (JAMA, 2005)

36 Strategies for Patent Extension Delayed-release preparationsDelayed-release preparations Minor changes in dosingMinor changes in dosing Fixed-dose combinationsFixed-dose combinations EnantiomersEnantiomers Metabolites, prodrugs, analogs RenamingRenaming

37 Metabolites, Prodrugs, and Analogs Although there are exceptions, many metabolites, analogs, and prodrugs have over the originator drug. Although there are exceptions, many metabolites, analogs, and prodrugs have no advantages over the originator drug.Example: Desloratidine (Clarinex) is the main metabolite of loratidine (Claritin). There is no evidence that desloratidine is superior

38 Vyvanse (for ADHD) Vyvanse (lisdexamfetamine) is dextroamphetamine linked to a lysine molecule, allowing for it to be cleaved to its components upon ingestion. Vyvanse (lisdexamfetamine) is dextroamphetamine linked to a lysine molecule, allowing for it to be cleaved to its components upon ingestion. While this allows for peak doses to be reached earlier, there is no advantage to this and could theoretically increase rates of adverse effects. While this allows for peak doses to be reached earlier, there is no advantage to this and could theoretically increase rates of adverse effects.

39 Strategies for Patent Extension Delayed-release preparations Delayed-release preparations Minor changes in dosing Minor changes in dosing Fixed-dose combinations Fixed-dose combinations Enantiomers Enantiomers Metabolites, prodrugs, analogs Metabolites, prodrugs, analogs Renaming

40 The Rename Game A new indication can extend the patent life of a drug. A new indication can extend the patent life of a drug. Some drugs are renamed upon approval for a new indication, allowing for patent extension. Some drugs are renamed upon approval for a new indication, allowing for patent extension. = Bupropion = = Sildenafil =

41 The Rename Game: Example Example: Fluoxetine is the generic version of both Prozac and Sarafem. Fluoxetine is the generic version of both Prozac and Sarafem. After Prozac lost patent exclusivity, Sarafem provided new life to the patent. After Prozac lost patent exclusivity, Sarafem provided new life to the patent. Fluoxetine could only be substituted for Prozac, Sarafem, because the indications for which the drugs were approved were different. Fluoxetine could only be substituted for Prozac, NOT Sarafem, because the indications for which the drugs were approved were different. Now that Sarafem has lost patent exclusivity, both drugs are available as generics. Now that Sarafem has lost patent exclusivity, both drugs are available as generics. =

42 Me-Too Drugs

43 Me-Too vs. First-In-Class Drugs First-in-class drugs are novel drugs. First-in-class drugs are novel drugs. Me-too drugs are similar, related drugs to first-in-class drugs. Me-too drugs are similar, related drugs to first-in-class drugs. Marketing may exaggerate the benefits of a me-too drug versus the original first-in-class drug. Marketing may exaggerate the benefits of a me-too drug versus the original first-in-class drug.

44 Me-Too Drugs A me-too drug could be better than a first-in-class drug, or it could be worse.A me-too drug could be better than a first-in-class drug, or it could be worse. Example:, a me-too drug, is a more effective statin than, a first-in-class drug.Example: Simvastatin, a me-too drug, is a more effective statin than lovastatin, a first-in-class drug. On the other hand, Baycol (cerivastatin) was withdrawn from the market due to a disproportionate number of cases of rhabdomyolysis.On the other hand, Baycol (cerivastatin) was withdrawn from the market due to a disproportionate number of cases of rhabdomyolysis. Graphic reprinted by permission from Pill Advised.

45 “Rare cases of rhabdomyolysis have been reported with cerivastatin” “Cases of rhabdomyolysis have been reported with cerivastatin” NEJM, January 1999 NEJM, January 1999 NEJM, January 2001

46 Baycol was withdrawn from the market in August 2001 due to excess cases of rhabdomyolysis.

47 Me-Too Drugs: Marketing Messages Increased potency or longer duration of effectIncreased potency or longer duration of effect Faster onset of actionFaster onset of action Fewer unwanted effectsFewer unwanted effects Improved receptor selectivityImproved receptor selectivity Conversely, first-in-class drugs may market their longer history and larger body of research Conversely, first-in-class drugs may market their longer history and larger body of research

48 Me-Too Drugs: Marketing Messages Increased potency or longer duration of effect Faster onset of actionFaster onset of action Fewer unwanted effectsFewer unwanted effects Improved receptor selectivityImproved receptor selectivity

49 Increased Potency or Longer Duration of Effect May add no clinical benefitMay add no clinical benefit May increase the risk of adverse eventsMay increase the risk of adverse events May increase flexibility in dosing optionsMay increase flexibility in dosing options

50 Me-Too Drugs: Marketing Messages Increased potency or longer duration of effect Increased potency or longer duration of effect Faster onset of action Fewer unwanted effects Fewer unwanted effects Improved receptor selectivity Improved receptor selectivity

51 Faster Onset of Action In chronically used drugs, such as statins, faster onset of action would only affect the first dose.

52 Me-Too Drugs: Marketing Messages Increased potency or longer duration of effect Increased potency or longer duration of effect Faster onset of action Faster onset of action Fewer unwanted effects Improved receptor selectivity Improved receptor selectivity

53 Fewer Unwanted Effects Unwanted effects take time to be discovered and reported.Unwanted effects take time to be discovered and reported. Pre-market studies cannot pick up long- term adverse effects, drug interactions, or effects that occur only in elders, diabetics, or other subpopulations.Pre-market studies cannot pick up long- term adverse effects, drug interactions, or effects that occur only in elders, diabetics, or other subpopulations. Claims of increased safety for new drugs are not trustable without long-term data.Claims of increased safety for new drugs are not trustable without long-term data.

54 Me-Too Drugs: Marketing Messages Increased potency or longer duration of effect Increased potency or longer duration of effect Faster onset of action Faster onset of action Fewer unwanted effects Fewer unwanted effects Improved receptor selectivity

55 Decreased Risk for Drug Interactions Molecular stories, such as improved receptor selectivity, may not necessarily have a clinical benefit.

56 To properly assess a me-too drug, adequate controlled studies with patient-oriented endpoints in relevant populations are required. Does treatment with the me- too drug result in the patient living longer or better? Ask yourself: Does treatment with the me- too drug result in the patient living longer or better?

57 Promotes rational prescribing.Promotes rational prescribing. Provides Grand Rounds, seminars, and free, web-based CME.Provides Grand Rounds, seminars, and free, web-based CME. Offers teaching tools, videos, slideshows, patient factsheets, “No Drug Reps” certificate, and many other resources.Offers teaching tools, videos, slideshows, patient factsheets, “No Drug Reps” certificate, and many other resources. Internships available!Internships available! PharmedOut is supported by individual donations. Please consider supporting us! or


Download ppt "The Lifecycle of a Drug: Pharmaceutical Advertising, Patent Extension, & Me-Too Drugs ©PharmedOut 2013 Georgetown University Medical Center Part of the."

Similar presentations


Ads by Google