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© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Pharma Lifecycle Management
and Brand Defense Strategy
Strategic and Tactical Options for 
Continuing Your Product Success Story
Pharma‐Lifecycle‐Management‐and‐Brand‐Defense‐Strategy
20 July 2014
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Terminology
The term "product lifecycle" in this presentation 
extends beyond the official patent‐protected 
period and includes the years directly following 
the loss of market exclusivity.
"There is life to a brand even after patent expiry"
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Goal: Maintain Success 
Keep the brand at the top of its lifecycle curve 
in order to get more out of the assets.
Manage the Brand's late lifecycle so that
we realize the brand's full medical and 
commercial value
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Nature of Issue
Managing the loss of market exclusivity is
a complex legal, regulatory and marketing 
challenge. 
The situations in the various countries differ.
This may require approaches on a national basis.
There is no "one size fits all"
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Wake up call
Many big research‐based pharma companies have
experienced rude awakenings when generic
companies took away most of their top product
sales ‐ virtually overnight.
They should have seen it coming.
Be prepared and take an active approach 
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Research‐based companies focus on innovation 
(taking the high road). 
Goal: Launch new products and maximize their 
commercial potential. 
Therefore, an innovative successor drug would 
best fill the gap. Ideally, it could shift the value 
created by the old brand to the new brand.
The Company Portfolio
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Situation Appraisal: Regulatory Authorities
Regulatory authorities have been making their
own decisions about the approval of generic 
version of expensive drugs.
They may surprisingly grant marketing 
authorization to low‐priced generic versions
‐ due to national healthcare budget constraints in 
an increasingly cost‐conscious environment.
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Situation Appraisal: Patent Protection
History shows that even apparently iron‐clad 
patents have not been safe.
Big pharma has sometimes paid settlements to 
avoid costly litigation and the possibility of losing 
years of exclusivity through questionable court 
action.
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Types of Competitors
1) "Me‐too products"
Other companies may legally "circumvent" 
the patent by producing similar products 
long before the patent expires
2) Generics from generic drug companies
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Situation Appraisal: Generic Competition
Competing generic companies may initiate a downward 
price spiral in an attempt to dominate the market.
Aggressive generic companies are no longer waiting for 
patent expiration. Teva has launched over a dozen products 
"at risk" in the United States prior to patent expiration. 
Many other generic companies have entered markets prior 
to patent expiry in Europe. 
In some cases generic companies launched prior to the 
innovator's own product launch (Example:  Amgen/Pfizer's 
rheumatoid arthritis agent Enbrel in China)
(Source: http://www.pharmexec.com/pharmexec/Strategy/Rethinking‐Product‐Lifecycle‐Management/ArticleStandard/Article/detail/805006)
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Option Overview 
1) Short‐term tactics
2) Develop strategic options
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Short‐Term Tactics 1
Litigation
Fight generic competitors in court
Discuss legal aspects with experienced patent lawyers 
familiar with these issues.
Ask: What is the likelihood of defending the company's
rightful patent situation in court?
Possible patent infringement could concern:
Ingredients, formulation, manufacturing processes,  
production methods, indication, data protection, etc.
(Note: The generic companies usually win this game)
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Short‐Term Tactics 2
Once generics are on the market:
Reactive approach to discussing generics during 
calls with physicians:
When the doctor asks the sales rep, 
raise elements of doubt, but do not 
spend time on competitors
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Range of Usual Strategic Options
‐ New dosage forms
‐ New pharmaceutical formulation
‐ Additional indications
‐ Supplementary Protection Certificate
‐ Combination product
‐ Switch to OTC‐Status
‐ Competing solely on price
‐ Arrangements with payers
‐ Early entry strategy
‐ Portfolio management in formularies
‐ Original Generic
Note: Additional (ineffective or non‐applicable) approaches can be found in the appendix
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Providing regulators with data on pediatric use may 
prolong market exclusivity by 6 months in the US
PIP      =  Paediatric Investigation Plan
PUMA =  Paediatric Use Marketing Authorisation
Supplementary Protection Certificate
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Switch to OTC‐Status
Ask Regulatory Affairs experts if an Rx‐to‐OTC 
switch is a viable option
Preconditions:
Regulatory approval and willingness to establish 
the brand name in the consumer market
Examples: 
Antimycotics: Clotrimazol: Canesten®
Proton Pump Inhibitors: Omeprazol, Pantoprazol
Rx = Prescription only,   OTC = Over The Counter
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Competing Solely  on Price
Typical, very‐low price generic product strategy:
Prices can be 40 to 80% lower than the original.
One would act as a generic company fighting the 
established generic companies 
(that are fast, flexible and aggressive). 
Other companies (e.g. Novartis) have set up
their own generic division (Sandoz).
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Arrangements with Payers:
Deals with national governments
In Germany: "Rabattvertrag für Originale"
MSD made special arrangements with the German 
Statutory Sickness Fund (AOK) for the
cardiovascular brands Lorzaar / Fortzaar and the 
anti‐osteoporosis product Fosavan at a time when 
the brands still enjoyed patent protection.
Other options: Disease management programs
Source: Dr. Lukas Pfister, MSD, PM‐Report June 2008  
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Early Entry Strategy
Partner with a generic drug company that
sells an authorized generic version through 
licensing arrangements for about six months
prior to patent expiry.
Then the generic drug company can 
independently sell their own product.
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Early Entry Strategy: USA
Bayer and Barr Pharmaceuticals signed a 
contract: Barr sells an "authorized generic" 
version of Bayer's birth control pill Yasmin several 
years before the product's last patent expires. 
Barr gets exclusive rights to sell the products 
in the US, and Bayer will supply the pills. 
In return, Bayer will get a share of the sales.
FiercePharma <editors@fiercepharma.com> 06.24.08
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Portfolio Management in Formularies
Smart portfolio management in 
regional / provincial / hospital drug formularies
Example: "Bundling"
Responsible: National Key Account Managers
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
"Original Generic"
Introduce product in the form of second, 
separate brand ‐ about 20% to 40% cheaper 
than the original
Consumer Market:
"Fighter Brand"
Example: Lufthansa und Germanwings
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
The company introduced: "Originalgenerikum" 
Maxim® ‐ "Das OC Generikum von Valette"
Flexible price strategy
Around 10 Euro cheaper. 
They adapt to competitive price level
Example of "Original Generic"
Original: Valette®
from Jenapharm 
Patent expiry in 
January 2011
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Price Strategy by Dr. Kade 
Utrogest®    : Original
Progestan® : 17%     cheaper 
Fachanzeige von Dr. Kade in "gyn" Juni 2014 
Both are Brands from Dr. Kade 
Example of "Original Generic"
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Recommended Next Steps
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Initiate a cross‐functional team integrated 
in the existing structure:
‐ That will develop a comprehensive approach 
‐ Is in charge of contacts with relevant stakeholders 
‐ Pays attention to time line
‐ Makes recommendation to the management 
board asking for business planning decisions
(Involvement of the leadership team is essential) 
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Task Force: Objectives
‐ Understand lessons learned from previous cases
‐ Avoid pitfalls, such as "group think"
‐ Analyse the competitive environment
‐ Detect new entrants early
‐ Identify opportunities to exploit
‐ Evaluate risk return ratios of strategic options
‐ Estimate levels of resources needed
* There is no magic bullet.
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Task Force: Proposed Members 
‐ Strategic Marketing
‐ Market Research (for market intelligence)
‐ Medical
‐ Market Access
‐ Regulatory
‐ Legal
Preferably persons with experience in late lifecycle 
management to benefit from "corporate memory" 
(ideas and strategies that either worked or failed)
Note: Interest from the countries will be limited, because they are unlikely to reap the fruits
of this endeavour (People will probably have moved to a different position by the year 2020).
© Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com
Additional Recommendations,
Back‐up Charts and 
Background Information:
Please contact us:
umbach@umbachpartner.com

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Pharma Product Lifecycle Management and Brand Defense Strategy: Tips

  • 1. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Pharma Lifecycle Management and Brand Defense Strategy Strategic and Tactical Options for  Continuing Your Product Success Story Pharma‐Lifecycle‐Management‐and‐Brand‐Defense‐Strategy 20 July 2014
  • 2. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Terminology The term "product lifecycle" in this presentation  extends beyond the official patent‐protected  period and includes the years directly following  the loss of market exclusivity. "There is life to a brand even after patent expiry"
  • 3. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Goal: Maintain Success  Keep the brand at the top of its lifecycle curve  in order to get more out of the assets. Manage the Brand's late lifecycle so that we realize the brand's full medical and  commercial value
  • 4. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Nature of Issue Managing the loss of market exclusivity is a complex legal, regulatory and marketing  challenge.  The situations in the various countries differ. This may require approaches on a national basis. There is no "one size fits all"
  • 5. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Wake up call Many big research‐based pharma companies have experienced rude awakenings when generic companies took away most of their top product sales ‐ virtually overnight. They should have seen it coming. Be prepared and take an active approach 
  • 6. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Research‐based companies focus on innovation  (taking the high road).  Goal: Launch new products and maximize their  commercial potential.  Therefore, an innovative successor drug would  best fill the gap. Ideally, it could shift the value  created by the old brand to the new brand. The Company Portfolio
  • 7. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Situation Appraisal: Regulatory Authorities Regulatory authorities have been making their own decisions about the approval of generic  version of expensive drugs. They may surprisingly grant marketing  authorization to low‐priced generic versions ‐ due to national healthcare budget constraints in  an increasingly cost‐conscious environment.
  • 8. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Situation Appraisal: Patent Protection History shows that even apparently iron‐clad  patents have not been safe. Big pharma has sometimes paid settlements to  avoid costly litigation and the possibility of losing  years of exclusivity through questionable court  action.
  • 9. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Types of Competitors 1) "Me‐too products" Other companies may legally "circumvent"  the patent by producing similar products  long before the patent expires 2) Generics from generic drug companies
  • 10. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Situation Appraisal: Generic Competition Competing generic companies may initiate a downward  price spiral in an attempt to dominate the market. Aggressive generic companies are no longer waiting for  patent expiration. Teva has launched over a dozen products  "at risk" in the United States prior to patent expiration.  Many other generic companies have entered markets prior  to patent expiry in Europe.  In some cases generic companies launched prior to the  innovator's own product launch (Example:  Amgen/Pfizer's  rheumatoid arthritis agent Enbrel in China) (Source: http://www.pharmexec.com/pharmexec/Strategy/Rethinking‐Product‐Lifecycle‐Management/ArticleStandard/Article/detail/805006)
  • 11. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Option Overview  1) Short‐term tactics 2) Develop strategic options
  • 12. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Short‐Term Tactics 1 Litigation Fight generic competitors in court Discuss legal aspects with experienced patent lawyers  familiar with these issues. Ask: What is the likelihood of defending the company's rightful patent situation in court? Possible patent infringement could concern: Ingredients, formulation, manufacturing processes,   production methods, indication, data protection, etc. (Note: The generic companies usually win this game)
  • 13. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Short‐Term Tactics 2 Once generics are on the market: Reactive approach to discussing generics during  calls with physicians: When the doctor asks the sales rep,  raise elements of doubt, but do not  spend time on competitors
  • 14. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Range of Usual Strategic Options ‐ New dosage forms ‐ New pharmaceutical formulation ‐ Additional indications ‐ Supplementary Protection Certificate ‐ Combination product ‐ Switch to OTC‐Status ‐ Competing solely on price ‐ Arrangements with payers ‐ Early entry strategy ‐ Portfolio management in formularies ‐ Original Generic Note: Additional (ineffective or non‐applicable) approaches can be found in the appendix
  • 15. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Providing regulators with data on pediatric use may  prolong market exclusivity by 6 months in the US PIP      =  Paediatric Investigation Plan PUMA =  Paediatric Use Marketing Authorisation Supplementary Protection Certificate
  • 16. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Switch to OTC‐Status Ask Regulatory Affairs experts if an Rx‐to‐OTC  switch is a viable option Preconditions: Regulatory approval and willingness to establish  the brand name in the consumer market Examples:  Antimycotics: Clotrimazol: Canesten® Proton Pump Inhibitors: Omeprazol, Pantoprazol Rx = Prescription only,   OTC = Over The Counter
  • 17. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Competing Solely  on Price Typical, very‐low price generic product strategy: Prices can be 40 to 80% lower than the original. One would act as a generic company fighting the  established generic companies  (that are fast, flexible and aggressive).  Other companies (e.g. Novartis) have set up their own generic division (Sandoz).
  • 18. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Arrangements with Payers: Deals with national governments In Germany: "Rabattvertrag für Originale" MSD made special arrangements with the German  Statutory Sickness Fund (AOK) for the cardiovascular brands Lorzaar / Fortzaar and the  anti‐osteoporosis product Fosavan at a time when  the brands still enjoyed patent protection. Other options: Disease management programs Source: Dr. Lukas Pfister, MSD, PM‐Report June 2008  
  • 19. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Early Entry Strategy Partner with a generic drug company that sells an authorized generic version through  licensing arrangements for about six months prior to patent expiry. Then the generic drug company can  independently sell their own product.
  • 20. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Early Entry Strategy: USA Bayer and Barr Pharmaceuticals signed a  contract: Barr sells an "authorized generic"  version of Bayer's birth control pill Yasmin several  years before the product's last patent expires.  Barr gets exclusive rights to sell the products  in the US, and Bayer will supply the pills.  In return, Bayer will get a share of the sales. FiercePharma <editors@fiercepharma.com> 06.24.08
  • 21. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Portfolio Management in Formularies Smart portfolio management in  regional / provincial / hospital drug formularies Example: "Bundling" Responsible: National Key Account Managers
  • 22. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com "Original Generic" Introduce product in the form of second,  separate brand ‐ about 20% to 40% cheaper  than the original Consumer Market: "Fighter Brand" Example: Lufthansa und Germanwings
  • 23. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com The company introduced: "Originalgenerikum"  Maxim® ‐ "Das OC Generikum von Valette" Flexible price strategy Around 10 Euro cheaper.  They adapt to competitive price level Example of "Original Generic" Original: Valette® from Jenapharm  Patent expiry in  January 2011
  • 24. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Price Strategy by Dr. Kade  Utrogest®    : Original Progestan® : 17%     cheaper  Fachanzeige von Dr. Kade in "gyn" Juni 2014  Both are Brands from Dr. Kade  Example of "Original Generic"
  • 25. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Recommended Next Steps
  • 26. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Initiate a cross‐functional team integrated  in the existing structure: ‐ That will develop a comprehensive approach  ‐ Is in charge of contacts with relevant stakeholders  ‐ Pays attention to time line ‐ Makes recommendation to the management  board asking for business planning decisions (Involvement of the leadership team is essential) 
  • 27. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Task Force: Objectives ‐ Understand lessons learned from previous cases ‐ Avoid pitfalls, such as "group think" ‐ Analyse the competitive environment ‐ Detect new entrants early ‐ Identify opportunities to exploit ‐ Evaluate risk return ratios of strategic options ‐ Estimate levels of resources needed * There is no magic bullet.
  • 28. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Task Force: Proposed Members  ‐ Strategic Marketing ‐ Market Research (for market intelligence) ‐ Medical ‐ Market Access ‐ Regulatory ‐ Legal Preferably persons with experience in late lifecycle  management to benefit from "corporate memory"  (ideas and strategies that either worked or failed) Note: Interest from the countries will be limited, because they are unlikely to reap the fruits of this endeavour (People will probably have moved to a different position by the year 2020).
  • 29. © Healthcare Marketing Dr. Umbach & Partner www.umbachpartner.com Additional Recommendations, Back‐up Charts and  Background Information: Please contact us: umbach@umbachpartner.com