Counter-Generics Tactics and Biosimilars Projected Publication Date: August 2010

Before you begin: Your personal information will be kept confidential and your company information will be blinded before being published in our reports. If you have any questions about this survey or the project please contact Ryan McGuire at 919-433-0382 or Ryan_McGuire@cuttingedgeinfo.com

Your Information

Name

Company

Title

Phone

Email

Q1	In what capacity do you work to develop or implement counter-generics strategy?
	Product/Brand Management		Pricing
	Market Research/Competitive Intelligence		Legal/Patents
	Business Development		Regulatory Affairs
	Strategic Planning		Medical Affairs
	Lifecycle Management		Other
	Sales

	Please Specify

Structure and Staffing

Q2	Is there a team, group or task force that meets regularly to discuss counter-generics strategies?
	--Click Here--NoYes

Q2a	Which departments/functions are represented on this team, group or task force? (Check all that apply)
	Product/Brand Management		Legal/Patents
	Market Research/Competitive Intelligence		Regulatory Affairs
	Business Development		Medical Affairs
	Strategic Planning		Discovery
	Lifecycle Management		Pharmacoeconomics
	Sales		Clinical Development
	Pricing		Other

	Please Specify

Q2b	How many FTEs from each department are on this team, group or task force?

	Product/Brand Management		FTEs
	Market Research/Competitive Intelligence		FTEs
	Business Development		FTEs
	Strategic Planning		FTEs
	Lifecycle Management		FTEs
	Sales		FTEs
	Pricing		FTEs
	Legal/Patents		FTEs
	Regulatory Affairs		FTEs
	Medical Affairs		FTEs
	Discovery		FTEs
	Pharmacoeconomics		FTEs
	Clinical Development		FTEs
	Other		FTEs

Q2c	Who leads this team, group or task force? (Choose one)
	Product/Brand Management		Legal/Patents
	Market Research/Competitive Intelligence		Regulatory Affairs
	Business Development		Medical Affairs
	Strategic Planning		Discovery
	Lifecycle Management		Pharmacoeconomics
	Sales		Clinical Development
	Pricing		Other

	Please Specify

Q2d	How many years prior to patent expiration does this team, group or task force begin working with a drug?
	--Click Here--0-2 years before primary patent expiration2-4 years before primary patent expiration4-6 years before primary patent expiration6-8 years before primary patent expiration8-10 years before primary patent expiration10+ years before primary patent expiration

Q3	What other departments/functions are involved with counter-generics strategy at your company? (Check all that apply)
	Product/Brand Management
	Market Research/Competitive Intelligence
	Business Development
	Strategic Planning
	Lifecycle Management
	Sales
	Pricing
	Legal/Patents
	Regulatory Affairs
	Medical Affairs
	Discovery
	Pharmacoeconomics
	Clinical Development
	Other

	Please Specify

Company-Wide Strategies

Q4	Please check all of the strategies your company attempted to use in the past 3 years (2008-2010), or are currently using, to maximize revenues for drugs in the face of generic competition:
	Litigation: Launched legal action to delay generic market entry and preserve patent protection
	Citizen Petitions: Filed citizen petition with FDA to delay generic market entry
	Pricing: Lowered pricing, renegotiated with buyers, negotiated bulk prices, etc.
	OTC: Attempted to switch branded drug from Rx to OTC
	Authorized Generic: Negotiated an authorized generic agreement with an external company
	Generics Subsidiary: Transitioned drug to corporate-owned generics subsidiary unit
	Counter-Promotion: Increased marketing/promotion (increased call frequency, sampling, etc.)
	Formulations: Attempted to develop and launch new formulation(s)
	Indications: Attempted to develop and win approval for new indication(s)
	Pediatric: Attempted to conduct trials and win approval to six-month pediatric exclusivity
	Next-Generation Drug: Attempted to develop and launch a next-generation product
	Combination Drug: Attempted to develop and launch a combination product that includes the end-life drug
	Other
	Other

	Please Specify

Q5	Please check all of the strategies your company plans to use in the next 3 years (2011-2013) to maximize revenues for drugs in the face of generic competition:
	Litigation: Launched legal action to delay generic market entry and preserve patent protection
	Citizen Petitions: Filed citizen petition with FDA to delay generic market entry
	Pricing: Lowered pricing, renegotiated with buyers, negotiated bulk prices, etc.
	OTC: Attempted to switch branded drug from Rx to OTC
	Authorized Generic: Negotiated an authorized generic agreement with an external company
	Generics Subsidiary: Transitioned drug to corporate-owned generics subsidiary unit
	Counter-Promotion: Increased marketing/promotion (increased call frequency, sampling, etc.)
	Formulations: Attempted to develop and launch new formulation(s)
	Indications: Attempted to develop and win approval for new indication(s)
	Pediatric: Attempted to conduct trials and win approval to six-month pediatric exclusivity
	Next-Generation Drug: Attempted to develop and launch a next-generation product
	Combination Drug: Attempted to develop and launch a combination product that includes the end-life drug
	Other
	Other

	Please Specify

Q6	At what stage of a product's lifecycle do you begin to develop strategies for dealing with forthcoming generic competition?

Please select your answers for BOTH development phase and proximity to patent expiration.

	Strategy Development - By Lifecycle Stage
	--Click Here--Pre Clinical - Phase IIPhase IIILaunch YearLaunch +2 YearsLaunch +4 YearsLaunch +6 YearsLaunch +8 YearsLaunch +10 or more Years

	Strategy Development - Relative to Patent Expiration
	--Click Here--0-2 years before primary patent expiration2-4 years before primary patent expiration4-6 years before primary patent expiration6-8 years before primary patent expiration8-10 years before primary patent expiration10+ years before primary patent expiration

Brand-Specific Activity

Please consider one drug for which you were involved in counter-generics planning.  The remaining questions will concern your experience with this brand.

Q8	For which drug will you be answering the remaining survey questions? (Your answer will remain confidential and all data will be blinded)

Q9	In what countries is this drug marketed and/or what are the target markets for this drug? (Check all that apply)
	United States		Italy
	Canada		Other Europe
	United Kingdom		Japan
	France		Asia (Ex-Japan)
	Germany		South America
	Spain		Other

	Please Specify

Q10	Does this brand currently face generic competition?
	--Click Here--NoYes

Q11	What are the projected peak global sales?
	--Click Here-- 0 - $100 million$100 - $250 million$250 - $500 million$500 million - $1 Billion$1 - $5 Billion

Q11	What were the peak global sales?
	--Click Here-- 0 - $100 million$100 - $250 million$250 - $500 million$500 million - $1 Billion$1 - $5 Billion

Q12	Is this drug a biologic?
	--Click Here--NoYes

Q12a	What are the brand's current annual revenues?
		USD

Q12b	When do you expect your brand to face its first biosimilar competition?
	--Click Here--Already facing2010201120122013-20152016-20202020+NEVER

	Where?

	What percentage of revenue do you expect to lose in the first 12 months of biosimilar competition?
		%

Q12c	Please qualify the threat posed by changes in biosimilar legislation to your brand in the US?
	--Click Here--No threatMinimal loss of market shareModerate loss of market shareCompletely erode market share

Q12d	Are you creating a counter-generics strategy in the US for you biologic brand?
	--Click Here--NoYes

	How many FTEs are dedicated to this strategy?
		FTEs

Q13	How many generic entrants did your brand face in the first 12 months of generic competition, including those entrant(s) with Hatch-Waxman exclusivity?

Q13	How many generic entrants do you expect your brand to face in the first 12 months of generic competition, including those entrant(s) with Hatch-Waxman exclusivity?

Q14	What is your brand's therapeutic area?

Q15	What year was/is the primary patent set to expire?

Q16	What were this product's sales before, during and after a generic entered the market?

Sales in Calendar Year Before Generic Entrant

USD

Sales in Calendar Year During which Generic Entered

USD

Sales in Calendar Year After First Generic Appeared

USD

Q17	Please select the tactics used to extend the patent life for your brand. (Please select all that apply)
	Litigation
	Citizen Petition
	Pediatric Exclusivity
	None of the above

Q17a	Please answer the following questions concerning litigation:

	At what point did litigation begin on your brand?
	--Click Here--0-2 years before primary patent expiration2-4 years before primary patent expiration4-6 years before primary patent expiration6-8 years before primary patent expiration8-10 years before primary patent expiration10+ years before primary patent expiration

	What was the company's investment in litigation for this brand?
		USD

	What was the end result of the patent litigation?
	--Click Here--No loss of market exclusivity due to litigationLoss of market exclusivity due to litigationSettlement

	How long did the litigation process take?
		months

	How long were you able to delay the appearance of a generic as a result of litigation?
		months

	How much was this delay worth in terms of additional revenue?
		USD

Q17b	Please answer the following questions concerning citizen petitions:

	At what point did your brand begin planning to file a citizen petition with the FDA?
	--Click Here--0-2 years before primary patent expiration2-4 years before primary patent expiration4-6 years before primary patent expiration6-8 years before primary patent expiration8-10 years before primary patent expiration10+ years before primary patent expiration

	How long did the process take?
		months

	How long were you able to delay the appearance of a generic as a result of the citizen petition?
		months

	What was the company's investment for the citizen petition?
		USD

	How much was this delay worth in terms of additional revenue?
		USD

Q17c	Please answer the following questions concerning pediatric exclusivity:

	At what point did your brand begin planning to file for pediatric exclusivity with the FDA?
	--Click Here--0-2 years before primary patent expiration2-4 years before primary patent expiration4-6 years before primary patent expiration6-8 years before primary patent expiration8-10 years before primary patent expiration10+ years before primary patent expiration

	How long did the process take?
		months

	What was the total cost to the company (including clinical and R&D expenses) to file for pediatric exclusivity?
		USD

	Were you successful in gaining an extra six months protection for pediatric  exclusivity?
	--Click Here--NoYes

	How much was this delay worth in terms of additional revenue?
		USD

Q18	Which of the following marketing tactics did your brand use to preserve market share against generic competition? (Check all that apply)
	Pricing
	Counter-promotion
	None of the above

Q18a	Please answer the following questions concerning pricing strategies:

	At what point did your brand begin planning for a pricing strategy to combat generic competition?
	--Click Here--0-2 years before primary patent expiration2-4 years before primary patent expiration4-6 years before primary patent expiration6-8 years before primary patent expiration8-10 years before primary patent expiration10+ years before primary patent expiration

	How long did the process take?
		months

	What price changes were made to your brand 2 years before generic competition?
	--Click Here--RaiseLowerNo Change

	By what percentage?
		%

	What price changes were made to your brand 1 year before generic competition?
	--Click Here--RaiseLowerNo Change

	By what percentage?
		%

	What price changes were made to your brand the first year of generic competition?
	--Click Here--RaiseLowerNo Change

	By what percentage?
		%

	What was the company's investment in this pricing strategy?
		USD

	How much did this pricing strategy add in terms of additional revenue?
		USD

Q18b	Please answer the following questions concerning counter-promotion strategies:

	At what point did your brand begin planning for a counter-promotions strategy to combat generic competition?
	--Click Here--0-2 years before primary patent expiration2-4 years before primary patent expiration4-6 years before primary patent expiration6-8 years before primary patent expiration8-10 years before primary patent expiration10+ years before primary patent expiration

	What types of counter-promotion strategies were used for your brand? (Check all that apply)
	Increased Advertising
	Coupons
	Co-pay Rebate
	Patient Program
	Promote Dangers of Weak Bioequivalence
	Other

	Please Specify

	How long did the process take?
		months

	What was the company's investment in counter-promotion strategies?
		USD

	How much did the counter-promotion strategies add in terms of additional revenue?
		USD

Q19

Please complete the following table about counter-generics strategies. When answering "Point at Which Planning Began", consider the number of YEARS before patent protection expired for each tactic.  For "Total Company Investment" in each tactic, consider all company costs including clinical, R&D and marketing.

Point at Which Planning Began

Time to Execute

Total Company Investment (Including R&D costs)

	OTC Switch				yr.				mo.				USD
	New Formulations				yr.				mo.				USD
	New Indications				yr.				mo.				USD
	Next-Generation Drug				yr.				mo.				USD
	Combo Drug				yr.				mo.				USD
	Generics Subsidiary				yr.				mo.				USD
	Authorized Generic				yr.				mo.				USD

Q20	How much of the drug's sales were you able to preserve (or increase) with your selection of counter-generics tactics?  Please consider all formulations, indications, brands, OTC products, new products and line extensions, etc, within the drug franchise:

Quarter before generic appears

1st Quarter after generic appears

2nd Quarter after generic appears

3rd Quarter after generic appears

4th Quarter after generic appears

	Brand Sales (In USD)
	Number of Generic Competitors