Transcript Corporate Presentation - Massachusetts Biotechnology Council

Current Bills on U.S. Capitol Hill
Waxman Schumer
HR1427 S.726
Data Exclusivity:
Kennedy
Eschoo
HR1548
5 years
12 years
New Indication Extension:
6 months
2 years
Pediatric Exclusivity Extension:
6 months
6 months
Similarity Standard:
no clinically meaningful differences
high degree of similarity/per indication
Clinical Studies:
FDA discretion
1+ clinical studies/HHS secretary can waive
Guidance Documents:
FDA discretion
required
Patent Notification:
applicant can request patent info
no link between approval & litigation
Naming:
same as innovator
Interchangeability:
Exclusivity for 1st product:
FDA to determine
6 months
challenges OK 3 years before expiration
no approval before patent expiry/invalidity
unique name
only if HHS secretary has issued guidance
2 years
US Patent Expiry vs. Data Exclusivity
Most marketed MAbs have patent coverage beyond even
longest contemplated data exclusivity period
Product
Brand
Approved
US Expiry
Patent Protection
(Years)
2008 Sales
($B)
Infliximab
Remicade
8/24/1998
2018
20
6.5
Rituximab
Rituxan
11/26/1997
2018
21
5.6
Trastuzumab
Herceptin
9/25/1998
2016
18
4.8
Bevacizumab
Avastin
2/26/2004
2018
14
4.7
Adalimumab
Humira
12/31/2002
2017
15
4.4
Etanercept
Enbrel
11/2/1998
2014
16
3.6
Cetuximab
Erbitux
2/12/2004
2019
15
2.0
Palivizumab
Synagis
6/19/1998
2015
17
1.2
Omalizumab
Xolair
6/20/2003
2014
11
0.85
Natalizumab
Tysabri
11/23/2004
?
?
0.6
Alemtuzumab
Campath
5/7/2001
2015
14
0.12
Erbitux – Payback Curve ($700M Cost Model)
6
5
Revenues
COGS + SG&A
Profit (before tax)
Cumulative Profit (before tax)
4
$Billion
5x Return
3
3x Return
2
1
0
Breakeven
-1
Development
Cost
-2
1
2
3
4
5
6
7
8
2004
2005
2006
2007
2008
2009
2010
2011
9
2012
Erbitux – Payback Curve ($1.2B Cost Model)
5x Return
6
5
Revenues
COGS + SG&A
Profit (before tax)
Cumulative Profit (before tax)
4
$Billion
3x Return
3
2
1
0
Breakeven
-1
-2
Development Cost
1
2
3
4
5
6
7
8
2004
2005
2006
2007
2008
2009
2010
2011
9
2012
Xolair – Payback Curve ($700M Cost Model)
6
5
Revenues
COGS + SG&A
Profit (before tax)
Cumulative Profit (before tax)
4
$Billion
5x Return
3
3x Return
2
1
0
Breakeven
-1
Development
Cost
-2
1
2
3
4
5
6
7
8
2004
2005
2006
2007
2008
2009
2010
2011
9
2012
Xolair – Payback Curve ($1.2B Cost Model)
5x Return
6
5
Revenues
COGS + SG&A
Profit (before tax)
Cumulative Profit (before tax)
4
$Billion
3x Return
3
2
1
0
Breakeven
-1
-2
Development Cost
1
2
3
4
5
6
7
8
2004
2005
2006
2007
2008
2009
2010
2011
9
2012