Pipeline for New Drugs and Potential New Generic Drugs By Marv Shepherd, Ph.D. Director Center for...
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Transcript of Pipeline for New Drugs and Potential New Generic Drugs By Marv Shepherd, Ph.D. Director Center for...
Pipeline for New Drugs andPipeline for New Drugs andPotential New Generic Potential New Generic
DrugsDrugsByBy
Marv Shepherd, Ph.D.Marv Shepherd, Ph.D.DirectorDirector
Center for Pharmacoeconomic Center for Pharmacoeconomic StudiesStudies
University of TexasUniversity of TexasAustin, TexasAustin, Texas
Email: Email: [email protected]@mail.utexas.edu
Property ofMarv Shepherd
Presentation ObjectivesPresentation Objectives
Trend in costs for drug development.Trend in costs for drug development. Overview of the problems with the drug Overview of the problems with the drug
development process.development process. Examine the decline in new drug Examine the decline in new drug
products.products. List of potential new drugs for 2005.List of potential new drugs for 2005. Shop the expanding generic market.Shop the expanding generic market. List of potential new generic drugs.List of potential new generic drugs.
Property ofMarv Shepherd
Trend in Domestic R&D for Trend in Domestic R&D for Pharmaceutical CompaniesPharmaceutical Companies
($Billions)($Billions)
1.53.4
6.9
12.0
21.423.5
25.727.4
32.0*
0
5
10
15
20
25
30
35
1980 1985 1990 1995 2000 2001 2002 2003 2004
Billions in U.S. $
*Value for 2004 is an estimate
Property ofMarv Shepherd
FirmFirm 2003 R&D2003 R&D
Billions Billions
% Change % Change from 2002from 2002
PfizerPfizer $7.131 $7.131 38%38%
MerckMerck $3.178$3.178 19%19%
NovartisNovartis $3.758$3.758 32%32%
GSKGSK $4.526$4.526 1.4%1.4%
RocheRoche $3.542$3.542 12%12%
AventisAventis $3.309$3.309 (15%)(15%)
BMSBMS $2.279$2.279 3%3%
J&JJ&J $4.684$4.684 18%18%
Eli LillyEli Lilly $2.350$2.350 9%9%
WyethWyeth $2.094$2.094 1%1%
AstraZenecaAstraZeneca $3.451$3.451 12%12%
Property ofMarv Shepherd
Decrease in New Drug ApprovalsDecrease in New Drug Approvals
Despite the increase in R&D investment Despite the increase in R&D investment fewer drugs are being submitted to FDA for fewer drugs are being submitted to FDA for approval.approval.
Many believe that the industry has not kept Many believe that the industry has not kept up with the new developments in the up with the new developments in the biomedical sciences.biomedical sciences.
In other words, the industry is having In other words, the industry is having troubles taking the promise of biomedical troubles taking the promise of biomedical sciences and putting them into clinical sciences and putting them into clinical applications. Look at the decrease in NDAs.applications. Look at the decrease in NDAs.
Property ofMarv Shepherd
Number of FDA New Chemical Entity Applications (1995-2003)
5045 43
30 32
2225
3741
0
10
20
30
40
50
60
'95 '96 '97 '98 '99 '00 '01 '02 '03
Year
Number of NCEs
Source: FDA.gov
Property ofMarv Shepherd
Number of New Approved Chemical Entities Number of New Approved Chemical Entities 1985-20031985-2003
23 23
3026 28
53
39
3035
2724
1721
252220 2021
30
0
10
20
30
40
50
60
'85 '86 '87 '88 '89 '90 '91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02 '03
Year
Number of NCEs
Property ofMarv Shepherd
Number of Drugs Approved and in the Pipeline(2001-May 2004)
134
142
169
61
167
620
687
404
0 100 200 300 400 500 600 700 800
Approved 2001
Approved 2002
Approved 2003
Approved 2004
Waiting Approval
Phase I
Phase II
Phase III
Property ofMarv Shepherd
Although there has be a decreasing trend in Although there has be a decreasing trend in the number of new drug products, 2004 the number of new drug products, 2004 should be a better year than 2003.should be a better year than 2003. As of September, 2004 there were 16 new As of September, 2004 there were 16 new
chemical entities approved and 69 new drug chemical entities approved and 69 new drug applications—compared with 21 and 72 in 2003.applications—compared with 21 and 72 in 2003.
Perhaps an upswing in the number of new Perhaps an upswing in the number of new drug discoveries is coming. drug discoveries is coming.
Property ofMarv Shepherd
FDA has stated that there is an urgent need FDA has stated that there is an urgent need to improve the process of clinical testing to improve the process of clinical testing including trial design, end points and including trial design, end points and analyses. analyses.
Unacceptable drug performance in the Unacceptable drug performance in the clinical trials is very high; one out every two clinical trials is very high; one out every two drugs in clinical trials doesn’t make it to an drugs in clinical trials doesn’t make it to an NDA.NDA.
Clinical testing is the most expensive part of Clinical testing is the most expensive part of drug development, improvements are needed drug development, improvements are needed to identify potential products.to identify potential products.
Property ofMarv Shepherd
Development CostsDevelopment Costs Drug development costs is directly related to Drug development costs is directly related to
disease being treated.disease being treated. For example, analgesics/anesthetic drugs are For example, analgesics/anesthetic drugs are
the cheapest to develop requiring on average the cheapest to develop requiring on average $350 million in clinical costs, whereas CNS $350 million in clinical costs, whereas CNS drugs cost on average $525 million in clinical drugs cost on average $525 million in clinical costs. costs. ((Med Ad NewsMed Ad News, supplement, 2004), supplement, 2004)
These are just clinical trial costs. Total drug These are just clinical trial costs. Total drug development cost can run from less than development cost can run from less than $500 million to $1.5 billion depending on the $500 million to $1.5 billion depending on the product/disease.product/disease.
Property ofMarv Shepherd
Clinical Trial Time Differences by Clinical Trial Time Differences by Therapeutic Area Therapeutic Area
Analgesics/anesthetics-----61.8 monthsAnalgesics/anesthetics-----61.8 months Anti-infective agents---------63.0 monthsAnti-infective agents---------63.0 months Cardiovascular-----------------82.0 monthsCardiovascular-----------------82.0 months CNS agents--------------------114.6 monthsCNS agents--------------------114.6 months All drugs--------------------------90.3 monthsAll drugs--------------------------90.3 months
Property ofMarv Shepherd
New Drug DevelopmentNew Drug Development
The clinical trial testing costs of The clinical trial testing costs of developing a new drug have increased developing a new drug have increased 55% since 1999. Tests are requiring 55% since 1999. Tests are requiring more patients, more trials and more more patients, more trials and more long-term monitoring.long-term monitoring.
Problem: The industry is spending Problem: The industry is spending more money, but producing less.more money, but producing less.
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In response, research from the top 15 pharmaceutical firms are more interested in developing drugs from high net-return therapeutic areas rather than low-net returning areas. Thus, they are not interested in developing analgesic nor anesthetic drugs; they are interested in cancer drugs, cardiovascular agents and CNS drugs (depression, anxiety, schizophrenia, Alzheimer’s disease).
Property ofMarv Shepherd
Promising New Drugs for 2005Promising New Drugs for 2005
VareniclineVarenicline®® (Pfizer) smoking cessation (Pfizer) smoking cessation product. Easing the craving and withdrawal product. Easing the craving and withdrawal symptoms from nicotine. In clinical trials, symptoms from nicotine. In clinical trials, half the patients quite smoking within seven half the patients quite smoking within seven weeks compared to 19% on placebo. Product weeks compared to 19% on placebo. Product could be launched in 2005.could be launched in 2005.
Lyrica Lyrica ®® (Pfizer) first agent to treat (Pfizer) first agent to treat neuropathic pain associated with diabetic neuropathic pain associated with diabetic peripheral neuropathy and shingles. peripheral neuropathy and shingles. Received FDA approval December 2004.Received FDA approval December 2004.
Property ofMarv Shepherd
Continuation: Other New ProductsContinuation: Other New Products Arcoxia Arcoxia ®® (Merck) a Cox 2 inhibitor approved (Merck) a Cox 2 inhibitor approved
in October for osteoarthritis, rheumatoid in October for osteoarthritis, rheumatoid arthritis, chronic low back pain and arthritis, chronic low back pain and dysmenorrhea. However, FDA has asked for dysmenorrhea. However, FDA has asked for more data on long-term use of the product.more data on long-term use of the product.
Tygracil Tygracil ®® (Wyeth) an antibiotic which is an (Wyeth) an antibiotic which is an alternative to IV antibiotics which are alternative to IV antibiotics which are increasingly becoming ineffective due to increasingly becoming ineffective due to resistance.resistance.
ExuberaExubera®® (Sanofi-Aventis and Pfizer) an (Sanofi-Aventis and Pfizer) an inhaled insulin powder taken prior to eating. inhaled insulin powder taken prior to eating. FDA decision in 2005.FDA decision in 2005.
Property ofMarv Shepherd
Continuation: Other New ProductsContinuation: Other New Products
Wyeth is also conducting research on new Wyeth is also conducting research on new low-dose birth control pill, Librel low-dose birth control pill, Librel ®®. The . The product is in phase III development. Librel product is in phase III development. Librel ®® causes continuous suppression of ovulation causes continuous suppression of ovulation allowing women to be period free.allowing women to be period free.
Clofarabine Clofarabine ®® also known as Clolar also known as Clolar ®® (Genzyme) is a promising treatment for (Genzyme) is a promising treatment for leukemia in children and solid cancer tumors leukemia in children and solid cancer tumors which have fail chemotherapy. FDA approved which have fail chemotherapy. FDA approved the drug in January 2005.the drug in January 2005.
Entecavirfor Entecavirfor ®® (BMS) treatment of hepatitis (BMS) treatment of hepatitis B. Approval is expected late 2005.B. Approval is expected late 2005.
Property ofMarv Shepherd
Other Promising ProductsOther Promising Products AbataceptAbatacept®® (BMS) treatment for arthritis. First- in- (BMS) treatment for arthritis. First- in-
class T-cell costimuation modulator. Clinical trial class T-cell costimuation modulator. Clinical trial data is impressive, expected to be on the market in data is impressive, expected to be on the market in late 2005.late 2005.
Acomplia Acomplia ®® (Sanofi-Aventis) weight-loss drug. Very (Sanofi-Aventis) weight-loss drug. Very promising results from clinical trial data. Has promising results from clinical trial data. Has created a lot of media attention. NDA is expected to created a lot of media attention. NDA is expected to be submitted in spring 2005.be submitted in spring 2005.
Macugen Macugen ®® (Eyetech and Pfizer) first therapy for (Eyetech and Pfizer) first therapy for slow vision loss for people with wet age-related slow vision loss for people with wet age-related macular degeneration. FDA approved in December macular degeneration. FDA approved in December 2004.2004.
Property ofMarv Shepherd
Other Promising ProductsOther Promising Products
Freestyle Navigator Freestyle Navigator ®® (Abbott) is a glucose (Abbott) is a glucose sensor inserted under the skin. It is paired sensor inserted under the skin. It is paired with a wireless monitor, which can be placed with a wireless monitor, which can be placed in a purse or on a belt. Monitor sounds an in a purse or on a belt. Monitor sounds an alarm when the glucose level is abnormal. It alarm when the glucose level is abnormal. It also stores data. FDA decision expected in also stores data. FDA decision expected in 2005.2005.
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2005 Patent 2005 Patent ExpirationsExpirations
2003 U.S. Sales2003 U.S. Sales
$ Millions$ Millions
Zithromax Zithromax ®® $2,010$2,010
Zofran Zofran ®® $1,269$1,269
Biaxin Biaxin ®® $1,221$1,221
Amaryl Amaryl ®® $674$674
Altace Altace ®® $527$527
TotalTotal $5,701$5,701
Source: Source: Med Ad NewsMed Ad News, May 2004, May 2004
Property ofMarv Shepherd
2006 Patent 2006 Patent ExpirationsExpirations
U.S. SalesU.S. Sales
$ Millions$ Millions
Zocor Zocor ®® $5,011$5,011
Pravachol Pravachol ®® $2,827$2,827
Zoloft Zoloft ®® $2,900$2,900
Proscar Proscar ®® $606$606
TotalTotal $8,444$8,444
Source: Source: Med Ad NewsMed Ad News, May 2004, May 2004
Property ofMarv Shepherd
2007 Patent 2007 Patent ExpirationsExpirations
U.S. SalesU.S. Sales
$ Millions$ Millions
Norvasc Norvasc ®® $4,336$4,336
Paxil Paxil ®® $3,078$3,078
Zyrtec Zyrtec ®® $1,338$1,338
Imitrex Imitrex ®® $1,246$1,246
Clarinex Clarinex ®® $694$694
Coreg Coreg ®® $592$592
TotalTotal $11,284
Source: Source: Med Ad NewsMed Ad News, May 2004, May 2004
Property ofMarv Shepherd
2008 Patent 2008 Patent ExpirationsExpirations
U.S. SalesU.S. Sales
$ Millions$ Millions
Advair Advair ®® $3,631$3,631
Effexor SR Effexor SR ®® $2,712$2,712
Risperdal Risperdal ®® $2,512$2,512
Depakote Depakote ®® $927$927
Casodex Casodex ®® $854$854
Serevent Serevent ®® $710$710
TotalTotal $11,346$11,346
Property ofMarv Shepherd
BiotechnologyBiotechnology
ProductsProducts
2003 U.S. Sales 2003 U.S. Sales (Billions)(Billions)
Humulin Humulin ®® $1.06$1.06
Procrit Procrit ®® $3.98$3.98
Epogen Epogen ®® $2.43$2.43
Neupogen Neupogen ®® $1.40$1.40
Intron A Intron A ®® $1.85$1.85
Generic Development of Selected Biotech Products, 2003 Sales
Property ofMarv Shepherd
Trend in Sales for Drugs Comming Off Patent (2003 Sales $ Billions)
$5,701
$8,444
$11,284 $11,346
$0
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000
$14,000
2005 2006 2007 2008
2003 U.S. Dollars (Millions)
Property ofMarv Shepherd
ConclusionConclusion
Although in recent years there has been a decreasing trend in the number of new chemical entities, in 2004 the trend may have leveled out or slightly increased. A number of new innovative drug products will enter the market in 2005.
Basic science research is more than just a step ahead of translational research to get new products on the market. Inefficiencies in drug research needs to be corrected.
patents on over $5 billion of brand name drugs will expire in 2005 and over the next four years, patents on over $30 billion dollars will expire. This will bring an estimated savings to consumers of $12 billion.