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.


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


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%


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.


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


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


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


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.


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.


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.


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


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.


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).


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.


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.


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.


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.


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.


Promise of New Generic Drugs


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



U.S. SalesU.S. Sales


Zocor Zocor ®® $5,011$5,011

Pravachol Pravachol ®® $2,827$2,827

Zoloft Zoloft ®® $2,900$2,900

Proscar Proscar ®® $606$606







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






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



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


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)


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.


Thanks you very much.

Any Questions?

Hope you have a nice stay in San Antonio and a successful conference.

Marv Shepherd

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