Pipeline for New Drugs and Potential New Generic Drugs

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Pipeline for New Drugs andPotential New Generic
Drugs

• By
• Marv Shepherd, Ph.D.
• Director
• Center for Pharmacoeconomic Studies
• University of Texas
• Austin, Texas
• Email marvshepherd_at_mail.utexas.edu

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Presentation Objectives

• Trend in costs for drug development.
• Overview of the problems with the drug
  development process.
• Examine the decline in new drug products.
• List of potential new drugs for 2005.
• Shop the expanding generic market.
• List of potential new generic drugs.

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Trend in Domestic RD for Pharmaceutical
Companies(Billions)
Value for 2004 is an estimate
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Decrease in New Drug Approvals

• Despite the increase in RD investment fewer
  drugs are being submitted to FDA for approval.
• Many believe that the industry has not kept up
  with the new developments in the biomedical
  sciences.
• In other words, the industry is having troubles
  taking the promise of biomedical sciences and
  putting them into clinical applications. Look at
  the decrease in NDAs.

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Source FDA.gov
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Number of New Approved Chemical Entities
1985-2003
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• Although there has be a decreasing trend in the
  number of new drug products, 2004 should be a
  better year than 2003.
• As of September, 2004 there were 16 new chemical
  entities approved and 69 new drug
  applicationscompared with 21 and 72 in 2003.
• Perhaps an upswing in the number of new drug
  discoveries is coming.

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• FDA has stated that there is an urgent need to
  improve the process of clinical testing including
  trial design, end points and analyses.
• Unacceptable drug performance in the clinical
  trials is very high one out every two drugs in
  clinical trials doesnt make it to an NDA.
• Clinical testing is the most expensive part of
  drug development, improvements are needed to
  identify potential products.

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Development Costs

• Drug development costs is directly related to
  disease being treated.
• For example, analgesics/anesthetic drugs are the
  cheapest to develop requiring on average 350
  million in clinical costs, whereas CNS drugs cost
  on average 525 million in clinical costs. (Med
  Ad News, supplement, 2004)
• These are just clinical trial costs. Total drug
  development cost can run from less than 500
  million to 1.5 billion depending on the
  product/disease.

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Clinical Trial Time Differences by Therapeutic
Area

• Analgesics/anesthetics-----61.8 months
• Anti-infective agents---------63.0 months
• Cardiovascular-----------------82.0 months
• CNS agents--------------------114.6 months
• All drugs--------------------------90.3 months

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New Drug Development

• The clinical trial testing costs of developing a
  new drug have increased 55 since 1999. Tests
  are requiring more patients, more trials and more
  long-term monitoring.
• Problem The industry is spending 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, Alzheimers
disease).
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Promising New Drugs for 2005

• Varenicline (Pfizer) smoking cessation product.
  Easing the craving and withdrawal symptoms from
  nicotine. In clinical trials, half the patients
  quite smoking within seven weeks compared to 19
  on placebo. Product could be launched in 2005.
• Lyrica (Pfizer) first agent to treat
  neuropathic pain associated with diabetic
  peripheral neuropathy and shingles. Received FDA
  approval December 2004.

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Continuation Other New Products

• Arcoxia (Merck) a Cox 2 inhibitor approved in
  October for osteoarthritis, rheumatoid arthritis,
  chronic low back pain and dysmenorrhea. However,
  FDA has asked for more data on long-term use of
  the product.
• Tygracil (Wyeth) an antibiotic which is an
  alternative to IV antibiotics which are
  increasingly becoming ineffective due to
  resistance.
• Exubera (Sanofi-Aventis and Pfizer) an inhaled
  insulin powder taken prior to eating. FDA
  decision in 2005.

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Continuation Other New Products

• Wyeth is also conducting research on new low-dose
  birth control pill, Librel . The product is in
  phase III development. Librel causes continuous
  suppression of ovulation allowing women to be
  period free.
• Clofarabine also known as Clolar (Genzyme)
  is a promising treatment for leukemia in children
  and solid cancer tumors which have fail
  chemotherapy. FDA approved the drug in January
  2005.
• Entecavirfor (BMS) treatment of hepatitis B.
  Approval is expected late 2005.

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Other Promising Products

• Abatacept (BMS) treatment for arthritis. First-
  in-class T-cell costimuation modulator. Clinical
  trial data is impressive, expected to be on the
  market in late 2005.
• Acomplia (Sanofi-Aventis) weight-loss drug.
  Very promising results from clinical trial data.
  Has created a lot of media attention. NDA is
  expected to be submitted in spring 2005.
• Macugen (Eyetech and Pfizer) first therapy for
  slow vision loss for people with wet age-related
  macular degeneration. FDA approved in December
  2004.

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Other Promising Products

• Freestyle Navigator (Abbott) is a glucose
  sensor inserted under the skin. It is paired with
  a wireless monitor, which can be placed in a
  purse or on a belt. Monitor sounds an alarm when
  the glucose level is abnormal. It also stores
  data. FDA decision expected in 2005.

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Promise of New Generic Drugs
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• Source Med Ad News, May 2004

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Source Med Ad News, May 2004
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• Source Med Ad News, May 2004

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Generic Development of Selected Biotech Products,
2003 Sales
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Conclusion
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.
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Thanks you very much. Any Questions? Hope you
have a nice stay in San Antonio and a successful
conference. Marv Shepherd