Top 10 Therapies

Top 10 Drugs

Risk/reward Estimated cost for developing a

new drug - $800M to $1.7B (see class web site)

Five Blockbusters of 2006Drug Company Peak Sales

AcompliaSuppress appetite, smoking

Sanofi-Aventis $2-5B

ExuberaInhalable insulin

Pfizer $2.25B

GardasilHPV, cervical cancer vaccine

Merck $1-2B

OrenciaArthritis treatment

Brisol-Meyers $1B

SutentShrink cancer tumors

Pfizer $1B

http://money.cnn.com/magazines/fortune/fortune_archive/2006/01/23/8366988/index.htm

Acomplia Status Sanofi announced that the FDA has set April 26 as the

new date to review Acomplia and give Sanofi a thumbs-up or -down on marketing it in the U.S. Back in February, the drug received an approvable letter for its weight-loss indication and was deemed non-approvable as a treatment to help people stop smoking.  

Acomplia was approved in the European Union back in late June, but the U.S. is where the big money is, especially now that France and Germany have been enacting new measures such as higher taxes on drug sales and rules to encourage doctors to prescribe cheaper prescriptions or generic drugs.

December 11, 2006 http://www.fool.com/News/mft/2006/mft06121118.htm

Exubera Status Miller Tabak projected that annual sales will

peak at the range of $250 million to $275 million in 2008, but added, "That may be too optimistic."

In an Oct. 26 report titled "Inhalable insulin: reality doesn't live up to the hype," Datamonitor analyst Daniel Poso projected an Exubera sales peak of about $200 million by 2015, far short of billion-dollar blockbuster status.

November 28 2006 http://money.cnn.com/2006/11/28/news/companies/exubera/index.htm

Gardasil Status Approved May 2006 Sales of HPV vaccine Gardasil,

garnering $70 million for the quarter despite being marketed only since June

October 23, 2006 http://www.fool.com/investing/dividends-income/2006/10/23/merck-

mints-money.aspx

Benefits Each additional dollar spent on

newer medicines saves $4.44 on hospitalizations.

New medicines generated 40 percent of the two-year gain in life expectancy achieved in 52 countries between 1986 and 2000.

New Drugs 2007

Assignment #1 What is the reward protection for

drug developers? How does it work?

What is meant by Phase 1, 2, 3? How does this work?

Risk/reward Patent protection – “The term of a

new patent is 20 years from the date on which the application for the patent was filed in the United States.” (http://www.uspto.gov/web/offices/pac/doc/general/)

Road to Approval – Phase 1 Phase 1 includes the initial introduction of an

investigational new drug into humans. These studies are usually conducted in healthy volunteer subjects. These studies are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. Phase 1 studies also evaluate drug metabolism, structure-activity relationships, and the mechanism of action in humans. The total number of subjects included in Phase 1 studies is generally in the range of twenty to eighty.

Road to Approval – Phase 2 Phase 2 includes the early controlled

clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short-term side effects and risks associated with the drug. Phase 2 studies usually involve several hundred people.

Road to Approval – Phase 3 Phase 3 studies are intended to gather the

additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Phase 3 studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase 3 studies usually include several hundred to several thousand people.

http://www.fda.gov/cder/about/smallbiz/faq.htm