Tomoxetine

NEW YORK -- With pharmaceutical research and development efforts at an all-time high, the outlook is bright for major new drug entries next year as well as in the foreseeable future.

Even anticipated patent expirations on key pharmaceutical products over the next five years won't dim the chances for a rapidly expanding drug pipeline full of new treatments in important therapeutic categories. If anything, the patent expirations are expected to act as a prod to the large research manufacturers seeking to replace lost revenues with sales from newly developed drugs.

Eli Lilly and Co. is a case in point. The anticipated loss of patent protection for Prozac next year will hamper earnings in the short term, but the company has high hopes for some nine products in late-stage development, some of which are expected to be "blockbusters," in the opinion of Sidney Taurel, Lilly's chief executive.

They include tomoxetine, a drug said to be a safer alternative to Ritalin for the treatment of attention deficit hyperactivity disorder, and a synthetic version of human activated protein C to combat sepsis, a severe bacterial infection that claims the lives of hundreds of thousands of hospitalized patients each year.

In surveys of its members, the Pharmaceutical Research and Manufacturers of America has pinpointed hundreds of drugs in development in categories ranging from anti-infectives to cancer treatments to medications for mental illness. Most of them will never reach drug store prescription shelves, but a small number will, and a handful of those will be blockbusters generating a billion dollars or more a year.

Retail nears $100 billion

The strong prescription market, spurred by the impact of new drug launches and heavy promotional spending by pharmaceutical companies, has given a tremendous boost to drug sales in retail outlets. According to IMS Health, North American retail prescription sales increased 17 percent to $98 billion for the 12 months ended Aug. 31. Looking at the total U.S. drug market--including retail, hospital and other pharmacy outlets--total sales reached $131.1 billion in 1999, a gain of 17 percent. U.S. sales represented 39 percent of global drug revenues, according to IMS Health.

Many of the pharmaceutical breakthroughs will be coming from discoveries in genetic research, one of the hottest areas in drug development. The biotechnology arm of the pharmaceutical industry has been producing products for some two decades, long enough for some of the original discoveries to begin losing patent protection.

But today the pace of biotech research is accelerating. In a survey of pharmaceutical manufacturers, PhRMA found 369 medicines in development that use proteins and other substances manufactured by the human body to fight diseases--the association's definition of biotechnology drugs. Almost half of them-175--are for various types of cancer.

The rapidly emerging field of genomics-based research, where investigations are yielding hundreds of new targets for drug development, has enhanced biotechnological innovation. These drugs promise to be highly selective for specific diseases and their symptoms and thus less likely to produce the toxic side effects that can sometimes be worse than the diseases themselves.

Drug research has also been helped by powerful computer software programs that allow vast libraries of existing chemical compounds to be rapidly screened for their potential in targeting the activity of specific enzymes linked to disease processes and thus curbing or eliminating their effects.

Junction of genetics and technology

Pharmaceutical and biotechnology companies have been increasing their investments in "bioinformatics," part of the new vocabulary describing the junction where human genetic information, biochemistry and computer technology are colliding in a starburst of discovery. Industry surveys cited by the Genomics Corp., one of the leading players in the new field, show that spending on bioinformatics "is expected to increase dramatically in 2001," to as much as $2 billion from an estimated $400 million this year.

Many of the top pharmaceutical companies are partnering with biotechnology and generics research firms to increase the potential of their investments and thus more quickly fill their pipelines with innovative new medicines.

Bayer, for example, is collaborating with Millennium Pharmaceuticals to streamline the drug discovery process and thus accelerate the identification and development of compounds likely to offer new and safer medicines for treating and preventing disease.

Targeted drug development for older Americans is important not only because the average life expectancy in the United States has reached 77, but also because of the huge baby boomer bubble that is making its way right now through its middle years and into the earliest stages of older age.

According to PhRMA, developmental drugs for this demographic group include more than 350 for cancer; more than 100 for heart disease and stroke; 28 for respiratory and lung diseases; 26 for Alzheimer's; 26 for depression; 25 for diabetes; 16 for Parkinson's disease; 14 for osteoporosis; 11 for rheumatoid arthritis; 11 for gastrointestinal disorders, and nine for prostate disease.

Attacking the old enemies

In addition to its report on pipeline medicines for aging, PhRMA has also issued reports on developmental drugs for women, for children, and for other disease categories, including infection, mental illness, neurological disorders, HIV/AIDS, heart disease and stroke, and cancer. Reports can be accessed on PhRMA's Web site, www.phrma.org.

In its latest survey, on infectious diseases, PhRMA reported that there are 137 medicines in development for the treatment and prevention of what PhRMA president Alan Holmer called "humankind's oldest and most tenacious enemies.

They include 22 medicines to attack such viruses as hepatitis, herpes and influenza; 19 new antibiotics aimed at overcoming antibiotic resistance, and 42 vaccines to prevent diseases from birth defects to pneumococcal infections in the elderly. In addition, there are 103 other medicines in development for AIDS and AIDS-related conditions.

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