Strong R & D efforts focal point of the '90s - For the Pharmacist

Strong R & D efforts focal point of the '90s

NEW YORK -- Despite an FDA scandal that sent shock waves throughout the pharmacetucial manufacturing community and slowed drug approvals to a crawl, branded and generic pharmaceutical manufacturers continue to pump large sums of money into research and development.

While federal officials weed out the last of the corrupt participants in the industry-wide drug approval scandal, the FDA has reorganized, naming Dr. David Kessler as commissioner. Hopefully, the necessary process of moving the hundreds of new and abbreviated new drug approvals through a very clogged pipeline will begin to pick up steam.

Good news

That would be good news for the scores of generic and branded pharmaceutical companies that have invested millions into developing and bringing new drugs to market. According the Pharmaceutical Manufacturers Association (PMA), branded pharmaceutical manufacturers (also referred as PMA companies), spent some $8.2 billion in 1990 for worldwide research and development of human and veterinary drugs.

New product introductions from this sector of the industry is particularly vital because of expected losses from drugs going off patent over the next five years.

According to David Saks, an analyst with Wedbush Morgan Securities, the market for "brand name generics and multi-drug source products could double to $16 billion in sales." Saks credits much of that gain to "$10.7 billion worth of brand name prescription drugs losing patent protection between 1990 and 1995." (See chart)

The best selling drugs fall into three therapeutic categories> cardiovascular, central nervous system, and anti-infectives. According to PMA, sales of products in these three categories alone account for approximately 60 percent of all prescription drugs sold in the U.S.

Cardiovascular research

According to a 1989 PMA survey of drugs in development, 48 companies spent $1.7 billion (or 27 percent of total research dollars) to develop 91 medicines for heart disease, hypertension and stroke.

The bulk of the industry's investment in cardiovascular research is going toward the treatment of hypertension.

Alzheimer's disease

Drugs in development for Alzheimer's disease are not expected to cure this deteriorating condition, but ease its symptoms. Approximately four million Americans suffer from Alzheimer's and, according to Edward F. Truschke, president, Alzheimer's Association.

Many of the drugs being developed for this disease fall into a category known as cholinesterase inhibitors. They are designed to interrupt the action of cholinesterase enzyme, the enzyme that blocks acetylcholine, the neuro-transmitter responsible for sending messages between brain cells.

Diabetes

Approximately 11 million Americans suffer from diabetes. According to John F. Beary, III, M.D., senior vice president for Science and Technology, PMA, diabetes researchers are concentrating their efforts in three major areas: 1. Type I (insulin-dependent) diabetes> 2. Type II (non-insulin-dependent) diabetes and> 3. prevention of complications in the eyes, nerves and blood vessels associated with both Type I and Type II diabetes.

AIDS

As of this past summer, there were 77 drugs being investigated to treat AIDS, AIDS-related diseases, and opportunistic infections (OI) common to AIDS victims (OI account for up to 90 percent of all AIDS-related deaths).

According to PMA, 15 medicines under investigation to treat AIDS fall into the category of biotechnology drugs. This category is comprised of several drug subcategories.

Generics

Generic drug approvals, which have virtually come to a standstill because of the recent FDA probe, will pick up and continue to grow steadily as patent protection on the top 100 drugs expire over the next decade.

According to Wedbush Morgan Securities analyst David Saks, in 1990 alone, generics accounted for approximately 20 percent of the $40 billion in prescription drug sales. His forcast is for the generic market to double as a "colossal pileup of generic ANDAs" finally get approved.

COPYRIGHT 1991 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2004 Gale Group