Biotechnology Versus Pharmaceutical Biotechnology

Biotechnology, like beauty, is in the eye of the beholder—a last hope for a patient with Alzheimer's disease; an anathema to an environmentalist. Seeking a broad consensus, we define biotechnology as an integrated application of scientific and technical understanding of a biologic process or molecule to develop a useful product. Biologic processes of interest include cellular activities such as protein synthesis, DNA replication, transcription (to RNA), protein processing, receptor-ligand interactions at cell surfaces, fermentation of bacteria, yeast, and mammalian cells.

Our broad definition of biotechnology includes beer and wine fermentation technology to produce distinctive beverages with commercial advantages, the isolation or passaging of viruses to produce nonvirulent variants for use as vaccines, genetic manipulation to coax bacteria to express metabolic enzymes that transform petroleum products into water-soluble forms for environmental cleanup after a spill, and the development of a recombinant, disease-resistant fruit or vegetable crop with prolonged freshness. Very often biotechnology means commercialization of biological sciences by integrating discoveries from many disciplines, including

■TABLE 1.2. Sales of top 12 selling biotech drugs

1999

1998

1997

1996

Drug

Marketer

Developer

Indication

($millions)

($millions)

($millions)

($millions)

Epogen

Amgen

Amgen

Anemia

1760

1380

1161

1150

Procrit

Amgen

Ortho Biotech

Anemia

1505

1363

1169

995

Neupogen

Amgen

Amgen

Neutropenia

1260

1120

1056

1017

Humulin

Genentech

Eli Lilly

Diabetes

1088

959

936

884

Engerix-B

Genentech

SmithKline Beeham

Hepatitis B

540

887

584

568

Intron A

Biogen

Shering-Plough

Hairy cell leukemia, Kaposi's sarcoma, and Hepatitis C

650

718

598

524

Kogenate

Bayer Biological

Bayer Biological

Hemophilia A

403

429

335"

NA

Genotropin

Genentech

Pharmacia

Growth failure

461

395

349

391

Avonex

Biogen

Biogen

Multiple sclerosis

621

395

158b

NA

Betaseron

Chiron/ Berlex

Berlex/Schering AG

Multiple sclerosis

545"

369"

387

353

ReoPro

Centocor

Eli Lilly, Centocor

Cardiac ischemic complications

447

365

NA

NA

Ceredase/

Genezyme

Genzyme

Gaucher's disease

479c

441c

333

265

Cerezyme

Total

9759

8821

7066

6147

Source: Data from Ernst & Young LLP for the last four years except where indicated. "Data from Schering AG annual report 1999 and expressed in Euro-dollars. 'Data from Biogen annual report 1998. cData from Genzyme annual report 2000, p. 52.

Source: Data from Ernst & Young LLP for the last four years except where indicated. "Data from Schering AG annual report 1999 and expressed in Euro-dollars. 'Data from Biogen annual report 1998. cData from Genzyme annual report 2000, p. 52.

microbiology, biochemistry, genetics, and bioengineering.

Currently biotechnology is an integral component of many industries, in addition to pharmaceutical companies. Our treatment of biotechnology and biopharmaceu-ticals will focus only on the application of biotechnology with respect to biologic entities and biologic processes to develop pharmaceutical products.

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