Biotechnology Companies

Therapeutic, vaccine, and diagnostic human proteins, as well as a great many other proteins, are produced using the tools and processes of modern biotechnology in companies across the globe owned by members of a new industry, the biotechnology industry. The companies of the biotechnology industry are involved in the research, process development, manufacture and production of these protein products. A growing number of biotechnology companies are traded on the stock market as part of a class of high technology stocks that includes the telecommunications and electronics industries. Biotechnology companies that focus on the production of human therapeutic proteins, including the human genomics upon which these proteins are dependent, tend to be the most valuable, since the income per year for the sale of each different human therapeutic protein is so great.

It is important to understand that costs (average of $200 million dollars) and the time involved (12+ years) from research to the production of a particular protein, are also great. For instance, the first human protein produced by modern biotechnology methods was humulin or human insulin. Humulin, first appeared on the market in 1982. It is produced by Eli Lily, a biopharmaceutical company. The marketing of humulin was preceded by many years of struggle culminating with the development of a cell line that could make recombinant human insulin (research), the development of standard operating procedures for the manufacture and production of humulin (process development), and conduction of animal trials and clinical trials to prove the drug's safety and efficacy, followed by full scale manufacture. A summary of the steps in getting a drug to market follows:

3+ years for in vitro and preclinical animal studies.
<1 year to file an IND (investigational new drug) application with the FDA, have it reviewed by the FDA, and approved so that clinical testing on humans can begin.
6+ years for clinical trials including Phase I trials (1+ years) for safety testing to determine dose and route of administration, pharmacological properties and side-effects on healthy volunteers; Phase II trials (2+ years) to assess the drug's safety and therapeutic potential when given to patients with the conditions it is thought to help; Phase III trials (3+ years) to further verify the drug's long term safety and therapeutic potential when given to several thousand patients with the conditions it is thought to help.
3+ years to file a NDA (new drug application) with the FDA, have it reviewed by the FDA, and approved so that the product can be marketed.

According to a recent editorial in Science magazine, about 1000 U.S. biotechnology companies are working to develop protein pharmaceuticals. In early 1996, 16 therapeutic protein pharmaceuticals and 8 vaccines based on biotechnology had been approved by the FDA. There are an additional 150 products in the final (Phase III) clinical trials. The total number of biotechnology medicines in clinical trials (Phase I, II, and III) is about 284, according to a study by the Pharmaceutical Research and Manufacturers of America (PhRMA). According to PhRMA President, Gerald J. Mossinghoff, "Over the next decade or so, we will see the results of this biotechnology research in the form of cures and treatments for many of our age-old diseases. This could be the beginning of a new 'Golden Age' of medicine." Diseases targeted by biotechnology include: cancer, osteoporosis, Parkinson's disease, and AIDS.

According to a recent article in Nature Biotechnology, over 230 public biotechnology companies earned close to $10 billion. If one counts investment by private companies, multinational corporations, governments, and investors this value is more like $30 billion. Only thirty-nine companies turned a profit in 1995, about $1 billion. Over half the profit ($537 million) came from Amgen in Thousand Oaks, CA. Genentech (S. San Francisco, CA) was second with a profit of about $100 million. Enormous amounts of capital is being invested in research. For instance, biotech drug companies have spent more than $700 million to obtain access to data banks on the human genome that are being developed by nine different biotechnology companies. These human genome companies include: Myriad Genetics, Incyte Pharmaceuticals, and Human Genome Sciences (HGS). A recent article in Nature Biotechnology indicates that 216 public biotechnology companies spent over $4 billion in research and development in 1995. These companies and their expenditures are listed in the same article.

Biotechnology Company Study

In order to practice utilizing some of the resources available to you, study the company that produces the protein you have decided to research. (Inform me and your classmates via our discussion group of the name of your company.) Start out with the listing of biotechnology companies found at the Bioindustry Organization (BIO) HomePage and proceed from there. By clicking on your biotechnology company you will be offered information about your company and your protein. Some things that may be of interest to you include: the ease or difficulty with which the company brought your protein to market, the gross yearly sale of your protein both in terms of the total number of grams sold and the gross income from the sale; other protein products offered by the company or in the pipe-line; and various other interesting tid-bits. Compose a 500 word (2 double spaced typewritten pages) paper on your company and post it to your virtual lab notebook.

Also, using one of the Internet's Stock Guide's look up your biotechnology company's ticker symbol. Using the ticker symbol to identify your stock, determine it's value each day, Monday through Friday, throughout the duration of the course. At the end of the course make a graph, plotting the value of the stock each day throughout the semester. Please comment on any pronounced changes in value and when and why the changes occurred. Place the graph of your company's stock performance (and your comments) in your virtual lab notebook at the end of the course.

REFERENCES

Walsh, Gary and Denis R. Headon 1994 Chapter 4: Therapeutic proteins: special considerations. In Protein Biotechnology, John Wiley and Sons, New York, NY.

http://www.bio.com/co/profilelist.html (Bioindustry Organization (BIO) hot list of biotechnology companies)

Internet stock market quotes: http://www.teleserv.co.uk (This is the best place to find stock quotes on the Internet. Check it out. For the purpose of your assignment, you can access this WWW address near to the end of the semester, indicate the dates for the beginning and the end of the semester, and click on PRICES. You will be given a complete graph of your stock's performance during the semester that you can then hand submit along with the 500 word research paper on your company.)

Abelson, Philip H. 1996 Pharmaceuticals based on biotechnology. Science 273: 719. (You might be able to find this editorial at the Science HomePage at http://www.sciencemag.org)

PhRMA 1996 Biotechnology therapeutic medicines and vaccines under development. Genetic Engineering News: September 15: p29-34.

Hodgson, John 1996 Companies earn $10 billion of biotech's $30 billion. Nature Biotechnology 14: 560-561.

Glaser, Vicki and John Hodgson 1996 Public companies spend over $4 billion on R&D. Nature Biotechnology 14: 934-935.

Many companies have their own World Wide Web sites. For example, Biogen's WWW site is at http://www.biogen.com and Amgen's site is at http://www.amgen.com.

Sonia Wallman, NHCTC. 1997