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Plain Talk About Technology
In laymen's terms, what leading area bioscience companies actually do.
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Business New Haven
4/14/2003
By: Richard Rangoon
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When the next blockbuster drug - the next Prozac, the next Viagra - hits the market, there's a decent chance the driving idea behind the compound just may come from a lab in greater New Haven.
The region's two dozen biotechnology firms are continually working to get their ideas to market, and building a solid body of research in the process.
Following is a description of five of these companies, their products and their goals, in language for those without a single lab coat or slide rule in their entire closet.
New Haven's Achillion Pharmaceuticals develops drugs for viral, bacterial and fungal infections.
Achillion is presently is testing a compound licensed from Yale that fights HIV (the virus that causes AIDS), and Hepatitis B (a virus that attacks the liver). Achillion's lab tests have shown the drug - known as elvucitabine - to have efficacy in battling both viruses, according to Amy Enders, Achillion's manager of corporate communications.
Elvucitabine is in the second of three phases of clinical testing required by the U.S. Food & Drug Administration (FDA). The compound entered clinical testing on human volunteers after undergoing preclinical testing on cells, laboratory cultures and animals. According to Enders, the compound is in Phase II trials for its application to HIV and to Hepatitis B.
In its application to HIV, elvucitabine would become a component of the "cocktail" of drugs administered to infected AIDs patients. The compound has shown promise in battling HIV strains that mutate, thus helping to slow the rate at which the virus reproduces, says Enders.
Currently, HIV infection in the U.S. is spreading at the rate of 50,000 new cases a year.
Moreover, in its application to the Hepatitis B virus (HBV), elvucitabine would address the seventh-leading cause of death worldwide. About 1.25 million Americans have HBV, but many of them are not aware they are infected. Achillion is evaluating potential partners to market elvucitabine and hopes to market it by late 2005 to early 2006, Enders says.
The company also is researching drugs for Hepatitis C, for a new approach to attacking HIV, as well as drugs that fight bacterial infections.
Achillion was founded in 2000 by CEO William Rice and today has 75 full-time employees, 57 of whom are researchers. In 2002, Achillion's market value was $70 million, with $16.6 million invested in R&D. The company is privately owned and has a strategic alliance with Yale University.
New Haven's Agilix Corp. generates data on genes and proteins. Agilix analyzes organic material and reports on how the genes are expressed. Clients submit samples to determine whether genes are turned "off" or "on," explains Grant Carlson, Agilix' vice president of marketing and business development.
For example, a company that seeks to develop drought-resistant corn or rice might contract Agilix to obtain genetic data. This information would help the client by identifying the active (or "turned on") genes in the sample submitted for evaluation.
The full genetic sequences of only about 100 organisms - most of them bacteria - have been identified. Therefore, Agilix' technology would be useful to analyze any of the millions of unmapped gene sequences remaining.
Pharmaceutical companies researching new compounds are attracted to Agilix' gene technology because it is among the most innovative in its field, Carlson says. At the same time, clients also can submit biologic samples without fully understanding their genetic makeup.
One of the company's distinguishing characteristics is that it makes its technology available to a wide range of clients. This policy provides access to data on genes and organisms that otherwise might not be available to some researchers, according to Carlson.
Through analyzing the samples of many clients, Agilix is helping to advance the progress of genetic mapping. Agilix was founded in 1999 and has 50 full-time employees, 40 of whom are researchers. Its CEO is Martin Mattessich.
Agilix has a strategic alliance with Yale and is the exclusive licensee of the university's GenCompass technology. The company is privately owned.
Branford-based Neurogen Corp. develops drugs for depression, insomnia, anxiety, arthritis, urinary incontinence and other medical problems dealing with nervous disorders, inflammation and metabolism.
The company is in Phase II clinical testing of a compound that fights inflammation caused by rheumatoid arthritis and asthma. Both conditions are caused by a person being attacked by their own immune system. Neurogen has designated the compound NGD 2000-1.
The company is considering partnering with pharmaceutical companies for further development of the drug, according to Vice President of Drug Regulatory Affairs Charles Ritrovato.
Since 1992, Neurogen has partnered with pharmaceutical giant Pfizer Inc. in Groton, to work on GABA drugs. Neurogen's research in this area is targeting the GABA receptors in the brain that influence depression and insomnia. The research on insomnia is in Phase I of clinical testing, says Ritrovato.
Biotechnology companies must go through substantial trial and error before settling on a compound promising enough to be promoted to Phase I. Most compounds are rejected during pre-clinical testing.
That's why few chemists at even the largest biotechnology companies can point to a marketed drug that incorporates their research. Only about ten percent of compounds developed in biotechnology labs reach the clinical testing phase, Ritrovato says.
Neurogen also has partnered with New Jersey-based Aventis Pharmaceuticals to work on a drug that attempts to block the receptors of the nervous system hormone CRF, which is elevated in people with major depression, according to Ritrovato.
Another compound under development in Neurogen labs numbs the types of receptors that make a person's tongue burn after eating spicy food. Through desensitizing these receptors, the compound shows evidence of decreasing inflammation in the body.
Neurogen chemists have also seen indications that the compound also diminishes urinary incontinence, says Ritrovato.
Neurogen was founded in 1987 and has 170 full-time employees, 121 of whom are researchers. Its CEO is William H. Koster. The company has developed and owns all of its compounds.
Neurogen's market capitalization is about $73.3 million, with $34.5 million going toward annual research and development. Its stock trades on the NASDAQ under the ticker symbol NRGN.
VaxInnate Corp. focuses on preventing infectious diseases, but performs research in other therapeutic areas as well. The company has two upcoming research projects - one dealing with an infectious disease, the other with a cancer.
VaxInnate researchers are working on a vaccine that first bypasses inflammation, the immune system's natural first-state reaction to an injury. Then the vaccine stimulates the immune system's second-state reaction. This second state is more adaptive, helping to heal the injury while reducing inflammation, according to Jeff Powell, the company's senior director of R&D.
The compound relies on an immune system-boosting substance derived from bacteria, explains Powell. This substance is incorporated into the technology and addresses different receptors than the compounds of competing laboratories.
VaxInnate currently has a partnership with one pharmaceutical company, and is open to working with others. VaxInnate and the undisclosed pharmaceutical company are scheduled to begin pre-clinical studies during the next two quarters.
The company licenses the technology from Yale University, where it was developed. VaxInnate is an independent company working to commercialize Yale's know-how, Powell says.
The company has strong ties to the university - its founders are from Yale, the university is a stockholder, and Yale is represented on VaxInnate's advisory committee and board of directors.
Founded in May 2002, VaxInnate is the most recently formed of Greater New Haven's biotechnology companies.
The company has eight full-time employees, seven of whom are researchers, and is evaluating candidates for CEO. VaxInnate is privately owned.
Vion Pharmaceuticals develops small-molecule compounds to treat cancer.
Although cancer has been commonly thought of as a single disease, researchers have found that it may be as many as 160 diseases.
Because a cure has yet to be identified for these diseases, innovative approaches should be explored, says Terrence Doyle, Vion's director of R&D.
Using bacteria as anti-cancer agents is a new angle on tackling cancer, and Vion's technology is on the leading edge of this approach, according to Doyle.
However, being a pioneer has its drawbacks. For one, the FDA places a higher burden of proof on compounds that work through unconventional means. The result tends to be longer approval times for drugs that take a fresh approach, Doyle says.
To meet market demand, companies try to build on conventional approaches so as to create drugs rapidly and inexpensively. However, if these compounds fail to make it to market, researchers are compelled to move onto new territory.
Vion's compounds are thoroughly screened for toxicity through animal testing before being made available to human volunteers, Doyle explains. Patients who have failed to respond to conventional treatments generally are those who request the drug.
As scientists build on knowledge acquired through their research, they are becoming more selective about the compounds they choose to work with. The result is more-productive research and - in theory - less time for prospective drugs to reach the market.
However, biotechnology companies must do a vast amount of work to determine whether the prospective drug is safe, effective and marketable. Then, the drug must meet FDA's stringent standards for safety and efficacy.
It is not unusual for the entire process - from the drug's conception to its availability to the public - to take ten to 12 years. And very few compounds make it that far, Doyle says.
Based in New Haven's Science Park, Vion was founded in 1993 and employs 25 full-time researchers. Its CEO is Alan Kessman. The company has strategic alliances with Yale University and the National Cancer Institute.
Vion's recent market capitalization was about $9 million, with $12.5 million going toward research-and-development expenses annually. Its stock trades on the NASDAQ exchange under the ticker symbol VION.
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