by Gary Haber, The News Hournal, 15 Oct 2006
Pharmaceutical makers are increasingly developing drugs that target specific groups of patients, and a Newark company is playing a leading role.
In recent years, drug companies have launched drugs to treat conditions like a form of leukemia in patients with a genetic condition called Philadelphia chromosome, and a treatment for an aggressive form of breast cancer among women whose genetic makeup makes them less likely to benefit from other drugs.
Benjamin Chien, the chairman, president and chief executive officer of Quest Pharmaceutical Services, saw that drug companies were starting to make more drugs that, rather than treating broad groups of people, target a disease or condition in a specific group of patients who share the same genetic makeup.
Last summer, Quest, which is based at Delaware Technology Park, launched a new division to handle genetic testing for drug companies doing clinical trials of new drugs.
Quest screens blood samples from patients who have been selected to participate in a particular trial, looking for the genetic mutations that could make the person more likely to benefit from a particular drug, or most likely to suffer side effects.
"This business has great potential because the pharmaceutical industry is moving in this direction," says Chien, who holds a doctorate in analytical chemistry from the University of Michigan and worked at DuPont Merck Pharmaceutical Co. where he helped develop Efavirenz, an anti-viral drug for the treatment of HIV.
The division is headed by LingSing Chen, who holds a doctorate in molecular biology from Princeton University and worked as director of molecular and cell biology for Wyeth, the New Jersey-based pharmaceutical giant.
Under Chen's direction, the division has grown to six employees. It has 10 customers and is screening clinical trial candidates for some of the biggest drug manufacturers who are testing drugs to treat colon cancer, obesity and Alzheimer's disease, among other conditions.
The company invested $2 million in new laboratory facilities for its molecular biology division, says Chien, who expects additional growth.
"We anticipate the business will grow and we'll have more people in this area," Chien says of his 10-year-old company, which has expanded from three employees to 156 today. The privately held company does not disclose its revenue.
What is called "personalized medicine" represents a departure from the drug industry's current pursuit of blockbusters -- such as Pfizer Inc.'s Lipitor, the world's biggest-selling drug -- designed to treat broad groups of patients.
Instead, think of "personalized medicine" as the pharmaceutical world's version of the hundreds of TV channels available today.
The broadcast networks like ABC and Fox beam their programming to a broad audience, while cable TV outlets like the Game Show Network and ESPN target a more narrow audience.
A two-pronged approach
While it may seem strange for drug companies to adopt a two-pronged strategy -- producing some drugs for a broad audience and others for more narrow ones -- the two strategies aren't inconsistent, says Francis Palumbo, executive director of the University of Maryland's Center on Drugs and Public Policy.
Palumbo points to cholesterol-lowering statin drugs like Pfizer's Lipitor. A statin like Lipitor may not be equally effective on two patients with the same cholesterol level, Palumbo says.
He can see a time when the drug company could potentially offer a variety of different statin drugs aimed at different groups of patients.
"I think they're genuinely interested in this because they see it as the future," Palumbo says of the drug companies. "We're far away from that right now, but it's moving."
Personalized medicine may have great potential, but it still is in early stages and there are only about a dozen personalized drugs or diagnostic tests on the market.
"We're in the foothills of a mountainous medical journey," says Edward Abrahams, executive director of the Personalized Medicine Coalition, a Washington D.C.-based trade group.
Personalized medicine started developing after the Human Genome Project mapped the Human Genome in 2003, Abrahams said.
Some well-known drugs
The movement has spawned some high-profile drugs, such as Gleevac, Herceptin and BiDil.
Gleevac, which is made by Novartis AG, is a drug for treating chronic myeloid leukemia in patients with a genetic mutation called Philadelphia chromosome.
Herceptin, which is made by Genentech Inc., helps treat metastatic breast cancer specifically in women who have too many copies of the gene HER2, or human epidermal growth factor receptor 2. The excess genes fuel the growth of cancer cells, by producing excess amounts of the protein these cells need to grow and divide.
Herceptin had $747 million in U.S. sales last year, making it the San Francisco-based Genentech's third-largest seller.
A third drug, BiDil, which was developed by NitroMed Inc., of Lexington, Mass., is designed to treat heart disease in blacks.
The personalized medicine movement has picked up some high-profile supporters.
The acting commissioner of the Food and Drug Administration, Dr. Andrew von Eschenbach, has come out in support of personalized medicine.
In August, Sen. Barack Obama, D-Ill., introduced the "Genomics and Personalized Medicine Act of 2006," a bill that would facilitate personalized medicine, by among other things, setting aside $150 million for research.