“Without profit you wouldn’t have the incentives
PHYLLIS GRABER JENSEN
or resources to innovate, ys. innovate,” Wicks say says.
In the end, it may not prove effective, and Phase 3 has been a “real graveyard” for drug candidates like CMX2043, Kates says. While testing a new cancer-fighting drug is straightforward — because success is measured in lives saved — Kates’ drug seeks a goal that’s less bold and harder to measure: minimizing postblockage heart damage that’s not necessarily life-threatening. “Drug success has been very challenging for these indications,” he says. The lynchpin of the drug discovery process is the patent system. In the U.S., drug compounds have 20 years of patent exclusivity before low-cost generics can enter the market and sap a brand-name drug’s profit potential. However, this two-decade clock begins ticking not when the drug is approved by the FDA but when the drug is patented. So a company has a limited window to earn back its investment. Not surprisingly, the industry often criticizes the FDA for taking too long to vet drug candidates for sale. In recent years, the agency has in fact dramatically cut its average approval time to a little over a year while vowing not to sacrifice safety in the name of speed. “The FDA gets criticized for being too fast and too slow at the same time,” says Anne Ruggles Pariser ’83, recently appointed acting associate director of rare diseases at the FDA’s Office of New Drugs at the Center For Drug Evaluation and Research. A chemistry major at Bates, she earned a medical degree at Georgetown. “That is probably the biggest challenge, figuring out the balance.” Mike Bonney ’80 knows well the rollercoaster ride that is drug discovery. Bonney is president and CEO of Cubist Pharmaceu-
28 Bates SUMMER 2010
Victoria Wicks ’74 is vice president of external affairs at sanofi-aventis U.S.
ticals, based in Lexington, Mass. He is credited with shepherding to market the drug Cubicin, a highly successful intravenous drug in the fight against certain antibioticresistant bacteria. Last year, Cubist was ranked No. 1 among the “Top 100” publicly traded Massachusetts-based businesses by The Boston Globe. And in April, Mike Bonney was honored by the Massachusetts Biotechnology Council for his success in making Cubist a model biotech company. Recently, however, Cubist had a setback of its own. The company had hoped that a drug in its pipeline called Ecallantide would stop blood loss in patients during heart bypass surgery. But clinical human trials showed that it did not, and on March 31 Cubist announced it had stopped all work with Ecallantide. Losing a promising drug hurts, Bonney says, and he’s not just talking about the bottom line. “The vast majority of people at Cubist are doing this work because they think they have the opportunity to make a difference in millions of peoples’ lives,” he says. “When it goes down, particularly in a case like this where we had early data suggesting it would work, it’s disappointing.”
An economics major at Bates, Bonney also knows that the business model of the drug industry doesn’t always add up in the public’s mind. Or, for that matter, to investors. “If you are a business person, the pharmaceutical or biotech industry is a complete anathema — unless you grew up in it,” Bonney says. He sums up the typical reaction from an investor unfamiliar with the industry: “‘You commit hundreds of millions of dollars to develop a product that might not be a product for 10 to 12 years and there’s no revenue? How does that work?’” Of course, when the risks pay off, they can pay off big, and sometimes drug companies just get lucky. Scientists at a Pfizer facility in England were experimenting in the mid-1990s with a compound called UK-92,480 designed to treat angina. The drug didn’t work so well on angina but was remarkably successful stimulating blood flow in another part of the body. That’s how Viagra became a $1 billion-a-year franchise. For the biggest companies, revenues grew a robust 8.6 percent a year between 2001 and 2008. Lipitor, the world’s bestselling drug, generates $12.8 billion a year in sales for Pfizer; last year, the company’s CEO earned $13.7 million. But the era of blockbuster drugs like Lipitor, Prilosec, and Plavix is coming to an end. Eighteen of the world’s 20 biggest drugs will end their patent-protected lives in the next five years. And while the anticipated rise in generic competition is good for consumers, it sends fear into the hearts of pharmaceutical executives, who worry about eroding profits.