Here's today's WSJ: The Wall Street Journal -- May 15, 1998
Technology & Health:
Ergo Science
Diabetes Drug
Is Voted Down
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By Laura Johannes
Staff Reporter of The Wall Street Journal
A Food and Drug Administration advisory panel voted unanimously to recommend disapproval of Ergo Science Corp.'s once-a-day oral drug for diabetes because of concerns about its limited effectiveness and mysterious mechanism of action, which has to do with resetting the body's metabolic clock.
Since the FDA rarely goes against the recommendations of its advisory panels, the negative vote is a major blow to the Boston company, which had hoped the drug, called Ergoset, would be its first product. Ergo Science, which is testing the same drug for use in obesity, said it was "disappointed" in the vote and "will meet with the FDA to consider the appropriate next step."
One possibility is for the company to perform additional clinical trials, which could take a year or more, to prove longterm effectiveness. The drug showed only modest effect in the company's six-month trials, in which separate groups were given the drug and a placebo.
The scientific panel "was very encouraging" to Ergo Science to perform additional clinical trials and return for review, says Alexander Fleming, one of the FDA officials who reviewed the application.
Stock in Ergo Science, which has no other near-term products, was halted all day yesterday. It had dropped in recent days as rumors of a tough review at the advisory-panel meeting circulated. On Wednesday, the stock closed at $13.8125, down 6%, in Nasdaq Stock Market trading. Ergo Science went public in 1995 at $9 a share and has traded as high as $20 in the past year. There are 14 million shares outstanding.
Ergo Sciences had agreed to co-market the drug in the U.S. with pharmaceutical giant Johnson & Johnson, which would share equally in profits. Analysts had predicted that annual sales of Ergoset could reach $200 million to $500 million for the diabetes indication alone. But even those rooting for its approval believe those estimates are too high, because the drug appears less effective than inexpensive generic drugs called sulfonylureas, which have been around for decades.
Ergoset would "be a useful drug, but not a blockbuster," predicted Los Angeles endocrinologist Mayer B. Davidson, president of the American Diabetes Association.
Ergoset does appear to have one big selling point-early indications are that it may may help patients become leaner while treating their diabetes. Ergoset is aimed at the estimated 15 million Americans with type 2 diabetes, which usually occurs in people over 40 and is often undiagnosed.
"The great majority of type 2 diabetics in America are overweight. If you can lower blood sugar and cause a reduction in weight, you have a very attractive therapy combination," said Stuart Weiss, a San Diego diabetes doctor who served as principal investigator for clinical trials of Ergoset. He said that Ergoset when used alone appears to have a less significant effect on the disease than some existing drugs, but added, "we won't know for sure without head-to-head clinical trials."
Diabetics either make insufficient quantities of insulin, a hormone that controls blood-sugar levels, or they are resistant to the hormone, or both. The goal of treatment is to lower blood-sugar levels; if left untreated, diabetes can lead to heart disease, blindness and kidney failure.
About 40% of diagnosed type 2 diabetics take insulin, sometimes in combination with other oral treatments that can also be taken alone. The noninsulin treatments include Bristol-Myers Squibb Co.'s Glucophage, Warner Lambert Co.'s Rezulin and a variety of generics that health-maintenance organizations tend to favor. But their incomplete effectiveness and side effects-Rezulin for example can be toxic to the liver-leave the road clear for competition.
"This market is like the Marianas trench, the deepest spot in the ocean. It's bottomless," says Sherwyn Schwartz, director of the Diabetes and Glandular Diseases Clinic in San Antonio, a private facility that has conducted numerous trials, including pivotal research for Ergoset. "The more agents we have out there, the better off the patients will be."
Ergoset is a proprietary formulation of bromocriptine, which has been approved by the FDA to treat Parkinson's disease and a rare form of cancer. Its known side effects, which usually only last a few weeks, include nausea, headaches and a stuffy nose.
Ergo Science, founded in 1990, said the science behind Ergoset was based on the fact that the lean-to-fat ratio changes seasonally in migratory birds based on levels of brain neurotransmitters. The drug is believed to affect brain levels of key neurotransmitters, such as dopamine, noradrenaline and serotonin, which in turn influence the body's sensitivity to insulin.
"We don't understand how it works that well -- but we didn't understand how aspirin worked for years either," said Dr. Schwartz. |
