By Randall Osborne
An FDA advisory panel said it had insufficient evidence to recommend approval of Ergo Science Corp.'s lead product, Ergoset (bromocryptine mesylate tablet) for Type II diabetes.
The panel's decision sent the Boston company's stock (NASDAQ:ERGO) plummeting 55 percent Friday, ending the day at $6.25.
"[Panel members] were hung up on two things," said Donna LaVoie, spokeswoman for Ergo. "They were interested in seeing longer-term efficacy, and they were concerned about mechanism of action."
LaVoie said the company will meet soon with the FDA to decide the next step, maybe as early as next week.
"We plan to bring some experts from our medical advisory board down with us," she said.
Ergoset is the spearhead of Ergo's Neuroendocrine Resetting Therapy (NRT), based on research showing that daily activity patterns of neurotransmitters can be controlled to normalize glucose and lipid metabolism.
Taken orally once per day at a specific time, the drug is a fast-release formulation of bromocriptine, a dopamine-receptor agonist already approved for treatment of Parkinson's disease.
"It has a whole history, in various databases, on safety," LaVoie said. "It's rather peculiar they were concerned about it."
Phase III trial results showed Ergoset was effective in controlling blood glucose levels in Type II diabetics. But the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, saying it did not have enough data, declined to recommend the FDA clear Ergoset for marketing. The vote was 9-0.
"We have six months of data, and they were hoping for a longer-term study," LaVoie told BioWorld Today. Newer guidelines recommend 12 months of data, but six months was deemed adequate when Ergo began its trial, she said.
Panel Wants Phase IV Type Data, Says Ergo
"The problem is, they're asking for information generally required in a Phase IV marketing study, which is what the agency had discussed with us," LaVoie said.
"[Ergoset] works through the central nervous system, and it's a very different approach to diabetes," she added. "I think it was scientifically challenging to some of the members on the panel."
In February, Johnson & Johnson entered an agreement with Ergo for NRT worth up to $40 million. A month later, New Brunswick, N.J.-based J&J made a $10 million equity investment in Ergo as part of the deal, and pulled out of its diabetes partnership with Amylin Pharmaceuticals Inc., of San Diego, sending Amylin's stock down 46 percent. (See BioWorld Today, Feb. 25, 1998, p. 1, and March 3, 1998, p. 1.)
Ergo made its deal with the R.W. Johnson Pharmaceutical Research Institute and Ortho-McNeil Pharmaceuticals Inc. units of J&J.
Linda Fedow, spokeswoman for Ortho-McNeil, declined to comment on the future of J&J's collaboration with Ergo.
"Obviously, we're disappointed," Fedow said. "[Ergo] will continue to explore the next steps in the review process."
Ergo began a Phase II clinical trial with Ergoset in non-diabetic obesity last July. The study of 400 subjects is expected to yield data in 1999.
The company has two preclinical programs. One is focused on chronobiology, examining how the brain's "biological clock" regulates metabolism and the immune system. Ergo expects to develop drugs that fix neuroendocrine malfunctions.
Photodynamic therapy (PDT) is the focus of the second preclinical program, conducting experiments with animals to investigate the immune-system effects of chronobiological drugs when used with PDT. *