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Jan B. Wade · #1 (**permalink**) 02-27-2004, 01:24 PM

Biopure CEO resigns

Moore's departure amid company's woes sparks 16% stock drop

By Jeffrey Krasner, Globe Staff, 2/25/2004

Less than a week after he declared, "In my heart, I'm quite sure we will succeed," Biopure Corp. chief executive Thomas A. Moore abruptly resigned yesterday, prompting a 16 percent plunge in the company's shares and casting further doubt over the company's ability to win approval for Hemopure, a blood substitute made from cow's blood.

The company did not explain the reasons for Moore's resignation other than to say he was "stepping down to pursue other interests."

Moore, 53, was unavailable to comment. In a statement, he said, "I've enjoyed the challenges at Biopure, and my decision was a difficult one."

Shares plunged 26 cents to $1.36, a 52-week low for the company, on volume of 3.5 million shares. So far this year, Biopure is the worst-performing stock of the 259 issues in the Bloomberg Massachusetts index, down more than 44 percent. Francis H. Murphy, senior vice president of engineering and process technology, was named interim chief executive while the company conducts an executive search.

Moore's resignation caps a disastrous 18-month run in which Biopure delayed plans to build a manufacturing plant, misleadingly told investors that a Food and Drug Administration letter indicated Hemopure would likely be approved, withheld information from shareholders that the FDA had stopped a clinical trial due to safety concerns, and unveiled layoffs totaling nearly 50 percent of its workforce.

In December, the company said the Boston office of the Securities and Exchange Commission had recommended taking legal action against Biopure and Moore for failing to disclose material information to investors. Moore received a Wells Notice from the SEC, indicating the commission was considering taking civil legal action against him.

A Biopure spokesman said Moore's resignation was unrelated to the ongoing SEC investigation. "This news today is absolutely not related to the SEC inquiry," said Douglas Sayles.

A lawyer for Moore could not be reached to comment.

Last week, in a phone conference with investors, the company said it would be unable to meet a self-imposed deadline to respond to a lengthy list of questions from the FDA by the end of June. In addition to three animal studies required by the FDA to show Hemopure's safety, the company said the agency would require a fourth animal study.

Requiring animal trials is a huge setback for Biopure. The company completed two pivotal trials in human subjects in 2000, and has been working since then to win approval for Hemopure in patients who have undergone elective orthopedic surgery. For regulators to again require trials in animals suggests fundamental questions about the safety of Hemopure.

Last spring, Biopure had sought FDA approval to conduct a trial of Hemopure in trauma patients. But regulators put the trial on hold citing safety concerns, and ordered Biopure to conduct the animal trials.

Biopure last week raised $5 million in a private sale of shares to an institutional investor at $1.50 a share. The stock closed at $1.95 on the day the financing was finalized.

Jeffrey Krasner can be reached at krasner@globe.com.