NoBlood

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.

__________________
Mr. Jan B. Wade
Blood Management Consultant
Enhance Outcomes - Control Cost
For Information Call - 360 296-1807
Email

In another post Hemopure was said to be made from blood that is too old for normal usage. I assumed that this meant human blood.
This post says that it is made from Cow's blood.
Does anyone know which is correct please?

Hemopure



OVERVIEW

A First-In-Class Oxygen Therapeutic
Hemopure® [hemoglobin glutamer - 250 (bovine)], or HBOC-201, Biopure's first-in-class product for human use, is approved in South Africa for the treatment of adult surgical patients who are acutely anemic and for the purpose of eliminating, reducing or delaying the need for allogenic red blood cell transfusion in these patients.

In October 2002, the U.S. Food and Drug Administration (FDA) accepted for review Biopure's biologic license application (BLA) to market Hemopure in the United States for a similar indication in orthopedic surgical patients. This acceptance is the first time a hemoglobin-based oxygen therapeutic for human use has reached this stage in the U.S. regulatory process. On July 30, 2003, the FDA issued Biopure a letter requesting additional information and suspending the BLA review clock. The company is now preparing a comprehensive written response to these questions. Mechanism of Action


Hemopure consists of chemically stabilized bovine hemoglobin formulated in a balanced salt solution. On a gram-for-gram basis, this cross-linked hemoglobin carries the same amount of oxygen as the hemoglobin in red blood cells. However, these linked hemoglobin molecules circulate in plasma, and are smaller, have lower viscosity (resistance to flow) and more readily release oxygen to tissues than red blood cells. Consequently, they can carry oxygen at low blood pressure and can carry oxygen through constricted or partially blocked blood vessels to areas of the body that red blood cells cannot reach due to their larger size.

For graphics:

__________________
Mr. Jan B. Wade
Blood Management Consultant
Enhance Outcomes - Control Cost
For Information Call - 360 296-1807
Email

Thanks Jan - No wonder they wanted to make further checks on it. Mention "Bovine" and everybody runs away now that CJD has been found in the US.

I think I was getting mixed up between Hemopure and Polyheme.