Merry Christmas to all
and a lump of coal,hell a whole coal mine from BPUR, put in your stocking past 5pm on Christmas eve:
Biopure says SEC aims to bring civil charges
Cambridge biotech firm also details FDA woes
By Ross Kerber and Jeffrey Krasner, Globe Staff, 12/25/2003
Biopure Corp. said yesterday that it was told by the Securities and Exchange Commission the agency's staff made a preliminary decision to pursue civil legal action against the Cambridge company, which develops artificial blood.
In an unusual Christmas Eve news release, Biopure also disclosed problems it has had trying to get the Food and Drug Administration to approve a trial of its Hemopure product for trauma patients.
Biopure's disclosures were made yesterday evening, hours after the close of trading, even though the company said it received notice from the SEC Monday evening. One of the reasons the SEC may bring charges against Biopure involves disclosure issues, the company said.
A company spokesman, Douglas Sayles, said Biopure's timing of the release on Christmas Eve was not done in the hope that the negative news would receive less attention. Sayles said the company needed two days to prepare its news release. "We did it as quickly as possible to ensure that it was accurate," he said.
To Stanley Keller, a partner at Palmer & Dodge LLP and former chairman of the American Bar Association's Committee on Federal Regulation of Securities, the timing raised questions. "From a public perception and market credibility point of view, it doesn't help that it appears the company is trying to slip information in on a slow day," Keller said.
According to Sayles and the news release, the company believes the SEC is looking at whether Biopure publicly disclosed enough about its communications with the FDA to keep investors informed. The company said it believes the SEC is looking at disclosure about its ongoing efforts to win permission to sell Hemopure for use in patients undergoing voluntary orthopedic surgery, and about its efforts to start a trial for trauma patients. The company, chief executive Thomas A. Moore, and a former executive all received what are known as Wells Notices, which give the subjects a chance to rebut the agency's claims before the SEC proceeds.
The notices come at a difficult time for Biopure, whose ambitions to market Hemopure, a human blood substitute derived from cow's blood, have suffered a series of setbacks that threaten the company's future.
In October, the company said it would lay off 72 people, or a third of its staff, to conserve cash. The same month the FDA sent a warning letter to a Florida doctor involved in a key clinical trial of Hemopure. The FDA said the doctor endangered patients and did not follow the trial instructions. Thirteen other clinical trial sites are being reviewed by the FDA.
Two weeks ago, Biopure also said it would probably receive a going-concern notice from its auditors, a warning to investors that the company could go out of business if it doesn't receive additional funding or make other changes. The company's news release yesterday included much of those previously undisclosed dealings with the FDA. Biopure said in March that it was working with the Army and Navy to develop a trial of Hemopure in trauma situations where a patient cannot immediately get a blood transfusion, akin to the battlefield. At the same time, it said it was preparing to submit a trial plan to the FDA for the use of Hemopure in trauma patients at emergency rooms.
Yesterday, however, the company disclosed for the first time that the hospital trauma trial ran into serious problems at the FDA. The company's justification for keeping the problems with such a major initiative under wraps was that it "wasn't material."
Biopure said the FDA placed a hold on the trial "due to safety concerns," the company said. In particular, it cited adverse events -- serious complications to patients, including death -- during the company's trial for orthopedic use, completed in 2000. In May, the company said yesterday, the FDA ordered Biopure to conduct three additional animal studies to prove the safety of Hemopure before it could be tested in humans under trauma conditions. The agency is concerned about administering high doses of Hemopure, the company said.
In July, the FDA sent Biopure a letter with numerous questions about the proposed trauma trial. Despite attempts by the company to assauge the agency's concerns, the FDA has twice refused to let the trial go forward. In August, the company said it received a letter about its application to allow the use of Hemopure in orthopedic patients. It characterized the letter as a sign Hemopure was close to approval. The company's stock soared. But in October, the company said it would need until next summer to answer all the questions raised by regulators.SEC officials did not answer telephone messages left yesterday evening. Ross Kerber can be reached at kerber@globe.com. Jeffrey Krasner can be reached at krasner@globe.com.
© Copyright 2003 Globe Newspaper Company.
© Copyright 2003 The New York Times Company
** note the time**
Press Release Source: Biopure Corporation
Biopure Receives 'Wells Notice' From Securities and Exchange Commission
Wednesday December 24, 5:52 pm ET
CAMBRIDGE, Mass., Dec. 24 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR - News) reported that on December 22, 2003, it received a "Wells Notice" from the staff of the Securities and Exchange Commission (SEC) indicating the staff's preliminary decision to recommend that the SEC bring a civil injunctive proceeding against the company. As permitted under the Wells process, Biopure intends to respond promptly and thoroughly in writing before the SEC staff formally decides what action, if any, to recommend. The company's chief executive officer and its former senior vice president of Regulatory and Operations also received Wells Notices.
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Biopure believes the notices relate to the company's disclosures concerning its communications with the Food and Drug Administration (FDA) about a trauma study protocol the company submitted to the Agency in March 2003 and about the company's biologics license application (BLA) for Hemopure® [hemoglobin glutamer - 250 (bovine)]. The company did not publicly disclose its communications with the FDA about the proposed trauma protocol and investigational new drug application (IND) because it does not believe communications about proposed clinical trials are material prior to the initiation of a trial. This trauma trial was not initiated in the United States and no product was shipped under this IND. Biopure also believes that its disclosures about the BLA are accurate. The company will continue to cooperate with the SEC staff.
Biopure submitted the trauma protocol for a Phase II clinical trial of Hemopure for the treatment of hemorrhagic shock casualties in the hospital setting, where red blood cell transfusions are available. The FDA placed this trauma protocol under a new IND that is separate from the company's previous IND and its BLA to market Hemopure for the treatment of acutely anemic adult patients undergoing orthopedic surgery and for the elimination or reduction of red blood cell transfusions in these patients. The protocol sought to administer up to 15 units of Hemopure, a proposed dosage that was 50 percent higher than administered in previous clinical trials.
After the in-hospital trauma protocol was submitted to the FDA and the new IND was assigned, the Agency placed a clinical hold on the proposed trauma trial due to safety concerns. The FDA referred to a review of adverse event data from the company's Phase III orthopedic surgery trial, which was submitted in the BLA. The data from that Phase III trial has been previously presented at medical meetings.
In May 2003, Biopure responded to the FDA's clinical hold and also filed the response as a BLA amendment because it discussed data previously submitted with the BLA. That amendment resulted in the FDA extending its BLA review period up to 90 days, as previously announced on May 30, 2003. The Agency also requested three additional pre-clinical animal studies of Hemopure in conscious swine to address its concerns regarding high-volume administration. After the company's responses, the FDA has twice declined to lift the clinical hold, most recently in a letter dated July 30, 2003. This letter is separate from the FDA complete response letter Biopure received on that date in response in to its BLA for orthopedic surgery. The questions in the FDA's trauma letter were the same as some of the questions in the BLA complete response letter and had two additional questions, one about the company's analysis of age-specific effects in individuals over age 75 in the Phase III orthopedic surgery trial and a second question about dosing.
Biopure submitted a similar study protocol for in-hospital testing of Hemopure in trauma patients to the Medicines Control Council (MCC) in South Africa. The MCC approved the protocol after modifications including lowering the maximum dose of Hemopure. In addition, the company continues to work with its trauma advisors, including military and academic researchers, to develop a clinical trial protocol, with funding from the U.S. Department of Defense, to test Hemopure in trauma patients in an out-of-hospital setting where blood is not available. The company believes that the risk-benefit ratio is different in the out-of-hospital setting. The company has withdrawn the U.S. in-hospital trauma protocol that was on clinical hold while it continues to develop its trauma program.
A Biopure-requested meeting has been scheduled with the FDA on January 6, 2004, to discuss the BLA. If there are significant developments at or following this meeting, the company intends to report them promptly. Biopure still expects to respond to the questions in the FDA's complete response letter by June 30, 2004.
Biopure Corporation
Biopure Corporation, headquartered in Cambridge, Mass., develops, manufacturers and .. yada yada |
