BioPure/HemoPure Update

by Lee Elder 10 Replies latest jw friends

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  Lee Elder

  Biopure CEO and Clinical Investigator to Present Hemopure(R) Overview At JP Morgan H&Q Healthcare Conference

  CAMBRIDGE, Mass., Jan 7, 2002 /PRNewswire via COMTEX/ -- Biopure Corporation (Nasdaq: BPUR) today announced that company Chairman and CEO Carl W. Rausch and a leading South African surgeon, Dr. Lewis J. Levien, will present today at 10:30 a.m. PST at the JP Morgan H&Q 20th Annual Healthcare Conference at the Westin St. Francis Hotel in San Francisco. The presentation will include a brief overview of clinical trial data supporting regulatory approval of the company's oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] by South Africa's Medicine's Control Council in April 200l.

  A live web cast of the presentation will be available online via the Investor Relations area of Biopure's website at http://www.biopure.com and via the JP Morgan website at http://www.jpmhq.com . Listeners are advised to log on to the event at least 15 minutes prior to the scheduled broadcast. An archive of the web cast will be available via Biopure's website for at least one week following the event.

  Presentation Overview

  Dr. Levien is a vascular and general surgeon at Milpark Hospital in Johannesburg, South Africa, and is a clinical trial investigator of Hemopure. During the January 7th presentation, he will discuss clinical data from the South Africa regulatory submission, including integrated safety data from all 19 completed Hemopure clinical trials and data from the company's three completed red blood cell controlled trials in cardiac, vascular and general surgery. These 19 trials represent 719 total patients -- 421 in the Hemopure group and 298 in the control groups -- and do not include the 693 patients from the company's pivotal Phase III clinical trial in orthopedic surgery.

  Dr. Levien's presentation will also include a patient case summary from South Africa, where Hemopure is approved 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 cells in adult surgical patients.* In June 2001, Biopure began shipping Hemopure to South Africa for use in a pre-launch medical education program. Commercial launch of the product in South Africa is scheduled for later this year.

  Biopure is also preparing to submit an electronic Biologic License Application (eBLA) to the U.S. Food and Drug Administration (FDA) this year, followed by an application in Europe, for perioperative use of Hemopure to eliminate or reduce red blood cell transfusion in patients undergoing elective surgery. In preparation for these filings, the company is expanding the production capacity of its pilot manufacturing facility in Cambridge, Mass. and is completing the final study report for the pivotal Phase III orthopedic surgery trial. The company is also close to breaking ground on a new, large-scale manufacturing facility in Sumter, S.C.

  Biopure has forwarded summary information from the Phase III orthopedic trial to the FDA and has requested a meeting to confirm the proposed product labeling. Preliminary study results have shown that the primary endpoints of the Phase III trial were met per the study protocol and analysis plan. Further Phase III trial results will be presented at upcoming medical meetings.

  Hemopure(R) [hemoglobin glutamer - 250 (bovine)]

  Hemopure is a sterile, intravenously administered oxygen therapeutic that delivers oxygen to tissues and enhances the offloading of oxygen from circulating red blood cells. Each unit consists of 30 grams of ultra-pure, chemically cross-linked bovine hemoglobin (the protein that carries oxygen) formulated in 250 milliliters of a balanced salt solution. This stabilized, acellular hemoglobin circulates directly in plasma (the fluid part of blood) when infused and has lower viscosity and releases oxygen to tissues more efficiently than red blood cells.

  Hemopure is compatible with all blood types, stable at room temperature (2 degrees to 30 degrees C) up to three years, and purified through patented and proprietary techniques that are validated to remove potential contaminants, including infectious agents such as bacteria, viruses and transmissible spongiform encephalopathy (TSE) agents.

  To date more than 1300 patients have been enrolled and more than 800 patients have been administered Hemopure in 22 clinical trials (19 completed, 1 in report stage, 2 ongoing) at doses up to 36 units, including four advanced, red blood cell controlled trials at doses up to 10 units. To ensure that only patients in need of a transfusion were entered into these red blood cell controlled trials, each patient was randomly assigned to receive either Hemopure or allogeneic red blood cells at the first transfusion decision. In this respect, Biopure's trials are unique compared to other clinical trials completed to date for investigational oxygen-carrying solutions.

  Biopure Corporation

  Biopure Corporation, headquartered in Cambridge, Mass., is a leading developer, manufacturer and supplier of a new class of pharmaceuticals, called oxygen therapeutics, which are intravenously administered to deliver oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, 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 cells in adult surgical patients. The company is preparing to file a marketing application for Hemopure in the United States, followed by an application in Europe, for perioperative use of the product in patients undergoing elective surgery. The product is also being developed for use in trauma, cancer and ischemic events such as heart attack and stroke. Oxyglobin(R) [hemoglobin glutamer - 200 (bovine)], the only product of its kind approved by the U.S. FDA and the European Commission, is commercially available in the United States, Germany, France and the United Kingdom for the treatment of anemia in dogs.

  Statements in this press release that are not strictly historical may be forward-looking statements. There can be no assurance that Biopure Corporation will be able to commercially develop its oxygen therapeutic products, that necessary regulatory approvals will be obtained, that anticipated milestones will be met in the expected timetable, that any clinical trials will be successful, or that any approved product will find market acceptance and be sold in the quantities anticipated. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in the company's operations and business environment. These risks include, without limitation, the company's stage of product development, history of operating losses and accumulated deficits, and uncertainties and possible delays related to clinical trials, regulatory approvals, possible healthcare reform, manufacturing capacity, marketing, market acceptance, competition and the availability of sufficient financing to support operations. The company undertakes no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof. A full discussion of Biopure's operations and financial condition, and specific factors that could cause the company's actual performance to differ from current expectations, can be found on the company's website at www.biopure.com/corporate/legal/home_legal.htm and in the company's filings with the U.S. Securities and Exchange Commission, which can be accessed in the EDGAR database at the SEC website, www.sec.gov, or through the Investor section of Biopure's website, www.biopure.com .

  * The South Africa package insert for Hemopure is available online at http://www.biopure.com/hemopurepi/rsa or per request by calling (617) 234-6863.

  SOURCE Biopure Corporation

  CONTACT: Douglas Sayles, Director, Corporate Communications of Biopure Corporation, +1-617-234-6826, or [email protected]; or media, Brad Miles of BMC Communications, +1-212-477-9007, ext. 17; or investors, Lee Stern of The Trout Group, +1-212-477-9007, ext. 22
  < http://media.corporate-ir.net/media_files/priv/10648/images/comtex.gif>;
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  Joyzabel

  Thank you Lee Elder for keeping us updated with this blood 'thang.
  j2bf
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  anewperson

  An investigative friend in Australia says the Watchtower Society owns stock in the company, and the product is not as effective as their press releases via the newspapers etc make it look.
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  Scully

  JWs in the congregations where I was a member would extrapolate on the comparison between forced blood transfusion and rape in order to rationalize that accepting blood products of any kind being the same as fornication.

  I always wondered why the Hemopure concept of bovine hemoglobin was acceptable, considering their rationale would make it tantamount to bestiality. Now we know why....

  An investigative friend in Australia says the Watchtower Society owns stock in the company, and the product is not as effective as their press releases via the newspapers etc make it look.

  Thanks for that interesting tidbit, anewperson.

  By the way, the WTS sang the praises of Fluosol when it was being developed too, despite its poor effectiveness in use.

  I was able to obtain the Manufacturer's Information on Pentaspan, which is one of the plasma volume expanders that was allowed on JWs "no blood" cards in the past. I would be happy to post the info on the Blood area of the discussion board if there's interest.

  Love, Scully RN

  It is not persecution for an informed person to expose a certain religion as being false. - WT 11/15/63
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  zev

  thanks lee for the update.

  can anyone tell me how i can find out, on the web if possible if the w.t. has an investment with biopure? proof positive if possible.

  i went to the web site for biopure, but was no wiser about who has vested interest in them.

  how or where would you start looking into something like this?

  thanks

  -Zev
  Learn about the Wtbts and the U.N.
  ** http://www.geocities.com/plowbitch69 **
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  Lindy

  Scully,

  "JWs in the congregations where I was a member would extrapolate on the comparison between forced blood transfusion and rape in order to rationalize that accepting blood products of any kind being the same as fornication."

  Yeah, I remember hearing the same crap when I was going too.

  Lindy
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  hawkaw

  I just sometimes wonder about Lee Elder and Marvin Shilmer on this story. I sometimes feel you people aren't getting the whole story with these substitutes such as HemoPure or aren't bothering to follow the whole story. And you people who are willing to put your lives on the line deserve the full story.

  The following is what I posted this on a separate thread at http://www.jehovahs-witness.com/forum/thread.asp?id=18569&site=3
  ------------------------------------------------------------------

  This is an important story on the "approved" cow's blood substitute (hemoglobin based blood product called Hemopure made by a company called Biopure). This "Hemopure" product was approved by the JW's Hospital Information Service back in 2000 as a substitute for red blood cell transfusions. This would help a lot of JW trauma victims who could not accept red blood cells. Of course at the time it was not approved by the FDA. The South African government supposedly gave its blessing to this product last year!!! BUT - it seems this government didn't wait until all the evidence was collected on the safety of the product. At least the FDA has not gone this far.

  Now, I would first like to apologize to this board. I have been following this product through out last year but some unknown reason I did not check up on its status in December with Adam Feuerstein. Well Adam did another story on this and I should have gotten it posted sooner - I again am sorry for the delay.

  I also recall Lee Elder's comments on the delay of another blood substitute called "polyheme". You may find the thread link here:

  ( http://www.jehovahs-witness.com/forum/thread.asp?id=15959&site=3

  So now I have, and with great sadness have to tell you folks that the cow's (or bovine) blood substitute product called "HEMOPURE" made by Biopure Inc. is not going anywhere fast. As I previously informed this board, the product has serious problems and well, I will let the article say the rest.

  You may note that below I have highlighted something in a "blue colour" for the reader. Why did I highlight it? If a company doesn't explain the safety concerns upfront then what else are they hiding?

  . http://www.thestreet.com/tech/adamfeuerstein/10005028.html

  Biopure Admits Its Blood Substitute Will Be Delayed

  By Adam Feuerstein
  Staff Reporter
  12/07/2001 10:31 AM EST

  Updated from 7:42 p.m. EST
  Biopure (BPUR:Nasdaq - news - commentary - research - analysis) admitted Thursday that problems with its human blood substitute Hemopure are forcing it to delay filing an approval application with U.S. drug regulators for at least six months.

  TheStreet.com first reported late last month that a Hemopure delay was likely. Consultants hired by Biopure to assist with its pivotal clinical trial for Hemopure noted numerous, serious problems with data collection and analysis. In addition, TheStreet also reported that a Washington, D.C., law firm was crossing the country interviewing doctors involved with the Hemopure study.

  Biopure executives had long maintained that Hemopure's filing would hit the doorsteps of the Food and Drug Administration by year-end. But late Thursday, the company acknowledged that the filing would not occur until the middle of 2002.

  In a statement, CEO Carl Rausch says the delay is being caused by FDA questions about a proposed expansion to the company's Cambridge, Mass., manufacturing plant. In his statement Rausch repeated his confidence in Hemopure and in the way Biopure conducted the trial.

  "We believe that the data [are] sound and supportive of an approvable product indication, and we continue to prepare for regulatory review and further public reporting of the Phase III data beginning in early 2002," he said.

  Safety Concerns

  Doctors and consultants familiar with Biopure say that Thursday's acknowledgement of a filing delay might be just a strategy to buy the company time while it figures out how to salvage something positive from a product with serious safety problems. TheStreet has addressed these safety issues extensively over the past several months.

  Biopure's own statement gives a hint of possible problems. In lieu of an actual approval application, the company now says that it will submit an "interim safety report for the pivotal Phase III clinical trial to the FDA by year-end."

  But Rausch and other Biopure executives said earlier that a full safety analysis of Hemopure already has been completed. On Aug. 27, the company issued a press release stating that an independent committee of experts had conducted a statistical analysis of its Phase 3 data that showed Hemopure was safe.

  That raises the following question: If the safety analysis is completed, why is the company now only able to give the FDA an "interim" safety report on Hemopure? Biopure has never released any actual safety data for review by investors or the outside medical community, and the company would not return phone calls seeking answers Thursday.

  Biopure concluded its pivotal trial for Hemopure in August 2000, which should have given it plenty of time to get all the data analyzed.

  Thursday, Biopure also said that it hopes to meet with the FDA in early 2002 to "confirm the proposed product labeling of Hemopure." The statement is confusing, according to those experienced with the process, because the seemingly positive outcome of the completed trial should have clearly dictated the product's label.

  In an earlier report, a doctor familiar with Biopure's work told TheStreet that the company could be trying to retrospectively change its plans for Hemopure by recasting results to give a more positive outlook to the data -- something the FDA frowns upon. This doctor, contacted again Thursday, says the company's statement supports his previous beliefs. This doctor has no position in Biopure.

  Cash Shortage

  The filing delay for Hemopure -- for whatever the reason -- also puts increasing pressure on Biopure to raise more cash. The company had $48 million in its coffers as of the end of July -- enough to last until July 2002 -- according to its last 10-Q filed with the Securities and Exchange Commission.

  But Wall Street sources tell TheStreet that Biopure executives have been trying to raise money since late this summer. Thursday's acknowledgment that there are problems with Hemopure's approval won't make this task any easier.

  In August, Biopure -- joined by Salomon Smith Barney bankers -- quietly made the rounds of institutional investors seeking to raise upward of $50 million in a private placement. A Wall Street money manager who was approached by Biopure says the company was able to receive commitments for only about $20 million by the second week of September.

  After Sept. 11, the deal was taken off the table. In the following weeks, Biopure and Salomon went their separate ways. Biopure then hired Shoreline Pacific, a boutique investment bank based in Sausalito, Calif., to pick up the fund-raising hunt. But these efforts haven't yielded any results.

  Biopure can fall back on a $75 million equity line of credit it has with French bank Societe Generale. But the company has been reluctant to go this route because any money it raises by selling stock to Societe Generale comes with significant costs. The French bank gets the stock at a discount, which it then will sell for a quick profit. But the bank also is allowed to bolster its gains using various shorting strategies that could put even more downward pressure on the stock, according to SEC documents filed that explain the agreement.

  Biopure can take down money from the agreement in installments of only about $3 million each.

  "This [equity line] agreement is really a fund-raising strategy of last resort," says one fund manager familiar with its details. "Biopure is reluctant to use it, especially given the company's weak stock price." This fund manager is short Biopure.

  Shares of Biopure were trading down more than 11% Friday. Since Oct. 11, Biopure shares have fallen 23%, while the American Stock Exchange Biotech Index has risen 22%.

  Now I know people are going to post stuff on this thread saying I am again jumping the gun and I have no merit in my concerns. BUT and a big BUT this whole issue with Biopure just stinks.

  Maybe the technology invented by Biopure may help in obtain future blood substitutes but other than that this product, as is, looks dead in the water.

  hawk
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  anewperson

  Also AJWRB has become a do-nothing organization, virtually dead in activity for the past 1-1 1/2 years now. Children and adults are bleeding to death, an estimated 3 daily, so 1000 to 1500 have died during the AJWRB's doing-nothing hiatus. I'm thinking about posting this in its own thread. You have a reason why I shouldn't tell me fast, Lee, at [email protected]
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  hawkaw

  Also AJWRB has become a do-nothing organization, virtually dead in activity for the past 1-1 1/2 years now.

  Lately yes they have not been around all that much but there is a serious reason. Sam Muramoto's parents are not well and he has to help them. Lee has also been very busy doing some other information.

  I have no idea what happened to Wayne. He never did respond to me when I Emailed him after Lee invited me into the small little group last year.

  However, Lee, Sam, Marvin and others did a great job from about December to March, 2001 with the British Medical journal publication and subsequent major discussion at bmj.com. I know my time has been bogged down with this UN thingy. But based on the number of people who I now know have left the Borg and the increase in this site, I think it was time worth while.

  I know what you mean though and I understand your frustration. I did up a lot of stuff that Maximus and I worked on. I offered it to Lee a few weeks back and I got a "too busy right now" response. Thus, I gave it to someone else for posting.

  But like I said before, I just wish that you guys fully know the score when dealing with this HemoPure product and this company BioPure. It seems this product has safety concerns that could risk the health of Witnesses and others who take it experimentally - this is something AJWRB fails to report - yet.

  One final point that Lisa made on my thread. Don't you find it absolutely f__king wild that this Borg allows Witnesses to use their conscience to take an "experimental non approved (by FDA)" animal blood substitute that has safety concerns but bans certain human blood products that have little risk to you.

  hawk
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  anewperson

  A financial vestment explains why the Borg allows such usage.

  Sam's situation is readily understood. Lee's somewhat. As you say the real mystery is Wayne.

  He popped up, pushed to the top fast then has sat still. If things continue this way we'll just have to move on around them. If they intend to do more then they need to speak up.

  I'm guessing Lee is also puzzled about Wayne and while waiting for Wayne to show himself more is using his own time for these other endeavors you speak of.

  Fortunately if Wayne won't push the cart ahead, there are alternative tools to utilize.