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biopure

1. Nel 9 februari 2006 20:41

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   voor de liefhebbers
   
   COMPANY TICKER
   PRICE
   RATING
   TARGET
   ANALYST
   
   Biopure
   BPUR
   $0.81
   Spec. Buy
   $3.00
   Dunn
   
   Biopure to file Hemopure® for European Approval: Biopure announced that they will apply for European regulatory approval in mid-2006 for Hemopure® to treat acute anemia in elective orthopedic surgery patients. The data will include the 688-patient Phase III orthopedic surgery trial conducted in the U.S., South Africa, Europe and Canada plus the 160-patient Phase III general non-cardiac surgery trial conducted in South Africa and Europe.
   
   Sales of Hemopure® commence in South Africa: On January 30th, Biopure announced that sales of Hemopure® started in South Africa to treat adult surgical patients who are acutely anemic and for the purpose of eliminating, delaying or reducing the need for donated red blood cell transfusions. This represents the first-ever commercial sale of a hemoglobin-based oxygen therapeutic in humans.
   
   TIMELINE
   EVENT
   
   February 16th
   Q1 Financial Results (FYE Oct.)
   
   February
   Phase II Enrollment in Wound Healing
   
   February/March
   Phase II Enrollment in CABG
   
   March
   Phase II Enrollment in PCI
   
   Mid-2006
   File for European Approval
   
   2006
   Additional Hemopure Indications
   
   2006
   Oxyglobin Initiatives
   
   2006
   U.S. Navy Trauma - FDA Hold Lifted
   
   2006
   Possible Oncology Program
   
   Mid-2007
   European Approval for Hemopure
   
   Late ‘07/Early ‘08
   Hemopure Launch in Europe
   
   Congress funds Hemopure® for an additional $4M for Military & Civilian use: The 2006 Defense Appropriations Bill signed by President Bush on December 30th included an additional $4M in funding for the U.S. Navy to continue development Hemopure® for use in military and civilian trauma applications.
   
   New Clinical Trials Started – New Indications: Biopure received regulatory authorization in the U.K. and South Africa for a Phase II trial in patients for wound healing in lower limb amputation. Biopure also received regulatory authorization in the U.K. for a Phase II in Artery Bypass Graft (CABG) surgery and in Belgium for a Phase II trial in patients with multi-vessel coronary artery disease who are undergoing percutaneous coronary intervention (PCI). Patient enrollment has begun in wound healing, late-Feb. in CABG and late-Q1 for PCI.
   Possible New Initiatives: Biopure may launch initiatives to increase sales of Oxyglobin® in the veterinarian market, additional cardiac indications and a possible oncology program using Hemopure® as a radiation sensitizer.
   
   Conclusion / Stock Valuation: We believe investors should value Biopure in two distinct segments. Despite the U.S. Navy fighting the FDA clinical hold on their Trauma trial, we believe Biopure’s Hemopure® currently has significant traction in the European market. It is important to note that the Europeans have accepted every clinical trial request and is allowing Biopure to file for European marketing approval in mid-2006 for commercial sales despite the FDA clinical hold. Biopure’s situation is very similar to Transkaryotic Therapies which could never get their drugs (Replagal and Dynepro) approved by the FDA yet they were both approved in Europe with annual sales trending to $100M during 2005. In July 2005, Shire Pharmaceuticals (Nasdaq:SHPGY) bought Transkaryotic for $1.6B yielding a 44% premium for shareholders.
   
   Our model only takes into account European activity for Hemopure® with a 35X multiple and 40% discount for risk on 2010 EPS resulting in a 12-18 month price target of $3.00. However, should the U.S. Navy get the FDA to lift the clinical hold on the Trauma trial, we would expect a significant upward revision to our target price.
   
   succes op naar de 3
2. Nel 9 februari 2006 22:08

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   0,85 5% gestegen,this pas het begin,zie schema
   
   succes
3. [verwijderd] 10 februari 2006 14:41

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   Was in 2001 ooit 180 dollar waard zie ik... Wat is de reden van recente dalingen? (in 1 jaar van 3.00 naar 0.80 / 2 jaar geleden nog op 13... ???
   Verwachtingen lijken positief; tevens uitbodeming en hogere bodem in chart.
4. linco 10 februari 2006 14:45

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   Laat die chart eens zien, dank U.
5. [verwijderd] 10 februari 2006 14:47

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   The Securities and Exchange Commission filed a civil complaint against Biopure (BPUR:Nasdaq - commentary - research - Cramer's Take), charging the Cambridge, Mass., drug company with fraud relating to its efforts to develop an artificial blood substitute.
   
   The SEC said Wednesday the company and three officers engaged in a "fraudulent scheme to misrepresent and conceal from investors the truth" about its application to the Food and Drug Administration for the blood substitute called Hemopure.
   
   
   
   
   1. Sirius' Game of Chicken
   2. JBL: Ford, GM Will Lose This Game of Chicken
   3. Monitoring the 'Mad Money' Madness
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   5. Gold Bugs Eye $600, $850 and Far Beyond
   
   
   
   
   In addition to the company, regulators named as defendants Thomas Moore, 54, the former CEO; Howard Richman, 53, the former senior vice president of regulatory affairs and operations; and Jane Kober, currently senior vice president, general counsel and corporate secretary.
   
   "The company intends to seek dismissal of the SEC's claims or judgment in its favor and expects to prevail," said Robert A. Buhlman, the company's attorney. "Biopure intends to establish that its disclosures were accurate based on governing law, testimony provided by the FDA to the SEC, the FDA's review procedures and practices, and what was communicated by FDA at the relevant times."
   
   The 49-page SEC complaint was filed in a federal District Court in Boston.
   
   Biopure is one of several companies that have spent years working on blood substitutes. By mid-2003, Biopure appeared to have a commanding lead over the competition because its application had been accepted for review by the FDA.
   
   Biopure issued a press release on Aug. 1, 2003, saying the FDA didn't require any additional tests for Hemopure. That caused the stock to jump, as the company said it could answer a number of FDA questions in a relatively short time.
   
   The SEC complaint said this press release was "fraudulent and misleading" and "gave the false impression the company had received positive news from the FDA." In fact, the SEC complaint said, the FDA began sending Biopure "negative information" in April 2003 and imposed a clinical hold on trials of Hemopure on trauma victims because of safety concerns.
   
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6. [verwijderd] 10 februari 2006 14:48

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   Just before Biopure issued that press release, the FDA sent the company two detailed letters, according to the complaint. One letter said the FDA was refusing to lift the ban on clinical testing due to "an unreasonable and significant risk of illness and injury."
   
   The other letter said the FDA was rejecting Biopure's application due to "extensive and significant deficiencies" in the company's application and "because of concerns about the lack of safety and efficacy" of Hemopure.
   
   
   
   
   1. Sirius' Game of Chicken
   2. JBL: Ford, GM Will Lose This Game of Chicken
   3. Monitoring the 'Mad Money' Madness
   4. Cisco Call Shines Through
   5. Gold Bugs Eye $600, $850 and Far Beyond
   
   
   
   
   Over time, Biopure's regulatory problems were made public, sending the stock into a tailspin, triggering a government investigation, leading to Moore's departure and placing the company in a severe cash crunch.
   
   The SEC complaint also alleges that in 2003 Biopure touted Hemopure's potential "in multiple securities offerings, public filings, press releases and investor conference calls."
   
   The SEC complaint asks that Moore, Kober and Richman be barred from serving as an officer or director in a public company and that each defendant be fined for their "egregious" violations of federal law. The SEC also asks that Biopure pay a civil fine.
   
   Biopure continues to conduct tests on its blood substitute. For the quarter ended July 31, the company lost $6.4 million, or 26 cents a share, vs. a loss of $9.4 million, or $1.16 a share, for the same period in 2004. Total revenue for the third quarter of fiscal 2005 was $483,000 compared with $333,000 for the same period in 2004.
   
   On Wednesday, Biopure's stock dropped 14 cents, or 9.8%, to $1.29.
   
   Go to THESTREET.COM HOME PAGE | Go to BEGINNING OF STORY
   
   
   
7. [verwijderd] 10 februari 2006 14:49

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   finance.yahoo.com/q/h?s=BPUR&t=2005-1...
8. [verwijderd] 10 februari 2006 14:51

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   Ajaj, fraude met research..... daar zullen ze toch wel geleerd van hebben hoop ik? ;-)
9. Nel 10 februari 2006 14:54

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   gaan zich nu op europa richten,kansen vele malen groter dat dit wel slaagt,zie schema staat genoeg op de planning komendetijd,koers kan leuke bewegingen maken,denk zelf deze keer positief
10. [verwijderd] 10 februari 2006 15:06

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    Misschien nog ff toevoegen aan mn rijtje:
    
    Pharming Group
    Generex Biotech. Corp.
    GTC Biotherapeutics Inc.
    Insmed Inc
    Peregrine Pharmaceuticals Inc.
    
    Wordt wel steeds meer biotech gerichte portfolio zo... :-)
12. Nel 10 februari 2006 15:37

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    biopure is een goede kanshebber voor je rijtje zo tezien,bedrijven die allemaal in de eind fase zijn om goud teworden,
13. [verwijderd] 10 februari 2006 16:01

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    Voor de liefhebber:
    
    www.iex.nl/forum/topic.asp?forum=215&...
    
    Psycho
14. Nel 10 februari 2006 22:05

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    weer een goed slot op TA door gebroken en volgende week boven de 1 dollar
    
    succes
15. Nel 13 februari 2006 16:22

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    Investors show faith in Biopure
    
    By Gregory Roumeliotis
    
    
    03/02/2006 - Oxygen therapeutics company Biopure has announced another $3 million (€2.5 million) public offering to boost its working capital, despite its major drug for humans, Hemopure, an artificial blood product, being licensed only in South Africa.
    
    The announced public offering of 4,110,000 shares of its stock and options is the second for the company in the less than a month, demonstrating the confidence of investors in Biopure and the artificial blood market, which in the US alone is estimated to be worth $5 billion (€4.1 billion) a year.
    On December 28, Biopure closed a $5.8 (€4.8 billion) million financing deal selling 10,120,000 shares.
    
    In America, the Securities and Exchange Commission filed a civil complaint against Biopure in September accusing the Massachusetts-based corporation of a fraudulent scheme to “misrepresent and conceal from investors the truth” about its application to the FDA for Hemopure in 2002.
    
    However, Biopure has a research agreement with the American Naval Medical Research Center, which has primary responsibility for designing, seeking FDA acceptance and conducting a proposed Phase 2/3 clinical trial of Hemopure in trauma patients with severe hemorrhagic shock in the out-of-hospital setting.
    
    The biotechnology company also hopes to apply in mid 2006 for approval of Hemopure in Europe for the treatment of acute anemia in elective orthopedic surgery patients.
    
    “We believe that Hemopure will be approved in the US but it's difficult to put a time frame on it,” Douglas Sayles, Biopure's associate director of marketing communications, told In-Pharmatechonologist.com.
    
    “We need to keep our operations going, so we needed the public offering for our working capital.”
    
    Herb Lanzet, a communication consultant for Biopure's investor relations, said to In-Pharmatechonologist.com: “2006 will be a bright year for Biopure where it will make progress correcting its overhangs.”
    
    “There will be Hemopure in the US market sometime in the future.”
    
    Hemopure consists of chemically stabilized bovine hemoglobin that can carry oxygen at low blood pressure and through constricted or partially blocked blood vessels to areas of the body that red blood cells cannot reach because to their larger size.
    
    It 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.
    
    But in many countries there are concerns about blood products derived from cows.
    
    For example, a recent EU-funded survey by Nottingham University suggests that the British public would favour truly artificial blood over blood derived from cows, due to fears of variant CJD and objections from religious groups like Hindus .
    
    Biopure's veterinary product Oxyglobin, the only oxygen therapeutic approved by the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs.
    
    
16. [verwijderd] 13 februari 2006 17:57

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    Vlugger dan je denkt. Goed gezien papaa :)
    
    

    quote:

    papaa schreef:

    weer een goed slot op TA door gebroken en volgende week boven de 1 dollar
    
    succes
    

17. positivo73 13 februari 2006 19:33

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    Goedenavond,
    Wat is jullie opinie betreffende dit aandeel. Hebben we het zo wel gehad of verwachten jullie dat ie langzaam maar zeker hogere toppen gaat vormen?
    m.v.g.Willem
18. Nel 13 februari 2006 19:49

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    denk dat de koers weer richting de 1,50 gaat komendetijd,kijk je naar de planning komendetijd kunnen er nog leuke dingen aankomen.
    
    succes
19. positivo73 13 februari 2006 20:06

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    Ku je mij vertellen hoeveel aandelen er zijn en hoeveel daarvan in vaste handen?
    m.v.g.Willem
20. Nel 13 februari 2006 20:10

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    na de laaste emmisie rond de 35 mln waarvan,hoeveel invaste handen!!!
    dus uitstaande aandelen valt mee,beetje goed nieuws en we kunnen fors omhoog,vandaag is het op TA dat de koers omhoog gaat en de cijfers komen eraan en wellicht meer nieuws opkomst.
    
21. positivo73 13 februari 2006 20:16

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    Dat zijn er inderdaad niet veel. Ik heb net een pluk gekocht, de koers stijgt m.i. echt nog wel 20 a 30% en als er nieuws komt dan kan het ook wel een stukje meer worden.
    m.v.g.Willem