Navigation Links
Biopure Operations Compliant With U.K. Manufacturing Guidelines
Date:4/11/2008

CAMBRIDGE, Mass., April 11 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has found the company's Pennsylvania manufacturing facility to be in general compliance with the principles and guidelines of good manufacturing practices as identified in the Commission Directives. The company received confirmation that it has responded successfully to the issues classified as "Other" in the MHRA's original inspection letter. The original inspection report contained no "Critical" or "Major" deficiencies.

As previously announced, Biopure has been invited by the MHRA to meet with the MHRA team of reviewers to discuss issues still outstanding from the application for registration of Hemopure for use in the treatment of acute anemia following orthopedic surgery blood loss when blood is not readily available or not an option. The company intends to announce the date of this meeting when it is set, as well as the outcome of the meeting and an anticipated timeline for the resolution of issues.

Biopure Corporation

Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. The company is developing Hemopure for other indications and is supporting the U.S. Navy's government- funded efforts to develop a potential out-of-hospital trauma indication. Biopure's veterinary product Oxyglobin(R)[hemoglobin glutamer - 200 (bovine)], or HBOC-301, the only oxygen therapeutic approved for marketing by both the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 200,000 units of Oxyglobin since 1998.

Statements in this release that are not strictly historical are forward- looking statements, including any statements implying that the company will be able to respond to the MHRA questions or that Hemopure will attain marketing authorization in the United Kingdom and including statements implying that any clinical trial will be initiated and/or carried out to completion or that study results will be as desired, and any statements that might imply that Hemopure may receive marketing approval in the UK or any other jurisdictions or for additional indications in South Africa. Actual results and their timing may differ materially from those projected in these forward-looking statements due to risks and uncertainties. These risks include, without limitation, uncertainties regarding the company's financial position, including its limited cash resources and need to raise additional capital to pursue its business, the company's ability to satisfactorily address the issues raised in the MHRA correspondence or additional issues raised at a later date, unexpected costs and expenses, delays and adverse determinations by regulatory authorities, unanticipated problems with the product's commercial use, whether or not product related, and with product distributors, sales agents or other third parties, delays in clinical trials, and the other factors identified under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q filed on March 17, 2008, which can be accessed in the EDGAR database at the U.S. Securities and Exchange Commission's (SEC) website, http://www.sec.gov. 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 the company's operations and financial condition can be found in the company's filings with the SEC.

Contact: Tiana Gorham

Biopure Corporation

(617) 234-6826

IR@biopure.com


'/>"/>
SOURCE Biopure Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Biopure Appoints New Independent Auditor
2. Biopure Completes U.K. Regulatory Agency Inspection
3. Biopure Announces 2008 First Quarter Financial Results
4. Biopure Launches Updated Website
5. Biopure Announces Pricing of Equity Offering
6. Biopure Gives Update on Malaysia Joint Venture Discussions
7. Genta Restructures Operations to Focus on Priority Initiatives
8. NxStage Appoints Tom Shea as Senior Vice President of Manufacturing Operations
9. NanoLogix Inc. Presents at the National Hydrogen Association Conference & Provides Operations, Management and Director Update
10. Mentice AB Announces Leadership Changes Within Its Worldwide Operations
11. Michael J. Simms Joins Alexza Pharmaceuticals as Senior Vice President, Operations and Manufacturing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/20/2017)... ... 2017 , ... Dr. Asher Kimchi, Founder and Chairman of the International ... at the 22nd World Congress on Heart Disease held in Vancouver, BC, Canada. In ... Distinguished Fellowship Awards. , Dr. Asher Kimchi, together with Co-Chairmen Dr. John A. Elefteriades ...
(Date:7/20/2017)... and PLYMOUTH, Minn., July 20, 2017 /PRNewswire/ ... , a personalized genetic evaluations company, today announced ... their partnership investigating a genetic mutation implicated in ... extend the partnership for a second case involving ... year, the KCNQ2 Cure Alliance and Pairnomix entered ...
(Date:7/18/2017)... ... , ... Sourcing custom glass or quartz parts can be a daunting task. ... execute your job can take many hours of emails, phone calls and on-line research. ... showcase the company’s capabilities and core custom categories, and enables you to start the ...
(Date:7/18/2017)... ... July 18, 2017 , ... Allotrope Foundation won the 2017 ... of the Allotrope Framework for commercial use. , The Bio-IT World Best Practices ... elevate the critical role of information technology in modern biomedical research, but also ...
Breaking Biology Technology:
(Date:4/6/2017)... Forecasts by Product Type (EAC), Biometrics, Card-Based ... & Logistics, Government & Public Sector, Utilities / Energy ... Nuclear Power), Industrial, Retail, Business Organisation (BFSI), Hospitality & ... for a definitive report on the $27.9bn Access Control ... ...
(Date:4/5/2017)... April 4, 2017 KEY FINDINGS ... expand at a CAGR of 25.76% during the forecast ... the primary factor for the growth of the stem ... https://www.reportbuyer.com/product/4807905/ MARKET INSIGHTS The global stem cell ... application, and geography. The stem cell market of the ...
(Date:3/30/2017)... , March 30, 2017  On April 6-7, ... Hack the Genome hackathon at Microsoft,s headquarters ... two-day competition will focus on developing health and wellness ... Hack the Genome is the first ... tremendous. The world,s largest companies in the genomics, tech ...
Breaking Biology News(10 mins):