Agency Takes Adverse Decision to Biopure's Product Registration in South Africa
28 Oktober 2008 - 9:15PM
PR Newswire (US)
CAMBRIDGE, Mass., Oct. 28 /PRNewswire-FirstCall/ -- Biopure
Corporation (NASDAQ:BPUR) announced today that it had received a
notice from the Medicines Control Council (MCC) of South Africa
indicating its decision to discontinue the registration of Hemopure
[hemoglobin glutamer-250 (bovine)], Biopure's oxygen therapeutic
for human use. The decision is subject to appeal. Biopure intends
to appeal the decision promptly and expects to continue to market
the product while the appeal is pending. The appeal is estimated to
take a year to resolve. The MCC decision comes after a letter sent
to the South Africa Minister of Health on May 22, 2008, asking that
the then ongoing clinical trials of Hemopure in South Africa be
brought to a halt because of the "evidence against blood
substitutes." The letter was sent by Public Citizen and signed by
three of the authors of a so-called meta-analysis of
hemoglobin-based blood substitutes published online April 28, 2008,
by the Journal of the American Medical Association. The letter to
the Minister of Health characterized the results of, and enclosed a
copy of, the article. Biopure expects that an appeal before a
hearing body, to be chosen by the Minister of Health, but subject
to challenge by Biopure, will succeed. Biopure has done all
required reporting on Hemopure's usage since its approval for
marketing in South Africa in 2001, including monitoring and
reporting to the MCC on use of the product in the first 80 patients
treated. Thereafter, a South African doctor consulting for Biopure
collected patient data on more than 200 patients, published an
article on that clinical experience and submitted the information
to the MCC. Since Hemopure was approved for marketing in South
Africa, there have been no serious adverse events required to be
reported to the MCC from clinical use of the product in
approximately 500 patients. Consequently, an appeal should
establish that there is not a basis for this action. Biopure
expects that local experts will strongly support its appeal. Upon
learning that the negative communication had been sent to the
Minister of Health of South Africa and to each other country where
Biopure had ongoing trials, Biopure demanded a retraction and sent
an objection to the National Institutes of Health (NIH) regarding
Charles Natanson of the NIH signing the Public Citizen letters
using his NIH title. Earlier this month, Biopure brought an action
against Natanson alleging various torts, including defamation,
trade libel and intentional interference with prospective business
advantage, seeking injunctive relief and damages. Biopure is
announcing the filing of that litigation separately. The MCC also
ordered the halt of clinical trials in South Africa, but Biopure
had already stopped patient enrollment in its trials there earlier
this year, for reasons of slow enrollment and cost containment.
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 its launch. Statements in this release
that are not strictly historical are forward-looking statements,
including any statements implying that any appeal will be
successful. 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, 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 September 15, 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 DATASOURCE: Biopure Corporation CONTACT:
Tiana Gorham of Biopure Corporation, +1-617-234-6826, Web Site:
http://www.sec.gov/
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