Good Morning,
thought this might be of some interest.
March 9, 2000
Israel Approves Busulfex(R) With Broad Indication for Use
MINNEAPOLIS, March 9 /PRNewswire/ -- Orphan Medical, Inc. (Nasdaq: ORPH)
announced today that Israel's Ministry of Health has approved
Busulfex(R)(busulfan) Injection for marketing in that country. This
approved
indication provides for the use of Busulfex, in combination with other
chemotherapeutic agents and/or radiotherapy, as a conditioning regimen
prior to
hematopoietic progenitor cell transplantation. There are approximately
550 transplants
per year in Israel. Busulfex will be sold in Israel by Tzamal Pharma,
Orphan
Medical's marketing partner in that country.
This approval follows a September 1999 submission to the Ministry of
Health and represents the third market approval for Busulfex since
February
1999 The U.S. Food and Drug Administration granted the first approval of
Busulfex on February 4, 1999, followed by approval in Canada in July of
1999.
Orphan Medical CEO John Bullion commented, "This is the second
international approval for Busulfex in less than one year. The approval
in Israel
preceded this week's European Bone Marrow Transplant meeting being held
in
Austria. At this meeting, attended by transplant specialists worldwide,
two
presentations in the scientific sessions addressed Busulfex: one
focusing on the use of Busulfex in patients with CML (chronic
myelogenous leukemia);
and the other a retrospective comparison between oral and IV busulfan,
showing a lower rate of HVOD (hepatic veno-occlusive disease) and
100-day
mortality in the patient group receiving Busulfex."
Orphan Medical, Inc. is dedicated to patients with inadequately treated
anduncommon diseases. To that end, the Company acquires, develops, and
market products of high medical value within selected strategic
therapeutic
market segments. Orphan Medical's Internet Web Site address is
http://www.orphan.com
The information in this press release may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of
1995. A number of factors could cause actual results to differ
materially from
the Company's assumptions and expectations including failure to enter
into a
definitive agreement or to obtain necessary regulatory approvals as well
a those set forth in the cautionary statements included in Exhibit 99 to
Orphan Medical's most recent Form 10-Q or Form 10-K filed with the
Securities and Exchange Commission. All forward-looking statements are
qualified by, and should be considered in conjunction with, such
cautionar statements.
SOURCE Orphan Medical, Inc
God Bless All,
marty auslander
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