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Orphan Medical Attends American Society of Clinical Oncology (ASCO) Annual Meeting.

MINNEAPOLIS, May 18 /PRNewswire/ -- ORPHAN MEDICAL, INC. (Nasdaq: ORPH) announced today that two presentations relating to Busulfex(TM) (busulfan) Injection were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO). An estimated 18,000 cancer specialists from around the world attend this important four day meeting which features over 150 scientific and educational sessions and nearly 2,500 abstracts highlighting the latest advances in clinical cancer research.

The presentations at the meeting discussing Busulfex were:

William Vaughan, M.D., of the University of Alabama at Birmingham -- Body Surface Area (BSA) Dosing Using Actual Body Weight (ABW) Yields Less Variation in Area Under the Concentration X Time Curve (AUC) for High Dose IV Busulfan (NU) Than BSA Dosing Using Ideal Body Weight (IBW), Adjusted Ideal Body Weight (AIBW) or Dosing Using ABW, IBW or AIBW Directly.

Borje Andersson, M.D., Ph.D., of M.D. Anderson Cancer Center -- Stem Cell Transplantation (SCT) for Non-Hodgkin Lymphomas (NHL) after IV Busulfan (Bu), and Cyclophosphamide (Cy).

Busulfex, for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML), was approved by the Food and Drug Administration (FDA) on February 4, 1999. An oral form of busulfan has been used in the bone marrow transplant setting for a number of years. Many authors have cited the need for an intravenous form of busulfan. Orphan Medical has answered this need being the only company to successfully bring an intravenous form of busulfan to the market. In clinical trials, Busulfex demonstrated consistency within individual patients, as demonstrated by reproducibility of pharmacokinetic parameters between doses (doses 9 to 13, steady state Cmax). In addition, 93% of the patients attained an AUC less than the target of 1500 mMol/min, without dose adjustments, which indicates the consistency of Busulfex (55/59). Busulfex produced profound myelosuppression in all patients, and engraftment was achieved in 100% (60/60) of evaluable patients. Additionally, there were no graft failures reported.

"The M.D. Anderson Cancer Center data underscores our strong belief that Busulfex has utility in bone marrow and stem cell transplants well beyond CML. We intend to aggressively assess the potential of other indications to broaden the use of Busulfex in transplants," said John Bullion, Chairman and Chief Executive Officer of Orphan Medical, Inc. "In addition, the ASCO meeting offers Orphan Medical the opportunity to continue building the awareness of Busulfex. Sales to date have met our expectations and we are very pleased that Busulfex is now being used in many leading bone marrow and stem cell transplant centers. We anticipate that sales will continue to increase as additional transplant centers adopt Busulfex as a standard in their protocols. We also expect to license marketing rights for Busulfex in Europe in the near future."

Despite the advanced condition of the trial patients, the overall mortality rate through day 100 post-transplant was 13% (8/61). The most common adverse events in patients treated with Busulfex include profound myelosuppression in 100% of patients, nausea (97%, mild/moderate in 92%), stomatitis (97%, grade 3 in 26%), vomiting (95%, all mild/moderate), and anorexia (85%). The type of adverse events seen with Busulfex did not differ from those seen with oral busulfan in the transplant setting.

Orphan Medical, Inc. is dedicated to patients with inadequately treated or uncommon diseases. To that end, the Company acquires, develops, and markets products of high medical value within selected strategic therapeutic market segments. In addition to Busulfex, Orphan Medical currently markets Antizol(R) (fomepizole) Injection, an antidote for ethylene glycol (antifreeze) poisoning; Cystadane(R) (betaine anhydrous for oral solution) for homocystinuria (abnormally high blood levels of homocysteine); and Sucraid(R) (sacrosidase) oral solution for sucrase deficiency (the inability to digest common table sugar). The Company is developing Xyrem(TM) (sodium oxybate) oral solution which is intended for the treatment of narcolepsy, particularly the debilitating narcolepsy symptom of cataplexy, a sudden loss of muscle control. Orphan Medical's Web Site address is http://www.orphan.com

For a complete discussion of INDICATIONS and USAGE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and OVERDOSAGE, please see the full prescribing information attached, available through the Company, on the Orphan Medial Web Site at http://www.orphan.com , or toll free at 888-8ORPHAN (888-867-7426).

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. These are 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 cautionary statements.
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Publication:PR Newswire
Geographic Code:1USA
Date:May 18, 1999
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