MINNEAPOLIS--(BUSINESS WIRE)--Oct. 12, 2006--MGI PHARMA, INC.
(NASDAQ:MOGN), a biopharmaceutical company focused in oncology and
acute care, today announced it has received an approvable letter from
the U.S. Food and Drug Administration (FDA) for Saforis(TM)
(glutamine) Powder in UpTec(TM) for Oral Suspension, an
investigational therapy for the treatment and prevention of oral
mucositis. The FDA has requested an additional phase 3 trial to
evaluate the efficacy of Saforis in the proposed indication.
"Based upon the FDA's request, we will be evaluating options to
maximize the value of Saforis," said Lonnie Moulder, President and CEO
of MGI PHARMA. "Our operating plans for next year did not anticipate a
significant contribution from Saforis. We remain committed to
achieving pro forma operating profitability in 2007 and executing on
our core commercial and development initiatives."
About MGI PHARMA
MGI PHARMA, INC. is a biopharmaceutical company focused in
oncology and acute care that acquires, researches, develops and
commercializes proprietary products that address the unmet needs of
patients. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride)
Injection, Dacogen(TM) (decitabine) for Injection and Gliadel(R) Wafer
(polifeprosan 20 with carmustine implant) in the United States. MGI
PHARMA directly markets its products in the U.S. and collaborates with
partners to reach international markets. For more information, please
visit www.mgipharma.com.
This news release contains certain "forward-looking" statements
within the meaning of the Private Securities Litigation Reform Act of
1995. These statements are typically preceded by words such as
"believes," "expects," "anticipates," "intends," "will," "may,"
"should," or similar expressions. These forward-looking statements are
not guarantees of MGI PHARMA's future performance and involve a number
of risks and uncertainties that may cause actual results to differ
materially from the results discussed in these statements. Factors
that might cause MGI PHARMA's results to differ materially from those
expressed or implied by such forward-looking statements include, but
are not limited to, the ability of MGI PHARMA's product candidates to
be proven safe and effective in humans, to receive marketing
authorization from regulatory authorities, and to ultimately compete
successfully with other therapies; continued sales of MGI PHARMA's
marketed products; development or acquisition of additional products;
reliance on contract manufacturing; changes in strategic alliances;
continued access to capital; ability of MGI PHARMA to successfully
complete the integration of Guilford with its existing operations; the
risk that the perceived advantages of the Guilford transaction may not
be achieved; and other risks and uncertainties detailed from time to
time in MGI PHARMA's filings with the Securities and Exchange
Commission including its most recently filed Form 10-Q or 10-K. MGI
PHARMA undertakes no duty to update any of these forward-looking
statements.
CONTACT: MGI PHARMA, INC.
Jennifer Davis, 212-332-4381
ir@mgipharma.com
SOURCE: MGI PHARMA, INC.