CORRECTING and REPLACING Savient Pharmaceuticals Receives FDA Approval to Market Soltamox(TM); The First Oral Liquid Tamoxifen i
31 Oktober 2005 - 10:41PM
Business Wire
The references to Soltamox in the headline and first graf should
read: Soltamox(TM) (sted: Soltamox(R) ). The following is the
corrected release: SAVIENT PHARMACEUTICALS RECEIVES FDA APPROVAL TO
MARKET SOLTAMOX(TM); THE FIRST ORAL LIQUID TAMOXIFEN IN U.S.;
U.K.-BASED LIQUIDS MANUFACTURING FACILITY MEETS THE FDA'S CURRENT
GOOD MANUFACTURING PRACTICES Savient Pharmaceuticals, Inc. (NASDAQ:
SVNTE), an emerging specialty pharmaceutical company engaged in
developing, manufacturing and marketing pharmaceutical products
that address unmet medical needs, announced today that the U.S.
Food and Drug Administration (FDA) has approved its New Drug
Application (NDA) for Soltamox(TM) (tamoxifen oral solution) for
the treatment of breast cancer in adjuvant and metastatic settings
and to reduce risks of breast cancer in women with ductal carcinoma
in situ (DCIS) and reduction of breast cancer incidence in women
with high risk of breast cancer. Soltamox is the product of
Savient's wholly-owned subsidiary, Rosemont Pharmaceuticals Ltd.
located in Leeds, U.K. Soltamox represents the first oral liquid
product entry into the U.S. from Savient's wholly-owned U.K.
subsidiary and it will be the first oral solution of tamoxifen
available in the United States. Soltamox is currently sold in the
U.K., Ireland and Germany. The Company is currently in discussions
with potential partners to form an alliance to market Soltamox in
the United States and expects to conclude negotiations early in
2006. Christopher Clement, Savient's President and Chief Executive
Officers, said, "The approval of Soltamox marks a significant
milestone for Savient and represents a major step in the
advancement of our strategic plan to position the Company as an
emerging pharmaceutical company. Soltamox is the first of
Rosemont's products to be introduced into the United States as we
seek to expand the geographic reach of our oral liquids
pharmaceutical business. This approval follows the FDA review of
our U.K. manufacturing facility and establishes the regulatory
pathway for additional Rosemont products to follow into the U.S.
market as we continue to enhance the value of this asset."
Tamoxifen is a cytostatic estrogen receptor antagonist used
extensively for the treatment and prevention of breast cancer.
Soltamox is the only oral liquid presentation licensed in the U.K.,
Ireland, Germany and now in the U.S. Rosemont Pharmaceuticals, Ltd.
holds a global portfolio of patents covering this product.
Important safety information for Soltamox Use of Soltamox in risk
reduction setting (women at high risk for cancer and women with
DCIS) has shown to cause cancer of the uterus, stroke, and blood
clots. The benefits of Soltamox outweigh its risks in women already
diagnosed with breast cancer. Soltamox should not be used in women
who require concomitant use of coumarin-type anticoagulant, or in
women with history of deep vein thrombosis or pulmonary embolus.
Women who are pregnant or plan to become pregnant should not take
Soltamox. Cataracts and cataract surgery can also occur more
frequently with Soltamox. The most frequently reported adverse
reactions with Soltamox were hot flashes and vaginal discharge.
About Savient Pharmaceuticals, Inc. Based in East Brunswick, New
Jersey, Savient Pharmaceuticals, Inc. is a specialty pharmaceutical
company dedicated to developing, manufacturing and marketing novel
therapeutic products that address unmet medical needs. The
Company's lead product development candidate, Puricase(R), for the
treatment of refractory gout has reported positive Phase 1 and 2
clinical data. Savient's experienced management team is committed
to advancing its pipeline and expanding its product portfolio by
in-licensing late stage compounds and exploring co-promotion and
co-development opportunities that fit the Company's expertise in
specialty pharmaceuticals and initial focus in rheumatology. The
Company's operations also include a wholly-owned U.K. subsidiary,
Rosemont Pharmaceuticals Ltd., which develops, manufactures and
markets liquid formulations of prescription pharmaceutical
products. Rosemont's product portfolio includes over 90 liquid
formulations primarily targeting the geriatric population. Further
information on the Company can be accessed by visiting
www.savientpharma.com. Safe Harbor Statement This news release
contains forward-looking statements within the meaning of Section
21E of the Securities Exchange Act of 1934. All statements, other
than statements of historical facts, included in this report
regarding the Company's strategy, expected future financial
position, discovery and development of products, strategic
alliances, competitive position, plans and objectives of management
are forward-looking statements. Words such as "anticipate,"
"believe," "estimate," "expect," "intend," "plan," "will" and other
similar expressions help identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. In particular, statements as the timing of the
completion of a potential partnering alliance in the U.S. and the
launch of Soltamox are forward-looking statements. These
forward-looking statements involve substantial risks and
uncertainties and are based on current expectations, assumptions,
estimates and projections about the Company's business and the
biopharmaceutical and specialty pharmaceutical industries in which
the Company operates. Such risks and uncertainties include, but are
not limited to, delisting of the Company's common stock from The
Nasdaq Stock Market, delay or failure in developing Prosaptide(TM),
Puricase(R) and other product candidates; difficulties of expanding
the Company's product portfolio through in-licensing; introduction
of generic competition for Oxandrin(R); fluctuations in buying
patterns of wholesalers; potential future returns of Oxandrin or
other products; our continuing to incur substantial net losses for
the foreseeable future; difficulties in obtaining financing;
potential development of alternative technologies or more effective
products by competitors; reliance on third-parties to manufacture,
market and distribute many of the Company's products; economic,
political and other risks associated with foreign operations; risks
of maintaining protection for the Company's intellectual property;
risks of an adverse determination in on-going or future
intellectual property litigation; and risks associated with
stringent government regulation of the biopharmaceutical and
specialty pharmaceutical industries. The Company may not actually
achieve the plans, intentions or expectations disclosed in its
forward-looking statements, and you should not place undue reliance
on the Company's forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements that the
Company makes. The Company's forward-looking statements do not
reflect the potential impact of any future acquisitions, mergers,
dispositions, joint ventures or investments that the Company may
make. The Company does not assume any obligation to update any
forward-looking statements.
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