Savient (NASDAQ:SVNTE)
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From Jun 2019 to Jun 2024
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.