SICOR Announces Tentative ANDA Approval for Fluconazole Injection
2004年1月7日 - 10:00PM
PRニュース・ワイアー (英語)
SICOR Announces Tentative ANDA Approval for Fluconazole Injection
IRVINE, Calif., Jan. 7 /PRNewswire-FirstCall/ -- SICOR Inc. today
announced that the Food and Drug Administration (FDA) has issued a
tentative approval of an Abbreviated New Drug Application (ANDA)
submitted by its wholly owned subsidiary, SICOR Pharmaceuticals,
Inc., for fluconazole injection. Fluconazole is an antifungal agent
indicated for the treatment of vaginal candidiasis, oropharyngeal
and esophageal candidiasis, and cryptococcal meningitis. SICOR's
approval covers single-use vial sizes 200 mg/100 mL and 400 mg/200
mL. Based on data from IMS, a market research firm, U.S. sales of
fluconazole injection in 2002 were approximately $175 million. The
branded product, Diflucan(R), is marketed by Pfizer. SICOR Inc. is
a vertically integrated, multinational pharmaceutical company that
focuses on generic finished dosage injectable pharmaceuticals,
active pharmaceutical ingredients, or APIs, and generic
biopharmaceuticals. Using internal research and development
capabilities, together with operational flexibility and
manufacturing and regulatory expertise, SICOR is able to take a
wide variety of products from the laboratory to the worldwide
market. Leveraging these capabilities, SICOR concentrates on
products and technologies that present significant barriers to
entry or offer first-to- market opportunities. SICOR operates
several manufacturing facilities in the U.S., Western and Eastern
Europe and Mexico, while maintaining its corporate headquarters in
Irvine, California. For more information, please visit our website
at http://www.sicor.com/ . Forward-Looking Statement This press
release contains forward-looking statements that are subject to
risks and uncertainties that could cause actual results to differ
materially from those set forth in the forward-looking statements,
including whether the Company will receive final approval for
fluconazole, whether the Company will successfully launch this
product, whether fluconazole will receive market acceptance and
those matters set forth in the risk factors section of Teva's
Amendment to Registration Statement on Form F-4 filed with the
Securities and Exchange Commission on December 12, 2003, regarding
Teva's acquisition of SICOR Inc. These forward-looking statements
represent SICOR's judgment as of the date of this press release.
SICOR disclaims any intent or obligation to update these
forward-looking statements. Additional Information About the Merger
and Where to Find It This news release is for informational
purposes only and is not an offer to buy or the solicitation of an
offer to sell any Teva shares, and is not a solicitation of a
proxy. In connection with the proposed merger, Teva Pharmaceutical
Industries Limited and SICOR Inc. filed a definitive proxy
statement/prospectus with the Securities Exchange Commission on
December 12, 2003, as part of an Amendment to Registration
Statement on Form F-4. Investors and security holders are advised
to read the definitive joint proxy statement/prospectus dated
December 12, 2003, because important information is contained
therein. The definitive proxy statement/prospectus has been sent to
stockholders of SICOR Inc. in connection with the solicitation of
their approval of the proposed merger of SICOR Inc. with a
subsidiary of Teva Pharmaceutical Industries Limited. You may
obtain a free copy of the Amendment to Registration Statement on
Form F-4 and other documents filed by the companies with the
Commission at the Commission's website at http://www.sec.gov/. The
Amendment to Registration Statement also is available from Teva by
contacting Teva Pharmaceutical Industries Limited, 5 Basel St.
Petach Tikva 49131, Israel, Attention: Investor Relations
(972-3-926-7554) and from SICOR Inc. by contacting SICOR Inc., 19
Hughes, Irvine, CA 92618, Attention: Investor Relations (949)
455-4879. Teva Pharmaceutical Industries Limited and SICOR Inc.,
and their respective directors and executive officers, may be
deemed to be participants in the solicitation of proxies from the
stockholders of SICOR Inc. in connection with the merger.
Information about the directors and executive officers of SICOR
Inc. and their interests in the merger, including their ownership
of SICOR Inc., is set forth in the proxy statement for SICOR Inc.'s
2003 annual meeting of stockholders. Information about the
directors and executive officers of Teva Pharmaceutical Industries
Limited and their interests in the merger, including their
ownership of Teva Pharmaceutical Industries Limited stock, is set
forth in its annual report on Form 20-F for the year ended December
31, 2002. Investors may obtain additional information regarding the
interests of such participants in the merger by reading the
definitive proxy statement/prospectus. DATASOURCE: SICOR Inc.
CONTACT: Laurie W. Little of SICOR Inc., +1-949-455-4879 Web site:
http://www.sicor.com/
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