could be option related, right! checkout NPRO here is story:
Napro BioTherapeutics, Inc. Announces FDA Advisory Panel Recommendation For Approval of Anti-Cancer Drug Paxene(R)
BusinessWire, Friday, September 19, 1997 at 14:30
BOULDER, Colo.--(BW HealthWire)--September 19, 1997--NaPro
BioTherapeutics, Inc. (NASDAQ:NPRO) today announced that the United
States Food and Drug Administration's Oncologic Drugs Advisory
Committee recommended by a unanimous vote that Paxene(R)
(paclitaxel) be approved by the FDA for use "after failure of
first-line or subsequent systemic chemotherapy for the treatment of
advanced AIDS-related Kaposi's sarcoma." The FDA often follows the
recommendation of its advisory committees, though it is not bound to
do so.
Paclitaxel was originally developed by the National Cancer
Institute and was licensed to Bristol-Myers Squibb Company in 1992.
To date, a United States marketing approval for second-line therapy
of Kaposi's sarcoma has been granted to Bristol-Myers Squibb's
paclitaxel product, Taxol(R), which received an Orphan Drug approval
on August 4, 1997, providing Bristol-Myers Squibb with a seven-year
exclusivity for sale of this drug for second-line therapy of
Kaposi's sarcoma. Taxol(R)'s Orphan Drug status limits the
circumstances under which the FDA may approve Paxene(R) for Kaposi's
sarcoma.
Under an agreement signed in 1993 with IVAX Corporation's
wholly-owned subsidiary Baker Norton Pharmaceuticals, NaPro
manufactures and supplies the active raw material for Paxene(R),
while Baker Norton is responsible for commercializing Paxene(R) in
the United States and other territories including Western Europe and
Japan. Paxene(R) is IVAX's trade name for the proprietary
formulation of NaPro's paclitaxel, an anti-cancer agent found in
certain species of yew (Taxus) trees. IVAX Corporation submitted a
New Drug Application for Paxene(R) to the FDA on March 31, 1997.
IVAX Corporation markets the product in two South American countries
and plans to file applications for marketing in Europe later this
year. Through an alliance with F.H. Faulding & Co. Ltd., NaPro's
paclitaxel product is sold under the trade name Anzatax(TM) in
Australia for refractory breast and ovarian cancers. Faulding also
markets the product in China and several countries in the Middle
East. Manufacturing facilities in both the U.S. and Canada have
been inspected and approved by the Australian Therapeutic Goods
Administration, and the U.S. facilities have been inspected but not
yet approved by the U.S. FDA.
NaPro BioTherapeutics, Inc., headquartered in Boulder, Colorado,
with additional manufacturing and plantation operations in British
Columbia, Canada, is a biopharmaceutical company focused on the
development, production and licensing of complex natural-product
pharmaceuticals.
Certain statements in this Press Release constitute "forward-
looking statements" within the meaning of the Securities Litigation
Reform Act of 1995. Such forward-looking statements may include
completion of clinical trials and regulatory filings; prospects for
and timing of FDA regulatory approvals, and other statements of
expectations, beliefs, future plans and strategies, and similar
expressions concerning matters that are not historical facts.
Such forward-looking statements involve known and unknown risks that
may cause actual results, performance or achievements of the Company
to be materially different from the results, performance or
achievements expressed or implied by such forward-looking statements.
Such factors include, among other things, competition from
Bristol-Myers Squibb and other existing and new producers of
paclitaxel and other drugs; timing of regulatory filings and
approvals, including those by the FDA, relative to those of
competitors; and the effectiveness of commercial formulations of
paclitaxel in treating disease.
(1) TAXOL(R) is a registered trademark of Bristol-Myers Squibb Company
for an anti-cancer preparation containing paclitaxel.
(2) Paxene(R) is a registered trademark of Baker Norton
Pharmaceuticals, a wholly-owned subsidiary of IVAX Corporation.
Anzatax(TM) is the trade name of F.H. Faulding & Co. Ltd.
CONTACT: NaPro BioTherapeutics
Gordon H. Link
VP, Chief Financial Officer
303-530-3891
or
Burns McClellan, Inc.
Ruth Markowitz (investors)
Karen L. Bergman (media)
212-213-0006
KEYWORD: NEW YORK COLORADO
INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL BIOTECHNOLOGY PRODUCT
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Copyright 1997, Business Wire
Companies or Securities discussed in this article:
Symbol
Name
NASDAQ:NPRO
Napro Biotherapeutics Inc
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