SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 of the
Securities Exchange Act of 1934
Date of Report (date of earliest event reported): October 31, 2000
NAPRO BIOTHERAPEUTICS, INC.
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Incorporated in Delaware Commission File IRS ID No. 84-1187753
Number 0-243201
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6304 Spine Road, Unit A
Boulder, Colorado 80301
(303) 530-3891
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Item 5. Other Events
On September 18, 2000, NaPro BioTherapeutics, Inc., together with its licensee
Abbott Laboratories, filed a complaint against Bristol Myers Squibb Company in
the United States District Court for Colorado alleging infringement of NaPro's
U.S. patents # 5,972,992 and 5,977,164 for paclitaxel, an ingredient in the drug
Bristol sells as Taxol(R), and seeking damages and other relief. On October 31,
2000 NaPro was issued U.S. patent # 6,140,359; NaPro and Abbott are evaluating
the inclusion of this patent in the above referenced litigation. Pursuant to
certain arrangements between NaPro and Abbott, Abbott will be responsible for
the cost associated with the aforementioned litigation.
Item 9. Regulation FD Disclosure
NaPro's ability to generate sufficient revenue to support its operations depends
primarily upon the successful completion of a joint drug development program
with Abbott culminating in approval of a marketing application by the U.S. Food
and Drug Administration, followed by Abbott's successful marketing of NaPro
paclitaxel. The FDA has approved two Abbreviated New Drug Applications, referred
to as ANDA's, covering paclitaxel for companies affiliated with Ivax and has
tentatively approved a paclitaxel ANDA for at least one other company. NaPro
believes, but cannot assure, that the FDA will approve its paclitaxel in 2001 or
2002 through an ANDA.
NaPro believes Bristol's current selling price for Taxol(R) to be between $4,500
and $5,000 per gram. Abbott will determine the selling price of NaPro
paclitaxel. NaPro believes it can be cost competitive with other manufacturers
of paclitaxel once NaPro's commercial production has been scaled up. NaPro
believes the total current U.S. market for Taxol(R) to be at least 200
kilograms. Under the current agreement with Abbott, at anticipated volumes NaPro
believes its revenue sharing percentage will approximate that which it receives
from Faulding (approximately 40%). NaPro cannot assure the Taxol(R) selling
price, NaPro's manufacturing cost, the U.S. market for Taxol(R) or NaPro's
revenue sharing percentage.
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In its new product development program NaPro has a number of proprietary early
stage targets, including a new class of mitotic inhibitors for cancer, a new
class of selective protein synthesis inhibitors for cancer, a new class of
enzyme inhibitors for cancer, a novel formulation/compound for pain, and a
proprietary delivery technology for cytotoxics. NaPro anticipates that it will
advance at least two proprietary candidates to preclinical studies by 2001.
However, NaPro cannot assure that such filing or advancement of candidates will
occur or that any of these products or technologies will be successful. NaPro is
seeking to in-license or purchase for cash, royalties and/or NaPro stock at
least two Phase II / Phase III products by the end of 2001; NaPro cannot assure
that it will do so.
NaPro believes its existing capital, anticipated sales in 2000, and available
borrowing and milestone payments from its development partners can provide
adequate funding for its necessary operations and capital expenditures in the
near future. The cost of developing and acquiring new pharmaceutical products,
and related capital and operating expenditures, may be significant in the
future. NaPro, therefore, expects to seek additional capital in the near future,
which may include the sale of common stock, if it is available at financially
acceptable terms. NaPro cannot assure that it will be able to do so.
NaPro is actively pursuing additional partners to assist in the development and
marketing of NaPro paclitaxel. NaPro anticipates entering into a licensing
and/or simple distribution arrangement with one or more marketing partners in
Europe by the end of 2000 or in the first quarter of 2001 and in Japan by the
end of 2001 or the beginning of 2002. NaPro cannot assure it will be able to do
so, however. If a European licensing or distribution partner cannot be secured
prior to the end of the year, under terms that are financially acceptable to
NaPro, NaPro may seek to secure marketing approvals prior to reopening its
search for such a marketing partner. NaPro believes it may be able to secure
such approvals from its own financial resources. NaPro expects but cannot assure
some approvals of NaPro paclitaxel in selected countries in Europe by the end of
2003.
Special Note Regarding Forward-looking Statements
This report contains forward-looking statements that involve known and unknown
risks, including, without limitation, statements containing the words
"believes", "anticipates", "estimates", "may" and words of similar import or
statements of management's opinion or statements that are not historical fact.
Such forward-looking statements include, among others:
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NaPro's ability to generate sufficient revenue to support its
operations depending primarily upon the successful completion of a
joint drug development program with Abbott culminating in approval of a
marketing application by the FDA, followed by Abbott's successful
marketing of NaPro paclitaxel; NaPro's belief that the FDA will approve
NaPro paclitaxel in 2001 or 2002 through an ANDA; NaPro's belief that
Bristol's current selling price for Taxol(R) is between $4,500 and
$5,000 per gram; NaPro's belief that it can be cost competitive with
other manufacturers of paclitaxel once NaPro's commercial production
has been scaled up; NaPro's belief that under the current agreement
with Abbott, at anticipated volumes NaPro's revenue sharing percentage
will approximate that which it receives from Faulding (approximately
40%);
NaPro's anticipation that it will advance at least two new proprietary
candidates to pre-clinical studies by mid-2001; NaPro's belief that it
may in-license or purchase at least two Phase II or Phase III products
by the end of 2001;
NaPro's belief that its existing capital, anticipated sales in 2000,
and available borrowing and milestone payments from its development
partner will provide adequate funding for its necessary operations and
capital expenditures in the near future; NaPro's expectation that it
will seek additional capital, which may include the sale of common
stock, if it is available at financially acceptable terms;
NaPro's anticipation that it will license or enter into a distribution
arrangement for NaPro paclitaxel with a marketing partner in Europe by
the end of 2000 or the first quarter of 2001 and in Japan by the end of
2001 or the beginning of 2002; and NaPro's expectation that it will
receive European approvals for NaPro paclitaxel by the end of 2003.
Such forward-looking statements involve known and unknown risks, uncertainties
and other factors which may cause the actual results, performance or
achievements of NaPro, or industry results, to be materially different from any
future results, performance or achievements expressed or implied by such
forward-looking statements. Such factors include, among other things, the
following:
adverse economic and general business conditions;
competition from Bristol and other existing and new producers of
paclitaxel and other drugs; potential price erosion in response to
increased competition; technological advances in cancer treatment and
drug development that may obsolesce paclitaxel; the ability to obtain
rights to technology; the ability to obtain and enforce patents; the
ability to maintain trade secrets; the ability to obtain raw materials
at reasonable prices and to commercialize new manufacturing processes;
the effectiveness of NaPro paclitaxel and other pharmaceuticals
developed by NaPro in treating disease; the results of clinical
studies; the results of research and development activities; the
ability to purchase or license new products; the successful development
of new products; the business abilities and judgment of NaPro's
management and other personnel; the ability to hire skilled personnel
to perform research and development and to run NaPro's manufacturing
operations;
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the ability of contract manufacturers to perform adequately under
anticipated contracts; changes in and compliance with governmental
regulations; the decision-making processes of regulatory agencies; the
effect of capital market conditions and other factors on capital
availability for NaPro and other biopharmaceutical companies; the
ability of Abbott to successfully penetrate the paclitaxel market and
to perform its obligations under its existing agreements with NaPro;
the ability of NaPro to perform its obligations under its existing
agreements with Abbott; the ability of NaPro to establish relationships
with capable strategic partners to develop and market NaPro paclitaxel
in Europe and Japan; NaPro's limited relevant operating history upon
which an evaluation of its prospects can be made; and the effect on
NaPro's revenue, cash flow and earnings of foreign exchange rate
fluctuations.
The forward-looking statements included in this report represent NaPro's view as
of the date of this report, and it should not be assumed that the statements
made herein remain accurate at any future date. NaPro does not intend to update
these statements and undertakes no duty to any person to make any update under
any circumstance.
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Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, NaPro has
duly caused this report to be signed on its behalf.
NaPro BioTherapeutics, Inc.
/s/ Gordon H. Link, Jr.
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November 6, 2000 Gordon H. Link, Jr.
Vice President
Chief Financial Officer
