NOVEN
AND ENDO ANNOUNCE LICENSING AGREEMENT |
BackAgreement Includes Collaboration for Development of New Prescription Patches
Miami, FL, February
26, 2004 -- Noven Pharmaceuticals,
Inc. (Nasdaq: NOVN) and Endo Pharmaceuticals Inc., a wholly
owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP),
today announced that they have signed an agreement under which Noven
will license the U.S. and Canadian rights to its developmental
transdermal fentanyl patch to Endo. The agreement also establishes
an ongoing collaboration between the two companies for the development
of additional prescription transdermal products.
Noven's fentanyl patch is a transdermal delivery system for the management
of chronic pain. It is intended to be the generic equivalent of Johnson & Johnson's
Duragesic® (fentanyl transdermal system), which had
U.S. sales of approximately $1.3 billion in 2003. An Abbreviated
New Drug Application
for Noven's patch is pending at the U.S. Food & Drug Administration.
"With market leadership in pain management and outstanding generic
drug distribution capabilities, Endo is an ideal commercialization
partner
for our fentanyl patch," said Robert C. Strauss, Noven's President,
CEO and Chairman.
"With our proven success within selective generic markets, including
pain management, we see this agreement with Noven to market a generic
fentanyl patch as a natural fit, and we also look forward to benefiting
from their considerable expertise in patch technology to potentially
develop and commercialize innovative branded transdermal products
as well," said Carol A. Ammon, Endo's Chairman and Chief Executive
Officer.
Noven received $8.0 million from Endo upon signing the agreement. Upon
Endo's first commercial sale of the fentanyl patch, Noven is entitled
to receive an additional payment ranging from $5.0 million to $10.0
million, depending on the timing of launch and the number of generic
competitors on the market. Noven will manufacture and supply the product
at its cost, and the two companies will share profits on undisclosed
terms.
Based on the current patent and exclusivity status of Duragesic®,
the companies believe that the generic fentanyl patch could be launched
in January 2005, assuming FDA approval is received by that time. Noven
has retained all rights to the fentanyl patch outside of the U.S. and
Canada, and is exploring strategies to commercialize the product in
other territories.
In addition to the fentanyl license, Noven and Endo have established
a collaboration to identify and develop additional new transdermal
therapies. As part of this effort, Noven will undertake feasibility
studies to determine whether certain compounds identified by the parties
can be delivered through Noven's transdermal patch technology. Endo
is expected to fund and manage clinical development of those compounds
proceeding into clinical trials.
"Endo shares our commitment to developing a range of innovative prescription
transdermal products," said Strauss. "We hope to build a
successful and productive collaboration that extends beyond generic
fentanyl and ultimately expands the universe of proprietary transdermal
therapies."
About Endo
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq:
ENDP -News ), Endo Pharmaceuticals Inc. is a fully integrated specialty
pharmaceutical company with market leadership in pain management
products. The company researches, develops, produces and markets
a broad product
offering of branded and generic pharmaceuticals, meeting the needs
of healthcare professionals and consumers alike. Endo's pain management
franchise includes Lidoderm® (lidocaine patch 5%)
and Percocet® (oxycodone
and acetaminophen tablets, USP). As a result of the strong growth
of these products, the company's net sales in 2003 increased 49%
to $595.6
million. More information on Endo, including this and past press
releases, is available online at http://www.endo.com.
About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is
a leading developer of advanced transdermal drug delivery technologies
and prescription transdermal products. Noven's existing prescription
patches are sold in over 30 countries, and a range of new patches
are
being developed in collaboration with Novartis Pharma AG, Shire
Pharmaceuticals Group plc, P&G Pharmaceuticals, Endo Pharmaceuticals
Inc. and others. Together with Novartis Pharmaceuticals Corporation,
Noven owns Novogyne
Pharmaceuticals, a profitable women's health products company with
over $100 million in annual sales. Among other products, Novogyne
markets and sells Noven's Vivelle-Dot® product --
the smallest estrogen patch in the world, and the most dispended
estrogen patch in the U.S.
With the most efficient and broadly applicable transdermal technology
in its class, Noven is committed to expanding the universe of available
transdermal therapies for the benefit of patients, partners and
shareholders. See http://www.noven.com for additional information.
Information for Endo Investors. This
press release contains forward-looking statements, within the meaning
of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
as
amended, that are based on management's beliefs and assumptions,
current expectations, estimates and projections. Statements that
are not historical
facts, including statements which are preceded by, followed by,
or that include, the words "believes," "anticipates," "plans," "expects" or
similar expressions and statements are forward-looking statements.
Endo's estimated or anticipated future results, product performance
or other non-historical facts are forward-looking and reflect Endo's
current perspective on existing trends and information. Many of
the factors that will determine the Company's future results are
beyond
the ability of the Company to control or predict. These statements
are subject to risks and uncertainties and, therefore, actual results
may differ materially from those expressed or implied by these
forward-looking statements. The reader should not rely on any forward-looking
statement.
The Company undertakes no obligation to update any forward-looking
statements whether as a result of new information, future events
or otherwise. Several important factors, in addition to the specific
factors
discussed in connection with these forward-looking statements individually,
could affect the future results of Endo and could cause those results
to differ materially from those expressed in the forward-looking
statements contained in this press release. Important factors that
may affect
future results include, but are not limited to: market acceptance
of the Company's products and the impact of competitive products
and pricing;
dependence on sole source suppliers; the success of the Company's
product development activities and the timeliness with which regulatory
authorizations
and product launches may be achieved; successful compliance with
extensive, costly, complex and evolving governmental regulations
and restrictions;
the availability on commercially reasonable terms of raw materials
and other third party manufactured products; exposure to product
liability and other lawsuits and contingencies; dependence on third
party suppliers,
distributors and collaboration partners; the ability to timely
and cost effectively integrate acquisitions; uncertainty associated
with
pre-clinical studies and clinical trials and regulatory approval;
uncertainty of market acceptance of new products; the difficulty
of predicting
FDA approvals; risks with respect to technology and product development;
the effect of competing products and prices; uncertainties regarding
intellectual property protection; uncertainties as to the outcome
of litigation; changes in operating results; impact of competitive
products
and pricing; product development; changes in laws and regulations;
customer demand; possible future litigation; availability of future
financing and reimbursement policies of government and private
health insurers and others; and other risks and uncertainties detailed
in
Endo's filings with the Securities and Exchange Commission, including
its Registration Statement on Form S-3 filed with the SEC on July
1, 2003. Readers should evaluate any statement in light of these
important
factors.
Information for Noven Investors.
Except for historical information contained herein, the matters discussed
in this press release contain
forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 that involve substantial risks and uncertainties. When
used
in this press release, the words "believe," "expect," "hope," " will" and
similar expressions identify certain of such forward-looking statements.
Actual results, performance or achievements could differ materially
from those contemplated, expressed or implied by the forward-looking
statements contained herein. These forward-looking statements are
based largely on the current expectations of Noven and are subject
to a number
of risks and uncertainties that are subject to change based on
factors which are, in many instances, beyond Noven's control, including:
the
possibility that Noven's fentanyl patch may not be approved by
the FDA on a timely basis or at all; the possibility that milestone
payments
may be reduced and/or Endo may exercise its contractual right to
terminate the license agreement if the product launch is delayed
for any reason,
including delay in obtaining FDA approval; patent or other strategies
by third parties could delay or prevent the launch of Noven's fentanyl
patch or other products; the possibility that Noven may be unable
to recover significant costs to manufacture fentanyl patches prior
to
product launch if FDA approval is not obtained on a timely basis
or at all; the possibility that Noven may experience difficulties
in manufacturing
the product on a commercial scale; the possibility that Endo and/or
Noven may be unable to obtain sufficient DEA quota of fentanyl
to satisfy their marketing requirements; the possibility that supply
of the active
ingredient may be limited or that the active ingredient is unavailable
in sufficient quantities to satisfy the parties' marketing requirements;
the possibility that, even if approved, Noven's fentanyl patch
or other products may not be successfully commercialized due to
product pricing
and other competitive factors, including physician/patient preferences
for other therapies; the possibility that Noven's technologies
may not be approvable or suitable for use in additional therapeutic
categories,
including those categories proposed to be addressed through products
developed with Endo; the possibility that Endo does not advance
any additional Noven products through the regulatory process; and
Noven's
success at managing the risks relating to the foregoing. In addition
to the risks and factors identified above, reference is also made
to the other risks and factors detailed in reports filed by Noven
with
the Securities and Exchange Commission. Noven cautions that the
foregoing list of factors is not exhaustive.
Contact:
Investor & Media Contact
Joseph
C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
or
Bill Newbould
Endo Pharmaceuticals
(610) 558-9800
Copyright © 2004 Noven Pharmaceuticals, Inc. All rights reserved.