San Mateo, California and Staines, England (ots/PRNewswire) -
- Conference Call Today at 9:00am ET
- Covers Europe, Middle East and Africa
- Includes Licensing Option and Development Funding for NGX-1998
NeurogesX, Inc. (NASDAQ: NGSX) and Astellas Pharma Europe Ltd.,
(Astellas), the European subsidiary of Tokyo based Astellas Pharma
Inc. announced today that the companies have entered into an
exclusive Distribution, Marketing and License agreement for the
commercialization of Qutenza(TM) in the European Economic Area (EEA)
including the 27 countries of the European Union, Iceland, Norway,
and Liechtenstein as well as Switzerland, certain countries in
Eastern Europe, the Middle East and Africa. The agreement closely
follows the European Commission's approval received in May 2009, of
Qutenza (capsaicin 179 mg) cutaneous patch for the treatment of
peripheral neuropathic pain in non-diabetic adults, either alone or
in combination with other medicinal pain products.
Under terms of the agreement, Astellas will commercialize Qutenza
in the above-mentioned territories and perform certain development of
Qutenza including post-marketing commitments, to support Qutenza in
the EU market. NeurogesX will receive EUR 30 million (approximately
$42 million) for Qutenza commercialization rights, and EUR 5 million
(approximately $7 million) for a license option of NGX-1998, the
next-generation liquid formulation which uses the same active
ingredient as Qutenza.
Astellas has an established and strong product portfolio with
franchises in the therapeutic areas of urology, transplantation,
dermatology and infectious disease. Commenting on the agreement,
Masao Yoshida, President and CEO of Astellas Pharma Europe Ltd.,
said, "We are very pleased to enter into this agreement with
NeurogesX. Astellas is dedicated to developing a specialty focused
franchise and Qutenza's launch in the European Union fits with our
strategy. We are confident in the market potential for Qutenza given
its safety and efficacy to provide site-specific pain management for
up to 12 weeks. Leveraging our foothold in these territories with our
strong sales and marketing teams and Qutenza's product profile, we
are positioning for a successful commercial launch that will
introduce an important new product to patients with neuropathic
Anthony DiTonno, CEO of NeurogesX, commented, "Securing an
agreement with Astellas for the commercialization of Qutenza in
Europe and additional territories is a significant milestone
achievement for NeurogesX. Selecting the right partner was especially
important to us since the European Union represents the first
approval and the initial launch market for Qutenza. Astellas brings a
tremendous amount of sales experience and presence across Europe and
we are confident in our partner's ability and commitment to launch
Qutenza with the motivation required for commercial success. Having
secured a commercial partnership in Europe, we are now turning our
full attention to the remaining steps involved for the potential U.S.
approval and commercialization of Qutenza."
Under the Distribution, Marketing and License Agreement,
NeurogesX will receive two upfront payments from Astellas, EUR 30
million (approximately $42 million) for Qutenza commercialization
rights and EUR 5 million (approximately $7 million) for a
co-development and commercialization option of NGX-1998.
NeurogesX is eligible for additional sales-based milestone
payments and additional option payments related to the liquid
formulation totaling approximately EUR 70 million ($97 million) and
royalties based on a double-digit percentage of net sales for
Astellas has committed investment for additional studies to
support the marketing and promotion of Qutenza and to fulfill
post-marketing commitments outlined in the European Commission's
approval. These post-marketing commitments include a long-term safety
study of Qutenza in on-label indications.
The option payment to license NGX-1998 includes an initial
upfront payment as mentioned previously as well as further option
payments as development progresses. These payments are intended, in
part, to accelerate NGX-1998 into Phase 2 clinical evaluation. In the
event that Astellas exercises its option for NGX-1998, the companies
expect to collaborate in Phase 3 development.
All payments to NeurogesX are expressed in euros and the dollar
equivalents expressed in this press release are stated at current
exchange rates. Actual conversion rates will vary depending on
exchange rates in effect at the time payments are due.
Conference Call Details
NeurogesX will hold a teleconference today at 9:00 a.m. ET (6:00
a.m. PT) to discuss the distribution and licensing agreement with
Astellas Pharma Europe Ltd.
To participate, please dial 1-877-407-0789 (USA) or
1-201-689-8562 (International). To access the live web cast please
visit the Investor Relations section on the corporate web site at
A replay of the conference call will be available beginning June
22, 2009 at 12:00 p.m. ET (9:00 a.m. PT) and ending on July 2, 2009
by dialing 1-877-660-6853 (USA) or 1-201-612-7415 (International),
Account Number: 3055, Conference ID Number: 326456. A replay of the
webcast will also be available on the corporate website for one
month, through July 22, 2009.
About NeurogesX, Inc.
NeurogesX (NASDAQ: NGSX) is a biopharmaceutical company focused
on developing and commercializing novel pain management therapies.
Its initial focus is on chronic peripheral neuropathic pain,
including postherpetic neuralgia (PHN), painful HIV-distal sensory
polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN).
NeurogesX' late stage product portfolio is led by its product
candidate Qutenza, a dermal patch designed to manage pain associated
with peripheral neuropathic pain conditions. Qutenza is currently
approved in the European Union for the treatment of neuropathic pain
in non-diabetic adults, either alone or in combination with other
medicinal products for pain. NeurogesX submitted a new drug
application (NDA) for Qutenza to the U.S. Food and Drug
Administration (FDA) which was accepted for filing by the FDA in
December 2008 and was given a Prescription Drug User Fee Act (PDUFA)
date of August 16, 2009.
NeurogesX' second most advanced product candidate, NGX-1998, is a
topically applied, liquid formulation containing a high concentration
of capsaicin designed to treat pain associated with neuropathic pain
conditions. NGX-1998 has completed three Phase 1 studies and
NeurogesX is currently evaluating the timing of entering Phase 2
NeurogesX' early stage product pipeline includes pre-clinical
compounds, which are prodrugs of acetaminophen and various opioids.
The company has evaluated these compounds in vitro and in vivo and is
currently seeking development partners for these programs.
About Astellas Pharma Europe Ltd.
Astellas Pharma Europe Ltd., located in the UK, is a European
subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a
pharmaceutical company dedicated to improving the health of people
around the world through the provision of innovative and reliable
pharmaceutical products. The organization is committed to becoming a
global company by combining outstanding R&D and marketing
capabilities and continuing to grow in the world pharmaceutical
market. Astellas Pharma Europe Ltd., is responsible for 20 affiliate
offices located across Europe, the Middle East and Africa, an R&D
site and three manufacturing plants with approximately 3,400 staff.
For more information about Astellas Pharma Europe Ltd., please visit
our website at http://www.astellas-europe.co.uk/.
Safe Harbor Statement
This press release contains forward-looking statements for
purposes of the Private Securities Litigation Reform Act of 1995 (the
"Act"). NeurogesX disclaims any intent or obligation to update these
forward-looking statements, and claims the protection of the Safe
Harbor for forward-looking statements contained in the Act. Examples
of such statements include, but are not limited to, expectations with
respect to the successful commercial launch and market potential of
Qutenza; expectations with respect to the activities of NeurogesX and
Astellas under the Distribution, Marketing and License Agreement (the
Agreement); the potential receipt of post-execution payments under
the Agreement; potential uses of proceeds from the Agreement;
expectations regarding additional studies, including a safety study
to be carried out by Astellas under the Agreement; the timing of
regulatory decisions with respect to the NDA for Qutenza with the
FDA, including the PDUFA date for the NDA; plans for entry into a
U.S. commercialization partnership for NeurogesX pre-clinical
compounds; and plans for clinical development of NGX-1998.
Such statements are based on management's current expectations,
but actual results may differ materially due to various risks and
uncertainties, including, but not limited to; NeurogesX' product
candidates may have unexpected adverse side effects or inadequate
therapeutic efficacy; Astellas may not devote sufficient resources or
personnel to the commercialization of Qutenza; adoption of Qutenza by
physicians may be longer than anticipated; discussions with
governmental or administrative entities may not result in adequate
reimbursement or pricing to support commercialization efforts for
Qutenza; Astellas may not elect to make option related payments or
co-develop NGX-1998; positive results in Qutenza clinical trials may
not be sufficient to obtain FDA approval; the FDA may request
additional clinical trials or other information prior to granting
approval for Qutenza; and other difficulties or delays in the
successful commercialization of Qutenza, carrying out activities or
obtaining payments under the Agreement and in clinical development
of, and obtaining regulatory approval for, NeurogesX' product
candidates. For further information regarding these and other risks
related to NeurogesX' business, investors should consult NeurogesX'
filings with the Securities and Exchange Commission.
ots Originaltext: Astellas Pharma Europe Limited
Im Internet recherchierbar: http://www.presseportal.ch
NeurogesX, Inc., Stephen Ghiglieri, Chief Financial Officer,
+1-(650)-358-3310, Astellas Pharma Europe. Mindy Dooa, Corporate
Communications Director, +44-(0)7826-912-339,
firstname.lastname@example.org. The Ruth Group, Sara Pellegrino
(investors), +1-(646)-536-7002, email@example.com. Jason
Rando (media)/Janine McCargo, +1-(646)-536-7025/7033,