ACCESS LOGO SPEPHARM
LOGO
ACCESS
- SPEPHARM NEWS
Access
and SpePharm Announce Licensing of MuGard™ for Europe
-
SpePharm Will Market MuGard in Europe for the Treatment of Oral Mucositis
-
Dallas,
Texas,
USA / Amsterdam,
The Netherlands, August 27,
2007. Access Pharmaceuticals, Inc. (OTC BB: ACCP) and
SpePharm Holding,
B.V. today announced the signing of a definitive licensing agreement
under which SpePharm will market Access’s product MuGard™ in
Europe.
MuGard™
is Access’ proprietary product for the management of oral mucositis, a
debilitating side effect of many anticancer treatments. MuGard has received
marketing allowance in the United States from the Food and Drug Administration
under a 510(k) procedure.
SpePharm
will be responsible for marketing MuGard throughout the European Union plus
Switzerland and Norway, as well as for manufacturing and for obtaining the
necessary regulatory approvals for the product in the territory.
“We
are
very excited about the opportunity to commercialize MuGard in Europe,” said
Jean-François Labbé, CEO of SpePharm. “We believe MuGard has the potential to
address an area of significant unmet medical need in supportive care of cancer
patients. Moreover, MuGard is an excellent complement to our existing product,
Loramyc, and strengthens our strategic focus in this important therapeutic
area.
We anticipate launching MuGard during 2008 and expect to have a dedicated sales
force of 50-60 representatives across Europe promoting both MuGard and
Loramyc.”
“SpePharm
is an ideal partner for us in Europe,” added Stephen R. Seiler, President and
CEO of Access. “We are excited about the focus SpePharm will bring to MuGard and
the tremendous fit with Loramyc. Jean-François and his team bring a wealth of
experience and professionalism which we believe will benefit the development
and
marketing of MuGard.”
In
connection with the exclusive Licensing Agreement, SpePharm will pay Access
an
upfront fee and substantial double-digit royalties on net sales.
About
MuGard™:
MuGard
is
a ready-to-use mucoadhesive oral wound rinse. The mucoadhesive formulation
forms
a protective coating over the oral mucosa when washed around the mouth. In
a
retrospective comparison of cancer patients receiving standard mucositis care
with those patients receiving
Access
Pharmaceuticals, Inc. – SpePharm Holding,
B.V.
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2
MuGard,
the incidence and severity of mucositis was significantly lower in the MuGard
treated group.
Up
to 40%
of all patients receiving chemotherapy and/or radiation therapy develop moderate
to severe mucositis, and almost all patients receiving radiotherapy for head
and
neck cancer and those undergoing stem cell transplantation develop mucositis.
Updated clinical practice guidelines for the prevention and treatment of
mucositis recommend the use of a preventive oral care regimen as part of routine
supportive care along with a therapeutic oral care regimen if mucositis
develops. The market for the treatment of oral mucositis is estimated to be
in
excess of $1 billion world-wide.
About
SpePharm Holding, BV:
SpePharm
Holding, B.V. is a Dutch company with its registered office in Amsterdam, and
an
operational base in Paris, France. SpePharm is an emerging pan-European
specialty pharmaceutical company focused on acquiring, registering and marketing
high medical value specialty medicines essentially for the hospital and
specialty markets. Particularly areas of therapeutic interest are in oncology,
haematology, critical & supportive care and endocrinology. SpePharm aims to
be the preferred partner for pharmaceutical and biotechnology companies,
especially those from outside of Europe, seeking to maximize product and
commercial opportunities within Europe.
SpePharm
was founded in September 2006 by Jean-François Labbé together with leading life
science investment firms TVM Capital and Signet Healthcare Partners (part of
the
Sanders Morris Harris Group). Jean-François Labbé is a former top executive at
Hoechst Marion Roussel and Parke Davis with over 30 years of experience in
international pharmaceutical management. SpePharm, through its founding
management team, has a proven track record of successful development,
registration, and/or commercialization of quality therapeutic products in
supportive care, oncology & hematology, and orphan diseases. For more
information about SpePharm, please visit the web site at
www.spepharm.com
About
Access:
Access
Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops
and
commercializes propriety products for the treatment and supportive care of
cancer patients. Access' products include ProLindac™, currently in
Phase II clinical testing of patients with ovarian cancer and MuGard™ for the
management of patients with mucositis. The company also has other advanced
drug
delivery technologies including Cobalamin™-mediated targeted delivery and oral
drug delivery. For additional information on Access Pharmaceuticals, please
visit their website at www.accesspharma.com
This
press release contains certain statements that are forward-looking within the
meaning of Section 27a of the Securities Act of 1933, as amended, and that
involve risks and uncertainties. These statements include those relating to:
Access’ plans to initiate clinical trials, the value of our products in the
market (including MuGard and the size of the overall market for mucositis
products), our ability to achieve clinical and commercial success, our ability
to successfully develop marketed products and the ability to obtain or meet
the
closing conditions in the merger agreement with Somanta Pharmaceuticals, Inc.
and applicable regulatory and tax requirements, and to otherwise complete the
merger in a timely manner. These statements are subject to numerous risks,
including but not limited Access’ need to obtain additional financing and to the
risks detailed in Access’ and Annual Report on Form 10-KSB and other reports
filed by Access with the Securities and Exchange Commission. For more
information on Access and this transaction please see Access’s Securities and
Exchange Commission filings at http://www.sec.gov/Archives/edgar/data/318306/000031830607000050/r8k-230.htm.
Access
Pharmaceuticals, Inc. – SpePharm Holding,
B.V.
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3
Media
contacts:
SpePharm
Holding, BV
Jean-François
LABBE
Managing
Director
Tel:
+33 (0) 1 56 60 52 46
jean-francois.labbe@spepharm.com
|
Northbank
Communications
Douglas
Pretsell, Account Director, Munich Bureau Chief
Tel:
+49 (0)89 57 00 18 06
d.pretsell@northbankcommunications.com
|
Access
Pharmaceuticals, Inc.
Stephen
B. Thompson
Vice
President, Chief Financial Officer
(214)
905-5100
stephen.thompson@accesspharma.com
|
Wolfe
Axelrod Weinberger LLC
Donald
C. Weinberger/Alisa Steinberg (media)
(212)
370-4500
don@wolfeaxelrod.com
CEOcast,
Inc.
Andrew
Hellman
(212)
732-4300
ahellman@ceocast.com
|
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