Filed
by
Access Pharmaceuticals, Inc.
pursuant
to Rule 425 under the Securities Act of 1933
Filer
and
Subject Company: Access Pharmaceuticals, Inc.
Commission
File No. 001-15771
This
information is not an offer to sell securities and is not soliciting
an
offer
to buy securities. If Access Pharmaceuticals, Inc. and Somanta
Pharmaceuticals,
Inc. enter into a definitive acquisition agreement,
investors
are urged to read the documents relating to the proposed
transaction
that may be filed from time to time by either party with
the
Securities and Exchange Commission. These documents will contain
important
information regarding the proposed transaction and may be
obtained
after they are filed free of charge at the Securities and
Exchange
Commission's website at www.sec.gov.
ACCESS
NEWS
Contact:
Company Contact:
Investor Relations
Stephen
B. Thompson Adam
Lowensteiner/Alisa Steinberg (media)
Vice
President, Chief Financial Officer Wolfe
Axelrod Weinberger LLC
(214)
905-5100(212)
370-4500
Andrew
Hellman, CEOcast, Inc.
for Access Pharmceuticals
(212)
732-4300
ACCESS
PHARMACEUTICALS SIGNS LETTER OF INTENT
TO
ACQUIRE SOMANTA PHARMACEUTICALS
Acquisition
of Four Potent Anti-Cancer Compounds, Including Phase 2 Drug Candidate and
Experienced Clinical Development Team Positions Access as a Leading Developer
of
Oncology Therapeutics
Dallas,
TX/Irvine,
CA, February 21, 2007, ACCESS PHARMACEUTICALS, INC. (OTCBB:
ACCP)
and
Somanta Pharmaceuticals, Inc. (OTCBB:
SMPM)
announced today that they have signed a letter of intent for Access to acquire
Somanta. Somanta is an Irvine, California based biotechnology company with
four
novel anti-cancer compounds in development, one of which is currently in Phase
2
clinical trials. Each of Somanta’s drug candidates acts by a unique mechanism of
action, and has the potential to target a wide range of different cancer types.
In addition to its significant product pipeline, Somanta brings an experienced
team of clinical development and regulatory professionals who have an
established track record of guiding compounds through the FDA and EMEA approval
processes. Upon consummation of the acquisition, Somanta’s preferred and common
shareholders will receive an aggregate of 1.5 million shares of Access common
shares which would represent approximately 13% of the combined company assuming
the conversion of Access’s existing convertible debt under existing terms of
conversion. The letter of intent is non-binding. The acquisition is expected
to
close in the second quarter.
Access Pharmaceuticals, Inc.
Page 2
“The
proposed acquisition of Somanta is very exciting for Access from a number of
perspectives,” stated Stephen R. Seiler, Access’ President and CEO. “Somanta
comes with four very interesting anti-cancer
compounds, one of which is already in Phase 2 clinical trials. Each compound
acts by a novel mode of action, and one represents a novel platform technology.
As a result, the combined Access and Somanta will have a broad cancer-focused
portfolio which will include one approved product, two drug candidates in Phase
2 trials and three novel and exciting pre-clinical products. Our goal has always
been to make Access a leader in the oncology space and this acquisition fills
out our product pipeline extremely well.”
“In
addition, the Somanta clinical development team fits well with our current
management group,” continued Mr. Seiler. “I look forward to leveraging their
expertise to assist in accelerating and broadening the clinical program for
Access’ ProLindac which is in Phase 2 trials in the EU and in the U.S. as well
as on our oral insulin program.”
“The
proposed combination of Somanta with Access is highly synergistic,” added
Agamemnon Epenetos, M.D., Ph.D., Somanta’s CEO. “Each company is at a position
where the combination makes strategic sense, and the product pipelines and
management teams come together very well, with little overlap. I believe the
combined product and technology pipeline is extremely exciting, and I look
forward to working closely with the Access team to advance both companies’
products through the development and regulatory process.”
About
Somanta
Somanta
Pharmaceuticals is a company focused on the development of novel oncology
compounds and anti-cancer agents. Somanta's lead clinical product Sodium
Phenylbutyrate (PB) is currently in Phase 2 development. In National Institute
of Health sponsored trials, PB has demonstrated the greatest activity in CNS
cancers, several of which are "orphan" indications such as Glioblastoma
Multiforme. Moreover, promising data has also emerged which suggests PB may
be
an effective therapy for certain blood cancers and other solid tumors. PB has
been well tolerated; its safety profile has generally been established due
to
its many years of clinical use in pediatrics for inherited urea cycle
disorders.
Access
Pharmaceuticals, Inc.
Page
3
Somanta's
other drug candidates include Alchemix, Prodrax and Angiolix. Alchemix is
pan-target
inhibitor that is effective in tumor cells resistant to conventional
chemotherapy by targeting and irreversibly binding to DNA. Prodrax, a technology
platform, is a novel family of prodrugs that enables compounds to remain inert
until they reach the hypoxic region of tumors where they become toxic, thus
targeting tumor cells which are typically difficult to kill. Somanta believes
Alchemix and Prodrax have the ability to overcome many different pathways of
drug resistance, and will be studied in a broad range of cancers including
lung,
colon, ovarian and renal. Proof-of-principle pre-clincal studies have been
completed in both of these compounds, and Phase 1 dose escalation trials are
being planned. Additionally, Somanta is developing a humanized monoclonal
antibody, Angiolix, which appears to induce cell death selectively to tumor
blood vessels using a different mode of action than VEGF-oriented therapies.
Somanta has prepared clinical development plans for all preclinical projects.
For additional information on Somanta Pharmaceuticals, please visit www.somanta.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 our website at www.accesspharma.com.
About
ProLindac™
Access’
lead compound, ProLindac™, is a novel DACH platinum prodrug which has been shown
to be active in a wide variety of solid tumors in both preclinical models and
in
human trials. The Company believes that ProLindac's unique molecular design
potentially could eliminate some of the toxic neurological side effects seen
in
currently marketed DACH platinums. The Company is currently enrolling patients
in two Phase II clinical trials, one in ovarian cancer and one in head and
neck
cancer, and plans to initiate one or more additional Phase II trials, including
one in colorectal cancer in 2007.
About
MuGard™
Access
has received 510(k) clearance from the FDA to market MuGard™ in the United
States. MuGardTM
is
Access’ proprietary oral rinse product for the management of oral mucositis, the
debilitating side-effect which afflicts more than 40% of cancer
patients
Access
Pharmaceuticals, Inc.
Page
4
undergoing
radiation and chemotherapy. There is currently no well-accepted treatment for
mucositis. Access is actively seeking marketing partners in Europe and the
US.
About
Cobalamin™
The
Company is actively pursuing development of its novel Cobalamin™ drug delivery
technology, particularly as it pertains to the oral delivery of large molecule
drugs that are only currently deliverable by injection or subcutaneous
administration. Pre-clinical animal studies utilizing Access' Cobalamin™
technology have demonstrated the ability to deliver insulin by oral
administration in therapeutic levels.
The
conclusion of the acquisition of Somanta by Access as anticipated in the Letter
of Intent is subject to a number of conditions, including, without limitation
negotiation of a definitive acquisition agreement which will contain standard
and customary provisions, completion of due diligence to the full satisfaction
of each party, approval by the respective Boards of Directors and by Somanta
shareholders, completion of all government filings and receipt of all necessary
government approvals and all required third party consents.
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, including statements relating to the number
of,
and percentage of the combined company represented by, the shares to be received
by Somanta's shareholders, the product portfolio and pipeline and clinical
program of the combined company, the effectiveness of PB as a therapy and
Somanta's belief that Alchemix and Prodrax have the ability to overcome many
different pathways of drug resistance. These statements are subject to numerous
risks, including but not limited to the risks detailed in Access's Annual Report
on Form 10-K for the year ended December 31, 2005, Somanta's Annual Report
on
Form 10-KSB for the year ended April 30, 2006 and other reports filed by the
companies with the Securities and Exchange Commission.
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