Transaction Value In Excess of $25 Million; Access Gains Second Source
Manufacturing And Significant Clinical Trial Support
DALLAS and NANJING, PRC, June 4 /PRNewswire-FirstCall/ -- Access
Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP) and Jiangsu Aosaikang
Pharmaceutical Co., LTD. ("ASK"), a premier pharmaceutical company focused
on bringing oncology medicines to the China market, today announced the
signing of a definitive licensing agreement under which ASK will
manufacture, develop and commercialize Access' proprietary product
ProLindac(TM) for the Greater China Region which includes the People's
Republic of China, the Hong Kong Special Administrative Region, the Macau
Special Administrative Region and Taiwan. ProLindac is Access' novel DACH
platinum prodrug currently in Phase 2 clinical studies which has been shown
to be active in a wide variety of solid tumors in both preclinical models
and in human trials.
Under the terms of the agreement ASK will pay Access an upfront fee and
subsequent milestone payments along with a double digit royalty upon
commercialization of ProLindac. In addition, in co-operation with Access,
ASK has committed to fund and execute two (2) Phase 2 studies for ProLindac
in colorectal cancer and one other indication to be determined by the
Parties. These major Phase 2 studies would cost up to $20 million if
conducted in the US or Europe. ASK has also committed to become a second
source for the manufacturing of ProLindac. ASK will be responsible for
obtaining the necessary regulatory approvals for ProLindac and
commercializing the product in the Greater China Region.
"We are very pleased to have ASK, a leading supplier of platinum based
agents in China, as our first partner for ProLindac," said Jeffrey B.
Davis, Access' President & CEO. "ASK is the second largest supplier of
platinum based oncology agents in China and has a long history of
successfully manufacturing and commercializing agents similar to ProLindac.
They will be a valuable second source for the manufacturing of ProLindac
and their commitment to fund two Phase 2 studies will save us up to $20
million in clinical trial funding we would otherwise have to raise from the
equity markets. With the recently announced positive results from the
ongoing clinical study plus this commitment from ASK, we believe we are
well positioned to quickly advance the development of ProLindac."
"ProLindac is a synergistic product to our current product portfolio,
and represents a significant innovation in the area of platinum-based
cytotoxic agents," added Qingcai Chen, PhD, President and Chairman of ASK.
"We are excited about the potential for ProLindac in China, and we are
committed to bringing exciting, innovative new oncology products like
ProLindac to the rapidly emerging China market. We look forward to a long
and productive relationship with Access over the long term."
About ProLindac(TM):
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. Access believes that ProLindac's unique molecular design
potentially could eliminate some of the toxic side effects seen in the
currently marketed DACH platinum, Eloxatin, which has sales in excess of $2
billion. Access recently presented data from the ongoing Phase 2
monotherapy clinical study of ProLindac in patients with recurrent ovarian
cancer. In two dosing regimens, ProLindac was given once every two weeks
and once every three weeks. During the last and highest dose levels
explored, sustained and significant reductions in the specific serum market
Ca-125 were seen over multiple dosings in several patients. ProLindac was
well-tolerated with minimal side-effects.
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(TM),
currently in Phase 2 clinical testing of patients with ovarian cancer, and
MuGard(TM) for the management of patients with mucositis. The company also
has other advanced drug delivery technologies including
Cobalamin(TM)-mediated targeted delivery and oral drug delivery, its
proprietary nanopolymer delivery technology based on the natural vitamin
B12 uptake mechanism; Angiolix(R), a humanized monoclonal antibody which
acts as an anti-angiogenesis factor and is targeted to breast cancer;
Prodrax(R), a non-toxic prodrug which is activated in the hypoxic zones of
solid tumors to kill cancer cells; Alchemix, a chemotherapeutic agent that
combines multiple modes of action to overcome drug resistance. For
additional information on Access Pharmaceuticals, please visit our website
at http://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: our ability to close the financing transaction, early
results from our clinical trial, Access' plans to continue and initiate
clinical trials, the value of its products in the market, its ability to
achieve clinical and commercial success and its ability to successfully
develop marketed products. These statements are subject to numerous risks,
including but not limited Access' need to obtain additional financing in
order to continue the clinical trial and operations and to the risks
detailed in Access' Annual Reports on Form 10-K and other reports filed by
Access with the Securities and Exchange Commission.
[Via Healthcare]
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