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    ACCP Generates 21% Gains in a Week, Spurred by Progress of CobaCyte Platform and Commercial Launch of MuGard

    Access Pharmaceuticals Inc. (OTC BB: ACCP) closed October 5 session at $2.37, up 21.5% since the September 30 price of $1.95.  The company’s price was driven by several developments concerning the SiRNA program, particularly related to the rebranding of the targeted-drug delivery technology as CobaCyte and submitting of additional patent applications for its improved formulations. In addition, two weeks ago Access Pharmaceuticals signed a $30 million supply agreement for its approved product MuGard with RHEI Pharmaceuticals to distribute the product across China.

    Access Pharmaceuticals is a biopharmaceutical company touting one FDA-approved product, two products at phase II of clinical development, and several products in pre-clinical development. MuGard is the company’s approved product for the management of oral mucositis, a frequent side-effect of cancer therapy for which there is no established treatment. The global market for mucositis treatment is estimated to be in excess of $1 billion. To date, MuGard has been launched in several European countries as well as in the U.S., and is scheduled for launch in China and Korea by the end of 2010.

    Last month, the company reported the first order for MuGard from its specialty distribution partner Bioscript (NASDAQ: BIOS). BioScrip’s initial purchase order, totaling more than $700,000, aims to provide adequate inventory for its various distribution channels to support the company’s first phase of the launch in the U.S. Access Pharmaceuticals has been given comprehensive access to BioScrip’s nationwide distribution platform, which includes extensive physician relationships, more than 100 specialty pharmacies, a mail distribution network and more.

    The company has also signed a $30 million supply agreement for MuGard with RHEI Pharmaceuticals Inc., which is focused on bringing proprietary medicines to the China market.  Simultaneously with the signing of the above agreement, Access Pharmaceuticals has also approved a sub-license agreement between RHEI Pharmaceuticals and Jian An Pharmaceuticals Limited in Shenzhen, China, in an effort to leverage Jian An’s extensive sales, marketing and regulatory infrastructure for the launch of MuGard in China and Taiwan.

    Access Pharmaceuticals has two other drug candidates in its portfolio currently in phase II studies, known as ProLindac and Thiarabine, both targeting the multi-billion dollar cancer market. The company has recently completed a phase II clinical trial on ProLindac in the European Union, in patients with recurrent ovarian cancer. The clinical study had positive safety and efficacy results. Access Pharmaceuticals is currently looking at combining ProLindac with other cancer agents in solid tumor indications including colorectal and ovarian cancer. The DACH-platinum incorporated in ProLindac is the same active moiety as that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in excess of $2.0 billion.

    Thiarabine, or 4-thio Ara-C, is the company’s next generation nucleoside analog licensed from Southern Research Institute. Previously named SR9025 and OSI-7836, the compound has been in two phase I/II solid tumor human clinical trials and was shown to have anti-tumor activity. Access Pharmaceuticals is currently working with leukemia and lymphoma specialists at MD Anderson Cancer Center in Houston and intend to initiate additional phase II clinical trials in adult AML, ALL and other indications.

    In addition, Access Pharmaceuticals recently reported that it has made significant progress with its proprietary Cobalamin-targeted drug-delivery program for siRNA therapies.  As a result of the continued advancements, the company rebranded the targeted-drug delivery technology as CobaCyte™; and submitted additional patent applications for its improved CobaCyte formulations, including siRNA compositions.  SiRNA therapy is used to turn off or silence specific genes at choice, which could potentially benefit a host of diseases that are activated by errant genes, such as cancer.

    The recent news surrounding MuGard, including the agreement to launch it in China and the initial product purchase order received in the U.S., reveals significant revenue potential for the company. In addition, the upcoming positive news concerning the progress of CobaCyte™ delivery technology or ProLindac trials in the EU could significantly boost Access Pharmaceuticals’ valuation.

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