Access Pharmaceuticals, Inc. Newsroom » Strategic partnerships

ACCESS PHARMACEUTICALS RETAINS EDELMAN AS PUBLIC RELATIONS FIRM

admin — Fri, 05 Aug 2011 19:38:23 +0000

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Public Relations Firm Focused on Increasing Media Awareness of Company’s

Oral Mucositis Treatment

Dallas, TX and New York, NY, August 05, 2011

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, has hired Edelman, the leading full service global public relations firm, to support its media outreach initiatives. Edelman will assist Access in implementing a media communications outreach program primarily aimed at introducing MuGard and building awareness of its ability to treat oral mucositis, a potentially debilitating disease which can cause painful inflammation and lesions of the mucous membranes lining the mouth and GI tract.

“Edelman has a great track record in conveying the value of company pipelines to a broad range of media outlets,” said Jeffrey Davis, Chief Executive Officer, Access Pharmaceuticals, Inc. He continued, “We believe we are at the right time in the Access story and the commercialization of MuGard to expand our reach in within trade and consumer publications. As we continue to execute on our strategy of growing the MuGard brand, capitalizing on Edelman’s strategic skills, creativity and global reach to communicate the benefit and control it provides cancer patients will be key in achieving our MuGard education and communications objectives.”

Bruce Hayes, general manager of Health for Edelman in the company’s New York office stated, “We are pleased that Access has made the decision to join our portfolio of health clients. An emerging player in the cancer supportive care industry, Access is helping patients who suffer from oral mucositis. We are confident that our public engagement strategies will assist in building the MuGard brand and raising Access’ visibility among its key audiences.”

About Edelman

Edelman is the world’s largest independent public relations firm, with wholly-owned offices in 53 cities and 3,700 employees worldwide. Edelman was named Advertising Age’s top-ranked PR firm of the decade and one of its “2010 A-List Agencies” and “2010 Best Places to Work;” PRWeek’s “2011 Large PR Agency of the Year” and “2009 Agency of the Year;” European Excellence Awards’ “2010 Agency of the Year;” Holmes Report’s “Agency of the Decade” and “2009 Asia Pacific Consultancy of the Year;” and among Glassdoor’s top five “2011 Best Places to Work.” Visit http://www.edelman.com for more information.

About Access Pharmaceuticals, Inc.

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation DACH Platinum in Phase 2 clinical testing of patients with ovarian cancer, and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers; currently in a Phase 1/2a trial in hematological malignancies at M.D. Anderson Cancer Center in Houston, Texas.

The company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our 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: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to 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.

ACCESS PHARMACEUTICALS RECEIVES LETTER OF ACCEPTANCE FOR MUGARD FILING FROM SFDA OF CHINA

admin — Mon, 27 Jun 2011 13:52:59 +0000

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Dallas, TX and New York, NY, June 17, 2011

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, diabetes, and RNAi, announced that its MuGard partner in China, RHEI Pharmaceuticals has received the acceptance letter from the State Food and Drug Administration (SFDA) of China acknowledging all necessary documentation for the MuGard has been submitted and accepted. Together with its marketing partner Jian An, RHEI Pharmaceuticals completed the required process required to satisfy all requirements to receive marketing approval in China and its other South East Asian territories. RHEI has advised Access of the next steps the SFDA will take to grant approval in its territories and anticipates receiving marketing approval in the second half of this year.

As part of its licensing agreement with Access, RHEI is responsible for obtaining the necessary regulatory approvals for MuGard. Access and RHEI recently signed a $30 million supply agreement for MuGard to ensure manufacturing capacity of up to a minimum of $30 million of product in the licensed territories. In addition, Access also approved a sub-license agreement between RHEI Pharmaceuticals and Jian An Pharmaceuticals (“Jian An”) Limited in Shenzhen, China to leverage Jian An’s extensive sales, marketing and regulatory infrastructure for the launch of MuGard in China and Taiwan. Jian An is headquartered in Shenzhen, China and has a 25-year history of selling pharmaceutical and other medical products in the China market. Jian An has 1400 sales representatives covering all majors centers in China through 169 sales offices.

With Jian An’s sales and marketing infrastructure, the supply agreement and the letter of acceptance, Access Pharmaceuticals’ commercialization efforts remain on track in China. Access retains its existing milestone and royalty structure for the territory.

“The acceptance of MuGard submission is a critical step in receiving marketing approval for MuGard in China and South East Asian territories,” said Phillip Wise, Vice President of Business Development and Strategy, Access Pharmaceuticals, Inc. He continued, “We knew that the SFDA would perform a significant amount of due diligence before it would accept our MuGard submission. Receiving the acceptance letter helps us, as a company, gauge more accurately the timeline to marketing approval. We are pleased with RHEI and Jian An’s ability to streamline the process thus far and their continued progress and commitment to advancing the marketing approval.”

About MuGard:
MuGard is a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and radiotherapy 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. For more information, please visit www.MuGard.com.

About RHEI Pharmaceuticals:
RHEI Pharmaceuticals is a specialty pharmaceutical company with operations in the U.S. and in China that acquires licenses, develops and commercializes in China proprietary drug therapies based upon the unmet needs of the emerging China pharmaceuticals market. RHEI leverages its proprietary and extensive network of experienced clinical development and regulatory professionals in China to expedite approvals for pharmaceuticals new to the China market. RHEI’s growing sales and marketing capabilities then provide broad patient access in China to these new and critically necessary therapeutics. RHEI specializes in hospital-based proprietary products with a therapeutic focus on urgent unmet needs in the areas of cancer, cardiovascular disease, diabetes, neurology, and other life threatening conditions.

About Access:
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation DACH Platinum in Phase 2 clinical testing of patients with ovarian cancer, and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers; currently in a Phase 1/2a trial in hematological malignancies at M.D. Anderson Cancer Center in Houston, Texas.

Access Pharmaceuticals Signs Agreement With Major Global Pharmaceutical Company for its CobOral™ Oral Insulin Formulation

admin — Wed, 08 Dec 2010 13:00:59 +0000

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Significant Step Validates Company’s Unique Value-Driven Strategy For Exploiting Multi-applicable Oral Drug Delivery Technology Platform

Dallas, TX and New York, NY, December 08, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has entered into an agreement with a major global pharmaceutical company to test Access’ oral insulin formulation based upon its proprietary vitamin B-12-based CobOral™ Drug Delivery Technology. Access will provide CobOral insulin to the pharmaceutical company. Access anticipates completion and delivery of its CobOral insulin formulation to the pharmaceutical company by the end of the month.

“We continue executing on our broad strategy for unlocking the value of the CobOral and CobaCyte platform technologies through formulation agreements with high-quality partners,” said Jeffrey Davis, President and CEO, Access Pharmaceuticals, Inc. He continued, “We are confident in our technology’s ability to improve the existing standard of administering insulin. The CobOral technology has significant potential in creating oral versions of currently marketed injectables, while providing our partners a valuable patent life-cycle management tool that can secure the IP extension on existing products. Additionally, we believe that successful testing of the oral insulin product can lead to development programs on additional injectable drugs.”

Access recently announced an agreement with a biopharmaceutical company to develop an oral formulation of its widely-marketed injectable for prostate cancer. In addition, Access has filed supplementary patents covering the application of both platforms, CobOral (oral delivery) and CobaCyte (disease targeting), with most of the top 100 currently-marketed, injectable drugs. Access continues seeking additional collaborations for oral versions of the various injectable drugs.

Access’ CobOral product development program initially focused on the oral delivery of insulin and human growth hormone (hGH), two peptides which currently can only be given by injection. Since presenting promising results at a major conference in mid-2008, Access has made substantial improvements to the formulation technology. An improved CobOral insulin-containing nanoparticle formulation delivered orally provided a pharmacological response (lowering of blood glucose levels in an animal model of diabetes) equivalent to greater than 80% of that achieved by insulin delivered subcutaneously. This represents a substantial oral bioavailability, indicating that this formulation has potential for clinical development and ultimate commercialization. Adaptation of this technology has provided a CobOral hGH formulation that has demonstrated good efficacy, represented by more than 25% improvement in weight gain, when given orally in an established animal model.

About Access:

Access Pharmaceuticals, Inc. Signs $30m MuGard Supply Agreement With RHEI Pharmaceuticals HK LTD.

admin — Tue, 21 Sep 2010 12:30:12 +0000

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Sub-license to JianAn Pharmaceuticals Provides Extensive Infrastructure to Support Sales and Marketing of MuGard in China

DALLAS, TX and NEW YORK, NY, September 21, 2010

Access Pharmaceuticals, Inc. (OTC BB: ACCP), a biopharmaceutical company specializing in products for cancer and supportive care signed a $30 million supply agreement for MuGard with RHEI Pharmaceuticals, Inc. (“RHEI”), a specialty pharmaceutical company focused on bringing proprietary medicines to the China market. Access will ensure manufacturing capacity of up to a minimum of $30 million of product in the licensed territories. Coinciding with the signing of the above agreement, Access also approved a sub-license agreement between RHEI Pharmaceuticals and Jian An Pharmaceuticals (“Jian An”) 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.

Jian An is headquartered in Shenzhen, China and has a 25-year history of selling pharmaceutical and other medical products in the China market. Jian An has 1400 sales representatives covering all majors centers in China through 169 sales offices. With Jian An’s sales and marketing infrastructure and the supply agreement which will provide up to $30 million of MuGard to the territory, Access Pharmaceuticals’ commercialization efforts remain on track in China and its other South East Asian territories. Access retains its existing milestone and royalty structure for the territory. In addition, Access and RHEI have also filed a new patent application in China covering MuGard for the relief and reduction of erythema. This new application is expected to provide additional IP protection as well as the potential for a new indication for MuGard.

“We are excited about the new relationship with Jian An in China, as it greatly expands our reach throughout the region with significant sales representative presence,” said Sven de Backer, CFO of RHEI Pharmaceuticals. He continued, “We believe Jian An’s local expertise will expedite the ongoing marketing approval process allowing us to begin providing patients with an effective treatment for oral mucositis. We are thankful to Access for ensuring adequate MuGard supply for the commercial launch.”

“We look forward to working with Access and RHEI and bringing MuGard to market in China,” said Zhan Zhangyi, CEO of Jian An Pharmaceuticals. He continued, “We believe MuGard is the right product to help us continue increasing our pharmaceutical market penetration in China. MuGard is an important addition to our growing product portfolio and we look forward to its commercial launch.”

“Oral mucositis is a growing problem in the greater China region and we are confident that RHEI’s marketing capabilities, with the addition of Jain An’s established product-promotion experience, will greatly enhance our effort to bring MuGard to the many patients that may otherwise suffer from the debilitating side effect of anticancer treatments,” said Jeffrey Davis, CEO of Access Pharmaceuticals, Inc. He continued, “The recent news surrounding MuGard, including this agreement and the initial product purchase order received in the US, underscores the significant revenue potential we believe MuGard will provide our company.”

About MuGard:

MuGard is a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and radiotherapy 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. For more information, please visit www.mugard.com.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary 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, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. For additional information on Access Pharmaceuticals, please visit www.accesspharma.com.

About RHEI Pharmaceuticals:

Rhei Pharmaceuticals Ltd. (RHEI) is a global pharmaceutical business development firm, with special focus on bringing core medicines from the U.S., Europe and Japan into the fast-growing South-East Asian marketplace. They are experts in business development, regulatory approval and clinical development and have a management team that combines a Western approach to pharmaceuticals with a long experience in Europe, North America and South-East Asia. They use their development capabilities and network of preferred commercial partners to help other pharmaceutical companies introduce their products into specific niche markets, such as the European institutional health care market and the Chinese hospital market. RHEI is headquartered in Hong Kong and has operations in Belgium, the US and China. www.rheipharma.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 cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our 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.

Access Pharmaceuticals Receives Initial Purchase Order for MuGard in North America

admin — Tue, 14 Sep 2010 12:30:21 +0000

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Company To Ship Over $700,000 Of MuGard To Distribution Partner for Initial Live-Pharmacy And Online Inventory Demand

DALLAS, TX and New York, NY September 14, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company specializing in products for cancer and supportive care, announced today it has received its first commercial order for MuGard from BioScrip (Nasdaq: BIOS), its specialty distribution partner. BioScrip’s initial purchase order of MuGard, totaling over $700,000, will provide adequate inventory for its various distribution channels to support the Company’s first phase of its product launch for MuGard. Access Pharmaceuticals has inventory on hand and will begin shipping product to BioScrip immediately. MuGard is an FDA-approved, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of radiation and/or chemotherapy.

“After months preparing for the official North American MuGard launch, this commercial order represents a significant milestone as it marks Access’ first sales of MuGard in the US,” said Jeffrey Davis, CEO of Access Pharmaceuticals, Inc. He continued, “With the help of our partners, especially BioScrip, we continue to broaden our reach within the medical community to further strengthen MuGard’s position as the optimal treatment option for oral mucositis currently on the market.”

“BioScrip and our MuGard-focused team have been great to work with, and we look forward to a close collaboration going forward,” stated Frank Jacobucci, VP Marketing & Sales at Access Pharmaceuticals, Inc. “Together with iMedicor/DMS, we have sampled almost all of the initial 500 MuGard sample kits and are preparing for additional sampling efforts. Initial feedback from the in-the-field reps, clinicians and patients has been very positive, and it is clear from discussions that a product for oral mucositis, such as MuGard, addresses a very significant unmet clinical need.”

As previously announced, Access signed two distribution and marketing agreements in the US, one with BioScrip and one with iMedicor/DMS. BioScrip, a leader in comprehensive pharmacy services, provides nationwide distribution for MuGard with its extensive physician relationships, 30+ top metro BioScrip specialty pharmacies, mail distribution capability and diversified payor network. Access and its partners continue working with large oncology networks and key clinical sites to educate oncologists and radiation oncologists on MuGard and the benefit it provides patients undergoing radiation and chemotherapy. The Company indicated the initial feedback from clinicians and patients has been very positive, and it will update investors on the progress and feedback throughout the remainder of the year.

About MuGard:

MuGard is a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy 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 Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary 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, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. For additional information on Access Pharmaceuticals, please visit our 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: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our 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.

Access Pharmaceuticals, Inc.’s Partner Launches Multi-Channel Product Marketing Program For MuGard

admin — Tue, 27 Jul 2010 12:30:41 +0000

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DALLAS, TX and NEW YORK, NY July 27, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company specializing in products for cancer and supportive care, today announced its e-marketing partner, iMedicor (OTCBB: VMCI) commenced the initial phase of a multi-channel marketing program for MuGard. iMedicor’s two-pronged marketing approach involves leveraging its direct sales channel through Direct Medical Solutions (DMS) and its online pharma marketing portal to further support Access’ ongoing commercial launch efforts for its lead product. The initial phase of the marketing program for MuGard includes a targeted sampling program to DMS’ physician network.

MuGard, a FDA-approved, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis and stomatitis, is now being introduced to Centers of Excellence, Key Opinion Leaders, cancer research centers and selected physicians in the United States. The full national launch of the marketing program is expected during the third quarter where Access will utilize iMedicor’s highly-targeted Physician Communication System (PCS) reaching over 200,000 select physicians, while further leveraging iMedicor’s strategic partnership with DMS and other strategic partners.

“Teaming up with iMedicor and DMS is an important strategic step in launching MuGard in North America as it provides us the ability to introduce MuGard more rapidly and cost-effectively than we would expect through traditional distribution channels to doctors,” said Jeffrey Davis, CEO of Access Pharmaceuticals, Inc. He continued, “Along with this initial and on-going sample program, Access will be able to utilize the medical education aspects of the iMedicor system to further inform doctors about oral mucositis and MuGard, and to accelerate commercial uptake in the U.S. market.”

“After many months of planning, we look forward to assisting Access Pharma with its introduction of MuGard on a national level,” said Fred Zolla, CEO of iMedicor. He continued, “MuGard represents a potential blockbuster product that could significantly improve the quality of life for patients undergoing certain cancer treatments. iMedicor’s ability to deliver essential information from a trusted source to specific physician audiences will significantly increase Access Pharma’s marketing ROI.”

“Our collective efforts have led to the positive acceptance of the first phase sampling program throughout the DMS network,” commented Marian Bartosiewicz, CEO of DMS. She continued, “We are pleased to be part of the introduction of a product like MuGard that can offer measurable relief to patients undergoing radiation and chemotherapy.”

The market for the treatment of oral mucositis, expanding to include all patients undergoing chemotherapy and radiotherapy, is estimated to be in excess of $5 billion worldwide. iMedicor and DMS will share in a portion of the revenue as sales are developed within North America. 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.

About iMedicor:

iMedicor is the only HIPAA-compliant solution for interoperable health information transfer that is offered to physicians, healthcare providers and patients at no cost. The iMedicor portal enables disparate EMR (electronic medical record) systems to communicate, collaborate and exchange records in real time; pharmaceutical companies to deliver customized educational marketing programs to more than 730,000 healthcare providers nationwide in a highly targeted, cost-effective and non-intrusive manner. More information on iMedicor is available at www.imedicor.com.

About Direct Medical Solutions

DMS provides a one-stop shopping network of “Best of Breed” ancillary, medical and operational strategies to compliment healthcare businesses. Along with recent expansion into wellness and preventive health as the need to adopt preventative strategies grows in future healthcare, the DMS network of products offers innovative ways to improve the bottom line of a healthcare practice. DMS‘ approach is that of an advisor, analyzing key practice attributes and workflow to customize a plan for services to compliment and integrate into core business operations. By implementing a “One Stop Shopping” business model and integrating technology designed to move healthcare in the direction of “Meaningful Use”, practices can meet the demands of the new regulations, increase revenue, while enhancing patient satisfaction.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary 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, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. For additional information on Access Pharmaceuticals, please visit our 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: clinical trial plans and timelines and clinical results for ProLindac and product candidates acquired in the MacroChem transaction, our ability to execute licensing agreements in the future, Access’ plans to continue and initiate clinical trials, the value of its products in the market (including MuGard and the size of the overall market for mucositis products), 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.

Access Pharmaceuticals Signs Exclusive Specialty Distribution Agreement With BioScrip

admin — Tue, 20 Jul 2010 12:30:24 +0000

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Agreement Provides Multi-level Distribution Of Lead Product, Including Inventory In Over 30 Top Metro Areas

DALLAS, TX and NEW YORK, NY July 20, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company specializing in products for cancer and supportive care, announced today it has signed an exclusive specialty distribution agreement with BioScrip (Nasdaq: BIOS) for its lead product, MuGard – an FDA-approved, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of radiotherapy and/or chemotherapy. The agreement aligns the Company with comprehensive access to BioScrip’s nationwide distribution platform and the ability to leverage the company’s extensive physician relationships, 110 BioScrip specialty pharmacies, mail distribution capability and diversified payor network.

BioScrip, Inc. (www.bioscrip.com) (Nasdaq: BIOS) is a national provider of specialty pharmacy and home care products and services that partners with patients, physicians, hospitals, healthcare payors and pharmaceutical manufacturers to provide clinical management solutions and delivery of cost-effective access to prescription medications. Its services are designed to improve clinical outcomes for chronic and acute healthcare conditions while controlling overall healthcare costs.

“As one of the largest, top-tier players in this space, BioScrip is well-established, reputable and focused on tailoring its programs to best fit and meet product manufacturers, provider and payers and patients’ pharmacy service needs,” said Frank Jacobucci, VP of Sales and Marketing for Access Pharmaceuticals, Inc. He continued, “In addition to the varied services that they will provide us, this partnership also results in multiple delivery options for patients in need of MuGard, including overnight delivery, home delivery and live retail pharmacy sites in the top metropolitan areas. We believe offering various methods of receiving MuGard can significantly increase patient compliance and ultimately provide an important additional weapon to help improve the treatment outcome.”

“BioScrip is proud to have been selected by Access to be its exclusive distribution and service partner for MuGard. Our vast clinical, sales and operational specialty pharmacy assets, combined with our deep oncology experience, put us in an unique position to provide services to the patient, manufacturer, provider and payor communities,” said Scott Friedman, Senior VP of Trade Relations and Business Development for BioScrip, Inc.

“Signing a strong specialty distribution partner is a critical milestone for a successful entrance into the US market,” said Jeffrey Davis, CEO of Access Pharmaceuticals, Inc. He continued, “With its significant resources, deep capabilities and strong commitment to cancer patients, BioScrip is an ideal partner to have in place as we continue executing on our global-commercialization strategy for MuGard.”

About MuGard:

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary 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, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. For additional information on Access Pharmaceuticals, please visit our 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: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our 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.

Access Pharmaceuticals Signs Agreement With Major Biotech Company To Develop Oral Formulations Of Leading Injectable Drug

admin — Thu, 15 Jul 2010 12:30:31 +0000

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DALLAS, TX and NEW YORK, NY July 15, 2010

Access Pharmaceuticals, Inc. (OTCBB: ACCP), announced today that it has entered into a pre-licensing feasibility agreement with a leading biotechnology company to develop an oral formulation of its currently-marketed, proprietary injectable drugs. Access will utilize its proprietary Cobalamin Oral Drug Delivery Technology to develop oral formulations of the drug for pre-clinical testing. Although the terms of the agreement have not been disclosed, Access indicated that any successful formulation developed will be subject to a subsequent full-licensing agreement.

Access recently reported that its novel Cobalamin-coated insulin containing nanoparticle formulations delivered orally provided a pharmacological response (lowering of blood glucose levels in animal models) equivalent to greater than 80% of that achieved by insulin delivered subcutaneously. The Company believes the substantial oral bioavailability found underscores the formulation’s potential for clinical development and ultimate commercialization.

“We are excited to begin this collaboration for the development of an oral formulation of one of the leading injectable drugs” said David Nowotnik, Senior Vice President for R&D for Access Pharmaceuticals, Inc. He continued, “We have seen significant oral bioavailability and promise in our previously-developed oral formulations of insulin and believe we can have similar success with many other marketed injectables. We believe this agreement further demonstrates the growing interest in our Cobalamin Oral Drug Delivery Technology.”

Access’ worldwide-exclusive patented Cobalamin™ technology utilizes the body’s natural vitamin B12 oral uptake to facilitate oral absorption of pharmaceuticals by a “Trojan horse” mechanism. This technology platform provides Access with the ability to develop a number of different formulations with improved benefits for various disease applications. In addition to insulin, Access has applied this technology to human growth hormone (HGH) and resulted in a formulation demonstrating efficacy that represents of over 25% improvement in weight gain, when given orally in an established animal model. Access continues to move its insulin and HGH products towards clinical development, while submitting additional patents surrounding both formulations.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ for the management of patients with mucositis, ProLindac™, currently in Phase II clinical testing of patients with ovarian cancer, and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.

The company also has other advanced drug delivery technologies including Cobalamin™-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our 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: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our 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.

Access Pharma Launches Clinical Development Program for Oral Insulin Product

admin — Tue, 30 Mar 2010 12:30:08 +0000

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Company Takes Critical Step to Fast-Track Oral Insulin Product Development And Strengthen
Validation Of Its Novel Technology Platform

Dallas, TX, March 30, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) signed a collaborative development agreement with bioRASI, LLC, a full-service global CRO specializing in the accelerated development of novel therapeutics, to facilitate clinical development for its Cobalamin™-based oral insulin and other Cobalamin-based products. A major focus of this program will be a first-in-man study for Access’ oral insulin product. The study is an important step in obtaining human confirmation of the significant oral bioavailability present in Access’ Cobalamin oral insulin formulations. The collaboration agreement comes on the heels of the Company’s recent announcement confirming significant oral bioavailability of the Cobalamin-based insulin, greater than 80% of that achieved through insulin injection, in two different animal species models. bioRASI will utilize its Translational Clinical Development Process which has demonstrated the ability to generate high quality human proof-of-principle data very quickly and cost-effectively, particularly in the Russian Federation.

Under the agreement, bioRASI will implement the development program necessary to initiate the first-in-man study in Russia and satisfy all regulatory requirements through approval. Preclinical and clinical studies will be conducted at highly-respected research facilities within Russian Federation and will follow the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines to support regulatory submissions in Europe, Japan and the United States.

While facilitating the studies and satisfying all necessary regulatory requirements for the program, bioRASI will also assist Access in finding partners for oral insulin and other Cobalamin-based products in Russia and other Eastern European and CIS countries. Access has the option to extend the agreement to additional Cobalamin-based products following a similar development pathway. At a future time the Parties may agree for bioRASI to take an equity position in Access for some or all of the expenses associated with this project.

“We are excited about this collaboration with bioRASI and the strategy we set forth in this agreement,” saidJeffrey Davis, Access Pharmaceuticals’ President and CEO. He continued, “Capitalizing on bioRASI’s distinct expertise in developing drugs for diabetes and in obtaining necessary regulatory approvals provides Access with a solid foundation for accelerated and cost-effective development of our Cobalamin oral insulin product and future Cobalamin-based products. We believe our Cobalamin drug delivery technology has been an undervalued part of our portfolio and we look forward to demonstrating its true value.”

bioRASI is a full-service global CRO specializing in the accelerated development of novel therapeutics through its close collaboration with the Russian Academy of Sciences and extensive experience with Russian and other Eastern European regulatory systems. In addition, through its partnership with The Diabetes Research Institute at the University of Miami Miller School of Medicine, bioRASI has considerable expertise in the areas of development of drugs for the treatment of diabetes. bioRASI is primarily focused on the development and approval of pharmaceutical products under 505(b)(2) and 505(j) NDA regulatory pathways. The Cobalamin-based oral insulin product approval path is expected to be a 505(b)(2) process.

Boris Reznik, PhD, President and CEO of bioRASI commented, “This program is a great fit for the capabilities of both bioRASI and our established partners. Given the well understood clinical utility of insulin, establishing the human oral bioavailability of Access’ product could be a huge step forward for both the oral insulin product and the broader Cobalamin formulation technology platform. Following initial success in the oral insulin program, we look forward to expanding this collaboration to several other promising Cobalamin-based products.”

About Cobalamin

About bioRASI

bioRASI, LLC is a Full Service Global CRO that collaborates with the leading biotech and pharmaceutical companies in the clinical development of novel and generic therapeutics. Specializing in ANDA and 505(b)(2) NDA programs, bioRASI facilitates obtaining FDA approvals by delivering high quality regulatory and clinical strategies, solutions and services, while saving their clients critical time. bioRASI services include the full spectrum of program management, regulatory, clinical, data management and analysis, and compliance and audit. bioRASI leverages its access to well renowned researchers and facilities, in the U.S., Europe and Asia, to achieve unparalleled scientific, clinical and business results at significantly lower costs. Further information about bioRASI is available at http://www.biorasi.com/.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products includeProLindac™, 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, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. 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 cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our 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.

Access Pharma’s Korean Partner Gains Marketing Approval for MuGard

admin — Thu, 25 Mar 2010 12:30:29 +0000

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First Asian Approval Furthers Global Availability of Access’ FDA-Approved Product for Management of Oral Mucositis

DALLAS, TX, March 25, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced that JCOM Co., Ltd., its Korean licensee for both MuGard™and ProLindac™, has received approval from the Korean Food and Drug Administration (KFDA) of its Registration Dossier for MuGard, an oncology supportive-care treatment for the management of oral mucositis. Under the agreement, JCOM is responsible for obtaining the necessary regulatory approvals for MuGard in Korea. As soon as JCOM has completed the additional steps required to import MuGard from the United States, marketing will commence.

“JCOM is a well-regarded company with an extensive distribution network in Korea,” said Jeffrey Davis, CEO of Access Pharmaceuticals. Davis continued, “JCOM receiving technical approval is a critical step in the launch of MuGard in Korea and it fits in nicely with our broad commercialization strategy of MuGard in the global market. We look forward to working with them on next steps, including a potential supply arrangement, and to leveraging their expertise throughout the region.”

“We are pleased with the continued progress being made to commercialize MuGard in Korea,” stated Mr. Yong Seok Kang, CEO of JCOM Co., Ltd. ”We remain on track and look forward to commercializing actively in the second half of the year.”

As previously announced, MuGard has been launched in the UK, Germany, Italy, Sweden, Norway and Greecethrough its European partner, SpePharm. Additionally, Access Pharmaceuticals and its respective marketing partners continue preparing for the commercial rollout of MuGard in the United States and additional countries in Europe, set for later this year.

About MuGard:

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy 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 JCOM

JCOM Co., LTD has operations in two areas, biotechnology and information technology. The Company’s biotechnology division specializes in the manufacturing and distribution of medicine and various chemical pharmaceuticals, with a particular emphasis on biosimilars. The majority of the Company’s pipeline is in the areas of diabetes/insulin, cancer, stem cells and horse cloning.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary 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, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. For additional information on Access Pharmaceuticals, please visit our 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: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our 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.