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Access Pharmaceuticals provides update on MuGard commercial launch in Europe

admin — Thu, 03 Dec 2009 17:50:02 +0000

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Health care professional and patient feedback very positive

DALLAS, TX, December 3, 2009

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), today provided an update on its European commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy. MuGard is commercially launched by Access’ partner, SpePharm, in six European countries, including the UK, Germany, Italy, Norway, Greece and Sweden. Access is conducting pre-marketing activities, including ramping of commercial production, with the goal of a commercial launch in 1H 2010 in the US. MuGard was granted the CE mark certification in Europe in late 2008 with the labeling “prevention and management of the lesions and symptoms of oral mucositis.” Key findings and feedback from SpePharm’s ongoing commercial launch and patient assessment project include:

• Over 15,000 bottles of MuGard have been used by over 2,000 patients since launch.

• The European patient population includes adult patients undergoing radiotherapy and/or chemotherapy regimens.

• Patients experience includes those being prescribed and using MuGard prophylactically, as well as those using MuGard following the onset of oral mucositis.

• Initial feedback continues to reflect that MuGard is well accepted by both patients and healthcare professionals both as a preventative and curative treatment for oral mucositis.

• Patients and healthcare professionals like MuGard’s ready-to-use formulation, and believe it supports treatment compliance by patients.

• SpePharm is currently gathering feedback from clinicians in the UK, Germany and Italy that are participating in a patient assessment project. SpePharm expects that out of a total of approximately 1,500 patients who will be given Mugard in this project, a consistent number of patient forms will be collected by year end, and the information will be quality checked for potential presentation at a scientific or medical conference or meeting in the first half of 2010.

• Introduction of MuGard into several additional countries in Europe is anticipated over the next 12 to 18 months.

“As of today, more than 2,000 cancer patients undergoing radiotherapy and/or chemotherapy have been treated with MuGard,” stated Jean-Francois Labbe, SpePharm’s President & CEO. “We are very pleased with progress to date, and MuGard is well accepted by patients and by healthcare professionals, both as a preventative and curative treatment. MuGard’s ready-to-use formulation helps to support treatment compliance by the patients, and we believe is leading to its adoption as treatment-of-choice to prevent and treat oral mucositis.”

“Access is pleased with the early acceptance of MuGard as a preventative and curative treatment for oral mucositis,” stated Jeffrey B. Davis, Access’ President & CEO. “We hope to be able to leverage SpePharm’s early experiences around its launch in Europe to jump start our efforts here throughout the remainder of the year and into 2010.”

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 80% of all patients receiving radiotherapy and approximately 40% of all chemotherapy patients develop oral mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop oral mucositis. The market for the prevention and treatment of oral mucositis, expanding to include all patients undergoing chemotherapy and radiotherapy, is estimated to be in excess of $5 billion worldwide. MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.

About Access:

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 provides update on MuGard commercial launch and first European clinicians feedback

admin — Thu, 15 Oct 2009 12:00:38 +0000

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European launch on target — initial clinician and patient feedback very positive

Dallas, TX, October 15, 2009

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), today provided an update on it’s European commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy. MuGard is commercially launched by Access’ partner, SpePharm, in five European countries, having been granted the CE mark certification in October 2008 with the labeling “prevention and management of the lesions and symptoms of oral mucositis.” SpePharm is currently gathering feedback from clinicians in the UK, Germany and Italy that are participating in a patient assessment project. SpePharm expects that out of a total of approximately 1500 to 2000 patients who will be assessed in this project, a subset of patient forms will be collected by year end, and aggregated clinician and patient feedback will continue to be available on a rolling basis during the fourth quarter 2009 and 2010. Introduction of MuGard into France, Central and Eastern Europe, the Benelux countries and the rest of Europe is anticipated over the next 12 to 18 months.

“SpePharm is very pleased with the commercial launch of MuGard thus far, and I am happy to report that initial clinician and patient feedback has been very positive,” stated Jean-Francois Labbe, SpePharm’s President & CEO. “Our intention is to continue to gather clinician and patient feedback, and use this information to expand our presence throughout Europe. MuGard faces limited competition in Europe as traditional palliative solutions offer limited efficacy and/or poor compliance.”

“As Access prepares for the MuGard commercial launch in North America, we look forward to close cooperation with our European partner particularly with respect to planned market assessments studies here in the US,” stated Jeffrey Davis, Access’ President & CEO. “We hope to be able to leverage SpePharm’s early experiences around its launch in Europe to jump start our efforts here throughout the remainder of the year and into 2010. Access’ recently announced agreements with Accupac in manufacturing and iMedicor with e-marketing and education reflect our commitment to the MuGard launch.”

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 80% of all patients receiving radiotherapy and approximately 40% of all chemotherapy patients develop oral mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. 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 world-wide. MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.

About Access:

Access Pharmaceuticals Announces Commercial Launch of MuGard™ in Norway by SpePharm

admin — Mon, 27 Jul 2009 13:00:11 +0000

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Early Market Assessment Studies Suggest Larger Market Potential

DALLAS, TX, July 27, 2009

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), announced today that its European partner, SpePharm, has commenced commercial launch of MuGard in Norway. This follows previous commercial launches in the UK, Germany, Italy and Greece. Under a license from Access Pharmaceuticals, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. SpePharm plans to launch MuGard throughout Europe over the next 12 months, with direct launches planned in France, Spain and the Benelux countries, and launches through local distributors in Central and Eastern Europe. The license agreement includes royalties on net sales to Access.

Central to the MuGard commercial launch strategy is a coordinated effort to seek reimbursement from governmental agencies, placement in pharmacy formularies and an aggressive seeding strategy in leading cancer treatment centers and with leading clinicians. Aggressive sampling and education of patients and clinicians on early prophylactic use is proving important in reducing incidence, severity and duration of oral mucositis.

“The early feedback includes a high rate of enthusiasm and intention to continue use by practicing clinicians and patients, who have used MuGard,” stated Jeffrey B. Davis, Access’ President & CEO. “We believe this enhanced awareness of the benefits associated with use of MuGard as a preventative treatment is likely to result in solid marketing traction and market penetration in Europe as SpePharm continues market seeding studies in the major EU markets to continue to develop awareness within the medical community. Access continues to aggressively seek ways to maximize MuGard’s potential for cancer patients and for its shareholders.”

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse 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, expanding to include all patients undergoing chemotherapy and radiotherapy, is estimated to be in excess of $5 billion world-wide.

MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.

About Access:

Access Pharmaceuticals to Present at Jesup & Lamont 2009 Growth Stock Conference

admin — Wed, 22 Jul 2009 13:00:06 +0000

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Access to Provide Details on MuGard Launch in Europe

DALLAS, TX, July 22, 2009

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced today that Jeffrey B. Davis, President & CEO, will present at the Jssup & Lamont 2009 Growth Stock Conference organized by the LifeTech Capital Group on Thursday, July 30, 2009 at 10:45 am EST. The presentation will occur live and will be held at the Waldorf Astoria Boca Beach Club in Boca Raton, Florida.

“We are pleased to have the opportunity to present Access Pharmaceuticals to the large group of institutional and retail investors that attend Jesup’s annual growth stock conference,” stated Jeffrey B. Davis, Access’ President & CEO. “The conference provides a forum for Access to highlight in many product programs, and specifically the very significant and positive initial results and feedback from the commercial launch of MuGard, our FDA approved treatment for oral mucositis. Initial clinical feedback and experience exceeds our expectations.”

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Access Pharmaceuticals Announces Commercial Launch of MuGard™ in Greece by SpePharm

admin — Mon, 29 Jun 2009 16:00:54 +0000

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Two MuGard US Patents Issued

DALLAS, TX, June 29, 2009

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced today that its European partner, SpePharm has commenced commercial launch of MuGard in Greece. This follows previous commercial launches in Germany, Italy and the UK. Under a license from Access Pharmaceuticals, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. The license agreement includes royalties on net sales to Access.

Additionally, the Company announced that two MuGard™ patents have been issued from the United States Patent and Trademark Office, as US Patent numbers 7,544,348 and 7,547,433. The second patent includes claims on formulations with actives against mucocutaneous disorders, which provides protection of product line extensions.

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse 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 Access:

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 Report on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

Access Pharmaceuticals Provides Update on Global Launch of Mugard

admin — Wed, 27 May 2009 16:00:44 +0000

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New FDA-Approved Treatment for Oral Mucositis

DALLAS, TX, May 27 2009

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), announced today that MuGard , its proprietary oral mucositis product has been launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm , a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care. The Company has previously announced commercialization agreements in North America, China and eight Southeast Asian countries and Korea , and is actively seeking additional marketing partners in other regions; MuGard expects commercial launches in these regions throughout the remainder of 2009 as manufacturing and reimbursement gets established regionally.

MuGard is a ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. 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-wid e.

“Access is pleased with the commercial launch of MuGard in Europe , and the progress made by our partners in other regions of the world,” said Phillip Wise, Vice President of Business Development at Access. “Access is also working with its partners outside of Europe to establish GMP manufacturing and secure necessary approvals and/or reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option,” he continued.

Access Pharmaceuticals Announces the European Launch of MuGard™ by its European Partner, SpePharm

admin — Wed, 22 Apr 2009 16:00:29 +0000

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DALLAS, TX, April 22, 2009

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), announced today that MuGard™, its proprietary polymer-based oral mucositis product has been launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care.

Under a license from Access Pharmaceuticals Inc, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. In October 2008, MuGard was granted CE Mark certification by the Dutch Notified Body (KEMA). SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. Access will receive significant royalties on net sales.

“SpePharm and Access are pleased with the commercial launch of MuGard in Europe, and while it is still in the early days, initial feedback has been positive,” said Phillip Wise, Vice President of Business Development at Access. “SpePharm is also working hard to secure reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option. We look forward to further commercial launches from our other MuGard commercialization partners,” he continued.

MuGard is a ready-to-use mucoadhesive oral wound rinse 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 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 propriety products for the treatment and supportive care of cancer patients. Access’ products include ProLindac™, currently in Phase 2 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; Angiolix®, a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; Prodrax®, 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. Access is also developing Phenylbutyrate (“PB”), an HDAC inhibitor and differentiating agent currently a Phase 2 clinical candidate. Access recently announced the acquisition of MacroChem Corporation. This acquisition provides Access with three additional late-stage product candidates. Pexiganan, a novel topical anti-infective for the treatment of diabetic foot infection, has already completed two Phase 3 trials. EcoNail is a topically applied econazole lacquer based on Access’ proprietary SEPA polymer technology, for the treatment of onychomycosis, a condition commonly known as nail fungus. Thiarabine is 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.