Accessing Access Pharma
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PowerRating), which trade over the counter, touched a new 52-week intraday high of $4.74 on Monday before closing the day at $4.50, up nearly 17% from the previous day's close. Access Pharma is an emerging biopharmaceutical company with a primary focus on oncology and supportive care of cancer patients.
The company has one approved product -- MuGard, an oral rinse for the management of oral mucositis, a debilitating side effect of many anticancer chemotherapy and radiation treatments.
MuGard has received marketing allowance in the United States under a 510(K | Quote | Chart | News | PowerRating) procedure from the FDA and also has the European CE Mark approval.
Access Pharma already has licensing agreements in place to commercialize its proprietary product MuGard. Under the licensing agreements, privately-held specialty biotech company Milestone Biosciences LLC will market MuGard in the United States and Canada; SpePharm Holding BV will market the product in Europe; RHEI Pharmaceuticals will be responsible for marketing MuGard in China and certain South East Asian countries, while JCOM Ltd, an affiliate of DONG-A Pharmaceuticals, will promote MuGard in the Republic of Korea. In addition to the receipt of an upfront payment from its licensing partners, Access is also eligible to receive royalties on net sales.
On July 27, Access and its European partner SpePharm commenced commercial launch of MuGard in Norway. The product has already been launched in the UK, Germany, Italy and Greece. SpePharm, which is responsible for manufacturing, regulatory approval and commercialization of MuGard in the 27 countries of Europe, plans to launch the product throughout Europe over the next 12 months.
MuGard is expected to be launched in the U.S. and Asia by the end of this year.
Market Opportunity For MuGard
According to Access Pharma, 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.
The usual oral care provided for patients with cancer include frequent mouth cleansing and rinsing with buffered saline and fluoride solutions and administration of topical and systemic antimicrobial agents.
In clinical studies, it has been found that the incidence and severity of mucositis is significantly lower in patients treated with MuGard, compared to patients undergoing standard of care. According to the clinical studies, 43% of patients on MuGard experienced no mucositis compared with only 7% in the historical control group.
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, according to the company. As mentioned, Access Pharma is eligible to receive royalties on net sales of MuGard.
In the pipeline...
Access Pharma has one product in phase III clinical development, four phase II clinical candidates, and a few preclinical programs in oncology.
Pexiganan is the company's late-stage drug, which is being tested as a potential topical treatment for mild diabetic foot infection.
According to phase IIII study results published in the December 15, 2008 issue of Clinical Infectious Diseases, topical Pexiganan might be an effective alternative to oral antibiotic therapy in treating diabetic patients with a mildly infected foot ulcer, and might reduce the risk of selecting antimicrobial-resistant bacteria. The company is actively seeking a partner with dermatology expertise to assist in the development and ultimate commercialization of Pexiganan.
EcoNail, a potential treatment of onychomycosis, a condition commonly known as nail fungus, has completed a phase II clinical trial and the company is currently evaluating its development and partnering strategy.
Sodium phenylbutyrate is yet other investigational drug of Access Pharma that is being investigated as cancer therapy in phase II trials sponsored by the National Cancer Institute. The drug is currently approved by the FDA for the treatment of hyperuremia, a pediatric orphan indication.
ProLindac, the company's lead investigational oncology drug, completed a phase II monotherapy clinical study in pretreated patients with advanced ovarian cancer. ProLindac is a next-generation platinum anti-cancer compound. Access Pharma believes that ProLindac's unique molecular design potentially could eliminate some of the toxic side effects seen in Sanofi-Aventis' (SNY | Quote | Chart | News | PowerRating) blockbuster platinum-based anticancer drug Eloxatin.
Access Pharma has licensed ProLindac to Jiangsu Aosaikang Pharmaceutical Co., Ltd. for the Greater China Region and to JCOM, Ltd for South Korea. Under these agreements both the partners will be conducting phase II combination studies with ProLindac in specific tumor types at their expense.
Thiarabine is a next generation nucleoside analogue that Access Pharma has licensed from Southern Research Institute. The company is now working with leukemia and lymphoma specialists to initiate additional phase II clinical trials in acute myeloid leukemia, acute lymphocytic leukemia and other indications. Access Pharma is actively seeking co-development partners for Thiarabine.
In preclinical development are the Angiolix, Prodrax, Alchemix, and Cobalamin programs targeting tumors.
With a significant unmet medical need for MuGard, which has solid commercial sales potential, and a well-stoked pipeline, Access Pharma could be worth a look. But that said, OTC stocks are very high-risk investments and due diligence is mandatory.
Stay tuned to the Jesup & Lamont 2009 Growth Stock Conference organized by the LifeTech Capital Group on Thursday, July 30, 2009 at 10:45 am EDT, during which Jeffrey Davis, President & CEO of Access Pharma will highlight the initial results and feedback from the commercial launch of MuGard.
For comments and feedback: contact editorial@rttnews.com
Copyright(c) 2009 RTTNews.com, Inc. All Rights Reserved
The company has one approved product -- MuGard, an oral rinse for the management of oral mucositis, a debilitating side effect of many anticancer chemotherapy and radiation treatments.
MuGard has received marketing allowance in the United States under a 510(K | Quote | Chart | News | PowerRating) procedure from the FDA and also has the European CE Mark approval.
Access Pharma already has licensing agreements in place to commercialize its proprietary product MuGard. Under the licensing agreements, privately-held specialty biotech company Milestone Biosciences LLC will market MuGard in the United States and Canada; SpePharm Holding BV will market the product in Europe; RHEI Pharmaceuticals will be responsible for marketing MuGard in China and certain South East Asian countries, while JCOM Ltd, an affiliate of DONG-A Pharmaceuticals, will promote MuGard in the Republic of Korea. In addition to the receipt of an upfront payment from its licensing partners, Access is also eligible to receive royalties on net sales.
On July 27, Access and its European partner SpePharm commenced commercial launch of MuGard in Norway. The product has already been launched in the UK, Germany, Italy and Greece. SpePharm, which is responsible for manufacturing, regulatory approval and commercialization of MuGard in the 27 countries of Europe, plans to launch the product throughout Europe over the next 12 months.
MuGard is expected to be launched in the U.S. and Asia by the end of this year.
Market Opportunity For MuGard
According to Access Pharma, 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.
The usual oral care provided for patients with cancer include frequent mouth cleansing and rinsing with buffered saline and fluoride solutions and administration of topical and systemic antimicrobial agents.
In clinical studies, it has been found that the incidence and severity of mucositis is significantly lower in patients treated with MuGard, compared to patients undergoing standard of care. According to the clinical studies, 43% of patients on MuGard experienced no mucositis compared with only 7% in the historical control group.
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, according to the company. As mentioned, Access Pharma is eligible to receive royalties on net sales of MuGard.
In the pipeline...
Access Pharma has one product in phase III clinical development, four phase II clinical candidates, and a few preclinical programs in oncology.
Pexiganan is the company's late-stage drug, which is being tested as a potential topical treatment for mild diabetic foot infection.
According to phase IIII study results published in the December 15, 2008 issue of Clinical Infectious Diseases, topical Pexiganan might be an effective alternative to oral antibiotic therapy in treating diabetic patients with a mildly infected foot ulcer, and might reduce the risk of selecting antimicrobial-resistant bacteria. The company is actively seeking a partner with dermatology expertise to assist in the development and ultimate commercialization of Pexiganan.
EcoNail, a potential treatment of onychomycosis, a condition commonly known as nail fungus, has completed a phase II clinical trial and the company is currently evaluating its development and partnering strategy.
Sodium phenylbutyrate is yet other investigational drug of Access Pharma that is being investigated as cancer therapy in phase II trials sponsored by the National Cancer Institute. The drug is currently approved by the FDA for the treatment of hyperuremia, a pediatric orphan indication.
ProLindac, the company's lead investigational oncology drug, completed a phase II monotherapy clinical study in pretreated patients with advanced ovarian cancer. ProLindac is a next-generation platinum anti-cancer compound. Access Pharma believes that ProLindac's unique molecular design potentially could eliminate some of the toxic side effects seen in Sanofi-Aventis' (SNY | Quote | Chart | News | PowerRating) blockbuster platinum-based anticancer drug Eloxatin.
Access Pharma has licensed ProLindac to Jiangsu Aosaikang Pharmaceutical Co., Ltd. for the Greater China Region and to JCOM, Ltd for South Korea. Under these agreements both the partners will be conducting phase II combination studies with ProLindac in specific tumor types at their expense.
Thiarabine is a next generation nucleoside analogue that Access Pharma has licensed from Southern Research Institute. The company is now working with leukemia and lymphoma specialists to initiate additional phase II clinical trials in acute myeloid leukemia, acute lymphocytic leukemia and other indications. Access Pharma is actively seeking co-development partners for Thiarabine.
In preclinical development are the Angiolix, Prodrax, Alchemix, and Cobalamin programs targeting tumors.
With a significant unmet medical need for MuGard, which has solid commercial sales potential, and a well-stoked pipeline, Access Pharma could be worth a look. But that said, OTC stocks are very high-risk investments and due diligence is mandatory.
Stay tuned to the Jesup & Lamont 2009 Growth Stock Conference organized by the LifeTech Capital Group on Thursday, July 30, 2009 at 10:45 am EDT, during which Jeffrey Davis, President & CEO of Access Pharma will highlight the initial results and feedback from the commercial launch of MuGard.
For comments and feedback: contact editorial@rttnews.com
Copyright(c) 2009 RTTNews.com, Inc. All Rights Reserved
For full details on (ACCP.OB) ACCP.OB. (ACCP.OB) has Short Term PowerRatings at TradingMarkets. Details on (ACCP.OB) Short Term PowerRatings is available at This Link.
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