Critical step toward U.S.. marketing launch of MuGard
DALLAS, TX, December 15, 2009
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), today announced the appointment of Frank Jacobucci to the position of Vice President, Sales and Marketing. Mr. Jacobucci will be primarily responsible for the Company’s marketing launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy. Mr. Jacobucci has over 20 years experience in sales management, including senior sales executive positions at oncology focused companies including MGI Pharma, Genetics Institute, Wyeth Oncology, Aventis, Precision Therapeutics and CRC Oncology Services. Mr. Jacobucci has significant experience launching pharmaceutical products, with a particular expertise in oral mucositis and related oncology supportive care therapies and also has developed significant experience with MuGard.
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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:
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DALLAS, TX., November 17, 2009
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) today announced that a recommendation report was issued by ChangeWave, a research network that identifies emerging trends and companies best-positioned to capitalize in today’s marketplace. The report was written by Mr. Joshua Levine, Editor of ChangeWave Investing and ChangeWave MicroCap Investor.
According to Mr. Levine, “Finally, with MuGard now commercialized, Access is already receiving its first royalties, and cash flow will steadily ramp up in the coming quarters. Since MuGard has pharmaceutical-type margins, it will instantly impact Access’ financial situation. The increase in revenue will provide financial security for this company with an active partnering and outsourcing model and a very small $3 million-a-year burn rate.”
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European Launch Ongoing– Initial Clinician And Patient Feedback Very Positive
DALLAS, TX, November 11, 2009
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), today provided an update on its North American commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy. Access intends to commercially launch MuGard in North America in the first quarter of 2010. Key strategic items pertaining to the launch include:
• Manufacturing: Access is currently working with its contract liquid manufacturer, Accupac, on initial clinical and stability batches, and expects to have initial commercial quantities available in 1Q 2010.
• Reimbursement: Access is working with outside regulatory consultants in developing and finalizing its reimbursement strategy as it pertains to third-party payors and Medicare/Medicaid.
• Clinical: Consistent with strategies employed by its global marketing partners, Access is working with key opinion leaders to develop a strategy for post-approval studies if and as needed. Access believes that its approved label indication and directions for use supports positioning MuGard as a preventative for oral mucositis caused by radiation and chemotherapy treatments, and provides for expansion into treatment of all types of oral wounds including aphthous ulcers, canker sores and traumatic ulcers, such as those caused by oral surgery.
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October 26, 2009
Jeffrey B. Davis, Chief Executive Officer of Access Pharmaceuticals, Inc. (OTCBB: ACCP) recently conducted an interview with OneMedPlace.com to discuss recent developments with the company including: reasons Access differentiates itself from other small-cap biotech companies, MuGard launch in Europe and market assessment studies discussions with potential partners about ProLindac, market opportunity for Thiarabine, and the market opportunity for Access’ Cobalamin oral drug delivery technology
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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.
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To Launch MuGard Through iMedicor’s Proprietary Alerts System Application
Dallas, TX, October 6, 2009
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced today that it had signed an agreement with iMedicor (OTCBB: VMCI) for the North American commercial launch of MuGard, its FDA approved mucoadhesive oral rinse for the management of oral mucositis and stomatitis caused by radiotherapy and/or chemotherapy. Using iMedicor’s highly targeted Alerts System application, initial introduction of MuGard to the 216,000 selected physicians in the US is expected to begin by the end of the year. MuGard is being commercially launched worldwide, with initial launches in the United Kingdom, Germany, Italy, Norway and Greece having been previously announced. Access expects additional commercial launches in Europe, and in the Far East through two partners to start shortly.
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Business columnist Gene Marcial discusses potential for MuGard
October 2, 2009
Renowned business columnist and author Gene Marcial listed Access Pharmaceuticals, Inc. (OTCBB: ACCP) as one of three promising companies to watch in his latest Inside Wall Street column.
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DALLAS, TX, September 11, 2009
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) has entered into an agreement with a leading commercial manufacturer to produce its FDA-approved MuGard for North American distribution. One or more U.S. market seeding studies could begin as early as Q4 2009, the company says.
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Finalizing plans for combination studies in liver, pancreatic and ovarian cancers
Dallas, TX September 10, 2009
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), provided an update today on the Company’s clinical development plan for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. Access’ clinical development team recently met with its partners Aosaikang Medicinal Group (ASK) in Nanjing, China and JCOM, Ltd. (“JCOM”) in Seoul, Korea, together with key opinion leaders in oncology indications to discuss the protocols for the three planned ProLindac combination studies. Access and its partners are finalizing development plans and protocols for clinical trials strategically designed to examine ProLindac in combination with gemcitabine and/or taxol in hepatocellular carcinoma (a form of liver cancer), pancreatic cancer and recurrent ovarian cancer.
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