Access Pharmaceuticals provides update on MuGard commercial launch in North America
Source: money.cnn.com Author: press release Access Pharmaceuticals, Inc., 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. Marketing/Sales: Access has signed a deal with iMedicor to support online eMarketing efforts and education of oncologists, radiation oncologist and support staff as it pertains to oral mucositis and MuGard specifically. Access intends to build a hybrid, dedicated salesforce with oncology supportive care experience. Co-Promotion: Access continues to seek potential co-promotion arrangements with pharmaceutical and biotechnology companies in the [...]