On 9/10/09, Access Pharma (OTCQB:ACCP) announced that its clinical development team recently met with its partners Aosaikang Medicinal Group (ASK) in China and JCOM, Ltd. (NASDAQ:JCOM) in Korea, along 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 recurarent ovarian cancer.
Below is a summary from an update article posted in late August at BioMedReports.com based on information provided by the President and CEO of Access Pharma, Jeffrey B. Davis.
Access is working with the leading cancer doctors in China and Korea, together with the clinical teams at ACCP, ASK and JCOM, to put together protocols and plans for up to three combination trials for ProLindac in combination with gemcitabine in hepatocellular carcinoma and pancreatic cancer, and in combination with gemcitabine/Taxol in recurrent ovarian cancer (and be able to get first or second relapse patients in recurrent ovarian, in contrast to the very heavily pre-treated population which was part of our mono-therapy trial).
Access will be working closely with the KOL and with in-country regulators, with the goal of enrolling the first patients by year-end, depending upon regulatory approvals of the trial protocols and certain other matters. The company’s director of clinical development, Esteban Cvitkovic, is excited about these new indications, and believes that they represent a much quicker registration pathway to approval in Europe, and possibly the U.S., than going after colorectal cancer.
On 9/11/09, Access announced that it entered an agreement with a leading commercial manufacturer which specializes in liquid formulations to produce MuGard for distribution in North American markets. Access has contracted with Accupac, Inc. to serve as its commercial manufacturer of MuGard in North America. Accupac manufactures, fills and packages a wide range of consumer commodity, over-the-counter (OTC) and prescription (Rx) products for the world’s largest pharmaceutical and consumer products companies.
Access intends to use the initial batches of MuGard in connection with one or more market seeding studies to be conducted in the U.S. pursuant to protocols that are currently being developed, and the company hopes to finalize these protocols and begin one or more market seeding studies during 4Q09. Below are additional development milestones and catalysts expected before year-end for Access:
- Final results (all 280 patients over the entire seven-week duration) for SpePharm's UK post-approval marketing study of MuGard with interim results demonstrating no cases of oral mucositis in 140 patients with head and neck cancer being treated with radiation therapy. Also, a continuous flow of clinical data (including journal publications and presentations at medical/scientific conferences) for MuGard expected throughout 2H09 as SpePharm is also conducting post-approval marketing studies in Germany and Italy. Access also expects to initiate similar marketing assessment studies within three months (mid-November) in North America as well.
- Listing on either the AMEX or NASDAQ exchanges
- MuGard commercial launch in Asia
- North American Commercialization Strategy for MuGard: The company's strategy is to initiate GMP manufacturing of MuGard; continue to put the reimbursement strategy in place (get codes, etc.); and then go back to about 5-6 leading OM doctors to conduct US-based post-approval marketing studies. Access will proceed "as-if" preparing for a commercial launch alone while taking a position with potential new North America partners that they can do a new license deal (with better economics for Access, but give them control to do it all themselves), or a "co-promote" deal where Access retains the rights to co-promote MuGard in North America.
- Licensing discussions for the company's cobalamin-based nanopolymer drug delivery technology for the oral administration of a basal (long-acting) insulin product following mid-June announcement that two bio-pharmaceutical companies will conduct preclinical, animal studies before proceeding to more formal negotiations. The results of these preclinical studies will be made public, including one North American biotech company and one European biotech company. Access is providing the oral insulin while the two interested companies will conduct one animal study each (including a rat and dog model) with data expected before year-end. Ongoing discussions with these companies may result in the evaluation of other drugs utilizing this delivery platform, including human growth hormone (hGH) and erythropoietin (EPO).
Please visit the stock research section of BioMedReports.com to view or download my latest 19-page PDF research report for Access Pharma published on 8/14/09, which includes an earnings model for MuGard through 2012 and key upcoming catalysts for the company that are expected to unlock substantial shareholder value. The stock research section also includes an updated report for Access written by Griffin Securities with a buy rating and $11 price target in addition to the most recent corporate presentation for the company.
Disclosure: Long ACCP.OB.