Seeking Alpha
Long-term horizon
Profile| Send Message|
( followers)

Access Pharma (OTC: ACCP.OB) provided an update this morning on the clinical and commercial status of MuGard, which has already been launched by its partner, SpePharm, in five European countries for the prevention and treatment of oral mucositis. SpePharm is currently collecting information from approximately 1,500-2,000 patients as part of a comprehensive set of post-marketing / seeding studies being conducted in the UK, Germany, and Italy.

SpePharm anticipates that data from these studies will be made on a rolling basis throughout 4Q09-1Q10 while the commercial launch of MuGard in France and other European countries will continue over the next 12-18 months. Initial patient and clinician feedback has been very positive, according to SpePharm’s President / CEO, Jean-Francois Labbe, which validates interim data released from the UK study that demonstrated no cases of oral mucositis in 140 patients who received MuGard while undergoing treatment for head and neck cancer.

The number of patients being evaluated in the European post-marketing studies is more than originally anticipated and Access will be able to utilize the data in North America for both marketing and licensing negotiations. A steady stream of data is expected to occur over the next 3-6 months now given the larger patient population being analyzed and compiled by SpePharm. I have confirmed with Access President / CEO, Jeffrey Davis, that data is expected in a matter of weeks with the final UK results expected first, followed by data from Germany.

While the $1.55 million in cash / equivalents for Access as of 8/12/09 would normally be a major concern for most companies; it should be noted the cash burn rate is very low (i.e. $241,000 per month or about $0.72M per quarter through 1H09). Also, Mr. Davis confirmed that the current liquidity is sufficient to fund operations through mid-2010 without even considering any MuGard royalties from Europe or the potential for upfront cash in a North American licensing deal for this product or any others in development such as oral insulin.

Mr. Davis also indicated that Access can afford to be patient and evaluate alternatives that are in the best interest of increasing shareholder value (since this is also his perspective as part of SCO Capital). Financing alternatives could include institutional investments and / or upfront cash in a North American licensing deal for MuGard. Given the right terms, additional equity capital from institutional investors would also be welcomed to facilitate a stock listing on AMEX / NASDAQ and provide a stronger negotiating position for licensing the rights to MuGard in North America.

Another upcoming clinical data catalyst for Access that is expected before year-end involves the Company's cobalamin (vitamin B12) based nanopolymer drug delivery system for the oral administration of large molecules such as insulin, human growth hormone (hGH), and erythropoietin (EPO) in preclinical animal models. This novel delivery mechanism utilizes the body's vitamin B12 absorption system in a Trojan Horse manner with the potential to eliminate the need for injections of widely used drugs such as insulin, hGH, and EPO.

A long-acting, basal insulin product (similar to the activity profile of Lantus insulin) is the most advanced in terms of achieving oral bioavailability of about 80-90% after initially achieving results in the 30-40% range, and Access previously announced in June that two bio-pharmaceutical companies are conducting preclinical studies to validate the Company’s results for a long-acting oral insulin product before entering formal licensing negotiations.

In terms of other progress in the clinical development pipeline, Access hopes to begin enrolling patients in a pair of Phase 2 studies at MD Anderson for thiarabine in the treatment of adult AML / ALL and B-Cell lymphomas. Thiarabine is the Company's next-generation nucleoside analogue (e.g. fludarabine, cladrabine) designed for the treatment of blood-based cancers such as lymphoma and leukemia (in addition to promising preclinical data for the prevention and treatment of rheumatoid arthritis). ACCP is working with the leader in this field, Dr. Hagop Kantarjian, who is Head of the Leukemia Department at the M.D. Anderson Cancer Center in Houston (which is the primary treatment center in the U.S. for leukemia and lymphoma).

Access and its partners are also 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. Access will be working closely with its partners and 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. as compared to an indication for colorectal cancer.

The e-Marketing / oncologist education deal with iMedicor announced earlier this month and pending domestic MuGard commercial launch is part of Access Pharma’s strategy that also includes ongoing discussions for a potential licensing agreement with a major oncology-related bio-pharmaceutical company for North America. In addition, the encouraging feedback and interim results for MuGard in Europe being reported by SpePharm, with a steady stream of additional clinical data expected over the next few months, bodes very well for the U.S. launch that is expected to occur within the next 3-6 months.

Disclosure: Long ACCP.OB.

See my full disclaimer at MikeHavRx.com (bottom of any page).

Source: Access Pharma: Clinical and Commercial MuGard Updates