Staff Writer

Access Pharmaceuticals Inc. has licensed the U.S. and Canadian rights for its oncology support product MuGard to Milestone Biosciences LLC for $10 million, having previously secured partners in Europe and Asia.

The money likely is to be used to advance Dallas-based Access' next-generation platinum drug, ProLindac, as a possible replacement for Paris-based Sanofi-Aventis' Eloxatin, Jeffrey B. Davis, president and CEO, told BioWorld Today.

Davis described his company as small but with "fairly rich assets," adding that his firm is in an enviable position.

Access has a number of late-stage development programs and a preclinical monoclonal antibody, all of which could get some funding from the MuGard deal, Davis said. Under the agreement, the company could see royalties on MuGard in the double digits.

The deal with privately held Milestone Biosciences, of Altamonte Springs, Fla., is the third such partnership to stem from the MuGard asset, Davis said.

A year ago, Access entered a $1 million licensing deal with SpePharm Holding BV, of Amsterdam, the Netherlands, to market MuGard throughout the European Union plus Switzerland. Access entered a similarly sized deal earlier this year with RHEI Pharmaceuticals Inc., of New Haven, Conn., to market MuGard in China and other Southeast Asian countries.

MuGard is an FDA-approved coating agent for oral mucositis (mouth sores) caused by chemotherapy or radiation. It is classified by the agency as device rather than a drug, due to its coating mechanism of action.

The product fit with Milestone Biosciences' mission to commercialize niche oncology products for small companies that are launching their first product or that have no background in commercialization, or large firms that meet the company's product criteria. Milestone seeks products that meet unmet medical needs and have a revenue potential of about $100 million.

Current treatments for mucositis include lidocaine mixed with other products, a formulation known as "magic mouthwash," widely viewed by health professionals as providing only temporary relief for pain.

Other products for oral mucositis include Thousand Oaks, Calif.-based Amgen Inc.'s Kepivance (palifermin) approved for use in stem cell transplantation patients only; GelClair, sold by EKR Therapeutics, Inc., of Cedar Knolls, N.J.; and Caphosol by EUSA Pharma Ltd., of Oxford, UK.

Clinical data suggested that MuGard may be better at reducing the duration of mucositis and preventing the development of those lesions, noted Eric Loukas, CEO of Milestone.

Milestone, launched in 2007 by former executives and sales representatives from oncology-focused companies, including MGI Pharma, Amgen and Genentech Inc., is seeking to do other similar deals with companies that need commercialization partners.

Initially, Milestone BioSciences wanted a diagnostic test, the Microculture Kinetics (MiCK) assay, to be its flagship product. But the company divested of that product after encountering obstacles related to reimbursement and other issues. MuGard will be Milestone's second product launch. It expects to aggressively pursue additional financing to continue over the next two to five years.

At Access, the company's products include ProLindac, currently in Phase II clinical testing of patients with ovarian cancer; Cobalamin-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism; and Angiolix, a humanized monoclonal antibody which acts as an antiangiogenesis factor and is targeted to breast cancer.

Earlier this year, Access closed a deal to acquire Somanta Pharmaceuticals Inc. and expects to close on another acquisition, MacroChem Corp., in 30 to 45 days.

Shares of Access (OTC BB:ACCP) climbed 8 cents to close at $3.07.