Access Pharmaceuticals, Inc. and SpePharm Holding, B.V. announced the signing of a definitive licensing agreement under which SpePharm will market Access's product MuGard in Europe.
MuGard is Access' proprietary product for the management of oral mucositis, a debilitating side effect of many anticancer treatments. MuGard has received marketing allowance in the United States from the Food and Drug Administration under a 510(k) procedure.
SpePharm will be responsible for marketing MuGard throughout the European Union plus Switzerland, Norway and Iceland, as well as for manufacturing and for obtaining the necessary regulatory approvals for the product in the territory.
"We are very excited about the opportunity to commercialize MuGard in Europe," said Jean- François Labbé, CEO of SpePharm. "We believe MuGard has the potential to address an area of significant unmet medical need in supportive care of cancer patients. Moreover, MuGard is an excellent complement to our existing product, Loramyc, and strengthens our strategic focus in this important therapeutic area. We anticipate launching MuGard during 2008 and expect to have a dedicated sales force of 50-60 representatives across Europe promoting both MuGard and Loramyc."
"SpePharm is an ideal partner for us in Europe," added Stephen R. Seiler, president and CEO of Access. "We are excited about the focus SpePharm will bring to MuGard and the tremendous fit with Loramyc. Jean-François and his team bring a wealth of experience and professionalism which we believe will benefit the development and marketing of MuGard."
In connection with the exclusive licensing agreement, SpePharm will pay Access an upfront fee and substantial royalties on net sales.
MuGard is a ready-to-use mucoadhesive oral wound rinse. The mucoadhesive formulation forms a protective coating over the oral mucosa when washed around the mouth. In a retrospective comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group.
Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
SpePharm Holding, B.V. is a Dutch company with its registered office in Amsterdam, and an operational base in Paris, France. SpePharm is an emerging pan-European specialty pharmaceutical company focused on acquiring, registering and marketing high medical value specialty medicines essentially for the hospital and specialty markets.
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access' products include ProLindac, currently in Phase II clinical testing of patients with ovarian cancer and MuGard for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin™-mediated targeted delivery and oral drug delivery.