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MuGard(TM) is Access' proprietary product for the management of oralmucositis, a debilitating side effect of many anticancer treatments. MuGardhas received marketing allowance in the United States from the Food and DrugAdministration under a 510(k) procedure.
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SpePharm will be responsible for marketing MuGard throughout the EuropeanUnion plus Switzerland, Norway and Iceland, as well as for manufacturing andfor obtaining the necessary regulatory approvals for the product in theterritory.
"We are very excited about the opportunity to commercialize MuGard inEurope," said Jean-Francois Labbe, CEO of SpePharm. "We believe MuGard has thepotential to address an area of significant unmet medical need in supportivecare of cancer patients. Moreover, MuGard is an excellent complement to ourexisting product, Loramyc, and strengthens our strategic focus in thisimportant therapeutic area. We anticipate launching MuGard during 2008 andexpect to have a dedicated sales force of 50-60 representatives across Europepromoting 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 willbring to MuGard and the tremendous fit with Loramyc. Jean-Francois and histeam bring a wealth of experience and professionalism which we believe willbenefit the development and marketing of MuGard."
In connection with the exclusive Licensing Agreement, SpePharm will payAccess an upfront fee and substantial royalties on net sales.
About MuGard(TM):
MuGard is a ready-to-use mucoadhesive oral wound rinse. The mucoadhesiveformulation forms a protective coating over the oral mucosa when washed aroundthe mouth. In a retrospective comparison of cancer patients receiving standardmucositis care with those patients receiving MuGard, the incidence andseverity of mucositis was significantly lower in the MuGard treated group.
Up to 40% of all patients receiving chemotherapy and/or radiotherapydevelop moderate to severe mucositis, and almost all patients receivingradiotherapy for head and neck cancer and those undergoing stem celltransplantation develop mucositis. Updated clinical practice guidelines forthe prevention and treatment of mucositis recommend the use of a preventiveoral care regimen as part of routine supportive care along with a therapeuticoral care regimen if mucositis develops. The market for the treatment of oralmucositis is estimated to be in excess of $1 billion world-wide.
About SpePharm Holding, BV:
SpePharm Holding, B.V. is a Dutch company with its registered office inAmsterdam, and an operational base in Paris, France. SpePharm is an emergingpan-European specialty pharmaceutical company focused on acquiring,registering and marketing high medical value specialty medicines essentiallyfor the hospital and specialty markets. Particularly areas of therapeuticinterest are in oncology, haematology, critical & supportive care andendocrinology. SpePharm aims to be the preferred partner for pharmaceuticaland biotechnology companies, especially those from outside of Europe, seekingto maximize product and commercial opportunities within Europe.
SpePharm was founded in September 2006 by Jean-Francois Labbe togetherwith leading life science investment firms TVM Capital and Signet HealthcarePartners (part of the Sanders Morris Harris Group). Jean-Francois Labbe is aformer senior executive at Hoechst Marion Roussel and Parke Davis with over 30years of experience in international pharmaceutical management. SpePharm,through its founding management team, ha
