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HOME » PRODUCT
DEVELOPMENT: PARTNERS & COLLABORATORS CUTANEA LIFE SCIENCES, Inc. (Malvern, PA)
A license agreement for the development and commercialization of omiganan for use in dermatological diseases was executed on December 7, 2005 with Cutanea Life Sciences, Inc., (“Cutanea”) a private, dermatological pharmaceutical company based in metropolitan Philadelphia, Pennsylvania. Cutanea is focused on the development and commercialization of novel products to treat diseased and aging skin and is a member of the family of bio/pharmaceutical companies founded in conjunction with Paramount BioSciences, Inc.
In January 2007, Cutanea initiated a Phase II rosacea clinical trial in the United States using CLS001, a topical formulation of omiganan for dermatologic use. Based on the promising results from this study, Cutanea has selected a once daily dose of omiganan 2.5% gel for further development for the treatment of papulopustular rosacea. Cutanea had a successful end-of-Phase II meeting with the FDA in 2008 and is now preparing to initiate their Phase III clinical program.
Pursuant to the license agreement, MIGENIX can receive up to approximately US$21 million in development and commercialization milestone payments, as well as royalties on net sales. Cutanea received exclusive worldwide rights to develop and market omiganan and its analogues for dermatological indications. Cutanea is responsible for funding all development activities including formulation, clinical, regulatory, and commercialization costs.
In December 2003, we completed a license agreement with Spring Bank of Milford, MA, under which Spring Bank acquired exclusive worldwide rights to MX-1313 (now called SB 9000), a dinucleotide under development as a treatment for HBV chronic infections. Under the license agreement, MIGENIX received convertible/redeemable preferred shares in Spring Bank (recorded as a Long Term Investment on the balance sheet at a nominal carrying amount) rights for up to US$3.5 million in milestone payments during development of SB 9000 and royalties upon commercialization. Spring Bank will fund all development and patent costs for SB 9000. Spring Bank has received a grant from the NIH to advance development of SB 9000.
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