Monday, December 22, 2008

Santarus, Cosmo sign pact for US rights to Budesonide & Rifamycin

Santarus, Inc has entered into a strategic collaboration with Cosmo Technologies Limited (Cosmo), which grants Santarus exclusive rights to develop and commercialize Budesonide MMX and Rifamycin SV MMX for the US market.

Terms of the agreements include an upfront payment to Cosmo of cash and Santarus common stock, shared development costs, clinical/regulatory and commercial milestones and a royalty on net sales.

Budesonide MMX is an oral corticosteroid currently being investigated in two multi-centre phase-III clinical trials involving more than 800 patients in North America and Europe for the induction of remission of mild-to-moderate ulcerative colitis. Budesonide MMX is designed to retain the effectiveness of classical corticosteroids, but with reduced side effects due to its targeted controlled release in the colon with minimal systemic absorption. Rifamycin SV MMX is a broad spectrum, semi-synthetic antibiotic that also has targeted release characteristics when taken orally. The application of MMX technology to Rifamycin SV allows the antibiotic to be delivered directly to the colon, with the goal of minimizing unwanted effects on the bacterial flora in the small intestine. Cosmo has completed a phase-II clinical programme in traveler's diarrhoea. These two compounds are formulated using Cosmo's patented MMX Multi Matrix System technology.

MMX is a proprietary technology platform designed to produce a controlled release, homogeneous local application of the active pharmaceutical ingredient (API) throughout the colon, thereby limiting systemic absorption and offering an opportunity for reduced side effects. The MMX technology is covered by two issued US patents that expire in mid-2020, and additional patent applications are pending at the USPTO.

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