Positive data from a second Phase III trial evaluating Budesonide MMX® in the treatment of ulcerative colitis has led Cosmo Pharmaceuticals to confirm plans to file a marketing approval application for the drug with the Dutch regulatory agencies during the first half of 2011. The firm in addition reports that Santarus, its U.S. partner for Budesonide MMX, aims to submit an NDA to FDA during the second half of 2011, after the completion of an ongoing extended-use study with the drug.
The newly reported European Phase III study, CB-01-02/02, included some 400 patients with mild to moderate ulcerative colitis. Participants were randomized to receive either 6 mg or 9 mg Budesonide MMX once-daily, or therapy with either the reference drug Entocort® EC (budesonide), or placebo. The primary endpoint was the induction of remission after eight weeks of therapy, as measured by UCDAI (ulcerative colitis disease activity index) scores.
A preliminary analysis of the results showed that remission rates for the intent-to-treat population were 17.4% for the higher 9 mg dose of Budesonide MMX, compared with 12.6% for the Entocort-treated cohort, and 4.5% for patients receiving placebo. The data mirrors those of the U.S.-based Phase III study, CB-01-02/01, which compared Budesonide MMX with the placebo and the reference drug Asacol (mesalamine). The U.S. data were reported by Santarus and Cosmo at the end of September.
Budesonide MMX has been developed using Cosmo’s controlled-release Multi Matrix (MMX) technology, which is designed to delay absorption of the drug until it reaches the lumen of the colon. The MMX technology effectively coats tablet-formulated drugs with pH-resistant acrylic co-polymers that protect the active substances from adverse pH conditions and enzymatic attack in the upper digestive tracts.
The MMX platform is separately being exploited for the development of Rifamycin SV MMX for the treatment of traveller’s diarrhea, and low molecular weight (LMW) Heparin MMX for the treatment of mild-to-moderate ulcerative colitis. The Rifamycin product, also partnered with Santarus for the U.S. market, is in Phase III development. The LMW Heparin MMX candidate is poised to start in Phase III trials.
Cosmo teamed up with Santarus for U.S. development of Budesonide MMX and Rifamycin SV MMX in 2008. Cosmo’s European partner for Budesonide MMX is Ferring Pharmaceuticals. Its European partner for Rifamycin SV MMX is Dr. Falk Pharma.
Cosmo’s flagship MMX-based ulcerative colitis therapy, Lialda®/Mezavant®/Mesavancol®, was launched in the U.S. and Europe by partners Shire Pharmaceuticals and Giuliani, in 2007. Cosmo claims Liadla was the fastest growing ulcerative colitis drug in the U.S. in 2009, where it achieved an overall market share of 18% of all 5-amino salicylic acid (5-ASA). The firm earned nearly €4 million in royalties during the first half of 2010 from sales of Lialda/Mezavant/Mesavancol.