14.09.2012 - Cosmo's new anti-diarrhoea formulation of rifamycin meets the Phase III trial primary endpoints.
Cosmo Pharmaceuticals S.p.A. from Lainate (Lombardy) announced on 12 September the top-line results of a Phase III clinical trial with rifamycin SV MMX. Its US licensee Santarus, Inc. from San Diego (US) conducted a multicentre, randomised, placebo-controlled study where patients with traveller’s diarrhoea were treated with 800 mg rifamycin SV MMX a day for three consecutive days. The scored primary endpoints were a reduction of the time to last unformed stool (TLUS, down from 68 hours in placebo-group to 46 hours in active drug-group) and the clinical cure (56,9% placebo, 81,4% active treatment).
Cosmo is now awaiting results of a second Phase III study conducted by German Dr. Falk Pharma GmbH from Freiburg. Here the drug is tested against ciprofloxacin treatment. The results are expected in H2/2012. Milestone payments from Santarus will be due at regulatory acceptance as well as at the successful conclusion of a Phase III trial in another indication. Cosmo is also having an interest in sales royalties which amount to more than 20% – plus certain revenue milestones.
Rifamycin SV is a non-systemic antibiotic which has been used for years intravenously and intramuscularly. Combined with Cosmos’s MMX delivery technology, the antibiotic now passes the upper gastrointestinal tract without degradation for final release in the colon. The lipophilic and amphiphilic matrices disperse within a hydrophilic matrix and are coated with gastro-resistant polymers. Cosmo, Santarus and Swiss Ferring Pharmaceuticals S.A. are also working together on another MMX drug named Ultesa/Uceris. That drug offers potentially improved side-effect profiles compared with established systemic corticosteroids used to treat ulcerative colitis. However, signs were bleak when the approval of the drug in the Netherlands failed in August.
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