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.
20.01.2015 Ebola research projects are set to receive €215m in funding from the European Commission’s IMI2 Ebola+ programme. Among the project partners are vaccine developers Glaxosmithkline, Johnson&Johnson and Merck.
13.01.2015 Shire beefs up its rare disease portfolio after acquiring NPS Pharma with the aim of becoming a leading biotech in a US$5.2bn deal. Part of the deal is the US biotech's lead portfolio of gastrointestinal and hormone replacement therapies.
09.01.2015 The excitement surrounding CRISPR genome editing shows no sign of abating. This month, Novartis and US biotech Intellia Therapeutics became the first ever biotech-pharma collaboration to use the groundbreaking technology.
06.01.2015 With the aim to utilise Ireland’s many natural resources and keep abreast of the latest EU developments in bioeconomy, a multi-disciplinary team has been funded to maximise national income, exports and job creation related to Ireland’s bioeconomy.