Mallinckrodt is a global specialty pharmaceutical company with a major focus within the hospital acute and critical care settings, including pain management, autoimmune and rare diseases, and specialty generic pharmaceuticals. The company’s key branded products in these areas, generating multi-billion dollar revenues, include H.P. Acthar Gel (repository corticotrophin injection) andTherakos Immunotherapy platform,OFIRMEV (acetaminophen injection), andINOMAX (nitric oxide) gas, for inhalation. Recently, Mallinckrodt has entered the regenerative medicine fieldwith the acquisition of an investigational human keratinocyte-based regenerative medicine platform tobolster its pipeline of hospital products withan off-the-shelf skin substitute beginning Phase 3 testing for partial thickness burns. Mesoblast Chief Executive Silviu Itescu said: We are pleased that Mallinckrodt has chosen to make an investment in Mesoblast. Mallinckrodt has a track record of success in commercializing medicines for immune-mediated diseases and pain management, and we believe that its majorfootprint in hospitals addressing acute care needs canbe leveraged to realize the full commercial and clinical value of our innovative cellular medicines. Steven Romano, M.D., Executive Vice President and Chief Scientific Officer of Mallinckrodt, commented: “This agreement provides Mallinckrodt with a potential opportunity to extend our regenerative medicine pipeline in areas of high unmet patient need. We see Mesoblast as a leader in developing innovative cell-based medicines and look forward to establishing a fruitful partnership.” Mesoblast’s product candidate MPC-06-ID is currently being evaluated in a 360-patient Phase 3 trial as a treatment for moderate/severe CLBP due to disc degeneration in patients who have failed other non-surgical options, including steroid injections and opioids. Data from 24-month follow up of 100 patients participating in a randomized, placebo-controlled Phase 2 trial of MPC-06-ID were presented in August 2016 at the 24th Annual Scientific Meeting of the Spine Intervention Society. Mesoblast’s product candidate MSC-100-IV is currently being evaluated in a 60-patient open label Phase 3 trial as a front-line therapy for children with steroid-refractory acute GVHD. The trial was recently successful in a pre-specified interim futility analysis, and Mesoblast expects to fully read out trial results during 2017. Based on guidance from the United States Food and Drug Administration (FDA), Mesoblast believes that positive data from this Phase 3 trial may be sufficient for filing for accelerated approval of MSC-100-IV in the United States.
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