Cumberland Pharmaceuticals has made an agreement with a subsidiary of Apotex Health, a Canadian-based pharmaceutical company, to integrate their branded US businesses. Under the terms of the agreement, Apotex has acquired Cumberland’s line of branded pharmaceuticals for cash consideration of $100 million funded at closing, which followed approval by Cumberland’s shareholders.
Cumberland has retained its robust portfolio of innovative product candidates and its majority ownership position in Cumberland Emerging Technologies Inc. Following the closing, Cumberland will focus its resources on developing ifetroban, a potent thromboxane antagonist currently being studied across clinical programs targeting serious rare and progressive diseases:
- Duchenne muscular dystrophy cardiomyopathy: Cumberland announced breakthrough results in a phase 2 clinical study of ifetroban in patients with cardiomyopathy associated with this rare, fatal genetic neuromuscular disease. Interactions with the FDA have been underway regarding study results and requirements for approval. The program has received FDA Orphan Drug, Rare Pediatric Disease and Fast Track designations.
- Systemic sclerosis: Cumberland has conducted a phase 2 clinical study evaluating the safety of ifetroban in patients with this debilitating autoimmune disorder. Evaluation of the study data is underway with top-line results anticipated as the next milestone.
- Idiopathic pulmonary fibrosis: a phase 2 study evaluating ifetroban in patients with the most common form of progressive fibrosing interstitial lung disease is actively enrolling at medical centres across the US Favourable interim safety findings have been announced and the next milestone is the announcement of the efficacy results.
Cancer metastasis: Cumberland, in collaboration with Vanderbilt Health, recently announced the results of a Pilot Study of ifetroban in patients with high-risk solid tumours. The findings suggest the potential to block cancer metastasis, as a favourable trend was identified with fewer deaths due to metastatic disease in those receiving ifetroban rather than a placebo. The Phase 2 clinical trial also found ifetroban to be safe and well tolerated in the oncology patients, supporting further development of the drug to prevent cancer
