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Headquartered in Madrid, Spain, PharmaMar is a leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs, with an important pipeline of drug candidates and a strong oncology research and development program. Recently, the company announced that the Australian Medicines Agency (TGA) has approved the drug Alidin (plitidepsin) for the treatment of patients with recurring or resuscable multiple myeloma (MM) who have failed or are resistant to other therapies.
this approval, which is Apradin's first regulatory approval worldwide. Specifically, Aplidin is suitable for: 1) MM patients who have relapsed after receiving third-line therapy (including protease inhibitors or immunomodulants);
estimated that in Australia, about 1800 new MM cases are confirmed each year, about 1000 deaths per year, and the five-year survival rate after the diagnosis of MM is less than 50 per cent. MM accounts for about 10%-15% of all hematological malignancies, mainly in the elderly, with a medium age of diagnosis of 65-70 years. The disease usually causes an increase in bone dissolution, leading to pathological fractures, kidney failure, hypercalcemia, immunosuppression, increased risk of infection, and bone marrow failure. Despite significant progress in front-line, maintenance, and supportive treatment options, MM remains incurable and all patients end up with incurable relapses.
plitidepsin is an ocean-derived pioneering (first-in-class) cancer drug, originally obtained from Aplidiumalbicans, a primary animal, that is specifically combined with euthanoidal extension factor 1A2 (eEF1A2) and targets the atypical effect of the protein, resulting in tumor cell death through apoptosis (procedural death). Currently, the drug is being clinically developed for the treatment of a variety of hematological tumors, including a combination of the treatment of recurring or resusciable MM, as well as a phase II study for the treatment of recurring or resuscable vascular immunoblastocyte T-cell lymphoma. In both the United States and the European Union, plitidepsin has been granted the qualification of orphan medicine.
PharmaMar has launched its first marine-sourced anti-tumor drug, Yondelis, in the European market. In addition to platidepsin, the company has three clinical phases of projects (PM1183, PM184, PM14) that are being developed for use in many types of solid tumors and blood cancers.
It's worth noting that in 2001 Johnson and Johnson obtained an exclusive license from Zeltia, a company owned by PharmaMar, to the U.S. market, and after three six-year approval marathons, Johnson and Johnson finally won FDA approval for Yondelis in 2015 for the treatment of non-excisive or chemotherapy-resistant liposarcoma and smooth muscular tumor patients. (Bio Valley)