Date: 2015-08-20
Type of information: Licensing agreement
Compound: Aplidin® (plitidepsin)
Company: PharmaMar (Spain) Specialised Therapeutics Australia (Australia)
Therapeutic area: Cancer - Oncology
Type agreement: licensing commercialisation
Action mechanism: depsipeptide derivative. Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the tunicate Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programmed death). Plitidepsin is currently in clinical development for hematological cancers, including a Phase III study in relapsed or refractory multiple myeloma, a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. Plitidepsin has received orphan drug designation by the EMA and the FDA.
Disease: multiple myeloma, T cell lymphoma
Details: * On August 20, 2015, PharmaMar has entered into an exclusive license and commercialization agreement with the pharmaceutical company Specialised Therapeutics Australia Pty (STA) to market and distribute the drug candidate Aplidin® (plitidepsin) in Australia and New Zealand. Under the terms of the agreement, PharmaMar will receive an upfront payment, royalties as well as additional remunerations for regulatory and sales milestones achieved by Aplidin® (plitidepsin). PharmaMar will retain exclusive production rights and will supply the finished product to STA for commercial use in Australia and New Zealand. Aplidin® (plitidepsin) is PharmaMar´s second anticancer drug candidate obtained from a marine organism and is currently under development for the treatment of multiple myeloma and a type of T cell lymphoma. The company announced in June that patient recruitment of the international pivotal Phase III trial (ADMYRE) for Aplidin® (plitidepsin) in refractory/relapsed multiple myeloma was successfully completed.
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