Date: 2016-02-02
Type of information: Licensing agreement
Compound: Aplidin® (plitidepsin)
Company: PharmaMar (Spain) Specialised Therapeutics Asia Pte (Singapore)
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. Plitidepsin is the second anti-tumour compound to be developed by
PharmaMar from a marine organism. It has been granted orphan drug status by the regulatory agencies in Europe (EMA) and the US (FDA) in 2004.
Disease: hematological cancers
Details: * On February 2, 2016, PharmaMar announced an agreement with Singapore-based Specialised Therapeutics Asia Pte, Ltd (STA) to market marine-based anti-tumour compound Aplidin® (plitidepsin) for the treatment of haematological tumours in 12 Asian countries: Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Myanmar, Papua New Guinea, Philippines, Singapore, Thailand and Vietnam. A number of clinical trials are currently under way in relapsed/refractory multiple myeloma, such as the ADMYRE phase III trial, as well as a Phase II trial in T-cell lymphoma. Under the terms of the agreement, PharmaMar is entitled an upfront payment, recurring payments for sales, and additional remuneration for sales and regulatory milestones attained by Aplidin® (plitidepsin). PharmaMar will retain exclusive production rights and will supply the product to STA for sale in those 12 Asian countries.
Financial terms:
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