Date: 2014-07-14
Type of information: Licensing agreement
Compound: Aplidin® (plitidepsin)
Company: PharmaMar, Zeltia Group (Spain) Chugai Pharmaceutical (Japan)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: licensing
Action mechanism: Aplidin® (plitidepsin) is an antitumour agent of marine origin, originally isolated from the marine tunicate Aplidium albicans, and currently obtained by chemical synthesis. This marine-derived cyclodepsipeptide is PharmaMar\'s second most advanced compound. It is currently in phase II clinical trials for solid and haematological malignant neoplasias like T cell lymphoma and in phase III clinical trials for multiple myeloma. Aplidin® has been designated an orphan drug by the European Commission (EC) and the FDA for multiple myeloma (MM).
Disease: multiple myeloma
Details: * On July 14, 2014, Zeltia and Chugai Pharmaceutical announced that they have entered into a license agreement where Chugai Pharma Marketing would promote PharmaMar’s Aplidin® for the treatment of multiple myeloma in eight European countries (France, Germany, the UK, Belgium, the Netherlands, Luxemburg, Ireland and Austria). The Phase III trial (ADMYRE) for the treatment of relapsed and refractory multiple myeloma is currently ongoing. Aplidin® showed a favorable safety profile and efficacy in combination with dexamethasone vs. dexamethasone alone in the Phase II trial. Submission of a marketing authorisation application (MAA) in Europe is expected in 4Q 2015. The dossier for EU approval will also be valid for more than 40 countries outside the EU and PharmaMar is looking into opportunities to license the compound in those territories. Aplidin® has orphan designation for multiple myeloma in Europe.
Financial terms: Under the terms of the agreement, PharmaMar receives an upfront payment of € 5 million and will be eligible for more than € 30 million related to the regulatory, development and sales milestones. PharmaMar will retain exclusive production rights and will sell the product to Chugai for commercial use.
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