Apealea (paclitaxel micellar) is a patented solvent-free formulation: it applies paclitaxel – a cornerstone within chemotherapy for many different forms of cancer – through Vivesto’s XR-17 technology platform. Apealea is approved by the European regulatory authority EMA for use in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Apealea has also received orphan drug designation from the US regulatory authority FDA for the treatment of epithelial ovarian cancer, which could entail several potential benefits, including seven years of market exclusivity.
|Product||Indication||Pre-clinical||Phase I||Phase II||Phase III||Registration/ approval||Commercial Launch||Geography|
|Apealea/ Paclical (paclitaxel)||Ovarian cancer||EU/EEA|
Global partnership with Elevar Therapeutics, Inc.
In March 2020 Vivesto signed a global licensing agreement with US-based Elevar Therapeutics Inc. for the further development and commercialization of Apealea. The agreement gives Elevar exclusive rights to develop and commercialize Apealea globally, with the exception of the Nordics, Baltics, Russia and the Commonwealth of Independent States, which remained as Vivesto’s territory.
The agreement includes milestone payments of up to USD 678 million depending on achievement of future sales milestones, clinical development milestones and regulatory approval milestones. Elevar will also pay Vivesto double-digit royalties on sales of Apealea. Vivesto received USD 20 million as an upfront payment.
Commercialization in Europe by Inceptua Group
In December 2020 Elevar Therapeutics signed a licensing agreement with Inceptua Group for the commercialization of Apealea in Europe, excluding the Nordics and Baltics.
In June 2021 Vivesto entered into an agreement to transfer the rights for the Nordics and Baltics to Inceptua Group. Under the terms, Inceptua obtains the rights to commercialize Apealea throughout the whole of Europe. Vivesto will be eligible for double-digit royalties on sales.
Regional partnership with FarmaMondo Group for Russia and CIS
In September 2021 Vivesto entered a license agreement with the Swiss-based FarmaMondo Group for the commercialization of Paclical® (Apealea) in Russia and the Commonwealth of Independent States. Under the terms of the agreement, the marketing authorizations which Vivesto holds in Russia and Kazakhstan are transferred to FarmaMondo. FarmaMondo is responsible for all future development and commercialization activities in Russia and the Commonwealth of Independent States, which includes Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, and Uzbekistan. Vivesto will supply FarmaMondo with Paclical and will receive product supply revenues.