Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that it has entered into an exclusive agreement with Inceptua Group (“Inceptua”) for the distribution and commercialization of Apealea® (paclitaxel micellar) in Europe. Apealea has been authorized by European regulatory authorities for use in the European Economic Area 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.
“We are very pleased to announce our partnership with Inceptua to make Apealea® (paclitaxel micellar) available to patients with ovarian cancer in Europe,” said Alex Kim, Chief Executive Officer of Elevar Therapeutics. “Apealea is the only non-Cremophor based paclitaxel treatment approved in Europe for ovarian cancer, providing a treatment option with a higher paclitaxel dose and shorter infusion time without mandatory premedication versus Cremophor-based paclitaxel. Inceptua’s proven capabilities to develop and commercialize oncology and orphan treatments in Europe make them the ideal partner to accelerate access to Apealea in this important region. This agreement further propels progress for Apealea development and commercialization, an important step in Elevar’s strategy to optimize the value of its portfolio in global markets.”
Under the terms of the agreement, Inceptua will have exclusive rights to distribute and commercialize Apealea in Europe. These rights do not extend to the Nordic countries (Denmark, Finland, Norway, Sweden, Iceland).
“We are delighted to enter into this agreement with Elevar to commercialize Apealea® (paclitaxel micellar) in Europe,” said Stefan Fraenkel, Chief Executive Officer of Inceptua. “We believe there is great potential for Apealea to help patients with ovarian cancer who cannot tolerate paclitaxel formulated with Cremophor, and we look forward to leveraging our established sales force, distribution networks, and market access capabilities to bring this important treatment to patients and healthcare providers throughout Europe.”
Apealea® (paclitaxel micellar) is a non-Cremophor based formulation of paclitaxel. It received marketing authorization from the European Commission in 2018, which was the first approval in Europe for a non-Cremophor EL paclitaxel in ovarian cancer and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).