Apealea (paclitaxel micellar)

Apealea® (paclitaxel micellar)

Apealea® (paclitaxel micellar) is a non-Cremophor based formulation of paclitaxel. It received market authorization by the European Commission in November of 2018, making it Europe’s first non-Cremophor formulation of paclitaxel approved for use in ovarian cancer. Branded as Paclical® in certain countries, Apealea® was developed by Oasmia Pharmaceutical AB in Sweden utilizing their proprietary XR17 micelle platform technology. In its pivotal clinical study comparing to Taxol®, Apealea® preserved activity of paclitaxel with similar OS and PFS with a comparable safety and tolerability profile despite higher drug load. Pre-treatment, shorter infusion times, and reduction of Cremophor-associated side effects were also observed.

Elevar Therapeutics licensed the global rights for Apealea® with the exception of Nordics, Russia, and select CIS countries. The Company intends to file for market authorization in the US where Apealea® has been registered as a orphan indication. Elevar is also seeking partners for commercial launch in key regions worldwide.

Technical Description

Apealea® is a patented, water-soluble, intravenously injectable formulation of paclitaxel. It was developed using a proprietary solubilization technology platform developed by Oasmia Pharmaceutical AB in Sweden. Taxol® is one of the most well-known chemotherapy agents used to treat breast, ovarian, lung, bladder, prostate, melanoma, and gastric/esophageal cancer, as well as other types of solid tumor cancers. However Taxol® and its generics are formulated using Cremophor-EL which is highly toxic, requires long infusion times, and can cause cause serious hypersensitive allergic reactions requiring premedication with steroids and antihistamines. Apealea® has been authorized for marketing by the European Commission for use in combination with carboplatin in adult patients with a first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.