Apealea^®

Apealea^® (paclitaxel micellar)

Apealea^® (paclitaxel micellar) is a non-Cremophor based formulation of paclitaxel. It received market authorization by the European Medicines Agency (EMA) 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 PFS. No pre-treatment for hypersensitivity was needed and Apealea was able to be infused over a much shorter time.

Elevar Therapeutics licensed the global rights for Apealea^® with the exception outside of Russia and select CIS countries. The company intends to file for market authorization in the US where Apealea^® has received an orphan drug designation in ovarian cancer indication.

Elevar has licensed the commercialization rights of Apealea in Europe to Inceptua Group and in the Middle East and North Africa (MENA) region to Taiba Middle East FZ LLC.

Technical Description

Apealea^® is a patented, water-soluble, intravenously injectable non-cremophor based formulation of paclitaxel. It was developed using a proprietary Vitamin A based solubilization technology platform developed by Oasmia Pharmaceutical AB in Sweden. Paclitaxel 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. Apealea^® has been authorized for marketing by the European Medicines Agency (EMA) 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.

Publications

• Gynecologic Oncology: Phase 3 Publication of Efficacy & Safety Results Comparing Paclitaxel Micellar & Cremophor EL-Paclitaxel