On December 1, 2020 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, and Tanner Pharma Group ("Tanner"), a global provider of integrated specialty access solutions, reported that they have launched a global named patient program to facilitate access to Apealea (paclitaxel micellar) on a named patient basis in areas outside of the United States (U.S.) and Middle East North Africa (MENA) where Apealea is not yet commercially available (Press release, Elevar Therapeutics, DEC 1, 2020, View Source [SID1234572062]). Apealea has been approved by the European regulatory authorities 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.

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A named patient program is a mechanism through which physicians can legally and ethically prescribe investigational or approved drugs for patients prior to their commercial availability. Under the terms of the agreement, Tanner is the exclusive supplier of Apealea to healthcare providers outside of the U.S. and MENA on a named patient basis in countries where Apealea is not yet commercially available.

Healthcare professionals can obtain details about the Apealea Access Program by contacting Tanner at:

About Apealea (paclitaxel micellar)

Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and esophageal cancer, as well as other types of solid tumor cancers. Cremophor EL, is a toxic formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel and is associated with allergic reactions. Apealea received market authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer.

In a pivotal clinical study comparing Apealea to Cremophor-containing Taxol, Apealea preserved activity of paclitaxel with similar overall survival and progression-free survival rates with a comparable safety and tolerability profile despite higher drug load. Less pre-treatment, shorter infusion times, and reduction of Cremophor EL-associated side effects were also observed.