SALT LAKE CITY and CHARLOTTE, N.C., Dec. 1, 2020 /PRNewswire/ — 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, announced today 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. 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.
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.
About Elevar Therapeutics
Elevar Therapeutics (formerly LSK BioPharma) is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidates include rivoceranib (apatinib) and Apealea® (paclitaxel micellar). Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer (China, Dec 2014). It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide in numerous cancer indications. Apealea® (paclitaxel micellar) is a non-Cremophor EL based formulation of paclitaxel that 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. Elevar Therapeutics has offices in Utah, California and South Korea, and additional information is available at www.elevartherapeutics.com.
About Tanner Pharma Group
Tanner Pharma Group is a specialist pharmaceutical services provider based in Charlotte, USA with offices in Europe and Latin America. Over 18 years, Tanner has developed a portfolio of service offerings focused on improving the global access to medicines. Through its Managed Access Programs division, Tanner supports manufacturers by providing ethical, controlled and compliant access to their innovative medicines in countries where they are not commercially accessible. For more information, visit www.tannerpharma.com.
Elevar Media Contact:
Elixir Health Public Relations
Tanner Pharma Group Media Contact:
SOURCE Elevar Therapeutics
About Tanner Pharma Group
For over 16 years, Tanner Pharma Group has partnered with biopharmaceutical companies to provide turn-key commercialization solutions to increase patient access to medicines around the world. By partnering with Tanner Pharma, biotech and pharma companies are able to focus on their primary markets while ensuring that patients in international markets of need are receiving their products through a strictly controlled channel.
Tanner Pharma believes that access to medicines should have no borders and measures its value as a company based on the lives it helps to improve. With an unparalleled blend of local market knowledge, international supply chain expertise across more than 130 countries, and high regulatory compliance and quality standards, it provides tailored solutions to biopharmaceutical companies outside their core markets of focus.
Headquartered in the U.S., Tanner’s reach includes Europe, Northeast Asia, Southeast Asia, the Middle East, Australia, Canada and Latin America, including Brazil, Mexico, the Caribbean, Central America and all of South America.
For more information about Tanner Pharma Group, please visit www.tannerpharma.com.