Elevar Therapeutics, Inc. (“Elevar”), a late-stage biopharmaceutical company focused on developing and commercializing promising therapies to address unmet needs in cancer, and Tanner Pharma Group (“Tanner”), a global provider of integrated specialty access solutions, today announced a partnership that will facilitate access to Apealea®( paclitaxel micellar) on a named patient basis in areas outside of the United States (U.S.) where Apealea is not 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, also known as an early or expanded access 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 will be the exclusive supplier of Apealea to health care providers outside of the U.S. on a named patient basis in countries where Apealea is not yet commercially available.
“We are excited to partner with Tanner to ensure patients outside of the U.S. who have no therapeutic alternatives are able to access to Apealea through a named patient program,” said Alex Kim, chief executive officer of Elevar Therapeutics.
“We are pleased to give hope to patients around the world through our partnership with Elevar for Apealea,” said Banks Bourne, chairman and founder of Tanner Pharma Group. “The named patient program will help ensure that patients who have no alternative therapeutic options for their disease receive access to Apealea in a manner that is reliable, responsible, ethical and in accordance with all local regulatory requirements.”
“We are delighted to see that patients and doctors in European countries outside the Nordic region, where Oasmia has already launched Apealea, will now get early access,” said Francois Martelet, CEO of Oasmia. “Elevar partnering with Tanner Pharma for a named patient program is a valid means to achieve that access outside of the US. We continue to support Elevar in the identification and selection of regional commercialization partners worldwide and will update our progress in due course.”