Oasmia Pharmaceutical AB notes that its partner 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 for a named patient program that will facilitate access to Apealea 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.
“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 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, Chief Executive Officer 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 identification and selection of regional commercialization partners worldwide and will update our progress in due course.”
For more information:
Oasmia Pharmaceutical AB
Francois Martelet, Chief Executive Officer
Michael af Winklerfelt, Chief Financial Officer
Phone: +46 18-50 54 40
E-mail: IR@oasmia.com
Consilium Strategic Communications
Jonathan Birt, Chris Welsh
Phone: +44 (0)20 3709 5700
E-mail: oasmia@conailium-comms.com
About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops, manufactures, markets and sells an improved generation of drugs within human and veterinary oncology. Oasmia produces novel formulations of well-established cytostatic agents which show improved performance, an improved side-effect profile and a wider range of therapeutic areas compared with existing alternatives. Product development is based on Oasmia’s proprietary technology platform XR-17. Oasmia has been successful in driving its first product candidate, Apealea® (paclitaxel micellar), through clinical development, and has applied for and achieved market approval in the European Union and other territories. Oasmia is in the process of transitioning into the commercialization phase of the product Apealea and making the product accessible to patients via its partnership with Elevar and its existing operations and partnerships in its retained territories.
About Elevar Therapeutics
Elevar Therapeutics (formerly LSK BioPharma) is a late-stage biopharmaceutical company focused on developing and commercializing promising therapies to address unmet needs in cancer. Elevar Therapeutics’ lead proprietary drug candidates include rivoceranib (apatinib), a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors, and Apealea® (paclitaxel micellar), a non-Cremophor based formulation of paclitaxel. Apealea received market authorization by the European Commission in November of 2018, making it Europe’s first Cremophor-free formulation of paclitaxel approved for use in ovarian cancer. Elevar Therapeutics has locations in Utah, California and South Korea, and additional information is available at www.elevartherapeutics.com.
About Apealea® (paclitaxel micellar)
Apealea® is a patented, water-soluble, intravenously injectable formulation of paclitaxel, developed using Oasmia’s proprietary technology platform – XR-17 – which facilitates the formulation of paclitaxel without Cremophor. 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. 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. It is Europe’s first Cremophor-free formulation of paclitaxel approved for use in ovarian cancer.
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 http://www.tannerpharma.com.
Elevar Media Contact:
Elixir Health Public Relations
Lindsay Rocco
(862) 596-1304
lrocco@elixirhealthpr.com
Tanner Pharma Group Media Contact:
CBQ Communications
Christine Quern
617.650.8497
cq@christinequern.com