"We are pleased to partner with taiba for the registration and commercialization of Apealea® (paclitaxel micellar) in the Middle East and North Africa, which marks the beginning of our expansion to global markets," said Alex Kim, chief executive officer of Elevar Therapeutics. "Regional partners with strong experience in oncology and well-established local relationships, such as taiba, are an integral part of our strategy to grow our portfolio and elevate treatment experiences and outcomes for patients. If regulatory approval is obtained, Apealea will be the first Cremophor free formulation of paclitaxel approved for use in ovarian cancer in the MENA region."
Under the terms of the agreement, taiba will be responsible for managing named-patient requests through which physicians can legally and ethically prescribe Apealea for patients prior to commercial availability. Taiba will be responsible for sales, marketing, medical and distribution in this region. The partnership agreement will include royalties and arrangements for manufacturing and supply.
"Taiba is committed to providing people of the MENA region with access to high quality treatments like Apealea® (paclitaxel micellar), which has the potential to improve clinical outcomes for patients with limited treatment options," said Dr. Saif-Al Hasani, chief executive officer of taiba. "We are pleased to add Apealea to our distinguished portfolio of treatments and we look forward to partnering with Elevar to help bring Apealea to patients and their healthcare providers throughout the MENA region."
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 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.
Healthcare professionals can obtain details about the Apealea Access Program by contacting:
About taiba Healthcare Group
Taiba is a leading specialty marketing, sales and distribution company in the MENA region, providing innovative treatments to patients suffering from orphan and rare diseases. Taiba's vision is to cover the unmet medical need in its region, providing high quality products and a high level of service to healthcare organizations and hospitals, with a commitment to patient treatment. Taiba's focus is addressing the needs of specialty and rare disease patients and providing them with access to innovative medicines, either through named patient sales or commercialization. Over the last ten years, taiba has earned a reputation as a leading regional company in its segment and currently represents leading multinational companies that are pioneers in their fields such as Alnylam, Alexion, Aegerion, Biomarin, Chiesi, Dyax, Genzyme, Lucane, Veloxis and Vertex.
Elevar Media Contact:
Elixir Health Public Relations
Taiba Middle East FZ LLC
SOURCE Elevar Therapeutics
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