Healthcare Industry News: paclitaxel micellar
News Release - May 26, 2020
Elevar Therapeutics Appoints Mark Gelder, M.D. as Global Head of Medical AffairsSALT LAKE CITY, May 26, 2020 -- (Healthcare Sales & Marketing Network) -- Elevar Therapeutics, Inc., a late-stage biopharmaceutical company focused on developing and commercializing promising therapies to address unmet needs in cancer, today announced that Mark Gelder, M.D. has been named vice president of medical affairs, effective immediately. Dr. Gelder will build and lead Elevar's global medical organization, ensuring scientific and strategic alignment for scientific communication and evidence generation activities that support Elevar's pipeline, new product launches and lifecycle opportunities.
"We are pleased to welcome Mark whose extensive experience as a clinician and pharmaceutical physician as well as his strong track record in global medical and scientific affairs will be a tremendous asset in optimizing the value of our pipeline and accelerating our growth as a global biotechnology company," said Alex Kim, chief executive officer of Elevar. "Our lead drug candidate, rivoceranib (apatinib), is progressing through several late-stage clinical trials targeting some of the largest unmet medical needs in oncology, while Apealea® (paclitaxel micellar) is Europe's first Cremophor-free formulation of paclitaxel approved for use in ovarian cancer. We are pursuing filings with the U.S. FDA for both products while in discussions with potential partners for registrations and commercial launches in other regions. As our portfolio expands, we are responding by strengthening our medical affairs infrastructure and strategy – and we are thrilled to have Mark onboard to help advance the clinical and pre-commercial development of Elevar's pipeline."
"This is a very exciting time to be joining Elevar," said Mark Gelder, M.D., vice president of medical affairs at Elevar. "I am excited to contribute towards the advancement of Elevar's pipeline with a team that combines the nimbleness of a start-up with the expertise and rigor of a mature biotechnology company. I look forward to working closely with Elevar's leadership to drive the continued success of the Company as we work together to deliver promising new therapeutic options for underserved patients."
Dr. Gelder brings 17 years of global medical affairs experience leading therapeutic oncology programs for companies like Pfizer, Wyeth and Bayer, where he was involved in the approval and launch of several cancer therapeutics. He has also led successful global trials, launch plans and Phase I-Phase IV studies for several emerging oncology organizations and has been instrumental in the approval and launch of numerous oncology products.
Dr. Gelder earned his medical doctorate from the University of Virginia School of Medicine and completed his residency training internal medicine and obstetrics and gynecology followed by a gynecologic oncology fellowship. He is a Fellow of the American College of Physicians and the American College of Obstetrics and Gynecology and has extensive clinical experience in both the academic and private practice settings. Prior to joining the industry, Dr. Gelder was an investigator in multiple clinical trials and has authored numerous scientific papers in the areas of women's health and oncology.
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 – XR17 – 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 Rivoceranib (Apatinib)
Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China to treat advanced gastric cancer in 2014 and is marketed by the Chinese-territory license-holder, Jiangsu Hengrui Medicine Co., Ltd. Elevar Therapeutics holds the global rights (ex-China) to rivoceranib. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. Elevar Therapeutics has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the U.S. Food and Drug Administration (FDA), as well as the Ministry of Food and Drug Safety (MFDS) in South Korea.
Source: Elevar Therapeutics
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