Galena Biopharma, Inc., a biopharmaceutical company, focuses on developing and commercializing targeted treatments that address major unmet medical needs to advance cancer care. The company’s development portfolio ranges from mid- to late-stage clinical assets. NeuVax (nelipepimut-S) is in Phase 3 clinical trial. NeuVax (nelipepimut-S) NeuVax (nelipepimut-S), the company’s primary product candidate, is a targeted cancer immunotherapy and is being developed for the prevention of cancer recurrence in human epidermal growth factor receptor (HER2) expressing cancers. NeuVax is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast and gastric carcinomas. The NeuVax vaccine is combined with granulocyte macrophage-colony stimulating factor (GM-CSF) for injection under the skin, or intradermal administration. GALE-301 (folate binding protein or FBP) The company’s second immunotherapy product candidate, GALE-301, targets FBP receptor-alpha, a therapeutic target, which is highly over-expressed (20-80 fold) in ovarian, endometrial and breast cancers. GALE-301 is an immunogenic peptide and can stimulate CTLs to recognize and destroy FBP-expressing cancer cells. GALE-301 consists of an FBP peptide combined with GM-CSF, and is in a Phase 2a clinical trial for the prevention of recurrence in patients with ovarian and endometrial cancers. GALE-401 (anagrelide controlled release (CR)) In 2014, the company announced the acquisition of the worldwide rights to anagrelide CR, which it renamed GALE-401, through its acquisition of Mills Pharmaceuticals, LLC. GALE-401 contains the active ingredient anagrelide, an the U.S. Food and Drug Administration (FDA) approved product, for the reatment of patients with myeloproliferative neoplasms (MPNs) to lower abnormally elevated platelet levels. MPNs are a closely related group of hematological malignancies in which the bone marrow cells that produce the body's blood cells develop and function abnormally. Abstral (fentanyl) Sublingual Tablets The company’s first commercial product, Abstral (fentanyl) Sublingual Tablets, is an important treatment option for inadequately controlled breakthrough cancer pain (BTcP), which affects approximately 50% of all cancer patients. Abstral is a transmucosal immediate release fentanyl (TIRF) product with product class oversight by the TIRF Risk Evaluation and Mitigation Strategy (REMS) access program. Abstral is manufactured for the company by contract manufacturers and it distributes and sells Abstral in the U.S. through its commercial organization. Zuplenz (ondansetron) Oral Soluble Film In 2014, the company expanded its commercial portfolio through the licensing of its second commercial product, Zuplenz (ondansetron) Oral Soluble Film, from MonoSol Rx, LLC. Zuplenz is approved by the FDA in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved in pediatric patients treated with moderately emetogenic CINV. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation. Out-License Agreements In 2012, the company entered into a license and supply agreement with ABIC Marketing Limited, a subsidiary of Teva Pharmaceuticals (ABIC). Under the agreement, the company granted ABIC exclusive rights to seek marketing approval in Israel for its NeuVax product candidate for the treatment of breast cancer following its approval by the FDA or the European Medicines Agency, and to market, sell and distribute NeuVax in Israel assuming such approval is obtained. In 2014, the company entered into a strategic development and commercialization partnership with Dr. Reddy's Laboratories Ltd. (Dr. Reddy's), under which it licensed commercial rights in India to Dr. Reddy's for NeuVax in breast and gastric cancers. Strategy The company’s clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. The key elements of the company’s strategy include developing novel cancer immunotherapies; expanding its development pipeline; and maintaining commercial capabilities. Competition Marketed products against which the company directly competes include Teva Pharmaceutical Industries Ltd.’s Fentora and Actiq, Insys’s Subsys, and Depomed Inc's Lazanda.. Some generic fentanyl products against which Abstral competes are marketed by Mallinckrodt, Inc., Par Pharmaceutical Companies, Inc. and Actavis, Inc. The major branded competitor for ondansetron is GlaxoSmithKline, PLC's Zofran. History The company was founded in 2003. It was incorporated as Argonaut Pharmaceuticals, Inc. in Delaware in 2006 and changed its name to RXi Pharmaceuticals Corporation in November 2006. In 2011, the company changed its name to Galena Biopharma, Inc.
galena biopharma inc (GALE:NASDAQ CM)
4640 SW Macadam Avenue
Portland, OR 97239
Fax: 503- 400-6611www.galenabiopharma.com
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