Last $2.14 USD
Change Today +0.08 / 3.88%
Volume 1.5M
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As of 8:10 PM 10/29/14 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

4640 SW Macadam Avenue

Suite 270

Portland, OR 97239

United States

Phone: 855-855-4253

Fax:

Galena Biopharma, Inc., a biopharmaceutical company, focuses on developing and commercializing targeted treatments that address major unmet medical needs to advance cancer care. Strategy The company’s strategy is to build value for patients and shareholders by achieving revenue goals for Abstral (fentanyl) sublingual tablets, to which it acquired for the U.S. rights in March 2013 and launched in 2013; completing the pivotal Phase 3 randomized, multicenter PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment) study of its primary product candidate, NeuVax (nelipepimut-S) in 700 patients under a U.S. Food and Drug Administration (FDA)-approved Special Protocol Assessment (SPA); completing the Phase 2b randomized, multicenter clinical trial in 300 patients to study NeuVax in combination with Herceptin (trastuzumab; Genentech/Roche); completing the Phase 2 clinical trials of GALE-301 (folate binding protein (FBP)) cancer immunotherapy trials in both ovarian and endometrial cancers; initiating a Phase 2 clinical trial with GALE-401 (anagrelide controlled release (CR)), which it acquired in January 2014, in essential thrombocythemia (ET); and pursuing strategic alliances and acquisitions of other cancer treatments to complement its existing product pipeline and commercialization capabilities. Establishing Commercial Capabilities Abstral (fentanyl) Sublingual Tablets The company’s primary commercial product, Abstral (fentanyl) Sublingual Tablets, is a major treatment option for inadequately controlled breakthrough cancer pain (BTcP). Abstral is approved by the FDA as a sublingual (under the tongue) fentanyl tablet only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The Abstral formulation delivers the analgesic power and increased bioavailability of micronized fentanyl in a convenient sublingual tablet, which is designed to dissolve under the tongue in seconds, provide relief of breakthrough pain within minutes, and match the duration of the pain episode. Abstral is available throughout the United States, with full launch of the product having commenced in the fourth quarter of 2013. Sales, distribution and marketing: The company has established an experienced specialty sales force in the United States, including sales management, account management, managed care and product access management, and field sales personnel. Patient Support Services: The company launched Galena Patient Services (GPS), a full service support program overseen by a third party vendor, designed to navigate patient access to its products. Regulatory Compliance: The company has established required internal processes and reporting to ensure the full compliance with applicable Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) requirements. Developing Novel Cancer Immunotherapies The company is developing peptide vaccine (off-the-shelf) cancer immunotherapies, which address major patient populations of cancer survivors to prevent recurrence of their cancers. NeuVax (nelipepimut-S) NeuVax (nelipepimut-S), the company’s primary cancer immunotherapy, is being developed for the prevention of cancer recurrence in 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, nelipepimut-S peptide, is combined with the immune adjuvant, recombinant human granulocyte macrophage-colony stimulating factor for administration. NeuVax is a targeted cancer immunotherapy for approximately 30,000-40,000 of the 230,000 breast cancer patients annually diagnosed in the US who are at high risk of their breast cancer recurring, which the company refers to as disease recurrence, after achieving remission (or becoming a survivor) with standard therapy (surgery, chemotherapy, radiation). In

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Price/Book 8.6x
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TEV/Sales 27.8x
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