Galena Biopharma, a biopharmaceutical company commercializing and developing targeted oncology treatments that address major unmet medical needs to advance cancer care, in reporting its second-quarter results, highlights several company milestones, including its advances in taking Abstral® to market.
"We have made rapid progress toward successfully commercializing Abstral®," Mark J. Ahn, Ph.D., president and CEO, stated in the press release. "While the NeuVax™ PRESENT trial continues its enrollment and our other development programs advance, Galena has now evolved into a fully integrated biopharmaceutical company. Building our capabilities allows us to seize opportunities to better serve patients and increase shareholder value."
Abstral is the company's treatment option for breakthrough cancer pain (BTcP) in patients who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The Abstral formulation delivers the analgesic power of micronized fentanyl in a sublingual tablet, which dissolves under the tongue in seconds, designed to provide rapid relief that lasts the entire duration of the breakthrough pain episode. GALE points to key achievements toward the commercialization of Abstral:
•Scaled up commercial operations with field leadership, field sales, and account management teams in preparation for the official fourth quarter Abstral launch.
•Abstral now available commercially nationwide. Galena has secured stocking and distribution partnerships with major wholesalers and specialty distributors, and Abstral is available to patients and healthcare professionals at pharmacies nationwide. Established broad and easy access to patient assistance programs to ensure efficient and timely patient access to Abstral treatment.
GALE's lead product, NeuVax™, is the first adjuvant breast cancer vaccine to enter pivotal phase 3 clinical trials. NeuVax works by stimulating the body's own immune system to seek out and destroy micrometastatic cancer cells that may be circulating in a patient's body after their cancer treatment. The company is currently enrolling its randomized, multi-national phase 3 trial entitled PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax treatment). The study is being conducted under a Special Protocol Assessment (NYSE:SPA) granted by the FDA, and is currently enrolling in more than 130 clinical sites worldwide.
The company is also enrolling patients for a 300-patient phase 2b clinical trial to study NeuVax in combination with Herceptin®.
Also in the second quarter, GALE made changes to its management team and expanded its board of directors with the addition of experts in oncology commercialization:
•Christopher S. Lento joined Galena as its vice president of sales and commercial operations to launch Abstral. Lento has 20 years of experience in senior level positions managing the sales, business development and operations at major healthcare companies including Genentech BioOncology, Altos Solutions, Abraxis Bioscience (acquired by Celgene Corporation), and US Oncology Network.
•William L. Ashton joined GALE's board in May. He is a senior executive with more than 28 years of experience in biotechnology and pharmaceutical leadership and management. Most recently, at Amgen, Inc., he served as vice president of corporate and government affairs and vice president of sales, and was directly responsible for product launches, as well as interaction with key government agencies including the Centers for Medicare and Medicaid Services. After retiring from Amgen, Ashton joined the University of the Sciences in Philadelphia where he currently serves as associate provost and senior vice president of strategic business development, founding dean, Mayes College of Healthcare Business and Policy, and assistant professor of Pharmaceutical Business.
On the financial side, GALE's second-quarter operating loss was $7.9 million, including $0.5 million in stock-based compensation charges, compared with an operating loss of $5.7 million for the comparable quarter of 2012, which includes $0.2 million in stock-based compensation charges. However, with the impending Abstral launch and two promising therapies currently in clinical trials, investors are very optimistic about the financial performance expected in following quarters.
As of June 30, 2013, Galena had cash, cash equivalents, and marketable securities of $26.8 million, compared with $35.6 million as of December 31, 2012.
For more information, visit galenabiopharma.com
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