Galena Biopharma is a developer of targeted oncology treatments designed to address major unmet medical needs to advance cancer care. As part of its overarching goals, Galena is seeking commercialization partners for its current clinical programs.
The company’s clinical development pipeline is headed by NeuVax™, which has been granted by the FDA a Special Protocol Assessment (SPA) for a phase 3 clinical trial testing the product’s efficacy to prevent breast cancer recurrence. NeuVax is currently undergoing this phase 3 testing in combination with Herceptin®; phase 2 for breast cancer; and phase 1 for prostate cancer.
Galena is also developing Folate Binding Protein-E39 (FBP), a targeted vaccine aimed at preventing the recurrence of ovarian, endometrial and breast cancers. FBP is in phase 1 studies for this indication.
The company in October officially launched Abstral®, its sublingual (under the tongue) rapid-acting formulation of fentanyl for the management of breakthrough cancer pain in patients who are tolerant to background opioid pain-relief therapy.
When the company earlier this month reported third-quarter revenues of $1.2 million, the results reflected significant contribution of Abstral sales ahead of the product’s official launch and promotional efforts slated for the fourth quarter.
Abstral has achieved considerable success as the leading rapid acting fentanyl product in Europe, where it achieved full-year sales of $54 million by ProStrakan/Kyowa Hakko Kirin in 2012. By the second half of 2012, the average volume market share of Abstral in the major European markets reached 29%. Abstral is marketed in Canada by Paladin Labs, and has been filed for regulatory approval in Japan by Kyowa Hakko Kirin Co Ltd.
The U.S. market for rapid acting fentanyl products is also growing, and in 2012 reached $400 million. Based on this trend and the company’s initial commercial success with Abstral, Galena said it expects to see continued growth in the fourth quarter of 2013 and fiscal 2014.
For more information, visit www.galenabiopharma.com
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