Galena Biopharma Inc. is a Portland, Oregon-based biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. The company's lead program, NeuVax, is for the treatment of HER2 1+ and 2+ breast cancer patients in the adjuvant setting. The company has initiated its phase 3 trial under an approved special protocol assessment. Galena's second program, Folate Binding Protein-E39 (FBP), is a targeted vaccine aimed at preventing the recurrence of ovarian, endometrial and breast cancers. A phase 1/2 trial has been initiated in ovarian and endometrial cancer.
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The Life Sciences Report Interview with Echo He
"The company's lead drug candidate, NeuVax (nelipepimut-S or E75), a cancer vaccine, is already in a phase 3 trial. . .we could see a potential regulatory approval of NeuVax sometime in 2017. . .we think NeuVax has a good chance of showing positive results."
TLSR: You wrote a note back in March about Galena's acquisition of a sublingual fentanyl product, a narcotic. You were so positive on this that you raised your target price 20%, from $5 to $6/share. . .
EH: . . .The contribution of the fentanyl product, Abstral, is near-term cash flow. Also, the company can train a small sales force to get experience in the oncology field. According to the management, the prescribers of sublingual fentanyl, which controls the breakthrough pain of cancer patients, would be the same oncologists who would prescribe vaccines to breast cancer patients. . .the company's valuation still primarily relies on the success of NeuVax. . .the company tends to be overlooked because investors don't have anything comparable to follow, and they don't know where to lay their confidence. I understand that. But from the scientific level, from the trial design, I think Galena has a good shot on this phase 3 trial."
Len Zehr, Seeking Alpha
"Galena Biopharma Inc. plans to make its recently acquired Abstral sublingual tablets the market leader for the treatment of breakthrough cancer pain in the U.S. . .Abstral is the transmucosal immediate-release fentanyl (TIRF) market leader in Europe. . .Abstral's advantages include rapid absorption into the oral mucosa, rapid onset of action compared with other TRIF's, the fact that the drug can be titrated quickly by physicians to meet the pain needs of patients, convenient administration under the tongue and a favorable side-effect profile."
Rahul Jasuja, Noble Financial
"[Enrollment in] Galena Biopharma Inc.'s Phase 3 NeuVax PRESENT trial (700 patients) is ongoing at over 125 sites worldwide. . .Abstral (sublingual fentanyl tablets) for breakthrough cancer pain is slated for commercial launch Q4/13; Abstral may have competitive advantages over other fentanyl-based products; peak sales [are projected at] $40–60M (in a $400M U.S. market) in 3–5 years."
Mara Goldstein, Cantor Fitzgerald
"Galena Biopharma Inc. has evolved into a peptide-based vaccine development company with a strong commercial focus, having acquired the U.S. marketing rights to Abstral, a drug for breakthrough cancer pain; this acquisition will likely bring a revenue component to the company beginning in Q4/13, but it is the clinical trials of the peptide-based vaccines that are the bulk of the company's valuation, in our view. The most advanced candidate, NeuVax, in phase 3 testing for prevention of recurrence of breast cancer in women at high risk for recurrence, targets low HER2 expressers and represents a new paradigm in treating patients."
Joseph Pantginis, ROTH Capital Partners
"We believe Galena Biopharma Inc. is well positioned for a successful outcome of the phase 3 NeuVax PRESENT study based on both optimized selection of dosing regimen (including boosting) and patient population. . .the company is on track to launch Abstral in the U.S. by year-end. . .we see two potential synergies for Abstral with Galena's drug development efforts: 1) It should allow for earlier detailing of physicians (especially those who treat breast cancer) in order to build relationships for NeuVax's anticipated success and 2) Projected revenues could help to manage the company's burn rate effectively."
Galena Biopharma Inc. Content
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