Each year, nearly 1.6 million new cases of cancer are diagnosed in the United States, excluding skin cancer, making it the second leading cause of death. It is estimated that at least 40 percent of cancer patients experience episodes of breakthrough pain multiple times per day, each lasting roughly 30 minutes. Breakthrough pain is generally defined as chronic pain for which a patient must take a long-term analgesic for relief.
It is for this indication that small-cap biopharmaceutical company Galena Biopharma plans to launch Abstral, an FDA-approved therapy for breakthrough cancer pain in opioid-tolerant cancer patients. Abstral is the first and only fentanyl sublingual tablet for pain management in this context. The formulation rapidly dissolves under the patient’s tongue in a matter of seconds, providing pain relief within minutes and lasting through the duration of the entire pain episode.
Abstral has garnered favorable analyst attention following positive phase 2 results and expectations for ongoing phase 3 clinical trials.
JMP Securities has assigned GALE stock with a Market Outperform rating and a price target of $5, with analysts stating, “We believe that a clear scientific rationale, well-established therapeutic target, and encouraging phase 2 results are supportive of a favorable probability of success in the ongoing phase 3 trial. Additionally, we see upside from the expected 4Q13 launch of Abstral, an approved rapid-onset, sublingual fentanyl tablet in the established cancer breakthrough pain market.”
Roth Capital Partners issued similar sentiment on GALE, initiating a Buy rating on the stock with price target of $7, highlighting GALE’s opportunity for collaboration for Abstral and GALE’s lead candidate, NeuVax.
“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’ anticipated success and 2) projected revenues could help to manage the company’s burn rate effectively,” the firm previously stated.
The $400 million U.S. fentanyl market is currently dominated by Cephalon (CEPH) and Teva (TEVA), which controls the largest piece of the fentanyl market in the U.S. with $161 million in annual sales.
GALE is preparing to take its own shot in the fentanyl market with the commercial release of Abstral in the U.S. slated for the fourth quarter of 2013. The company anticipates revenues between $1.5 million-$3 million in 2013, $8 million-$12 million in 2014, and peaking at $40 million-$60 million in revenues in three to five years, assuming a 10-15 percent market share.
For more information, visit www.GalenaBioPharma.com
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