Galena Biopharma Inc. has a bit of a wait ahead of it.
The biotech initiated a Phase III trial testing NeuVax (nelipepimut-S) as an adjuvant breast cancer treatment at the beginning of 2012. The 700-patient PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial is expected to complete enrollment by the end of the year.
The trial, conducted under a special protocol assessment, will measure disease-free survival at three years or 139 events, defined as the recurrence of cancer.
While it's waiting, Galena, of Lake Oswego, Ore., decided to license a product that it could market now.
"We looked at a bunch of different ideas," Mark Ahn, Galena's president and CEO told BioWorld Insight. "From a strategy perspective what we were trying to do was build value."
Last week, the biotech secured its value-build with the license of Orexo AB's Abstral (fentanyl) Sublingual Tablets. The drug was approved by the FDA in January 2011. Galena expects to launch Abstral in the fourth quarter.
Galena will pay $10 million up front and $5 million within the first 12 months of closing, funded through a non-dilutive debt financing, for the rights to market the drug in the U.S. It's also agreed to pay low double-digit royalties and one-time payments based on undisclosed pre-specified net sales milestone.
Abstral is approved for the treatment of breakthrough cancer pain in patients who aren't receiving adequate pain relief from opioid therapy.
Fentanyl is approved in other dosage forms including Fentora, a buccal tablet, and Actiq, a transmucosal lozenge, both sold by Jerusalem-based Teva Pharmaceutical Industries Ltd.
Abstral offers an advantage over tablets or lozenges because the sublingual tablet dissolves under the tongue within seconds. By entering the blood stream in the mouth, the drug avoids first-pass metabolism by liver enzymes, increasing bioavailability. "It gets the drug on board quickly and matches the PK profile of the pain," Ahn said.
Avoiding the gut also reduces complications with constipation, a common problem for patients taking large amounts of opioids.
Part of Abstral's appeal for Galena was the potential to build relationships with physicians that will prescribe NeuVax if it's approved in a few years. Because of the high likelihood of metastasizing to the bone, breast cancer patients are among the largest users of drugs to control breakthrough cancer pain. "It's a bridge to future prescribers of NeuVax," Ahn said.
The idea of in-licensing a drug to build a sales force isn't new. Cephalon Inc. signed a co-promotion agreement with Bristol-Myers Squibb Co. to market Stadol NS (butorphanol tartrate) before preparing to market Provigil (modafinil). And Acorda Therapeutics Inc. acquired the U.S. rights to Zanaflex (tizanidine) from Elan Corp. plc to establish a sales force before gaining approval of Ampyra (dalfampridine). (See BioWorld Today, Aug. 3, 1994, and July 30, 2004.)
Ahn said Galena will need at least 30 sales reps to market Abstal. The company is leaning toward hiring an internal sales force, but hasn't made a final decision yet.
Abstral won't necessarily make Galena profitable. "We think we can get 10 to 15 percent of the $400 million market in three to five years," Ahn said, putting potential revenue in the $40 million to $60 million range.
But it isn't a loss leader either. Ahn said Abastral will deliver positive cash flow within two years, helping cut down on the cash burn as Galena waits for NeuVax data.