In its first foray into the commercial drug world, small cap Galena Biopharma (GALE) said Thursday morning that it has officially launched Abstral® Sublingual Tablets in the United States. Delivering the medication in an “under the tongue” application, Abstral is indicated for pain in adults 18 and over who are already receiving, and tolerant of, opioid drugs for persistent cancer pain. It is the only fentanyl sublingual tablet for the management of this type of pain on the market today.
Galena, a Lake Oswego, Oregon-based cancer drug developer, acquired Abstral from Swedish specialty drugmaker Orexo AB in March for sale and distribution in the U.S. Per the deal, Galena paid Orexo $10 million upfront and is to pay another $5 million within one year, in addition to low double-digit royalties and one-time milestone payments based on pre-specified net sales.
The U.S. market for transmucosal immediate-release fentanyl, or TIRF, is estimated at $400 million. Investors are cautiously optimistic for Galena to penetrate the TIRF markets given the fact that about one-third of all cancer patients suffer from controlled breakthrough pain. In late-stage cancer patients, the percentage rises to approximately 80 percent.
The treatment was approved by the Food and Drug Administration in January 2011. Sales in Europe by ProStrakan/Kyowa Kirin in 2012 totaled $54 million. Abstral is also sold in Canada by Paladin Labs ($PLB:CA). In Japan, Kyowa Hakko Kirin has filed for approval of the drug.
"We believe Abstral delivers best in class performance because it is simple to carry, simple to use, and requires no special handling or disposal,” said Mark J. Ahn, president and chief executive at Galena in a statement today. “We have a commercial team of highly dedicated, patient-focused professionals with experience in both pain and oncology who have helped us reach this tremendous milestone for Galena."
In September, Galena raised approximately $32.6 million (net proceeds), a portion of which is earmarked for marketing of Abstral as well as its ongoing phase 3 clinical trial of NeuVax™, a drug in development for HER2-positive breast cancer patients.
Last week, Ahn signaled that the company was ready to roll-out Abstral this week. With that, shares have been on the move upward, rising from around $1.90 last week to a close at $2.29 on Tuesday, a 20 percent climb in six days. Shares have continued to rise in early Thursday trading, printing as high as $2.58 before pulling back to $2.44 for gains of another 6.5 percent at 11 AM ET as some traders appear to be “selling the news.”
Through Tuesday’s close, shares of GALE were up about 50 percent in 2013.