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Galena Biopharma (GALE) Launches New Product for Cancer Pain

By  +Follow October 3, 2013 5:04AM
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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.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer


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Results for GALE
Capital Market Labs
28 Mar 15 13:17:54
$GALE vs. $SPPI vs. $ENTA vs. $HPTX Compared Across 9 Critical Measures Chart: http://t.co/tLnxGrXt68
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28 Mar 15 11:11:06
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28 Mar 15 09:06:34
$GALE Information for Galena Biopharma, Inc. From our Stock News Alerts App
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28 Mar 15 07:23:17
$GALE had some decent ah buying Friday 1.41
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alexander
27 Mar 15 20:05:42
Commented on StockTwits: no doubut about it... $GALE shitty management caused this stock to become worthless. all... http://t.co/09aLhByzF1
BuyersStrike
27 Mar 15 17:36:36
With everything else going on this week, easy to miss that $GALE obv has been having trouble enrolling patients into its scamvax+hercept p2.
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27 Mar 15 14:23:09
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27 Mar 15 13:12:10
$GALE tripled down
alexander
27 Mar 15 12:52:09
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alexander
27 Mar 15 12:17:14
$GALE amazing how many pumpers are still active on this board ....
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27 Mar 15 12:07:51
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27 Mar 15 11:47:41
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27 Mar 15 10:39:30
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27 Mar 15 10:39:14
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27 Mar 15 10:29:16
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27 Mar 15 10:23:17
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27 Mar 15 10:22:01
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Cash
27 Mar 15 09:31:05
RT @momotrader: In $GALE 1.37. Bottom chart, financing completed (51% higher at 2.08). Has sellers right now and needs to clear 1.40 for …
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27 Mar 15 09:21:59
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BM
27 Mar 15 09:00:53
$GALE Dbl bottom? On Watchlist https://t.co/vwc6yP5Vby
Cash
27 Mar 15 09:00:31
In $GALE 1.37
Breaking News Now
27 Mar 15 08:27:05
$GALE: MLV Reiterates Buy on Galena Biopharma Inc Following Enrollment ...: http://t.co/KWbLFmR8Q2
Smarter Analyst
27 Mar 15 08:24:45
$GALE MLV Reiterates Buy on Galena Biopharma Inc Following Enrollment Expansion of NeuVax Combo Phase 2b http://t.co/1TsQXqq61K
Ben Bankhead
27 Mar 15 08:14:42
Picked up $GALE at 1.37
momotrader
27 Mar 15 08:09:37
In $GALE 1.37. Bottom chart, financing completed (51% higher at 2.08). Has sellers right now and needs to clear 1.40 for momo. Stops 1.3.
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27 Mar 15 08:09:34
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27 Mar 15 07:57:02
$SDRL $GALE: Eye Catching Stocks: SeaDrill Limited (NYSE:SDRL), Galena ...: http://t.co/GUzbs05iVI
Chet Stedman
27 Mar 15 07:35:27
@MoxReports cc: $GALE
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27 Mar 15 07:06:03
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27 Mar 15 06:22:07
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27 Mar 15 06:18:32
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Breaking News
27 Mar 15 05:04:04
$GALE: 4 High-Gross Margin Stocks: Galena Biopharma , (GALE ...: http://t.co/igiNlOYuSQ
Bill Evancho
27 Mar 15 04:07:54
@ACInvestorBlog What are your thoughts on $gale ? 52 wk low; dilution settled in; nice pipline. Average price target around $5.00.......
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26 Mar 15 19:23:57
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By  +Follow October 3, 2013 5:04AM
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