Galena Biopharma and Leica Biosystems Announce Partnership to Develop Companion Diagnostic for HER2 Screening in Women With

Galena Biopharma and Leica Biosystems Announce Partnership to Develop
Companion Diagnostic for HER2 Screening in Women With Breast Cancer

  *Leica Biosystems will develop a fully automated HER2 diagnostic to support
    identification of appropriate HER2 negative (IHC 1+/2+) patients for
    NeuVax™ (nelipepimut-S or E75)
  *Galena strengthens its NeuVax personalized medicine and regulatory pathway
    with companion diagnostic development

LAKE OSWEGO, Ore. and NEWCASTLE-UPON-TYNE, United Kingdom, Dec. 6, 2012 (GLOBE
NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE) and Leica Biosystems today
announced a partnership to develop a companion diagnostic for Galena's NeuVax™
(nelipepimut-S or E75) breast cancer therapeutic. Galena Biopharma is a United
States based biotechnology company focused on developing innovative, targeted
oncology treatments addressing major unmet medical needs to advance cancer
care. Leica Biosystems is a global leader in workflow solutions and laboratory
automation for anatomic pathology, bringing clinicians and researchers high
workflow efficiency and confidence in cancer diagnostics. Leica Biosystems
provides a comprehensive product range with easy-to-use and consistently
reliable solutions for the entire laboratory.

Leica's Bond Oracle™ HER2 IHC System companion diagnostic will be used to
support the selection of the appropriate patients for the NeuVax™ Phase 3
PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer
with Low-to-Intermediate HER2 Expression with NeuVax Treatment) study. NeuVax
targets HER2 negative patients (IHC 1+, or 2+ and FISH <2.2) who achieve
remission with current standard of care, but have no available HER2-targeted
adjuvant treatment options to maintain their disease-free status.

"This agreement with Leica marks a significant milestone for Galena, and is a
continuation of our focus on developing personalized and targeted medicines to
advance cancer care," said Mark J. Ahn, Ph.D., President and Chief Executive
Officer. "By partnering with Leica, we will be able to help pioneer
personalized medicine for patients while ensuring the proper and accurate
assessment of breast cancer patients considering participation in the NeuVax
PRESENT trial."

Leica's Bond Oracle™HER2IHCSystem is an FDA cleared semi-quantitative
immunohistochemical (IHC) assay to determine HER2(Human Epidermal Growth
Factor Receptor 2) oncoprotein status in breast cancer tissue processed for
histological evaluation.

"The Leica Bond Oracle HER2 IHC System is validated as a fully-automated HER2
IHC test, and delivers the diagnostic confidence that comes with proven HER2
FISH concordance.We are pleased to be working with Galena Biopharma to
potentially expand our indication for this product to HER2 negative patients,"
added Arnd Kaldowski, President of Leica Biosystems.

About NeuVax™ (nelipepimut-S or E75)

NeuVax™ (nelipepimut-S) is the immmunodominant nonapeptide derived from the
extracellular domain of the HER2 protein, a well-established target for
therapeutic intervention in breast carcinoma.The nelipepimut-S sequence
stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to
HLA-A2/A3 molecules on antigen presenting cells (APC).These activated
specific CTLs recognize, neutralize and destroy through cell lysis HER2
expressing cancer cells, including occult cancer cells and micrometastatic
foci.The nelipepimut-S immune response can also generate CTLs to other
immunogenic peptides through inter- and intra-antigenic epitope
spreading.Based on a successful Phase 2 trial, which achieved its primary
endpoint of disease free survival (DFS), the Food and Drug Administration
(FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3
PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer
with Low to Intermediate HER2 Expression with NeuVax Treatment) study.The
Phase 3 trial is ongoing and additional information on the study can be found
at www.neuvax.com.

According to the National Cancer Institute, over 230,000 women in the U.S. are
diagnosed with breast cancer annually.Of these women, only about 25% are HER2
positive (IHC 3+). NeuVax targets approximately 50-60% of HER2-negative
patients (IHC 1+/2+ or FISH <2.2) who achieve remission with current standard
of care, but have no available HER2-targeted adjuvant treatment options to
maintain their disease-free status.

About Galena Biopharma

Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company that develops innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer care.For
more information please visit us at www.galenabiopharma.com.

The Galena Biopharma, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=10647.

About Leica Biosystems

Leica Biosystems is a global leader in workflow solutions and automation,
striving to advance cancer diagnostics to improve patients' lives. Leica
Biosystems provides anatomical pathology laboratories and researchers a
comprehensive product range for each step in the pathology process, from
sample preparation and staining to imaging and reporting. Leica's easy-to-use
and consistently reliable offerings help improve workflow efficiency and
diagnostic confidence. The company is represented in over 100 countries. It
has manufacturing facilities in 7 countries, sales and service organizations
in 19 countries, and an international network of dealers. The company is
headquartered in Nussloch, Germany. Further information can be found at
www.LeicaBiosystems.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995.Such statements include,
but are not limited to, statements about the preliminary results of the trends
in CTS in patients treated with NeuVax, as well as statements about
expectations, plans and prospects for the development of Galena's product
candidates.These forward-looking statements are subject to a number of risks,
uncertainties and assumptions, including those identified under "Risk Factors"
in Galena's Annual Report on Form 10-K for the year ended December 31, 2011
filed with the SEC.Actual results may differ materially from those
contemplated by these forward-looking statements. Galena does not undertake to
update any of these forward-looking statements to reflect a change in its
views or events or circumstances that occur after the date of this press
release.

CONTACT: Galena Biopharma Contacts:

         Madeline Hatton
         Toll free: +1 (855) 855-GALE (4253), ext. 109
         info@galenabiopharma.com
        
         or

         Remy Bernarda
         IR Sense, LLC
         +1 (503) 400-6995
         remy@irsense.com
        
         Leica Biosystems Contact:
        
         Tim Lyons
        
         Telephone: + 1 847 405 5455
         Email: tim.lyons@LeicaBiosystems.com

Galena Biopharma, Inc.
 
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