UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): December 4, 2012

GALENA BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)

 
					
Delaware	 	001-33958	 	20-8099512	
(State or other jurisdiction of incorporation or organization)	 	(Commission
File Number)	 	(I.R.S. Employer
Identification No.)	
			
	 	310 N.State Street, Suite 208
Lake Oswego, Oregon 97034	 		
	 	(Address of Principal Executive Offices) (Zip Code)	 		
Registrant’s telephone number, including area code: (855) 855 – 4523
Not Applicable
Former name or former address, if changed since last report

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)	
 
¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)	
 
¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))	
 
¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))	

 

Item 1.01	Entry into a Material Definitive Agreement	
Effective December 4, 2012, Galena Biopharma, Inc. (“we,” “us,” “our” and the “Company”) entered into a license and supply agreement with ABIC Marketing Limited, a subsidiary of Teva Pharmaceuticals (“ABIC”), under which we granted ABIC exclusive rights to seek marketing approval in Israel for our NeuVax™ product candidate for intradermal injection for the treatment of breast cancer following its approval by the U.S. Food and Drug Administration or the European Medicines Agency, and to market, sell and distribute NeuVax™ in Israel assuming such approval is obtained. ABIC’s rights also include a right of first refusal in Israel for all future indications for which NeuVax™ may be approved.
Under the license and supply agreement, ABIC will assume responsibility for regulatory registration of NeuVax™ in Israel, provide financial support for local development, and commercialize the product in the region in exchange for making royalty payments to us based on future sales of NeuVax™. ABIC also agrees in the license and supply agreement to purchase from us all supplies of NeuVax™ at a price determined according to a specified formula.
 
Item 8.01	Other Events	
On December 4, 2012, we issued a press release announcing the license and supply agreement. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
 
Item 9.01	Exhibits	
(d) Exhibits
We are filing as part of this report the exhibit listed on the accompanying Index to Exhibits, which information is incorporated herein by reference.
 
1

Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	 		 	GALENA BIOPHARMA, INC.	
				
Date: December 4, 2012	 		 	By:	 	/s/ Mark J. Ahn	
	 		 		 	Mark J. Ahn, Ph.D.	
	 		 		 	President and Chief Executive Officer	
 
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Index to Exhibits

Exhibit
No.	  	Description	
		
99.1	  	Press release of Galena Biopharma, Inc. issued on December 4, 2012.	
 
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Exhibit 99.1

GALENA BIOPHARMA ANNOUNCES SIGNATURE OF
COMMERCIALIZATION PARTNERSHIP WITH TEVA FOR ISRAEL
    • Partnership includes future commercialization of NeuVax™ in Israel and financial support
    • Key clinical sites approved and established in Israel for PRESENT Phase 3 trial
Lake Oswego, Oregon, December 4, 2012 – Galena Biopharma, Inc. (NASDAQ: GALE), a biotechnology company focused on developing innovative, targeted oncology treatments, today announced it has signed an agreement with a subsidiary of Teva Pharmaceutical Industries Limited for the commercialization of NeuVax™ (nelipepimut-S or E75) in Israel.
“This agreement is the first piece of our global commercialization strategy,” said Mark Ahn, Ph.D., President and Chief Executive Officer, Galena Biopharma. “Teva is a world-class pharmaceutical company and a major pharmaceutical company in Israel. We look forward to their valuable financial support towards our development goals in Israel, as well as market leadership for NeuVax commercialization in the region.”
Under the agreement, Teva Israel will assume responsibility for regulatory registration in Israel, provide financial support for local development, and will commercialize the product in the region. Specific financial terms were not disclosed, but the agreement allows for significant royalty payments to Galena Biopharma on future sales.
Israel will be the location of at least four clinical trial sites for the NeuVax Phase 3 PRESENT ( P revention of R ecurrence in E arly- S tage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 E xpression with N euVax T reatment) study.
“We are embarking on a very exciting and innovative venue for the adjuvant treatment of early breast cancer. In this study we are boosting the body’s natural immune system to deal with possible residual cancer cells still present. The biological reasoning behind this treatment is sound. We hope that the results of this large randomized study will confirm the encouraging results seen in earlier studies using this agent,” commented Dr. Noa Efrat (Ben-Baruch), M.D., Head Department of Oncology at Kaplan Medical Center, and an investigator for the trial in Israel.
About NeuVax (nelipepimut-S)
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 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 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 ( P revention of R ecurrence in E arly- S tage, Node-Positive Breast Cancer with Low to Intermediate HER2 E xpression with N euVax T reatment) 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 .
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 possible commercialization of NeuVax™ and benefits of Galena’s new product candidates. These forward-looking statements are subject to a number of risks and uncertainties, including those identified under “Risk Factors” in Galena’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings Galena periodically makes 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 presentation.
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