Current Report Filing (8-k)

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): July 17, 2014

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.)

	4640 S.W. Macadam Avenue Suite 270 Portland, Oregon 97239
	(Address of Principal Executive Offices) (Zip Code)

Registrant’s telephone number, including area code: (855) 855-4253

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):


o	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


o	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


o	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


o	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

On July 22, 2014, Galena Biopharma, Inc., a Delaware corporation (the “Company”), and MonoSol Rx, a private specialty pharmaceutical company, entered into a definitive agreement to license the exclusive U.S. rights to Zuplenz^® (ondansetron) oral soluble film, subject to the court approval of a settlement that MonoSol Rx has reached with the former U.S. licensee of Zuplenz. Zuplenz was approved by the U.S. Food and Drug Administration ("FDA") in 2011. The asset was licensed from MonoSol Rx, LLC the developer of the oral soluble film technology, PharmaFilm^®, and manufacturer and supplier of the product.

Zuplenz was approved by the FDA in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV), and in pediatric patients for moderately emetogenic CINV. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and it is estimated that up to 90% of chemotherapy and up to 80% of radiotherapy patients will experience CINV and RINV, respectively. The active pharmaceutical ingredient in Zuplenz, ondansetron, is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery.

In exchange for the U.S. rights to Zuplenz, upon the effectiveness of the license and transfer to the Company of the New Drug Application (NDA) for Zuplenz, the Company will pay MonoSol Rx a total of $5 million in cash and stock. In addition to the up-front payment, the Company will pay MonoSol Rx: (i) $0.5 million upon the earlier of (a) a predetermined managed care achievement or (b) by December 31, 2014, (ii) future cash milestone payments based on our "net sales" of Zuplenz and (iii) a fixed double-digit royalty on future "net sales."

Under the terms of the license agreement, we assumed responsibility for the U.S. commercialization of Zuplenz and for all regulatory and reporting matters in the U.S. The license agreement includes various representations, warranties, covenants, indemnification and termination and other customary provisions for transactions of this type.

The foregoing descriptions of the license agreement do not purport to be complete descriptions of the terms and conditions therein and are qualified in their entirety by reference to the full text of the license agreement that will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the nine months ending September 30, 2014. On July 22, 2014, the Company issued a press release announcing its license agreement of Zuplenz, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.



Item 9.01	Financial Statements and Exhibits.

(d) Exhibits




Exhibit No.			Description

99.1			Press Release of Galena Biopharma, Inc. dated July 22, 2014.

SIGNATURES

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:	July 22, 2014	By:	/s/ Mark J. Ahn
			Mark J. Ahn, Ph.D. President and Chief Executive Officer

Galena Biopharma Enters into Definitive Agreement to License

U.S. Rights for Zuplenz® (ondansetron) Oral Soluble Film


•	Novel, rapidly dissolving oral PharmFilm® enables faster absorption, increased convenience and better compliance for patients.


•	Planned launch in multiple indications-chemotherapy-, radiation- and post operative-induced nausea and vomiting-in early 2015.


•	FDA-Approved product to be added to Galena’s established oncology commercial team.

Portland, Oregon, July 22, 2014- Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced it has entered into a definitive agreement to license the U.S. rights for the commercial product Zuplenz® (ondansetron) oral soluble film. The asset was licensed from MonoSol Rx, LLC, the developer of the oral soluble film technology, PharmFilm®, and manufacturer of the product.

Zuplenz was approved in 2010 by the U.S. Food and Drug Administration (FDA) in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved in pediatric patients for moderately emetogenic CINV. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation. It is estimated that up to 90% of chemotherapy and up to 80% of radiotherapy patients will experience CINV and RINV respectively.

The active pharmaceutical ingredient in Zuplenz, ondansetron, is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron belongs to a class of medications called serotonin 5-HT₃ receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting. According to data from Wolters Kluwer, the oral 5-HT₃market exceeds $1 billion in the U.S.

Zuplenz utilizes MonoSol Rx’s proprietary PharmFilm® technology, an oral soluble film that dissolves on the tongue in less than thirty seconds. This rapidly dissolving, oral soluble film eliminates the burden of swallowing pills during periods of emesis and in cases of oral irritation, therefore increasing patient adherence and reducing emergency room visits and hospitalization due to a lack of patient compliance or the patient’s inability to keep the medication down without vomiting. Zuplenz is supplied in both 4 mg and 8 mg ondansetron doses with a safety profile equivalent to other products in the class.

“We believe the innovative product benefits of Zuplenz, combined with our experienced oncology sales team, will create significant acceleration and leverage to our commercial product portfolio,” said Mark J. Ahn, Ph.D., President and Chief Executive Officer of Galena Biopharma. “Our commercial franchise was established last year with the acquisition of Abstral® for the treatment of breakthrough cancer pain. Adding Zuplenz to our commercial portfolio enhances our offering of supportive care products that are simple to take and provide reliable dosing to improve the quality of life for patients suffering from cancer or recovering from surgery and the associated side-effects.”

Galena has entered into an exclusive license and supply agreement with MonoSol Rx, the effectiveness of which is subject to the court approval of a settlement that MonoSol Rx has reached with a former licensee of Zuplenz. Under the terms of the license agreement, upon effectiveness of the license and transfer to Galena of the New Drug Application (NDA) for Zuplenz, Galena will pay MonoSol Rx a total of $5,000,000 in cash and stock. The license agreement also provides for fixed double-digit royalties on net sales and pre-specified, one-time sales milestones.

Zuplenz has issued and pending U.S. patent applications with an anticipated expiration date of 2029. Galena expects to launch Zuplenz in early 2015.

“MonoSol Rx has established our proprietary PharmFilm technology in multiple approved and pipeline products, including Zuplenz and Suboxone®. We believe Galena’s established, oncology focused commercial team understands the advantages of our PharmFilm technology and can successfully commercialize Zuplenz in all three indications,” concluded, A. Mark Schobel, Co-President and CEO of MonoSol Rx.

About Zuplenz® (ondansetron) Oral Soluble Film

Zuplenz® (ondansetron) Oral Soluble Film is approved by the U.S. Food and Drug Administration (FDA). Zuplenz is approved in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved in pediatric patients for moderately emetogenic CINV. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation.

Zuplenz utilizes the proprietary PharmFilm® technology as an oral soluble film that dissolves on the tongue in under 30 seconds. This rapidly dissolving film eliminates the burden of swallowing pills during periods of emesis and in cases of oral irritation, therefore increasing patient adherence and reducing emergency visits and hospitalization due to a lack of patient compliance or the patient’s inability to keep their treatment down without vomiting. Zuplenz is supplied in both 4 mg and 8 mg ondansetron doses with a safety profile equivalent to other products in the class.

About Chemotherapy-, Radiation- and Post Operative-Induced Nausea and Vomiting

It is estimated that up to 90% of patients receiving chemotherapy experience CINV and up to 80% of patients undergoing radiotherapy will experience RINV. For patients, CINV/RINV is among the most feared and distressing side effects, and uncontrolled or poorly controlled CINV/RINV can cause patients to be malnourished or dehydrated, have electrolyte imbalances, or experience physical and mental deterioration. In extreme cases, patients may choose to discontinue beneficial therapy because of this side effect.

Postoperative nausea and vomiting (PONV) is one of the most commonly occurring complications as a result of anesthesia and/or the pain medications given during surgery. PONV results in high levels of patient discomfort and dissatisfaction, and can result in increased recovery room time, expanded nursing care, and potential hospital admission-all factors that may increase total health care costs.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to develop products which address the unmet needs of patients. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in film drug delivery is supported by strong intellectual property, a pipeline of prescription formulations based on PharmFilm® technology, and two FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the treatment of opioid dependence. For press releases and other company information visit www.monosolrx.com.

About Galena Biopharma

Galena Biopharma, Inc. (NASDAQ: GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information visit 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 timing of commercial launch of Zuplenz, Galena’s ability to successfully commercialize Zuplenz, as well as statements about our expectations, plans and prospects. 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, 2013 and most recent Quarterly Reports on Form 10-Q 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:

Remy Bernarda

VP, Marketing & Communications

(503) 405-8258

rbernarda@galenabiopharma.com

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