CTI BIOPHARMA CORP (Form: 8-K, Received: 04/25/2017 16:31:39)

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): April 21, 2017

CTI BIOPHARMA CORP.

(Exact name of registrant as specified in its charter)



Washington	001-12465	91-1533912
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification Number)

3101 Western Avenue, Suite 600

Seattle, Washington 98121

(Address of principal executive offices)

Registrant’s telephone number, including area code: (206) 282-7100

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:



¨	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.

On April 21, 2017 (the “Restatement Date”), CTI BioPharma Corp. and its wholly-owned subsidiary, CTI Life Sciences Limited (collectively, the “Company”), entered into an Amended and Restated Exclusive License and Collaboration Agreement (the “Restated Agreement”) with Les Laboratoires Servier and Institut de Recherches Internationales Servier (collectively, “Servier”, and together with the Company, the “Parties”) pursuant to which the Parties amended and restated the Exclusive License and Collaboration Agreement entered into by the Parties on September 16, 2014 (the “Original Agreement”) regarding the development and commercialization of pixantrone dimaleate (PIXUVRI ^® ) (the “Compound”, and to the extent incorporated in a pharmaceutical product, the “Licensed Product(s)”). The Restated Agreement replaces the Original Agreement in its entirety.

The Company has obtained conditional marketing authorization in the European Union to market PIXUVRI ^® for the treatment of adult patients with relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. Under the Restated Agreement, the Company will transfer its European marketing authorization to Servier upon positive, statistically significant results in an ongoing post-authorization Phase III clinical trial, PIX306, unless Servier elects to terminate the Restatement Agreement within thirty (30) days after the positive results.

Under the Restated Agreement, the Company has granted to Servier an exclusive, sublicensable (subject to certain exceptions) license to manufacture the Licensed Products worldwide, and an exclusive, sublicenseable (subject to certain exceptions) license to develop and commercialize the Licensed Products worldwide, excluding the United States (the “Company Territory”). The Parties have agreed to enter into a commercialization transition plan by July 31, 2017 whereby the Company will transfer to Servier medical affairs and commercialization activities relating to the Licensed Products in Israel, Turkey, Germany, Austria, the United Kingdom, Denmark, Finland, Norway and Sweden (collectively, the "Transition Territory"). Upon the implementation of the commercialization transition plan, the Company will terminate or assign certain distributor and wholesaler contracts to Servier in the Transition Territory. Each party will be responsible for the manufacture and supply of drug products and substances in their respective territories.

The Company will receive payments of €12 million from Servier, which includes €2 million for a new milestone previously achieved, and Servier is obligated to purchase a certain amount of Pixuvri drug product for an additional €900,000 within 30 days of the Restated Agreement. Subject to the achievement of certain conditions, the Company is eligible to receive additional milestone payments from Servier in the aggregate amount of up to €76 million (or approximately $82.6 million at the exchange rate as of April 24, 2017), which is comprised of the following: up to €36 million (or approximately $39.1 million at the exchange rate as of April 24, 2017) in potential regulatory milestone payments and up to €40.0 million (or approximately $43.5 million at the exchange rate as of April 24, 2017) in potential sales milestone payments. The Company is eligible to receive tiered royalty payments ranging from a low-double digit percentage up to a percentage in the low-twenties based on net sales of the Licensed Product, subject to certain reductions of up to mid-double digit percentages under certain circumstances. The Parties will no longer use a joint marketing plan, and marketing costs will no longer be shared equally between the Parties; instead Servier will be solely responsible for marketing costs within Europe. Mutually agreed upon development costs other than PIX306 will continue to be shared equally between the Parties, which represents no change to the development cost sharing.

The Restated Agreement also requires the Parties to amend the trademark license agreement entered into between the Parties on June 8, 2015 to provide for Servier’s right to use of the Company’s trademark PIXUVRI ^® in connection with Licensed Products worldwide, excluding the Company Territory.

The foregoing description of the terms and conditions of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Agreement, a redacted copy of which will be filed as an exhibit to the Company's quarterly report on Form 10-Q for the quarterly period ended March 31, 2017, and upon filing will be incorporated herein by reference. The Company intends to submit a Confidential Treatment Request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), requesting that it be permitted to redact certain portions of the Agreement. The omitted material will be included in the request for confidential treatment.

Item 7.01. Regulation FD Disclosure.

The information provided pursuant to this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any filing or other document filed by the Company pursuant to the Exchange Act or the Securities Act of 1933, as amended, except as shall be

expressly set forth by specific reference in such filing or document. The information provided pursuant to this Item 7.01 shall instead be deemed “furnished.”

On April 25, 2017, the Company issued a press release announcing the Company’s entry into the Restated Agreement with Servier. The full text of such press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits



Exhibit No.	Description	Location

99.1	Press Release of CTI BioPharma Corp., dated April 25, 2017.	Furnished herewith.

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.



	CTI BIOPHARMA CORP.
Date: April 25, 2017	By:	/s/ Bruce J. Seeley
		Bruce J. Seeley
		Executive Vice President, Chief Commercial Officer and Administrative Officer

EXHIBIT INDEX



Exhibit No.	Description	Location

99.1	Press Release of CTI BioPharma Corp., dated April 25, 2017.	Furnished herewith.

Servier and CTI BioPharma Expand License and Collaboration Agreement to Develop and Commercialize PIXUVRI ^®


•	Servier will commercialize PIXUVRI in all markets except the US


•	CTI BioPharma will retain rights to commercialize PIXUVRI in the US

Paris, France and Seattle, Washington – 25 April 2017 – Servier and CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today jointly announced that they agreed to expand their existing license and development collaboration agreement for PIXUVRI ^® (pixantrone). Under this expanded agreement, Servier will have rights to PIXUVRI in all markets except the US, where CTI BioPharma will retain the commercialization rights. Servier will pay CTI BioPharma €12 million with the potential for CTI BioPharma to receive €76 million in additional sales and regulatory milestone payments as well as royalties on net product sales.

PIXUVRI has been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma (NHL). ⁱ As a specific post-authorization requirement, PIXUVRI is currently being investigated in a Phase III clinical trial, PIX306. If positive, the results from this trial will confirm the treatment’s current indication and could support broader indications.

In 2014, CTI granted Servier rights to commercialize the drug globally except in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, UK and the US. With this expanded agreement, which provides Servier’s rights to all markets except the US, the companies will continue to work closely together to build the efficacy and safety evidence for PIXUVRI and to ensure that as many eligible patients as possible are benefitting from it.

“Over the past three years, we have worked hand in hand with our partner, CTI BioPharma, to bring new treatment options to patients in Europe”, said U. Marion Schrenk, MD, Head of Therapeutic Area Oncology of Servier. “We are looking forward to leveraging our expertise in these additional markets to ensure more eligible patients have access to PIXUVRI. Oncology is an important focus for us, and we are fully committed to working with our partners, researchers and scientists to provide patients with novel therapeutic options in areas with high unmet needs.”

“Servier is an important strategic partner for us and has helped bring PIXUVRI to many patients “, said Adam R. Craig, President and CEO of CTI BioPharma. “We look forward to our expanded partnership as we aim to complete the PIX306 trial in the near-term.”

About PIXUVRI (pixantrone)

PIXUVRI is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells in B-cell NHL cannot divide and eventually die. ⁱⁱ

PIXUVRI is conditionally approved in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The benefit has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.

The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.servier.com.

About NHL

NHL is an uncommon type of cancer that affects the lymphatic system, which is defined as a network of vessels and glands that run throughout the body . ⁱⁱⁱ The lymphatic system is a key component of the immune system, as it plays a role in destroying old or abnormal cells and fighting bacteria and other infections. ^iv

Around 93,500 new cases of NHL were diagnosed in Europe in 2012, making it the eleventh most common cancer on the continent. ^v

NHL comprises more than 60 subtypes, with each requiring a different diagnostic evaluation and treatment approaches. Lymphoma patient groups around the world, led by the umbrella group Lymphoma Coalition, have been recently calling for accurate subtype reporting to allow patients to clearly understand their subtype and have better communication with their doctors. Given the complexities of the condition, access to information is essential to empower patients.

About Servier

Servier is an international pharmaceutical company governed by a foundation and headquartered in Suresnes (France). With a strong international presence in 148 countries and a turnover of 4 billion euros in 2016, Servier employs 21,000 people worldwide. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular diseases, diabetes, cancers, immune-inflammatory diseases, and neurodegenerative diseases, as well as by its activities in high-quality generic drugs. Being completely independent, the Group reinvests 25% of turnover (excluding generics) in research and development and uses all its profits for growth.

Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are nine molecular entities in clinical development in this area, targeting gastric and lung cancers and other solid tumors, as well as various leukemias and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, targeted, immune and cellular therapies, to deliver life-changing medicines to patients.

More information is available at: www.servier.com and www.servier-oncology.com

About CTI BioPharma

CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially

and/or adversely affect actual future results and the trading price of CTI BioPharma's securities. Such statements include, but are not limited to, expectations with respect to milestone and royalty payments, the expected benefits and potential of the collaboration and PIXUVRI, including with respect to possibly expanding PIXUVRI into new indications. The statements are based on assumptions about many important factors and information currently available to us to the extent we have thus far had an opportunity to fully and carefully evaluate such information in light of all surrounding facts, circumstances, recommendations and analyses. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI BioPharma and its product and product candidate portfolio in particular including, among others, risks associated with the following: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality or patient safety issues; product development risks; the impact of competitive products and pricing and reimbursement; that CTI BioPharma cannot predict or guarantee the outcome of preclinical and clinical studies, as well as other risks listed or described from time to time in CTI BioPharma's most recent filings with the SEC on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI BioPharma does not intend to update any of the statements in this press release upon further developments.

Servier Contact

Karine Bousseau

Servier External Communications

Tel: +33 1 5572 6037

Email: media@servier.com

CTI BioPharma Contact

Ed Bell

Tel +1 206-272-4345

Email: ebell@ctibiopharma.com

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ⁱ http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000925.jsp [last accessed March 2017]

ⁱⁱ http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124 [last accessed March 2017]

ⁱⁱⁱ NHS Conditions webpage. NHL cancer. Available at http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx [last accessed March 2017]

^iv Cancer Research UK. Lymphatic System. Available at http://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/the-lymphatic-system-and-cancer [Last accessed March 2017]

^v Cancer Research UK. Non-Hodgkin lymphoma incidence statistics. Available at

http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/non-hodgkin-lymphoma/incidence#GCwFbl4szbj1GQxD.99 [last accessed March 2017]