CTI BIOPHARMA CORP. (NASDAQ:CTIC) Files An 8-K Entry into a Material Definitive Agreement

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CTI BIOPHARMA CORP. (NASDAQ:CTIC) Files An 8-K Entry into a Material Definitive Agreement

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) 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 Serviers right to use of the Companys
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 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 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 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 to this Item 7.01 shall instead
be deemed furnished.
On April 25, 2017, the Company issued a press release announcing
the Companys 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.


About CTI BIOPHARMA CORP. (NASDAQ:CTIC)

CTI BioPharma Corp. (CTI) is a biopharmaceutical company focused on the acquisition, development and commercialization of targeted therapies covering a spectrum of blood-related cancers to patients and healthcare providers. The Company is primarily focused on commercializing PIXUVRI in select countries in the European Union, for multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL). It is also engaged in evaluating pacritinib for the treatment of adult patients with myelofibrosis. Its earlier stage product candidate, tosedostat, is an oral, once-daily aminopeptidase inhibitor that has demonstrated responses in patients with acute myeloid leukemia (AML). It also evaluates its pipeline candidate paclitaxel poliglumex (Opaxio), which targets solid tumors. It is evaluating Opaxio through cooperative group sponsored trials and investigator-sponsored trials (ISTs), such as the ongoing maintenance therapy trial in patients with ovarian cancer.

CTI BIOPHARMA CORP. (NASDAQ:CTIC) Recent Trading Information

CTI BIOPHARMA CORP. (NASDAQ:CTIC) closed its last trading session up +0.28 at 4.26 with 30,619 shares trading hands.