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 14, 2010 (July 9, 2010)
CELL THERAPEUTICS, INC.
(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) |
501 Elliott Avenue West, Suite 400
Seattle, Washington 98119
(Address of principal executive offices)
Registrants 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 (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. |
On July 13, 2010, Cell Therapeutics, Inc. (the Company) entered into a Drug Product Manufacturing Supply Agreement (the Agreement) with NerPharMa, S.r.l. (NPM). The Agreement is effective as of July 9, 2010 (the Effective Date). Pursuant to the Agreement, NPM has agreed to manufacture and supply to the Company, the bulk unlabeled vials of drug product for the Companys drug candidate pixantrone, which is BBR 2778 (pixantrone dimaleate) (the Product). From the Effective Date through the fifth anniversary of the date that the first government or regulatory approval has been obtained for the Product in the United States or in Europe, whichever is earlier (unless earlier terminated, the Term), the Company has agreed to purchase the Product from NPM on the basis of a rolling commercial forecast, which the Company has agreed to submit to NPM by the end of each quarter of the calendar year during the Term. Such forecast may be subsequently increased or decreased by the Company pursuant to the terms of the Agreement. The Company has agreed to purchase on a non-exclusive basis, and NPM has agreed to produce, for the entire Term, no less than 50% of the 18-month forecast submitted by the Company on the last quarter of each calendar year. Each party has agreed to indemnify the other party from and against certain third-party claims related to breaches of the Agreement or any negligent or willful act or omission by a party, as the case may be.
On July 14, 2010, the Company issued a press release entitled Cell Therapeutics, Inc. (CTI) Signs Long-Term Manufacturing Agreement for Pixantrone with NerPharMa, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
The following exhibit is furnished with this report on Form 8-K:
Exhibit Number |
Description | |
99.1 | Press Release, dated July 14, 2010, entitled Cell Therapeutics, Inc. (CTI) Signs Long-Term Manufacturing Agreement for Pixantrone with NerPharMa. |
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.
CELL THERAPEUTICS, INC. | ||||||
Date: July 14, 2010 | By: | /S/ JAMES A. BIANCO, M.D. | ||||
James A. Bianco, M.D. | ||||||
Chief Executive Officer |
EXHIBIT INDEX
Exhibit |
Description | |
99.1 | Press Release, dated July 14, 2010, entitled Cell Therapeutics, Inc. (CTI) Signs Long-Term Manufacturing Agreement for Pixantrone with NerPharMa. |
Exhibit 99.1
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501 Elliott Ave. W. #400 Seattle, WA 98119 |
T 206.282.7100 F 206.284.6206 |
Cell Therapeutics, Inc. (CTI) Signs Long-Term Manufacturing
Agreement for Pixantrone with NerPharMa
CTI Plans Marketing Authorization Application Filing in Europe This Year
July 14, 2010 SeattleCell Therapeutics (CTI) (NASDAQ and MTA: CTIC) today announced that it has signed a manufacturing agreement with NerPharMa, S.r.l. (NerPharMa) (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences S.r.l., in Nerviano, Italy) for CTIs drug candidate pixantrone. The five-year contract between CTI and NerPharMa provides for both the commercial and clinical supply of pixantrone. CTI is developing pixantrone as a treatment option for patients with relapsed or refractory aggressive non-Hodgkins lymphoma (NHL). CTI is currently preparing to submit a Marketing Authorization Application (MAA) in the European Union, and plans to initiate a Phase III trial of pixantrone in patients with relapsed or refractory aggressive NHL in the U.S. Both are planned for this year.
CTI announced on June 14, 2010 that the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, had approved the facility at NerPharMa for the production of pixantrone.
We are pleased to have reached an agreement with NerPharMa for the long-term manufacture of pixantrone, said Craig W. Philips, President of CTI. Entering into this agreement puts us one step closer to fulfilling our mission of being able to provide pixantrone to patients with relapsed or refractory aggressive NHL, a setting for which there are currently no approved treatment options.
About Pixantrone
Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclinesrather than intercalation with DNApixantrone alkylates DNAforming stable DNA adducts, with particular specificity for CpG rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone to prevent the binding of iron and perpetuation of superoxide productionboth of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline like potency in the treatment of relapsed/refractory aggressive lymphoma without unacceptable rates of cardiotoxicity.
www.CellTherapeutics.com
About Nerviano Medical Sciences (NMS)
Nerviano Medical Sciences is the largest pharmaceutical research and development facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.celltherapeutics.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTIs securities. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory, aggressive NHL as determined by the European Medicines Agency (EMEA), that CTI may not submit its MAA to the EMEA, that the EMEA may not approve CTIs new drug application for pixantrone, that CTI may not initiate a Phase III trial of pixantrone in the U.S., CTIs ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTIs filings with the Securities and Exchange Commission including, without limitation, CTIs most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
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Media Contact:
Dan Eramian T: 206.272.4343 C: 206.854.1200 E: deramian@ctiseattle.com www.CellTherapeutics.com/press_room |
Investors Contact:
Ed Bell T: 206.282.7100 Lindsey Jesch Logan T: 206.272.4347 F: 206.272.4434 E: invest@ctiseattle.com www.CellTherapeutics.com/investors
Medical Information Contact:
T: 800.715.0944 E: info@askarm.com |
www.CellTherapeutics.com