SEATTLE, Jan. 14 /PRNewswire-FirstCall/ -- In meetings held in association with the JP Morgan Healthcare Conference in San Francisco, Cell Therapeutics, Inc. (CTI) reviewed 2009 targeted milestones and 2008 accomplishments. CTI is seeking to obtain two new drug approvals in 2009 in addition to potential label expansion for Zevalin(R). In November CTI established a 50/50 joint venture with Spectrum Pharmaceuticals, Inc. (Spectrum) for Zevalin.
“With a focus on cutting-edge oncology drug products, CTI aims to complete its transition from a research-based organization to a leading commercial oncology company,” said James A. Bianco, M.D., CEO of Cell Therapeutics. “In 2008 we set the stage for becoming a multi-product commercial oncology operating company, with Zevalin currently under priority review by the FDA in the U.S. for label expansion, OPAXIO(TM) under review for market authorization application approval in Europe and, based on positive Phase III data for pixantrone, we expect to file a rolling NDA in 2009. Additionally, we continue to focus on improving our capital structure, streamlining our operations and significantly reducing our cash burn rate. With potential approval of pixantrone and OPAXIO in 2009, and potential sales revenue growth due to possible Zevalin label expansion, we are on target to accomplish our goal of reaching cashflow break-even in the fourth quarter of 2009,” Bianco added.
Targeted 2009 Milestones:
ZEVALIN -- First- line consolidation indication approval for Zevalin with a target decision date by the FDA of April 2, 2009, based on a supplemental biologics license application (sBLA) submitted on October 2, 2008 for the use of Zevalin as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin’s lymphoma. CTI and Spectrum have a joint venture for the sales, marketing and development of Zevalin which doubles the resources available to potentially expand U.S. Zevalin sales following a new first-line consolidation indication.
PIXANTRONE -- Based on preliminary results from its phase III extend trial for Pixantrone reported on November 11, 2008 and a forthcoming FDA meeting later this quarter, CTI currently plans to submit a rolling NDA filing for pixantrone with potential Q4- 2009 approval and launch in U.S. which could result in upfront and approval payment and milestones to CTI should Novartis elect to exercise their option to enter into an exclusive worldwide license to develop and commercialize pixantrone.
OPAXIO -- Potential Marketing Authorization Application approval by the European Medicines Agency or EMEA for OPAXIO for first-line treatment of patients with non-small cell lung cancer (NSCLC). If Novartis elects to commercialize OPAXIO in Europe based on EMEA acceptance of the MAA filing CTI could earn additional cash reimbursement payments and royalties on sales from OPAXIO.
Continued improvement of our capital structure through a comprehensive recapitalization plan intended to help CTI regain compliance with the Nasdaq listing standards, and which may include additional equity or debt offerings, and the reduction of our outstanding indebtedness, through the previously announced potential tender offer for a portion of our outstanding convertible notes or otherwise as disclosed on December 5, 2008.
Review of 2008 Key Accomplishments:
Entered into an agreement with Bayer Schering Pharma to gain access to its positive phase III Zevalin First-line Indolent Trial (FIT) data for submission to the FDA in connection with the Zevalin sBLA.
Successful pre-sBLA meeting with FDA and submission of sBLA for expansion of the label for Zevalin for use in first-line consolidation treatment for non-Hodgkin’s lymphoma. FDA has granted the sBLA priority review shortening the timeframe for FDA review from 10 months to six months with a target decision date of April 2, 2009.
Formed RIT Oncology, LLC, a 50/50 joint venture with Spectrum, by contributing all assets exclusively related to the Zevalin product in exchange for $15 million in payments to CTI and a 50% membership interest in the joint venture. CTI may also receive up to an additional $15 million in product sales milestones payments upon achievement by the joint venture of certain revenue targets. The partnership will enable CTI to deploy a larger combined sales and marketing team to accelerate top-line product revenues in the near- term and reduce costs to develop Zevalin for new growth opportunities, and could help realize a successful first-line consolidation launch in 2009 and beyond if the Zevalin sBLA is approved. The new joint venture will initially double the sales force and marketing operations for Zevalin in the U.S.
Successfully achieved the primary efficacy endpoint in our pivotal phase III study of pixantrone in relapsed aggressive non-Hodgkin’s lymphoma and have scheduled pre-NDA meeting with the FDA in early 2009.
Submitted a marketing authorization application (MAA) to the European Medicines Agency for OPAXIO for first-line treatment of patients with non- small cell lung cancer with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). OPAXIO is a drug candidate which is exclusively partnered with Novartis.
Reduced net cash used for operating activities for the reported nine months ended September 30, 2008 while maintaining key milestone timelines.
Raised significant operating capital to fund operations resulting in advancement of our product portfolio and strategic initiatives in a challenging economic and capital market environment. Even with this additional capital, CTI expects that it will need to access additional capital in 2009 through potential funding from partnerships or joint ventures, public or private equity financings, debt financings or restructurings, dispositions of assets or through other means in order to fund its continued operations. CTI could also choose to raise additional capital through the exercise of a sale option, exercisable in its sole discretion from January 15, 2009 through July 15, 2009, to sell its 50% membership interest in the Zevalin joint venture to Spectrum for $18 million.
Strengthened executive and commercial team with addition of Craig Philips, previously Vice President and General Manager of Bayer Healthcare Oncology, as President of CTI U.S. and Christina Waters, Ph.D., formerly Director of Scientific Development at Genomics Institute of the Novartis Research Foundation, as President of CTI Europe and CTI’s Systems Medicine subsidiary.
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 http://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. Specifically, the risks and uncertainties that could affect future results include the risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, the determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, the potential for Zevalin FIT data to be acceptable to the FDA for an expanded indication or any other indication, the risk that if label expansion of Zevalin is approved, it may not result in a significant market increase for the drug due to the presence of other treatment options, failure to gain market acceptance and other factors, the success of the joint venture in commercializing and developing Zevalin, the ability of the joint venture to accelerate top-line revenues in the near-term, the ability to integrate Zevalin into Spectrum’s commercial, marketing and medical affairs teams, the results of complete safety and progression free survival information for pixantrone which is still being assembled, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the determination by the FDA that the PIX301 trial is insufficient to support an NDA filing, marketing approval review of the OPAXIO MAA may not result in a marketing approval in Europe, the costs of developing, producing and selling Zevalin, OPAXIO, pixantrone and brostallicin, the risk that Novartis may not elect to participate in the development and marketing of OPAXIO or may not exercise its option with regard to pixantrone, the Company may be unable to complete its recapitalization plan as it continues to have a substantial amount of debt outstanding, the quarterly interest expense associated with the debt is significant and the Company’s operating expenses continue to exceed its net revenues, the Company will be successful in reducing its operating expenses, and the Company will continue to need to raise capital to fund its operations. You should also review the risk factors listed or described from time to time in the Company’s filings with the Securities and Exchange Commission including, without limitation, the Company’s most recent filings on Forms 10-K, 8-K, and 10-Q. 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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