CTI is moving from a preclinical research organization to a commercial enterprise, and is now focusing on bringing its two late-stage drug candidates OPAXIO and pixantrone to market as quickly as possible.
The global credit crisis has forced the company to drastically lower its operating expenses. Closing the Bresso operation will save $14 million in annual operating costs. Throughout 2008, CTI cut $44 million in operating costs, including employee layoffs at its U.S operations.
CTI has been searching for alternative strategies for keeping the workforce and mission at CTE operating since it has shifted its business strategy. At this point, the utilization rate of the Bresso operation's preclinical capabilities is extremely low, and the only alternative is to move forward with the closure of the center.
Despite current economic conditions, CTI continues to attempt to keep intact the mission and workforce of the Bresso branch. The company has recently engaged a management consulting firm, Adjuvant Global Advisors, to assist in developing strategic options for partnership, asset divestment, or joint venture opportunities for the branch. These, along with internal company efforts, are a priority and have been taken in order to identify any opportunities. Adjuvant is actively seeking partnerships with global small molecule drug development firms and CROs who could leverage the unique qualifications of the Bresso team and their existing portfolio of clinical and preclinical oncology programs. However, at present no alternative solution has been found.
Bresso employees were informed of the company's plans today. The company anticipates starting negotiations with the Trade Unions in the near future.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating anti-tumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.
In January 2009, CTI announced that pixantrone met its primary endpoint of progression-free survival (PFS), and it expects to begin submission of a rolling NDA and request priority review for pixantrone to treat relapsed aggressive NHL in the first quarter of 2009.
About OPAXIO
CTI currently has one drug for lung cancer, OPAXIO(TM), awaiting approval in Europe. OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX(TM), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that OPAXIO metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.
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
About Adjuvant Global Advisors, LLC
Adjuvant Global Advisors is a strategic advisory firm serving a global pharmaceutical and biotechnology clientele. Its management team consists of scientific and business development experts with significant operational and transaction experience in the drug discovery and development industry. Adjuvant leverages a global industry network and expertise in regulatory, reimbursement, valuation and financial modeling strategies to rapidly develop strategic partnering and licensing options for clinical and preclinical programs. Adjuvant also advises on the repositioning of secondary assets and the promotion and positioning of novel discovery platforms. The firm maintains offices in Bethesda, MD and San Jose, CA. For more information about Adjuvant Global Advisors, please visit www.adjuvant.com
Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_news.htm
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, potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, marketing approval review of the OPAXIO MAA may not result in a marketing approval in Europe, the costs of developing, producing and selling pixantrone and OPAXIA, 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 not be successful in identifying or completing a partnership, asset divestiture or joint venture with respect to the Bresso facility, the Company may not be successful in reducing its cash burn rate, the Company continues to have negative cash flow and a significant amount of debt outstanding; the Company will not be able to raise additional capital to fund its continued operations; and 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.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: media@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
