Milestones

Making History

Since 1991, CTI has focused on the development and commercialization of new oncology therapy products. Our commitment to patients is an important value at CTI, with the goal of making standard-of-care treatment less toxic and more effective. This commitment is reflected in the events that have shaped CTI during the past two decades.

2009 - Pixantrone NDA Initiated

In April, we began a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). We will request priority review by FDA.

Earlier in the year, we announced that our pivotal phase III EXTEND (PIX301) trial achieved its primary endpoint, with patients randomized to treatment with pixantrone achieving a significantly higher rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy.

2009 - Option to Sell Zevalin Interest Exercised

CTI and Spectrum Pharmaceuticals, Inc. established a joint venture, RIT Oncology, LLC, in December 2008 to develop and commercialize Zevalin^® (ibritumomab tiuxetan). At that time we contributed all Zevalin-related assets to the joint venture and sold a 50% membership interest in the joint venture to Spectrum for $15 million, plus certain milestone payments. In early 2009, we exercised our option to sell our interest in the Zevalin joint venture to Spectrum for $18 million.

2008 - Supplemental Biologics License Application for Zevalin

We gained access to phase III Zevalin First-line Indolent Trial (FIT) data in June through an agreement with Bayer Schering Pharma AG, who used the data to obtain approval for Zevalin as first-line consolidation treatment in Europe. Using this data, in October we submitted a supplemental Biologics License Application (sBLA) with FDA for use of Zevalin as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma. If approved, Zevalin would be the only radioimmunotherapy in the U.S. with approval for use as first-line consolidation therapy.

2008 - MAA Submission to Market OPAXIO in Europe

In March 2008, we submitted a marketing authorization application (MAA) seeking European approval for OPAXIO on equivalent effectiveness (non-inferiority) and improved safety as a single-agent in first-line PS2 NSCLC patients. The European Medicines Agency (EMEA) has accepted our application for review. Validation of the MAA for OPAXIO initiates the marketing approval review process, which generally takes 15 to 18 months.

2007 - CTI completes acquisition of Zevalin from Biogen Idec

In December 2007, we acquired Zevalin for an initial payment of $10 million to Biogen Idec. The acquisition gave us responsibility for marketing, sales, and development of the drug in the United States.

2007 - CTI acquires Systems Medicine

In August 2007, we completed the acquisition of Systems Medicine, Inc., a privately held oncology company, in a stock for stock merger valued at $20 million. The acquisition provided us with worldwide rights to brostallicin, a DNA minor groove binding agent with proven anti-tumor activity. Now known as Systems Medicine LLC (SM), SM will continue to operate as a wholly-owned subsidiary of CTI. SM applies a systems biology approach to drug development that combines pharmacogenomics and bioinformatics with preclinical, clinical, and regulatory expertise to find and exploit a specific cancer’s context of vulnerability. This helps identify and select patient populations that will be specifically responsive to a drug candidate in clinical trials.

2007 - CTI forms Aequus BioPharma, Inc.

In the first half of 2007, we formed a spin-off company, Aequus BioPharma, Inc. to develop the Genetic Polymer^™ technology that was created at CTI to speed the manufacture, development, and commercialization of novel biopharmaceuticals including follow-on biologics or biosimilars.

2006 - CTI enters agreement with Novartis for OPAXIO^™

In September 2006, we entered into an exclusive worldwide licensing agreement with Novartis for the development and commercialization of OPAXIO (formerly known as XYOTAX). Total product registration and sales milestones due from Novartis for OPAXIO under the agreements could reach up to $270 million. The agreement also provides Novartis with an option to develop and commercialize pixantrone based on agreed terms. As part of the agreement Novartis made a $15 million equity investment in CTI.

2005 - CTI divests TRISENOX to Cephalon

In July 2005, we sold the TRISENOX brand and certain proteasome assets to Cephalon for an aggregate of approximately $68 million. We may receive up to an additional $100 million if certain sales and regulatory milestones are achieved in the future.

2004 - CTI completes merger with Novuspharma

In 2004, we acquired Novuspharma (near Milan, Italy) and their novel drug candidate, pixantrone. The complementary expertise of the two companies resulted in an integrated biopharmaceutical company with capabilities across the entire spectrum of drug discovery, development, and commercialization. With this acquisition, we benefit from a stronger European presence with more global access to patients, physicians, and capital markets.

2000 - CTI acquires TRISENOX^®

In January 2000, we acquired PolaRx and its drug TRISENOX (arsenic trioxide) injection. We submitted a New Drug Application to the United States Food and Drug Administration in record time.

In September 2000, less than six months after the submission—and within three years of entering clinical trials—TRISENOX was approved for treating patients whose disease has recurred or who failed to respond to standard therapy for a rare type of leukemia called acute promyelocytic leukemia (APL). Within nine days of approval, the drug was being shipped.

1998 - CTI acquires polyglutamate polymer technology

In June 1998, we entered into an agreement with PG-TXL Company, L.P. granting us an exclusive worldwide license for the rights to PG-TXL, now known as OPAXIO^™ (paclitaxel poliglumex, CT-2103), and to all potential uses of PG-TXL’s polymer technology.

1997 - CTI becomes a publicly traded company

On March 26, 1997, we completed our initial public offering (IPO) raising gross proceeds of $30 million.

1991 - CTI is Formed

In the fall of 1991, CTI was founded by two oncologists, Drs. James Bianco and Jack Singer, and a financial executive, Louis Bianco. While treating patients in the clinic, Drs. Bianco and Singer had some very encouraging results from the combination of two already approved drugs. In an effort to determine why these drugs appeared to work for these patients, the entrepreneurs founded the company initially called Combined Therapeutics.