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"Bringing Craig Philips on board at this time represents a milestone atCTI as the company has shifted from a research and development organization toa commercial operating company with the potential to expand the marketindication for Zevalin(R), report pixantrone pivotal trial results, andpotentially file a NDA, as well as the potential for an OPAXIO(TM) launch in2009," said Bianco.
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"With the opportunity to bring two new cancer drugs to market and expandthe label of another in the near term, CTI could transform itself into asuccessful commercial enterprise," said Philips. "I look forward to helping tobring value to CTI shareholders, and to improving the treatment optionsavailable to individuals suffering with cancer."
In late 2007, CTI acquired the U.S. sales and marketing rights to Zevalin,a drug for treating relapsed follicular non-Hodgkin's lymphoma (NHL). The fullmarketing and sales team has recently come on line, and Zevalin sales for 2008are on track at a projected $15 million for the year. Recently, CTI has gainedaccess rights to Bayer's FIT trial data, and will meet with the Food and DrugAdministration (FDA) in September to discuss label expansion in the U.S. Thephase III First-line Indolent Trial (FIT) evaluated the benefit and safety ofa single dose of Zevalin in patients with CD20-positive follicular lymphomawho had achieved a full or partial remission following first-line chemotherapytreatment.
In addition CTI has submitted an application for approval to market itslung cancer drug candidate OPAXIO in Europe and expects to receive a responsefrom the European Medicines Agency (EMEA) regarding that application in 2009,and also expects final data on another late stage phase III drug, pixantrone,for relapsed or refractory aggressive NHL in the second half of 2008. Positivepixantrone data could allow CTI to submit an application for FDA approval inearly 2009. OPAXIO is also being studied independently in a phase III trialfor ovarian cancer, with interim data results expected in late 2009.
Pixantrone is an investigational agent under development for the potentialtreatment of various blood cancers. It was developed to improve the activityand safety of the anthracycline family of anti-cancer agents and to reduce thepotential for the most common side effects of anthracyclines, severecardiotoxicities and cumulative heart damage.
CTI has a worldwide licensing agreement with Novartis on OPAXIO. Novartisalso holds an option for an exclusive license for pixantrone.
CTI is also developing brostallicin, another cancer drug for sarcomacurrently in phase II/III trials. Brostallicin, a novel synthetic second-generation DNA minor groove binder, has potent cancer killing activity and hasdemonstrated activity in combination with standard cytotoxic agents as well aswith newer targeted therapies in preclinical, experimental tumor models.
Since 2006, Philips has been leading Bayer's U.S. oncology operationsfollowing the integration of the U.S. oncology businesses from Berlex andBayer. In this capacity, he oversaw the U.S. oncology operations with sales of$350 million and a staff of over 150. Philips was also either a member orchair of alliance executive committees which included Onyx, Novartis, Genzyme,and Favrille.
Prior to Bayer Healthcare, Philips was the head of Berlex Oncology since2004. He was responsible for the U
