Healthcare Industry News: ChemGenex Pharmaceuticals
News Release - May 22, 2012
Talon Therapeutics Appoints Head of Commercial Operations and PlanningSAN MATEO, Calif., May 22, 2012 -- (Healthcare Sales & Marketing Network) -- Talon Therapeutics Inc. (OTCBB:TLON.OB ) today announced the appointment of Thomas DeZao to head the commercial operations and planning function. Mr. DeZao's experience includes senior commercial and marketing positions related to hematologic cancer product candidates at ChemGenex Pharmaceuticals, Genitope Corporation, and Corixa/Coulter Pharmaceuticals. Prior to that, Mr. DeZao worked for Schering-Plough Corp. and Chiron Corp., where he spent 10 years in various product sales, marketing and commercialization positions.
"We are delighted to add Tom to our senior management team," stated Steve R. Deitcher M.D., President, Chief Executive Officer and Talon Board Member. "Tom is a seasoned commercial executive with exceptional recent and relevant experience in the leukemia and lymphoma fields. With Marqibo(R)'s PDUFA date of August 12, 2012, active partnership discussions, and ongoing Phase 3 trials in adult acute lymphoblastic leukemia (ALL) and adult non-Hodgkin's lymphoma (NHL), Talon will greatly benefit from the addition of Tom's commercial, business development, and strategy experience," Dr. Deitcher added.
About Marqibo(R) (vincristine sulfate liposome injection)
Marqibo is a novel, targeted Optisome(TM) encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon is primarily developing Marqibo for the treatment of Philadelphia chromosome-negative adult acute lymphoblastic leukemia (ALL). Vincristine, a microtubule inhibitor, is FDA-approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias. Talon's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner.
Talon has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the FDA. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.
In addition to the Phase 3 confirmatory study of Marqibo in front-line adult elderly ALL, Marqibo is being evaluated in an on-going Phase 3 trial in front-line adult elderly aggressive NHL conducted by the German High Grade Non-Hodgkin's Lymphoma Study group, and in a Phase 1 trial in pediatric cancers, including ALL, being conducted by the National Cancer Institute. A Phase 2 trial of Marqibo in front-line adult ALL to be conducted by the M.D. Anderson Cancer Center is expected to begin enrolling in the third quarter of 2012.
About Talon Therapeutics
Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees.
In addition to Marqibo, the Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the potential of Marqibo to replace existing therapies, the timing of Talon's ongoing and planned clinical trials, Talon's ability to obtain approval of its Marqibo NDA, its ability to successfully launch Marqibo if approved, and its ability to secure a strategic partnership relating to the commercialization of Marqibo. Such statements involve risks and uncertainties that could cause Talon's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Such risks and uncertainties include: that there can be no assurances that any of Talon's clinical and regulatory development efforts relating to Marqibo will be successful; that Talon's NDA for Marqibo will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of the NDA for Marqibo; that the results of the clinical trials of Marqibo will support Talon's claims or beliefs concerning Marqibo's safety and effectiveness; that Talon will be able to secure the additional capital necessary to fund its product development programs, including Marqibo, to completion; that it will be able to secure a strategic partnership relating to the commercialization of Marqibo; Talon's reliance on third-party researchers to develop its product candidates; and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2011, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2012. Talon assumes no obligation to update these statements, except as required by law.
Source: Talon Therapeutics
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