Healthcare Industry News: YONDELIS
News Release - June 13, 2011
Spectrum Pharmaceuticals Announces Promotions of Steven M. Fruchtman, MD, to Chief Medical Officer, Head of Medical & Regulatory Affairs, and Nozar Azarnia, PhD, to Head of Biostatistics and Data ManagementDr. Fruchtman, a Hematologist and Oncologist, Joined Spectrum as Vice President of Clinical Development in February 2011 from Allos Therapeutics, Where He Directed Development of FOLOTYN® for Hematologic and Oncologic Indications
Earlier He Served at Novartis and Ortho Biotech
Dr. Azarnia, a Biostatistician with Decades of Experience in Data Management and Analysis of Oncology Clinical Trials and More Than Ten Marketing Applications for Oncology Products
Was Previously at ImClone Systems, Where He Was Instrumental in Approval of Erbitux® for Colorectal and Head and Neck Cancers
HENDERSON, Nev.--(Healthcare Sales & Marketing Network)-- Spectrum Pharmaceuticals (NasdaqGS:SPPI ), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced the promotion of Steven M. Fruchtman, MD, to the position of Vice President and Chief Medical Officer, and Nozar Azarnia, PhD, to the position of Vice President of Biostatistics and Data Management. Dr. Fruchtman will report directly to Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. His new responsibilities include clinical research, clinical affairs, preclinical research, biostatistics, data management and regulatory affairs, in addition to managing the Company’s clinical development of belinostat, apaziquone, and its other pipeline products and indications. Dr. Azarnia will report directly to Dr. Fruchtman and will be responsible for all statistical and data management support, from design of clinical trials through marketing applications.
“We are pleased to promote Dr. Fruchtman as Chief Medical Officer, Head of Medical and Regulatory Affairs, and Dr. Azarnia as Head of Biostatistics and Data Management,” said Dr. Shrotriya. “While we continue to grow FUSILEV® and ZEVALIN® revenues, we are also focused on preparing for potentially two NDA filings over the next 12-18 months. Having individuals with the expertise and experience of Drs. Fruchtman and Azarnia is important for the timely filing of the belinostat and apaziquone NDAs and advancing clinical research activities related to ZEVALIN, FUSILEV and other drugs in the pipeline.”
“Dr. Fruchtman has had a significant impact on the belinostat clinical program in the short time he has been with Spectrum. His promotion coincides with our expectations of completing enrollment in the belinostat PTCL trial before the year end and filing a NDA in 2012.”
“Dr. Azarnia has also made a significant contribution to Spectrum,” said Dr. Shrotriya. “He has been instrumental in the filings for the colorectal cancer indication for FUSILEV and the filing of the Prior Approval Supplement for the removal of the ZEVALIN bioscan requirement.”
Dr. Fruchtman joined Spectrum in February 2011 to head clinical development. Previously, Dr. Fruchtman was with Allos Therapeutics, where he was involved with the development of pralatrexate (Folotyn) for hematologic and oncologic indications. Prior to joining Allos, Dr. Fruchtman was Senior Director of US Clinical Development and Medical Affairs for Novartis Pharmaceuticals. At Novartis, he was responsible for the development of LBH589 (Panobinostat) for hematologic and oncologic indications and was responsible for registration trials in the United States for several indications; lead development of post marketing trials for Proleukin (IL-2) in renal cell carcinoma and melanoma; and lead development of RAD001 (Afinitor) for hematological indications. Prior to his tenure at Novartis, he was the Medical Director of Hematology and Oncology Therapeutics and Clinical Affairs at Ortho Biotech Products (OBI), L.P., a division of Johnson and Johnson Pharmaceuticals. At OBI, he was responsible for the clinical development of DOXIL® Phase 4 trials in hematological malignancies (multiple myeloma and non-Hodgkin’s lymphoma), Velcade and DOXIL® for 2nd line multiple myeloma, Zarnestra® (tipifarnib) Phase 1 and 2 trials in myelodysplastic syndrome (MDS) and acute myeloid leukemia, Procrit® for MDS, and YONDELIS® (trabectedin) trials in soft tissue sarcoma and ovarian cancer. Prior to his career in industry, Dr. Fruchtman enjoyed a successful academic career at Mount Sinai Hospital and Medical School in New York, where he was Chief of the Stem Cell Transplantation Program.
Dr. Fruchtman has served as an external reviewer for the New England Journal of Medicine, Mayo Clinic Proceedings, Experimental Hematology, European Journal of Hematology, Leukemia, and served on the editorial board of The Mount Sinai Journal of Medicine. Dr. Fruchtman is an author of more than 170 lectures, presentations, books, chapters, and abstracts. Dr. Fruchtman received his Bachelor of Arts with Honors from Cornell University, and his MD from New York Medical College.
Dr. Azarnia joined Spectrum in September 2010. Previously, Dr. Azarnia was the president of Oncology Statistics, a Cherry Hill, New Jersey based consultancy, where he was responsible for statistical support in late phase development of oncology drugs, from design of pivotal trials and statistical analyses of clinical data, to marketing applications for the approval of drugs. Prior to that, he was Assistant Vice President of Biostatistics and Data Management for ImClone Systems, where he was responsible for data from clinical trials of ERBITUX® (cetuximab), and coordinated all statistical activities with partners Merck KGaA of Germany and Bristol-Myers Squibb in the United States. At ImClone, he shared in the development of procedures for independent radiologic assessment of tumor response. He was instrumental in accelerated approval of ERBITUX in refractory metastatic adenocarcinoma of colon and rectum, and later was the pivotal team member in full approval of ERBITUX with radiotherapy in locally and regionally advanced squamous-cell carcinoma of head and neck.
Dr. Azarnia started his career in clinical cancer research as the statistician for the Leukemia Intergroup project of the National Cancer Institute at Roswell Park Cancer Institute. From there he moved to Radiation Therapy Oncology Group as Senior Biostatistician. Dr. Azarnia entered the pharmaceutical industry as Associate Director of Oncology Biometrics for DuPont Pharmaceutical Company, and later as Director and Executive Director of Biostatistics and Data Management for The Liposome Company, before joining ImClone Systems.
Dr. Azarnia is an author in more than 100 journal articles and abstracts. He received his Doctorate in Applied Mathematics at the University of Cincinnati in Cincinnati, Ohio, his Master of Science in Physics at the University of Pittsburgh in Pittsburgh, Pennsylvania, and his Bachelor of Science in Physics, where he graduated summa cum laude, at Miami University in Oxford, Ohio.
These two promotions are part of a reorganization of Spectrum’s scientific and research and development operations in order to streamline functions for the approaching NDAs of belinostat and apaziquone. Dr. George Tidmarsh has resigned his position at Spectrum to pursue other interests. “I wish to thank him for his service to Spectrum over the past year, and I wish him well in his future endeavors,” concluded Dr. Shrotriya.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN, and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Source: Spectrum Pharmaceuticals
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