SOURCE Advanced Accelerator Applications
SAINT-GENIS-POUILLY, France, April 29, 2014 /PRNewswire/ --
Advanced Accelerator Applications S.A. ("AAA" or "the Company"), an international specialist in Molecular Nuclear Medicine, today announced that Dr Kapil Dhingra has joined the Company Board of Directors as an Independent Non-Executive Director.
Stefano Buono, Chief Executive Officer of AAA, commented: "Dr. Dhingra's guidance and perspective on clinical development, regulatory and commercial strategy will be of tremendous benefit as we advance our pipeline of product candidates and our lead product candidate, Lu-DOTATATE (Lutathera®), currently in a pivotal Phase III trial for the treatment of gastro-entero-pancreatic neuroendocrine tumors ("GEP-NETs"). Dr. Dhingra's recent experience serving on the Board of Algeta, which had its key radiopharmaceutical product, Xofigo®, approved in the United States and Europe last year for targeted internal radiotherapy for advanced prostate cancer, will be also extremely valuable."
Dr Dhingra said: "I am delighted to join AAA's Board of Directors. AAA is a company with great potential. Radiopharmaceuticals represent an important new modality of cancer therapeutics. I look forward to working with the Board to fully leverage the opportunity with Lu-DOTATATE as it advances towards commercialization as well as building the future pipeline."
Dr Dhingra has over 25 years' experience in oncology clinical research and drug development, including nine years at Roche Pharmaceuticals, where he played a key role in the expansion of Roche Oncology. From 1999 to 2008 he served in positions of increasing responsibility at Roche, including Vice President, Head, Oncology Disease Biology Leadership Team, and Head, Oncology Clinical Development.
Prior to his time at Roche, Dr. Dhingra worked in the oncology clinical development group at Eli Lilly and Company. He has also previously served as a Clinical Instructor, Assistant Professor of Medicine at the University of Texas M.D. Anderson Cancer Center. Dr. Dhingra holds an M.B.,B.S. (equivalent to a U.S. M.D.) degree from the All India Institute of Medical Sciences. He is Board-certified in Internal Medicine and Medical Oncology.
Dr Dhingra is Head of KAPital Consulting, a healthcare consulting firm he founded in 2008, dedicated to helping biotechnology, pharmaceutical and diagnostic companies realize the clinical and commercial advances in oncology. Dr. Dhingra is currently an advisor to and/or member of the board of directors of several biotechnology and pharmaceutical companies and organizations. He has previously served on the Boards of several successful biotech companies, including Biovex, Micromet, Algeta, and YM Biosciences, which were acquired by major pharmaceutical companies.
The AAA Board is chaired by Claudio Costamagna and consists of nine Directors.
About Advanced Accelerator Applications
Advanced Accelerator Applications (AAA) is a privately owned European pharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA's main focus is in the field of Molecular Imaging and targeted, individualized therapy for the management of patients with serious conditions ("Personalized Medicine"). AAA currently has 17 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 290 employees in 11 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, Israel, U.S. and Canada). In 2012 AAA reported revenues of €44.6 million (+22.5% vs. 2011) and an EBITDA of €9.4 million (+59% vs. 2011). For more information please visit: http://www.adacap.com
AAA has a portfolio of Molecular Nuclear Medicine products, including Lu-DOTATATE, currently in Phase III clinical trials for the treatment of GEP-NETs (an orphan disease) in 51 clinical centers in the United States and European Union. Lu-DOTATATE is an example of a theragnostic product candidate, because it integrates diagnostic and therapeutic properties into the same compound, allowing physicians to evaluate and monitor its efficacy using imaging at every therapeutic injection, without additional product costs. Enrollment for the ongoing Lu-DOTATATE Phase III clinical trial (study known as Netter-1) is currently going as planned with over 200 individuals enrolled to date.
About Molecular Nuclear Medicine ("MNM")
Molecular Nuclear Medicine is a medical specialty using trace amounts of active substances, called radiopharmaceuticals, to create images of organs and lesions and to treat various diseases, like cancer. The technique works by injecting targeted radiopharmaceuticals into the patient's body that accumulate in the organs or lesions that reveal specific biochemical processes.
Molecular Nuclear Diagnostics employs a variety of imaging devices and radiopharmaceuticals. PET (Positron Emission Tomography) and SPECT (Single Photon Emission Tomography) are highly sensitive imaging technologies that enable physicians to diagnose different types of cancer, cardiovascular diseases, neurological disorders and other diseases in their early stages.
Theragnostics is today used to define "companion drugs". This means that a therapeutic drug is developed and is approved to be used together with a diagnostic test. The test can tell you if the drug is suitable for a specific disease in a specific patient and checks if the treatment could be effective, thus increasing the cost-effectiveness of the whole treatment. MNM can integrate diagnostics and therapeutics properties into a single theragnostic drug and is a key discipline in the transition from population-based medicine to Personalized Medicine.
Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, EMA, U.S. FDA and other regulatory approvals for our product candidates, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, and uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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