Kapil
Dhingra, Former Head of Roche Oncology, Joins Advanced Accelerator Applications
Board of Directors
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).
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.
