Advanced Accelerator Applications S.A.
(NASDAQ:AAAP) (AAA or the Company), an international specialist in
Molecular Nuclear Medicine (MNM), today announced that the European
Commission (EC) has approved the marketing authorization of
lutetium (177Lu) oxodotreotide* (Lutathera®) for “the treatment of
unresectable or metastatic, progressive, well differentiated (G1
and G2), somatostatin receptor positive gastroenteropancreatic
neuroendocrine tumors (GEP-NETs) in adults.” This approval allows
for the marketing of lutetium (177Lu) oxodotreotide* (Lutathera®)
in all 28 European Union member states, as well as Iceland, Norway
and Liechtenstein.
Stefano Buono, Chief Executive Officer of AAA,
commented, “This is a historic moment. We are proud to bring this
first-in-class drug, and the very first registered Peptide Receptor
Radionuclide Therapy (PRRT), to the European NET patient community.
We will continue to work closely with the respective health
authorities to make lutetium (177Lu) oxodotreotide (Lutathera®)
widely available. We believe numerous clinical studies in the
nuclear medicine field have demonstrated the advantages of
selectively delivering radiation to tumor cells over certain other
therapies, and we are committed to advancing this approach to
cancer treatment.
“With this approval, AAA has become the first
theragnostic radiopharmaceutical company in the oncology market. We
believe our unique platform, which involves radiolabeling a single
targeting molecule with either gallium Ga 68 for diagnostic use or
lutetium Lu 177 for therapeutic use will deliver improved patient
outcomes. NET patients who have had tumors successfully localized
using Positron Emission Tomography (PET) scans with our SomaKit
TOC™ diagnostic drug approved in Europe or our first-in-class
NETSPOT® diagnostic drug approved in the United States, may also be
candidates for therapy with lutetium (177Lu) oxodotreotide
(Lutathera®), since the drugs bind to the same receptor. This
theragnostic pairing for NETs is one of three drugs in our oncology
pipeline, through which we are leveraging the same targeting
molecule to license two separate products. Our next pairings in
development target malignancies such as prostate and breast cancers
and gastrointestinal stromal tumors.”
The marketing authorization is based on results
of a randomized pivotal Phase 3 study, NETTER-1 that compared
treatment using lutetium (177Lu) oxodotreotide (Lutathera®) to a
double dose of Octreotide LAR in patients with inoperable midgut
NETs progressive under standard dose Octreotide LAR treatment and
overexpressing somatostatin receptors; as well as efficacy and
safety data from a Phase 1/2 trial conducted by Erasmus Medical
Center in more than 1,200 patients with a wide range of NET
indications including foregut (including bronchial and pancreatic),
midgut and hindgut.
The European Medicines Agency requested an
update of NETTER-1 efficacy results with a cut-off date of June 30,
2016. The findings of this update were consistent with previously
published results (Strosberg, et al. N Engl J Med 2017;376:125-35).
The NETTER-1 study met its primary endpoint, showing a reduction of
risk of progression or death of 79% using lutetium (177Lu)
oxodotreotide (Lutathera®) compared to octreotide LAR 60 mg.
Although the final Overall Survival (OS) analysis (secondary
endpoint) is planned for after the first of either 158 cumulative
deaths, or five years after the last patient is randomized; the
current update (after 71 cumulative deaths), also confirmed the
favorable trend of 28 deaths in the lutetium (177Lu) oxodotreotide
(Lutathera®) arm versus 43 in the octreotide LAR 60 mg arm. The
median OS in the octreotide LAR arm was 27.4 months, but was still
not reached in the lutetium (177Lu) oxodotreotide (Lutathera®) arm
after 42 months, with a Hazard Ratio (HR) of 0.536, meaning a
reduction of risk of death of 46% using lutetium (177Lu)
oxodotreotide (Lutathera®) compared to octreotide LAR 60 mg).1
Gastroenteropancreatic neuroendocrine tumors,
also known as GEP-NETs, are a group of tumors originating in the
neuroendocrine cells of numerous organs. According to the European
Society for Medical Oncology (ESMO), the crude incidence of
GEP-NETs is estimated to be 5.25/100,000 per year.2 Lutetium
(177Lu) oxodotreotide (Lutathera®) has received orphan drug
designation from the European Medicines Agency.
The Summary of Product Characteristics for
lutetium (177Lu) oxodotreotide (Lutathera®) may be found at:
http://ec.europa.eu/health/documents/community-register/2017/20170926138665/anx_138665_en.pdf
A New Drug Application is currently under review
by the US Food and Drug Administration. The Prescription Drug User
Fee Act (PDUFA) action date is January 26, 2018.
* USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu)
oxodotreotide
1 Advanced Accelerator Applications. (177Lu) oxodotreotide
(Lutathera®) Summary of Product Characteristics. 2017.2 Öberg K,
Knigge U, Kwekkeboom D, Perren A. Neuroendocrine
gastro-entero-pancreatic tumors: ESMO Clinical Practice Guidelines
for diagnosis, treatment and follow-up. Annals of Oncology. 2012;23
(Supplement 7):vii124–vii130.
About USAN: lutetium
Lu 177 dotatate/INN: lutetium (177Lu)
oxodotreotide (Lutathera®)
USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu)
oxodotreotide (Lutathera®) is an investigational 177Lu-labeled
somatostatin analog peptide. USAN: lutetium Lu 177 dotatate/INN:
lutetium (177Lu) oxodotreotide, (Lutathera®) belongs to an emerging
form of treatments called Peptide Receptor Radionuclide Therapy
(PRRT), which involves targeting tumors with radiolabeled molecules
that bind to specific receptors expressed by the tumor. This novel
compound has received orphan drug designation from the European
Medicines Agency (EMA) and the US Food and Drug Administration
(FDA). Currently, USAN: lutetium Lu 177 dotatate/INN: lutetium
(177Lu) oxodotreotide (Lutathera®) is administered on a
compassionate use and named patient basis for the treatment of NETs
and other tumors over-expressing somatostatin receptors in ten
European countries and in the US under an Expanded Access Program
(EAP).
About Advanced Accelerator Applications
S.A.
Advanced Accelerator Applications is an
innovative radiopharmaceutical company that develops, produces and
commercializes Molecular Nuclear Medicine products. AAA’s lead
investigational therapeutic candidate, USAN: lutetium Lu 177
dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®), is a
novel MNM compound in development for the treatment of
neuroendocrine tumors, a significant unmet medical need. Founded in
2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA
currently has 21 production and R&D facilities able to
manufacture both diagnostics and therapeutic MNM products, and more
than 500 employees in 13 countries (France, Italy, the UK, Germany,
Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium,
Israel, the US and Canada). AAA reported sales of €109.3 million in
2016 (+23% vs. 2015) and €69.2 million in 1H17 (+27% vs. 1H16). AAA
is listed on the Nasdaq Global Select Market under the ticker
“AAAP”. For more information, please visit: www.adacap.com.
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 and reveal specific
biochemical processes. MNM can be divided in two branches:
Molecular Nuclear Diagnostics and Molecular Nuclear Therapy.
Molecular nuclear diagnostics employs a variety of imaging devices
and radiopharmaceuticals. PET (Positron Emission Tomography) and
SPECT (Single Photon Emission Computed 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. Molecular
nuclear therapy uses radioactive sources (radionuclides) to treat a
range of tumor types. Using short-range particles, this therapy can
target tumors with little effect on normal tissues.
Cautionary Statement Regarding
Forward-Looking Statements
This press release contains 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 that appear in a number of places in
this press release include the Company's current expectation
regarding future events and various matters, including expected
timing of filings with the FDA and EMA, and approval dates. 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, the timing of
our submission of applications for regulatory approvals, EMA, FDA
and other regulatory approvals for our product candidates, the
occurrence of side effects or serious adverse events caused by or
associated with our products and product candidates; our ability to
procure adequate quantities of necessary supplies and raw materials
for USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu)
oxodotreotide (Lutathera®) and other chemical compounds acceptable
for use in our manufacturing processes from our suppliers; our
ability to organize timely and safe delivery of our products or
product candidates by third parties; any problems with the
manufacture, quality or performance of our products or product
candidates; the rate and degree of market acceptance and the
clinical utility of USAN: lutetium Lu 177 dotatate/INN: lutetium
(177Lu) oxodotreotide (Lutathera®) and our other products or
product candidates; our estimates regarding the market opportunity
for USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu)
oxodotreotide (Lutathera®), our other product candidates and our
existing products; our anticipation that we will generate higher
sales as we diversify our products; our ability to implement our
growth strategy including expansion in the US; our ability to
sustain and create additional sales, marketing and distribution
capabilities; our intellectual property and licensing position;
legislation or regulation in countries where we sell our products
that affect product pricing, taxation, reimbursement, access or
distribution channels; regulatory actions or litigation; and
general economic, political, demographic and business conditions in
Europe, the US and elsewhere. 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.
Contacts:
AAA Corporate Communications Rachel
LevineDirector of Communications rachel.levine@adacap.comTel: +
1-212-235-2395
AAA Investor Relations Jordan Silverstein Head
of Investor Relations jordan.silverstein@adacap.com Tel: +
1-212-235-2394
Media inquiries:
Makovsky & CompanyLee
Daviesldavies@makovsky.comTel: +212-508-9651
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