Advanced Accelerator Applications Announces New Prescription Drug User Fee Act (PDUFA) date of January 26, 2018, for Lutetium...
28 Agosto 2017 - 9:08AM
Advanced Accelerator Applications S.A.
(NASDAQ:AAAP) (AAA or the Company), an international specialist in
Molecular Nuclear Medicine (MNM), today announced that the US Food
and Drug Administration (FDA) has acknowledged receipt and
considered complete the resubmission of the New Drug Application
(NDA) for investigational drug lutetium Lu 177 dotatate*
(Lutathera®). The Agency provided a new Prescription Drug User Fee
Act (PDUFA) date of January 26, 2018.
AAA resubmitted the NDA following receipt of a
complete response letter (CRL) from the FDA in December 2016, in
which the Agency cited issues with the format, traceability,
uniformity, and completeness relating to the NETTER-1 and Erasmus
clinical datasets, which precluded FDA reviewers from performing
the required independent analysis of these clinical studies. The
CRL also requested subgroup analyses for gender, age and racial
subgroups, as well as other stratification factors and important
disease characteristics, and a safety update on clinical and
non-clinical studies. In addition, the CRL noted that any
observations made during inspections of manufacturing facilities
supporting the NDA need to be resolved prior to approval of the
NDA. No additional clinical studies were requested in the CRL and
there were no comments at that time on other sections of the NDA
submission.
The company recently announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) issued a positive opinion
recommending 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.
* USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu)
oxodotreotide
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). 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 Levine
Director of Communications
rachel.levine@adacap.com
Tel: + 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 & Company
Lee Davies
ldavies@makovsky.com
Tel: +212-508-9651
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