News

December 21, 2016

Advanced Accelerator Applications Receives Complete Response Letter from FDA for Lutathera®, an Investigational Treatment for Neuroendocrine Tumors

AAA today announced that following the issuance of a previously disclosed Discipline Review Letter (DRL) in November, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

No additional clinical studies were requested in the CRL and there were no comments at this time on other sections of the NDA submission.

December 15, 2016

Advanced Accelerator Applications Announces European Commission Approval of SomaKit TOC™

AAA today announced that following a positive opinion issued by the European Medicines Agency in October 2016, the European Commission has approved SomaKit TOC™ 40 μg, a kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEPNETs) for localizing primary tumors and their metastases. The drug has 10-year orphan market exclusivity in the European territory.

December 8, 2016

Advanced Accelerator Applications Announces CMS Pass-Through Reimbursement Code for its First FDA Approved Drug NETSPOT®

AAA today announced that the Centers for Medicare & Medicaid Services (CMS) has granted NETSPOT® Transitional Pass-Through status under an “A-code” (A9587) for drug reimbursement, effective January 1, 2017. Additionally, the same Healthcare Common Procedure Coding System (“HCPCS”) “A Code” will be used on claims to private payers.

A first-in-class drug, NETSPOT® was approved after a record-breaking 23 months from the first pre-Investigational New Drug meeting with the FDA. The product has been used and paid for over the past six months, even prior to the issuance of this Pass-Through code, demonstrating recognition of NETSPOT’s® value to NET patient management.

Stefano Buono, Chief Executive Officer of AAA said, “The enthusiastic response of the NET patient and physician community to NETSPOT® has been remarkable. Once effective, this coding will streamline billing and reimbursement for all institutions using the product. The NETSPOT® rollout is progressing in line with our expectations and recent changes in the Nuclear Regulatory Commission guidelines should facilitate placement of additional gallium Ga 68 generators around the country.

November 28, 2016

Advanced Accelerator Applications Reports 15.4% Sales Growth in the Third Quarter of 2016 and Feedback from the FDA for Lutathera®, an Investigational Treatment for Neuroendocrine Tumors

AAA today announced its financial results for the third quarter of 2016 and that the U.S. Food and Drug Administration (FDA) issued feedback on its New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

Third Quarter Highlights:

– Sales for the third quarter of 2016 increased 15.4% compared to the third quarter of 2015
– Closed $150 million follow-on public offering and subsequent underwriters option to purchase additional $22.5 million
– The U.S. Food and Drug Administration (FDA) issued feedback via a Discipline Review Letter on the New Drug Application (NDA) for Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
– The European Medicines Agency (EMA) issued a positive opinion on the Marketing Authorization Application for SomaKit TOC
– Achieved marketing authorization in Switzerland for DOPAVIEW and AAACholine
– Initiated two Phase II clinical studies evaluating 99MTc-rhAnnexin V-128 (Annexin) in cardiovascular and cardio-oncology indications

November 23, 2016

Advanced Accelerator Applications to Announce Third Quarter and Nine-Month 2016 Financial Results on November 28

AAA today announced that the company will report its financial results for the third quarter and nine-month period ended September 30, 2016, on November 28.

Stefano Buono, Chief Executive Officer and Heinz Mausli, Chief Financial Officer will host a conference call at 4:30 p.m. ET to review the quarter and discuss business updates.

Interested parties may participate by dialing 877-407-8133 (US) or +1-201-689-8040 (International), approximately five minutes before the call start time. A live webcast of the conference call will be available at: http://www.investorcalendar.com/IC/CEPage.asp?ID=175484.

November 2, 2016

Advanced Accelerator Applications Announces Swiss Marketing Authorization for Two PET Diagnostic Products

AAA announced today that the company has been granted marketing authorization in Switzerland for two Positron Emission Tomography (PET) products, DOPAVIEW and AAACholine.

DOPAVIEW is AAA’s brand name for 6-fluoro-(18F)-L-DOPA, a DOPA analogue. DOPA is an aromatic amino acid that accumulates rapidly in target tissues of the human brain and is transformed into dopamine, a neurotransmitter. In neurology, PET imaging with DOPAVIEW is indicated for diagnosis of Parkinson’s disease and differentiation between essential tremor and parkinsonian syndromes. In oncology, PET imaging with DOPAVIEW enables diagnosis, localization and characterization of various tumor types, such as neuroendocrine tumors, gliomas, and thyroid cancer.

DOPAVIEW will benefit from a 10-year marketing exclusivity, since AAA is the first company to obtain marketing authorization for this product in Switzerland.

AAACholine is AAA’s brand name for 18F-choline. 18F-choline is indicated for PET imaging in prostate cancer patients, including localization of lesions, characterization of the tumor in case of biochemical relapse and evaluation of the response and follow-up of patients with loco/regional and/or metastatic recurrence.

October 17, 2016

Advanced Accelerator Applications Announces Positive EMA Opinion on Application for SomaKit TOC

AAA today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Marketing Authorization Application for SomaKit TOC 40 µg, a kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NET) for localizing primary tumors and their metastases.

The European Commission (EC) decision regarding granting of marketing authorization in all EU countries is expected in the coming months. Once marketing authorization is granted, SomaKit TOC will benefit from 10-year orphan market exclusivity in the European territory.

October 11, 2016

Advanced Accelerator Applications Announces Presentations on Lutathera® NETTER-1 Phase III and NeoBOMB1 at EANM

AAA today announced that data from the pivotal NETTER-1 Phase III study investigating the treatment of Lutathera® (lutetium Lu 177 dotatate) in patients with somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) and preclinical oncology studies with NeoBOMB1, a novel GRPR antagonist, will be presented at the 29th Annual Congress of the European Association of Nuclear Medicine (EANM), October 15-19, in Barcelona, Spain.

October 5, 2016

Advanced Accelerator Applications S.A. Announces Pricing of $150 Million Public Offering of American Depositary Shares

AAA today announced the pricing of an underwritten public offering of 3,947,369 American Depositary Shares (“ADSs”) representing ordinary shares of the Company at a public offering price of $38.00 per ADS, before underwriting discounts and offering expenses. The gross proceeds from the sale of the ADSs, before underwriting discounts and commissions and offering expenses, are expected to be approximately $150 million. In addition, the underwriters have a 30-day option to purchase up to an additional 592,104 ADSs on the same terms and conditions.

October 4, 2016

Advanced Accelerator Applications S.A. Announces Proposed Public Offering of American Depositary Shares

AAA today announced that it has commenced an underwritten public offering of $125 million of American Depositary Shares (“ADSs”) representing ordinary shares of the Company. All ADSs will be offered by AAA. In addition, AAA expects to grant the underwriters a 30-day option to purchase up to $18,750,000 of additional ADSs at the public offering price, less the underwriting discount.

September 22, 2016

EMA Prematurely Announced Opinion on SomaKit TOC® Kit Application

AAA announced today that the European Medicines Agency (EMA) prematurely notified the public and the company of its opinion on the Marketing Authorization Application for SomaKit TOC®, a kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NET) for localizing primary tumors and their metastases.

The EMA posted the following statement on its website: “The adoption of the CHMP opinion for SomaKit TOC was included in the CHMP highlights in error. This opinion has now been removed from the highlights as this procedure is still ongoing. Once the procedure is finalised, EMA will communicate its outcome.”

SomaKit TOC® is composed of both a medicinal product and a device component. Finalization of the opinion on the kit is subject to the device component being certified by the relevant notified body. This requirement should have no impact on the benefit-risk assessment of the product. Once it has been fulfilled, the EMA will issue its final opinion on SomaKit TOC®.

We are actively collaborating with the EMA staff to move forward as quickly as possible,” said Stefano Buono, Chief Executive Officer of AAA.

September 20, 2016

Advanced Accelerator Applications Announces Revised EMA Review Timeline for Lutathera®

AAA today announced that the Accelerated Assessment timeline for the European Medicines Agency (EMA) review of the Marketing Authorization Application (MAA) for Lutathera®, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of neuroendocrine tumors (NETs), has been modified to a standard review period due to additional clarifications requested by the EMA, as well as their request to inspect one of AAA’s contract research organizations (CRO).

Our team is working closely with EMA reviewers to facilitate this process,” said Stefano Buono, Chief Executive Officer of AAA. “While the time required to address these requests and conduct the work with the involved CRO will prevent the achievement of the original Accelerated Assessment timeline, the EMA’s revised approval timeline continues to be in line with what we have anticipated for our commercial planning in Europe. I am pleased to share that in the last month, the U.S. Food and Drug Administration has successfully completed inspections of both of our CROs, several clinical sites and all of our manufacturing sites.

September 16, 2016

Advanced Accelerator Applications Announces Positive EMA Opinion on Application for SomaKit TOC Kit for Radiopharmaceutical Preparation of Gallium (Ga 68) Edotreotide for Gastroenteropancreatic Neuroendocrine Tumor Detection

AAA today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Marketing Authorization Application for SomaKit TOC 40µg, a kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NET) for localizing primary tumors and their metastases. The European Commission (EC) decision regarding granting of marketing authorization in all EU countries is expected in the coming months.

Following approval by the EC, SomaKit TOC will be made available to the European market as soon as possible. In most European countries, SomaKit TOC will be available as a unique kit for reconstitution, including two vials and a cartridge for direct elution using a gallium Ga 68 generator.

We are excited to have achieved a positive EMA opinion on our SomaKit TOC application,” said Stefano Buono, Chief Executive Officer of AAA. “This milestone comes soon after U.S. Food and Drug Administration (FDA) approval of NETSPOT™ (gallium Ga 68 dotatate) in June. We believe our diagnostic products offer NET patients superior accuracy and specificity compared to previously available diagnostic products, while reducing patient burden.

AAA is committed to bringing innovation to NET patients,” added Buono. “Between NETSPOT™, SomaKit TOC, and our therapeutic product, Lutathera, our team has simultaneously managed four major regulatory submissions to the FDA and EMA for this indication over the course of this year.

September 6, 2016

Advanced Accelerator Applications Announces Two Phase II Studies Evaluating 99MTc-rhAnnexin V-128 Imaging in Cardiovascular and Cardio-Oncology Indications at University of Ottawa Heart Institute and Ottawa Hospital

AAA today announced the initiation of two Phase II clinical studies evaluating 99MTc-rhAnnexin V-128 (Annexin), a single-photon emission computed tomography (SPECT) diagnostic candidate for the assessment of apoptosis and necrosis, forms of cell death in cardiovascular and cardio-oncology indications at the University of Ottawa Heart Institute and The Ottawa Hospital.

Stefano Buono, Chief Executive Officer of AAA said, “Having diagnostic tools that can accurately detect apoptosis and necrosis in cardiovascular settings can facilitate early diagnosis of potentially life-threatening conditions, enable more precise risk stratification, and help physicians monitor the efficacy and safety of treatments in individual patients during the course of therapy. Our goal is to develop Annexin into a personalized disease management tool for multiple inflammatory diseases.”

September 1, 2016

Advanced Accelerator Applications Reports 24.4% Sales Growth in the Second Quarter of 2016

AAA today announced its financial results for the second quarter of 2016. Commenting on the second quarter performance, Stefano Buono, AAA’s CEO, said: “We are very excited about the launch of our first FDA approved product in the U.S. We have established national distribution for NETSPOTTM (Somakit-TATE) and are pleased by the initial demand and patient support we have received. In the meantime, we are quite encouraged by the Priority Review designation for Lutathera and that patients are starting to receive treatment under the U.S. Expanded Access Program. These developments and the establishment of our first U.S. facility further support our preparations for launch in both the U.S. and Europe.” Buono added, “We look forward to continuing our momentum in the second half of 2016, with the December 28 PDUFA date for Lutathera, and our plans to begin advancing the NeoBOMB1 and PSMA assets into clinical development.”

Second Quarter Highlights:

– Sales for the second quarter of 2016 increased 24.4% compared to the second quarter of 2015
– The U.S. Food and Drug Administration (FDA) granted Priority Review for Lutathera, with a Prescription Drug User Fee Act (PDUFA) target action date of December 28, 2016
– First patient was treated with Lutathera under the U.S. Expanded Access Program
– The FDA approved NETSPOTTM (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography
– Established first U.S. distribution and future production site
– Expanded theragnostic pipeline with NeoBOMB1, a novel GRPR antagonist in development for gastrointestinal stromal tumors, prostate cancer and breast cancer
– Acquired two F-18 production sites in Germany

August 3, 2016

Advanced Accelerator Applications Announces First Administration of NETSPOT™ at Holy Name Medical Center

AAA today announced the first administration of NETSPOT, a product recently approved by the U.S. Food and Drug Administration (“FDA”) for the preparation of gallium Ga 68 dotatate for injection, for the localization of somatostatin receptor positive neuroendocrine tumors (“NETs”) in adult and pediatric patients using Positron Emission Tomography (“PET“) at Holy Name Medical Center (“Holy Name”) in Teaneck, NJ.

Stefano Buono, Chief Executive Officer of AAA said, “We are very excited to bring NETSPOT, a widely anticipated new imaging product to patients in the U.S. We believe NETSPOT offers superior sensitivity and accuracy compared to previously available diagnostics for NET patients. In a clinical study, NETSPOT demonstrated the ability to change management decisions regarding patients in 71% of cases previously imaged with Octreoscan.1 Saving just one patient from futile surgery can improve the treatment experience, as well as generate cost savings greater than the cost of providing a year’s worth of NETSPOT injections to every NET patient treated in the same hospital! We are proud to contribute to the introduction of pharmaceutical products that improve patient care, while decreasing healthcare costs.”

NETSPOT is currently available in the U.S. in two forms: As a kit for reconstitution using a Ga 68 generator, and as NETSPOT Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas. AAA has partnered with four radiopharmacies in the U.S. to facilitate availability of NETSPOT nationally, including Zevacor Pharma Inc., that delivered the NETSPOT injection to Holy Name Medical Center.

August 2, 2016

Advanced Accelerator Applications Announces Clinical Trial Agreement with National Cancer Institute for Study of Lutathera in Patients with Inoperable Pheochromocytoma and Paraganglioma

AAA today announced a clinical trial agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, whereby NCI will sponsor and conduct a study of Lutathera, an investigational drug, in patients with inoperable pheochromocytoma and paraganglioma.

Frank Lin, M.D., Medical Officer with the NCI’s Cancer Imaging Program and collaborator with the Molecular Imaging Program, directed by Peter Choyke, M.D., F.A.C.R., in NCI’s Center for Cancer Research will be the Principal Investigator for a planned NCI-sponsored study. The envisioned trial will draw from the unique population of pheochromocytoma and paraganglioma patients being evaluated at the NIH.

We applaud the NCI’s efforts to address the needs of patients suffering from these rare malignancies and are pleased to facilitate the exploration of additional potential indications for Lutathera,” said Stefano Buono, Chief Executive Officer of AAA. “Over the past three years, Lutathera has been used under compassionate use and named patient programs in 10 European countries in almost 1,300 patients, including those with pheochromocytoma and paraganglioma. In a Phase II trial conducted at the Erasmus Medical Center that is part of our New Drug Application to the U.S. Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency, 45 patients with these indications were treated with a median Progression Free Survival of 24.8 months and a median Overall Survival that was not reached. We hope these results will be confirmed by the NCI trial.”

July 26, 2016

Advanced Accelerator Applications Announces Opening of First U.S. Manufacturing Facility; Preparation for Anticipated Lutathera Launch

AAA today announced the opening of its first U.S. manufacturing facility in Millburn, NJ.

The 15,000 square foot facility features 12 production lines dedicated to Lutathera, as well as storage and office space. The site is conveniently located near Newark airport, enabling future delivery of Lutathera directly to hospitals and treatment centers around the country. There are currently more than 15 pharmaceutical manufacturing, sales and marketing, and administrative employees working on site, with plans to expand to 50 people.

In addition, the Millburn plant serves as a distribution center for NETSPOT™, a AAA product recently approved by the U.S. Food and Drug Administration for the preparation of Gallium Ga 68 dotatate for injection, a first in class drug for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography (“PET”). Oxygen-18 enriched water, an important precursor for the production of fluorodeoxyglucose used in PET, is also distributed by the new facility on behalf of Marshall Isotopes, a AAA company.

“We are excited to have our first U.S. manufacturing facility operational in preparation for the anticipated approval and launch of Lutathera,” said Stefano Buono, Chief Executive Officer of AAA. “The Millburn plant is our 22nd manufacturing site globally and we believe this facility will provide us with sufficient capacity to meet future demand for Lutathera in the North American market and manage distribution of our new generation of PET products.”

June 27, 2016

Advanced Accelerator Applications Announces FDA Priority Review for Lutathera

AAA today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for Lutathera, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastro entero pancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The Prescription Drug User Fee Act (PDUFA) target action date is December 28, 2016.

Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.

The Lutathera NDA is based on the results of a randomized pivotal Phase 3 study, NETTER-1 that compared treatment using Lutathera with a double dose of Octreotide LAR in patients with inoperable midgut NETs progressive under Octreotide LAR treatment and overexpressing somatostatin receptors. The NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera was associated with a statistically significant and clinically meaningful risk reduction of 79% in disease progression or death versus a treatment with a double dose of Octreotide LAR. Efficacy and safety data from a large Phase I-II trial conducted in more than 1,200 patients in NET indications is also part of the NDA.

We are encouraged that the FDA has granted Priority Review for Lutathera as a potential treatment for GEP-NETs,” said Stefano Buono, Chief Executive Officer of AAA. “We believe this action emphasizes the need to improve the lives of these patients.

June 10, 2016

Advanced Accelerator Applications Expands U.S. NETSPOT™ Supply Chain with Two Additional Radiopharmacy Networks

AAA announced that it has further strengthened its U.S. supply chain for NETSPOT(TM) with the addition of two radiopharmacy networks, Triad Isotopes, Inc., the second largest radiopharmaceutical company in the United States, and Nuclear Diagnostic Products, Inc. (“NDP”), a company with three radiopharmacies in the Northeast and a member of United Pharmacy Partners Inc. (“UPPI”), to supply gallium 68 (“Ga 68”) dotatate doses prepared with a novel kit to U.S. hospitals and imaging centers.

NETSPOT (formerly known as Somakit-TATE) is a patented kit recently approved by the U.S. Food and Drug Administration (“FDA”) for the preparation of Ga 68 dotatate for injection, for the localization of somatostatin receptor positive neuroendocrine tumors (“NETs”) in adult and pediatric patients using Positron Emission Tomography (“PET“). The product has received orphan drug designation from the FDA.

Triad and NDP will each prepare and deliver NETSPOT patient doses to advanced medical imaging sites in selected metropolitan areas. The addition of these partnerships completes the foundation of a robust nationwide supply chain that now includes four radiopharmacy networks.

June 9, 2016

Cardinal Health to Prepare NETSPOT™ Doses for Advanced Accelerator Applications

Cardinal Health, Inc. (NYSE: CAH), a healthcare services company operating the largest radiopharmaceutical network in the United States, has been selected to supply gallium 68 (Ga 68) dotatate doses prepared with a novel kit to U.S. hospitals and imaging centers for Advanced Accelerator Applications S.A. (NASDAQ:AAAP).

NETSPOT(TM) (formerly known as Somakit-TATE) is a patented kit recently approved by the U.S. Food and Drug Administration (“FDA”) for the preparation of Ga 68 dotatate for injection, for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography (“PET“). The product has received orphan drug designation from the U.S. Food and Drug Administration (“FDA“).

Cardinal Health’s extensive U.S. network of radiopharmaceutical manufacturing facilities will prepare and deliver NETSPOT patient doses to advanced medical imaging sites in key metropolitan areas where high demand is anticipated. This partnership makes Cardinal Health the second radiopharmacy network that will participate in the NETSPOT supply chain, after the announcement of the Zevacor Pharma partnership earlier this year.

June 7, 2016

Advanced Accelerator Applications Announces Expansion of Theranostic Pipeline with NeoBOMB1 – Two Oral Presentations Featured at SNMMI Annual Meeting

AAA today announced the expansion of its pipeline of theranostic products with the addition of NeoBOMB1, a novel GRPR antagonist, and that two abstracts presenting NeoBOMB1 data have been selected for oral presentations at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2016 Annual Meeting in San Diego, California. One of the two submissions was given the “International Best Abstract” Award.

These two independent studies evaluated NeoBOMB1 in a prostate cancer model, with both diagnostic and therapeutic isotopes, including an initial clinical evaluation performed in prostate cancer patients.

We are broadening our pipeline with NeoBOMB1 by leveraging a formula that we have already successfully applied to develop our lead therapeutic candidate, Lutathera and diagnostic product, Somakit, which was recently approved by the US Food and Drug Administration. Our plan is to radiolabel NeoBOMB1 to develop a theranostic pair: 177Lu-NeoBOMB1 for treatment and a 68Ga-NeoBOMB1 for diagnosis. I believe NeoBOMB1 may have potential utility in PET diagnosis and as a targeted therapy in GRPR-expressing malignancies,” said Stefano Buono, Chief Executive Officer of AAA.

NeoBOMB1 was originally developed by Marion De Jong of Erasmus University Medical Center and Theodosia Maina and Berthold Nock of Demokritos. AAA has acquired the rights to develop NeoBOMB1 and is currently planning three clinical studies in different indications including gastrointestinal stromal tumors, prostate cancer and breast cancer.

June 2, 2016

Advanced Accelerator Applications Announces FDA Approval of NETSPOT™ (Somakit-TATE), a Kit for the Preparation of Gallium Ga 68 Dotatate for Neuroendocrine Tumor Detection – NETSPOT™ will be the new name for Somakit-TATE, a PET (Positron Emission Tomography) Diagnostic

AAA today announced that the US Food and Drug Administration (FDA) has approved NETSPOT(TM) (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETSPOT received approval following a Priority Review from the FDA.

NETSPOT is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the US. NETSPOT is the first approved drug using Ga 68 as a positron emitter. Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and European Medicines Agency (EMA) in March 2014.

Following today’s approval, NETSPOT will be made available to the US market as soon as possible. AAA intends to commercialize the product in the US in two forms: As a kit for reconstitution using a Ga 68 generator, and as NETSPOT Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas.

NETSPOT is currently approved for use with the GalliaPharm Ga 68 generator from Eckert & Ziegler.

“The FDA approval of NETSPOT is a key milestone in our mission of improving the lives of NET patients,” said Stefano Buono, Chief Executive Officer of AAA. “NETSPOT has the potential to significantly improve the accuracy of NET diagnosis, while reducing radiation exposure for patients. We believe that the use of NETSPOT should also offer increased comfort for patients by potentially shortening a procedure that is currently performed over 24 hours or more to just a few hours.”

May 31, 2016

Advanced Accelerator Applications Reports 29.6% Sales Growth in the First Quarter of 2016 – Strengthens Commercial Platform for Launch of Somakit and Lutathera

AAA today announced its financial results for the first quarter of 2016. Commenting on the first quarter performance, Stefano Buono, AAA’s CEO, said, “Our continued sales momentum provides a strong foundation for the commercial launches of both Somakit and Lutathera, as well as the expansion of our theragnostic franchise as a whole.” Mr. Buono continued, “We are committed to continuing to deliver improved outcomes for patients with unmet medical needs through our specialized expertise in the development and production of molecular nuclear medicines, and the accomplishments of this past quarter underscore the progress we are making to that end.”

First Quarter Highlights:

– Sales for the first quarter of 2016 increased 29.6% compared to the first quarter of 2015
– Purchased 100% of the IDB Group to strengthen AAA’s commercial positioning of Lutathera
– Entered into a non-exclusive agreement with Zevacor for the preparation and delivery of SomaKit-TATE in the US
– Signed an exclusive licensing agreement with Johns Hopkins University to develop and market PSMA receptor ligand in prostate cancer for clinical therapeutic and diagnostic purposes

May 27, 2016

Advanced Accelerator Applications Expands its Presence in Germany with Strategic Acquisition of Two Production Sites

AAA announced today that AAA Germany GmbH has signed an asset purchase agreement to operate two new F-18 radiopharmaceutical production sites in South Germany. The transaction will close by June 1, 2016.

The first site, located in Erlangen, will be wholly owned and operated by AAA. The second site, located in Munich, will remain the property of the University Hospital of Munich (Klinikum der Universität München or KUM), with AAA responsible for production and commercialization onsite. The Munich contract includes a long-term F-18 in-house supply agreement with the KUM. Of particular value to AAA are the strong R&D activities of the KUM in radiotherapy with prostate specific membrane antigen (PSMA) and Lutetium.

Advanced Accelerator Applications is very active in the European F-18 PET market with production facilities based in France, Germany, Italy, Poland, Portugal and Spain,” noted Stefano Buono, Chief Executive Officer of AAA. “With the addition of these two new productions sites to the one AAA is already operating in Bonn, the Company will now have three production sites in Germany and a total of 15 PET production sites in Europe. This acquisition is in line with our strategy to continue consolidating the European PET market and expand our geographical reach.

Gérard Ber, Chief Operating Officer of AAA added: “Acquiring these two production sites in Germany will expand AAA’s presence in Germany and enable us to cover a very significant part of the German market. With this transaction AAA will become a market leader in Germany.

May 26, 2016

Advanced Accelerator Applications Appoints François Nader, M.D., to Board of Directors – Healthcare Veteran Brings Expertise in Developing Innovative Therapies

AAA today announced that François Nader, M.D., MBA has joined the Company Board of Directors as an Independent Non-Executive Director.

Dr. Nader’s guidance and perspective on global clinical development, regulatory, and commercial strategy will be of tremendous benefit as we advance our pipeline of product candidates led by Lu-DOTATATE (Lutathera®) for the treatment of Neuro Endocrine Tumors, a significant unmet medical need,“ stated Stefano Buono, Chief Executive Officer of AAA. “Dr. Nader’s deep biopharmaceutical expertise, coupled with his experience in orphan drug product launches, will be extremely valuable to help guide AAA in its mission to become a leading global player in Molecular Nuclear Medicine.”

I am delighted to join AAA’s Board of Directors. I believe that radiopharmaceuticals could represent a transformative new modality in cancer therapeutics, and I look forward to contributing to the company’s growth and success,” said François Nader, M.D.

Dr. Nader will be replacing Muriel de Szilbereky, who served as a Director in exemplary fashion from June 2013. The AAA Board will continue to be chaired by Claudio Costamagna, and will consist of eight Directors in total – 7 of which are independent.

May 23, 2016

Advanced Accelerator Applications preparing for Lutathera launch by scaling up production in Ivrea, Italy – Company provides update on key European production site

AAA today announced that it is scaling up its Ivrea site for Lutathera production. AAA has recently submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead Neuro Endocrine Tumor therapeutic candidate Lutathera. The EMA has recently granted Accelerated Assessment for Lutathera. The Ivrea extension is in anticipation of the NDA and MAA approvals.

The AAA Ivrea site hosts the Headquarters of AAA Italy and is located in the Bioindustry Park Silvano Fumero, between Turin and Milan. AAA started commercial operations on this site in 2008. Since then the site has almost doubled in size and increased headcount by 46 employees. The site currently covers 640sqm of laboratories and 530sqm of office space and employs 52 people.

The AAA Ivrea site is one of Lutathera’s birth places. It is in Ivrea that Lutathera was developed from a radiochemical point of view,” said Stefano Buono, Chief Executive Officer of AAA. “As we ramp up for the Lutathera launch we are putting all of the pieces in place to ensure seamless production and distribution of Lutathera in Europe and in the US. The extension of the AAA Ivrea site is essential to achieve these objectives.”

We are proud to have such an active company in the Bioindustry Park Silvano Fumero. We have helped AAA in its journey and are happy to see that eight years after its arrival the Company is still here and growing”, said Fabrizio Conicella, Director of the Bioindustry Park Silvano Fumero.

May 18, 2016

ITEL signs agreement with AAA to commercialize F-18 radiopharmaceuticals in Southern Italy

ITEL has signed an agreement with Advanced Accelerator Applications to manufacture and commercialise F-18 radiopharmaceuticals to hospitals and imaging centers in selected regions of Southern Italy.

Following AIFA authorisation, ITEL will manufacture F-18 radiopharmaceuticals under AAA license in its production plant in Ruvo di Puglia (BA) and commercialise them across the PET centers located in select regions of Southern Italy. AAA’s key F-18 product is Gluscan®, its branded fluorodeoxyglucose (FDG) PET imaging agent which assists in the diagnosis of serious diseases, primarily in oncology, by assessing glucose metabolism.

AAA is very active in the European F-18 PET market with 13 PET production facilities based in France, Germany, Italy, Poland, Portugal and Spain”, noted Stefano Buono, Chief Executive Officer of AAA. “This agreement will reinforce AAA’s position as one of the leading companies in the F-18 PET market in Italy.

April 29, 2016

AAA reports 26.8% sales growth in 2015 and continues to show significant clinical progress across both therapeutic and diagnostic platforms – Company announces completed submission of Lutathera NDA and MAA to FDA and EMA respectively

Advanced Accelerator Applications today announced its Q4 and full year 2015 financial results. The company reported an increase in year-on-year sales of 26.8% for the full-year and a 14% increase for Q4 2015 compared to Q4 2014. For the year ended 31 December 2015 total sales were €88.6 million (+26.8% vs. 2014).

Other key news announced is that the company had completed its rolling NDA submission to the FDA and that it had also recently submitted a Lutathera MAA to the EMA. In these filings AAA has asked for priority review to the FDA and Accelerated Assessment to the EMA.

Mr. Stefano Buono, AAA’s CEO, commented, “2015 was a pivotal year for AAA. We continued our trend of significant sales growth, and the year was marked by the completion of two key milestones, namely: the completion of our IPO and simultaneous listing on the Nasdaq under the ticker “AAAP” and the announcement of favourable results from the pivotal Phase 3 NETTER-1 trial evaluating our lead therapeutic candidate, Lutathera. We also submitted an NDA and MAA in the U.S. and Europe, respectively, for Somakit, which could be the ideal in-vivo companion diagnostic for Lutathera.”

Mr. Buono concluded, “In 2016, we have already achieved several key milestones to advance the company forward and support our future success. With our Lutathera filing now complete and submitted to the FDA and the EMA and the anticipated Somakit approval in both the US and Europe, we look forward to reporting our commercial developments gearing up towards the launch of both products.”

April 22, 2016

AAA to Announce Fourth Quarter and Year End 2015 Financial Results on April 29, 2016

AAA today announced that the company will provide an update on corporate activities for the fourth quarter and year-end 2015 on April 29, 2016. A press release for the fourth quarter and year-end 2015 will be released prior to the call.

Stefano Buono, Chief Executive Officer, Heinz Mäusli, Chief Financial Officer and Gérard Ber, Chief Operating Officer, will conduct a conference call at 11:00 am ET that day to provide a business update and review the Company’s fourth quarter and year-end 2015 financial results.

To access the conference call, please connect to the following webcast URL http://edge.mediaserver.com/m/p/9ucv3sgh/lan/en or dial 877-751-5015 from the U.S., or + 1-615-247-0178 internationally and use the audience passcode 96896214.

A recording of the conference call will be archived on the “Investors” section of the AAA website.

March 23, 2016

AAA Opens Lutathera Expanded Access Program In U.S. to Eligible Patients And Announces Forthcoming NDA Filing to FDA and EMA

AAA today announced that the company has initiated an expanded access program (EAP) in the United States for the investigational product, Lutathera. Through the program, Lutathera is being made available for patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors, progressive under somatostatin analogue therapy. Healthcare professionals and patients can learn more about the Lutathera EAP by visiting www.clinicaltrials.gov (trial number: NCT02705313).

Today AAA also announced a New Drug Application (NDA) filing plan for Lutathera, following the pre-NDA meeting held on the 14 March 2016. Given that rolling submissions are possible under the Fast-Track program granted for Lutathera, the Agency accepted a submission plan in which all parts of the NDA are to be sent by the end of the current month except for the ISS and ISE (Integrated Summaries of Safety and Efficacy Databases) which should be submitted within thirty days after the bulk of the submission.

The review clock for the NDA will not begin until AAA informs the FDA that a complete NDA has been submitted, including the ISS and ISE. The rolling submission will, however, allow the FDA to immediately start the review of the most relevant parts of the application, including the separate Clinical Reports of both NETTER-1 and the Phase 2 study.

Given the fact that rolling submissions are not permitted at the European Medicine Agency (EMA), a complete submission to the EMA will be completed by the end of April.

February 25, 2016

Advanced Accelerator Applications Provides Update on Lutathera and Somakit

Advanced Accelerator Applications today announced both updated data from the pivotal Phase 3 NETTER-1 study investigating the treatment of Lutathera (177-Lu-Dotatate) in patients with inoperable, progressive, somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) as well as Prescription Drug User Fee Act (PDUFA) date update for Somakit-TATE New Drug Application (NDA).

Additional Lutathera NETTER-1 Phase 3 study data will be presented on Friday, 11 March 2016 at the 13th Annual European Neuroendocrine Tumor Society (ENETS) Conference in Barcelona, Spain.

Additionally, AAA also announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of the Company’s New Drug Application (NDA) for Somakit-TATE (kit for the Preparation of 68Ga-DOTATATE for Injection), an investigational kit for neuroendocrine tumor diagnosis and follow-up. The PDUFA date has been extended by the standard extension period of three months from 1 March 2016 to the new goal date of 1 June 2016.

January 26, 2016

Zevacor to produce SomaKit-TATE doses for AAA – Novel kit for the preparation of Ga-68 DOTATATE for neuroendocrine tumor detection

Zevacor Pharma, Inc. (fka “IBA Molecular North America, Inc.”), a leader in the manufacture and distribution of radiopharmaceuticals, announced that it has been selected to supply Gallium 68 (Ga-68) DOTATATE doses prepared with a novel kit to U.S. hospitals and imaging centers for Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA”). SomaKit-TATE is a patented kit currently in development for the preparation of 68Ga-DOTATATE for injection, to help diagnose and manage somatostatin receptor-positive neuroendocrine tumor patients using Positron Emission Tomography (“PET“). The kit has received orphan drug designation from the U.S. Food and Drug Administration (“FDA“). The FDA has also granted Priority Review to AAA’s New Drug Application (“NDA”) for the kit. The license application for the kit is currently under review by the FDA and the agreement between Zevacor and AAA is in anticipation of NDA approval.

Zevacor’s U.S. network of radiopharmaceutical manufacturing facilities will prepare and deliver SomaKit-TATE patient doses to advanced medical imaging sites in key metropolitan areas where high demand is anticipated.

January 22, 2016

New Data Presented for AAA’s Lutathera NETTER-1 Phase 3 Study at 2016 Gastrointestinal Cancer Symposium ASCO GI.

AAA today presented new safety and efficacy data from the pivotal Phase 3 NETTER-1 study investigating the treatment of Lutathera (177-Lu-Dotatate) in patients with inoperable, progressive, somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) at the 2016 Gastrointestinal Cancer Symposium ASCO GI in San Francisco, California.

The results were presented today in oral session by key study investigator Prof. J. R. Strosberg and during the official ASCO GI presscast on Tuesday 19 January 2016. The abstract presented was abstract 194 “NETTER-1 phase III: Progression-free survival, radiographic response, and preliminary overall survival results in patients with midgut neuroendocrine tumors treated with 177-Lu-Dotatate.»

A webcast of the presscast with the NETTER-1 presentation is available online at: Gastrointestinal Cancers Symposium Media Resource Center

January 11, 2016

Advanced Accelerator Applications Signs Exclusive License Agreement With Johns Hopkins University to Develop PSMA Receptor Ligand in Prostate Cancer

AAA today announced an exclusive license agreement with Johns Hopkins University in Baltimore, Maryland to develop and market PSMA-SR6, a receptor ligand of Prostate-Specific Membrane Antigen (PSMA) for clinical therapeutic and diagnostic purposes. AAA will focus on developing this treatment and its companion diagnostic for prostate cancer through novel molecular nuclear medicine techniques similar to those implemented for the development of Lutathera and Somakit. Prostate cancer affects nearly 1 in 7 men during their lifetime worldwide.

The terms of the agreement include payment to Johns Hopkins of an upfront licensing fee, as well as certain milestone and royalty payments.

This licensing agreement is the first step toward broadening our development pipeline by leveraging a formula that we have already successfully applied to develop our lead therapeutic and diagnostic candidates Lutathera and Somakit. We plan to radiolabel PSMA-SR6, to develop a 177Lu-PSMA-SR6 to treat and monitor prostate cancer and a 68Ga-PSMA-SR6, which will help to diagnose and stage disease. The PSMA expression pathway has been widely investigated with labelled antibodies, but we believe that a small molecule, with very high specificity and rapid uptake into tumors and clearance from non-targeted organs could be the ideal candidate for a full theragnostic approach. We are very pleased to partner with the Johns Hopkins University as they have been pioneering and leading this new field for many years,” says Stefano Buono, Chief Executive Officer of AAA.

Our license agreement with AAA extends Johns Hopkins University’s research leadership in PSMA to benefit patients,” says Neil Veloso, Executive Director of Johns Hopkins Technology Ventures. “We are very pleased that AAA has selected PSMA-SR6 for full development for commercial applications in an area of significant patient need.

January 10, 2016

Advanced Accelerator Applications to Present New Data from Lutathera NETTER-1 Phase 3 Study at 2016 Gastrointestinal Cancer Symposium

AAA today announced that new safety and efficacy data from the pivotal Phase 3 NETTER-1 study investigating the treatment of Lutathera (177-Lu-Dotatate) in patients with inoperable, progressive, somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) will be presented on Friday, January 22, 2016 at the 2016 Gastrointestinal Cancer Symposium ASCO GI in San Francisco, California.

The NETTER-1 abstract has also been selected for ASCO GI’s official Press Program and the new findings of the NETTER-1 study will be presented to journalists in a presscast on Tuesday, January 19, 2016 from 12:00-1:30 PM ET.

January 7, 2016

Advanced Accelerator Applications Acquires the IDB Group

AAA announced today that it has acquired 100% of the shares of the IDB Group. The IDB Group, located in Baarle-Nassau, the Netherlands, includes IDB Holland bv, IDB Radiopharmacy bv and Beheermaatschappij Welde bv and is a leading manufacturer of Lutetium 177 (Lu-177). IDB produces, markets and sells Lu-177 under the brand name LuMark®, and has established this product as the leading brand of Lutetium 177 worldwide. LuMark® is the only Lu-177 product to have received European Marketing Authorization.

Acquiring the IDB Group will enable AAA to own one of its two providers of Lu-177 for Lutathera and build its own Lu-177 manufacturing business. This acquisition strengthens AAA’s leadership position in European MNM and is in-line with the Company’s vertical integration strategy. Owning the IDB Group will help AAA maintain a reliable supply of Lu-177 for the production of Lutathera and AAA’s future product candidates.

Stefano Buono, Chief Executive Officer of AAA commented: “We believe that our key product candidate Lutathera (177Lu-DOTATATE) has the potential to dramatically shift the treatment paradigm for patients with progressive neuroendocrine tumors and improve the standard of care for this disease. With this shift in treatment, Lu-177 chloride has a significant opportunity to be recognized as an important radiopharmaceutical precursor.

Gérard Ber, Chief Operating Officer of AAA added: “Acquiring the IDB Group enables AAA to gain the potential to expand the Company’s presence to the Netherlands for both our current portfolio of F-18 products as well as our product candidates Somakit and Lutathera. AAA will continue to serve IDB clients around the world and further expand and improve our services. This acquisition provides AAA with a key strategic asset allowing the Company to build an independent Lu-177 manufacturing business, while helping to expand the current presence of its F-18 portfolio, Lutathera, and Somakit, in the Netherlands.