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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

METTLER TOLEDO
Posted on: 29 Nov 16

Conference Call Today at 4:30 p.m. ET

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

SAINT-GENIS-POUILLY, France, Nov. 28, 2016 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or “the Company”), an international specialist in Molecular Nuclear Medicine (MNM), 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 2016 Financial Results

Total sales for the third quarter of 2016 were €26.72 million (USD(1) 30.03 million), a 15.4% year-on-year increase compared to €23.16 million (USD (1) 26.03 million) in the prior year period.

Operating loss for the third quarter of 2016 was €5.14 million (USD(1) 5.78 million), compared to a loss of €0.61 million (USD (1)  0.69 million) for the prior year period.

For the third quarter of 2016, the Company reported a net loss of €6.24 million (USD(1) 7.02 million), compared to €1.82 million (USD(1) 2.04 million) for the prior year period.

For the third quarter of 2016, adjusted EBITDA (see corresponding reconciliation exhibit below) was a loss of €1.73 million (USD(1) 1.95 million) compared to a profit of €2.13 million (USD (1) 2.4 million) for the prior year period.

In October, AAA closed a $150 million follow-on public offering of 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. After the closing of the public offering, the underwriters exercised their option to purchase up to $22.5 million of additional ADSs at the public offering price, less the underwriting discount.

(1) Translated solely for convenience into USD at the noon buying rate of €1.00=1.1238 at September 30, 2016.

Lutathera® Update

Last week, the FDA issued feedback to the NDA for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The FDA feedback identified issues with the format, traceability, uniformity, and completeness relating to the NETTER-1 and Erasmus clinical datasets, which are precluding FDA reviewers from performing the required independent analysis of these clinical studies.

AAA will work closely with the FDA and the company’s Contract Research Organizations to resolve these issues and revise the data format to permit FDA review. AAA has concluded at this time that approval of Lutathera® is unlikely to occur by the PDUFA date of December 28, 2016. The FDA comments were provided via a Discipline Review Letter, which is a letter sent to an applicant to convey early thoughts on possible deficiencies of an application. The letter refers to reviews of the Clinical, Statistical, and Clinical Pharmacology sections of the submission. The FDA noted that their feedback does not reflect a final decision, is preliminary and subject to change.

Stefano Buono, Chief Executive Officer of AAA, commented, “Our belief in Lutathera’s potential to benefit patients remains steadfast. We are disappointed by the delay that we expect this development to cause in the FDA’s consideration of Lutathera’s NDA and are focused on addressing these issues as soon as possible. We are engaging additional resources to facilitate the delivery of datasets meeting the requirements outlined by the FDA.”

Buono continued, “To help address the needs of the U.S. NET patient community until this situation is resolved, we are planning to extend our Expanded Access Program (EAP). More than 30 patients across seven centers in the U.S. have received Lutathera® since the EAP’s initiation in July 2016, and several additional centers will become active before the end of the year. In addition, our medical team will be using this time to continue their work with NET centers and providers around the country to ensure that they have the infrastructure and processes necessary to properly manage the administration of a Peptide Receptor Radionuclide Therapy (PRRT).”

In September, AAA announced that the Accelerated Assessment timeline for the EMA’s review of the Marketing Authorization Application for Lutathera®, had 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.

Additional Operational Updates

In October, AAA announced that the EMA 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 PET imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEPNET) for localizing primary tumors and their metastases.

In November, AAA announced that marketing authorization in Switzerland for two Positron Emission Tomography (PET) products, DOPAVIEW and AAACholine.

In September, AAA announced 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.

Conference Call Information

Advanced Accelerator Applications management will host a conference call today at 4:30 p.m. ET. 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. A replay of the call will be available through December 28, 2016, at 11:59 p.m. ET. Interested parties may access the replay by dialing 877-481-4010 (US) or +1-919-882-2331 (International) and entering ID number 10163. An archived webcast of the conference call will be available for 90 days on the Investor Relations page of the Advanced Accelerator Applications website: www.adacap.com.

About Lutathera®

Lutathera® (or lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue peptide currently in development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lutathera® belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting neuroendocrine tumors with radiolabeled somatostatin analogue peptides. This novel compound has received orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Currently, 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) for midgut NETs. In the analysis of the Lutathera® Phase III NETTER-1 trial’s primary endpoint of Progression Free Survival (PFS), the number of patients having disease progression or death was 23 in the Lutathera® arm and 68 in the Octreotide LAR 60 mg arm. 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% of disease progression or death versus Octreotide LAR 60 mg (hazard ratio 0.21, 95% CI: 0.13-0.33; p<0.0001).  New Drug Application and Marketing Authorization Application submissions to the FDA and EMA are currently under review.
  
About Advanced Accelerator Applications

Advanced Accelerator Applications (AAA) is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine (MNM) products. AAA’s lead therapeutic product candidate, Lutathera®, is a novel MNM compound that AAA is currently developing for the treatment of Neuro Endocrine Tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 22 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 480 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, U.S. and Canada). AAA reported sales of €88.6 million in 2015 (+26.8% vs. 2014). 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 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.

Reconciliation of adjusted EBITDA to net loss for the year from continuing operations for the three and nine months ended September 30, 2016 and 2015

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 29/11/2016

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