Lutathera® approved by European Commission for Patients with Advanced, Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs)

 

Saint-Genis-Pouilly, France – Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA), an international specialist in Molecular Nuclear Medicine (MNM), today announced that the European Commission (EC) has approved the marketing authorisation of lutetium (177Lu) oxodotreotide (Lutathera®), a targeted cancer medicine using small amounts of radioactivity to destroy tumour cells from within. This therapy is approved for tumours in the gut called gastroenteropancreatic neuroendocrine tumours (GEP-NETs), that cannot be removed by surgery, have spread to other parts of the body, or are not responding to treatment.

Neuroendocrine tumours are a group of tumours originating in the neuroendocrine cells of numerous organs. The term neuroendocrine refers to the dual features of these cells which are a cross between nerve cells and hormone-producing endocrine cells. Characteristics of these tumours can vary, depending on where they are located. Gastroenteropancreatic neuroendocrine tumours are subdivided into two primary categories: tumours of the gastrointestinal tract and those in the pancreas.

Gastrointestinal NETs are considered rare. NETs are more common in people over the age of 60 and symptoms may include stomach pain, changes in bowel habits and loss of appetite. NETs can be difficult to diagnose because symptoms can vary widely from patient to patient and NETs are often mistaken for other conditions.

Professor dr. W.W. de Herder, Internist Endocrinologist and Professor in Neuroendocrine tumors at the Erasmus Medical Center: “With the registration of Lutathera®,  one of the most effective therapies for neuroendocrine tumors is happily finally available to a wide patient population.”

This approval allows for the marketing of  Lutathera®in all 28 European Union member states, as well as Iceland, Norway and Liechtenstein. Lutathera®has received orphan drug designation from the European Medicines Agency.

Lutathera® is the therapeutic component of a theragnostic pairing developed by AAA. Theragnostics is a patient management strategy involving the integration of diagnostics and therapeutics. The diagnostic part of the pairing is called SomaKit TOC™, which is approved for locating primary tumours and their metastases in adult patients with confirmed or suspected well-differentiated GEP-NETS using Positron Emission Tomography (PET) imaging. Both drugs target the same receptor, which is expressed on 80% of NETs. Therefore, molecular imaging and diagnosis of the disease may be effectively followed by personalised treatment utilising the same molecular targeting compounds.

 

How Lutathera® works
Lutathera® is composed of a small targeting molecule carrying a radioactive particle in a chemical structure that acts as a cage, keeping it connected to the molecule. The drug is administered through infusion drip into the bloodstream. Once in the bloodstream, the molecule binds to a particular receptor expressed the surface of most NET cells. Once the targeting molecule is bound to the receptor, the receptor internalises and brings the molecule inside the tumour cell. Once inside the tumour cell, the radioactivity it emits kills the tumour cell from within, but has little effect on neighbouring cells.

Phase 3 clinical trials conducted by AAA demonstrated that Lutathera®reduced the risk of disease progression or death by 79% compared to a standard treatment (Octreotide LAR).

 

 


 

 

About Lutathera®
Lutathera® is a 177Lu-labeled somatostatin analog peptide. Lutathera® belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting tumours with molecules carrying radioactive particles that bind to specific receptors expressed by the tumour. 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 tumours over-expressing somatostatin receptors in ten European countries, including the UK, and in the US under an Expanded Access Program (EAP). A New Drug Application submission to the FDA is currently under review.

 

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 therapeutic candidate, Lutathera®, is a novel MNM compound in development for the treatment of neuroendocrine tumours, 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 tumour types. Using short-range particles, this therapy can target tumours 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 Lutathera® and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organise 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 Lutathera®and our other products or product candidates; our estimates regarding the market opportunity for 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

Media inquiries:
Pegasus
Yasmin Ghariani
yghariani@thisispegasus.co.uk
Tel: 01625 662 401

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