US investors include: Adage Capital Management LP, T. Rowe Price, and Rock Springs Capital Management LP
23 June 2015, Saint-Genis-Pouilly, France – Advanced Accelerator Applications S.A. (“AAA” or “the Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that it has completed a capital increase of €23 million (approx. $26 million), led by Adage Capital Management, LP (Adage). Alongside Adage as new investors in AAA are certain funds and accounts managed by T. Rowe Price Associates, Inc., and Rock Springs Capital Management LP.
Stefano Buono, Chief Executive Officer of AAA commented: “We are very pleased to have completed this pivotal capital increase, with the support of a strategic group of top US healthcare investors. This financing is a critical milestone for us, as we prepare for the Phase III trial results for Lutathera, and the continued progress of our Molecular Nuclear Medicine pipeline.”
AAA develops and commercializes innovative diagnostic and therapeutic products. Its main focus is on molecular imaging and personalized medicines for the treatment of diseases such as cancer. AAA is a European leader in the production and commercialization of PET (Positron Emission Tomography) and SPECT (Single Photon Emission Computed Tomography) products, with 17 production and R&D facilities in Europe, Israel and North America.
Lutathera is currently in Phase III clinical trials in 51 clinical centers in the US and EU for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs, an Orphan disease). Enrollment was completed in February 2015 and the number of events necessary to meet the primary endpoint has been reached. Results of the NETTER-1 trial for Lutathera will be presented during the ESMO European Cancer Congress in September 2015.
In July 2015 the Company also plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Somakit, Lutathera’s companion diagnostic. Somakit is a novel pharmaceutical kit for radiolabeling somatostatin analogue peptides to help diagnose NET lesions using Positron Emission Tomography (PET). A filing to the European Medicines Agency (EMA) will follow later in the summer.
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About Advanced Accelerator Applications
Advanced Accelerator Applications (AAA) is a radiopharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA’s main focus is in the field of Molecular Imaging and targeted, individualized therapy for the management of patients with serious conditions (“Personalized Medicine”). AAA currently has 17 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 340 employees in 11 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, Israel, U.S. and Canada). In 2014 AAA reported sales of €69.9 million (+29.9% vs. 2013). For more information please visit: www.adacap.com
About Lutathera and ongoing clinical trials
Lutathera (or 177Lu-DOTATATE) is a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This novel compound has received orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which provides post market authorization exclusivity in the US (7 years), and Europe (10 years). It has been approved for treatment of all NETs on a compassionate use and named patient basis in ten European countries.
Lutathera belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (PRRT) which involves targeting carcinoid tumors with radiolabeled somatostatin analogue peptides.
There is a real unmet medical need for an effective treatment of inoperable, advanced NETs and there are currently no therapeutic options available for patients with NETs other than pancreatic (about 10% of NETs are pancreatic) who are progressive under somatostatin analogues. Currently at the end of its Phase III development with the NETTER-1 pivotal study, Lutathera is the most advanced candidate in development for PRRT.
NETTER-1 is an international, multi-center, randomized, Phase III study comparing treatment with Lutathera to a double dose of Octreotide LAR in patients with inoperable, progressive under Octreotide LAR treatment, midgut carcinoids (midgut NETs) overexpressing somatostatin receptors. The primary endpoint of the trial is the assessment of progression-free survival. Secondary endpoints include safety, objective response rate, time to tumor progression, overall survival and quality of life. The study is conducted in 51 clinical centers in the United States and Europe. Enrollment was completed in February 2015 and 74 events are expected to meet the primary endpoint. Lutathera is aiming at covering an unmet medical need, as after progression from “cold” analogues of somatostatin such as Octreotide LAR (Novartis) or Somatuline (Ipsen), there are no alternative therapies approved in this indication.
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. 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.
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