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    <title>Advanced Accelerator Applications - Latest Press Releases on ReleaseWire</title>
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      <title>Advanced Accelerator Applications Reports over 24% Growth in Sales for the First Quarter of 2015</title>
      <link>http://www.releasewire.com/press-releases/release-3.htm</link>
      <description><![CDATA[<div class="newsleft"><div class="newsbody"><p class="subheadline">Advanced Accelerator Applications Receives FDA Fast Track Designation for Lutathera for the Treatment of Midgut Neuroendocrine Tumors</p><p>New York, NY -- (<a rel="nofollow" href="http://www.sbwire.com/">SBWIRE</a>) -- 06/17/2015 --  Advanced Accelerator Applications S.A. ("AAA" or "The Company"), an international specialist in Molecular Nuclear Medicine (MNM), today announced its financial results for the first quarter of 2015.<br />
<br />
Recent Highlights<br />
<br />
- Reported an increase in year-on-year sales of 24.5% for Q1 2015 compared to Q1 2014.<br />
<br />
- Received FDA Fast Track Designation for key drug candidate Lutathera for the treatment of patients with inoperable, progressive, well-differentiated, somatostatin receptor-positive carcinoid tumors of the midgut<br />
<br />
- Received Cohort Temporary Authorization for use of Lutathera in France for the treatment of midgut neuroendocrine tumors (NETs)<br />
<br />
- Received approval of Lutathera compassionate use program in Denmark<br />
<br />
- Enrolled first patients in a Phase I/II clinical trial for diagnostic candidate Annexin V-128 in rheumatoid arthritis and ankylosing spondylitis· <br />
<br />
- Signed supply distribution agreement with Lantheus Medical Imaging, Inc. for NEUROLITE(R) (kit for the preparation of Technetium Tc99m Bicisate for injection) for France and Spain<br />
<br />
Commenting on the first quarter performance, AAA&apos;s CEO Stefano Buono said: "I am pleased to announce that AAA is performing according to plans or better on both financial and clinical fronts. AAA continues to establish efficiencies in manufacturing, logistics, and financial discipline as we prepare for our global launch of Lutathera."<br />
<br />
"We believe that Lutathera provides the potential to significantly impact how physicians treat NETs overexpressing somatostatin receptors in the near future. The Fast Track Designation received from the FDA is an important step in broadening the treatment options for these patients, and highlights the significant impact nuclear medicine can play within the treatment paradigm. We expect the results to demonstrate a clinically important and statistically robust improvement in progression-free survival for patients treated with Lutathera."<br />
<br />
First Quarter 2015 Financial Results<br />
<br />
Total sales for Q1 2015 were €20.8 million (USD(1) 23.4 million), a 24.5% year-on-year increase compared to €16.7 million (USD(1) 18.8 million) in Q1 2014.<br />
<br />
For the quarter ending March 31, 2015, operating loss was €1.6 million (USD(1) 1.8 million), compared to €40K (USD(1) 45K) for the comparable period in 2014.<br />
<br />
Net loss for the first quarter 2015 was €5.9 million (USD(1) 6.7 million) versus a net loss for the first quarter 2014 of €1.6 million (USD(1) 1.8 million), a net loss increase of €4.3 million (USD(1) 4.8 million).<br />
<br />
Adjusted EBITDA for the quarter ended March 31, 2015 was €1.1 million (USD(1) 1.2 million) compared to €2.2 million (USD(1) 2.5 million) for the first quarter of 2014, a decrease of €1.1 million (USD(1) 1.2 million).<br />
<br />
As of March 31, 2015 the Company had cash and cash equivalents of €39.1 million (USD(2) 42.5 million).<br />
<br />
(1) Translated solely for convenience into USD. Applied for income statement of first quarter of 2015 and 2014 is an exchange rate of €1 = USD 1.127 (average for the first quarter of 2015).<br />
<br />
(2) Translated solely for convenience into USD. Applied for cash and cash equivalents at the end of the first quarter of 2015 is an exchange rate of €1 = USD 1.085 (rate of March 31st).<br />
<br />
Fast Track Designation<br />
The US Food and Drug Administration (FDA) has granted Lutathera Fast Track Designation for the treatment of midgut neuroendocrine tumors (midgut NETs). The New Drug Application (NDA) will also provide data corresponding to previous trials in gastroenteropancreatic neuroendocrine tumors (GEP-NETs).<br />
<br />
Lutathera is a novel compound currently in Phase III for the treatment of patients with inoperable, progressive, well-differentiated carcinoid tumors of the midgut (jejunum, ileum, appendix, ascending colon). Lutathera selectively targets somatostatin receptors, which are over-expressed in NETs. <br />
<br />
About 80% of all NETs overexpress somatostatin receptors (particularly sstr2). Lutathera is a radiolabeled somatostatin analogue that has a very high affinity for sstr2. Its mechanism of action consists in releasing radiation (high energy electrons) after internalization in the tumor cells through sstr2. A complete treatment consists of only four injections, one every 6-8 weeks.<br />
<br />
Lutathera is currently in a pivotal Phase III trial for the treatment of midgut NETs in 51 clinical centers in the United States and the EU (the NETTER-1 clinical study). Patient recruitment was completed in February 2015 and the number of events (74) needed to assess the primary endpoint (Progression-Free Survival) has been reached. Results will be disclosed in September 2015, during the ESMO congress in Vienna.<br />
<br />
About Advanced Accelerator Applications<br />
Advanced Accelerator Applications (AAA) is a radiopharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA&apos;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&amp;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<br />
<br />
About Lutathera and ongoing clinical trials<br />
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.<br />
<br />
Lutathera belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (PRRT) which involves targeting carcinoid tumors with radiolabeled somatostatin analogue peptides. <br />
<br />
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.<br />
<br />
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.<br />
<br />
About Molecular Nuclear Medicine ("MNM")<br />
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&apos;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.<br />
<br />
View Financial Table for AAA; <a class="extlink"  rel="nofollow noopener"  target="_blank"  title="http://news.yahoo.com/advanced-accelerator-applications-reports-over-110500401.html;_ylt=A0LEV0kVW4BVxkYAhe1XNyoA;_ylu=X3oDMTEzYmpraG03BGNvbG8DYmYxBHBvcwMxBHZ0aWQDVklQNTA0XzEEc2VjA3Ny" href="http://news.yahoo.com/advanced-accelerator-applications-reports-over-110500401.html;_ylt=A0LEV0kVW4BVxkYAhe1XNyoA;_ylu=X3oDMTEzYmpraG03BGNvbG8DYmYxBHBvcwMxBHZ0aWQDVklQNTA0XzEEc2VjA3Ny">http://news.yahoo.com/advanced-accelerator-applications-reports-over-110500401.html;_ylt=A0LEV0kVW4BVxkYAhe1XNyoA;_ylu=X3oDMTEzYmpraG03BGNvbG8DYmYxBHBvcwMxBHZ0aWQDVklQNTA0XzEEc2VjA3Ny</a></p><p>For more information on this press release visit: <a rel="nofollow" href="http://www.releasewire.com/press-releases/release-3.htm">http://www.releasewire.com/press-releases/release-3.htm</a></p></div><h2>Media Relations Contact</h2><p>Janet Vasquez<br />JV Public Relations NY Inc.<br />Telephone: 212-645-5498<br />Email: <a rel="nofollow" href="http://www.sbwire.com/press-releases/contact/604806">Click to Email Janet Vasquez</a><br />Web: <a rel="nofollow" href="http://www.adacap.com/">http://www.adacap.com/</a><br /></div><div><p><img src="https://cts.releasewire.com/v/?sid=604806&amp;s=f&amp;v=f" width="1" height="1" alt=""><span></span></p></div>]]></description>
      <pubDate>Wed, 17 Jun 2015 03:00:00 -0500</pubDate>
      <guid>http://www.releasewire.com/press-releases/release-3.htm</guid>
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      <title>AAA Fully Acquires Atreus Pharmaceuticals; Enrolls First Patient in a Phase I/II Clinical Trial for Its Key Diagnostic Candidate Annexin v-128 in Rheumatoid Arthritis</title>
      <link>http://www.releasewire.com/press-releases/release-3.htm</link>
      <description><![CDATA[<div class="newsleft"><div class="newsbody"><p>New York, NY -- (<a rel="nofollow" href="http://www.sbwire.com/">SBWIRE</a>) -- 01/21/2015 --  Advanced Accelerator Applications S.A. ("AAA" or "the Company"), an international specialist in Molecular Nuclear Medicine (MNM), announced that it has acquired the remaining 49.9% of Atreus Pharmaceuticals Corporation, a development-stage biopharmaceutical company headquartered in Ottawa, Canada and focused on the development of proprietary molecular imaging products aimed at imaging apoptosis and necrosis based on Annexin V. Atreus Pharmaceuticals Corporation is now a fully owned AAA subsidiary and has been renamed AAA Canada.<br />
<br />
AAA also announces the enrollment of the first patient in the Phase I/IIa clinical trial to evaluate the safety, pharmacokinetics and dosing of key diagnostic product candidate 99mTc-rhAnnexin V-128 in patients with rheumatoid arthritis or ankylosing spondylitis. The study will also assess the ability of 99mTc-rhAnnexin V-128 to identify the disease and to monitor the effectiveness of current drug treatment. 99mTc-rhAnnexin V-128 is a single photon emission computed tomography (SPECT) radiopharmaceutical agent being developed to detect early cell stress and apoptosis (programmed cell death) in a number of pathological conditions including rheumatoid arthritis and ankylosing spondylitis.<br />
<br />
In this Phase I/IIa clinical trial, 20 patients will be enrolled to receive two doses of 99mTc-rhAnnexin V-128, one at baseline and one after drug treatment. The principal investigator of the study is Prof. John Prior, University Hospital of Lausanne, Switzerland.<br />
<br />
A Phase I trial has been completed at the University of Ottawa Heart Institute in Canada to assess the safety, pharmacokinetics and dosing of 99mTc-rhAnnexin V-128 in 12 healthy volunteers. The results are currently being analyzed. The principal investigator of this study is Dr Terrence Ruddy.<br />
<br />
Stefano Buono, Chief Executive Officer of AAA, commented: "These two announcements are key milestones in AAA&apos;s progress. The acquisition of the remaining 49.9% of Atreus has been triggered by a number of successful milestones achieved during the development of Annexin V-128. I am delighted that Atreus&apos; founder, Bill Dickie, will now be President and CEO of AAA Canada and will continue working with us in what we expect will be the development of products based on Annexin V. We are also very excited to be initiating the first of a series of new Phase I/II clinical trials aimed at understanding the potential of 99mTc-rhAnnexin V-128 in different indications."<br />
<br />
Bill Dickie, President and Chief Executive Officer of AAA Canada, added: "99mTc-rhAnnexin V-128 potentially has multiple applications in cardiology, oncology and autoimmune disorders as it detects the fundamental process of apoptosis. Many diseases are increasingly treated with powerful and expensive biologic drugs. An imaging biomarker of apoptosis has the potential to be an important personalized disease management tool."<br />
<br />
Prof. John Prior said: "Early diagnosis and effective treatment management is crucial for the treatment of diseases such as rheumatoid arthritis and ankylosing spondylitis, and can lead to a significantly improved quality of life for patients suffering from these progressive, debilitating diseases."<br />
<br />
Dr Terrence Ruddy added: "99mTc-rhAnnexin V-128 imaging has many exciting potential applications. The single vial 99mTc-rhAnnexin V-128 kit being developed by AAA is convenient to use and has the potential to become a cost effective tool in the diagnosis and management of a wide range of diseases."<br />
<br />
AAA has an exclusive, worldwide license to develop proprietary molecular imaging products based on Annexin V-128.<br />
<br />
About 99mTc-rhAnnexin V-128 and SPECT<br />
99mTc-rhAnnexin V-128 is a single photon emission computed tomography (SPECT) radiopharmaceutical agent in development that aims to detect early cell stress and apoptosis in vivo to assess programmed cell death in a number of pathological conditions, including rheumatoid arthritis, ankylosing spondylitis and cardiovascular diseases.<br />
<br />
The product, based on a specifically designed recombinant form of Annexin V-128, is being developed as a single lyophilized vial 99mTc-rhAnnexinV-128 kit by AAA.<br />
<br />
Wild-type Annexin, labeled with Technetium-99m (Tc-99m), a medical isotope widely used in diagnostic imaging, has been studied extensively. In previous trials, Tc-99m labelled Annexin has demonstrated the ability to image cellular apoptosis and necrosis conditions associated with a variety of debilitating or fatal medical disorders including rheumatoid arthritis, Crohn&apos;s disease, Alzheimer&apos;s disease, myocarditis, cardiac transplant rejection, acute myocardial infarction and unstable atherosclerotic carotid artery disease. In addition, Tc-99m labelled Annexin has been used to evaluate the response to treatment for lymphoma and lung cancer.<br />
<br />
SPECT is a molecular nuclear diagnostic imaging technique in which a radioisotope such as Technetium-99m is injected into a patient through the bloodstream and reaches the lesion where it emits gamma rays that are detected by SPECT cameras. SPECT is used to diagnose a wide range of conditions within oncology, cardiovascular diseases, neurological disorders and other diseases in their early stages.<br />
<br />
About Rheumatoid Arthritis and Ankylosing Spondylitis<br />
Both rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are autoimmune diseases. RA is estimated to affect up to 70 million people worldwide. RA causes joints to become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone are damaged. AS is estimated to affect up to 33 million people worldwide. It is often called arthritis of the spine and is a painful and progressive form of spinal arthritis that usually affects people under the age of 35 years. AS typically begins in the late teens and early twenties and can result in fusing of the spinal vertebrae, hips and other joints. Often misdiagnosed as "just back pain", or undifferentiated arthritis, AS can affect vision and internal organs. Both RA and AS patients are often treated with a number of medicines, combining protein-based biologic therapies with methotrexate, the most common disease-modifying antirheumatic drug.<br />
<br />
About Advanced Accelerator Applications<br />
Advanced Accelerator Applications (AAA) is a radiopharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA&apos;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&amp;D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 330 employees in 11 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, Israel, U.S. and Canada). In 2013 AAA reported sales of €53.8 million (+31.77% vs. 2012). <br />
<br />
For more information please visit: <a class="extlink"  rel="nofollow noopener"  target="_blank"  title="http://www.adacap.com" href="http://www.adacap.com">http://www.adacap.com</a></p><p>For more information on this press release visit: <a rel="nofollow" href="http://www.releasewire.com/press-releases/release-3.htm">http://www.releasewire.com/press-releases/release-3.htm</a></p></div><h2>Media Relations Contact</h2><p>Janet Vasquez<br />Media contact (US only)<br />JV Public Relations NY Inc.<br />Telephone: 212-645-5498<br />Email: <a rel="nofollow" href="http://www.sbwire.com/press-releases/contact/575796">Click to Email Janet Vasquez</a><br />Web: <a rel="nofollow" href="http://www.adacap.com/">http://www.adacap.com/</a><br /></div><div><p><img src="https://cts.releasewire.com/v/?sid=575796&amp;s=f&amp;v=f" width="1" height="1" alt=""><span></span></p></div>]]></description>
      <pubDate>Wed, 21 Jan 2015 03:00:00 -0600</pubDate>
      <guid>http://www.releasewire.com/press-releases/release-3.htm</guid>
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      <title>AAA Acquires GE Healthcare's FDG-PET Radiopharmaceutical Business in Italy</title>
      <link>http://www.releasewire.com/press-releases/release-3.htm</link>
      <description><![CDATA[<div class="newsleft"><div class="newsbody"><p class="subheadline">Advanced Accelerator Applications Strengthens its Position in the Italian PET Radiopharmaceutical Market</p><p>Saint-Genis-Pouilly, France -- (<a rel="nofollow" href="http://www.releasewire.com/">ReleaseWire</a>) -- 09/11/2014 --  Advanced Accelerator Applications ("AAA" or "the Company"), an international specialist in Molecular Nuclear Medicine (MNM) announced today that it has entered into an agreement with GE Healthcare in Italy to acquire its Italian FDG-PET imaging agent business (fluorodeoxyglucose photon emission tomography). This acquisition includes the licence to market GE Healthcare&apos;s SteriPET® (FDG) imaging agent in Italy. With this acquisition AAA reinforces its position as one of the leading companies in the PET market in Italy.<br />
<br />
Stefano Buono, Chief Executive Officer of AAA, commented: "This acquisition is in line with AAA&apos;s growth strategy of further consolidating our position as a leading pan-European nuclear diagnostics company, alongside exploring additional product pipeline opportunities and avenues for expansion in the United States and outside Europe."<br />
<br />
Enrico De Maria, Director of AAA Italy, added: "We believe that this transaction will enable AAA Italy to benefit from economies of scale from which we can continue providing quality products and services at reduced costs in a market that has been experiencing a reduction of FDG&apos;s price over the last years." <br />
<br />
Today AAA is a leader in MNM in Europe with a portfolio of six diagnostic PET and SPECT products and several diagnostic and therapeutic product candidates including flagship product candidate Lu-DOTATATE, currently in a pivotal Phase III clinical trial for the treatment of GEP-NETs (an orphan disease) in 51 clinical centers in the United States and Europe. <br />
<br />
AAA&apos;s leading diagnostic PET product is Gluscan®, its branded fluorodeoxyglucose (FDG) PET imaging agent. Gluscan® assists in the diagnosis of serious diseases, primarily in oncology, by assessing glucose metabolism. AAA is building on its diagnostics foundation by developing additional MND product candidates to further strengthen its existing portfolio. <br />
<br />
AAA is very active in the European PET market with 13 PET production facilities based in France, Germany, Italy, Poland, Portugal and Spain. With this acquisition AAA intends to broaden its presence in the Italian PET market and add to its existing production capacity and portfolio.<br />
<br />
About Advanced Accelerator Applications<br />
Advanced Accelerator Applications (AAA) is a radiopharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA&apos;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&amp;D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 300 employees in 11 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, Israel, U.S. and Canada). In 2013 AAA reported sales of €53.8 million (+31.77% vs. 2012). For more information please visit: <a class="extlink"  rel="nofollow noopener"  target="_blank"  title="http://www.adacap.com/" href="http://www.adacap.com/">http://www.adacap.com/</a><br />
<br />
About Molecular Nuclear Medicine ("MNM")<br />
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&apos;s body that accumulate in the organs or lesions that reveal specific biochemical processes.<br />
<br />
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.<br />
<br />
Cautionary Statement Regarding Forward-Looking Statements<br />
This press release may contain forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company&apos;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 reflect the Company&apos;s current expectation regarding future events. 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, EMA, U.S. FDA and other regulatory approvals for our product candidates, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, and uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand. 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.<br />
<br />
<pre><br />
Contacts<br />
AAA Media Relations <br />
Laetitia Defaye					Veronique Mermet<br />
Head of Corporate Communications		Communications Officer<br />
laetitia.defaye@adacap.com			info@adacap.com<br />
Tel: +33 (0)6 86 65 73 52			Tel: +33 (0)4 50 99 30 70<br />
<br />
AAA Investor Relations<br />
Jordan Silverstein						<br />
Director of Investor Relations			<br />
jordan.silverstein@adacap.com<br />
Tel: + 1-212-235-2394<br />
<br />
Media enquiries<br />
FTI Consulting (UK)<br />
Julia Phillips					Natalie Garland-Collins<br />
Julia.Phillips@fticonsulting.com 		Natalie.Garland-Collins@fticonsulting.com <br />
Tel: +44 (0)203 727 1000			Tel: +44 (0)203 727 1000<br />
<br />
iCorporate (Italy)<br />
Elisa Piacentino				Rita Arcuri<br />
elisa.piacentino@icorporate.it 		        rita.arcuri@icorporate.it 	<br />
Tel: +39 02 4678754 - +39 366 9134595		Tel: +39 02 4678753	-<br />
+39 333 2608159<br />
<br />
JV Public Relations NY (US)<br />
Janet Vasquez<br />
jvasquez@jvprny.com<br />
Tel: + 1-212- 645-5498 - +1-917- 569-7470<br />
</pre></p><p>For more information on this press release visit: <a rel="nofollow" href="http://www.releasewire.com/press-releases/release-3.htm">http://www.releasewire.com/press-releases/release-3.htm</a></p></div><h2>Media Relations Contact</h2><p>Janet Vasquez<br />Media contact (US only)<br />Telephone: 212-645-5498<br />Email: <a rel="nofollow" href="http://www.releasewire.com/press-releases/contact/544325">Click to Email Janet Vasquez</a><br />Web: <a rel="nofollow" href="http://www.adacap.com/">http://www.adacap.com/</a><br /></div><div><p><img src="https://cts.releasewire.com/v/?sid=544325&amp;s=f&amp;v=f" width="1" height="1" alt=""><span></span></p></div>]]></description>
      <pubDate>Thu, 11 Sep 2014 06:00:00 -0500</pubDate>
      <guid>http://www.releasewire.com/press-releases/release-3.htm</guid>
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      <title>AAA Reports Full-Year 2013 Financial Results: Company Reports over 30% Growth in Sales</title>
      <link>http://www.releasewire.com/press-releases/release-3.htm</link>
      <description><![CDATA[<div class="newsleft"><div class="newsbody"><p class="subheadline">Company Bolsters Board of Directors with Industry Leaders</p><p>Saint-Genis-Pouilly, France -- (<a rel="nofollow" href="http://www.releasewire.com/">ReleaseWire</a>) -- 07/10/2014 --  Highlights<br />
<br />
- Sales up 31.77% to €53.8 million<br />
- Pivotal Phase III trial for Lu-DOTATATE (Lutathera®) progressing as planned<br />
- Key pipeline products Ga-68 DOTATATE (Somakit®) and 99mTc-rhAnnexin V-128 progressing well<br />
- Orphan Drug Designation obtained for Ga-68 DOTATATE from FDA and EMA<br />
- Continued expansion of network in Europe and the US<br />
- Acquired IEL and entered UK and Irish markets<br />
- Strong presence in Europe&apos;s G5<br />
- Strengthened presence in the US<br />
- Completed a capital increase of €41 million<br />
- 4 new Board members elected<br />
<br />
Advanced Accelerator Applications S.A. ("AAA" or "the Company"), an international specialist in Molecular Nuclear Medicine (MNM), is pleased to announce its results for the financial year 2013, with sales of €53.8 million (+31.77% vs. 2012). Other key news includes the appointment of four new independent Directors to AAA&apos;s Board.<br />
<br />
2013 financial performance <br />
<br />
AAA shareholders approved the Company&apos;s financial results for 2013. Sales for the year increased by 31.77% to €53.8 million (2012: €40.8 million). EBITDA, including costs of employee share-based payments, increased by 61.74% to €10.64 million (2012: €6.58 million) with net income representing a loss of €9.86 million for the year 2013 (vs loss of €16.91 million in 2012). Increased sales forecasts for Lu-DOTATATE compared to 2012 resulted in significant financial charges i.e. AAA has contractual obligations to pay royalties on sales of Lu-DOTATATE once the Company obtains Market Authorization and these estimated obligations need to be accounted for as a financial debt, these explain almost entirely the negative net income for 2013. These financial obligations based on sales estimates of Lutathera also explained for the most part the negative 2012 net income. Cash and cash equivalents were €13.6 million at the end of 2013, essentially the same as at the end of 2012. Net operating cash-flow was €11.94 million, an increase of 82.5% compared to the €6.52 million in 2012.<br />
<br />
AAA&apos;s CEO Stefano Buono commented: "2013 was a very good year for AAA. We exceeded our financial targets with strong demand for our existing products and we consolidated our presence in Europe. With Lu-DOTATATE, our product candidate currently in Phase III, we believe we are well positioned for future success."<br />
<br />
In 2013 AAA continued the expansion of its European MNM network with the creation of AAA Poland and the signing of an agreement with the University of Warsaw to operate its production site in 2014. A €4.8 million capital increase was completed in April 2013 to help fund expansion plans and finance clinical trials of a promising portfolio of MNM product candidates. <br />
<br />
AAA&apos;s proprietary pipeline continued to show progress with the Lu-DOTATATE pivotal Phase III trial recruitment on-track and other key pipeline products Ga-68 DOTATATE and 99mTc-rhAnnexin V-128 also progressing well. <br />
<br />
Recent progress<br />
<br />
In early 2014 AAA acquired Imaging Equipment Limited (IEL) giving the Company its first direct presence in the UK and Ireland, and a strong presence in all Europe&apos;s G5 countries. AAA continued its global expansion with the opening of an office in New York to support ongoing clinical studies for Ga-68 DOTATATE and Lu-DOTATATE. The NY office will be instrumental in overseeing the launch of AAA&apos;s commercial activity in North America. AAA also recently started operations in its new French site in Marseille which produced and delivered its first doses of GLUSCAN® on 12 May 2014.<br />
<br />
A €41 million capital increase, that included specialist biotech and pharma investment company HBM Healthcare Investments Ltd as a cornerstone investor, was completed on February 14, 2014 and, most recently, Ga-68 DOTATATE obtained Orphan Drug Designation from the FDA and EMA. <br />
<br />
Appointment of four new Board members<br />
<br />
During AAA&apos;s Annual General Meeting, the Shareholders approved the appointment of Yvonne Greenstreet, Steven Gannon, Christian Merle and Leopoldo Zambeletti as Non-Executive Directors. They joined Stefano Buono, Kapil Dhingra, Muriel de Szilbereky and Claudio Costamagna to form a new eight person Board of Directors chaired by Claudio Costamagna. All Board Members are elected for the duration of one year. Renewal of the mandate is subject to shareholder approval.<br />
<br />
Gerard Ber, Heinz Mausli, Eugenio Aringhieri, Andrea Ruben Levi and Raffaele Petrone stepped down from the Board.<br />
<br />
"We are delighted to welcome our four new members to AAA&apos;s Board of Directors," said Stefano Buono, CEO of AAA. "As the business of AAA becomes increasingly global, Board members with their breadth of experience are essential assets to the organization. These highly successful leaders will play a vital role in guiding AAA in its mission to become a leading global player in MNM. I would also like to extend my thanks and appreciation to those Board members stepping down for the time and energy they have devoted to AAA during their tenure as Board members. During the many years that they devoted to our Company, thanks to their contribution, AAA has been able to successfully grow internationally and rapidly become a European leader in MNM."<br />
<br />
Dr Yvonne Greenstreet has over 20 years of global experience in the pharmaceutical industry, where she has a proven track record as a business leader and drug developer. Dr. Greenstreet was a senior vice president and the Head of Medicines Development at Pfizer from 2010 to 2013. Prior to joining Pfizer, Dr. Greenstreet served in various roles at GlaxoSmithKline from 1992 to 2010, including Chief Medical Officer for Europe and Chief of Strategy. Dr. Greenstreet serves on the Advisory Board of the Bill and Melinda Gates Foundation and as a member of the Board of Directors of Pacira. She completed her medical training at the University of London Hospitals and received her MBChB from the University of Leeds. She subsequently completed a master&apos;s in business administration at INSEAD.<br />
<br />
Steven Gannon has extensive financial experience in corporate growth initiatives such as acquisitions, corporate alliances, and partnerships within the biotechnology and pharmaceutical sector. Mr Gannon is a Senior Vice President and the Chief Financial Officer and Treasurer at Aptalis Pharma Inc. Prior to joining Aptalis Pharma Inc., Mr. Gannon served as the Chief Financial Officer for Cryocath Technologies, Inc. from 1999 to 2006, as the Director of Finance and Administration of the Research Division of Astrazeneca Canada Inc. from 1996 to 1999, and as the Chief Financial Officer of Mallinckrodt Medical Inc.&apos;s Canadian operations from 1989 to 1995. He received a bachelor of commerce in accounting and business systems from Concordia University in Montreal and completed the Executive Program at the Richard Ivey School of Business at the University of Western Ontario. He is also a chartered accountant.<br />
<br />
Leopoldo Zambeletti is a highly respected figure within the life sciences sector. During a 19-year career as an investment banker, he led the European Healthcare Investment team at JP Morgan for eight years before taking up the same position at Credit Suisse for a further five years. Since 2013 Mr Zambeletti has been an independent strategic advisor to life science companies on Merger and Acquisitions, out-licensing deals and financing strategy. He is a Non-Executive Director of Summit Corporation plc. and Nogra Pharma and an advisor to the US medtech company Qardio. He serves as a trustee to Barts and the London Charity which helps fund the hospitals of the Barts NHS Trust including St Bartholomew&apos;s, the Royal London and the London Chest Hospitals. He is a founder of the cultural initiative 5x15 Italy. <br />
<br />
Christian Merle has 37 years of experience in Commercial, Private and Investment banking and is currently Managing Partner at Merle &amp; Partners, Advisory. He has held senior leadership roles in a number of leading banks in France, Italy and Switzerland. Prior to founding Merle &amp; Partners, Mr. Merle was the Chief Executive Officer of Banque Espirito Santo from 2007 to 2013, the Managing Partner of Gimar &amp; Cie from 2003 to 2007 and the Chief Executive Officer of Banca Intesa from 1998 to 2003. Prior to joining Banca Intesa, he served in various roles at Credit Agricole, including as the Executive Vice President of Credit Agricole Indosuez. He also served in various roles in the French Treasury, including the Chief Representative in the United States from 1987 to 1990. He received his undergraduate degree from the Institut d&apos;Etudes Politique and a master&apos;s in economics from the Universite de Paris I-Pantheon Sorbonne.<br />
<br />
About Advanced Accelerator Applications<br />
Advanced Accelerator Applications (AAA) is a radiopharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA&apos;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&amp;D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 300 employees in 11 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, Israel, U.S. and Canada). In 2013 AAA reported sales of €53.8 million (+31.77% vs. 2012). For more information please visit: <a class="extlink"  rel="nofollow noopener"  target="_blank"  title="http://www.adacap.com" href="http://www.adacap.com">http://www.adacap.com</a><br />
<br />
AAA has a portfolio of Molecular Nuclear Medicine products and product candidates, including Lu-DOTATATE, currently in a pivotal Phase III clinical trial for the treatment of GEP-NETs (an orphan disease) in 51 clinical centers in the United States and European Union. Lu-DOTATATE is an example of a theragnostic product candidate because it integrates diagnostic and therapeutic properties into the same compound, allowing physicians to evaluate and monitor its efficacy using imaging at every therapeutic injection, without additional product costs. Enrollment for the ongoing Lu-DOTATATE Phase III clinical trial (study known as Netter-1) is currently going as planned with over 220 individuals enrolled to date. <br />
<br />
About Molecular Nuclear Medicine ("MNM")<br />
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&apos;s body that accumulate in the organs or lesions that reveal specific biochemical processes.<br />
<br />
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.<br />
<br />
Reconciliation of EBITDA to net income (loss) for the year from continuing operations<br />
<br />
Year Ended December 31<br />
<pre><br />
	                                                     2013	   2012<br />
	                                                     Euro	   Euro<br />
<br />
Net income /(loss) for the year from continuing operations  (9,861)	(16,912)<br />
Adjustments:		<br />
Finance income		                                     (387)	  (232)<br />
Finance costs		                                    10,155	 16,512<br />
Income taxes		                                     1,059	    586<br />
Depreciation and amortization expense		             9,672	  6,623<br />
EBITDA		                                            10,638	  6,577<br />
</pre><br />
<br />
Cautionary Statement Regarding Forward-Looking Statements<br />
<br />
This press release may contain forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company&apos;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 reflect the Company&apos;s current expectation regarding future events. 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, EMA, U.S. FDA and other regulatory approvals for our product candidates, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, and uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand. 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.<br />
<br />
Contacts<br />
AAA Media Relations <br />
Laetitia Defaye						       <br />
Head of Corporate Communications				<br />
laetitia.defaye@adacap.com					<br />
Tel: +33 (0)6 86 65 73 52<br />
<br />
Veronique Mermet<br />
Communications Officer<br />
info@adacap.com<br />
Tel: +33 (0)4 50 99 30 70<br />
<br />
AAA Investor Relations<br />
Jordan Silverstein						<br />
Director of Investor Relations			<br />
jordan.silverstein@adacap.com<br />
Tel: + 1-212-235-2394<br />
<br />
Media enquiries<br />
FTI Consulting (UK)<br />
Julia Phillips							<br />
Julia.Phillips@fticonsulting.com 				<br />
Collins@fticonsulting.com <br />
Tel: +44 (0)203 727 1000					<br />
<br />
Natalie Garland-Collins<br />
Natalie.Garland-<br />
Tel: +44 (0)203 727 1000<br />
<br />
iCorporate (Italy)<br />
Elisa Piacentino						 <br />
elisa.piacentino@icorporate.it 				         	<br />
Tel: +39 02 4678754 - +39 366 9134595		                	-<br />
+39 333 2608159	<br />
<br />
Rita Arcuri<br />
rita.arcuri@icorporate.it<br />
Tel: +39 02 4678753<br />
<br />
JV Public Relations NY (US)<br />
Janet Vasquez<br />
jvasquez@jvprny.com<br />
Tel: + 1-212- 645-5498</p><p>For more information on this press release visit: <a rel="nofollow" href="http://www.releasewire.com/press-releases/release-3.htm">http://www.releasewire.com/press-releases/release-3.htm</a></p></div><h2>Media Relations Contact</h2><p>Janet Vasquez<br />US Media Contant<br />JV Public Relations NY Inc.<br />Telephone: 212-645-5498<br />Email: <a rel="nofollow" href="http://www.releasewire.com/press-releases/contact/528650">Click to Email Janet Vasquez</a><br />Web: <a rel="nofollow" href="http://www.adacap.com/">http://www.adacap.com/</a><br /></div><div><p><img src="https://cts.releasewire.com/v/?sid=528650&amp;s=f&amp;v=f" width="1" height="1" alt=""><span></span></p></div>]]></description>
      <pubDate>Thu, 10 Jul 2014 06:00:00 -0500</pubDate>
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