Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), a Novartis company and leader in nuclear medicine theragnostics, today announced that it has entered into an exclusive worldwide license agreement with Cancer Targeted Technology, LLC (CTT) to develop and market an investigational new drug product, F-18-labeled CTT1057. CTT1057 is a ligand of Prostate-Specific Membrane Antigen (PSMA) for Positron Emission Tomography (PET) imaging of prostate cancer.
CTT has developed a phosphoramidate-based peptide, which specifically binds to PSMA. A Phase I study in 20 patients was conducted at the University of California, San Francisco. AAA will work to further develop and commercialize this diagnostic agent for prostate cancer. The terms of the agreement include an upfront licensing fee, as well as certain milestone and royalty payments.
Susanne Schaffert, Ph.D., Chairperson and President of Advanced Accelerator Applications, stated, “This agreement expands our position in the important prostate cancer space. PSMA diagnostics represent an accurate staging and risk assessment tool with the potential to change patient management decisions. CTT1057 is highly complementary to our existing F-18 PET portfolio and AAA is well suited to exploit this opportunity with our proven manufacturing and development capabilities.”
“We are very excited to enter into this license agreement with AAA,” commented Beatrice Langton-Webster, Ph.D., Chief Executive Officer of Cancer Targeted Technology. “We are very encouraged by the results of our recently completed Phase I clinical trial and believe that AAA has the right expertise and team to rapidly develop this important new PSMA-directed diagnostic for prostate cancer.”
Prostate cancer is the most frequent malignant tumor in men worldwide, affecting nearly one in seven men during their lifetime. After initial therapy, biochemical recurrence is common and is usually expressed by an elevation in prostate-specific antigen (PSA) levels. PET imaging with PSMA ligands has been shown to improve the detection of metastatic lesions, even at low serum PSA values in biochemically recurrent prostate cancer.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for CTT1057 or the other investigational or approved products described in this press release, or regarding potential future revenues from such products or the license agreement with Cancer Targeted Technology. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that CTT1057 or the other investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that the license agreement with Cancer Targeted Technology will achieve any or all of its intended goals and objectives, or be commercially successful. Nor can there be any guarantee that CTT1057 or the other investigational or approved products described in this press release will be commercially successful in the future. In particular, our expectations regarding such products, and the license agreement with Cancer Targeted Technology, could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Advanced Accelerator Applications S.A.
Advanced Accelerator Applications (NASDAQ:AAAP), a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA’s theragnostic platform is based on radiolabeling a targeting molecule with either gallium Ga 68 for diagnostic use, or lutetium Lu 177 for therapy. AAA’s first theragnostic pairing for neuroendocrine tumors includes diagnostic drugs NETSPOT® in the US and SomaKit TOC® in Europe; and therapeutic Lutathera® (USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide). Additional theragnostics in development target gastrointestinal stromal tumors (GIST), and prostate and breast cancer. AAA is also an established leader in molecular nuclear diagnostic radiopharmaceuticals for PET and SPECT, mainly used in clinical oncology, cardiology and neurology. Headquartered in Saint-Genis-Pouilly, France, AAA currently has 20 production and R&D facilities, and more than 600 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 €106.4 million for the first 9 months of 2017 (+31% vs. first 9 months of 2016). For more information, please visit: www.adacap.com.