DGAP-News: Heidelberg Pharma AG / Key word(s): Alliance/Study Heidelberg Pharma AG: Partner Telix Pharmaceuticals Files Phase III Trial for Kidney Cancer Imaging in Europe 23.08.2018 / 09:00 The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- PRESS RELEASE Heidelberg Pharma AG: Partner Telix Pharmaceuticals Files Phase III Trial for Kidney Cancer Imaging in Europe Ladenburg, Germany, 23 August 2018 - Heidelberg Pharma AG (ISIN DE000A11QVV0 / WKN A11QVV / WL6) today announced that its partner Telix Pharmaceuticals Limited ("Telix") (ASX:TLX), has submitted a Clinical Trial Application (CTA) to initiate a Phase III trial in Europe for 89Zr-DFO-girentuximab (TLX250) for the imaging of renal (kidney) cancer with Positron Emission Tomography (PET). The study - referred to as ZIRCON ("Zirconium Imaging in Renal Cancer Oncology, EudraCT 2018-002773-21) - will be a global multi-center Phase III study with 15 sites in Europe, up to 4 sites in Australia and 6 to 8 sites in the US, subject to regulatory approval in the various jurisdictions. ZIRCON is a prospective imaging study in approximately 250 kidney cancer patients undergoing kidney surgery and will determine the sensitivity and specificty of TLX250 PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic "ground truth" determined from surgical resection specimens. The trial is expected to take 9 to12 months to fully recruit. Dr. Jan Schmidt-Brand, CEO/CFO of Heidelberg Pharma, said: "We warmly congratulate Telix on getting to this important stage of development so quickly. We believe that TLX250 has the potential to truly address a major unmet medical need by more accurately diagnosing a population of kidney cancer patients who are frequently mis-staged, which can lead to suboptimal treatment. We look forward to seeing this program advance through development and hopefully onto the market." In January 2017, Heidelberg Pharma granted Telix exclusive worldwide rights for the development and commercialization of the imaging agent REDECTANE(R), now called TLX250, a radiolabelled form of the monoclonal antibody girentuximab. As part of its optimization work, Telix has replaced the radioisotope Iodine 124 with Zirconium 89, which is expected to allow for even higher resolution images, lower production costs and a more streamlined clinical workflow. Telix CEO, Dr. Christian Behrenbruch, stated, "The filing of this clinical trial in Europe marks a major milestone for the company in terms of realizing the value of our product pipeline. We'd like to express our appreciation to our partner Heidelberg Pharma for the practical support over the last 18 months in terms of getting this program launched, as well as our academic collaborators in the US, Australia and Europe." Under the terms of the agreement with Telix, Heidelberg Pharma is eligible to receive upfront and milestone payments totaling USD 3.7 million. The approval of the CTA to initiate the Phase III trial in Europe with TLX250 will trigger a development milestone payment to Heidelberg Pharma. Heidelberg Pharma also is eligible to receive double-digit royalties on global net sales. Telix is responsible for all development costs, as well as manufacturing and commercialization costs of girentuximab, for both diagnostic and therapeutic applications. Further details can be found in Telix's recent press release at http://www.telixpharma.com. About Heidelberg Pharma Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg, Germany. Heidelberg Pharma is an oncology specialist and the first company to develop the toxin Amanitin into cancer therapies using its proprietary Antibody Targeted Amanitin Conjugate (ATAC) technology and to advance the biological mode of action of the toxin as a novel therapeutic principle. This proprietary technology platform is being applied to develop the Company's proprietary therapeutic ATACs, as well as in third-party collaborations, to create a variety of ATAC candidates. The proprietary lead candidate is HDP-101, a BCMA ATAC for multiple myeloma. The Company has entered into partnerships to further develop and commercialize its clinical assets MESUPRON(R) and REDECTANE(R), while RENCAREX(R) is available for out-licensing and further development. Heidelberg Pharma AG is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at www.heidelberg-pharma.com. Contact Heidelberg Pharma AG IR/PR support MC Services AG Sylvia Wimmer Tel.: +49 89 41 31 Katja Arnold (CIRO) Managing 38-29 Email: Director & Partner Tel.: +49 89 investors[at]hdpharma.com 210 228-40 Email: Schriesheimer Str. 101, 68526 katja.arnold[at]mc-services.eu Ladenburg This communication contains certain forward-looking statements relating to the Company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "will" "should" "future", "potential" or similar expressions or by a general discussion of the Company's strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments. --------------------------------------------------------------------------- 23.08.2018 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de --------------------------------------------------------------------------- Language: English Company: Heidelberg Pharma AG Schriesheimer Str. 101 68526 Ladenburg Germany Phone: +49 (0)89 41 31 38 - 0 Fax: +49 (0)89 41 31 38 - 99 E-mail: [email protected] Internet: www.heidelberg-pharma.com ISIN: DE000A11QVV0 WKN: A11QVV Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange End of News DGAP News Service --------------------------------------------------------------------------- 716675 23.08.2018