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Heidelberg Pharma AG
Regulatory Filings • Oct 26, 2017
201_rns_2017-10-26_53850913-8ce4-4ff8-b06b-72c1002524ca.html
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Corporate | 26 October 2017 10:53
Heidelberg Pharma AG: Partner RedHill Announces Orphan Drug Designation for MESUPRON
DGAP-News: Heidelberg Pharma AG / Key word(s): Miscellaneous
26.10.2017 / 10:53
The issuer is solely responsible for the content of this announcement.
PRESS RELEASE
Heidelberg Pharma AG: Partner RedHill Announces Orphan Drug Designation for MESUPRON
– US FDA has granted Orphan Drug Designation for MESUPRON for the treatment of pancreatic cancer
– MESUPRON was developed by Heidelberg Pharma until clinical Phase II, then out-licensed to RedHill
Ladenburg, Germany, 26 October 2017 – Heidelberg Pharma AG (ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6) today announced that its partner RedHill Biopharma Ltd., Tel Aviv, Israel / Raleigh, NC (NASDAQ/TASE: RDHL), was granted Orphan Drug Designation for its drug candidate MESUPRON (upamostat) by the US Food and Drug Administration (FDA) for adjuvant treatment of pancreatic cancer. Orphan Drug Designation provides various development incentives, including a seven-year marketing exclusivity period for the indication, if approved.
MESUPRON was developed by Heidelberg Pharma (formerly WILEX) until clinical Phase II. In 2014, RedHill acquired exclusive worldwide rights to MESUPRON, excluding China, Hong Kong, Taiwan and Macao for all indications. In addition to the upfront payment of USD 1 million, which had been paid upon signing of the licensing contract, RedHill will pay potential tiered royalties on net revenues, ranging from mid-teens up to 30%. RedHill is responsible for development, regulatory and commercialization of MESUPRON.
Further details can be found in RedHill Biopharma’s recent press release at http://www.redhillbio.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 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 Sylvia Wimmer Tel.: +49 89 41 31 38-29 Email: investors[at]hdpharma.com Schriesheimer Str. 101, 68526 Ladenburg |
IR/PR support MC Services AG Katja Arnold (CIRO) Managing Director & Partner Tel.: +49 89 210 228-40 Email: katja.arnold[at]mc-services.eu |
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.
26.10.2017 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.
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| 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.wilex.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 |