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uniQure Announces Second Quarter 2017 Financial Results and Recent Company Progress
~ Advancing Gene Therapy Programs in Hemophilia B and Huntingtons Disease ~
~ Provides Update on Research Collaboration with Bristol-Myers Squibb ~
~ Makes New Appointments to Company Leadership and Nominations to Board of Directors ~
LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Aug. 08, 2017 (GLOBE NEWSWIRE) uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the second quarter of 2017 and highlighted recent progress across its business.
We had a highly productive second quarter and past few weeks in which we announced substantial progress in advancing our lead program in hemophilia B through commercial-scale manufacturing and CMC accomplishments, regulatory preparation and the receipt of broader patent protection around our insect-cell platform technology, stated Matthew Kapusta, chief executive officer of uniQure.
We presented long-term clinical data in patients with severe hemophilia B demonstrating safety and durable clinical benefits, as well as the potential to treat nearly all patients suffering from this life-changing disorder. We now have full, unencumbered global rights to our hemophilia B program creating value for shareholders and opening the door to new potential opportunities, and we are advancing our Huntingtons disease program into an IND-enabling toxicology study in the fall, he added. Furthermore, based on recent encouraging data, uniQure and Bristol-Myers Squibb intend to advance our S100A1 product candidate into additional preclinical studies, including a therapeutic heart failure study that we expect to initiate as soon as possible. We are embarking on a very busy and equally productive second half of the year, and we look forward to providing additional company updates.
Second Quarter 2017 and Recent Company Progress:
· Successful development and scale up of manufacturing processes for hemophilia B and other gene therapy programs
· Developed and optimized a reproducible, commercial scale, manufacturing process for producing its hemophilia B gene therapy in accordance with Good Manufacturing Practices (GMP). This process will be leveraged across each of the Companys programs, including AMT-130 in Huntingtons disease for which uniQure expects to file an investigational new drug (IND) application in 2018. A comparability protocol also has been finalized, and the Company is planning to meet with U.S. and European regulators in the early fall to further discuss its plans to begin a pivotal program in hemophilia B in 2018.
· Continued progress on research collaboration with Bristol-Myers Squibb (BMS) in congestive heart failure
The following information was filed by Uniqure N.V. (QURE) on Tuesday, August 8, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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