~ Company Structure Simplified; Manufacturing to be Consolidated into Lexington, MA
~ Preparation Underway for Late-Stage Development in Hemophilia B
~ Cost Savings Expected to Extend Cash Resources into 2019
~ Company to Host Investor Conference Call Today at 8:30 a.m. ET
LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Nov. 15, 2016 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leader in human gene therapy, today announced the completion of a company-wide strategic review aimed at refocusing its pipeline, consolidating its manufacturing and enhancing overall execution to drive shareholder value. As a result of this initiative, the Company will prioritize programs in hemophilia B, Huntington’s disease and those associated with its landmark collaboration with Bristol-Myers Squib (BMS) in cardiovascular disease. Additionally, the Company will restructure its research and development organization in the Netherlands and consolidate manufacturing in the United States. These actions are expected to reduce operating expenses and create a more efficient company focused on the successful and timely development of gene therapies for patients with serious unmet medical needs.
As part of its effort to focus resources on key priorities, uniQure has initiated discussions with its collaborator regarding the potential discontinuation of licensing discussions for AMT-110 for the treatment of Sanfilippo B, and will pursue partnering opportunities for its academic-sponsored program in Parkinson’s disease.
uniQure expects to realize €5 to €6 million of annualized cost savings in personnel and other related operating expenses as a result of the elimination of approximately 50 to 60 positions, or 20% to 25% of global headcount, by the end of 2017. Additionally, the Company expects to further reduce planned operating expenses by €11 to €15 million over the next two years through the focusing of its pipeline. Based on its strong cash position and the above actions, uniQure believes its existing cash resources will be sufficient to fund operations into 2019.
“The strategic restructuring brings enhanced focus to our pipeline, streamlines operations and improves our financial strength,” stated Matthew Kapusta, interim chief executive officer of uniQure. “We are committed to the timely development of our programs in hemophilia B and Huntington’s disease, as well as the support of our collaboration with BMS. Along with our investigators and collaboration partner, we are enthusiastic about the interim data from our ongoing Phase I/II study of AMT-060 in hemophilia B and will allocate necessary resources to expedite bringing AMT-060 to market, with commercial manufacturing capabilities in our state-of-the-art U.S. facility which is already in place.”
“We are confident that these efforts will significantly streamline operations and position us well for the future,” Mr. Kapusta added. “We are grateful for the contributions that the employees affected by this outcome have made to uniQure, and we will be supporting them throughout this transition.”
Key Outcomes of the Strategic Review
uniQure has decided to prioritize the following programs within its gene therapy pipeline:
Consolidate Global Manufacturing
Streamline Research and Development
“We have simplified the structure of the Company to drive focus and provide for a strong foundation upon which to execute our key priorities,” stated Philip Astley-Sparke, chairman of the uniQure Board of Directors. “Further details on how we expect to position our hemophilia program will be provided after we have met with regulatory authorities early next year to discuss our plans for a pivotal study. We will further direct capital into programs that we believe will create near-term value, as well as continue to leverage our core assets, including next-generation vector development and best-in-class manufacturing capabilities.”
Conference Call Information
uniQure will host a conference call today, November 15, 2016 at 8:30 a.m. ET to discuss this announcement. To access the live call by phone, dial (877) 280-2296 (United States) or +44 (0)20 3427 1917 (international); the conference ID is 4243017. The call may also be accessed through the Investors section of the Company’s website at www.uniQure.com. Following the live webcast, a replay of the call will be available at the same location through November 30, 2016.
uniQure is delivering on the promise of gene therapy – single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary and partnered gene therapies to treat patients with hemophilia, Huntington’s disease and cardiovascular diseases. www.uniQure.com
uniQure Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to," "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding the implementation and effects of the Company’s new strategic and organizational changes, the development of our gene therapy product candidates, the success of our collaborations and the risk of cessation, delay or lack of success of any of our ongoing or planned clinical studies and/or development of our product candidates. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with corporate reorganizations and strategic shifts, collaboration arrangements, our and our collaborators’ clinical development activities, regulatory oversight, product commercialization and intellectual property claims, as well as the risks, uncertainties and other factors described under the heading "Risk Factors" in uniQure’s 2015 Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 4, 2016. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
Maria E. Cantor
Direct: +31 20 240 6103
Mobile: +31 6 52 33 15 79
PDF Version: http://hugin.info/157414/R/2056691/770399.pdfGlobeNewswire
Last updated on: 15/11/2016
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