November 15, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Lexington, Mass. and Amsterdam, the Netherlands-based uniQure NV , recently completed a strategic review with a decision to refocus its pipeline and cut 20 to 25 percent of its workforce.
The company plans to put its hemophilia B, Huntington’s disease and other programs associated with its collaboration with Bristol-Myers Squibb in cardiovascular disease at the top of its priority list. It also plans to restructure its research-and-development operations in the Netherlands and consolidate manufacturing in the U.S.
The company hopes to save five to six million euros annually in personnel and operating expenses as part of cutting 50 to 60 jobs. Those job cuts are expected to be completed by the end of 2017. It hopes to save another 11 to 15 million euros over the next two years as the result of its pipeline prioritization. uniQure believes it will then have enough funds to continue operations into 2019.
“The strategic restructuring brings enhanced focus to our pipeline, streamlines operations and improves our financial strength,” said Matthew Kapusta, interim chief executive officer of uniQure in a statement. “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.
At the top of the list is its hemophilia B and Huntington’s disease programs. It plans a pivotal trial in hemophilia B and to file an investigational new drug (IND) application for Huntington’s once it finishes ongoing IND-enabling evaluations. It also plans to generate new products from internal development or the in-licensing of new products in rare and orphan diseases that, it indicates, “can leverage the Company’s next-generation vector and promoter platform and manufacturing capabilities.”
It also plans to advance its S100A1 in congestive heart failure, which it is developing in collaboration with BMS. And it plans to evaluate its gene therapy programs that target Sanfilippo B and Parkington’s disease, and determine what, if any, partnering opportunities exist. It currently has a Phase I/II clinical trial in Sanfilippo B in progress.
As part of its restructuring, Deya Corzo, currently senior vice president of the liver and metabolic therapeutic area and Charles Richard, senior vice president of the CNS therapeutic area, will leave the company at the end of this year. Christian Meyer, the company’s chief medical officer, will take over the hemophilia B gene therapy program. Harald Petry, chief scientific officer, will continue to head its preclinical research, including the IND-related studies in Huntington’s disease.
“We have simplified the structure of the Company to drive focus and provide for a strong foundation upon which to execute our key priorities,” said Philip Astley-Sparke, chairman of the board, in a statement. “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.”
