Blog Coverage Biopharma Company uniQure Undertakes a Companywide Strategic Review Aimed at Increasing Shareholders Value

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LONDON, UK / ACCESSWIRE / November 16, 2016 / Active Wall St. blog coverage looks at the headline from uniQure N.V. (NASDAQ: QURE) as the company announced on November 15, 2016, that it had completed a companywide strategic review. The purpose of the review was three-pronged: firstly, to simplify the company structure by refocusing its pipeline; secondly consolidating its manufacturing; and thirdly enhancing overall execution to increase shareholders' value. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

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Shedding light on the strategic review, Matthew Kapusta, interim-CEO of uniQure said:

"The strategic restructuring brings enhanced focus to our pipeline, streamlines operations and improves our financial strength. We are confident that these efforts will significantly streamline operations and position us well for the future."

Goals of the Strategic Review

Set priorities on the Pipeline

Prioritization of the projects to be undertaken is the key initiative. uniQure has decided to prioritize programs in hemophilia B (a hereditary bleeding disorder caused by a lack of blood clotting factor IX, without which blood cannot clot properly to control bleeding), and Huntington's disease (an inherited condition in which nerve cells in the brain break down over time) to speed up the clinical development of its product candidates. It is in the process of starting pivotal trial for filing of investigational new drug (IND) application for Huntington's disease once the company completes the ongoing IND-enabling studies.
uniQure also wants to concentrate on cardiovascular disease projects where it has entered a collaboration with Bristol-Myers Squib.

In addition to the above, uniQure will now focus on new products development for rare and orphan diseases especially liver-directed diseases. It is also looking at options including partnership opportunities to work around gene therapy projects for Sanfilippo B (a metabolic disorder caused by an enzyme deficiency has four subtypes A, B, C, D. Each subtype corresponds to a specific deficient enzyme) and Parkinson's disease (a chronic and progressive movement disorder). The company's Phase I and Phase II clinical trials with regards to patients of Sanfilippo B have completed the 30-day evaluations and the results of the evaluation are expected in Q12017. For Parkinson's disease, it is exploring the possibility of an academic-sponsored trial to speed up the ongoing study and further develop the program.

These steps will help the company stay focused on the successful and timely development of gene therapies for patients with serious unmet medical needs.

Consolidate its Global manufacturing

uniQure will restructure its research and development organization in the Netherlands and consolidate manufacturing in the United States. The company plans to consolidate all its manufacturing at its new fully functional facility at Lexington, Massachusetts. The new facility has the capacity to scale up and is ideal for late-stage development and commercialization of its gene therapy products. uniQure has decided to maintain a small and fully integrated R&D facility at Amsterdam, the Netherlands and the team is set to move into the facility in the first half of 2017.

Streamline Research and Development

uniQure is redesigning its organizational structure where in it is eliminating the structure focused on therapeutic cures. The team leaders in the liver and metabolic therapeutic area and the central nervous system therapeutic area will be moving on and leave the company by the end of 2016. Christian Meyer, M.D., Ph.D., Chief Medical Officer, will lead the company's hemophilia B gene therapy program and Harald Petry, Ph.D., Chief Scientific Officer, will continue to lead the pre-clinical research, including IND – enabling studies in Huntington's disease.

Benefits of the review

The companywide exercise will help the company to streamline its operations and create a stronger organization that can sustain itself against future challenges. It will also lead to many benefits including:

  • Reduction in planned operating expenditure of €11-15 million in the next two years;

  • Annualised cost savings of €5-6 million in terms of in personnel and other related operating expenses;

  • Aims to reduce 20–25% headcount globally by end of 2017. This translates to loss of approximately 50–60 positions;

  • Cost saving exercise will result in extending cash reserves up to 2019;

  • Explore partnering opportunities for its academic-sponsored program in Parkinson's disease;

  • Organization structure changed to completely focus on gene therapy by elimination of the therapeutic area.

Stock Performance

At the closing bell, on Tuesday, November 15, 2016, uniQure's stock declined 6.87%, ending the trading session at $7.73. A total volume of 319.44 thousand shares were traded at the end of the day, which was higher than the 3-month average volume of 229.82 thousand shares. In the last month, shares of the company have advanced 7.66%. The stock currently has a market cap of $178.87 million.

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