RARE Daily

Orphazyme Begins In-Court Restructuring, Reducing Half of Current Workforce

March 11, 2022

Danish rare disease focused biotech Orphazyme said that, following the receipt of the negative Trend Vote as announced on February 23, 2022, and considering the company’s financial position, its board of directors decided to file a petition for an in-court restructuring of the company.

Photo: Anders Vadsholt, CEO of Orphazyme

As part of the restructuring efforts, Orphazyme will also institute a reduction of approximately 50 percent of the company’s current global workforce.

The aim of the in-court restructuring is to explore whether a basis can be established which allows for all or part of the company’s operations to continue, including a basis for injecting further capital, and/or a basis for a sale of all or parts of Orphazyme’s assets.

To reduce costs, Orphazyme recently closed its commercial operations in Germany, the United Kingdom, and the United States. Specifically, Orphazyme initiated formal negotiations under the Danish Act on Collective Redundancies and the Act on Information and Consultation.

“Following the very disappointing outcomes from the regulatory authorities in the U.S. and EU, we are forced to consider some extremely difficult choices. Our employees have worked tirelessly with a focus on bringing arimoclomol as a potential new treatment option to patients with Niemann-Pick disease type C,” said Anders Vadsholt, CEO of Orphazyme. “It is with a heavy heart that we are faced with the prospect of parting ways with valued colleagues, and I want to thank them for their hard work, their commitment to Orphazyme, and their outstanding dedication to showing up for patients in need.”

Niemann-Pick disease type C (NPC) is a rare, genetic, progressively debilitating, and often fatal neurodegenerative disease. It belongs to a family known as lysosomal storage diseases and is caused by mutations leading to defective NPC protein. As a consequence, lipids that are normally cleared by the lysosome accumulate in tissues and organs, including the brain, and drive the disease pathology. The incidence of NPC is estimated to be one in 100,000 live births and the number of NPC patients in the United States and in Europe to be approximately 1,800 individuals. There are no approved treatments for NPC in the United States.

Orphayzme’s lead experimental drug candidate, arimoclomol, amplifies the production of heat shock proteins (HSPs). HSPs can rescue defective misfolded proteins and improve the function of lysosomes. Arimoclomol is administered orally and has been studied in three pivotal phase 2/3 trials. Arimoclomol has received Orphan Drug designation (ODD) for NPC in the U.S. and EU; and Fast-Track, Breakthrough Therapy, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration for NPC.

Author: Rare Daily Staff

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