Post by icemandios on Jun 28, 2021 18:23:11 GMT
June 28, 2021 10:43 AM EDT R&D
Orphazyme plans to lay off most of its staff following a string of failures for lead 'pipeline-in-a-product'
Josh Sullivan
Associate Editor
Rémi Droller
Danish biopharma Orphazyme has been on a roller coaster of a ride lately, and the company plummeted down a bit further on Monday with the announcement that it will lay off two-thirds of its workforce.
The news comes nearly two months after arimoclomol, the company’s “pipeline-in-a-product,” flopped in ALS. The drug failed to meet primary or secondary endpoints for function and survival. The drug was handed a complete response letter from the FDA two weeks ago, and its stock plummeted 56.39 % to $6.35.
Data have not yet been released for that trial.
The layoffs are meant to support “essential activities,” the company said in a press release, which includes pursuing regulatory approval in Europe for arimoclomol. Rémi Droller, Martijn Kleijwegt, and Anders Hedegaard will all resign from the board of directors as well, the company said.
In a statement, CEO Christophe Bourdon said:
As a result of the restructuring of the company and our rigorous cost saving program, we will have to part ways with many of our most valued and talented colleagues. I thank each of them for their strong commitment to Orphazyme and dedication to showing up for patients in need. The immediate actions we are taking are necessary to protect and support the ongoing approval process in Europe and the evaluation of a path forward in the U.S.
Martijn Kleijwegt
In March, the company announced that arimoclomol failed to hit its endpoints in Phase II/III trials for patients with inclusion body myositis, a debilitating muscle-wasting disease. Nearly three years ago, the drug missed both primary endpoints in its Phase III Niemann-Pick disease type C study. There is no approved medicine for NPC, a rare disease that is estimated to impact 1 in 100,000 lives. Monday, Orphazyme also dropped data from a 36-month open-label extension trial, noting that there was a slow of progression in patients after three years. The drug also demonstrated a consistent safety profile. There were 41 total patients that joined the trial, the company said.
Anders Hedegaard
The company also intends to advance arimoclomol into clinical development in Gaucher disease, the inherited disorder that causes sugar-containing fats to accumulate in the lysosomes of cells and affect the brain, bone marrow, spleen and liver. That program is currently in Phase II.
The resignation of the board members and slashing of its staff are just the latest in a string of personnel moves. In December 2020, CEO Kim Stratton resigned abruptly, and the only explanation of that the move came “following a dialogue initiated by the board of directors.”
Orphazyme plans to lay off most of its staff following a string of failures for lead 'pipeline-in-a-product'
Josh Sullivan
Associate Editor
Rémi Droller
Danish biopharma Orphazyme has been on a roller coaster of a ride lately, and the company plummeted down a bit further on Monday with the announcement that it will lay off two-thirds of its workforce.
The news comes nearly two months after arimoclomol, the company’s “pipeline-in-a-product,” flopped in ALS. The drug failed to meet primary or secondary endpoints for function and survival. The drug was handed a complete response letter from the FDA two weeks ago, and its stock plummeted 56.39 % to $6.35.
Data have not yet been released for that trial.
The layoffs are meant to support “essential activities,” the company said in a press release, which includes pursuing regulatory approval in Europe for arimoclomol. Rémi Droller, Martijn Kleijwegt, and Anders Hedegaard will all resign from the board of directors as well, the company said.
In a statement, CEO Christophe Bourdon said:
As a result of the restructuring of the company and our rigorous cost saving program, we will have to part ways with many of our most valued and talented colleagues. I thank each of them for their strong commitment to Orphazyme and dedication to showing up for patients in need. The immediate actions we are taking are necessary to protect and support the ongoing approval process in Europe and the evaluation of a path forward in the U.S.
Martijn Kleijwegt
In March, the company announced that arimoclomol failed to hit its endpoints in Phase II/III trials for patients with inclusion body myositis, a debilitating muscle-wasting disease. Nearly three years ago, the drug missed both primary endpoints in its Phase III Niemann-Pick disease type C study. There is no approved medicine for NPC, a rare disease that is estimated to impact 1 in 100,000 lives. Monday, Orphazyme also dropped data from a 36-month open-label extension trial, noting that there was a slow of progression in patients after three years. The drug also demonstrated a consistent safety profile. There were 41 total patients that joined the trial, the company said.
Anders Hedegaard
The company also intends to advance arimoclomol into clinical development in Gaucher disease, the inherited disorder that causes sugar-containing fats to accumulate in the lysosomes of cells and affect the brain, bone marrow, spleen and liver. That program is currently in Phase II.
The resignation of the board members and slashing of its staff are just the latest in a string of personnel moves. In December 2020, CEO Kim Stratton resigned abruptly, and the only explanation of that the move came “following a dialogue initiated by the board of directors.”