May 25, 2017
By Alex Keown, Breaking News Staff


BASEL, Switzerland – Roche (RHHBY) is investigating reports of a German patient who was diagnosed with a deadly brain infection called progressive multifocal leukoencephalopathy after taking one dose of the company’s newly-approved multiple sclerosis drug Ocrevus.

According to reports, the patient took Ocrevus (ocrelizumab) after having taken Biogen (BIIB)’s Tysabri for three years. Roche said it is attempting to determine the source of the infection. However, the company noted that because Ocrevus suppresses the immune system in order to treat MS, the drug label carries warnings of potential problems. PML is a neurological disorder characterized by the destruction of the myelin that protects nerve cells in the central nervous system. The disorder is caused by the JC Virus. According to the National Organization for Rare Disorders, the virus is fairly widespread, but is only dangerous in people with a suppressed immune system.

Roche told Reuters that it intends to share information about the patient when it knows more about the source of the infection.

Patient safety is Roche’s highest priority and we are gathering more details about the case and the patient’s history,” Roche told Reuters.

The patient who came down with PML tested positive for the JC Virus, Reuters reported. Tysabri (natalizumab), which was approved for use with MS patients in 2004, is part of a class of drugs called immunomodulators. However, Tysabri does have a history with PML. The German patients who switched to Ocrevus is not the first Tysabri patient diagnosed with the deadly brain infection. Tysabri was pulled from the market in 2005 due to links to PML. Tysabri was brought back to market a year later, but with tougher prescribing restrictions that prevented physicians from prescribing it for off-label uses.

In a statement to Reuters, a Biogen spokesperson said the company was aware of the report of the patient being diagnosed with PML. The spokesman, Matt Fearer, said the company was assessing the information to confirm the reported PML. Fearer also said there are many unknowns around the safety of long-lasting drugs of this type “including occurrence and management of opportunistic infections,” Reuters said.

Ocrevus was approved by the U.S. Food and Drug Administration in March. It is the first and only approved disease-modifying therapy for primary progressive form of MS, Roche said. Ocrevus is a monoclonal antibody designed to targetCD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.

During clinical trials for Ocrevus, Roche said there were no cases of PML, but did include warnings on the label. During Phase III trials, Roche said the most common side effects were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity.

Some analysts project the drug could generate between $2.6 and $3.8 billion. Ocrevus has been seen as a potential tent-pole for Roche as the company looks to new revenue sources due to older blockbusters, such as Avastin and Herceptin, losing patent protection. If Ocrevus is determined to be the source of the PML, the warning label on the drug could be upgraded to the more serious black-box warning, which could hinder sales.

Shares of Roche are slightly down this morning, trading at $26.20.



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