Three Valley Bioscience Firms Reach FDA Milestones

Three Valley Bioscience Firms Reach FDA Milestones

Three local companies late last month reached milestones with the Food and Drug Administration.

Amgen Inc., the Thousand Oaks biotech giant, received FDA approval to market a “biosimilar” drug to the blockbuster Soliris drug to treat certain rare diseases.

Just down the road in Thousand Oaks, another biotech company, Atara Biotherapeutics Inc., submitted an application to the FDA for a drug to treat certain patients with Epstein-Barr virus-infected cells.

Meanwhile, Valencia-based Avita Medical Inc. received FDA approval for an upgraded version of a cell-harvesting device that treats burn patients with their own skin cells.

Amgen biosimilar drug approval

News of the Amgen drug approval came from the FDA. The drug, called Bekemv, is a biosimilar, meaning it shares many of the active properties of a drug that has already been licensed. In this case, it’s Soliris, developed by Cambridge, United Kingdom-based AstraZeneca. Soliris, which is used to treat a rare genetic blood disorder, generated $3.1 billion in sales last year.

In its announcement, the FDA said Bekemv is approved to treat two specific and rare blood-related disorders: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Soliris is also approved to treat those conditions.

Under the terms of a settlement reached in 2020, Amgen can begin marketing Bekemv in March 2025.

In the FDA’s announcement, the agency said it has put a priority on approving biosimilar drugs to expand patients’ options.

“The FDA is committed to help facilitate the development of safe and effective interchangeable biosimilar treatments that can expand access for individuals with rare diseases whose current treatment options are limited,” the agency said. 

Atara’s submission of immunotherapy drug

Atara’s drug, known as tabelecleucel, or tab-cel for short, is a T-cell immunotherapy derived from the company’s Epstein-Barr virus platform. It targets patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease, in which excessive amounts of white blood cells are produced. Under terms of a licensing agreement with Paris-based Pierre Fabre Laboratories, Atara is responsible for regulatory procedures until the drug is approved by the FDA, which the announcement from Pierre Fabre said could come in the first quarter of next year. Once the approval is granted, the drug will be transferred to Pierre Fabre, which will then market the drug. Atara will receive milestone payments from Pierre Fabre totaling $80 million.

“The BLA submission for tab-cel represents a significant moment for Atara, our partner Pierre Fabre, and the broader allogeneic T-cell therapy field, and is a critical step towards our goal of delivering this first-of-its-kind treatment to EBV+ PTLD patients in the U.S.,” said Pascal Touchon, Atara’s chief executive.

The drug was already approved for sale by the European Commission in late 2022 and in the United Kingdom last year.

Avita’s skin cell regeneration device approved

Unlike Amgen and Atara, Avita Medical’s approval from the FDA is for a medical device, which the company has called Recell-Go. It is the second generation of the company’s cell regeneration technology. The technology platform harvests skin cells from a patient’s body to treat burns or wounds in that patient.

The first-generation device has been approved in the United States and some international markets to treat thermal burn wounds and certain other skin defects. It generates skin cells that are then sprayed onto the affected areas.

This second-generation device streamlines the process of spraying on the skin cells to treat burns and other wounds.

“By streamlining processes and enhancing operational efficiency with the use of Recell Go, clinicians can now treat a greater number of patients and more broadly experience the proven benefits of Recell technology,” Jim Corbett, Avita Medical’s chief executive, said in the company’s announcement. “We believe that this transformative shift will empower more clinicians to achieve optimal outcomes for their patients, driving greater adoption, and fundamentally redefining wound care management.

About the author

Leave a Reply

Your email address will not be published. Required fields are marked *