After $3.7B Deal, Amgen Will Own Rights to AAV Therapy Tavneos

US-based biotech to acquire vasculitis therapy developer ChemoCentryx

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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After approximately $3.7 billion in acquisitions, Amgen will own the rights to Tavneos (avacopan), an approved oral therapy developed by ChemoCentryx to treat ANCA-associated vasculitis (AAV).

Amgen is acquiring ChemoCentryx in a cash deal, expected to be completed by year’s end, the companies announced.

“The acquisition of ChemoCentryx represents a compelling opportunity for Amgen to add to our decades-long leadership in inflammation and nephrology with Tavneos, a transformative, first-in-class treatment for ANCA-associated vasculitis,” Robert Bradway, chairman and CEO of Amgen, said in a company press release.

Tavneos was approved by the U.S. Food and Drug Administration (FDA) late last year as an add-on therapy for patients with severe and active microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) — the most common types of AAV. It was the first new therapy AAV to be approved by the FDA in more than a decade.

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“Last year, after 25 years of proud history, we at [ChemoCentryx] delivered on our founding promise with the approval of Tavneos for patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis),” said Thomas J. Schall, PhD, president and CEO of ChemoCentryx. “It is an honor to now join Amgen’s great mission, and together begin a bright new era bringing landscape-shaping medicines like Tavneos to those who will benefit most.”

Tavneos is designed to block the activity of C5a, an inflammatory protein that contributes to the autoimmune attack that drives AAV. Its approval in the U.S. was supported by data from a pivotal Phase 3 clinical trial called ADVOCATE (NCT02994927), which was conducted at 198 study sites worldwide.

The results demonstrated Tavneos outperformed standard steroid therapy at inducing long-term remission, improving kidney function, and ameliorating patients’ quality of life.

In the first quarter of 2022, sales of Tavneos in the U.S. amounted to $5.4 million, according to the companies.

“We are excited to join in the Tavneos launch and help many more patients with this serious and sometimes life-threatening disease for which there remains significant unmet medical need,” Bradway said, adding, “We also look forward to welcoming the highly skilled team from ChemoCentryx that shares our passion for serving patients suffering from serious diseases.”

The acquisitions deal has been approved by the board of directors at both Amgen and ChemoCentryx. It is expected to close later this year, pending regulatory approvals and other customary closing conditions.

“A fierce commitment to improving human lives is the bond that unites Amgen and ChemoCentryx today,” Schall said.

In addition to its U.S. indications, Tavneos has been approved for the treatment of MPA and GPA in the European Union, Canada, and Japan.

Vifor Fresenius Medical Care Renal Pharma holds exclusive rights to commercialize Tavneos outside the U.S., except in Japan and Canada. In Japan, those rights are held by Kissei Pharmaceutical, while Otsuka Canada Pharmaceutical holds commercialization rights in Canada.

In the U.S., Tavneos is being distributed by the rare disease pharmacy PANTHERx.