AstraZeneca and Fibrogen have serious disagreements: Cooperation on Roxadustat will be broken.

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AstraZeneca and Fibrogen have serious disagreements: Cooperation on Roxadustat will be broken.

In the months since the FDA high-profile refusal to approve the oral chronic kidney disease ( CKD ) anemia drug Roxadustat last August , AstraZeneca and FibroGen have been working to chart a potential path forward for the drug.

But now, the two partners may be at odds on this path, and prospects for a re-submission in the U.S. for the CKD anemia indication are bleak .

AstraZeneca and Fibrogen have serious disagreements: Cooperation on Roxadustat will be broken.

Fibregen CEO Enrique Conterno told investors on a recent conference call that despite ” significant discussions” , AstraZeneca and Fibregent ” have not been able to find a way for AstraZeneca to further fund the development of Roxadustat in the U.S. ” Pathways to anemia in CKD . ”

As a result, FibroGen said in its first-quarter filing of this year that FibroGen ” does not expect to receive most or all of the remaining” milestone payments from AstraZeneca, which are related to Rocha in the U.S. and certain markets.

It is related to the development progress of Sita. As of March , under this part of the agreement, FibroGen had received a payment of $ 439 million from AstraZeneca.

Because AstraZeneca has exclusive rights to Roxadustat in the U.S., Conterno said, FibroGen cannot bypass the British drugmaker.

Conterno also said: ” We do think there is a way forward in terms of what clinical trials need to be done, but we obviously need to be able to agree with AstraZeneca on this plan and get funding to move forward.”

In addition to the rejection, the FDA has requested additional clinical studies of Roxadustat as a condition of potential approval for CKD anemia. The design of the trial – or the trial – has been a key focus for industry observers seeking to assess the timeline and market potential of Roxadustat.

But some industry analysts have pointed out that AstraZeneca may be reluctant to fund another large phase III trial, especially if competitors are close to the market.

Roxadustat, once hailed as a blockbuster drug candidate , faced an FDA rejection last summer for an indication in patients with dialysis-dependent and non-dialysis CKD anemia due to heart-related side effects.

AstraZeneca and Fibrogen suggested that the cardiovascular safety signal seen in clinical trials of Roxadustat could be addressed by titrating the dose, but the FDA wants evidence from clinical trials.

Roxadustat is a novel oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) . With China’s approval in late 2018 for anemia due to CKD in patients undergoing dialysis (trade name: Arrizo), Roxadustat became the world’s first approved HIF-PHI . At the time, the drug also appeared to be the first of its kind to enter the United States.

Following the rejection of Roxadustat, the FDA also rejected Akebia Therapeutics and Otsuka ‘s second-line HIF-PHI drug vadadustat in CKD anemia in March , citing a higher risk of thromboembolic events and liver damage.

The two setbacks make GlaxoSmithKline’s daprodustat potentially the first of its kind to land in the U.S., with the FDA expected to make an approval decision by Feb. 1 , 2023 .

Globally, Roxadustat’s global sales in the first quarter of this year were $ 60.8 million, a year-on-year increase of 58% . Roxadustat ’s sales in 2021 will mainly come from the Chinese market, at $ 174 million.

Through the collaboration with Astellas, Roxadustat was approved for marketing (trade name Evrenzo ) in Japan and Europe in September 2019 and 2021 , respectively . In Europe, Astellas has marketed the drug in Germany, the UK, the Netherlands, Austria and the Nordic countries.

While the U.S. indication for CKD anemia appears to have run its course, Conterno said AstraZeneca is still involved in the development of Roxadustat in the U.S. for myelodysplastic syndrome anemia. Phase III data for the program is expected to be released in the first half of 2023 .

Meanwhile, FibroGen’s disclosure of Roxadustat cardiac safety data has sparked several investor lawsuits accusing the company and its executives of providing false and misleading information. The Securities and Exchange Commission has also launched an investigation and requested documents related to the data.

AstraZeneca and Fibrogen have serious disagreements: Cooperation on Roxadustat will be broken.

(source:internet, reference only)

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