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FibroGen Regains All Rights to Roxadustat from AstraZeneca in the United States and Other AstraZeneca Territories, Except China and South Korea

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FibroGen terminates U.S./RoW roxadustat collaboration agreement with AstraZeneca, retains rights outside China. FibroGen to explore licensing opportunities for roxadustat. Roxadustat remains a leader in China for CKD anemia treatment.
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The termination of the U.S./RoW collaboration agreement between FibroGen and AstraZeneca for roxadustat has significant implications for both companies. From a market perspective, this change suggests a strategic pivot for FibroGen, as they now regain full rights to roxadustat in most territories outside China. This opens the door for potential licensing deals, partnerships, or even solo commercialization efforts by FibroGen.

The fact that roxadustat maintains a strong brand value share in the chronic kidney disease (CKD) anemia category in China indicates a proven market acceptance, which could be leveraged in negotiations with potential partners. However, FibroGen's obligation to compensate AstraZeneca in the event of future monetization could impact the financial attractiveness of such deals.

For AstraZeneca, the return of rights may suggest a strategic realignment or a response to internal portfolio prioritization. This decision could affect investor perception of AstraZeneca's commitment to nephrology, potentially impacting its stock performance in the short term.

FibroGen's announcement has direct financial implications, particularly concerning their future revenue streams and capital allocation. Regaining control over roxadustat in key markets could lead to upfront payments, royalties, or profit-sharing from new licensing deals, which could provide a boost to FibroGen's financials.

However, the need to explore new partnerships and the associated financial obligations to AstraZeneca may introduce a level of uncertainty regarding the timing and magnitude of these potential benefits. Market participants will need to closely monitor FibroGen's ability to secure new agreements and the terms of such deals to assess the long-term financial impact.

Roxadustat's potential as a treatment for anemia in patients with CKD and particularly in those with higher transfusion burden low-risk-MDS, suggests that there is still a significant unmet medical need that FibroGen could address. The data presented at ASH 2023 highlights the ongoing research and development efforts, which are crucial for gaining regulatory approval in new markets.

It is important to understand that the regulatory pathway for drug approval can be complex and time-consuming and success is not guaranteed. FibroGen's ability to navigate this process, particularly in the U.S. where roxadustat is not yet approved, will be critical for the drug's commercial success and, by extension, for FibroGen's business prospects.

The FibroGen – AstraZeneca China Agreement for Roxadustat remains in place

FibroGen to explore licensing opportunities for Roxadustat

SAN FRANCISCO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced today that FibroGen and AstraZeneca have agreed to terminate the U.S./RoW roxadustat collaboration agreement entered into on July 30, 2013, under which AstraZeneca held development and commercialization rights in the United States and other territories outside of China not licensed to Astellas Pharma Inc. Pursuant to a termination and transition agreement entered into between the parties, AstraZeneca is returning all U.S./RoW roxadustat rights to FibroGen (with the exception of South Korea) and providing certain assistance during a transition period. FibroGen’s collaboration agreement with AstraZeneca for roxadustat in China remains in place and roxadustat remains the leader in China by brand value share in the chronic kidney disease (CKD) anemia category. In the event FibroGen subsequently monetizes or commercializes roxadustat in the territories formerly licensed under the U.S./RoW collaboration agreement, FibroGen will have certain financial obligations to AstraZeneca.

“We continue to believe that roxadustat represents an important potential therapy for patients in the U.S. and other territories where it has not yet been approved,” said Thane Wettig, FibroGen Chief Executive Officer. “Based on the data presented at ASH 2023 investigating roxadustat for the treatment of anemia in patients with higher transfusion burden low-risk-MDS, we will be evaluating opportunities to bring this innovative medicine to patients through outreach to companies that may be interested in a product opportunity to address a disease with significant unmet need and attractive commercial potential.”

About Roxadustat
Roxadustat is an oral HIF-PH inhibitor that promotes erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, by improving iron absorption and mobilization and downregulation of hepcidin. Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on-dialysis and not on-dialysis. AstraZeneca and FibroGen continue to collaborate on the development and commercialization of roxadustat in China. Roxadustat is in clinical development for chemotherapy-induced anemia and a Supplemental New Drug Application has been accepted by the China Health Authority. Several other licensing applications for roxadustat have been submitted by partners to regulatory authorities across the globe. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

About FibroGen  
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class oncology therapeutics. Pamrevlumab, an anti-CTGF fully-human monoclonal antibody, is in clinical development for the treatment of metastatic pancreas cancer and locally advanced unresectable pancreas cancer. FG-3246, an antibody-drug conjugate targeting CD46, is in Phase 1 development with potential applications in metastatic castrate resistant prostate cancer (mCRPC) and other CD46-expressing cancers. Roxadustat (爱瑞卓®, EVRENZO™) is in clinical development for chemotherapy-induced anemia and a Supplemental New Drug Application has been accepted by the China Health Authority. Roxadustat is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on-dialysis and not on-dialysis. FibroGen continues to research and develop its portfolio of novel oncology product candidates. For more information, please visit www.fibrogen.com.

Forward-Looking Statements
This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding the development and commercialization of roxadustat, including its commercial potential, and the potential safety and efficacy profile of roxadustat. These forward-looking statements include but are not limited to statements about FibroGen’s plans and objectives and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

Contacts:
FibroGen, Inc.

Investors:
David DeLucia, CFA
Vice President of Corporate FP&A / Investor Relations
ir@fibrogen.com

Media:
Meichiel Keenan
Director, Investor Relations and Corporate Communications
media@fibrogen.com


FAQ

What collaboration agreement did FibroGen terminate with AstraZeneca?

FibroGen terminated the U.S./RoW roxadustat collaboration agreement with AstraZeneca.

Which territories are excluded from the rights returned to FibroGen by AstraZeneca?

South Korea is excluded from the territories returned to FibroGen by AstraZeneca.

What did AstraZeneca provide to FibroGen during the transition period?

AstraZeneca provided certain assistance to FibroGen during the transition period.

What is the status of FibroGen's collaboration agreement with AstraZeneca for roxadustat in China?

FibroGen's collaboration agreement with AstraZeneca for roxadustat in China remains in place.

What potential therapy does FibroGen believe roxadustat represents?

FibroGen believes roxadustat represents an important potential therapy for patients in the U.S. and other territories.

FibroGen, Inc.

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About FGEN

fibrogen is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. the company has built upon its extensive research experience in fibrosis and hypoxia-inducible factor (hif) biology to generate clinical programs targeting multiple therapeutic areas. fibrogen's most advanced product candidate, roxadustat (fg-4592), is an oral small molecule inhibitor of hif prolyl hydroxylases (hif-phs), in phase 3 clinical development for the treatment of anemia in chronic kidney disease (ckd). our second product candidate, fg-3019, is a monoclonal antibody in phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (ipf), pancreatic cancer and liver fibrosis. for more information please visit: www.fibrogen.com.