Business Wire

Vifor Pharma and Angion Sign License Agreement for ANG-3777 in Nephrology Indications

Share

Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201108005065/en/

Vifor Pharma and Angion Biomedica Corp. (Angion) announced the signing of a licensing agreement for the commercialization of ANG-3777, currently developed for treatment of delayed graft function (DGF) and cardiac surgery-associated acute kidney injury (CSA-AKI). ANG-3777 was engineered to mimic the biological activity of HGF, activating critical pathways in the body’s natural organ repair process following an acute organ injury.

Under the terms of the agreement, Vifor Pharma will receive an exclusive global license, excluding China, Taiwan, Hong Kong and Macau, for all ANG-3777 nephrology indications.Angion will receive up to USD 80 million which includes a 30 million upfront payment, a 30 million equity investment and 20 million in clinical study milestone payments. Additionally Angion is eligible to receive up to USD 260 million in market access related milestones upon approval in US and EU, further payments in the form of sales milestones, and tiered royalties on global net sales up to 40% at the high end of the royalty range.

“This agreement highlights the leadership position that Vifor Pharma has developed in the nephrology space and the fact that it has become the company of choice for organizations committed to partnering innovative nephrology focused assets“ said Stefan Schulze, Chief Executive Officer of Vifor Pharma. “Angion is an excellent partner with an outstanding expertise leading to the development of this exciting asset and other pipeline products. We look forward to working closely with Angion who will be responsible for the ongoing development program of ANG-3777 and to leveraging our commercial expertise to bring this highly promising, innovative treatment with a unique mode of action to patients suffering from DGF and CSA-AKI. These are both critical conditions, currently without any effective or approved therapies.”

“Vifor Pharma is one of the world leaders in the nephrology space and we are very excited to partner with them on the commercialization of ANG‑3777 for nephrology indications,” stated Dr. Jay Venkatesan, President and CEO of Angion. “This is a major milestone for the team at Angion who has worked for many years to develop ANG-3777 as a therapy for patients with acute kidney injuries. We look forward to phase-III data in DGF towards the end of 2021 and working with Vifor Pharma to potentially bring ANG-3777 to nephrology patients worldwide.”

Addressable patients with DGF is estimated to be about 15,000 and approximately 110,000 with CSA-AKI in the US/EU5 each year.

Angion will be responsible for conducting the ongoing nephrology-focused clinical development programs. Angion and Vifor Pharma will share responsibilities for regulatory filings in the licensed territories and Vifor Pharma will be responsible for all commercialization activities related to nephrology indications in all licensed territories.

Conference call/webcast:

Vifor Pharma will host a conference call and webcast today, 9 November 2020 at 2:00 pm (CET), to discuss the license agreement.

Conference call link to get the dial-in number (open 30 minutes prior to start of the webcast): https://conferencing.swisscom.ch/conference/x/cU-8I7D0aXQc.

Webcast link: https://stream.swisscom.ch/vifor/20201109/

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit www.viforpharma.com

Angion Biomedica Corp. is a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases. Angion’s lead product candidate, ANG-3777, is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the HGF/c-Met pathway, which has a central role in tissue repair and organ recovery. ANG-3777 is currently in clinical trials investigating its impact on acute organ injury, including two forms of acute kidney injury and in acute lung injury. Angion is also developing ANG-3070, an orally-bioavailable small molecule, as a potential treatment for fibrotic diseases using a precision-medicine approach. For further information, please visit www.angion.com

About ANG-3777
ANG-3777 is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue repair and organ repair. ANG-3777 has a substantially longer half-life than HGF and Angion believes ANG-3777 has the potential to be a first-in-class therapeutic addressing acute organ injury. The ongoing clinical trials of ANG-3777 include a placebo-controlled Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, a Phase 2 proof-of-concept trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery, and a Phase 2 proof-of-concept trial in patients with acute lung injury associated with COVID-19 pneumonia. In 2018, Sinovant Sciences and Angion signed a development and licensing agreement for ANG-3777 in Greater China.

About CSA-AKI
During cardiac surgery, the use of cardiopulmonary bypass during the procedure may cause or exacerbate kidney injury as a result of reduced blood flow, non-pulsatile circulation, rupture of red blood cells creating oxidant damage and other causes. CSA-AKI is caused by many factors, including shear stress during cardiopulmonary bypass and injuries from nephrotoxic drugs and contrast agents. In addition, an important driver of CSA-AKI is ischemia-reperfusion injury, which is similar to the injury seen in DGF. There are no approved pharmacological treatments.1

About DGF
Delayed graft function is a severe form of acute kidney injury resulting from ischemia-reperfusion injury following kidney transplantation. It is distinct from transplant rejection and is most commonly seen in recipients of deceased-donor kidneys. In delayed graft function, the kidney fails to adequately filter the blood and patients require dialysis within the first week after transplantation.2 Dialysis does not treat acute kidney injury, but instead is renal replacement therapy for impaired kidneys. Patients with delayed graft function are more likely to experience transplant failure and have a higher mortality rate.3, 4, 5

References:

1

Bellomo R, et al. “Acute kidney injury.” The Lancet (2012); 380: 756-766.

2

Centers for Disease Control and Prevention. “Dialysis Safety.” October 2017.

3

Shoskes D, et al. “Delayed Graft Function in Renal Transplantation: Etiology, Managment and Long-term Significance.” The Journal of Urology (1996); 155: 1831-1840.

4

Brown, et al., “Duration of acute kidney injury impacts long-term survival after cardiac surgery. The Annals of thoracic surgery. (2010); 90(4).

5

Schnuellee, P et al., “Comparison of early renal function parameters for the prediction of 5-year graft survival after kidney transplantation.” Nephrology Dialysis Transplantation (2006); 22: 235–245.

Contact information

For Vifor Pharma:
Media Relations
Nathalie Ponnier
Global Head Corporate Communications
+41 79 957 96 73
media@viforpharma.com

Investor Relations
Julien Vignot
Head of Investor Relations
+41 58 851 66 90
investors@viforpharma.com

For Angion:
Investors
Daniel Ferry
LifeSci Advisors
daniel@lifesciadvisors.com
617-430-7576

Media
Cherilyn Cecchini, M.D.
LifeSci Communications
ccecchini@lifescicomms.com
646-876-5196

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Luxembourg to Start Real Life Testing of an International Standard for a Digital Circularity Fingerprint for Products27.11.2020 12:00:00 CETPress release

The Ministry of the Economy of Luxembourg just launched phase two of the development of an international standard. It provides information on the circularity of products to all stakeholders involved along their value chains. A first viable version of the standard is being tested in real life, allowing to identify the most suitable governance model, the audit scheme and reliable IT systems for its management. Luxembourg started the Circularity Dataset Initiative in 2018 to address the difficulty for industry and consumers to access reliable data on the circular properties of a product. A lot of circularity information is missing, as its generation and handling requires too many human and financial resources. Furthermore, trade secrets are hindering transparency and reporting standards are lacking, forcing manufacturers to send out different data sets in diverse formats to customers and product platforms. To tackle these challenges, the Luxembourg government is working with multinational

Chengdu Continues to Enhance Trade Links and Cultural Exchanges to Expand Circle of Friends Around the World27.11.2020 10:24:00 CETPress release

The Chengdu-Europe railway line spans over 10,000 kilometers across countless rivers and mountains, transporting goods to vast numbers of people across the Eurasian landmass. With increased trade, cultural links between Chengdu and Europe are also growing stronger. Against this backdrop, Chengdu-Eurasia National Pavilion Cluster (CENPC) has emerged in the Qingbaijiang District of Chengdu to further promote trade and cultural exchanges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201127005270/en/ Head of CENPC’s pavilion for France and the Netherlands Xu Dandan at work (Photo: Business Wire) CENPC is an important platform for trade exhibition and cultural exchange between countries along the Belt and Road. With trade promotion as a foundation, the project, which is expected to feature over 40 national pavilions, aims to deepen Sichuan’s global cooperation in fields such as culture, talent, education, and science and techno

Chengdu-Europe Railway Adds Momentum to Chengdu's Rise as an International Hub, Leading to Closer Cooperation Between Chengdu and Tilburg27.11.2020 10:14:00 CETPress release

Chengdu in China's Sichuan Province and Tilburg in The Netherlands, the two cities at the opposite ends of the Eurasian landmass, are now closely connected via an intercontinental railway that spans nearly 11,000 kilometers. In a recent interview with Xinhuanet, Roland Verbraak, general manager of GVT Group of Logistics - the Dutch partner of the Chengdu-Europe Railway, praised: "Not only are our relationships with Chinese partners getting closer, but the two cities of Chengdu and Tilburg have also become sister cities. Chengdu's international development is progressing well at a rapid pace." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201127005267/en/ Roland Verbraak, general manager of GVT Group of Logistics (Photo: Business Wire) Goods shuttling along the Chengdu-Europe Railway line have not only spurred economic growth in China and The Netherlands but also deepened links between Chengdu and places along the route, add

REPLY: Reply enters into eSports27.11.2020 09:00:00 CETPress release

Reply, on the eve of Milan Games Week, announces its entry into eSports in collaboration with Totem eSports, a project born in 2019 that spent the year battling its way through the most competitive titles of the main ESL circuits, which for the 2021 season will be renamed Reply Totem eSports. The Reply Totem eSports team, thanks to the experience gained by its young talents at national and international level, will compete in the next season in the ESL EVC circuits on the mobile titles including Clash Royale, Brawl Stars and on a series of other titles, ranging from sports such as FIFA to FPS and strategic cards. Reply's entry into eSports is part of a wider range of initiatives aimed at supporting young technology enthusiasts. With this collaboration, Reply, which already operates in the gaming sector with Game Studio and B2B initiatives, enters a market in continuous growth, that symbolizes the impact of digitalization in all sectors. Filippo Rizzante, Reply's CTO, commented: "The eS

Vertex Announces European Commission Approval for SYMKEVI ® (tezacaftor/ivacaftor) With KALYDECO ® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years27.11.2020 09:00:00 CETPress release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension for SYMKEVI® (tezacaftor/ivacaftor) with KALYDECO® (ivacaftor), to include the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T. “With this approval, children with CF in Europe ages 6 to 11 years with the most common mutation, F508del, have a new treatment option and children with certain residual function mutations will, for the first time, have a treatment option available that addresses the underlying cause of their CF,” said Reshma Kewalramani, M.D., Chief Executive O

Thales to Deliver the World’s First Fully Integrated Unmanned Mine Countermeasures System for the Royal Navy and French “Marine Nationale”26.11.2020 20:55:00 CETPress release

Following the first phase of the program in which two demonstrators have successfully proven their operational performances at sea, France and the United Kingdom marked the tenth anniversary of the Lancaster House treaties by signing a joint contract for Thales to start the production phase of MMCM to deliver eight unmanned mine hunting systems (four for France and four for the United Kingdom). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005783/en/ MMCM system at sea ©Thales With the threat of mines and improvised explosive devices present in all conflicts involving naval forces, countries need to strengthen the protection of their maritime domain, to ensure the protection of their assets and to safeguard the freedom of civil navigation. At the same time, it is essential to limit human exposure to mines. With 50 years of expertise serving navies around the world, Thales develops technologies that enable the transiti