ST GALLEN, SWITZERLA--(뉴스와이어)--Regulatory News:

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.

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