Business Wire

Vifor Pharma to spearhead development of vascular calcification field, through acquisition of Sanifit Therapeutics and Inositec AG

Share

Regulatory News:

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

Vifor Pharma has announced the acquisition of Sanifit Therapeutics, a Spanish clinical-stage cardio-renal biopharmaceutical company focused on treatments for end-stage kidney disease patients with progressive vascular calcification disorders, and Inositec AG, a Swiss company, developing first-in-class non-dialysis treatments for soft tissue and vascular calcification disorders. Through these acquisitions, Vifor Pharma will be able to serve a continuum of vascular calcification disorders at all stages of CKD.

Acquisition of Sanifit is for the continued clinical development and commercialization of SNF472, a novel, first-in-class intravenously administered inhibitor of vascular calcification, for the treatment of CUA and PAD in patients with end-stage kidney disease. There are currently no approved medicines indicated for CUA or for PAD specifically in this population. SNF472 has already been granted orphan drug designation for the treatment of CUA and PAD by the US Food and Drug Administration and for CUA by the European Medicines Agency.

Inositec’s novel asset INS-3001, is a once-daily subcutaneous treatment for patients with vascular calcification disorders PAD and AVS, which are both major contributors to cardiovascular morbidity and mortality in affected patient populations. With INS-3001 daily subcutaneous dosing, patients with earlier stages of vascular calcification can be optimally treated, while end-stage kidney disease patients will benefit from the three times per week dosing regimen of SNF472.

“We are gaining momentum with our ambitious strategic growth plans as we today add Sanifit, Inositec and their promising assets to our strong nephrology portfolio”, commented Abbas Hussain, Chief Executive Officer of Vifor Pharma. “These acquisitions are a perfect fit for our expanding nephrology pipeline, which now includes vascular calcification inhibition treatments across various stages of non-dialysis CKD and even non-CKD patient populations. Vifor Pharma will be spearheading the vascular calcification field, emphasizing our strategic focus to bring innovative assets to patients with high unmet medical need as we strive to improve lives of people suffering from serious diseases around the world.”

Under the terms of the acquisition agreement, Vifor Pharma will acquire 100% of the outstanding shares in Sanifit Therapeutics, receiving full global rights for SNF472, further enhancing the company’s portfolio of innovative assets. Shareholders of Sanifit will receive an upfront payment of EUR 205 million, clinical, regulatory and market access milestones for up to EUR 170 million and tiered sales-based milestones that could reach mid to high triple digit EUR millions at peak sales. Vifor Pharma will acquire 100% of the shares in Inositec AG, receiving full global rights for the lead asset INS-3001. Inositec will receive an upfront payment of CHF 20 million and be eligible for success based clinical earn-out payments in the low triple digit million range.

Joan Perelló, Ph.D., Chief Executive Officer of Sanifit, said; “From the very beginning, Sanifit has been a pioneer of new approaches to treat calcification disorders, a huge area of unmet need. This agreement is a testament to the enduring commitment of our dedicated team and investors, as well as our unique approach to combat vascular calcification, which originated from the University of the Balearic Islands. We are excited to join forces with Vifor Pharma, which has a world-renowned commitment to patient focused cardio-renal therapies. Vifor Pharma is the ideal partner to take the development of Sanifit’s calcification franchise forward and bring these novel treatments to patients as quickly as possible.”

“This acquisition builds on years of hard work from the entire Inositec team and provides a strong foundation for improving outcomes for patients suffering from cardiovascular and vascular calcification disorders,” said Mattias Ivarsson, Founder and Chief Executive Officer of Inositec, adding “Inositec’s transition to a clinical-stage company represents an ideal time to partner with Vifor Pharma to accelerate the clinical development of INS-3001.”

Sanifit conducted a phase-IIb trial (CaLIPSO) in 274 patients to assess the effect of SNF472 on slowing arterial calcification, a major risk factor for cardiovascular disease in dialysis patients. The trial met its primary endpoint in reducing coronary artery calcium progression in patients treated with SNF472, compared to patients receiving placebo over a 52-week period. SNF472 is currently in phase-III trials in CUA in patients on dialysis, to measure primary endpoints for wound healing and pain. A phase-III trial in PAD in patients on dialysis, is planned to commence in 2022.

Inositec’s lead vascular calcification inhibitor, INS-3001, is being developed to treat indications of high unmet medical need and has obtained approval for its phase-I trial, with the first healthy volunteer to be dosed on November 30, 2021. If successful, the plan is to initiate two phase-II programs in 2023, one in non-dialysis CKD patients suffering from PAD, and a separate trial in patients suffering from AVS, a serious condition whereby the aortic valves calcify to the extent that surgical intervention is the only available option.

The expected addressable patient population in the U.S. and EU suffering from calcifying non-dialysis and dialysis-associated PAD is estimated to be over 600,000. CUA is an ultra-orphan disease with approximately 10,000 patients across the US and EU. For AVS we are estimating approximately 1.1 million patients in the two geographies eligible to receive treatment.

Closing of both transactions is contingent on customary closing conditions, including for the Sanifit transaction a potential Foreign Direct Investments (FDI) procedure in Spain and a merger filing in the United States. Closing of the Sanifit transaction is expected to take place in Q1 2022 whereas closing of the Inositec transaction is expected to occur still in Q4 2021.

Live conference call and webcast

A live webcast and conference call will be held on 22 November 2021 at 3:30 pm CET.

Access to live webcast → link

Pin code and phone numbers for the live conference call:

Pin code: 3537174

Country

Phone number

Switzerland

+41 31 580 0059

France

+33 17 670 0794

Germany

+49 692 443 7351

United Kingdom

+44 207 192 8000

United States of America

+1 631 510 7495

Other countries

+44 207 192 8000

Replay

A webcast replay (link) will be available shortly after the end of the live conference.

About Vifor Pharma Group

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 viforpharma.com.

About SNF472

SNF472 is an intravenously administered selective calcification inhibitor, developed by Sanifit as a potential treatment for peripheral artery disease (PAD) and calcific uremic arteriolopathy (CUA) in hemodialysis, both rare diseases related to progressive cardiovascular calcification (CVC).

About INS-3001

INS-3001 is a subcutaneously applied calcification inhibitor based on the natural compound inositol hexaphosphate (IP6). In preclinical studies, INS-3001 was found to display superior efficacy, and more favorable pharmacokinetic and tolerability profiles than IP6 itself. The scientific foundations supporting the role of INS-3001 in several potential therapeutic indications has been rigorously validated in a variety of preclinical calcification models and safety studies. INS-3001 is entering Phase-I testing.

About CUA

Calcific uremic arteriolopathy also known as Calciphylaxis (CUA), is a rare but potentially devastating condition most often observed in patients with end-stage renal disease (ESRD), although it does occasionally develop in patients without renal failure. Calciphylaxis is a severe form of CVC in which the calcium deposits block small blood vessels in skin and fat tissue. These blockages cause the development of intensely painful and debilitating chronic skin lesions. Calciphylaxis is a devastating rare disease that affects 1-4% of dialysis patients and has a 1-year mortality rate of 55%.

About PAD

Peripheral artery disease (PAD) is a progressive vascular calcific disorder particularly common in chronic kidney disease patients and characterized by stenosis of arteries in the lower extremities causing reduced blood flow to the legs. Patients present with recurrent fatigue or pain that is known as intermittent claudication, which causes a poor quality of life. Progressive PAD requires vascular surgery to reduce the risk for limb amputation.

About AVS

Aortic Valve Stenosis (AVS) is a progressive deterioration of the aortic valve, which can only be treated by implantation of a new valve. AVS occurs when the orifice of the aortic valve is significantly reduced due to calcification. This causes an effective increase in afterload, left ventricular hypertrophy and, eventually, symptoms of congestive heart failure.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

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

About Business Wire

Business Wire
Business Wire



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

NTHU: A Model of Sustainability2.12.2021 11:00:00 CET | Press release

National Tsing Hua University (NTHU) was awarded the Taiwan University Sustainability Award at the 14th Taiwan Corporate Sustainability Awards (TCSA) held by the Taiwan Institute for Sustainable Energy (TAISE) on November 17. Standing out amongst the 38 participating universities, NTHU was ranked first in the comprehensive evaluation, and in the individual competitions also received the Social Inclusion Leadership Award and the University Sustainability Report Gold Award. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211202005031/en/ National Tsing Hua University was awarded the Taiwan University Sustainability Award. President Hocheng Hong (center) and Chief Sustainability Officer Tai Nyan-hwa (second from the left), Sustainability Office Director Lin Fu-ren (first from the left), Vice President and Chief of Staff King Chung-Ta (second from the right), Dean of International College Doong Ruey-an (first from the right). (Ph

Honor to Knight! DRAG S/X PnP-X Kit Is Launched2.12.2021 10:35:00 CET | Press release

In November, VOOPOO announced the overseas launch of the DRAG S/X PnP-X KIT. The product carries out comprehensive technical upgrading on the basis of DRAG S/X, endows the core concept of "Chivalry" in product design, and pays tribute to the glory and virtue of knights. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211202005381/en/ (Photo: Business Wire) Originated from the spirit of martial arts of German in the Middle Ages, the spirit of chivalry was then embodied in soldiers of the European battlefield in the 11th century, and guards of emperors and warriors of Christ. Nowadays, chivalry is culturally continued and nobly expressed as gentleman demeanor. Despite passage of time, the only constant is the faith that knight loyally holds and eight virtues of knights flowing in their blood. After learning about this legendary medieval history and digging out the core of chivalry, VOOPOO design and R&D personnel were deeply to

Zilliant Announces Significant Growth in Europe2.12.2021 09:30:00 CET | Press release

Zilliant, the industry leader in intelligent B2B price optimization, price management and sales guidance software, today announced significant growth in Europe, marked by compound annual revenue growth of 55% from 2018-2021 as well as significant growth of new customers. “B2B company leaders are increasingly seeking alternatives to the traditional means of managing prices and enabling sales teams,” said Zilliant President and Chief Executive Officer Greg Peters. “Tying strategy to effective execution can be even more difficult for companies in Europe, particularly in global, multi-country businesses. Our growth in the region can be attributed to the increased breadth of our product portfolio, addressing the full spectrum of pricing challenges in B2B, and our passion for powering intelligent commerce for our customers.” Zilliant maintains offices in Paris, London, Milan, Italy, and Walldorf, Germany. In recent years, a wide variety of B2B companies in Europe with worldwide operations ha

Hopp Secures $2.8 Million Funding From Brunnur Ventures to Build a Global Sustainable Micromobility Sharing Franchise2.12.2021 09:27:00 CET | Press release

Hopp (www.hopp.bike),the sustainable electric scooter rental company, is pleased to announce an investment by Brunnur Ventures of $2.8 million into the company to drive international growth of its worldwide franchise strategy. Hopp is the sustainable transportation solution for the world’s modern city enabling riders to travel without leaving a carbon footprint. Hopp's primary mission is to leave behind a cleaner planet, one ride at a time, with all parts of the business carbon negative. Hopp is uniquely focused on smaller cities, local travel and smaller fleets – an almost untouched market as more than 95% of cities in Europe with less than 500,000 inhabitants are currently unserved. “Our goal is to influence the electric scooter market in the same way as McDonald’s for the hamburger,” commented CEO Eythór Steinarsson. “We want to bring this technology to smaller cities where there is a big opportunity and to get locals to work with us. We want to bring the sharing economy to the way

Bitcoin Capital Expands its Crypto Asset Offering2.12.2021 09:11:00 CET | Press release

Bitcoin Capital announced today that it has again listed two world firsts on the SIX Swiss Exchange. With 1 FiCAS Active Bitcoin ETP and 1 FiCAS Active Ethereum ETP, the company has launched two products actively managed by the highly experienced crypto asset manager FICAS AG. With active management, the products aim to counter negative price fluctuations and therefore outperform the two largest cryptocurrencies by capitalization. With the listing, institutional, professional, and private investors in Switzerland, Liechtenstein, and the European Union (excluding Hungary) can easily invest in the new products via their bank or broker, just as they do with other listed financial investments such as equities or bonds. "Our purpose is to grant investors safe and easy access to digital assets and are convinced that crypto assets will soon be part of the diversification strategy of many investment portfolios. The two new products with the most relevant cryptocurrencies as underlying may, thr

Ricardo Announces Approved Science-based Targets as We Advance Towards Net Zero2.12.2021 09:00:00 CET | Press release

Ricardo, a world-class environmental, engineering and strategic-consulting company, is pleased to announce that our proposed greenhouse gas emissions reduction targets have been approved by the Science Based Targets initiative (SBTi) and that they are in line with the goals set forth in the 2015 Paris Agreement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211202005044/en/ Ricardo is pleased to announce that proposed greenhouse gas emissions reduction targets have been approved by the Science Based Targets initiative (Graphic: Business Wire) The Science Based Targets initiative (SBTi) is a collaboration between the CDP, the United Nations Global Compact, World Resources Institute (WRI) and the World Wide Fund for Nature (WWF). We now join a growing group of global businesses that have received approval of their targets, ensuring that greenhouse gas emissions from Ricardo’s operations (scopes 1 and 2)1 are consistent with t

CSC Global Financial Markets Expands its Depositary Services in the Netherlands with New Licenses for UCITS; Alternative Funds License Broadened2.12.2021 09:00:00 CET | Press release

CSC, the world’s leading provider of business, legal, tax, and digital brand services, has secured extra depositary licenses from the Netherlands Authority Financial Markets (AFM). After being one of the first nonbank depositaries to receive a depositary license for real estate and infrastructure funds, CSC has now extended its license to include undertakings collective investment in transferable securities (UCITS) funds. In addition, CSC’s alternative funds license has been extended to include the following asset classes—financial instruments, private equity, private debt, and shipping. “We’re delighted that our depositary services now cover an extensive list of investment strategies in the Netherlands. The addition of UCITS funds license is a major milestone in the history of CSC in the Netherlands. The market response is extremely positive and we are already onboarding our first UCITS fund manager,” says Mascha Hartskeerl, head of depositary services for CSC Global Financial Markets

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom