- Vifor Pharma to acquire Sanifit, a clinical-stage cardio-renal biopharmaceutical company focused on treatments for progressive vascular calcification disorders, complementing and reinforcing the Group’s growing nephrology portfolio
- Sanifit, based in Palma (Spain), has been backed by international funds including the Spanish funds Caixa Capital Risc, Ysios Capital, Alta Life Sciences, Columbus Venture Partners, Healthequity as well as Innvierte of the CDTI
- Sanifit’s lead compound, SNF472, is a novel Phase 3 vascular calcification inhibitor developed for the treatment of calcifying uremic arteriolopathy (CUA) and peripheral arterial disease (PAD) in patients with end-stage renal disease.
- The purchase price includes an upfront payment of EUR 205 million, pre-commercial milestone payments up to a maximum of EUR 170 million and further payments based on certain commercial milestones
St. Gallen, Switzerland, and Palma, Spain, November 22, 2021 – Vifor Pharma and Sanifit Therapeutics, a clinical-stage cardio-renal biopharmaceutical company focused on treatments for progressive vascular calcification disorders, announced today that they have entered into a definitive agreement. Vifor Pharma will acquire Sanifit, to continue the development and commercialization of SNF472, a novel, first-in-class vascular calcification inhibitor for the treatment of UC and PAD in patients with end-stage renal disease. There is currently no drug approved for UC or PAD specifically for these patients. The U.S. Food and Drug Administration (FDA) has already designated SNF472 as an orphan drug for the treatment of UC and PAD, and the European Medicines Agency has done so for UC.
Under the terms of the acquisition agreement, Vifor Pharma will acquire 100% of the shares of Sanifit Therapeutics and will receive in return all global rights to SNF472, thereby enhancing its portfolio of innovative assets. Sanifit shareholders will receive an upfront payment of €205 million and subsequent additional payments of up to €170 million linked to the achievement of certain clinical, regulatory and market access milestones, as well as successive milestone payments staggered over time that could reach high triple-digit million euro amounts if sales reach the expected peak.
“Today’s announcement helps us build on our strong portfolio of nephrology products to help patients with end-stage renal disease around the world,” commented Abbas Hussain, CEO of Vifor Pharma Group. “Through the acquisition of Sanifit and its lead compound SNF472, we will expand our growing portfolio of nephrology products for vascular calcification, a leading cause of morbidity and mortality in patients with end-stage renal disease. SNF472 is the only novel asset that addresses a major unmet medical need for end-stage renal disease patients with calcific uremic arteriolopathy and peripheral arterial disease. We look forward to bringing this innovative and highly promising treatment option to more than 330,000 patients in the U.S. and Europe living with UC or PAD as soon as possible.”
Joan Perelló, PhD, CEO of Sanifit comments, “From the beginning, Sanifit has pioneered new approaches to treat calcification disorders, an area of enormous unmet medical need. This agreement is a testament to the continued commitment of our team and our investors, as well as our unique approach to combating vascular calcification, which originated at the University of the Balearic Islands. We are delighted to join forces with Vifor Pharma and its globally recognized commitment to patient-centered cardio-renal therapies. Vifor Pharma is the ideal partner to take forward the development of the Sanifit calcification franchise and bring these novel treatments to patients as quickly as possible.
Pablo Cironi, head of the Pharma & Biotech investment area of Caixa Capital Risc, emphasizes “the importance of supporting and accompanying projects with a direct impact on people’s health and we are very proud to have supported this project from the beginning and in all its stages, a clear example that there are many business projects with great potential in Spain and that with an appropriate investment proposal it can generate a high impact on society”.
Joël Jean-Mairet, Managing Partner of Ysios Capital comments: “We are very proud to have supported Sanifit in its evolution and to see that it has become a success story that will undoubtedly serve as an inspiration for other early-stage Spanish companies. Sanifit has managed to bring together an exceptional team with a pioneering scientific project, backed by top international investors, and with the potential to transform the lives of patients and society in general”.
Jose Antonio Mesa, partner of Alta Life Sciences also highlights “This transaction is a clear demonstration of the level of maturity that companies, entrepreneurs and investors are reaching in the biotechnology sector in Spain”.
Damià Tormo, Managing Partner of Columbus Venture Partners: “The Sanifit team has managed to take a research project from basic research at the University of the Balearic Islands to the final clinical phases of a drug for diseases for which there are currently no effective treatments, something unthinkable years ago in Spain”.
Sanifit conducted a Phase IIb trial (CaLIPSO) to evaluate the effect of SNF472 in slowing arterial calcification, a major risk factor for cardiovascular disease in dialysis patients. The trial met its primary endpoint of reducing coronary artery calcium progression in patients treated with SNF472 compared to those receiving placebo over a 52-week period. SNF472 is currently in Phase III trials in CUA in dialysis patients to measure the primary endpoints of wound healing and pain. A Phase III trial in dialysis patients with PAD is scheduled to begin in 2022.
The closing of the transaction is subject to customary closing conditions, including the procedure for foreign direct investment in Spain and the filing of the merger in certain countries, and is expected to take place in the first quarter of 2022.
Contact
Sanifit:
Joan Perelló, CEO
Investor.Relations@sanifit.com
For Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Chris Welsh, Davide Salvi
sanifit@consilum-comms.com
About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceutical company. It aims to become the world leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for innovative patient-centric pharmaceutical products and solutions. Vifor Pharma Group strives to help patients around the world with serious and chronic diseases lead better and healthier lives. The company develops, manufactures and markets pharmaceutical products for precise patient care. The Vifor Pharma Group holds a leading position in all its core activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint venture 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, visit viforpharma.com.
About Sanifit Therapeutics
Sanifit is a clinical-stage biopharmaceutical company focused on treatments for vascular calcification disorders. Sanifit’s lead asset, SNF472, successfully completed a Phase 2 proof-of-concept study in calciphylaxis, and showed a significant reduction in the progression of coronary calcification in a Phase 2b study in hemodialysis patients. A pivotal Phase 3 study in calciphylaxis is currently underway and the company is also pursuing peripheral arterial disease in patients with end-stage renal disease as a second indication for SNF472. In 2015 and 2019, Sanifit announced the largest private fundraising in biotech in Spain and has been backed by a variety of healthcare-focused investors including: Caixa Capital Risc, Ysios Capital, Lundbeckfonden Ventures, Forbion Capital Partners, Gilde Healthcare, Andera Partners, Columbus Venture Partners, Alta Life Sciences, Baxter Ventures, HealthEquity and INNVIERTE ECONOMÍA SOSTENIBLE, a venture capital fund managed by the Spanish Government’s Centro para el Desarrollo Tecnológico Industrial (“CDTI”). Sanifit is based in Palma, Spain.
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 CUA
Calcific uremic arteriolopathy, also known as Calciphylaxis, is a rare but potentially devastating disease most commonly seen in patients with end-stage renal disease, although it occasionally develops in patients without renal failure. Calciphylaxis is a severe form of CVC in which calcium deposits block small blood vessels in the skin and fatty tissue. These blockages lead to the development of intensely painful and debilitating chronic skin lesions. Calciphylaxis is a rare and devastating disease that affects 1-4% of dialysis patients and has a one-year mortality rate of 55%.
About PAD
Peripheral artery disease in end-stage renal disease affects patients who are dependent on continued renal replacement therapy, usually hemodialysis. PAD causes patients to have reduced mobility, pain in the lower extremities and can lead to chronic limb-threatening ischemia and amputation. PAD is a marker of vascular calcification, a leading cause of death among dialysis patients.