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Vifor Pharma to acquire Sanifit To further away to reinforce latitudee-course pipeline in nephrology

• Vifor Pharma will acquire Sanifit, a clinical stage cardio-renal biopharmaceutical company specializing in the treatment of progressive disorders of vascular calcification, complementing and strengthening the Group’s growing nephrology portfolio

• Sanifit’s Composed of lead, SNF472 is a novel, first-order inhibitor of vascular calcification in phase 3, developed for the treatment of calcifying uremic arteriopathy (AUC) and peripheral artery disease (PAD) among the sick with end-stage renal disease

• Purchase price includes upfront payment of EUR 205 million, pre-commercial milestones up to 170 million euros and progressive business milestones

St. Gallen, Switzerland, and Palma, Spain, 22 November 2021 – Vifor Pharma and Sanifit Therapeutics, a clinical-stage cardio-renal biopharmaceutical company specializing in the treatment of progressive vascular calcification disorders, today announced the signing of a definitive agreement. Vifor Pharma will acquire Sanifit, for the further development and commercialization of SNF472, a new first-class inhibitor of vascular calcification for the treatment of AUC and PAD in patients with end-stage renal disease. There are currently no approved drugs indicated for AUC or PAD specifically in this population. SNF472 has already obtained orphan drug designation for the treatment of AUC and PAD by the United States Food and Drug Administration and for AUC by the European Medicines Agency.

Under the terms of the acquisition agreement, Vifor Pharma will acquire 100% of the outstanding shares of Sanifit Therapeutics, receiving full worldwide rights for SNF472, further enhancing the company’s portfolio of innovative assets. Sanifit shareholders will receive up-front payment of 205 million euros, clinical, regulatory and market access milestones of up to 170 million euros and staggered sales-based milestones that could reach millions of euros medium to high triple digits at peak sales.

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“Today’s exciting announcement helps us develop our strong nephrology pipeline to help end-stage kidney disease patients around the world,” commented Abbas Hussain, CEO of Vifor Pharma Group. “With the acquisition of Sanifit and its lead compound SNF472, we will extend our growing nephrology pipeline to include vascular calcification, a major cause of morbidity and mortality in patients with end-stage renal disease. SNF472 is the only new active ingredient to meet a large unmet medical need for patients with end-stage renal disease suffering from calcified uremic arteriolopathy and peripheral arterial disease. We look forward to bringing this innovative and highly promising treatment option to over 330,000 patients in the United States and Europe living with AUC or PAD as soon as possible. “

Joan Perelló, Ph.D., CEO of Sanifit, said; “From the very beginning, Sanifit has pioneered new approaches to treating calcification disorders, a vast area of ​​unmet need. This agreement is a testament to the enduring commitment of our team and dedicated investors, as well as our unique approach to combating vascular calcification, which originated from the University of the Balearic Islands. We are delighted to join forces with Vifor Pharma, which has a world-renowned commitment to patient-centered cardio-renal therapies. Vifor Pharma is the ideal partner to advance the development of the Sanifit calcification franchise and bring these new treatments to patients as quickly as possible.

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

The closing of the transaction is subject to customary closing conditions, including the FDI procedure in Spain and merger files in certain countries, and is expected to take place in the first quarter of 2022.

Contacts and additional information:

Sanifit:
Joan Perello, CEO
[email protected]

For media inquiries:
Strategic Communication Consilium
Amber Fennell, Chris Welsh, Davide Salvi
[email protected]

On Vifor Pharmaceutical group
The 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 pharmaceuticals and innovative patient-centric solutions. The Vifor Pharma Group strives to help patients around the world with severe and chronic illnesses lead better and healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. The Vifor Pharma Group occupies a leading position in all its main activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). The Vifor Pharma group is headquartered in Switzerland and is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viveorpharma.com.

On Sanifit Therapeutic
Sanifit is a clinical-stage biopharmaceutical company specializing in the treatment of vascular calcification disorders. The company is a spin-off of the University of the Balearic Islands and has offices in Spain and the United States. Sanifit’s principal active ingredient, SNF472, has successfully completed a Phase 2 proof of concept study in calciphylaxis and has shown a significant reduction in the progression of coronary artery 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 (PAD) in patients with end-stage renal disease as a second indication for SNF472. In 2015 and 2019, Sanifit announced the largest private biotechnology fundraisers in Spain and was supported by a variety of health-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 Center for the Development of Industrial Technology (“CDTI”) of the Spanish government. Sanifit is headquartered in Palma, Spain.

About SNF472
SNF472 is a selective calcification inhibitor administered intravenously, developed by Sanifit as a potential treatment for peripheral arterial disease (PAD) and calcified uremic arteriopathy (AUC) in hemodialysis, two rare diseases linked to progressive cardiovascular calcification. (CVC).

About AUC
Calcifying uremic arteriopathy, also known as calciphylaxis (AUC), is a rare but potentially devastating condition most commonly seen in patients with end-stage renal disease (ESRD), although it occasionally develops in patients without renal impairment. Calciphylaxis is a severe form of CVC in which calcium deposits block small blood vessels in the skin and fatty tissue. These blockages cause the development of chronic, intensely painful and debilitating 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) in end-stage renal disease (ESKD) affects patients who are dependent on ongoing renal replacement therapy, most commonly hemodialysis. PAD causes reduced mobility in patients, pain in the lower limbs, and can lead to chronic ischemia and limb-threatening amputation. PAD is a marker of vascular calcification – a major cause of death in patients on dialysis.