Sanifit Therapeutics acquired by Vifor Pharma

Lundbeckfonden Ventures’ portfolio company Sanifit Therapeutics acquired by Vifor Pharma

Logo af Vifor Pharma og Sanifit

Lundbeckfonden Ventures today announced its portfolio company, Sanifit Therapeutics, to be acquired by Vifor Pharma. The acquisition further strengthens Vifor Pharma’s late-stage pipeline in nephrology
Copenhagen, 22 November 2021

Vifor Pharma is acquiring Sanifit Therapeutics , a clinical-stage cardio-renal biopharmaceutical company developing novel treatments for progressive vascular calcification disorders. Vifor Pharma will continue the development and commercialization of SNF472, a novel, first-in-class inhibitor of vascular calcification for the treatment of Calcific Uremic Arteriolopathy (CUA) and Peripheral Artery Disease (PAD) in patients with end-stage kidney disease.

There are currently no approved medicines indicated for CUA or for PAD specifically in the dialysis 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.

Sanifit previously completed a successful Phase IIb trial (CaLIPSO) to assess the effect of SNF472 on slowing arterial calcification, a major risk factor for cardiovascular disease in dialysis patients. 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.

 

“As one of the early investors in Sanifit Therapeutics we are very proud and pleased to see our portfolio company being acquired. Given their track record and their strong product portfolio and pipeline in nephrology, Vifor is perfectly placed to take Sanifit to the next stage, meeting the needs of dialysis patients with life threatening vascular calcification disorders and kidney disease all over the world,” said Mette Kirstine Agger, Managing Partner of Copenhagen based Lundbeckfonden Ventures at the Lundbeck Foundation.

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. 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.

Closing of the transaction is contingent on customary closing conditions, including the FDI procedure in Spain and merger filings in certain countries, and is expected to take place in Q1 2022.

About Lundbeckfonden Ventures

Lundbeckfonden Ventures is an evergreen venture capital fund that invests internationally in life science companies.

We add value to investments through our active involvement in the portfolios and highly engaged collaboration with managements and boards. Lundbeckfonden Ventures has particular expertise and interest in specialized pharmaceutical products and technology platforms, which have demonstrated their potential to generate drug candidates.

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).

About Sanifit Therapeutics

Sanifit is a clinical-stage biopharmaceutical company focused on treatments for vascular calcification disorders. The Company is a spin-off from the University of the Balearic Islands and has offices in Spain and the U.S. Sanifit’s lead asset, SNF472, successfully completed a Phase II proof of concept study in calciphylaxis and showed a significant reduction in progression of coronary calcification in a Phase IIb study in hemodialysis patients. A Phase III pivotal study in calciphylaxis is currently underway and the company is also pursuing peripheral arterial disease (PAD) in patients with end-stage kidney disease as a second indication for SNF472. In 2015 and 2019, Sanifit announced the largest private biotech fundraises in Spain and has been supported 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 Centre for the Development of Industrial Technology (“CDTI”) of the Spanish Government. Sanifit is headquartered 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 (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) in end-stage kidney disease (ESKD) affects patients who depend on ongoing renal replacement therapy, most commonly haemodialysis. PAD causes patients to reduce their mobility, have pain in lower extremities, and can lead to chronic limb threatening ischemia and amputation. PAD is a marker for vascular calcification - a major contributing cause of death among patients in dialysis.