The Pharmaceutical company Vifor Pharma has acquired the Mallorcan company, Sanifit Therapeutics, which is a clinical-phase cardio-renal biopharmaceutical firm that focusses on treatments for progressive vascular calcification disorders.
Vifor says it will continue with the development and commercialisation of SNF472, a novel inhibitor of vascular calcification for the treatment of calcifying uremic arteriolopathy and peripheral arterial disease in patients with end-stage renal disease. At the moment there are no drugs approved specifically for these patients.
Under the terms of the acquisition agreement, Vifor Pharma will acquire 100% of the shares of Sanifit Therapeutics and in return it will receive all the global rights to SNF472, thus enhancing its portfolio of innovative assets. The US Food & Drug Administration has already designated SNF472 as an orphan drug for the treatment of AUC and PAD, and the European Medicines Agency has done so for the AUC.
Sanifit's shareholders will receive an initial payment of 205 million euros, additional subsequent payments of up to 170 million euros linked to the achievement of certain clinical, regulatory and market access milestones and successive payments for staggered milestones over time.
"Through the acquisition of Sanifit and its main compound SNF472, we will expand our growing portfolio of nephrological products for vascular calcification, one of the leading causes of morbidity and mortality in patients with end-stage renal disease," said Vifor Pharma Group CEO, Abbas Hussain.
SNF472 is the only novel asset that addresses the medical need for patients with end-stage renal disease with calcified uremic arteriolopathy and peripheral arterial disease.
“We look forward to bringing this innovative and highly promising treatment option to more than 330,000 patients who are living with CUA or PAD in the US and Europe,” said Sanifit’s Executive Director, Joan Perelló. “From the beginning, Sanifit has pioneered new approaches to treating calcification disorders, an area of enormous unmet medical needs. 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 recognised commitment to patient-centred cardio-renal therapies. Vifor Pharma is the ideal partner to carry out the development of the Sanifit calcification franchise and to bring these new treatments to patients as soon as possible.”
"We are very proud to have supported this project at the beginning and through all its stages; a clear sign that there are many business projects with great potential in Spain and that with an adequate investment proposal it is possible to generate a high impact on society,” added Pablo Cironi, Head of Caixa Capital Risc's Pharma & Biotech.
“We are very proud to have supported Sanifit in its evolution and to see it become a success story that will undoubtedly serve as inspiration for other Spanish companies,” said Joël Jean-Mairet, Managing Partner of Ysios Capital. “Sanifit has managed to bring together an exceptional team with a pioneering scientific project, supported by top international investors, and with the potential to transform the lives of patients and society in general.”
"This transaction is a clear demonstration of the level of maturity that companies, entrepreneurs and investors in the Biotechnology Sector in Spain are reaching,” stated José Antonio Mesa, Alta Life Sciences Partner.
“The Sanifit team has managed to carry out a research project from the basic research of the University of the Balearic Islands to the last clinical phases of a medicine for diseases in which there are currently no effective treatments, something unthinkable years ago in Spain,” said Damià Tormo, Managing Partner of Columbus Venture Partners.
Medicine Sanifit conducted a phase IIb trial (CaLIPSO) to evaluate the effect of SNF472 on slowing arterial calcification, a major risk factor for cardiovascular disease in dialysis patients. The trial met its primary goal of reducing the progression of calcium in the coronary arteries in patients treated with SNF472, compared with those receiving placebo over a 52-week period.
SNF472 is currently in phase III trials at AUC in dialysis patients, to measure the primary assessment criteria for wound and pain healing and a phase III trial in patients on dialysis with PAD is scheduled to begin in 2022.
The closing of the acquisition is subject to the usual closing conditions, including the procedure for foreign direct investment in Spain and the presentation of the merger in certain countries, which is expected to take place in the first quarter of 2022.