Inositec gets acquired by Vifor Pharma to advance the vascular calcification field
22.11.2021
Vifor Pharma has announced the acquisition of two companies: Swiss-based Inositec and Spanish-based Sanifit Therapeutics. Inositec develops first-in-class non-dialysis treatments for soft tissue and vascular calcification disorders. Inositec was a Venture Kick winner in 2012, a Venture Leader in 2014, and one of the TOP 100 Swiss Startups from 2016 to 2019. Sanifit Therapeutics is a clinical-stage cardio-renal biopharmaceutical company focused on treatments for end-stage kidney disease patients with progressive vascular calcification disorders. Through these acquisitions, Vifor Pharma will be able to serve a continuum of vascular calcification disorders at all stages of CKD (chronic kidney disease).
 Mattias Ivarsson, founder and CEO of Inositec
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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.
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.
“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 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. 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.
“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. He added, “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.”
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.
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.”
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 52 weeks. 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.
The expected addressable patient population in the US 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 are eligible to receive treatment.
The 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.
Source: Vifor Phrama press release
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.
“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 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. 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.
“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. He added, “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.”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.
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.”
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 52 weeks. 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.
The expected addressable patient population in the US 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 are eligible to receive treatment.
The 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.
Source: Vifor Phrama press release