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Vifor Pharma
Doubles Down on
Kidney Disease
with New Acquisitions
2021-11-22
·
BioSpace
孤儿药
First in Class
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©
Vifor Pharma
Switzerland-based Vifor Pharma is acquiring Spain’s
Sanifit Therapeutics
and Switzerland’s Inositec. In the first deal, Vifor picks up Sanifit’s
SNF472
, a novel, first-in-class inhibitor of vascular calcification. The drug is being developed to treat calcific uremic arteriolopathy (CUA) and
peripheral artery disease (PAD)
patients with
end-stage kidney disease
. No drug has been approved for these indications in this population. The drug has been granted orphan drug designation for both indications by the U.S. Food and Drug Administration (FDA) and CUA by the European Medicines Agency (EMA). Under the terms of the agreement, Vifor is buying all Sanifit’s outstanding shares. The company is paying 205 million euros upfront ($231 million U.S.) and 170 million euros ($192 million U.S.) in various milestones, as well as tiered sales-based milestones that could hit mid to high triple-digit euros at peak sales. “Today’s exciting announcement helps us to build on our strong nephrology pipeline to help
end-stage kidney disease
patients globally,” said Abbas Hussain, Vifor’s chief executive officer. “Through the acquisition of Sanifit and its lead compound
SNF472
, we will further expand our growing nephrology pipeline into vascular calcification, a major cause of morbidity and mortality in patients with
end-stage kidney disease
.” Hussain added, “
SNF472
is the only novel asset addressing a great unmet medical need for
end-stage kidney disease
patients with calcific uremic arteriolopathy and
peripheral artery disease
. We look forward to bringing this highly promising, innovative treatment option to 330,000 patients in the U.S. and Europe, living with CUA or
PAD
, as soon as possible.” Sanifit ran a Phase IIb CaLIPSO trial of
SNF472
in 274 patients. The study hit the primary endpoint, decreasing coronary artery calcium progression in patients who received the drug over a 52-week period. The drug is currently in Phase III trials in CUA in patients on dialysis. The primary endpoints are related to wound healing and
pain
. They expect to initiate a Phase III trial in
PAD
patients on dialysis in 2022. “From the very beginning, Sanifit has been a pioneer of new approaches to treat
calcification disorders
, a huge area of unmet need,” said Joan Perelló, Sanifit’s chief executive officer. “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
.” Vifor also announced today that it is acquiring Swiss-based
Inositec AG
as well.
Inositec
is developing first-in-class non-dialysis treatments for
soft tissue and vascular calcification disorders
.
Inositec
has a compound,
INS-3001
, a once-daily subcutaneous therapy for patients with
vascular calcification disorders PAD
and
aortic valve stenosis (AVS)
. The drug can help treat patients with early stages of vascular calcification, while the
SNF472
acquisition with Sanifit is focused on
end-stage kidney disease
treatments. “We are gaining moment with our ambitious strategic growth plans as we today add Sanifit,
Inositec
and their promising assets to our strong nephrology portfolio,” Hussain stated. Under the terms of the
Inositec
deal,
Vifor
is acquiring 100% of
Inositec
shares and paying 20 million in Swiss Francs (CHF) or $22.58 million (U.S.).
Inositec
will be eligible for clinical earn-out payments in the low triple-digit million range.
Inositec
has received the green light to initiate a Phase I trial of
INS-3001
, and the first healthy volunteer will be dosed on November 30, 2021. Mattias Ivarsson, founder and chief executive officer of
Inositec
, said, “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
.
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
.”
机构
Inositec AG
University of The Balearic Islands
Sanifit Therapeutics SA
[+2]
适应症
肾脏疾病
外周动脉闭塞性疾病
终末期肾脏病
[+6]
靶点
-
药物
植酸钠
INS-3001
标准版
¥
16800
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