Financing will advance Sanifit’s lead drug candidate through the end of phase IIb as a treatment for cardiovascular diseases linked to calcification and through phase II/III for calciphylaxis
Naarden, The Netherlands, 8 September 2015 – Forbion Capital Partners (“Forbion”), one of the leading Dutch Venture Capital firms investing in world-class healthcare technologies, announces its investment in Laboratoris Sanifit S.L. (“Sanifit”), a Spanish clinical-stage biopharmaceutical company, as part of Sanifit’s €36.6M ($41M) Series C financing round.
Sanifit is focused on the development of SNF472, an experimental drug for the treatment of cardiovascular diseases linked to calcification in patients with End Stage Renal Disease (ESRD) undergoing haemodialysis.
Forbion invested alongside a substantial syndicate of investors, led by Ysios Capital, and including Lundbeckfond Ventures, Gilde Healthcare, Edmond de Rothschild Investment Partners, “la Caixa” and Baxter Healthcare. Existing shareholders also supported the series C round.
This round of fundraising will enable Sanifit to advance its lead drug candidate, SNF472, through phase IIb proof of concept for the treatment for cardiovascular diseases linked to calcification in ESRD and to complete phase II/III for calciphylaxis.
ESRD patients treated with dialysis experience higher rates of serious cardiovascular adverse events and mortality as a consequence of an accelerated progression of cardiovascular calcification. Half of the mortality in dialysis patients is from cardiovascular complications. Calciphylaxis is the most severe form of cardiovascular calcification. It is a devastating rare disease that affects up to 4% of dialysis patients and has an overall mortality rate of about 80%. There are approximately 2.5 million dialysis patients worldwide with no effective treatment for this medical condition. ESRD represents a market opportunity of over €2Bn ($2.25Bn).
SNF472 has shown significant efficacy data in more than 20 preclinical studies. It has also shown excellent safety and tolerability in a phase Ia clinical trial in healthy volunteers. SNF472 is currently concluding a phase Ib/IIa pharmacology study in haemodialysis patients.
Sanifit has also announced the appointment of Dr Russell Greig as Chairman of the Board of Directors. Russell worked at GSK for nearly three decades, most recently as president of SR One, GSK's Corporate Venture Group. Prior to joining SR One, he served as president of GSK's Pharmaceuticals International and was on the corporate executive team from 2003 to 2008.
Geert-Jan Mulder MD, General Partner at Forbion commented: “It was a pleasure to work closely together with Sanifit’s management and with this syndicate of some of Europe’s most prominent VCs, resulting in this substantial financing round in Spain. Sanifit’s SNF472 is a first-in-class drug, with a unique mechanism of action, which could potentially transform the lives of dialysis patients suffering from cardiovascular complications due to calcification.”
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Forbion Capital Partners
Forbion Capital Partners is a dedicated Life Sciences venture capital firm with offices in Naarden, The Netherlands, Munich, Germany and representation in Boston, US. Forbion invests in life sciences companies in drug discovery & development as well as medical device companies addressing substantial unmet medical needs. Forbion’s investment team of ten investment professionals has built an impressive performance track record since the late nineties with successful investments in Rhein Biotech, Crucell, Neutec, Glycart, Borean, Impella, Alantos, Acorda (ACOR), Fovea, Insmed (INSM), PanGenetics, Argenta Discovery, BioVex, Pathway Medical, CircuLite, bluebird bio (BLUE), uniQure (QURE), Argos (ARGS), arGEN-X (ARGX.BR), Santaris, PneumRx, AM-Pharma and Promedior. Forbion also operates a joint venture with BioGeneration Ventures, who manages two separate seed and early stage funds focused on Benelux. Including the new fund FCF III, Forbion manages EUR 540M across 5 funds. Its investors include the EIF through its European Recovery Programme (ERP), LfA and Dutch Venture Initiative (DVI) facilities and the KFW through the ERP - Venture Capital Fondsfinanzierung facility.
For more information, please visit www.forbion.com.
Sanifit is a biopharmaceutical company focused on the development of SNF472, an experimental drug for the treatment of cardiovascular diseases linked to calcification in the End Stage Renal Disease population undergoing haemodialysis. The company, founded in 2007 as a spin-off of the University of the Balearic Islands, completed phase 1a studies with healthy volunteers in 2014. It is currently concluding a phase Ib/IIa study in haemodialysis patients. After a recent series C funding round of $41M (€36.6M), Sanifit will start a phase IIb study in ESRD and extend the orphan program in calciphylaxis into phase 2-3 clinical trials. www.sanifit.com
About End Stage Renal Disease (ESRD)
Renal disease leads to a progressive loss of kidney function. In its last phase, called End Stage Renal Disease (ESRD), kidney failure is permanent and irreversible. The patient requires renal replacement therapy through dialysis or a renal transplant. The etiology of ESRD is heterogeneous but the main causes of renal failure are diabetes and hypertension. There are more than three million ESRD patients worldwide; around 70% of them are treated with dialysis (2.5 million). ESRD patients suffer from accelerated cardiovascular calcification, which correlates with higher cardiovascular risk. The annual death rate in ESRD ranges from 20-30% and the annual cardiovascular event rate is around 20%. Half of the deaths in dialysis are due to cardiovascular mortality. Currently, no drugs are approved for this condition; patients are treated with calcimimetics and phosphate binders to control related risk factors such as hypercalcaemia and hyperphosphataemia. A therapy to directly treat cardiovascular disease in ESRD and reduce cardiovascular events rate would be a first-in-class drug which would fulfil an unmet medical need with a market potential over €2Bn ($2.25Bn).
Calcific Uremic Arteriolopathy (CUA), also called calciphylaxis, is a devastating rare disease, which affects up to 4% of dialysis patients. It starts with a calcification of small peripheral vessels that quickly becomes enlarged. This represents the most severe form of cardiovascular calcification in dialysis patients. The natural course of the disease leads to painful necrotic skin ulcers as a consequence of the vessel calcification process, with a one -year mortality rate of 55% and an overall mortality of about 80%. There are no therapies approved for this indication. Patients are usually treated with intensive care, including aggressive wound management and off-label therapies. Calciphylaxis is a dramatic life-threatening condition which urgently requires new and effective treatments.
SNF472 is an intravenous formulation with a novel mechanism of action for haemodialysis patients with cardiovascular diseases linked to calcification. SNF472 is being developed for two indications: reduction of cardiovascular events in dialysis patients and for the treatment of calciphylaxis. SNF472 has orphan drug status for the treatment of calciphylaxis from both the EMA and FDA. SNF472 selectively blocks the pathological cardiovascular calcification progression and poses an innovative solution for these unmet medical needs. The intravenous route is promising for dialysis patients as it assures 100% compliance.
Issued for and on behalf of Forbion by Instinctif Partners.
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Melanie Toyne-SewellManaging Partner