8 September 2015
Sanifit raises €36.6M ($41.3M) in Series C financing round
Financing will advance Sanifit’s lead drug candidate through phase IIb as a treatment for cardiovascular diseases linked to calcification and through phase II/III for calciphylaxis
Palma de Mallorca, Spain, September 8, 2015 – Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical company, today announces that it has raised €36.6M ($41.3M) in a Series C financing round. The company 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.
The investment was led by Ysios Capital and supported by a substantial syndicate of new investors including Lundbeckfond Ventures, Forbion Capital Partners, Gilde Healthcare, Edmond de Rothschild Investment Partners, “la Caixa” and Baxter Ventures. Existing shareholders also supported the series C round.
Sanifit also announces the appointment of Dr. Russell Greig as chairman of the board of directors. Dr. Greig 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.
This round of fundraising will enable Sanifit to advance its lead drug candidate, SNF472, through phase IIb proof of concept for the treatment of 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 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.
“We are delighted to have attracted such high profile investors to our company,” said Joan Perelló, CEO of Sanifit. “This funding will help SNF472 to address clear unmet medical needs and will help to change the lives of patients with cardiovascular complications in the field of dialysis.”
“We were excited to have the opportunity to participate in this financing,” said Joël Jean- Mairet, managing partner of Ysios Capital. “Sanifit is developing a first-in-class drug with a unique mechanism of action that can improve patient outcomes and positively impact patient lives. This is a pivotal moment to be investing in a company focused on a condition with such an attractive market opportunity.”
“This is an exciting and attractive opportunity to develop a new drug, SNF472, for two underserved and life threatening conditions, ESRD and calciphylaxis,” said Russell Greig, newly appointed chairman of Sanifit, “The company has already made significant progress and with the support of some of Europe’s top VC Funds, it is well positioned to make substantial and rapid progress in both these areas of pronounced unmet medical need.”
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 3 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 the rate of cardiovascular events 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 spreads. 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. The disease has 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.
Sanifit is a biopharmaceutical company focused on the development of SNF472. The company was founded in 2007 as a spin-off of the University of the Balearic Islands. SNF472 is an experimental drug for the treatment of cardiovascular diseases linked to calcification in the End Stage Renal Disease population undergoing haemodialysis. Sanifit has 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 $41.3M (€36.6M), Sanifit will start a phase IIb study in ESRD and extend the orphan program in calciphylaxis into phase II/III clinical trials. For me information please visit www.sanifit.com
About Ysios Capital
Ysios Capital is a leading Spanish venture capital firm that provides private equity financing to early and mid-stage human healthcare and life science companies with a special focus on pharmaceuticals, diagnostics and medical devices. Founded in 2008, Ysios Capital has currently over €125M ($140M) in assets under management, distributed over two funds. The second fund has a target size of €100M ($113M). It will remain open to new investors until the end of 2015. For me information please visit www.ysioscapital.com
About Lundbeckfond Ventures
Lundbeckfond Ventures is an evergreen life science venture fund established in the autumn of 2009 and wholly owned by the Lundbeck Foundation. The structure as an evergreen fund allows flexibility in the investment approach and the possibility, when appropriate, to take a long-term perspective in the investments. On an annual basis Lundbeckfond Ventures invests up to € 50 million. For me information please visit www.lundbeckfondventures.com
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, drug discovery & development and 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 and AM-Pharma. 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 €540M ($608M) 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
About Gilde Healthcare
Gilde Healthcare (Utrecht, The Netherlands and Cambridge, Massachusetts, US) is a private equity investor focused on fast growing healthcare businesses. It manages €550M ($619M) across two business lines. The Gilde Healthcare Technology funds target companies developing home & digital health solutions, medical devices and medicines in Europe and the USA. The Gilde Healthcare Services funds focus on healthcare service providers, such as specialist clinics, elderly care, primary care, mental health and other healthcare service providers in the Benelux and Germany. For a list of Gilde’s portfolio companies please visit the website at www.gildehealthcare.com
About Edmond de Rothschild Investment Partners
Edmond de Rothschild Investment Partners is a point of reference for minority investment in unlisted companies through development capital and in venture capital. Established in France, the company has deployed its investment teams in Paris, Lyon, Shanghai and Milan (through its exclusive partnership with Mast Capital). The management company consists of 41 individuals, including 29 investment professionals, and manages over €1.3Bn ($1.46Bn). Edmond de Rothschild Investment Partners is an Edmond de Rothschild Group company. Within Edmond de Rothschild Investment Partners, its Life Sciences Team of eight professionals brings together over 60 years of experience in the Life Science industry and more than 100 years of private equity and venture capital experience. The Team has raised €450M ($509M) through its BioDiscovery franchise and is currently investing BioDiscovery 4. Since inception in 2001, BioDiscovery Funds have invested in 50 companies, of which 15 have been sold and 14 listed on public financial markets, while 18 are active in the portfolios. BioDiscovery Funds, including BioDiscovery 4, are venture capital funds dedicated to professional investors. These funds are not authorized by the Autorité des Marchés Financiers and may adopt special investment rules. For more information, please visit: www.edrip.fr
About ”la Caixa”
“la Caixa” has created different tools in order to accompany the innovate business projects in different phases and situations. One such tool is venture capital which provides financing to companies with high growth potential. Caixa Capital Risc, the venture capital division of “la Caixa” invests in the early stages of innovative startups. To facilitated financing to these companies “la Caixa“ launched in 2004 a set of initiatives and specific funds depending on the sector and the stage of development. Currently, Caixa Capital Risc manages €160M ($180M) and invests in companies with a global vision keeping the focus on perceived emerging sectors: technology, digital industries, technologies for industry and life sciences.
About Baxter Ventures
Baxter Ventures is a venture initiative established in 2011 by Baxter International Inc. to invest in companies with innovative technologies, products and therapies with the ability to improve patient care globally and maximize value for investors and entrepreneurs. Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. For more information, visit www.baxter.com/baxterventures