NÎMES, France--(BUSINESS WIRE)--Regulatory News:
Advicenne (Paris:ADVIC) (BSE:ADVIC) (Euronext Paris & Brussels: ADVIC - FR0013296746), a specialty pharmaceutical company focused on the development and commercialization of therapeutic products for rare kidney diseases, announces today that it has signed a loan agreement in for the amount of € 20 million with the European Investment Bank (EIB), the bank of the European Union, within the framework of the Investment Plan for Europe, also known as the Juncker Plan.
The loan will support Advicenne’s latest strategic research and development initiatives, allowing the company to expand its portfolio of innovative medications for rare diseases. The financing agreement was signed by Ambroise Fayolle, Vice President of the EIB, and Paul Michalet, Chief Financial Officer of Advicenne.
The non-dilutive financing accorded by the EIB benefits from a European guarantee provided for in the Juncker Plan. The Plan’s objective is to support research and innovation in companies that demonstrate strong growth potential. Advicenne meets these criteria as the medical treatments developed by the company address high unmet medical need in the area of rare diseases, particularly among the pediatric patient population. Advicenne’s lead drug candidate, ADV7103, has been developed for the treatment of distal renal tubular acidosis (dRTA), a rare kidney disorder that can lead to severe complications if untreated.
The financing is structured in three tranches of € 7.5 million, € 5 million and € 7.5 million, respectively. In view of Advicenne’s current cash position, this additional funding will make it possible to extend the company’s financial visibility while it pursues its clinical research in dRTA and cystinuria. While it has not yet exercised it, Advicenne currently has the ability to draw down on the first tranche.
Vytenis Andriukaitis, European Union Health & Food Safety Commissioner commented on the financing: “Another excellent example of a European Fund for Strategic Investments (EFSI) project that allocates resources to causes most in need of support. Improving access to medications for children suffering from rare diseases is a necessity, but brings with it many challenges. This EU financing will contribute in large measure to assisting companies whose expertise is research and development in this area, thus ensuring innovative and accessible solutions for all.”
“This financing for Advicenne confirms yet again the great success of the Juncker Plan,” adds Ambroise Fayolle, Vice President of the European Investment Bank, “In view of its dedication to rare diseases, Advicenne is emblematic of those French biotechnology companies that combine both innovation and the mitigation of risk.”
Paul Michalet, Chief Financial Officer of Advicenne, adds: “This non-dilutive financing is in keeping with our financial strategy and will help us to further advance into our industrial and commercial phase while accelerating the development of our product pipeline of treatments for rare diseases. Put in place by Europe, this funding will in turn accelerate the creation of value for our shareholders.”
Dr. Luc-André Granier, Co-Founder and CEO of Advicenne, concludes: “I would like to thank all the stakeholders involved in this financing agreement, which will allow us to fully deploy our expertise in the treatment of rare diseases in patients of all ages, particularly the most fragile among them: children. We previously demonstrated our capacity to develop and commercialize medications with ADV6209 (Ozalin®), a moderate sedative, and are about to repeat this success with our lead candidate, ADV7103, in the treatment of dRTA. I am confident that, thanks to this additional financing, we will be able to continue to develop effective and well-tolerated treatments for patients suffering from diseases for which satisfying therapeutic solutions do not currently exist.”
About the European Investment Bank (ElB)
The European Investment Bank (ElB) is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.
About the Juncker Plan
The Investment Plan for Europe, the so-called "Juncker Plan", is one of the European Commission's top priorities. It focuses on boosting investments to create jobs and growth by making smarter use of new and existing financial resources, removing obstacles to investment and providing visibility and technical assistance to investment projects. The European Fund for Strategic Investments (EFSI) is the central pillar of the Juncker Plan. It provides a first loss guarantee, allowing the EIB to invest in more, often riskier, projects. The projects and agreements approved for financing under the EFSI so far are expected to mobilise almost EUR 410 billion in investments and support around 952,000 SMEs across all 28 Member States.
Advicenne (Euronext Paris & Brussels: ADVIC - FR0013296746) is dedicated to developing and commercializing innovative treatments for those suffering from rare kidney disease. Our lead drug candidate, ADV7103, is currently in late-stage clinical trials for two indications.
In 2017, ADV7103 was granted orphan drug designation by the European Commission in the treatment of distal renal tubular acidosis (dRTA), a rare kidney disorder that occurs when the kidneys are unable to effectively remove the buildup of circulating acids in the blood. Currently in Phase III clinical trials for this indication in Europe, the United States and Canada, ADV7103 is also in the registration phase in the European Union for the treatment of dRTA.
While we prepare its European commercial launch for dRTA, we are simultaneously conducting trials for ADV7103 in the treatment of cystinuria, a genetic disease characterized by a buildup of the amino acid cystine in the kidneys and bladder. ADV7103’s Phase II/III European clinical trials for cystinuria were recently expanded to Belgium.
At Advicenne, we are committed to innovating in the areas of formulation and dosage. Tasteless and easy to administer, our products are commercialized in small-size formats that offer flexible, personalized dosing – because path-breaking treatments for rare diseases should be available to patients of all ages.
Headquartered in Nîmes, France, Advicenne is listed on the Euronext Paris stock exchange since 2017 and cross-listed on the Euronext Brussels stock exchange in 2019.
Forward-Looking Statements - Advicenne
This press release contains certain forward-looking statements relating to the business of Advicenne, which shall not be considered per se as historical facts. Such statements include estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In some cases, forward-looking statements can be identified by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets" or similar words. Although the management of Advicenne believes that these forward-looking statements are reasonably made, they are based largely on the current expectations of Advicenne as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. In particular, the expectations of Advicenne could be affected by, among other things, uncertainties involved in the placing on the market and commercialization of Advicenne products or any other risks and uncertainties developed or identified in any public documents filed by Advicenne with the French Financial Markets Authority (Autorité des marchés financiers (AMF)), including those listed in Chapter 4, “Risk Factors,” of its reference document, filed with the latter on December 3, 2018, under number R.18-073 and in section 8 of its financial annual report published on April 30, 2019. Notwithstanding the compliance with article 223-1 of the General Regulation of the AMF (the information disclosed must be “accurate, precise and fairly presented”), Advicenne disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.