News & events

Advicenne Receives Orphan Drug Designation from the EU for ADV7103 for the Treatment of distal Renal Tubulopathy


6 Jul 2017

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Nîmes, France, July 5, 2017 – Advicenne, a late-stage biopharmaceutical company focused on the development of paediatric-friendly therapeutics for the treatment of orphan renal and neurological diseases, announces today that the European Union has granted orphan drug designation to its lead candidate ADV7103 for patients with distal Renal Tubular Acidosis (dRTA). ADV7103 is currently in a pivotal Phase III trial in Europe in children and adults with dRTA with the results from this study expected in the coming months.

ADV7103 is an innovative oral formulation that has the potential to become the first medicine to address dRTA, a disease that leads to an unbalanced pH in the body that causes various complications such as hearing loss, failure to thrive, rickets (a condition that affects bone development in children) and renal impairment, ultimately leading to renal failure.

ADV7103 is designed to manage the disease in children for whom the cause is genetic as well as in adults that have acquired the disease as a result of an autoimmune disease. There are an estimated 30,000 to 50,000 patients with dRTA in Europe, both with the genetic and acquired forms of dRTA.

ADV7103 is a paediatric-friendly, fixed dose, prolonged-release coated granules that combines two active pharmaceutical ingredients specifically formulated for a 12-hour absorption. The product is tasteless, easy to administer orally in either young children or adults and only requires 2 doses per day to achieve 24-hour efficacy. Advicenne believes that ADV7103’s bespoke formulation could improve compliance and the treatment outcomes for patients with dRTA.

Dr Luc-André Granier, CEO of Advicenne, commented: “The orphan drug designation that has just been granted by the European Union is a significant milestone for our team. It has come at a very appropriate time as we will be presenting preliminary clinical data in September at the European Society of Paediatric Nephrology (in Glasgow, UK). We believe ADV7103 could be a major advance in the treatment of dRTA and look forward to making a significant improvement to the lives of patients with this devastating renal disease.”

Press release



Advicenne to Present Preliminary Phase III Clinical Data on ADV7103 at the Upcoming European Society of Paediatric Nephrology’s Annual Meeting


22 Jun 2017

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Nimes, France, June 21, 2017 – Advicenne, a late-stage biopharmaceutical company focused on the development of paediatric-friendly therapeutics for the treatment of orphan renal and neurological diseases, announces today that the Company will present preliminary Phase III clinical data on ADV7103 in an oral presentation at the upcoming 50th European Society of Paediatric Nephrology (ESPN) 2017 Annual Meeting which is being held from the 7th to 9th of September in Glasgow, UK.

ADV7103 is an innovative oral formulation that is currently being evaluated in a pivotal Phase III trial in Europe in children and adults to address distal Renal Tubulopathy Acidosis (dRTA), a disease that leads to an unbalanced pH in the body that causes various complications such as hearing loss, failure to thrive, rickets (a condition that affects bone development in children) and renal impairment, ultimately leading to renal failure.

Title: “Efficacy and acceptability of ADV7103, an innovative prolonged-release oral alkalising formulation in distal Renal Tubular Acidosis (dRTA) patients” – Preliminary Phase III Results

Presenting author: Aurelia Bertholet-Thomas, M.D., Centre de Référence des Maladies Rénales Rares, Bron, France

Session: Understanding tubular physiology to improve patient care

Time: Saturday 9th September – 9.45-10.15 BST

“We very much look forward to sharing results from ADV7103 ongoing clinical studies with the global paediatric nephrology community,” said Dr Luc-André Granier, CEO of Advicenne. “We are focused on the development of effective and paediatric-friendly therapeutics for the treatment of orphan renal diseases for which there are currently no approved treatment options.”

In addition to the oral presentation, Advicenne will present three communications at the meeting as follows:

Title: An innovative treatment as prolonged release granules for tubular disorders specifically designed for twice a day treatment

Authors: C. Roussel-Maupetit, C. Guittet, L.A. Granier

Title: Pharmacodynamic evaluation of ADV7103, an innovative prolonged-release oral alkalising formulation

Authors: C. Guittet, M.A. Manso, F Vandenhende, L.A. Granier

Title: Alkalising treatments used to treat distal renal tubular acidosis (dRTA) in clinical practice – observations during a clinical study

Authors: A. Bertholet-Thomas (presenting author)

Press release 



Advicenne Announces the Closing of a €16 Million Financing Round


20 Mar 2017

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Nimes, France, 20 March 2017 – Advicenne, a late-stage biopharmaceutical company focused on the development of paediatric friendly therapeutics for the treatment of orphan renal and neurological diseases, announces today that it has closed a €16 million financing round. The fundraising was led by IRDI SORIDEC Gestion, Cemag Invest and MI Care alongside existing investors InnoBio (Bpifrance) and IXO Private Equity together with private individuals.

Advicenne plans to use these funds to advance its late-stage pipeline in nephrology and neurology, including:

The completion of the Phase III development of ADV7103, which is targeting a renal tubulopathy, an orphan indication. ADV7103 is currently in a pivotal phase III trial in Europe. The Company expects to announce the results of this study during summer 2017;

  • The development of ADV7103 in a second indication targeting another renal disease in Europe;
  • The registration of ADV6209, a paediatric anaesthesiology product outlicensed to Primex Pharmaceuticals in 2016.

Dr Luc-André Granier, CEO of Advicenne, states: “This financing round is designed to further develop our pipeline, particularly completing the pivotal Phase III study with ADV7103, in an orphan renal disease for which there are currently no approved treatment options. The results from this study are expected in the summer.”

Dr Granier adds: “We are very pleased to welcome IRDI SORIDEC Gestion, Cemag Invest and MI Care as new Advicenne shareholders, in addition to Bpifrance, IXO and private individuals, who have been supporting and working with us for many years.”

Jean-Michel Petit, Investment manager at IRDI SORIDEC Gestion, said: “Advicenne is a very promising company in the field of orphan diseases. Its unique approach convinced us of the value of its activities and we are delighted to be in  a position  to invest in  Advicenne at such an important time and to provide funding alongside a syndicate of highly supportive investors. Advicenne has the potential to be a game-changing biopharma company in the area of orphan renal and neurological diseases.”

Philippe Boucheron, Deputy Chief Life Sciences Investment at Bpifrance Investissement, comments: “The investment proposition presented by Advicenne attracted our interest very early on and we decided to give it our full backing. Three elements caught our attention as we looked at Advicenne: the clear unmet medical need in the orphan diseases it is targeting, the relatively de-risked business model, and the focus and experience of the management team to advance its pipeline from R&D all the way to commercialisation.”

Press Release



Advicenne appoints Ludovic Robin as Chief Business & Strategy Officer


8 Sep 2016

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Nîmes, September 1rst, 2016 – Advicenne a French pharmaceutical laboratory dedicated to pediatric and orphan diseases announces the nomination of Ludovic Robin as Chief Business & Strategy Officer,.

Ludovic Robin joins Advicenne to lead Global commercial and corporate development focusing on the main Business areas, both in the US and EU.

He brings over 25 years of international R&D, Marketing& Sales and Business development experiences in the Pharmaceutical industry. During his career, Ludovic launched more than 15 new original products for rare diseases or for highly specialized medicines.

He started his career in the United Kingdom as scientist developing new cosmetology and dermatological formulations for Procter & Gamble and Stiefel laboratories. Then he came back to France where he led various managerial and leadership roles in sales, marketing and business Development within L’Oréal, Servier and Laboratoires Expanscience. During this period, he originated, signed and executed 13 partnerships (registration, commercial) in more than 20 countries.

In 2004, he joined Shire to launch the dermatology and the nephrology franchises. He served as marketing manager, Business unit Director, Marketing Director and Commercial Operation Head for France and BeNeLux , concerning in particular nephrology and child psychiatry. He was a member of Shire French Executive board since 2008.

Ludovic Robin received his Doctorate in Pharmacy (PharmD) and his Master in Industrial Pharmacy from Lyon I University and completed his MBA at HEC Paris (and Mc Gill- Montreal).

Cp nomination ludovic robin



Advicenne Pharma sells to the Swiss Primex Pharmaceuticals its drug candidate dedicated to pediatric anesthesiology


23 Feb 2016

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A first strategic deal for Advicenne, validating its positioning, know-how and ambitions

Nîmes, Tuesday February 23rd – Incorporated since 2007, Advicenne is a French pharmaceutical laboratory dedicated to pediatric and orphan diseases. It announced today the sale of one of its lead products in anesthesiology, to the Swiss Primex Pharmaceuticals, a world leader in this domain.
The deal includes upfront, milestones and royalties.
The product is an oral solution dedicated to pediatric anesthesiology and was originally developed by a partnership with Amiens’s public hospital (centre hospitalo-universitaire).
Since its inception, Advicenne aimed to address unmet medical needs in the field of pediatric nephrology and neurology. Developing age-adapted therapeutic options, Advicenne is now a fully integrated pharmaceutical company with strong research and development teams as well as regulatory and commercial capabilities.
With this acquisition, Primex Pharmaceuticals expands its anesthesiology portfolio with a proven product.
« As one of the very first in-house developed products, the deal validates our strategy and capabilities in developing original pediatric-adapted drugs » says Dr Luc-André Granier, CEO of Advicenne. « Primex Pharmaceuticals is probably the best partner for the commercial success of the product as its network is global and its commitment for anesthesiology is very strong ».
« Besides, we can now focus on our main product development in the field of neuropediatry and nephropediatry as well as the launches of our two first products dedicated to pediatric epilepsy. » adds Dr Granier.
As the main shareholder of the company and board member representing Bpifrance, Philippe Boucheron, Directeur Adjoint of the Life Science team at Bpifrance Investment stated : « With this deal, Advicenne demonstrates its unique know-how and expertise in the development of pediatric medications. The company will pursue further the development and the expansion of its high quality portfolio, with exciting product in the field of nephrology, one of its main assets according to our vision ».

CP Advicenne Primex



French marketing authorization approval for Levidcen


23 Apr 2015

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French marketing authorization approval for Levidcen, coated granules of levetiracetam
Levidcen® has been approved by the French Agency on October 20th 2014. Levidcen is available in sachets with 4 different dosages of coated granules of levetiracetam: 250mg, 500mg, 750mg and 1 000mg
Levetiracetam coated granules have been developed by the German company Desitin. The specialty is currently marketed in Germany, UK, Spain, Portugal, Switzerland, Norway and Sweden and is indicated for the treatment of epilepsy

Notice LevidcenRCP Levidcen



Advicenne has signed a license agreement with Desitin, on a new anti-epileptic for the French market, Levidcen micro-granules


20 Feb 2014

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Levetiracetam micro-granules is an original formulation developed by Desitin. The small size (2 mm) of the granules makes them easy to swallow for young children or elderly people. Levetiracetam is indicated in the treatment of partial epilepsy, juvenile myoclonic epilepsy and idiopathic generalized tonic clonic epilepsy. Four dosages will be marketed, 250 mg, 500 mg, 750 mg and 1000 mg. This product is already available in many European markets including Germany, Great Britain, Spain, Portugal, Switzerland, Norway and Sweden. It is a great success towards patients who found the current big tablets of Levetiracetam difficult to swallow. Once registered, Advicenne will market the product on the French territory. Doctor Luc-André Granier, founder and CEO of Advicenne, is delighted with the signature of this commercial agreement, which is the second signed in 2013 by Advicenne. A first agreement on an anti-epileptic treatment available in a form that is suitable for children has been signed on June 5, 2013 with another company : “The signature of these two agreements is a huge step forward for Advicenne. Both products fill the needs and expectation of patients and practitioners and show a perfect fit with the portfolio of neurological products developed by Advicenne. We are proud and happy to collaborate with Desitin.” The Hamburg-based company is recognized as one of the largest pharmaceutical companies specialized in epilepsy. Desitin also develops and markets drugs for Parkinson’s disease.



Advicenne welcomes within its team, Catherine Martre, as Head of Strategy and Commercial Development


7 Feb 2014

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Graduated from the Ecole Centrale and holder of a DEA (Diplôme des Etudes Approfondies equivalent to Master of Advanced Studies) in applied chemistry and process engineering, Catherine Martre started her career as a consultant within Alcimed, dedicated to strategy consulting for  health and biotechnology companies. She then  joined the pharmaceutical industry in 2001. She worked for Laboratoires Altana and then Nycomed where she was responsible for market research, data management, business development and commercial effectiveness. Prior to joining Advicenne she held the position of Director of Strategy and Public Affairs at Laboratoire Takeda France, in charge of strategy, business development and public affairs, including the negotiation with French Health authorities for pricing and  reimbursement  of new drugs. Within Advicenne, Catherine Martre will be responsible for business development, economic affairs (pricing and reimbursement) and the marketing strategy for products of  Advicenne’s portfolio, whether developed internally or as a result of partnerships. Doctor Luc-André Granier, founder and CEO of Advicenne, is delighted that Ms Martre has joined the Advicenne team, “this recruitment is of essential strategic importance at a time when Advicenne Pharma is beginning to market its first products in Europe”.



Advicenne : Pharmaceutical company status since August 16, 2013


7 Feb 2014

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Following a favourable opinion delivered by ANSM, Advicenne, headquarters in Nimes, becomes a pharmaceutical company. Luc-André Granier, Founder, President – CEO and Medical Director, welcomes this excellent news taking place at a strategically important time for the development of the company: “One of our major objectives is to be able to start the sales of our first paediatric products by the end of 2013. Obtaining such authorisation was the first essential step of an important evolution for Advicenne, toward a full Pharmaceutical Company.” Pharmaceutical responsibility will be managed by Mme Nathalie Lemarié, QP, PharmD in Pharmacy at the University of Montpellier, France.