VALBIOTIS Succeeds in the Industrial Production of VALEDIA®, a Major Scientific Innovation for Prediabetic People, in Collaboration with the Pierre Fabre Group
VALBIOTIS (FR0013254851 – ALVAL / PEA/SME eligible), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the successful industrial production of VALEDIA® (active substance TOTUM-63), the most advanced product in the VALBIOTIS portfolio. This achievement is the result of a collaboration with the Pierre Fabre group, a world-renowned expert in the industrial production of plant-based active substances.
Since securing industrial property rights in Europe and the United States, VALBIOTIS has made another major breakthrough by demonstrating its capacity to produce VALEDIA® industrially, and in accordance with the regulations governing these two markets.
Sébastien Peltier, CEO of VALBIOTIS, comments: "The industrial production of VALEDIA ® has come at the best possible time for VALBIOTIS, after obtaining strong preclinical and clinical results and securing the industrial property rights, in the lead-up to the publication of our Phase IIA clinical results. This is an important milestone, thus completing our health claim application and supporting our negotiations with a partner company to market the product in 2021. This development confirms the sustainability of our project to market plant-based products which target the causal mechanisms of metabolic diseases. To achieve this, we are following the regulatory process for dietary supplements with a health claim, while maintaining almost pharmaceutical-grade development standards."
VALEDIA® will be the first of a new class of products, aiming to prevent and combat metabolic diseases.
Industrial batches for future studies
VALBIOTIS is currently developing VALEDIA ® for two labels: prediabetes and hepatic steatosis. The results of the Phase IIA clinical trial for prediabetes are expected by 31 July, 2019. They will be followed in the second half of the year by the launch of the European Phase IIB clinical study (REVERSE-IT) and the Phase IIB study (PREVENT-IT) in North America. The data from these studies will be used to submit the application to European and North American regulatory authorities, for a health claim to reduce the risk of type 2 diabetes, with a view to marketing the product in 2021.
Murielle Cazaubiel, Director of Development and Medical Affairs at VALBIOTIS, comments: "The success of this industrial production means we can progress to the next stages of clinical development with complete confidence. The new production capacities established with the Pierre Fabre group will be used in our two upcoming confirmation studies. This collaboration has enabled VALBIOTIS to benefit from leading expertise in the production of plant-based active substances, from extraction to standardization, ensuring that these results can be reproduced with both large and small quantities."
“In 2015, we put our expertise in extracting plant-based active substances at the service of VALBIOTIS and accompanied them in their development. We produce 3 plant extracts that make up VALEDIA ® at our Gaillac (Tarn) extraction site. Today, we are happy to accompany them in this industrial transposition by manufacturing the capsules on our Cahors (Gers) production site specialized in phytotherapy and aromatherapy,” adds François MACAREZ, Business Developer at Pierre Fabre Médicament.
About TOTUM-63, the active substance of VALEDIA®
Prediabetes is a growing public health issue worldwide that has been acknowledged by international organizations. Without appropriate management, 70% to 90% of prediabetic subjects will develop type 2 diabetes.
VALEDIA® intend to be be the first natural and clinically proven solution specifically designed for prediabetics. VALEDIA® contains the active substance TOTUM-63, a unique and patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms of type 2 diabetes.
The launch of VALEDIA® is planned for 2021, with a health claim for reducing the risk of type 2 diabetes.
TOTUM-63 has already been proven safe and effective in healthy human volunteers during a Phase I/II clinical study.
The results of the first international Phase IIA study are expected before 31 July 2019.
VALBIOTIS is a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases. Its products are made for major players in the health care sector. VALBIOTIS particularly focuses on solutions to prevent type 2 diabetes, NASH (nonalcoholic steatohepatitis), obesity and cardiovascular diseases.
VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top academic centers in France and abroad, including La Rochelle University, the CNRS and Clermont Auvergne University located in Clermont-Ferrand. These partnerships have enabled Valbiotis to benefit from strong financial leverage, particularly thanks to experts and technical partners who support its projects. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63) – and an American office in Boston (MA).
VALBIOTIS is a member of the "BPI Excellence" network and received the "Innovative Company" status accorded by BPI France. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs by obtaining support from the European Regional Development Fund (ERDF). VALBIOTIS is a PEA-SME eligible company.
Find out more about VALBIOTIS: http://valbiotis.com/
ISIN code: FR0013254851
Mnemonic code: ALVAL
This press release contains forward-looking statements about VALBIOTIS' objectives. VALBIOTIS considers that these projections are based on rational hypotheses and the information available to the company at the present time. However, in no way does this constitute a guarantee of future performance, and these projections can be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and doubts, including those described in the VALBIOTIS core document, filed with the French Financial Markets Regulator (AMF) on 5 April 2017 (application number I.17-012), as well as in the 2017 annual financial report, filed with AMF on 3 April 2018. These documents are available on the Company's website (www.valbiotis.com). VALBIOTIS does not accept any liability regarding the update or revision of these forward-looking statements. This press release, as well as the information contained herein, does not constitute an offer to sell or subscribe to, or a solicitation to purchase or subscribe to, VALBIOTIS' shares or securities in any country.
Carole Rocher /
+33 5 46 28 62 58
+33 1 56 88 11 14
Guillaume De Chamisso
+33 6 85 91 32 56
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Gilead and Galapagos Complete Closing of Their Transformative Research and Development Collaboration23.8.2019 20:01:00 CEST | Press release
Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced the closing of the global research and development collaboration agreement signed on July 14, 2019. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190823005335/en/ This agreement has received clearance from the U.S. Federal Trade Commission under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and merger control approval from the Austrian Federal Competition Authority. Under the terms of the agreement, the closing of this transaction triggers an upfront license fee payment of $3.95 billion by Gilead to Galapagos. In addition, Gilead has made an equity investment in Galapagos of approximately $1.1 billion (or approximately €960 million) by subscribing for new shares at a price of €140.59 per share, including issuance premium. As a result, Gilead now owns 13,589,686 ordinary shares of Galapagos, representing approximately 2
32 Leading Global Fashion and Textile Companies Make Commitments on Climate, Biodiversity and Oceans23.8.2019 07:47:00 CEST | Press release
Ahead of the G7 meeting at Biarritz from August 24-26, French President Emmanuel Macron, accompanied by Economy and Finance Minister Bruno Le Maire, Minister of Labour Muriel Pénicaud, and Deputy Minister of Ecological and Solidary Transition Brune Poirson, has invited to the Elysée Palace representatives of the 32 fashion and textile companies who have launched the Fashion Pact by his side. In April 2019, ahead of the G7 meeting, Emmanuel Macron had given François-Henri Pinault, Chairman and Chief Executive Officer of Kering (Paris:KER), a mission to bring together the leading players in fashion and textile, with the aim of setting practical objectives for reducing the environmental impact of their industry. In a historic move, given the scale and importance of the coalition that has been created, 32 leading companies from the fashion and textile industry have given themselves a set of shared objectives in the form of a Fashion Pact. The coalition includes groups and brands in Luxury,
Ethereum (ETH) Now Available on bitFlyer Buy/Sell23.8.2019 05:00:00 CEST | Press release
Cryptocurrency exchange bitFlyer has announced it is adding Ethereum (ETH) to its Buy/Sell trading platform. From today, bitFlyer Buy/Sell users across Europe and the US can send and receive ETH while ensuring they adhere to the same robust regulatory standards as bitFlyer guarantees for Bitcoin (BTC) transactions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190822005486/en/ Ethereum (ETH) Now Available on bitFlyer Buy/Sell (Graphic: Business Wire) Andy Bryant, Co-head and COO, bitFlyer Europe, said, “At bitFlyer, we want to offer not just the most popular coins, but the most respected ones too, which makes ETH a logical choice to expand our service offering. Not only has ETH proved itself as a useful altcoin, particularly in relation to smart contracts, it has an incredibly strong community that surrounds it. We’re committed to offering the best customer experience whilst prioritising security and regulatory standards, a
STALICLA Announces Completion of pre-IND Meeting With FDA on STP1 for Subgroup of Patients With Autism Spectrum Disorder (ASD)23.8.2019 00:00:00 CEST | Press release
STALICLA, a Swiss Biotech company, today announced the completion of its pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) on the preparation for entry of STP1 into clinical trials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190822005559/en/ STALICLA at the Food and Drug Administration (FDA) to discuss its investigational precision medicine for Autism Spectrum Disorder (Photo: STALICLA) “We are appreciative of FDA´s technical guidance and strong interest in personalized medicine approaches for patients with Autism Spectrum Disorder. STALICLA is committed to rapidly move forward with the submission of its STP1 IND. STP1 holds the potential to become the first precision medicine for a subgroup of patients with ASD, and herald a new age for this field.” - Lynn Durham, CEO and Founder of STALICLA. ASD is a common neurodevelopmental disorder, with high level of heterogeneity, that aff
San Fang Chemical Switches to Rimini Street Support for its Oracle EBS and Oracle Database Software22.8.2019 22:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that San Fang Chemical Co., Ltd., a global manufacturer and distributor of artificial leather products headquartered in Taiwan, has switched to Rimini Street support for its Oracle E-Business Suite application and Oracle Database software. In addition to immediately saving 50% of its annual maintenance costs that they were previously paying the vendor, the company can now maintain its core, robust Oracle system for a minimum of 15 years from the time that they switched to Rimini Street support with no forced upgrades. San Fang Chemical has also been able to liberate its IT resources and divert its substantial cost savings to invest in more forward-looking innovation projects to help pave the way for future growth and competitive advantage. This press release features mu
Gravity Unveils its Future Plans During Gamescom 201922.8.2019 15:46:00 CEST | Press release
Gravity Interactive, Inc., a subsidiary of Gravity Co., Ltd. (NASDAQ: GRVY) which is a leading global game company, participated in Gamescom which is one of the three largest game fairs in the world, held in Cologne, Germany from August 20th to 24th. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190822005507/en/ Gravity Interactive, Inc., a subsidiary of Gravity Co., Ltd. (NASDAQ: GRVY) which is a leading global game company, participated in Gamescom which is one of the three largest game fairs in the world, held in Cologne, Germany. At the fair, Gravity announced that it plans to launch ‘Ragnarok M: Eternal Love’ in the European region on September 4th 2019. ‘Ragnarok M: Eternal Love’ will be launched in Russia and Turkey, as well as Europe and it will be serviced in seven languages including English, Portuguese, Spanish, Russian, German, French, and Turkish. (Photo: Business Wire) On August 20th, Gravity held a presentati