VALBIOTIS Receives US and European TOTUM-070 Patent for Reducing Hypercholesterolemia
Regulatory News:
VALBIOTIS (Paris:ALVAL) (FR0013254851 - ALVAL, eligible for the PEA/SME), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, has announced that it has obtained an American and European patent for TOTUM-070, its active substance dedicated to reducing LDL-cholesterol in the blood (“bad cholesterol”).
TOTUM-070 is a combination of plant extracts that contains neither phytosterols nor red yeast rice, designed by VALBIOTIS’ proprietary R&D platform based in Riom (63). The patent has been granted for the United States, Europe and South Africa.
TOTUM-070 targets excess LDL-cholesterol, which is a well-known risk factor for cardiovascular disease and the main cause of atherosclerosis1. It is believed that over 174 million adults in the US and Europe will suffer from hypercholesterolemia in 2020. The market for non-prescription products is estimated at €1.2 billion in these regions2.
Sébastien Peltier, CEO of VALBIOTIS, said: “With TOTUM-070, we are targeting a major market, one in which we stand out for our specific plant know-how, a high level of clinical evidence and robust intellectual property worldwide. This strategy has already borne fruit, with a major partnership aiming at developping and marketing our first active substance, TOTUM-63. Obtaining this patent for TOTUM-070 in regions where populations are particularly affected by hypercholesterolemia marks a milestone in our development model aimed at building new partnerships of this scale.”
The TOTUM-070 patent covers a wide range of food and pharmaceutical applications relating to lipid metabolism disorders, for example dyslipidemia, cholesterol and triglycerides. It is the focus of an international filing strategy reaching beyond the United States and Europe.
A Phase II clinical study evaluating the efficacy of TOTUM-070 in people with untreated moderate hypercholesterolemia will be launched before the end of the year. The initiation of this study will be communicated subsequently.
The objective for VALBIOTIS is to obtain the first proprietary health claim for reducing LDL-cholesterol, notably in Europe and North America, for a product containing neither phytosterols nor red yeast rice.
ABOUT VALBIOTIS
VALBIOTIS is a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases in response to unmet medical needs.
VALBIOTIS has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of nutritional health solutions designed to reduce the risk of major metabolic diseases, based on a multi-target approach and made possible by the use of plant-based ingredients.
Its products are intended to be licensed to players in the health world.
VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top academic centers. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63).
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: www.valbiotis.com
Name: Valbiotis
ISIN code: FR0013254851
Mnemonic code: ALVAL
DISCLAIMER
This press release contains forward-looking statements about VALBIOTIS' objectives, 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 31 July 2020 (application number R20-018), these documents being available on the Company’s website (www.valbiotis.com).
1 2018 Guideline on the Management of Blood Cholesterol, a report from the American College of Cardiology / American Heart Association, Journal Of The American College Of Cardiology, 2019.
2 AEC Partners data for the United States and VALBIOTIS’ 5 priority European countries (Germany, Spain, France, Italy and the United Kingdom), 2020.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005535/en/
Contact information
CORPORATE COMMUNICATION / VALBIOTIS
Carole ROCHER / Marc DELAUNAY
+33 5 46 28 62 58
media@valbiotis.com
FINANCIAL COMMUNICATION / ACTIFIN
Stéphane RUIZ
+33 1 56 88 11 14
sruiz@actifin.fr
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
ESMO 2020: Cabometyx® (cabozantinib) in Combination With Opdivo® (nivolumab) Demonstrates Significant Survival Benefits in Patients With Advanced Renal Cell Carcinoma in Pivotal Phase III CheckMate -9ER Trial19.9.2020 19:30:00 EEST | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced the first presentation of results from the pivotal Phase III CheckMate -9ER trial, in which Cabometyx® (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) demonstrated significant improvements across all efficacy endpoints, including overall survival (OS), in previously untreated advanced renal cell carcinoma (RCC).1 Cabometyx® in combination with Opdivo® reduced the risk of death by 40% versus sunitinib (HR: 0.60 [98.89% Confidence Interval [CI]: 0.40–0.89]; p= 0.0010; median OS not reached in either arm). In patients receiving Cabometyx® in combination with Opdivo®, median progression-free survival (PFS), the trial’s primary endpoint, was doubled compared to those receiving sunitinib alone: 16.6 months versus 8.3 months respectively (Hazard Ratio [HR]: 0.51 [95% CI 0.41–0.64], p < 0.0001). In addition, Cabometyx® in combination with Opdivo® demonstrated a superior objective response rate, wit
Takeda Presents New Data Highlighting Scientific Advancements in Lung Cancer at ESMO Virtual Congress18.9.2020 13:55:00 EEST | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the company is presenting data from its lung cancer portfolio at the virtual European Society for Medical Oncology (ESMO) conference. Notably, insights from sub-analyses of the Phase 3 ALTA 1L study reinforce both the compelling evidence of intracranial efficacy with ALUNBRIG® (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) as well as associated quality of life (QoL) data. Takeda is also featuring updated 10-month follow-up results from the Phase 1/2 trial of mobocertinib (TAK-788), demonstrating mobocertinib achieved a duration of response (DoR) of more than one year in the trial’s study population of patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC). “We’re pleased to present our ongoing research in lung cancer at this year’s virtual ESMO congress, including new
Incyte Announces Encouraging Results From Phase 2 Trial of Retifanlimab (INCMGA0012) in Patients With Previously Treated, Advanced Squamous Cell Carcinoma of the Anal Canal18.9.2020 13:00:00 EEST | Press release
Incyte (Nasdaq:INCY) today announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with advanced squamous cell carcinoma of the anal canal (SCAC) who have progressed following standard platinum-based chemotherapy. The trial enrolled 94 patients, including those with well-controlled human immunodeficiency virus (HIV) infection (10%). Retifanlimab monotherapy resulted in a confirmed objective response rate (ORR) of 14% as determined by independent central review (ICR) using RECIST v1.1. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status. Retifanlimab was generally well-tolerated with a safety profile as expected of a PD-1 inhibitor and no loss of HIV infection control. Key findings from POD1UM-202: N=94 ORR* (95% CI) 13.8% (7.6-22.5) Best OR*, n 1 CR 12 PR 33 SD DCR 48.9% DOR, median (95% CI), months 9.5 (5.6-NE) PFS, median (95% CI), months 2.3 (1.9-3.6) OS, median (95
Sigfox and Cube Infrastructure Managers Announce Major Partnership in IoT Infrastructure18.9.2020 10:30:00 EEST | Press release
Sigfox, the global 0G network1 and cloud provider for industrial data, is proud to announce a new strategic alliance with Cube Infrastructure Managers (Cube), through the sale of its German 0G network to Cube. Sigfox has grown its 0G IoT services by rolling out 0G networks across 72 countries and regions, which was largely achieved with partners called Sigfox Operators. These operators are the owners of the 0G networks, which they operate as exclusive connectivity providers of Sigfox IoT services, offering worldwide connectivity to customers. The sale of the German network to Cube will allow Sigfox to finance its continued innovation efforts in data value extraction and improvements in cloud algorithms to reduce energy consumption and allow the implementation of even more cost-effective devices and sensors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200918005116/en/ Cube Infrastructure Managers, the European infrastructu
Sensorion successfully raises approximately €31 (US$ 36.5) million in an oversubscribed private placement to US and European investors18.9.2020 09:00:00 EEST | Press release
Regulatory News: Not for release, publication or distribution, directly or indirectly, in or into the United States, Canada, Australia or Japan. This press release is not intended as an offer and is for informational purpose only Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN – the “Company”) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders announces today the success of its previously announced capital increase. The Company has placed 18,236,000 new ordinary shares with a nominal value of €0.10 each (the “New Shares”), for total gross proceeds of approximately € 31 million by means of an accelerated bookbuild offering to the benefit of categories of persons (the “Reserved Offering”). The issue price of the New Shares is €1.70 per share, representing a 3.5% discount to the weighted average share price on the day preceding the date on which the issuance price
ESMO 2020: Phase II CLARINET FORTE Results Show Increasing Dose Frequencies of Somatuline® Autogel® (lanreotide) Allows Patients with NETs to Delay Treatment Escalation by up to 8.3 Months18.9.2020 08:00:00 EEST | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced the release of first efficacy and safety data from the CLARINET FORTE study, with the abstract to be presented as a mini-oral presentation at the 2020 European Society for Medical Oncology (ESMO) Congress, taking place virtually from 19-21 September 2020. The prospective single-arm, open-label, exploratory, international Phase II study investigated the efficacy and safety of increasing the dose frequency of Somatuline® Autogel ® (lanreotide) in patients with pancreatic or midgut NETs with centrally-assessed progression within the last two years while on a standard lanreotide regimen for ≥24 weeks. An extension of progression-free survival (PFS) rates and encouraging disease-control rates (DCR) were recorded in both tumor types, with no new safety signals. “These results support a clinically meaningful benefit to a population of patients with high unmet medical need by potentially delaying escalation to more toxic treatm
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom