Intsel Chimos SA

BERWYN, Pa. and WATFORD, United Kingdom, Oct. 17, 2024 (GLOBE NEWSWIRE) -- AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, announces the acquisition of CHAPPER healthcare, a global specialty pharmaceutical wholesaler, distributor and services provider established in 1975. The acquisition of this recognized leader in the import and export of specialty pharmaceuticals deepens AscellaHealth’s capabilities to serve international manufacturers and patients in more than 70 countries across the EU, Asia, Africa, Australia and the Americas. “The integration of CHAPPER healthcare into the AscellaHealth organization consolidates overall global market leadership, unlocking new opportunities for market access and product commercialization throughout the global life sciences industry,” says Bill Oldham, chairman and president, AscellaHealth. “Our combined experience, expertise and capabilities strengthen the AscellaHealth customer value proposition for delivering innovative, end-to-end solutions and providing our market-leading patient support programs throughout the world.” Complementing the AscellaHealth global reputation as a trusted partner in the pharmaceutical industry, CHAPPER healthcare specializes in the import and export of direct to hospital and non-registered medicines, with a specialty pharmacy to meet diverse market needs. As an acknowledged, reliable resource for ensuring continuity of care by providing uninterrupted access to critical medications, CHAPPER healthcare offers a complete range of logistical solutions and significant expertise in supplying medicines to the U.K. healthcare market and worldwide. Mario Patone, CFO, AscellaHealth adds, “A strategic transaction in the U.K. with access to global markets underscores our shared commitment to shaping the future of healthcare, driving business growth and expanding our international presence. This acquisition will significantly accelerate the global market reach and operational scale of both organizations.” Specialty drug manufacturers and patients benefit from expert supply management of named patient medicines, including unlicensed and orphan drugs for rare diseases. The Company’s global network efficiently sources and procures a wide range of products, expertly managing shipping processes, temperature controls, customs regulations and the critical timing needed to ensure patients receive their treatments on time. CHAPPER healthcare is also a founding member of EUROPACCESS, a partnership of seven leading European Companies (Ilapo, Intsel Chimos, Tetrago, Pharma International, Lenis and Euraxi), providing streamlined and faster access to European healthcare systems by supporting its manufacturer partners in the distribution of their medicines. Service offerings span the drug lifecycle from early access, through dossier filing to post-marketing authorization distribution. Jonathan Chapper, CEO, CHAPPER healthcare, says, “We are excited about the opportunity to join forces with the impressive AscellaHealth team and advance global access to vital medicines, particularly in times of urgent need. This is an opportunity to further strengthen our international market impact and serve the expanding AscellaHealth partner portfolio. Together, we are positioned to accelerate our mission of breaking down barriers to care while driving meaningful and sustainable advancements in the global specialty pharmaceutical landscape.” About AscellaHealth LLC AscellaHealth is a global partner that delivers proven end-to-end solutions to both life sciences and healthcare companies to enhance the quality of life for patients with complex, chronic conditions. A dedicated team gets critical healthcare products from manufacturers to patients while ensuring an efficient flow of funds between payers and pharma. Visit www.AscellaHealth.com. About CHAPPER healthcare CHAPPER healthcare is a leading global pharmaceutical distributor and wholesaler, specialising in importing and exporting pharmaceuticals to markets across the globe since 1975, regularly exporting to more than 70 different countries, with a longstanding relationship with clients across Europe, Asia, Africa, Australia and the Americas. Visit www.chapperhealthcare.com. This press release was published by a CLEAR® Verified individual.

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / September 19, 2023 / Biophytis SA (Nasdaq CM:BPTS, Euronext Growth Paris:ALBPS), (Biophytis), a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announced that it has received a response from the French National Authority for Health (HAS) to its request for Early Access Authorization in France for patients suffering from severe forms of COVID-19 and provides an update on its strategy in other countries. After examining the Early Access Authorization request at the end of May 2023, HAS considered that the Company had not provided sufficient data allowing it to evaluate precisely the benefit vs. risk ratio and to authorize the treatment of patients with severe forms of COVID-19, despite the statistically significant results of the phase 2-3 COVA study. The Company must therefore complete the providing in particular certain results of pharmaceutical studies, in progress with its industrial partner Sequens, as well as certain additional data and scientific arguments relating to its phase 2-3 COVA study. On the basis of these various elements, it is planned to resubmit the application to the HAS in the first quarter of 2024, with pharmaceutical partner Intsel Chimos, depending on the progress made in the development plan. At the same time, Biophytis is taking steps in Brazil to confirm the early access authorization obtained in early 2022 that was interrupted pending publication of the full results of the COVA study. This new authorization is expected by the end of the year. Finally, the Company is exploring the possibilities of launching early access programs in other key countries in Europe, in order to best respond to the medical need in a pathology that has become endemic. About BIOPHYTIS Biophytis SA is a clinical-stage biotechnology company specializing in the development of drug candidates for age-related diseases. Sarconeos (BIO101), our lead drug candidate, is a small molecule in development for age-related neuromuscular (sarcopenia and Duchenne muscular dystrophy) and cardiorespiratory (Covid-19) diseases. Promising clinical results were obtained in the treatment of sarcopenia in an international phase 2 study, enabling the launch of a phase 3 study in this indication (SARA project). The safety and efficacy of Sarconeos (BIO101) in the treatment of severe COVID-19 were studied in a positive international phase 2-3 clinical trial (COVA project). A pediatric formulation of Sarconeos (BIO101) is currently being developed for the treatment of Duchenne Muscular Dystrophy (DMD, MYODA project). The company is based in Paris, France, and Cambridge, Massachusetts. The Company's ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825) and the ADSs (American Depositary Shares) are listed on Nasdaq Capital Market (Ticker BPTS - ISIN: US09076G1040). For more information, visit Disclaimer This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. Such forward-looking statements are based on assumptions that Biophytis considers to be reasonable. However, there can be no assurance that the statements contained in such forward-looking statements will be verified, which are subject to various risks and uncertainties. The forward-looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered material by Biophytis. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. Please also refer to the "Risk and uncertainties the Company is to face» section from the Company's 2022 Financial Report available on BIOPHYTIS website ( ) and as exposed in the "Risk Factors" section of form 20-F as well as other forms filed with the SEC (Securities and Exchange Commission, USA). We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. Biophytis contacts Investor relations Nicolas Fellmann, CFO Investors@biophytis.com Media Antoine Denry: antoine.denry@taddeo.fr - +33 6 18 07 83 27 Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50 SOURCE: Biophytis View source version on accesswire.com:

PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / May 26, 2023 / Biophytis SA (NasdaqCM:BPTS)(Euronext Growth Paris:ALBPS) (the "Company" or "Biophytis"), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, today announced that it has through its pharmaceutical partner Intsel Chimos, an application for Early Access Authorisation (EAA) in France with the French National Authority for Health (HAS) for the use of Sarconeos (BIO101)[1] in the treatment of adult patients with a severe form of COVID-19, who are at risk of developing a critical form of the disease and for whom therapeutic alternatives are not appropriate. Following the positive results of the COVA phase 2-3 study, Biophytis met with the HAS on March 9, 2023 for a pre-submission meeting to review the eligibility requirements of the application. The Company is now pursuing this regulatory process by submitting the EAA application. If the application is approved by the HAS, the early access programme will allow certain patients with severe forms of COVID-19 to be treated in France with Sarconeos (BIO101), while awaiting conditional Marketing Authorisation (MA) in Europe. Biophytis expects a response by Q3 2023 at the latest, depending on the delays taken by the HAS, and the first patients could be treated as early as Q4 2023.The industrial scale production of Sarconeos (BIO101) has been initiated with pharmaceutical subcontracting partners (CDMOs), in order to be able to treat up to 6,000 patients if the EAA is approved. Distribution will be handled by Intsel Chimos, with whom a partnership was signed in March 2023. Stanislas Veillet, CEO of Biophytis, said: "We have demonstrated, through the positive results of the COVA study, a statistically significant 44% reduction in the risk of respiratory failure or early death. With the submission of our application for the early access program, we therefore intend to accelerate the availability in France of Sarconeos (BIO101) to hospitalized patients with severe forms of COVID-19 via our partner Intsel Chimos." Corinne Truffault, CEO of Intsel Chimos, said: "We are delighted and very proud to accompany Biophytis in this new regulatory step to obtain the EAA for Sarconeos (BIO101) in the treatment of severe forms of Covid-19. In parallel, we are preparing to ensure the distribution and availability of this treatment to patients in France as soon as the EAA is approved by the HAS. " ABOUT EARLY ACCESS Early access in France is granted by the HAS after the opinion of the National Agency for the Safety of Medicines and Health Products (ANSM) on the presumed efficacy and safety of the drug candidate. This is a system that allows the early availability and financial coverage, on an exceptional and derogatory basis, of certain medicinal products that meet an unmet therapeutic need, that are likely to be innovative, and that are not yet authorised in a therapeutic indication. About BIOPHYTIS Biophytis SA is a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19. Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, planned to be developed as a treatment for sarcopenia in upcoming Phase 3 clinical trials in the United States, Brazil and Europe (SARA-31 and SARA-32). It has also been studied in a clinical two-part Phase 2-3 study (COVA) for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America, and the US. A pediatric formulation of Sarconeos (BIO101) is being developed for thetreatment of Duchenne Muscular Dystrophy (DMD). The Company is based in Paris, France, and Cambridge, Massachusetts. The Company's ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825) and ADSs (American Depositary Shares) are listed on Nasdaq Capital Market (Ticker BPTS - ISIN: US09076G1040). For more information visit Disclaimer This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. Such forward-looking statements are based on assumptions that Biophytis considers to be reasonable. However, there can be no assurance that the statements contained in such forward-looking statements will be verified, which are subject to various risks and uncertainties. The forward-looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered material by Biophytis. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. Please also refer to the "Risk and uncertainties the Company is to face" section from the Company's 2022 Half Year Financial Report available on BIOPHYTIS website ( ) and as exposed in the "Risk Factors" section of form 20-F as well as other forms filed with the SEC (Securities and Exchange Commission, USA). We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. Biophytis Contact for Investor Relations Nicolas Fellmann, CFO Investors@biophytis.com Media Contacts Antoine Denry:antoine.denry@taddeo.fr +33 6 18 07 83 27 Agathe Boggio:agathe.boggio@taddeo.fr +33 7 62 77 69 42 [1] Sarconeos (BIO101) is the code name for Biophytis' drug candidate. The active molecule is 20-hydroxyecdysone (20E) SOURCE: Biophytis View source version on accesswire.com: