Recipharm och Moderna ingår avtal om aseptisk tillverkning för marknader utanför USA
Recipharm, ett ledande CDMO-företag (Contract Development and Manufacturing Organisation) och Moderna, ett amerikanskt bioteknikföretag med banbrytande budbärar-RNA (mRNA) läkemedel och vacciner, meddelar idag att de har ingått ett avtal om att formulera, fylla och packa en del av Modernas covid-19 vaccinförsörjning för marknader utanför USA. Produktionen kommer att ske vid Recipharms anläggning för läkemedelstillverkning i Frankrike.
Under förutsättning att vaccinet godkänns i relevanta länder utanför USA, förväntas leveranser påbörjas tidigt under 2021.
Nicolas Chornet, Senior Vice President, International Manufacturing vid Moderna, säger: ”Vi gör stora framsteg i utvecklingen av Modernas covid-19 vaccin och vi är glada att gå in i detta samarbete med Recipharm. Vi ser fram emot deras stöd när det gäller att snabbt leverera vårt vaccin till marknaden.”
I en kommentar säger Thomas Eldered, Recipharms VD: ”Det här är ett betydelsefullt avtal som även är strategiskt viktig för oss, och vi är mycket nöjda över att samarbeta med Moderna och deras partners i ett så här viktigt projekt i en långsiktig kamp mot covid-19. Vi har kommit långt i våra förberedelser med att rekrytera personal och göra investeringar i fabriken för att kunna möta den utmanande tidsplanen.”
Recipharm kontaktinformation
Thomas Eldered, VD, telefon: 08 602 52 10
Jean-François Hilaire, Executive Vice President, telefon: +33 695 447 507
Tobias Hägglöv, CFO, ir@recipharm.com, telefon: 08 602 52 00
Moderna kontaktinformation
Media: Colleen Hussey, Director, Corporate Communications, telephone: +1 617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar, Senior Vice President & Head of Investor Relations, telephone: +1 617-209-5834 Lavina.Talukdar@modernatx.com
Denna information är sådan information som Recipharm AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen i pressmeddelandet lämnades för offentliggörande den 30 december 2020 kl. 17:20.
Om Recipharm
Recipharm är ett ledande CDMO-företag (Contract Development and Manufacturing Organisation) inom läkemedelsindustrin och har nära 9 000 anställda. Recipharm erbjuder tillverkningstjänster av läkemedel i olika former, produktion av material till kliniska prövningar och API:er, farmaceutisk produktutveckling samt utveckling och tillverkning av medel för läkemedelsadministration. Recipharm tillverkar flera hundra olika produkter åt såväl stora läkemedelsföretag som mindre utvecklingsbolag. Bolaget omsätter cirka 11 miljarder kronor per år och har utvecklings- och tillverkningsanläggningar i Frankrike, Indien, Israel, Italien, Portugal, Spanien, Storbritannien, Sverige, Tyskland och USA med huvudkontor i Stockholm, Sverige. Recipharms B-aktie (RECI B) är noterad på Nasdaq Stockholm.
För mer information, besök företagets webbplats www.recipharm.com.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the terms of the collaboration between Recipharm and Moderna for the formulation, filling and finishing of pharmaceutical products, including the Moderna COVID-19 vaccine, and the timing for commencement of supply of the vaccine. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna’s regulatory approval strategies, components of the company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 vaccine; whether and when any biologics license applications and/or emergency use authorization applications may be filed and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties listed under the heading “Risk Factors” in Moderna’s most recent quarterly report on Form 10-Q filed with the SEC and in subsequent filings made by Moderna with the SEC, which are available on Moderna’s website at www.modernatx.com and on the SEC’s website at www.sec.gov. Except as required by law, Moderna and Recipharm each disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
Recipharm AB (publ), Org. nr 556498-8425
Adress Box 603, 101 32 Stockholm, Sverige, Telefon 46 8 602 52 00
www.recipharm.com
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