Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.

The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.
The main questions it aims to answer are:
* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)
* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.
Participants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication.
Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation.

Start Date12 Nov 2024

Sponsor / Collaborator

Queen Mary University of London

ChiCTR2400082184

/ SuspendedPhase 1IIT

Efficacy and safety of fondaparinux in prevention of deep venous thrombosis after total knee arthroplasty study

Start Date01 Apr 2024

Sponsor / Collaborator-

ChiCTR2300067693

/ SuspendedPhase 4IIT

The efficacy and safety of fondaparinux sodium in the thromboembolic prophylaxis of patients receiving total hip and knee arthroplasty: a prospective, single arm, mono-center clinical study

Start Date01 Feb 2023

Sponsor / Collaborator

The Second Affiliated Hospital of Chongqing Medical University

100 Clinical Results associated with Fondaparinux Sodium

100 Translational Medicine associated with Fondaparinux Sodium

100 Patents (Medical) associated with Fondaparinux Sodium

2,048

Literatures (Medical) associated with Fondaparinux Sodium

01 Mar 2025·Acta Biomaterialia

Cationic liposomes as broad-spectrum antidotes for heparin-based anticoagulants

Article

Author: An, Yang ; Sun, Ge ; Nie, Guangjun ; Huang, Yubiao ; Du, Jiarui ; Hou, Xueqin ; Zhang, Yinlong ; Du, Chong ; Dong, Zhenzhen ; Liu, Yang ; Cheng, Xiaoyu

Heparin-based anticoagulants have been widely used for the prevention and treatment of venous thrombotic diseases, as well as for anticoagulation during cardiopulmonary bypass and hemodialysis. However, excessive heparin usage brings serious bleeding risk, necessitating immediate reversal of their anticoagulant activity. Additionally, to prevent bleeding during surgery and restore hemostatic function post-cardiopulmonary bypass and hemodialysis, it is also crucial to reverse heparin's anticoagulant effects. Currently, protamine sulfate (PS) is the only clinically approved antidote for heparin. However, its effectiveness against low molecular weight heparin (LMWH) and fondaparinux sodium is limited. Moreover, PS has great potential to trigger fatal allergic reactions. Despite these concerns, no successful clinical substitutes for PS have been developed. In the current work, drawing inspiration from the mechanism by which PS efficiently reverses heparin, we modified the cationic liposome with cationic amino acids, arginine and lysine, to serve as a broad-spectrum antidote (CRKRK-Lipo) for heparin-based anticoagulants. This modification not only enhances their reversal efficiency but also reduces the overall surface charge, potentially improving their biocompatibility. In the tail bleeding and liver injury mouse models, CRKRK-Lipo demonstrated reversal efficiency comparable to PS for heparin and superior reversal efficiency for LMWH and fondaparinux sodium. Notably, CRKRK-Lipo exhibited a wider therapeutic dose window and did not exhibit severe cytotoxicity or immunogenicity, in contrast to PS. It is worth noting that cationic liposomes without polypeptide modification also displayed a significant heparin reversal effect. Our findings not only offer a potential alternative for PS but also broaden the application fields of cationic liposome. STATEMENT OF SIGNIFICANCE: This study introduces the cationic liposomes as a novel and effective alternative to protamine sulfate (PS) for the functional reversal of heparin-based anticoagulants. The results reveal that both CRKRK-modified cationic liposomes (CRKRK-Lipo) and unmodified cationic liposomes (Lipo) showed comparable reversal efficiency to PS for UFH and superior reversal efficiency for LMWH and fondaparinux sodium, with a wider therapeutic dose window and reduced toxicity. This work offers an alternative strategy for detoxifying heparin-based anticoagulants and expands the biomedical applications of cationic liposomes.

01 Mar 2025·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Part 1: Management of antithrombotic medications in dermatologic surgery

Review

Author: Samie, Faramarz H ; Trager, Megan H ; Humphreys, Tatyana R ; Gordon, Emily R

Perioperative management of antithrombotic agents requires practical and medical considerations. Discontinuing antithrombotic therapies increases the risk of thrombotic adverse events including cerebrovascular accidents, myocardial infarction, pulmonary embolism, deep vein thrombosis, and retinal artery occlusion. Conversely, continuation of antithrombotic therapy during surgical procedures has associated bleeding risks. Currently, no guidelines exist regarding management of antithrombotic agents in the perioperative period for cutaneous surgeries and practice differs by surgeon. Here, we review the data on antithrombotic medications in patients undergoing cutaneous surgery including medication-specific surgical and postoperative bleeding risk if the medications are continued, and thromboembolic risk if the medications are interrupted. Specifically, we focus on vitamin K antagonist (warfarin), direct-acting oral anticoagulants (rivaroxaban, apixaban, edoxaban, dabigatran), antiplatelet medications (aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole), unfractionated heparin, low molecular weight heparin (enoxaparin and dalteparin), fondaparinux, bruton tyrosine kinase inhibitors (ibrutinib, acalabrutinib), and dietary supplements (ie, garlic, ginger, gingko).

10 Jan 2025·CLINICAL NEPHROLOGY

Comparison of adverse drug reactions of heparin and its derivates in the European Economic Area based on data from EudraVigilance between 2017 and 2021

Article

Author: Wang, Mi ; Sui, Zhun ; Zuo, Li ; Gan, Liang-ying ; Wang, Yan

INTRODUCTION:

Hemodialysis patients need long-term frequent use of parenteral anticoagulants, and the side effects need to be taken seriously. This study aimed to assess the reporting of adverse drug reactions (ADRs) following administration of unfractionated heparin (UFH), low molecular weight heparins (LMWHs), fondaparinux, and danaparoid, in relation to their usage in European Economic Area (EEA).

MATERIALS AND METHODS:

The total number of ADRs of each anticoagulant between 2017 to 2021 was collected using data from the EudraVigilance database. The number of hemorrhages, thrombocytopenia, injection-site reaction, liver injury, hypersensitivity and bone disorder were collected, respectively. Usage of these anticoagulants was estimated using sales data from the IQVIA MIDAS database. The reporting rates of ADRs were calculated and compared using χ²-test.

RESULTS:

Between 2017 and 2021 in the EEA, the overall ADRs reporting rates per 10,000,000 standard units (SU) of UFH, enoxaparin, nadroparin, dalteparin, fondaparinux, and danaparoid were 12.3, 40.8, 23.6, 36.5, 91.4, and 430.0, respectively. There were significant differences among these drugs (χ² = 7,239.26, p < 0.001). Specifically, hemorrhage and thrombocytopenia were reported at higher rates, ranging from 2.8 to 140.1, and 2.0 to 115.9 per 10,000,000 SU among different anticoagulants. Injection-site reactions and hypersensitivity came in second, between 0.2 - 29.0 and 0.1 - 53.1 per 10,000,000 SU, respectively. The reporting rates for liver injury and bone disorder were reported at low rates.

CONCLUSION:

The reporting rates of ADRs for heparin and its derivates were all very low. In comparison, the reporting rate of ADRs for danaparoid and fondaparinux was relatively high. The most commonly reported ADRs were hemorrhage, thrombocytopenia, followed by injection-site reactions and hypersensitivity.

News (Medical) associated with Fondaparinux Sodium

18 Mar 2025

·www.globenewswire.com

CAMP4 Appoints Multiple Industry Veterans to its Board of Directors

With decades of experience in pharmaceutical development and extensive genetic medicine expertise, Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, will provide strategic guidance for CAMP4’s multiple drug development efforts CAMBRIDGE, Mass., March 18, 2025 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4”) (Nasdaq: CAMP), a clinical-stage biotechnology company developing a pipeline of regRNA-targeting antisense oligonucleotide (ASO) therapies to upregulate gene expression to restore healthy protein levels, today announced the appointments of Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, to the Company’s Board of Directors. “We are delighted to welcome Drs. Williams and Stewart to our Board of Directors,” said Josh Mandel-Brehm, Chief Executive Officer of CAMP4. “With their combined expertise spanning critical aspects of R&D and clinical development, we will benefit greatly from their strategic insights as we advance our lead clinical program for urea cycle disorders and our preclinical program for SYNGAP1-related disorders, while continuing to develop additional RNA-targeting medicines designed to upregulate gene expression and meaningfully address diseases where we believe modest increases in protein levels can have a tremendous impact on the lives of patients.” Dr. Williams commented, “CAMP4’s approach is opening exciting possibilities to upregulate gene expression, a long-sought-after and challenging feat in the field of genetic medicine. I look forward to working with the team to unlock the full potential of this approach and ultimately advance novel therapeutics to the clinic.” Dr. Stewart added, “I’m thrilled to join the CAMP4 team and support its mission of advancing programmable RNA therapeutics for genetic diseases where decreased protein expression drives disease pathophysiology. By pioneering new ways to restore gene expression, CAMP4 has the potential to bring life-changing therapies to patients who currently have limited or no disease-modifying treatment options.” With over 30 years in the biopharma industry, Dr. Williams has contributed to the development of several transformative drugs, including LEUKINE®, ENBREL®, ADCETRIS®, TECFIDERA®, APROLIX®, ELOCTATE®, and SPINRAZA®. He was previously President of R&D at Sana Biotechnology and the Founding President & CEO of Codiak BioSciences. Prior to Sana, Dr. Williams served as EVP of R&D at Biogen, and earlier in his career was CEO of ZymoGenetics (acquired by BMS), and held leadership roles at Seattle Genetics, Amgen, and Immunex. Over the course of his career, he has served on the Board of Directors and Advisory Boards of more than two dozen biotech companies. Dr. Stewart currently serves as a Senior Medical Advisor to several biopharma companies, and was most recently the Chief Medical Officer at Rhythm Pharmaceuticals. Prior to this position, he served as Head of R&D at Novelion Therapeutics. Before joining Novelion, he served as corporate Chief Medical Officer at GlaxoSmithKline. With extensive clinical development experience, he has led studies across all stages, from first-in-human trials to large Phase 4 cardiovascular outcome studies. Dr. Stewart has played a key role in the successful registration and launch of multiple therapies, including AVANDIA®, ARIXTRA®, TANZEUM®, and XOLREMDI®. Before transitioning to industry, he served as a Consultant Physician and Head of Clinical Services at the Diabetes Centre in Newcastle upon Tyne, UK, where his research was focused on lipid metabolism and type 2 diabetes. About CAMP4 Therapeutics CAMP4 is developing disease-modifying treatments for a broad range of rare and prevalent genetic diseases where increasing healthy protein levels may offer meaningful therapeutic benefits. Our approach allows for targeted gene upregulation by harnessing a fundamental mechanism of how genes are controlled. To increase gene expression, our therapeutic ASO drug candidates target regRNAs, which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAP Platform™ enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. Learn more about us at www.CAMP4tx.com and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning CAMP4’s plans, objectives, expectations and intentions. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; risks related to the operations of the Company’s suppliers; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain and are not guarantees of future events. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, you should not unduly rely on these forward-looking statements. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contacts Investor Relations:Sandya von der WeidLifeSci Advisorssvonderweid@lifesciadvisors.com Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com

Executive ChangeOligonucleotide

09 Nov 2022

·www.sanofi.com

Sanofi and GSK’s next-generation COVID-19 booster vaccine VidPrevtyn

Sanofi and GSK’s next-generation COVID-19 booster vaccine Vid P revtyn ® Beta approv ed by the European Commission First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe Strong immune response against all tested variants of concern Ready to supply for fall-winter COVID-19 vaccination campaigns in Europe Paris, November 1 0 , 2022 . After the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn ® Beta, the vaccine was approved by the European Commission, as a booster for the prevention of COVID-19 in adults 18 years of age and older. Designed to provide broad protection against multiple variants, the protein-based COVID-19 booster vaccine is based on the Beta variant antigen and includes GSK’s pandemic adjuvant. VidPrevtyn Beta is indicated as a booster for active immunization against SARS_CoV_2 in adults who have previously received an mRNA or adenoviral COVID vaccine. Shipments of VidPrevtyn Beta are ready to be distributed to European countries as per Advance Purchase Agreements. Thomas Triomphe Executive Vice President, Vaccines, Sanofi “ Today’s approval val i dates our research in developing a novel solution for the COVID-19 pandemic. As we’re ready to start first shipments , VidPrevtyn Beta will be an important new option to protect populations against multiple strains of COVID-19 . ” Philip Dormitzer Global Head of Research and Development Vaccines, GSK “This EC approval is an important step in providing further vaccine solutions to Europe for the coming winter. O ur protein-based, adjuvanted vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves further. ” In registration studies, carried out at times when Omicron strains were predominantly circulating, the vaccine induced a strong immune response against multiple variants. Registration studies included a Phase 3 primary efficacy trial (VAT08 Stage 2) and two separate immunogenicity studies, including one comparative study with approved mRNA booster as comparator i,ii . About Vid P revtyn Beta VidPrevtyn Beta is a monovalent, recombinant-protein next-generation COVID-19 vaccine developed by Sanofi, modelled on the Beta variant and including GSK’s pandemic adjuvant. The same recombinant-protein technology is used in Sanofi’s approved seasonal flu vaccines. Next-generation COVID-19 vaccines are based on a variant-adapted approach, using a strain other than the parental strain of SARS-CoV-2 (D614 strain). About COVIBOOST Immunogenicity & Safety Study The independent COVIBOOST (VAT013) study conducted by the Assistance Publique – Hôpitaux de Paris (AP-HP) investigated VidPrevtyn Beta following primary vaccination with two doses of Pfizer-BioNTech’s Comirnaty vaccine (BNT162b2). VidPrevtyn Beta generated a higher immune response (as measured by neutralizing antibody titers) than Pfizer-BioNTech’s booster or the Sanofi-GSK first-generation booster, both of which target the original D614 parent strain. In this study, which included 247 adult subjects (18-73 years-old), all three vaccines also elicited neutralizing antibodies against the Omicron BA.1 variant, with highest responses generated by the Sanofi-GSK next-generation candidate, one month after injection. VidPrevtyn Beta also elicited around 2.5 times more neutralizing antibodies against Omicron BA.1 and, in an exploratory analysis, against BA.4 / BA.5 strains than mRNA COVID-19 booster comparator. About the VAT02 Immunogenicity & Safety Study Immunogenicity studies included VAT02 Cohort 2 and COVIBOOST which evaluated the booster formulation modelled on the Beta variant and including GSK’s pandemic adjuvant. In the Phase 3 VAT02 Cohort 2 study, the vaccine induced (at day 15 following booster vaccination) a significant boost in antibody titers above baseline against multiple variants of concern (13-fold increase against D614 parent virus, 34-fold increase against the COVID-19 Beta strain) in 18-55 years-old adults previously primed with mRNA COVID-19 vaccines. In the VAT02 cohort 2 study, reactions were mostly mild to moderate, transient and self resolutive. About the VAT08 Stage 2 Efficacy & Safety Study The VAT08 Phase 3 Stage 2 study is a randomized, double-blind, placebo-controlled trial investigating primary vaccination with a bivalent COVID-19 vaccine containing both parental (D614) and Beta strains. The results showed a 64.7% efficacy against symptomatic SARS-CoV-2 infection in adults, regardless of their SARS-CoV-2 infection status prior to vaccination, and 75.1% efficacy in participants previously infected with SARS-CoV-2. This study was the first ever to report efficacy data in an Omicron environment. Across all the above-mentioned studies, the Sanofi-GSK bivalent next-generation vaccine candidate was well-tolerated, with an acceptable safety profile. About BARDA support Research and development for VidPrevtyn are supported by U.S. federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services under Contract # HHSO100201600005I, and in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002, and the National Institute of Allergy and Infectious Diseases (NIAID). About the Sanofi and GSK partnership In the collaboration between the two companies, Sanofi provides its recombinant antigen and will be the marketing authorization holder. GSK contributes with its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com Investor Relations Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | +1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. i https://www.sanofi.com/en/media-room/press-releases/2022/2022-06-24-05-29-02-2468538 ii https://www.sanofi.com/en/media-room/press-releases/2022/2022-06-13-05-30-00-2460833 Attachment Press Release

Clinical ResultVaccinePhase 3Drug ApprovalPhase 2

08 Sep 2020

·www.biospace.com

Mylan Acquires Aspen’s European Thrombosis Portfolio for $757.3 Million

The portfolio is made up of well-established injectable coagulants sold in Europe under various brand names, including Arixtra, Fraxiparine, Mon-Embolex and Orgaran. Netherlands-based Mylan is buying the intellectual property and commercialization rights to Aspen Pharmacare ’s thrombosis business in Europe for €641.9 million ($757.25 U.S.). The portfolio is made up of well-established injectable coagulants sold in Europe under various brand names, including Arixtra, Fraxiparine, Mon-Embolex and Orgaran. Under the terms of the deal, Mylan is paying €263.2 million in cash up front, then, using cash from operations, paying €378.7 million on June 25, 2021. The deal is expected to close before December 25, 2021. The portfolio Mylan is buying had a combined net sales for the 12 months ending June 30, 2020, of €231 million. “The acquisition of this thrombosis portfolio is a significant addition to Mylan’s European business that will not only make Mylan the second largest supplier of these products to patients in Europe, according to IQVIA, but also bolster our existing commercial infrastructure to further expand access to complex injectables,” said Rajiv Malik, president of Mylan. “By adding to our highly experienced sales and marketing team, we will further strengthen our current reach in hospitals and enhance the future growth of our biosimilars franchise in Europe.” Aspen will be responsible for manufacture of the drugs and product supply, delivering the finished product to Mylan. Aspen, the companies indicate, has a fully vertically integrated supply chain mostly located in Europe. Aspen Pharmacare is headquartered in Durban, South Africa, and is a global specialty and branded multinational pharma company. Mylan is merging with Pfizer’s generics division Upjohn, to form a new company called Viatris. That merger was announced in July 2019. Upjohn is Pfizer’s off-patent branded and generic established drugs business. It was an all-stock deal, with each Mylan share converted into one share of the new company. Pfizer shareholders will own 57% of the combined new company and Mylan shareholders will own 43%. Mylan has a portfolio across many geographies and therapeutic areas, including central nervous system and anesthesia, infectious disease and cardiovascular, and a robust pipeline, high-quality manufacturing and supply chain. Upjohn’s brands include Lipitor, Celebrex and Viagra, with strong commercial capabilities, including in China and other emerging markets. Viatris is expected to have pro forma 2020 revenues of $19 to $20 billion. It is to be led by Mylan’s current chairman Robert J. Coury, who will act as executive chairman. Michael Goettler, current Group President, Upjohn, will serve as chief executive officer, and Rajiv Malik, current Mylan president, will serve as president. Coury, of today’s announcement, said, “As we continue toward the launch of Viatris, we remain committed to executing on opportunities that will not only add to Mylan’s growth, but that also will be consistent with our vision for Viatris under the Global Healthcare Gateway, which we believe will establish the new company as a true Partner of Choice.” The Global Healthcare Gateway is part of the new branding and vision for Viatris. Viatris is Latin for “three paths,” and those three paths are apparently access, leadership and partnership. In a July 9, 2020 statement, Coury said, “Viatris will be focused on creating a more sustainable healthcare journey for patients worldwide while delivering value to all stakeholders for years to come. The Viatris branding reflects our drive to address the world’s emerging healthcare needs with passion and compassion. It also highlights our goal to chart a new course focused on improving patient outcomes by expanding access to medicine, providing leadership through innovative solutions and building best-in-class partnerships. We also will offer all partners ready access to more markets and the ability to reach more patients around the world through the company’s new and unique Global Healthcare Gateway, which leverages Viatris’ unmatched global infrastructure to connect people around the world to the high quality medicines and services they need, making Viatris a true Partner of Choice.”

AcquisitionExecutive Change

100 Deals associated with Fondaparinux Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D01844	Fondaparinux Sodium	B01AX05	DB00569

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Angina Pectoris	China	Glaxo Wellcome Production SAS	01 Jan 2008
Myocardial Infarction	China	Glaxo Wellcome Production SAS	01 Jan 2008
Acute Coronary Syndrome	Canada	GSK Plc	22 Mar 2007
Thromboembolism	Australia	Aspen Pharmacare Holdings Ltd.	25 Mar 2002
Angina, Unstable	European Union	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Angina, Unstable	Iceland	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Angina, Unstable	Liechtenstein	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Angina, Unstable	Norway	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Non-St Elevated Myocardial Infarction	European Union	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Non-St Elevated Myocardial Infarction	Iceland	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Non-St Elevated Myocardial Infarction	Liechtenstein	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Non-St Elevated Myocardial Infarction	Norway	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Pulmonary Embolism	European Union	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Pulmonary Embolism	Iceland	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Pulmonary Embolism	Liechtenstein	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
Pulmonary Embolism	Norway	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
ST Elevation Myocardial Infarction	European Union	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
ST Elevation Myocardial Infarction	Iceland	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
ST Elevation Myocardial Infarction	Liechtenstein	Viatris Healthcare (Pty) Ltd.	20 Mar 2002
ST Elevation Myocardial Infarction	Norway	Viatris Healthcare (Pty) Ltd.	20 Mar 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Knee Injuries	Phase 3	France	GSK Plc	01 Dec 2008
Knee Injuries	Phase 3	Germany	GSK Plc	01 Dec 2008
Knee Injuries	Phase 3	Italy	GSK Plc	01 Dec 2008
Knee Injuries	Phase 3	Netherlands	GSK Plc	01 Dec 2008
Knee Injuries	Phase 3	Russia	GSK Plc	01 Dec 2008
Knee Injuries	Phase 3	Spain	GSK Plc	01 Dec 2008
Wounds and Injuries	Phase 3	United States	GSK Plc	01 Dec 2007
Acrocallosal Syndrome	Phase 3	United States	GSK Plc	01 Jun 2007
Acrocallosal Syndrome	Phase 3	Canada	GSK Plc	01 Jun 2007
Coronary Artery Disease	Phase 3	Canada	GSK Plc	17 May 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02744092 (CANVAS, CTgov)	Not Applicable	Pulmonary Embolism \| Neoplasms \| Venous Thrombosis ... View more	811	Rivaroxaban+Edoxaban+Apixaban+Dabigatran (Randomized Arm 1 (DOACs))	huxyvowxcw = ndbeaaprer syghdvpmos (zomrimmhir, dsgyqxknoy - ljsijandzo) View more	-	03 Oct 2023
				Warfarin+Fondaparinux+Enoxaparin+Dalteparin (Randomized Arm 2 (LMWH))	huxyvowxcw = kswuxggjnr syghdvpmos (zomrimmhir, zzjlubtynr - hrsueojjyq) View more
NCT04406389 (IMPACT, CTgov)	Phase 4	COVID-19	14	Unfractionated heparin+Fondapariniux+Enoxaparin sodium (Intermediate Dose Prophylaxis)	uwfuimwied = pvnrofcxke gnkisfopqr (seqhihkvgh, qymdvixgtz - ssfwxzagfp) View more	-	21 Sep 2023
				Unfractionated heparin+Fondapariniux+Argatroban+Enoxaparin sodium (Therapeutic Dose Anticoagulation)	uwfuimwied = byvaiqhwsr gnkisfopqr (seqhihkvgh, jvsmahfnie - nxkwpbolac) View more
ISTH2023	Not Applicable	Antiphospholipid Syndrome	46	Fondaparinux	wgtumuvwuy(bqyghuhokw) = qvagznmdxx xgttpedazf (lifbzlvgzg ) View more	-	24 Jun 2023
ISTH2023	Not Applicable	Thromboembolism	85	Fondaparinux	ryxvknxcmz(kanwudnvuv) = jccxyagzsy mrktqxkgkt (onicedramq ) View more	-	24 Jun 2023
NCT00789399 (CTgov)	Not Applicable	Coronary Artery Disease \| Venous Thrombosis \| Venous Thromboembolism	78	Fondaparinux (Fondaparinux)	totagfleke = kajunhmavd yrajahzvjc (qbpficsoqc, tldwatqywk - mjjyrrewch) View more	-	08 Sep 2022
				Placebo (Placebo)	totagfleke = aeckpbkabl yrajahzvjc (qbpficsoqc, aexxdoqiyr - bdeackcbhu) View more
ESC2022	Not Applicable	Critical Illness \| COVID-19 \| Blood Coagulation Disorders D-dimer	465	D-dimer-driven fondaparinux	zlvkkmlqcc(lawklqtihk) = ymvhtrgtod pegqnfuiut (yyzcaxmfln ) View more	Negative	27 Aug 2022
				Standard prophylactic-dose fondaparinux	zlvkkmlqcc(lawklqtihk) = bqdcuogoeh pegqnfuiut (yyzcaxmfln ) View more
ISTH2020	Not Applicable	Protein S Deficiency	4	Fondaparinux 2.5 mg	ngvwtqvwpj(mlecohwygs) = nmdgpkfbim wtahmoelfg (qyyxfhbhbm )	Positive	12 Jul 2020
ONCOTEV (ISTH2020)	Not Applicable	Venous Thromboembolism	368	Fondaparinux	icdrsagsxi(kqjcwxqjpe) = wuiwikwaak rwcgjndylk (kprduhuyns )	-	12 Jul 2020
				Enoxaparin	icdrsagsxi(kqjcwxqjpe) = qzhfowbkkx rwcgjndylk (kprduhuyns )
ISTH2019	Not Applicable	Heparin-induced thrombocytopenia	89	Fondaparinux	oqsdlilqbj(hbnvntahii) = kbhnnveqpj wyucbtvsrv (fzibumrzzl )	-	10 Jun 2019
EASL2019	Not Applicable	Portal Vein Thrombosis	123	Fondaparinux	bukxthddse(igvjygnbbi) = One patient treated with FPX and 3 patients in LMWH had a major bleeding episodes lfeyxwfqut (hckwidvexc )	Positive	13 Apr 2019
				Low Molecular Weight Heparin (LMWH)

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