Feasibility and Efficacy of Intravenous Ferric Derisomaltose to Correct Pre-operative Iron-deficiency Anemia in Patients Undergoing Gynecologic Oncology Surgery: a Pilot Randomized Double Blinded Parallel Group Placebo-controlled Study

Iron deficiency has been reported in approximately 35% of patients with a gynecologic malignancy. Blood transfusions are known to be immunosuppressive and carry immediate and long-term risks. Pre-operative blood transfusion in gynecologic oncology patients is associated with higher rates of surgical site infection, length of stay, composite morbidity, cancer recurrence, and mortality. Pre-operative intravenous iron formulations have been shown in benign gynecology and other surgical specialities to increase pre-operative hemoglobin and decrease post-operative transfusion rates.
This is a randomized double-blinded clinical trial evaluating the effects of treating patients undergoing gynecologic oncology surgery with intravenous ferric derisomaltose to correct pre-operative iron-deficiency anemia.
The study aims to assess the effectiveness of preoperative ferric derisomaltose/iron isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy.

Start Date01 Sep 2024

Sponsor / Collaborator

AHS Cancer Control Alberta

NCT06350955

/ RecruitingPhase 4IIT

Intravenous Iron-induced Hypophosphatemia in Patients With Roux-en-Y Gastric Bypass: a Single-blind, Randomized Clinical Trial Comparing Iron Isomaltoside (Monofer®) and Ferric Carboxymaltose (Ferinject®)

The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®).

Start Date02 May 2024

Sponsor / Collaborator

Centre Hospitalier Universitaire Vaudois

100 Clinical Results associated with Ferric Derisomaltose

100 Translational Medicine associated with Ferric Derisomaltose

100 Patents (Medical) associated with Ferric Derisomaltose

222

Literatures (Medical) associated with Ferric Derisomaltose

01 Jan 2025·INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS

Fetal bradycardia and acidosis during maternal parenteral iron: Case reports and literature review

Review

Author: Chan, Lin Wai ; Law, Ho Ying ; Lee, Linus L. T.

Abstract:

Iron deficiency anemia is an important problem among pregnant women, and intravenous (IV) iron infusions have been increasingly used. Whether fetal monitoring is required during infusion has been debated, with a recent guideline by Hematologists recommending against such. We report two cases of fetal bradycardia after iron isomaltoside (IIM), in women with otherwise good maternal and fetal health. Both developed dyspnea with desaturation minutes from infusion, followed by persistent fetal bradycardia. Both underwent category 1 CS, with cord arterial pH of 7.08 and 6.94 respectively. Upon literature review, only three case reports on fetal bradycardia in IV iron were identified. For older IV iron formulations, a case was reported after IV dextran test dose, while two cases after ferric gluconate were reported. For the new formulation IIM, only one case was reported so far, but in a woman with Crohn's disease and intrauterine growth restriction. IV iron in pregnancy carries risk of anaphylactic or hypersensitivity reactions, even with the newest formulations and in women with good maternal and fetal health. While rarely reported so far, fetal bradycardia is a possible consequence, commonly preceded by respiratory symptoms. Fetal monitoring should therefore be considered during infusion.

01 Jan 2025·EUROPEAN JOURNAL OF HEART FAILURE

Effect of correcting iron deficiency on the risk of serious infection in heart failure: Insights from the IRONMAN trial

Article

Author: Wong, Yuk‐Ki ; Foley, Paul W. ; Spencer, Chales ; Lang, Ninian N. ; Kalra, Philip A. ; Ford, Ian ; Leslie, Stephen J. ; Petrie, Mark C. ; Campbell, Philip ; Graham, Fraser ; Chapman, Callum ; Donnelly, Patrick ; Pellicori, Pierpaolo ; Walsh, John ; Squire, Ian ; Kalra, Paul R. ; Cleland, John G.F. ; Hannah, Andrew ; Savage, Hernry O. ; Matthews, Iain ; Piper, Sue ; Ray, Robin

Aims:

Concerns exist that intravenous (IV) iron might increase the risk of infections. The IRONMAN trial provided an opportunity to investigate whether giving IV ferric derisomaltose (FDI) to patients with heart failure and iron deficiency alters the rate of hospitalization or death due to infections.

Methods and results:

IRONMAN was a randomized trial of IV FDI versus usual care in patients with symptomatic heart failure, left ventricular ejection fraction (LVEF) ≤45%, and transferrin saturation (TSAT) <20% or ferritin <100 μg/L. Infection was a pre‐specified, blindly‐adjudicated, safety endpoint. The primary analysis of interest was infection as the main reason for hospitalization or death, using first and recurrent events analyses. The composite primary event of interest tended to be lower in those randomized to FDI when analysed as first (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.62–1.01, p = 0.055) or recurrent event (rate ratio 0.85, 95% CI 0.64–1.13, p = 0.089). The composite results were driven by fewer hospitalizations for infection (HR 0.76, 95% CI 0.49–0.98, p = 0.032), with 5% fewer patients (absolute reduction) experiencing such an event if assigned to FDI. Similar trends were observed for recurrent events (HR 0.82, 95% CI 0.62–1.10). Further analyses suggested that the reduction in hospitalizations due to infection with FDI was restricted to patients with TSAT <20%.

Conclusions:

In patients with heart failure and a reduced LVEF, correction of iron deficiency is not associated with an increased risk of hospitalization or death from infection, and may reduce such events, especially when TSAT is <20%.Clinical Trial Registration: ClinicalTrials.gov, NCT02642562.

31 Dec 2024·Journal of medical economics

Cost-utility analysis of ferric derisomaltose versus ferric carboxymaltose in patients with inflammatory bowel disease and iron deficiency anemia in England

Article

Author: Iqbal, Tariq H. ; Kennedy, Nicholas ; Ahmed, Waqas ; Dhar, Anjan ; Pollock, Richard F.

AIMS:

Anemia is the most common extraintestinal complication of inflammatory bowel disease (IBD), with approximately half of cases caused by iron deficiency (ID). Intravenous iron is the preferred ID anemia (IDA) treatment where oral iron is contraindicated, ineffective or not tolerated, or where ID correction is urgent. The objective was to evaluate the cost-utility of ferric derisomaltose (FDI) versus ferric carboxymaltose (FCM) in patients with IBD and IDA in England, in whom IV iron treatment is preferred.

MATERIALS AND METHODS:

A patient-level simulation model was developed, capturing quality of life (QoL) differences based on SF-36v2 data from the PHOSPHARE-IBD randomized controlled trial, monitoring and incidence of post-infusion hypophosphatemia, and number of iron infusions required. Analyses were conducted over a five-year time horizon from the Department of Health and Social Care (DHSC) perspective, with healthcare provider and societal perspectives adopted in separate analyses. Future costs and effects were discounted at 3.5% per annum and one-way and probabilistic sensitivity analyses were performed.

RESULTS:

FDI increased quality-adjusted life expectancy by 0.075 QALYs versus FCM from 2.57 QALYs to 2.65 QALYs per patient. Patients receiving FDI required 1.63 fewer iron infusions over the five-year time horizon, driving infusion-related cost savings of GBP 496 per patient (GBP 2,188 versus GBP 1,692) from the DHSC perspective. Costs of monitoring and treating hypophosphatemia after FCM were GBP 226, yielding total savings of GBP 722 per patient (GBP 2,414 versus GBP 1,692) over the five-year time horizon. FDI also led to reduced costs versus FCM in the societal and provider analyses and was therefore the dominant intervention across all three perspectives.

LIMITATIONS:

The analysis did not capture patient adherence, hypophosphatemic osteomalacia, or fractures.

CONCLUSIONS:

Results showed that FDI improved patient QoL and reduced direct healthcare expenditure versus FCM in patients with IBD and IDA in England.

News (Medical) associated with Ferric Derisomaltose

07 Aug 2024

·www.globenewswire.com

Pharmacosmos Group to Acquire G1 Therapeutics

- Business Combination Expected to Provide Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) Optimal Access to G1’s COSELA® (trilaciclib), the First and Only Proactive Multilineage Myeloprotection Agent - - Pharmacosmos’ Significant Resources and Expertise in Hematology and Supportive Care to Maximize Availability of COSELA for Patients with ES-SCLC - - Transaction Expands and Strengthens Pharmacosmos’ Global Commercial Portfolio - - G1’s Shareholders to Receive U.S. $7.15 per Share in Cash for a Total Equity Value of Approximately $405 Million - RESEARCH TRIANGLE PARK, N.C. and HOLBAEK, Denmark, Aug. 07, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company focused on delivering next-generation therapies that improve the lives of those affected by cancer, and Pharmacosmos A/S, a leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anemia, today announced that they have entered into a definitive merger agreement under which Pharmacosmos A/S, through its U.S. subsidiary Pharmacosmos Therapeutics Inc., will acquire all outstanding shares of G1 Therapeutics common stock for U.S. $7.15 per share in cash for a total equity value of approximately $405 million, which represents a 68% premium to G1’s closing share price on August 6, 2024 and a 133% premium to G1’s prior 30-day volume weighted average price. The Boards of Directors of the parties have unanimously approved the transaction, which is expected to close late in the third quarter of 2024. G1’s COSELA is the first and only product approved by the U.S. Food and Drug Administration to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). Together, Pharmacosmos and G1 Therapeutics will execute on the shared vision to grow and accelerate the availability of COSELA for all appropriate patients with ES-SCLC. G1 brings a well-established and successful commercial, sales, and medical platform to Pharmacosmos, which has complementary expertise in commercializing hematology and supportive care products, a robust global commercial presence, and significant resources to maximize the penetration of COSELA into the ES-SCLC market. Together, the combined company will be able to optimize the commercial reach to oncologists and expand the availability of COSELA among patients living with ES-SCLC. “G1 and Pharmacosmos have a shared commitment to people living with cancer; the transaction announced today will enable a more rapid uptake of COSELA into the ES-SCLC market to maximize availability for patients who need this important drug,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “Importantly, this acquisition delivers significant value to G1’s stakeholders by providing better and broader access to this important product for the cancer patients we seek to treat and a significant premium to our shareholders. I am proud of all that the G1 team has accomplished over the years, thankful for their great effort, and excited about what’s possible by the combined Pharmacosmos/G1 team as we meet the needs of more cancer patients." “The acquisition of G1 Therapeutics Inc., its intellectual property, and the addition of COSELA® (trilaciclib) to our portfolio of innovative products is transformative for Pharmacosmos. By combining our existing colleagues with the great team at G1 Therapeutics, we will meaningfully expand our organization serving oncologists in the US. This will enable broader and better access for patients in need of COSELA as well as for our existing FDA approved drug, Monoferric® (ferric derisomaltose),” said Tobias S. Christensen, President and Chief Executive Officer of Pharmacosmos A/S. “COSELA is a first-in-class product that brings important benefits to patients and fits very nicely together with our lead product Monoferric® (ferric derisomaltose). While Monoferric is available around the World, COSELA is so far only approved in the US and in China. It will be a focus for us to bring this important product to more patients both in US and worldwide to help minimize the number of lung cancer patients suffering from myelosuppression after chemotherapy.” Transaction Terms Under the terms of the merger agreement, Pharmacosmos has agreed to commence a cash tender offer to acquire all issued and outstanding shares of G1 common stock for US $7.15 per share in cash. The transaction will be fully financed by Pharmacosmos’ existing cash on hand and existing corporate credit facilities. The closing of the tender offer will be subject to customary conditions, including the tender of shares which represent at least a majority of the total number of G1’s outstanding shares of common stock and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Upon successful completion of the tender offer, Pharmacosmos would acquire all shares not acquired in the tender offer through a second-step merger for the same consideration that the tendering stockholders will receive in the tender offer. It is anticipated the transaction will close late in the third quarter of 2024. Upon completion of the transaction, G1’s common stock will no longer be publicly listed. As previously announced, G1 will be releasing its second quarter 2024 financial results and filing its Form 10-Q Quarterly Report tomorrow. However, due to the pending transaction, we will no longer be hosting a conference call at 8:30 am ET, August 8 to review such results. Advisors For Pharmacosmos, MTS Health Partners, L.P. is serving as exclusive financial advisor, and Arnold & Porter Kaye Scholer LLP is serving as legal counsel. For G1, Centerview Partners LLC is serving as exclusive financial advisor, and Ropes & Gray LLP and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. are serving as legal counsel. About COSELA® (trilaciclib) for Injection COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021. Indication COSELA® (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer. Important Safety Information COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib. Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity. The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia. This information is not comprehensive. Please click here for full Prescribing Information. https://www.g1therapeutics.com/cosela/pi/ To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. About Monoferric (ferric derisomaltose) Indication Monoferric (ferric derisomaltose) is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral ironwho have non-hemodialysis dependent chronic kidney disease (NDD-CKD) Important Safety Information Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. Warnings and precautions include serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient. Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload. Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric. Adverse reactions related to treatment and reported by ≥1% of the treated patients were nausea (1.2%) and rash (1%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group. Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2. To report adverse events, please contact Pharmacosmos at 1-888-828-0655. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088. This information is not comprehensive. Please click here for full Prescribing Information. Pharmacosmos Group Pharmacosmos A/S, headquartered in Holbaek, Denmark, and founded in 1965, is a highly specialised company focused on carbohydrate chemistry and a global leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anaemia. With companies in the UK, Ireland, Nordics, Germany, the USA, and China, as well as through partners, Pharmacosmos markets its products around the world. With a strong and ongoing commitment to R&D, Pharmacosmos is able to leverage a unique carbohydrate production platform along with deep expertise in the synthesis of iron-carbohydrate complexes. The Pharmacosmos Group has more than 500 employees. About G1 Therapeutics G1 Therapeutics, Inc. is a commercial-stage oncology biopharmaceutical company whose mission is to develop and deliver next-generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). G1’s goal is to provide innovative therapeutic advances for people living with cancer. G1 is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on X (formerly known as Twitter) @G1Therapeutics and LinkedIn. G1 Therapeutics® and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc. Forward-Looking Statements This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the proposed acquisition of G1 by Pharmacosmos, the expected timetable for completing the transaction, and G1’s future financial or operating performance. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this document are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: (i) risks associated with the timing of the closing of the proposed transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed transaction will not occur; (ii) uncertainties as to how many of G1’s stockholders will tender their shares in the offer; (iii) the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; (iv) the possibility that competing offers will be made; (v) the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; (vi) unanticipated difficulties or expenditures relating to the proposed transaction, the response of business partners and competitors to the announcement of the proposed transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed transaction; (vii) G1’s ability to successfully demonstrate the efficacy and safety of its drug or drug candidates, and the preclinical or clinical results for its product candidates, which may not support further development of such product candidates; (viii) comments, feedback and actions of regulatory agencies; (ix) G1’s dependence on the commercial success of COSELA (trilaciclib); (x) the inherent uncertainties associated with developing new products or technologies and operating as commercial stage company; (xi) chemotherapy shortages; and (xii) other risks identified in G1’s SEC filings, including G1’s Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent filings with the SEC. G1 cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. G1 disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Additional Information and Where to Find It The tender offer referred to in this document has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares, nor is it a substitute for the tender offer materials that Pharmacosmos and its acquisition subsidiary will file with the SEC upon commencement of the tender offer. At the time the tender offer is commenced, Pharmacosmos and its acquisition subsidiary will cause to be filed a tender offer statement on Schedule TO with the SEC, and G1 will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the tender offer. THE TENDER OFFER STATEMENT (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY AND CONSIDERED BY G1’S STOCKHOLDERS BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. Both the tender offer statement and the solicitation/recommendation statement will be mailed to G1’s stockholders free of charge. A free copy of the tender offer statement and the solicitation/recommendation statement will also be made available to all stockholders of G1 by accessing https://investor.g1therapeutics.com/ or by contacting Investor Relations at ir@g1therapeutics.com. In addition, the tender offer statement and the solicitation/recommendation statement (and all other documents filed with the SEC) will be available at no charge on the SEC’s website: www.sec.gov, upon filing with the SEC. G1’S STOCKHOLDERS ARE ADVISED TO READ THE SCHEDULE TO AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER OFFER, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO. Pharmacosmos A/S Contact: Christian Lundquist MadsenVP Global Marketing & Communication+45 5948 5959 clm@pharmacosmos.com G1 Therapeutics Contacts: John W. Umstead VChief Financial Officer919-747-8419jumstead@g1therapeutics.com Will RobertsCommunications OfficerVice President, Investor Relations and Corporate Communications(919) 907-1944 wroberts@g1therapeutics.com

Drug ApprovalAcquisition

28 Aug 2023

·www.prnewswire.com

Ferinject® granted upgraded recommendations in 2023 ESC heart failure guidelines

The 2023 European Society of Cardiology (ESC) guidelines for acute and chronic heart failure (HF) include upgraded recommendations for intravenous (IV) iron supplementation, including Ferinject® (ferric carboxymaltose), for the management of iron deficiency in patients with HF. Phase IV HEART-FID study results and ferric carboxymaltose meta-analysis also presented at 2023 ESC Congress ST. GALLEN, Switzerland, Aug. 28, 2023 /PRNewswire/ -- CSL Vifor is pleased to announce that the European Society of Cardiology (ESC) have upgraded recommendations in the ESC 2023 guidelines for the treatment of iron deficiency acute and chronic HF with IV iron supplementation, including Ferinject®. The guidelines include higher level of recommendations and address a broader patient group for the management of iron deficiency in HF patients with compromised heart function (HFrEF and HFmrEF). Intravenous iron supplementation is recommended in symptomatic patients with HFrEF and HFmrEF, and iron deficiency, to alleviate HF symptoms and improve quality of life. (Class I, level A) Intravenous iron supplementation with ferric carboxymaltose or ferric derisomaltose should be considered in symptomatic patients with HFrEF and HFmrEF, and iron deficiency, to reduce the risk of HF hospitalization, irrespective of hospitalisation history (Class IIa, level A). "We are pleased that ESC's new heart failure guidelines have been updated to reflect the latest scientific evidence," said Fabio Dorigotti, Head of Global Medical Affairs at CSL Vifor. "Improving iron deficiency diagnosis followed by IV iron supplementation based on the updated guidelines means more patients may potentially benefit from IV iron treatment. We are particularly pleased with the updated recommendations for IV iron including Ferinject® in the new 2023 focused update of the 2021 treatment guidelines. This revision will enable cardiologists and physicians to better treat more of the symptomatic heart failure patients with iron deficiency." In addition, findings from the phase IV HEART-FID trial (NCT03037931) of ferric carboxymaltose were presented at the ESC congress 2023 in Amsterdam, Netherlands, and simultaneously published in the peer-reviewed medical journal New England Journal of Medicine.1 HEART-FID is the largest and longest duration trial to date evaluating IV iron in HF patients with reduced ejection fraction and iron deficiency. The trial approached but did not meet the pre-specified statistical significance of p<0.01 on the primary endpoint, which was a hierarchical composite of death and HF hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance (6-MWD). The results showed that with ferric carboxymaltose, there were numerically fewer deaths and hospitalizations for HF through 12 months and a modest benefit in the 6-MWD at 6 months compared to placebo. Ferric carboxymaltose was generally well tolerated and without unexpected safety findings. "While the results from the HEART-FID study did not meet statistical significance at the pre-specified level, the totality of evidence with ferric carboxymaltose from prior studies assessing symptomatic and functional status endpoints – combined with recent clinical outcomes studies – show overall safety and potential benefits," said Robert Mentz, MD, Chief of the Heart Failure Section at Duke University Medical Center, Durham, US, and Clinical Lead for the trial. To understand these new results in light of the totality of the evidence for IV iron in HF patients with iron deficiency, investigators also executed a pooled analysis using individual participant data from the three long-term trials FAIR-HF, CONFIRM-HF and HEART-FID of ferric carboxymaltose with a total of 4'501 patients. It represents the largest analysis to date to examine the effects of ferric carboxymaltose on clinical outcomes and was presented at the ESC congress 2023 with a parallel acceptance of the manuscript in the peer-reviewed European Heart Journal.2 Treatment with ferric carboxymaltose in iron-deficient HF patients with reduced or mildly reduced left ventricular ejection fraction was associated with a reduction in the composite endpoint of total cardiovascular hospitalizations and cardiovascular death compared with placebo, and with significantly reduced risks of hospitalization due to heart failure or cardiovascular causes, with no effect on survival. "One in two patients with chronic HF has iron deficiency, with a significant number of patients not being diagnosed or inadequately treated for iron deficiency," commented Steve Pascoe, MD, Senior Vice President, Clinical and Therapeutic Area Strategy, CSL. "We are confident that the outcomes of this trial and the pooled analysis of ferric carboxymaltose are an important contribution to the growing body of evidence showcasing the advantages of IV iron treatment for HF patients." About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, . About the ESC guidelines The ESC HF guidelines aim to provide practical, evidence-based recommendations for the diagnosis and treatment of HF, thereby improving and harmonizing standards of diagnosis and treatment of cardiovascular diseases for physicians, and potentially optimizing patient care. The ESC HF guidelines are updated periodically, with the 2023 version updated at the ESC congress end of August 2023. About HEART-FID HEART-FID is the first randomized clinical trial powered to evaluate the effects of intravenous ferric carboxymaltose on a hierarchical endpoint of death, heart failure hospitalizations, and functional status for adult patients with iron deficiency. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 3,065 patients at 281 international centers. Eligible patients were at least 18 years old in stable chronic heart failure with New York Heart Association functional class II to IV symptoms, ejection fraction ≤40%, iron deficiency (ferritin <100 ng/mL or ferritin 100–300 ng/mL with a transferrin saturation <20%), and documented heart failure hospitalization or elevated N-terminal pro-brain natriuretic peptide. The primary endpoint of the study was a hierarchical composite of death and heart failure hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance. About the meta-analysis The meta-analysis Impact of ferric carboxymaltose on heart failure-related clinical outcomes in patients with heart failure and iron deficiency: an individual participant data meta-analysis represents the largest pooled analysis to examine the effects of ferric carboxymaltose on clinical outcomes (hospitalizations and mortality) and the first to include the results of the HEART-FID trial. Patient-level data from the three randomized, placebo-controlled ferric carboxymaltose trials CONFIRM-HF, AFFIRM-AHF and HEART-FID with a total of 4'501 adults with HF and iron deficiency with ≥52 weeks follow-up were analysed. The co-primary efficacy endpoints were composite of total/recurrent cardiovascular hospitalizations and cardiovascular death and composite of total HF hospitalizations and cardiovascular death. Both endpoints were examined through 52 weeks of follow-up and based on events adjudicated independently by blinded events committees. Key secondary endpoints included individual components of the composite endpoints. About Ferinject® Ferinject® (ferric carboxymaltose) is an IV iron therapy with market authorization in 86 countries by August 2023. It has a track record of delivering significant value to patients and healthcare systems which is based on extensive clinical data and more than 25 million patient years of exposure. Ferinject ® is the most extensively studied IV iron.3 References: 1 Mentz RJ, Garg J, Rockhold FW, Butler J, De Pasquale CG, Ezekowitz JA, et al. Ferric carboxymaltose in heart failure with iron deficiency. N Engl J Med 2023 [published on-line] DOI: 10.1056/NEJMoa2304968. 2 Ponikowski P, Mentz RJ, Hernandez AF, Butler J, Khan MZ, van Veldhuisen DJ, et al. Efficacy of Ferric carboxymaltose in heart failure with iron deficiency: an individual patient data meta-analysis. Eur Heart J 2023 [published on-line] DOI: 10.1093/eurheartj/ehad586. 3 Data on file. Injectafer Studies. Daiichi Sankyo Inc., Basking Ridge, NJ. SOURCE Vifor International AG (CSL Vifor)

Clinical ResultAHAPhase 2

21 Jun 2022

·endpts.com

European Commission opens investigation into Vifor for potentially disparaging a competitor

As the European Commission looks to strengthen the pharma sector’s competitiveness, the commission is also cracking down on the sector in new ways. The commission on Monday opened a formal antitrust investigation into Swiss-based Vifor Pharma to see if the company has restricted competition by illegally disparaging its closest and potentially its only competitor in Europe, the Danish pharma company Pharmacosmos and its drug to combat iron deficiency Monofer. The commission said that Vifor Pharma, which Australia’s CSL agreed to pay $11.7 billion in 2021 to acquire, appeared to be hindering the uptake of Monofer as it competes against its own intravenous iron treatment dubbed Ferinject. The EC has indicated that, for several years, Vifor Pharma may have been disparaging Monofer by spreading misleading information regarding its safety, primarily targeting healthcare professionals, which may have hindered Monofer’s uptake in Europe. “Competition in the pharmaceutical sector is important. It provides access to affordable and innovative medicines to patients. The dissemination of misleading information regarding the safety of Pharmacosmos’ iron deficiency treatment, Monofer, may have delayed its uptake,” said Margrethe Vestager, EVP in charge of competition policy for the EC, in a statement. In a statement emailed to Endpoints News, Vifor Pharma acknowledged that the EC has opened the investigation into potential anti-competitive conduct with regard to Ferinject, but the opening of a formal investigation does not mean that any wrongdoing on their part has been established. Vifor also said they are fully cooperating and are convinced that they have not engaged in any anti-competitive behavior. “As a global pharmaceutical company, we support both fair competition and transparent scientific information. As this is an ongoing investigation and discussions with the (EC) are continuing, we are not in a position to comment further at this time,” Vifor said. Pharmacosmos added in a statement that the spreading of misleading information regarding Monofer’s safety may have unduly hindered Monofer’s uptake in the EEA, where approximately 1.8 million patients annually are being treated with high-dose intravenous iron products. “This alleged abuse would ultimately harm patients by stifling competition from an innovative medicine. Pharmacosmos, as the complainant, welcomes the (ECs) decision to open an in-depth and prioritized investigation into the alleged anticompetitive disparagement,” the statement said. The move to iron-based medicines has been a major shift for Pharmacosmos. In 2021 , the company dropped $225 million to purchase AbFero, a spinout from Raymond Bergeron’s lab at the University of Florida, to acquire its lead candidate that could be used as a treatment for transfusional iron overload.

100 Deals associated with Ferric Derisomaltose

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KEGG	Wiki	ATC	Drug Bank
D11808	Ferric Derisomaltose	B03AC	DB15617

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Iron deficiency	CA	Pharmacosmos A/S	22 Jun 2018
Anemia, Iron-Deficiency	AU	Pharmacosmos A/S	04 Dec 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Female Genital Neoplasms	Phase 3	-	Pharmacosmos A/S	30 Sep 2022
Uterine Hemorrhage	Phase 3	US	Pharmacosmos Therapeutics Inc.	15 Sep 2022
Hypophosphatemia	Phase 3	US	Pharmacosmos A/S	24 Oct 2017
chronic renal failure anemia	Phase 3	CN	Eton Pharmaceutical (China) Co., Ltd.	21 Sep 2015
chronic renal failure anemia	Phase 3	CN	Wasserburger Arzneimittelwerk GmbH	21 Sep 2015
chronic renal failure anemia	Phase 3	CN	Pharmacosmos A/S	21 Sep 2015
Postpartum Hemorrhage	Phase 3	DK	Pharmacosmos A/S	01 Jun 2013
Anemia	Phase 3	AT	Pharmacosmos A/S	01 Jun 2011
Anemia	Phase 3	HU	Pharmacosmos A/S	01 Jun 2011
Kidney Failure, Chronic	Phase 3	IN	Pharmacosmos A/S	01 Jun 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Pregnancy	-	Ferric Derisomaltose (FDI)	wvtwruesuu(adtkjpsngy) = Adverse reactions occurred in 42 (13.0%) patients who received IS and 10 patients (5.4%) who received FDI; most were mild, with only one patient treated with IS being sent to triage for further assessment cclbebslyy (ikrawuiidd )	-	09 Dec 2024
				Iron Sucrose (IS)
EHA2024	Not Applicable	-	50	Iron Isomaltoside	mvehaelhpk(opcucugtxy) = 94.0% experienced no adverse effects, while 6.0% reported mild transient adverse effects jacqnvxzey (solwghcvsx )	Positive	14 May 2024
ESC2024	Not Applicable	Myocardial Ischemia	-	IV ferric derisomaltose (FDI)	udfuyndnza(tyrzmdmwui) = fpjpnylltn weadvtvzuy (nmiupgxcdt ) View more	-	14 May 2024
				intravenous ferric derisomaltose (Usual care)	udfuyndnza(tyrzmdmwui) = eakmoxnnvh weadvtvzuy (nmiupgxcdt ) View more
NCT02642562 (IRONMAN, ESC2024)	Phase 4	transferrin saturation (TSAT) \| ferritin \| haemoglobin (Hb) ... View more	-	Ferric derisomaltose (FDI)	uhsmdokuuj(aztfqiftmr): HR = 0.51 (95% CI, 0.29 - 0.9) View more	Positive	12 May 2024
				ferric derisomaltose (Usual care)
UEGW2023	Not Applicable	Injection Site Reaction	-	Ferric Derisomaltose (FDI)	iifnbqbvwu(jhrpceiuiq) = Two patients with reactions to FDI were administered adrenaline (both reactions classified as Fishbane) with one requiring hospitalisation. No other patients required hospitalisation. yxclojxryp (qsxawqfbao )	-	15 Oct 2023
				Ferric Carboxymaltose (FCM)
NCT02642562 (IRONMAN, Pubmed \| Lancet)	Phase 4	Iron deficiency \| Heart Failure	1,137	Intravenous ferric derisomaltose	ndptkzoesh(qnixpbvrlb) = dweydqgtos lulrxhgdou (mrgiamovrm )	Positive	04 Nov 2022
				ferric derisomaltose (Usual care)	ndptkzoesh(qnixpbvrlb) = fnjvlifkhe lulrxhgdou (mrgiamovrm )
UEGW2022	Not Applicable	-	-	Ferric carboxymaltose (FCM)	mwmynxpryu(rlxjxesbki) = oridwysoqc saihgidmri (uwpdguxipp ) View more	-	09 Oct 2022
NCT03188445 (Pubmed \| Arch Gynecol Obstet) Manual	Phase 4	Iron deficiency	201	Ferric Derisomaltose	lhhreotoew(vuovrbcfwr) = leoghblvym tgjvxwmgbp (fndwvmggdk ) View more	Positive	15 Sep 2022
				Ferrous Fumarate	lhhreotoew(vuovrbcfwr) = pmlfxpgslt tgjvxwmgbp (fndwvmggdk ) View more
I4RON-HF (ESC2022)	Not Applicable	Heart Failure	65	IV Iron Isomaltoside	jduaozmkno(icmaqitedw) = kpdrrkufby fvueyodlgo (honneoduig ) View more	-	27 Aug 2022
				Routine iron supplements	jduaozmkno(icmaqitedw) = ziohcsfxnb fvueyodlgo (honneoduig ) View more
NCT04206228 (IIISAS, Pubmed \| Eur J Heart Fail)	Phase 2	Iron deficiency	149	Ferric derisomaltose	tvjtvsielv(kydmflygse) = bjsxdjgmii dadaokqscv (oiapyhuhbm )	Negative	17 May 2022
				Placebo	tvjtvsielv(kydmflygse) = tshnvojzpn dadaokqscv (oiapyhuhbm )

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