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 4

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

ChiCTR2400083168 / SuspendedPhase 4IIT

Application Study of Iron Isomaltoside in Patients with Iron Deficiency Anemia Six Months After Weight Loss Surgery

Start Date22 Apr 2024

Sponsor / Collaborator

Chengdu No. 3 People's Hospital

100 Clinical Results associated with Ferric Derisomaltose

100 Translational Medicine associated with Ferric Derisomaltose

100 Patents (Medical) associated with Ferric Derisomaltose

212

Literatures (Medical) associated with Ferric Derisomaltose

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

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.

01 Oct 2024·EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Dissimilar ferric derisomaltose formulations – In vitro comparisons between an originator and its intended similars

Article

Author: Tulpule, Sameer ; Sharma, Reetesh ; Hansen, Martin ; Auerbach, Michael ; Langguth, Peter

BACKGROUND:

The complex nature of intravenous (IV) iron formulations makes manufacturing and characterising similars challenging. This study examined whether simple in vitro tests can distinguish the high-dose IV iron formulation, Monofer® (ferric derisomaltose [FDI]), from the first intended copies of FDI, Rapifer® (FDI intended similar A [FDIIS-A]) and Tosiron® (FDI intended similar B [FDIIS-B]), approved in India and Pakistan, respectively. Neither intended similar is available in Europe or the United States.

METHODS:

Iron content, pH, density, non-volatile residue, carbohydrate content, molecular weight distribution, complex robustness (measured using acid hydrolysis half-life [t_½]) and free (dialysable) iron content were examined. Mean results from three batches of FDIIS-A were compared with mean values calculated from three batches of Monofer®. Due to product withdrawal, only one batch of FDIIS-B was available for comparison with Monofer®.

RESULTS:

Iron content was similar for all formulations (∼100 mg/mL). The chromatograms (obtained using gel permeation chromatography) of FDIIS-A and FDIIS-B differed from that of Monofer®. FDIIS-A was substantially less robust than Monofer® (t_½: 15 h versus 40.3 h); t_½ for FDIIS-B was not tested. Free iron content was substantially higher in FDIIS-A (0.091 % w/v) and FDIIS-B (1.0 % w/v) versus Monofer® (<0.003 % w/v). Where tested, remaining parameters varied between the formulations (insufficient sample quantities prevented all tests being conducted for all intended similars). For all tests, greater inter-batch variability was seen for FDIIS-A versus Monofer®.

CONCLUSIONS:

Simple in vitro tests demonstrated that, aside from total iron content, the first intended similars of FDI bear little resemblance to their originator drug. It is clear that the efficacy and safety profile of Monofer® cannot be extrapolated to the two intended similars. The results call for increased regulatory scrutiny of intended IV iron similars.

18 Sep 2024·ADVANCES IN THERAPY

A Cost-Utility Analysis of Ferric Derisomaltose Versus Ferric Carboxymaltose in Patients with Iron Deficiency Anemia in China.

Article

Author: Ahmed, Waqas ; Zhang, Fengkui ; Pollock, Richard F ; Shen, Aizong

INTRODUCTION:

Intravenous (IV) iron is the recommended treatment for patients with iron deficiency anemia (IDA) unresponsive to oral iron treatment, in whom oral iron is contraindicated, or where rapid iron replenishment is required. Ferric derisomaltose (FDI) and ferric carboxymaltose (FCM) are high-dose, rapid-infusion, IV iron formulations that have recently been compared in three head-to-head randomized controlled trials (RCTs), which showed significantly higher incidence of hypophosphatemia after administration of FCM than FDI. The present study objective was to evaluate the cost-utility of FDI versus FCM in a population of patients with IDA in China.

METHODS:

A previously-published patient-level simulation model was used to model the cost-utility of FDI versus FCM in China. The number of infusions of FDI and FCM was modeled based on the approved posology of the respective formulations using simplified tables of iron need in a population of patients with body weight and hemoglobin levels informed by a Chinese RCT of FCM. Data on the incidence of hypophosphatemia was obtained from the PHOSPHARE-IDA RCT, while data on disease-related quality of life were obtained from SF-36v2 data from the PHOSPHARE-IBD RCT.

RESULTS:

Over the 5-year time horizon, patients received 3.98 courses of iron treatment on average, requiring 0.90 fewer infusions of FDI than FCM (7.69 vs. 6.79). This resulted in iron procurement and administration cost savings of renminbi (RMB) 206 with FDI (RMB 3,519 vs. RMB 3,312). Reduced incidence of hypophosphatemia-related fatigue resulted in an increase of 0.07 quality-adjusted life years and further cost savings of RMB 782 over 5 years, driven by reduced need for phosphate testing and replenishment. FDI was therefore the dominant intervention.

CONCLUSIONS:

The results showed that FDI would improve patient quality of life and reduce direct healthcare expenditure versus FCM in patients with IDA in China.

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

07 Aug 2024

·firstwordpharma.com

After breast cancer disappointment, G1 to be bought by Pharmacosmos for $405M

Danish firm Pharmacosmos is primed to gain its second FDA-approved drug — and first oncology product — after it proposed on Wednesday to acquire G1 Therapeutics at a price per share that’s more than triple the beleaguered cancer drug developer’s trading lowpoint for the year. However, the offered $7.15 share purchase price, for about $405 million in total, is less than half the value of its public debut at $15 in May 2017 — and a far cry from G1’s peak of nearly $68 in September 2018.The company’s lead programme, CDK4/6 inhibitor Cosela (trilaciclib), was approved by the FDA in 2021 to reduce the frequency of chemotherapy-induced myelosuppression in adults receiving certain types of chemotherapy for extensive-stage small-cell lung cancer (SCLC). At the time, G1’s stock hovered around $30.Since those high points, however, G1 has traded mostly in the single digits since early 2022. This past June, the firm disclosed that Cosela had flunked a Phase III trial in breast cancer, sending its shares down to $2.22. Pharmacosmos’ proposed purchase price on Wednesday is a 222% premium over that trading trough. Pipeline additionHistorically, Pharmacosmos has focussed on iron deficiency treatments. Its lead programme, Monoferric (ferric derisomaltose) is FDA-approved to treat iron deficiency anaemia.According to Pharmacosmos CEO Tobias Christensen, Cosela “fits very nicely together” with Monoferric. He also hinted at the possibility of seeking additional global approvals for Cosela; besides its US clearance, the cancer drug is also approved in China. Jack Bailey, G1’s chief executive, commented that the acquisition “will enable a more rapid uptake of Cosela into the ES-SCLC market to maximise availability for patients.”The deal is expected to close later this quarter.

Drug ApprovalAcquisitionPhase 3

29 Jan 2024

·www.prnewswire.com

Renal Anemia Therapeutics Market to Record Growth of USD 2.08 billion from 2023 to 2028, Akebia Therapeutics Inc and Amgen Inc to emerge as Some of the Key Companies - Technavio

NEW YORK, Jan. 29, 2024 /PRNewswire/ -- The renal anemia therapeutics market is estimated to grow by USD 2.08 billion during 2023-2028, growing at a CAGR of 7.59%. Akebia Therapeutics Inc and Amgen Inc to emerge as some of the major companies. Akebia Therapeutics Inc offers adadustat. The report includes information on the product launches, sustainability, and prospects of leading companies including Akebia Therapeutics Inc., Amgen Inc., AstraZeneca Plc, Bayer AG, Covis Pharma GmbH, CSL Ltd., Daiichi Sankyo Co. Ltd., Dr Reddys Laboratories Ltd., F. Hoffmann La Roche Ltd., FibroGen Inc., GlaxoSmithKline Plc, Japan Tobacco Inc., JCR Pharmaceticals Co. Ltd., Kirin Holdings Co. Ltd., Mitsubishi Chemical Group Corp., Pfizer Inc., Pharmacosmos AS, Sun Pharmaceutical Industries Ltd., Travere Therapeutics Inc., and Astellas Pharma Inc.. For Comprehensive details on the market size of historic period(2018 to 2022) and forecast period (2024-2028) - View the Free Sample report Continue Reading Technavio has announced its latest market research report titled Global Renal Anemia Therapeutics Market 2024-2028 The market is fragmented; the companies are competing with competitors and are trying to get greater market share. The market is growing, and chances of new entrants cannot be overlooked. The major companies have well-established economies of scale and presence and generally rely on positioning, technological advances, and the price of the products - The report provides a full list of key companies, their strategies, and the latest developments. Buy Now The growing geriatric population drives the growth. The prevalence of chronic diseases like CKD, is high among the aging population. There is a direct relationship between aging and susceptibility to infections, as it deteriorates the immune system. Apart from the impaired functioning of the immune system, the reduced functioning of organs also increases the chances of acquiring diseases such as CKD. The growing adoption of biosimilars is an emerging trend shaping growth. Side effects of oral administration of renal anemia drugs is a major challenge hindering growth. Technavio has identified key trends, drivers, and challenges, which will help clients improve their strategies to stay ahead of their competitors. - View the Free Sample Report The report includes competitive analysis, a proprietary tool to analyze and evaluate the position of companies based on their industry position score andperformance score. The competitive scenario categorizes companies based on various performance indicators. Some of the factors considered include the financial performance of companies over the past few years, growth strategies, product innovations, new product launches, investments, and growth in market share, among others. Segmentation by Type The growth by the IV segment will be significant during the forecast period. The predominant segment is medications administered through the IV route, primarily attributed to the growing adoption and the convenience of absorption. Additionally, ferric carboxymaltose, sucrose, dextran, and other agents like ferumoxytol and isomaltoside contribute to this category. Gain instant access to 17,000+ research reports. Technavio's SUBSCRIPTION platform Applications The Renal Anemia Therapeutics Market is a dynamic landscape where medical interventions target conditions such as Chronic Kidney Disease (CKD) through a range of treatments. Erythropoiesis-Stimulating Agents (ESAs), including Darbepoetin Alfa and Epoetin Alfa, play a pivotal role in managing anemia associated with renal diseases. Innovative therapies like Roxadustat, a Hypoxia-Inducible Factor Prolyl Hydroxylase (HIF-PH) Inhibitor, showcase advancements in addressing anemia linked to CKD. Iron Supplements, both intravenous and oral, are essential components, alongside Ferric Citrate and Ferric Gluconate, contributing to comprehensive anemia management. The market encompasses diverse modalities, from Hemodialysis to Peritoneal Dialysis, recognizing the significance of tailored approaches. Related Reports The hormone replacement therapy (HRT) market size is estimated to grow by USD 8.44 billion, at a CAGR of 6.67% between 2023 and 2028. The equine supplement products market size is estimated to grow by USD 20,352.14 at a CAGR of 4.19% between 2023 and 2028. 1 Executive Summary 2 Landscape 3 Sizing 4 Historic Size 5 Five Forces Analysis 6 Segmentation by Type 7 Segmentation by Distribution Channel 8 Customer Landscape 9 Geographic Landscape 10 Drivers, Challenges, and Trends 11 Company Landscape 12 Company Analysis 13 Appendix About US Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging trends and provide actionable insights to help businesses identify opportunities and develop effective strategies to optimize their positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable insights to identify opportunities in existing and potential markets and assess their competitive positions within changing scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

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	Pharmacosmos A/S	21 Sep 2015
chronic renal failure anemia	Phase 3	CN	Wasserburger Arzneimittelwerk GmbH	21 Sep 2015
Postpartum Hemorrhage	Phase 3	DK	Pharmacosmos A/S	01 Jun 2013
Heart Diseases	Phase 3	DK	Pharmacosmos A/S	01 Jan 2012
Kidney Failure, Chronic	Phase 3	IN	Pharmacosmos A/S	01 Jun 2011
Neoplasms	Phase 3	IN	Pharmacosmos A/S	01 Oct 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2024	Not Applicable	-	50	Iron Isomaltoside	efpvnarlkz(anobihlwpf) = 94.0% experienced no adverse effects, while 6.0% reported mild transient adverse effects rzexobpbmg (zaiejmyfcq )	Positive	14 May 2024
NCT02642562 (IRONMAN, Pubmed \| Lancet)	Phase 4	Iron deficiency \| Heart Failure	1,137	Intravenous ferric derisomaltose	pzzkijhaeo(iezymkawkv) = tlumeazgwi xsvpzusyoy (ldaegvdrog )	Positive	04 Nov 2022
				ferric derisomaltose (Usual care)	pzzkijhaeo(iezymkawkv) = ymirsotwiv xsvpzusyoy (ldaegvdrog )
NCT03188445 (Pubmed) Manual	Phase 4	Iron deficiency	201	Ferric Derisomaltose	ctcubojpoi(qjfyjpozvc) = wwavjmidpu xhezwjgcrv (yanymvjxas ) View more	Positive	15 Sep 2022
				Ferrous Fumarate	ctcubojpoi(qjfyjpozvc) = ircomsguee xhezwjgcrv (yanymvjxas ) View more
I4RON-HF (ESC2022)	Not Applicable	Heart Failure	65	IV Iron Isomaltoside	rtgrydzupp(tkqnzzrqfg) = cwaesxlnmj zbxgvzzmgp (amdaoonjel ) View more	-	27 Aug 2022
				Routine iron supplements	rtgrydzupp(tkqnzzrqfg) = mzlxnzgvpv zbxgvzzmgp (amdaoonjel ) View more
NCT04206228 (IIISAS, Pubmed)	Phase 2	Iron deficiency	149	Ferric derisomaltose	(irmpuvehgz) = fofvnunmcs tmxrbcrenc (zykkheertq )	Negative	17 May 2022
				Placebo	(irmpuvehgz) = uxqhojnlzv tmxrbcrenc (zykkheertq )
MO529 (ERA2022)	Not Applicable	Anemia, Iron-Deficiency	-	Ferric Carboxymaltose (FCM)	idlhjzwnrc(eoajcolzkb) = yruqinqtzd hwzsuzkesa (qfrqcivwst )	Positive	03 May 2022
				Ferric Derisomaltose (FDI)	idlhjzwnrc(eoajcolzkb) = eomtdyfudu hwzsuzkesa (qfrqcivwst )
ERA2022	Not Applicable	-	26	Ferric Carboxymaltose (FCM)	gqdtrhlryd(qljceabrau) = vufwlgjaqg mmbxowtels (rimjppecwu, 8.5) View more	Positive	03 May 2022
				Ferric Derisomaltose (FDI)	gqdtrhlryd(qljceabrau) = ihgsswdqkq mmbxowtels (rimjppecwu, 11.3) View more
MO531 (ERA2022)	Not Applicable	Anemia, Iron-Deficiency NT-proBNP \| Troponin T \| fibroblast growth factor 23 ... View more	-	Ferric Carboxymaltose (FCM)	selrvcikms(voauspbdco) = tohqcpzaip xustgcsxnn (czfcenlxgo, (3033.0))	Positive	03 May 2022
				Ferric Derisomaltose (FDI)	selrvcikms(voauspbdco) = uhcdrfstdg xustgcsxnn (czfcenlxgo, (2976.0))
NCT03662789 (IronIC, CTgov)	Phase 2/3	Iron deficiency	102	Iron Isomaltoside 1000 (Iron Isomaltoside 1000)	nlkxkejixp(niqgazhmog) = rlwlobxrxm zokbdhfwmv (hlmrzjjind, dongsqsopp - xldmhrmgyg) View more	-	25 May 2021
				Placebo: NaCl 0,9% (Placebo)	nlkxkejixp(niqgazhmog) = nqvwnfpfgo zokbdhfwmv (hlmrzjjind, wzxbrycjaw - hvcdhygxep) View more
NCT03470649 (Pubmed \| Eur J Anaesthesiol)	Not Applicable	Anemia	89	Iron isomaltoside	hrbqmjfali(mfkebcxwcc) = wtlircahws mevjbixqxm (brwrgpklzo )	-	01 Apr 2021
				Placebo	hrbqmjfali(mfkebcxwcc) = njajxttnts mevjbixqxm (brwrgpklzo )

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