pharma · Breast Cancer · Multiple Sclerosis (MS)
Hoffmann-La Roche
Hoffmann-La Roche is a pharma organization headquartered in Basel, CH. Primary therapeutic focus areas include Breast Cancer, Multiple Sclerosis (MS), Spinal Muscular Atrophy (SMA), Non-Small Cell Lung Cancer, Solid Tumo
Approved · small molecule · Anemia
Epoetin beta (NeoRecormon) is a recombinant erythropoietin developed by Hoffmann-La Roche for the treatment of anemia. The drug is classified as a blood and blood-forming organs therapeutic agent and has been approved in multiple jurisdictions including Australia and the European Union. NeoRecormon was approved in Aust
Internal code ML20828
Epoetin beta (NeoRecormon) is a recombinant erythropoietin developed by Hoffmann-La Roche for the treatment of anemia. The drug is classified as a blood and blood-forming organs therapeutic agent and has been approved in multiple jurisdictions including Australia and the European Union. NeoRecormon was approved in Australia on 1 August 2006 and subsequently listed on the PBS with multiple product codes. In the EU, the product received marketing authorization under EMEA/H/C/000116 with Roche Registration GmbH as the marketing authorization holder.
The program, identified by internal code ML20828, was terminated as of the latest disclosed milestone on 20 December 2007. Despite termination of active development, the approved product remains available in regulated markets. The drug competes within a crowded anemia treatment landscape that includes multiple erythropoiesis-stimulating agents and iron-replacement therapies from competitors including Amgen (Aranesp), Takeda (Feraheme, Omontys), Teva (Eporatio), and fellow Roche product Mircera. The clinical evidence base includes at least one registered trial (NCT00440063), though detailed trial results and specific mechanism of action data are not disclosed in available sources.
Roche's strategic positioning in the anemia market includes both NeoRecormon and the longer-acting agent Mircera, suggesting a portfolio approach to different patient populations and treatment regimens. The termination status indicates the company has likely redirected resources toward newer-generation therapies or alternative indications.
Anemia represents a significant clinical burden affecting millions of patients globally, particularly those with chronic kidney disease, cancer, and other chronic conditions. Erythropoiesis-stimulating agents (ESAs) like epoetin beta address a critical unmet need by stimulating red blood cell production in patients unable to maintain adequate hemoglobin levels through endogenous erythropoietin production alone.
The competitive landscape for anemia treatment has evolved substantially since NeoRecormon's initial approval, with the market now encompassing multiple ESA formulations, novel erythropoiesis-stimulating agents, and iron-replacement therapies. The presence of approved competitors including Aranesp (darbepoetin alfa), Mircera (methoxy polyethylene glycol-epoetin beta), Eporatio (epoetin zeta), and newer agents like Evrenzo and Reblozyl indicates market maturity and significant clinical choice.
Despite program termination, NeoRecormon maintains commercial relevance in approved markets where it continues to be prescribed. The drug's ongoing availability in Australia (with PBS reimbursement codes) and the EU demonstrates sustained clinical utility. However, the termination status suggests Roche has deprioritized further development or expansion of this particular formulation in favor of alternative therapeutic approaches or next-generation products. The patient population for anemia treatment remains substantial, encompassing dialysis-dependent and non-dialysis chronic kidney disease patients, cancer patients receiving chemotherapy, and those with other chronic conditions causing anemia.
Epoetin beta is a recombinant human erythropoietin classified within the therapeutic class of blood and blood-forming organs agents (ATC code B03). The drug is marketed as NeoRecormon by Hoffmann-La Roche.
Also known as: anaemia (disease), anemia (disease)
A reduction in the number of red blood cells, the amount of hemoglobin, and/or the volume of packed red blood cells. Clinically, anemia represents a reduction in the oxygen-transporting capacity of a designated volume of blood, resulting from an imbalance between blood loss (through hemorrhage or hemolysis) and blood production. Signs and symptoms of anemia may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.
ClinicalTrials.gov lists 98 registered studies for Anaemia, (AACT aggregate).
Phase breakdown: NA (35), PHASE3 (21), PHASE1 (18), PHASE2 (12), PHASE4 (11), PHASE2/PHASE3 (1)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0002280), NCT00466297, NCT00767702, NCT01043133, NCT01317979, NCT01477281, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, NCT00140517, NCT00238043, NCT00258024, NCT00259142, NCT00276224, Open Targets Platform (CC BY 4.0).
Australian TGA Approval
Epoetin beta (NeoRecormon) approved in Australia with initial PBS listing.
Latest Disclosed Milestone
Program status updated; development terminated as of this date.
PBS Re-listing
Additional PBS codes assigned in Australia, indicating continued market availability.
Epoetin beta operates within a highly competitive anemia treatment market dominated by established erythropoiesis-stimulating agents and emerging novel therapies. Hoffmann-La Roche itself markets Mircera (methoxy polyethylene glycol-epoetin beta), a longer-acting ESA that may cannibalize NeoRecormon market share by offering extended dosing intervals. Amgen's Aranesp (darbepoetin alfa) represents a major competitor with established clinical evidence and broad market penetration. Takeda markets both Feraheme (ferumoxytol, an iron replacement agent) and Omontys (peginesatide, an ESA), providing alternative mechanisms for anemia management.
Teva's Eporatio (epoetin zeta) competes directly as a recombinant erythropoietin product. Newer-generation therapies including Evrenzo (roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor) and Reblozyl (luspatercept, an activin receptor ligand trap) represent mechanistic alternatives that may offer clinical advantages in specific patient populations. Additional approved competitors include Retacrit, Dynepo, Jesduvroq, Feraccru, and Epostim, collectively fragmenting the market across multiple mechanisms and formulations.
The program termination suggests Roche has strategically reallocated resources from NeoRecormon toward Mircera or other pipeline assets, potentially conceding market share in the shorter-acting ESA segment to competitors while focusing on longer-acting or mechanistically differentiated therapies.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| FERAHEME | Takeda | — | approved |
| OMONTYS | Takeda | — | approved |
| EPORATIO | Teva Pharma GmbH | — | approved |
| EPOSTIM | — | — | approved |
| JESDUVROQ | — | — | approved |
| FERACCRU | — | — | approved |
| ARANESP | Amgen | — | approved |
| MIRCERA | Hoffmann-La Roche | — | approved |
| RETACRIT | — | — | approved |
| EVRENZO | — | — | approved |
| REBLOZYL | — | — | approved |
| DYNEPO | — | — | approved |
| VOXELOTOR | — | Hemoglobin HbA positive modulator | Approved |
| TRIAMCINOLONE ACETONIDE | — | Glucocorticoid receptor agonist | Approved |
| SUTIMLIMAB | — | Complement C1s inhibitor | Approved |
| RUXOLITINIB PHOSPHATE | — | Tyrosine-protein kinase JAK2 inhibitor | Approved |
| RAVULIZUMAB | — | Complement C5 inhibitor | Approved |
| PREDNISONE | — | Glucocorticoid receptor agonist | Approved |
| PREDNISOLONE SODIUM PHOSPHATE | — | Glucocorticoid receptor agonist | Approved |
| PREDNISOLONE ACETATE | — | Glucocorticoid receptor agonist | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Australia (TGA): Epoetin beta approved with multiple PBS codes (5724G, 5725H, 5726J, 5727K, 5728L, 5729M, 6480C, 6481D, 6482E, 6483F). Initial listing date 1 August 2006; re-listed 1 July 2010. Sponsor: Roche Products Pty Ltd. Evidence available at TGA ARTG database.
European Union (EMA): Approved under centralized procedure. Marketing Authorization Holder: Roche Registration GmbH. EMA Product Number: EMEA/H/C/000116. Authorization date listed as 01/05/2025 in available records, though this may reflect a recent renewal or administrative update rather than initial approval. Full EPAR available via EMA website.
United States (FDA): Regulatory status not yet disclosed in available sources.
Japan (PMDA): Regulatory status not yet disclosed in available sources.
China (NMPA): Regulatory status not yet disclosed in available sources.
The product maintains active regulatory status in approved jurisdictions despite program termination, indicating continued commercial availability and market authorization maintenance by Roche.
Epoetin beta is used to treat anemia by stimulating red blood cell production. It is indicated for patients with anemia associated with chronic kidney disease, cancer, and other chronic conditions.
Yes. NeoRecormon is approved in Australia (TGA, approved 1 August 2006) and the European Union (EMA, EMEA/H/C/000116). Regulatory status in the US, Japan, and China is not yet disclosed.
Hoffmann-La Roche manufactures and markets NeoRecormon. In Australia, it is distributed by Roche Products Pty Ltd; in the EU, the marketing authorization holder is Roche Registration GmbH.
The NeoRecormon program was terminated as of 20 December 2007. Despite termination of active development, the approved product remains available in regulated markets.
Epoetin beta is a recombinant human erythropoietin that stimulates erythropoiesis (red blood cell production) by binding to erythropoietin receptors. Specific mechanism of action details are not yet disclosed in available sources.
The route of administration for NeoRecormon is not yet disclosed in available sources.
At least one registered trial (NCT00440063) is associated with the NeoRecormon program. Detailed trial design, results, and outcomes are not yet disclosed in available sources.
Both are Roche products for anemia treatment. Mircera (methoxy polyethylene glycol-epoetin beta) is a longer-acting formulation enabling less frequent dosing. NeoRecormon is a shorter-acting recombinant erythropoietin. Roche's program termination for NeoRecormon suggests strategic focus on Mircera.
Major competitors include Aranesp (darbepoetin alfa, Amgen), Eporatio (epoetin zeta, Teva), Feraheme and Omontys (Takeda), and newer agents like Evrenzo (roxadustat) and Reblozyl (luspatercept).
In Australia, NeoRecormon is listed on the PBS (Pharmaceutical Benefits Scheme) with multiple product codes (5724G, 5725H, 5726J, 5727K, 5728L, 5729M, 6480C, 6481D, 6482E, 6483F), indicating government reimbursement. EU reimbursement status varies by member state.
NeoRecormon was first approved in Australia on 1 August 2006. EU approval date is listed as 01/05/2025 in available records, though this may reflect a renewal rather than initial approval.
The specific reasons for program termination on 20 December 2007 are not disclosed. However, Roche's strategic focus on Mircera (a longer-acting formulation) and the competitive ESA market likely contributed to the decision to deprioritize NeoRecormon development.
NeoRecormon is classified as a blood and blood-forming organs agent (ATC code B03).
Yes. Despite program termination, NeoRecormon remains approved and marketed in Australia and the European Union, with ongoing PBS reimbursement in Australia.
NeoRecormon is indicated for patients with anemia, including those with chronic kidney disease (dialysis-dependent and non-dialysis), cancer patients receiving chemotherapy, and those with other chronic conditions causing anemia.
Patent status and expiration dates for NeoRecormon are not yet disclosed in available sources.
epoetin beta [NeoRecormon] → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: The termination of the NeoRecormon program as of December 2007 reflects Roche's portfolio rationalization within the ESA market. Rather than competing across multiple recombinant erythropoietin formulations, Roche appears to have consolidated its anemia franchise around Mircera, which offers pharmacokinetic advantages (longer half-life enabling less frequent dosing). This strategy allows Roche to maintain market presence while reducing development and commercialization costs associated with maintaining multiple similar products.
Competitive Implications: The program termination cedes the shorter-acting ESA segment to competitors including Amgen (Aranesp) and Teva (Eporatio). However, Roche retains competitive positioning through Mircera and may benefit from market consolidation as healthcare systems increasingly prefer longer-acting formulations. The emergence of mechanistically novel agents (roxadustat, luspatercept) suggests the broader anemia treatment market is shifting toward agents with differentiated mechanisms, potentially reducing reliance on traditional ESAs.
Future Catalysts: No active development milestones are anticipated for NeoRecormon given program termination. Future catalysts would be limited to regulatory maintenance activities (renewal of approvals in Australia and EU) or potential label expansions in approved markets, though these are not currently disclosed.
Expected Milestones: None anticipated. The program is terminated; the drug remains approved and marketed in Australia and the EU but is not subject to active clinical development.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.