February 2025 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
| Contractor | BioPharma Company | Event | Product | Relationship |
POTENTIALLY POSITIVE |
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| AGC Biologics Inc | Klinge Pharma GmbH | EMA approval of the drug for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO) | Ahzantive | Biologic API |
| Ajinomoto Bio-Pharma Services | GlaxoSmithKline UK Ltd | EMA expanded indication of the drug for the treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy | Jemperli | Parenteral manufacture & packaging |
| Almac Group Ltd | InflaRx NV | EMA approval of the drug for the treatment of adult patients with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)) | Gohibic | Parenteral manufacture & packaging |
| Ardena Holding NV | Anavex Life Sciences Corp | Positive Phase II/III top-line results of the drug for the treatment of Alzheimer’s Disease | ANAVEX 2-73 | Small mol API |
| AstraZeneca Plc | Merck Sharp & Dohme (UK) Ltd | NICE recommended the drug, within its marketing authorisation, as an option for the adjuvant treatment of non-small-cell lung cancer (NSCLC) with a high risk of recurrence after complete resection and platinum-based chemotherapy in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme (UK) Ltd | NICE recommended the drug, within its marketing authorisation, as an option for the adjuvant treatment of non-small-cell lung cancer (NSCLC) with a high risk of recurrence after complete resection and platinum-based chemotherapy in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Amgen Europe BV | EMA expanded indication of the drug for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (B-ALL) | Blincyto | Parenteral manufacture |
| Cardinal Health Inc | Supernus Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD) | Onapgo | Parenteral manufacture |
| Catalent Inc | InflaRx NV | EMA approval of the drug for the treatment of adult patients with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)) | Gohibic | Parenteral packaging |
| Dottikon Exclusive Synthesis AG | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT) | Calquence | Small mol API |
| Emergent BioSolutions Inc | SAB BIO | Positive Phase I top-line results of the drug for the treatment of type 1 diabetes | SAB-142 | Biologic API |
| Excella GmbH & Co KG | Pfizer Ltd (UK) | UK MHRA approval of the drug in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene mutated metastatic castration-resistant prostate cancer (mCRPC) | Talzenna | Solid dose manufacture & packaging |
| KBI Biopharma Inc | ALX Oncology Holdings Inc | Positive Phase II/III Final results of the drug for the treatment of Gastroesophageal (GE) Junction Carcinomas | ALX148 | Biologic API |
| Kennet Bioservices Ltd | Supernus Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD) | Onapgo | Parenteral manufacture |
| Lek Pharmaceuticals dd | Novartis Pharmaceuticals Corp | FDA expanded indication of the drug in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation | Mekinist | Solid dose manufacture & packaging |
| Lonza Biologics Plc | Amgen Europe BV | EMA expanded indication of the drug for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (B-ALL) | Blincyto | Biologic API |
| Lonza Biologics Porrino SL | AstraZeneca UK Ltd | NICE recommended the drug as an option for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding, only if the bleed is in the gastrointestinal tract, and the company provides the drug according to the commercial arrangement | Ondexxya | Biologic API |
| Lonza Group Ltd | Leap Therapeutics Inc | Positive Phase II Interim results of the drug for the treatment of advanced colorectal cancer | DKN-01 | Biologic API |
| Lonza Group Ltd | Daiichi Sankyo Inc | FDA expanded indication of the drug for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy | Enhertu | Biologic API & Parenteral manufacture |
| Lyophilization Services of New England Inc | ALX Oncology Holdings Inc | Positive Phase II/III Final results of the drug for the treatment of Gastroesophageal (GE) Junction Carcinomas | ALX148 | Parenteral manufacture |
| Midas Pharma GmbH | Klinge Pharma GmbH | EMA approval of the drug for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO) | Ahzantive | Parenteral manufacture & packaging |
| Novo Nordisk AS | AstraZeneca AB | NICE recommended the drug, within its marketing authorisation, as neoadjuvant treatment with platinum-based chemotherapy, then continued alone as adjuvant treatment, for treating non-small-cell lung cancer (NSCLC) in adults whose cancer is resectable (tumours 4 cm or over, or node positive) and has no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.Drug is only recommended if the company provides it according to the commercial arrangement | Imfinzi | Parenteral manufacture |
| Novo Nordisk AS | Sanofi UK | UK MHRA expanded indication of the drug for the treatment of eosinophilic esophagitis in adults, adolescents and children aged 1 year and older, weighing at least 15 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy | Dupixent | Parenteral manufacture & packaging |
| Organon & Co | Merck Sharp & Dohme (UK) Ltd | NICE recommended the drug, within its marketing authorisation, as an option for the adjuvant treatment of non-small-cell lung cancer (NSCLC) with a high risk of recurrence after complete resection and platinum-based chemotherapy in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Keytruda | Parenteral manufacture |
| Patheon NV | Leap Therapeutics Inc | Positive Phase II Interim results of the drug for the treatment of advanced colorectal cancer | DKN-01 | Biologic API |
| Patheon NV | Amgen Inc | FDA expanded indication of the drug for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy | Lumakras | Solid dose manufacture & packaging |
| Quotient Sciences Ltd | Ensysce Biosciences Inc | Positive Phase I interim results of the drug for the treatment of drug abuse | PF614-MPAR | Solid dose manufacture |
| Renaissance Lakewood LLC | Johnson & Johnson Innovative Medicine | FDA expanded indication of the drug for the treatment of first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants | Spravato | Non-sterile liquid manufacture & packaging |
| SEQENS | Johnson & Johnson Innovative Medicine | FDA expanded indication of the drug for the treatment of first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants | Spravato | Small mol API |
| Sharp Packaging Services | AstraZeneca AB | NICE recommended the drug, within its marketing authorisation, as neoadjuvant treatment with platinum-based chemotherapy, then continued alone as adjuvant treatment, for treating non-small-cell lung cancer (NSCLC) in adults whose cancer is resectable (tumours 4 cm or over, or node positive) and has no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.Drug is only recommended if the company provides it according to the commercial arrangement | Imfinzi | Parenteral packaging |
| University of Tennessee Plough Center for Sterile Drug Delivery | SciTech Development LLC | Positive Phase I interim results for the treatment of T-cell Non-Hodgkin Lymphoma | ST-001 | Parenteral manufacture |
| Veranova LP | Supernus Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD) | Onapgo | Small mol API |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca AB | NICE recommended the drug, within its marketing authorisation, as neoadjuvant treatment with platinum-based chemotherapy, then continued alone as adjuvant treatment, for treating non-small-cell lung cancer (NSCLC) in adults whose cancer is resectable (tumours 4 cm or over, or node positive) and has no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.Drug is only recommended if the company provides it according to the commercial arrangement | Imfinzi | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Supernus Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD) | Onapgo | Parenteral manufacture |
| WuXi Biologics Co Ltd | GlaxoSmithKline UK Ltd | EMA expanded indication of the drug for the treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy | Jemperli | Biologic API |
| WuXi Biologics Co Ltd | AstraZeneca AB | EMA approval of the drug for pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg and who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments | Kavigale | Biologic API |
| WuXi Biologics Co Ltd | InflaRx NV | EMA approval of the drug for the treatment of adult patients with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)) | Gohibic | Biologic API & Parenteral manufacture |
POTENTIALLY NEGATIVE |
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| Rentschler Biopharma SE | UCB Pharma Ltd | NICE is unable to make a recommendation about the use in the NHS of drug for treating moderate to severe hidradenitis suppurativa in adults. This is because UCB Pharma withdrew from the appraisal. UCB Pharma could not agree an economically sustainable route to reimbursement for this additional indication | Bimzelx | Biologic API |
| Samsung Biologics Co Ltd | UCB Pharma Ltd | NICE is unable to make a recommendation about the use in the NHS of drug for treating moderate to severe hidradenitis suppurativa in adults. This is because UCB Pharma withdrew from the appraisal. UCB Pharma could not agree an economically sustainable route to reimbursement for this additional indication | Bimzelx | Biologic API |
| Lonza Biologics Porrino SL | AstraZeneca UK Ltd | NICE is unable to make a recommendation about the use in the NHS of drug for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding in the skull (intracranial haemorrhage). This is because AstraZeneca has confirmed that it does not intend to make an evidence submission for the appraisal. AstraZeneca considers that currently there is not enough evidence that the technology is a cost-effective use of NHS resources in this population | Ondexxya | Biologic API |
Notes:
Source: GlobalData, Pharma Intelligence Center ©GlobalData
EMA = European Medicines Agency; NICE = National Institute for Health and Care Excellence
* New molecular entities are in bold
** Denotes product being marketed or in the pipeline for COVID-19 therapy area
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