December 2024 — 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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| Aenova Holding GmbH | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indication of the drug for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| AGC Biologics Inc | Allergy Therapeutics Plc | Positive Phase I/II Interim results of the drug for the treatment of Peanut Allergy | VLP-001 | Biologic API |
| Almac Group Ltd | PTC Therapeutics Inc | FDA approval of the drug for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency | Kebilidi | Parenteral manufacture |
| Almac Group Ltd | Jazz Pharmaceuticals Inc | FDA approval of the drug for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC) | Ziihera | Parenteral packaging |
| Almac Group Ltd | AbbVie Deutschland GmbH & Co KG | EMA approval of the drug for the treatment in adult patients with FRα positive, platinum-resistant epithelial ovarian who have received one to three prior systemic treatment regimens; for the treatment in adult patients with FRα positive, platinum-resistant fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens | Elahere | Parenteral manufacture & packaging |
| Almac Group Ltd | Bristol-Myers Squibb Pharmaceuticals Ltd | NICE recommended the drug as an option for treating disease-related splenomegaly or symptoms of primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis. It is recommended for adults, only if they have had ruxolitinib, and momelotinib is unsuitable, and the company provides drug according to the commercial arrangement |
Inrebic | Solid dose manufacture & packaging |
| AstraZeneca Plc | Merck Sharp & Dohme BV | NICE recommended the drug within its marketing authorisation, as an option for neoadjuvant treatment with platinum-based chemotherapy, then continued alone as adjuvant treatment, for resectable non-small-cell lung cancer (NSCLC) with a high risk of recurrence in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Keytruda | Biologic API |
| Biogen Inc | Janssen-Cilag Ltd | NICE recommended the drug as an option for treating relapsed and refractory multiple myeloma in adults, only after 3 or more lines of treatment (including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody) when the myeloma has progressed on the last treatment. It is only recommended if the company provides drug according to the commercial arrangement | Tecvayli | Biologic API |
| Boehringer Ingelheim Fremont Inc | Sandoz GmbH | EMA approval of the drug for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV) | Afqlir | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AbbVie Deutschland GmbH & Co KG | EMA approval of the drug for the treatment in adult patients with FRα positive, platinum-resistant epithelial ovarian who have received one to three prior systemic treatment regimens; for the treatment in adult patients with FRα positive, platinum-resistant fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens | Elahere | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme BV | NICE recommended the drug within its marketing authorisation, as an option for neoadjuvant treatment with platinum-based chemotherapy, then continued alone as adjuvant treatment, for resectable non-small-cell lung cancer (NSCLC) with a high risk of recurrence in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Keytruda | Biologic API |
| BSP Pharmaceuticals SpA | AbbVie Deutschland GmbH & Co KG | EMA approval of the drug for the treatment in adult patients with FRα positive, platinum-resistant epithelial ovarian who have received one to three prior systemic treatment regimens; for the treatment in adult patients with FRα positive, platinum-resistant fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens | Elahere | Parenteral manufacture |
| Catalent Germany Schorndorf GmbH | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indication of the drug for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| Catalent Indiana LLC | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT) | Imfinzi | Parenteral manufacture & packaging |
| Corden Pharma International GmbH | Rhythm Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) or genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or biallelic leptin receptor (LEPR) deficiency in adult and pediatric patients as young as 2 years old and older | Imcivree | Parenteral manufacture |
| Delpharm SAS | ViiV Healthcare UK Ltd | UK MHRA expanded indication of the drug for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected children of at least 3 months of age and weighing at least 6 kg to less than 25 kg | Triumeq | Solid dose manufacture |
| Delpharm SAS | Ipsen Ltd | NICE recommended the drug within its marketing authorisation, as an option for treating primary biliary cholangitis in adults, when used with ursodeoxycholic acid (UDCA), if the primary biliary cholangitis has not responded well enough to UDCA, or alone, if UDCA cannot be tolerated. Drug is only recommended if the company provides it according to the commercial arrangement | Iqirvo | Solid dose manufacture & packaging |
| Delpharm SAS | Roche Deutschland Holding GmbH | NICE recommended the drug within its marketing authorisation, as an option for the adjuvant treatment of stage 1B (tumours 4 cm or larger) to 3A ALK-positive nonsmall-cell lung cancer (NSCLC) after complete tumour resection in adults. It is only recommended if the company provides it according to the commercial arrangement | Alecensa | Solid dose packaging |
| Evonik Industries AG | Roche Deutschland Holding GmbH | NICE recommended the drug within its marketing authorisation, as an option for the adjuvant treatment of stage 1B (tumours 4 cm or larger) to 3A ALK-positive nonsmall-cell lung cancer (NSCLC) after complete tumour resection in adults. It is only recommended if the company provides it according to the commercial arrangement | Alecensa | Small mol API |
| Excella GmbH & Co KG | Roche Deutschland Holding GmbH | NICE recommended the drug within its marketing authorisation, as an option for the adjuvant treatment of stage 1B (tumours 4 cm or larger) to 3A ALK-positive nonsmall-cell lung cancer (NSCLC) after complete tumour resection in adults. It is only recommended if the company provides it according to the commercial arrangement | Alecensa | Solid dose manufacture |
| FUJIFILM Diosynth Biotechnologies USA Inc | Outlook Therapeutics Inc | NICE recommended the drug as an option for treating wet age-related macular degeneration in adults, only if the eye has a best-corrected visual acuity between 6/12 and 6/96, there is no permanent structural damage to the central fovea, the lesion size is 12 disc areas or less in greatest linear dimension, there are signs of recent disease progression (for example, blood vessel growth as shown by fluorescein angiography, or recent visual acuity changes) the company provides it according to the commercial arrangement | Lytenava | Parenteral manufacture |
| Lonza Group Ltd | Trevi Therapeutics Inc | Positive Phase I top-line results of the drug for the treatment of patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) | nalbuphine hydrochloride ER | Solid dose manufacture |
| MassBiologics | PTC Therapeutics Inc | FDA approval of the drug for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency | Kebilidi | Biologic API, Parenteral manufacture & packaging |
| Novartis AG | Sandoz GmbH | EMA approval of the drug for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV) | Afqlir | Parenteral manufacture |
| Organon & Co | Merck Sharp & Dohme BV | NICE recommended the drug within its marketing authorisation, as an option for neoadjuvant treatment with platinum-based chemotherapy, then continued alone as adjuvant treatment, for resectable non-small-cell lung cancer (NSCLC) with a high risk of recurrence in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Keytruda | Parenteral manufacture & packaging |
| Patheon NV | Samsung Bioepis Co Ltd | FDA expanded indication of the drug for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive | Epysqli | Biologic API |
| Patheon NV | Legacy Pharma Solutions | FDA expanded indication of the drug for the treatment of spasticity in adults | Zanaflex | Solid dose manufacture & packaging |
| Patheon NV | Janssen-Cilag Ltd | NICE recommended the drug as an option for treating relapsed and refractory multiple myeloma in adults, only after 3 or more lines of treatment (including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody) when the myeloma has progressed on the last treatment. It is only recommended if the company provides drug according to the commercial arrangement | Tecvayli | Parenteral manufacture & packaging |
| PCI Pharma Services | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indication of the drug for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| PCI Pharma Services | Janssen-Cilag Ltd | NICE recommended the drug as an option for treating relapsed and refractory multiple myeloma in adults, only after 3 or more lines of treatment (including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody) when the myeloma has progressed on the last treatment. It is only recommended if the company provides drug according to the commercial arrangement | Tecvayli | Parenteral packaging |
| PolyPeptide Group AG | Rhythm Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) or genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or biallelic leptin receptor (LEPR) deficiency in adult and pediatric patients as young as 2 years old and older | Imcivree | Biologic API |
| Recipharm AB | Rhythm Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) or genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or biallelic leptin receptor (LEPR) deficiency in adult and pediatric patients as young as 2 years old and older | Imcivree | Biologic API, Parenteral manufacture & packaging |
| Rentschler Biopharma SE | UCB Inc | FDA expanded indication of the drug for the treatment of adults with moderate to severe hidradenitis suppurativa | Bimzelx | Biologic API |
| Samsung Biologics Co Ltd | UCB Inc | FDA expanded indication of the drug for the treatment of adults with moderate to severe hidradenitis suppurativa | Bimzelx | Biologic API |
| SEQENS | Ipsen Ltd | NICE recommended the drug within its marketing authorisation, as an option for treating primary biliary cholangitis in adults, when used with ursodeoxycholic acid (UDCA), if the primary biliary cholangitis has not responded well enough to UDCA, or alone, if UDCA cannot be tolerated. Drug is only recommended if the company provides it according to the commercial arrangement | Iqirvo | Small mol API |
| Serum Institute of India Pvt Ltd | Novavax Inc | UK MHRA approval of the drug for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older | Nuvaxovid JN.1 | Biologic API |
| Sharp Packaging Services | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT) | Imfinzi | Parenteral packaging |
| Sharp Packaging Services | BeiGene Ltd | EMA expanded indication of the drug in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5%, in combination with platinum-based chemotherapy; indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD-L1 with a TAP score ≥ 5% | Tevimbra | Parenteral packaging |
| Tedor Pharma Inc | Adial Pharmaceuticals Inc | Positive Phase I top-line results of the drug for the treatment of Alcohol Use Disorder (AUD) | ondansetron hydrochloride | Solid dose manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Argenx SE | Trial planned - Phase I to assess the effects of efgartigimod on drug in healthy adult participants | empasiprubart | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT) | Imfinzi | Parenteral manufacture & packaging |
| Wasdell Packaging Group | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indication of the drug for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient | Slenyto | Solid dose packaging |
| WuXi Biologics Co Ltd | Jazz Pharmaceuticals Inc | FDA approval of the drug for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC) | Ziihera | Parenteral manufacture |
| Zhejiang Raybow Pharmaceutical Co Ltd | Novartis UK Ltd | EMA expanded indication of the drug in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence | Kisqali | Small mol API |
POTENTIALLY NEGATIVE |
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| MIAS Pharma Ltd | VBI Vaccines Inc | EMA withdrawal/discontinuation at the MAH's request | PreHevbri | Parenteral manufacture & packaging |
Notes:
Source: GlobalData, Pharma Intelligence Center (Accessed March 10, 2021) ©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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