August 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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| AGC Biologics SpA | Chemomab Therapeutics Ltd | Positive Phase II Top-line results of the drug in subjects With Primary Sclerosing Cholangitis | CM-101 | Biologic API |
| Ajinomoto Bio-Pharma Services | GlaxoSmithKline LLC | FDA expanded indication of the drug in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy | Jemperli | Parenteral packaging |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | NICE recommended the drug plus ivacaftor (IVA) within its marketing authorisation, as an option for treating cystic fibrosis in people 2 years and over who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Solid dose manufacture & packaging |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | NICE recommended the drug plus IVA, within its marketing authorisation, for treating cystic fibrosis in people 6 years and over who have 2 copies of the CFTR gene with F508del mutations, or a copy of the CFTR gene with an F508del mutation and a copy of the CFTR gene with 1 of the mutations | Symkevi | Solid dose packaging |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | NICE recommended the drug within its marketing authorisation, for treating cystic fibrosis in people 1 year and over who have 2 copies of the CFTR gene with F508del mutations | Orkambi | Solid dose manufacture |
| Almac Group Ltd | Pila Pharma AB | Trial planned - Phase II to assess the safety and tolerability and to determine any bodyweight effect following 3 months of drug treatment in obese people with type 2 diabetes | XEND-0501 | Small mol API |
| Almac Group Ltd | BioMarin Pharmaceutical Inc | FDA expanded indication of the drug to slow the loss of ambulation in children of all ages with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency | Brineura | Parenteral packaging |
| Baccinex SA | Ascendis Pharma Inc | FDA approval of the drug for the treatment of hypoparathyroidism in adults | Yorvipath | Parenteral manufacture & packaging |
| Bachem Holding AG | Ascendis Pharma Inc | FDA approval of the drug for the treatment of hypoparathyroidism in adults | Yorvipath | Biologic API |
| Biogen Inc | Janssen Biotech Inc | FDA expanded indication of the drug in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). Patients will have the opportunity to receive this Darzalex Faspro based quadruplet therapy at initial diagnosis, providing them with a new treatment that may significantly improve outcomes | Darzalex Faspro | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AbbVie Inc | EMA expanded indication of the drug for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy | Skyrizi | Biologic API, Parenteral manufacture |
| Boehringer Ingelheim Pharma GmbH & Co KG | Shire Pharmaceuticals Ltd | UK MHRA expanded indication of the drug for treatment of short bowel syndrome in patients aged ≥1 year | Revestive | Biologic API |
| Catalent Belgium SA | Novo Nordisk Ltd | UK MHRA expanded indication of the drug to reduce the risk of overweight and obese adults suffering serious heart problems or strokes | Wegovy | Parenteral packaging |
| Catalent Inc | Phathom Pharmaceuticals Inc | FDA expanded indication of the drug for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults | Voquezna | Solid dose manufacture & packaging |
| Catalent Indiana LLC | Janssen Biotech Inc | FDA expanded indication of the drug in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). Patients will have the opportunity to receive this Darzalex Faspro based quadruplet therapy at initial diagnosis, providing them with a new treatment that may significantly improve outcomes | Darzalex Faspro | Biologic API |
| Catalent Indiana LLC | AstraZeneca Plc | UK MHRA expanded indication of the drug in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by drug as monotherapy after surgery, for the treatment of adults with resectable (tumours ≥4cm and/or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements | Imfinzi | Parenteral manufacture & packaging |
| Catalent Indiana LLC | Novo Nordisk Ltd | UK MHRA expanded indication of the drug to reduce the risk of overweight and obese adults suffering serious heart problems or strokes | Wegovy | Parenteral packaging |
| Charles River Laboratories International Inc | Janssen Biotech Inc | FDA expanded indication of the drug in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). Patients will have the opportunity to receive this Darzalex Faspro based quadruplet therapy at initial diagnosis, providing them with a new treatment that may significantly improve outcomes | Darzalex Faspro | Biologic API |
| Corden Pharma International GmbH | Rhythm Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS), loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above | Imcivree | Parenteral manufacture |
| Delpharm SAS | Roche Products Ltd | UK MHRA expanded indication of the drug as monotherapy indicated as adjuvant treatment for adult patients with Stage IB (tumours ≥ 4cm) to IIIA (7th edition of the UICC/AJCC-staging system) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following complete tumour resection | Alecensa | Solid dose packaging |
| Esteve Quimica SA | Vertex Pharmaceuticals Inc | NICE recommended the drug plus ivacaftor (IVA) within its marketing authorisation, as an option for treating cystic fibrosis in people 2 years and over who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Small mol API |
| Esteve Quimica SA | Vertex Pharmaceuticals Inc | NICE recommended the drug plus IVA, within its marketing authorisation, for treating cystic fibrosis in people 6 years and over who have 2 copies of the CFTR gene with F508del mutations, or a copy of the CFTR gene with an F508del mutation and a copy of the CFTR gene with 1 of the mutations | Symkevi | Small mol API |
| Evonik Industries AG | Phathom Pharmaceuticals Inc | FDA expanded indication of the drug for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults | Voquezna | Small mol API |
| Evonik Industries AG | Roche Products Ltd | UK MHRA expanded indication of the drug as monotherapy indicated as adjuvant treatment for adult patients with Stage IB (tumours ≥ 4cm) to IIIA (7th edition of the UICC/AJCC-staging system) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following complete tumour resection | Alecensa | Small mol API |
| Excella GmbH & Co KG | Roche Products Ltd | UK MHRA expanded indication of the drug as monotherapy indicated as adjuvant treatment for adult patients with Stage IB (tumours ≥ 4cm) to IIIA (7th edition of the UICC/AJCC-staging system) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following complete tumour resection | Alecensa | Solid dose manufacture |
| Fabbrica Italiana Sintetici SpA | Vertex Pharmaceuticals Inc | NICE recommended the drug plus ivacaftor (IVA) within its marketing authorisation, as an option for treating cystic fibrosis in people 2 years and over who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Small mol API |
| Fabbrica Italiana Sintetici SpA | Boehringer Ingelheim Ltd | UK MHRA expanded indication of the drug in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise | Jardiance | Small mol API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Janssen Biotech Inc | FDA expanded indication of the drug in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). Patients will have the opportunity to receive this Darzalex Faspro based quadruplet therapy at initial diagnosis, providing them with a new treatment that may significantly improve outcomes | Darzalex Faspro | Biologic API |
| Hikma Pharmaceuticals Plc | Boehringer Ingelheim Ltd | UK MHRA expanded indication of the drug in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise | Jardiance | Solid dose packaging |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | NICE recommended the drug plus ivacaftor (IVA) within its marketing authorisation, as an option for treating cystic fibrosis in people 2 years and over who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Small mol API, Solid dose manufacture |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | NICE recommended the drug plus IVA, within its marketing authorisation, for treating cystic fibrosis in people 6 years and over who have 2 copies of the CFTR gene with F508del mutations, or a copy of the CFTR gene with an F508del mutation and a copy of the CFTR gene with 1 of the mutations | Symkevi | Small mol API; Solid dose manufacture & packaging |
| Minaris Regenerative Medicine LLC | Adaptimmune LLC | FDA approval of the drug for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P,-A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen | Tecelra | Biologic API |
| Noramco Inc | Mirum Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC) | Livmarli | Non-sterile liquid manufacture & packaging |
| Patheon NV | Vertex Pharmaceuticals Inc | NICE recommended the drug plus ivacaftor (IVA) within its marketing authorisation, as an option for treating cystic fibrosis in people 2 years and over who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Solid dose manufacture |
| Patheon NV | Chemomab Therapeutics Ltd | Positive Phase II Top-line results of the drug in subjects With Primary Sclerosing Cholangitis | CM-101 | Parenteral manufacture |
| Patheon NV | Samsung Bioepis Co Ltd | FDA approval of the drug for the treatment of Atypical Hemolytic Uremic Syndrome (Nondiarrhea - Associated Hemolytic Uremic Syndrome),Paroxysmal Nocturnal Hemoglobinuria | Epysqli | Biologic API |
| Patheon NV | Pierre Fabre Ltd | UK MHRA approval of the drug indicated in symptomatic treatment of adult patients with overactive bladder (OAB) syndrome | Obgemsa | Solid dose manufacture & packaging |
| Patheon NV | Novo Nordisk Ltd | UK MHRA expanded indication of the drug to reduce the risk of overweight and obese adults suffering serious heart problems or strokes | Wegovy | Parenteral packaging |
| Patheon NV | Shire Pharmaceuticals Ltd | UK MHRA expanded indication of the drug for treatment of short bowel syndrome in patients aged ≥1 year | Revestive | Parenteral manufacture & packaging |
| PCI Pharma Services | Vertex Pharmaceuticals Inc | NICE recommended the drug plus ivacaftor (IVA) within its marketing authorisation, as an option for treating cystic fibrosis in people 2 years and over who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Solid dose packaging |
| PCI Pharma Services | Mirum Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC) | Livmarli | Non-sterile liquid packaging |
| PCI Pharma Services | BioMarin Pharmaceutical Inc | FDA expanded indication of the drug to slow the loss of ambulation in children of all ages with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency | Brineura | Parenteral packaging |
| Piramal Pharma Solutions Inc | Kyowa Kirin Co Ltd | NICE recommended the drug, within its marketing authorisation, as an option for treating X‑linked hypophosphataemia (XLH) in adults. The drug is only recommended if the company provides it according to the commercial arrangement | Crysvita | Parenteral manufacture |
| PolyPeptide Group AG | Ipsen SA | NICE recommended the drug as an option for treating osteoporosis after menopause in women, trans men and non-binary people, only if they have a very high risk of fracture. The drug is only recommended if the company provides it according to the commercial arrangement | Eladynos | Small mol API |
| PolyPeptide Group AG | Rhythm Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS), loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above | Imcivree | Biologic API |
| Praxis Packaging Solutions | Boehringer Ingelheim Ltd | UK MHRA expanded indication of the drug in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise | Jardiance | Solid dose packaging |
| Rechon Life Science AB | Zealand Pharma AS | EMA approval of the drug for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus | Zegalogue | Parenteral manufacture & packaging |
| Recipharm AB | Vertex Pharmaceuticals Inc | NICE recommended the drug plus ivacaftor (IVA) within its marketing authorisation, as an option for treating cystic fibrosis in people 2 years and over who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Solid dose manufacture |
| Recipharm AB | Vertex Pharmaceuticals Inc | NICE recommended the drug within its marketing authorisation, for treating cystic fibrosis in people 1 year and over who have 2 copies of the CFTR gene with F508del mutations | Orkambi | Solid dose manufacture |
| Recipharm AB | Rhythm Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS), loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above | Imcivree | Biologic API, Parenteral manufacture & packaging |
| Rottendorf Pharma GmbH | Boehringer Ingelheim Ltd | UK MHRA expanded indication of the drug in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise | Jardiance | Solid dose manufacture & packaging |
| Sharp Packaging Services | AstraZeneca Plc | UK MHRA expanded indication of the drug in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by drug as monotherapy after surgery, for the treatment of adults with resectable (tumours ≥4cm and/or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements | Imfinzi | Parenteral packaging |
| Sharp Packaging Services | SFL Pharma GmbH | EMA approval of the drug in combination with platinum-based chemotherapy is indicated for the first line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations | Cejemly | Parenteral packaging |
| Siegfried Holding AG | Takeda Pharmaceuticals Europe Ltd | EMA approval of the drug for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP) and drug can be used for all age groups | Adzynma | Parenteral manufacture |
| Societal CDMO Inc | Ensysce Biosciences Inc | Trial planned - Phase I to assess the pharmacokinetics (PK) of drug, when administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes | PF-614 | Inhalational manufacture |
| The Biovac Institute | Eubiologics Co Ltd | Trial planned - Phase II/III to assess the safety and efficacy of drug compared to MENVEO or Nimenrix in healthy children through adults | EuMCV5 | Parenteral manufacture |
| Tjoapack BV | Stada Arzneimittel AG | EMA expanded indications of the drug for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g) | Kinpeygo | Solid dose packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Ipsen SA | NICE recommended the drug as an option for treating osteoporosis after menopause in women, trans men and non-binary people, only if they have a very high risk of fracture. The drug is only recommended if the company provides it according to the commercial arrangement | Eladynos | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | UK MHRA expanded indication of the drug in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by drug as monotherapy after surgery, for the treatment of adults with resectable (tumours ≥4cm and/or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements | Imfinzi | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | BioMarin Pharmaceutical Inc | FDA expanded indication of the drug to slow the loss of ambulation in children of all ages with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency | Brineura | Parenteral manufacture & packaging |
| WuXi Biologics Co Ltd | GlaxoSmithKline LLC | FDA expanded indication of the drug in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy | Jemperli | Biologic API |
| WuXi Biologics Co Ltd | SFL Pharma GmbH | EMA approval of the drug in combination with platinum-based chemotherapy is indicated for the first line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations | Cejemly | Biologic API |
| WuXi STA (Shanghai) Co Ltd | Vertex Pharmaceuticals Inc | NICE recommended the drug plus ivacaftor (IVA) within its marketing authorisation, as an option for treating cystic fibrosis in people 2 years and over who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Small mol API |
| Zhejiang Raybow Pharmaceutical Co Ltd | Novartis Pharmaceuticals Corp | FDA expanded indication of the drug for the treatment of adults with hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or with disease progression following endocrine therapy | Kisqali | Small mol API |
POTENTIALLY NEGATIVE |
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| Aspen Pharmacare Holdings Ltd | Janssen-Cilag International NV | EMA withdrawal/discontinuation at the MAH's request | JCOVDEN | Parenteral manufacture & packaging |
| Biological E Ltd | Janssen-Cilag International NV | EMA withdrawal/discontinuation at the MAH's request | JCOVDEN | Biologic API, Parenteral manufacture |
| Catalent Inc | Astellas Pharma Ltd | NICE is unable to make a recommendation about the use in the NHS of drug for treating non-metastatic prostate cancer after radical prostatectomy or radiotherapy. This is because Astellas Pharma has confirmed that it does not intend to make an evidence submission for the appraisal. Astellas Pharma considers that there is lack of mature overall survival data to provide an evidence submission for this appraisal | Xtandi | Solid dose manufacture |
| Curia Global Inc | Astellas Pharma Ltd | NICE is unable to make a recommendation about the use in the NHS of drug for treating non-metastatic prostate cancer after radical prostatectomy or radiotherapy. This is because Astellas Pharma has confirmed that it does not intend to make an evidence submission for the appraisal. Astellas Pharma considers that there is lack of mature overall survival data to provide an evidence submission for this appraisal | Xtandi | Small mol API |
| Grand River Aseptic Manufacturing Inc | Janssen-Cilag International NV | EMA withdrawal/discontinuation at the MAH's request | JCOVDEN | Parenteral manufacture & packaging |
| IDT Biologika GmbH | Janssen-Cilag International NV | EMA withdrawal/discontinuation at the MAH's request | JCOVDEN | Parenteral manufacture |
| Laboratorio Reig Jofre SA | Janssen-Cilag International NV | EMA withdrawal/discontinuation at the MAH's request | JCOVDEN | Parenteral manufacture & packaging |
| Merck & Co Inc | Janssen-Cilag International NV | EMA withdrawal/discontinuation at the MAH's request | JCOVDEN | Biologic API, Parenteral manufacture & packaging |
| PCI Pharma Services | Astellas Pharma Ltd | NICE is unable to make a recommendation about the use in the NHS of drug for treating non-metastatic prostate cancer after radical prostatectomy or radiotherapy. This is because Astellas Pharma has confirmed that it does not intend to make an evidence submission for the appraisal. Astellas Pharma considers that there is lack of mature overall survival data to provide an evidence submission for this appraisal | Xtandi | Solid dose packaging |
| PCI Pharma Services | Janssen-Cilag International NV | EMA withdrawal/discontinuation at the MAH's request | JCOVDEN | Parenteral packaging |
| Recipharm AB | Janssen-Cilag International NV | EMA withdrawal/discontinuation at the MAH's request | JCOVDEN | Parenteral manufacture |
| Sanofi | Janssen-Cilag International NV | EMA withdrawal/discontinuation at the MAH's request | JCOVDEN | Parenteral manufacture & packaging |
| Simtra BioPharma Solutions | Daiichi Sankyo Co Ltd | NICE rejection for the drug, within its marketing authorisation, for treating HER2‑low metastatic or unresectable breast cancer in adults after chemotherapy in the metastatic setting or recurrence during adjuvant chemotherapy or within 6 months after finishing it | Enhertu | Parenteral manufacture & packaging |
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