June 2023 — CDMO Opportunities And Threats Report

Source: Outsourced Pharma

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
AbbVie Inc Pfizer Inc FDA expanded indication for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Paxlovid** Small mol API & solid dose
AbbVie Inc AstraZeneca Plc FDA expanded indication in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration resistant prostate cancer (mCRPC) Lynparza Solid dose & packaging
AbbVie Inc Melinta Therapeutics LLC EMA expanded indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older Tenkasi Small mol API
Allpack Group AG Novartis AG EMA expanded indication in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction Entresto Solid dose packaging
Asymchem Inc Pfizer Inc FDA expanded indication for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Paxlovid** Small mol API
Baxter Biopharma Solutions Johnson & Johnson NICE approval for the drug with bortezomib and dexamethasone as an option for treating multiple myeloma in adults, only if they have had just 1 previous line of treatment and it included lenalidomide or lenalidomide is unsuitable as a second-line treatment and the company provides it according to the commercial arrangement Darzalex Parenteral manufacture
Berkshire Sterile Manufacturing LLC Fennec Pharmaceuticals Inc EMA approval for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours Pedmarqsi Parenteral manufacture
Biogen Inc Johnson & Johnson NICE approval for the drug with bortezomib and dexamethasone as an option for treating multiple myeloma in adults, only if they have had just 1 previous line of treatment and it included lenalidomide or lenalidomide is unsuitable as a second-line treatment and the company provides it according to the commercial arrangement Darzalex Biologic API
Boehringer Ingelheim Biopharmaceuticals GmbH AbbVie Inc NICE approval for the drug as an option for treating moderately to severely active Crohn's disease in people 16 years and over, only if the disease has not responded well enough or lost response to a previous biological treatment, or a previous biological treatment was not tolerated, or tumour necrosis factor (TNF)-alpha inhibitors are not suitable Skyrizi Biologic API & Parenteral manufacture
Cambrex Corp Fennec Pharmaceuticals Inc EMA approval for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours Pedmarqsi Small mol API
Cardinal Health Inc Fennec Pharmaceuticals Inc EMA approval for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours Pedmarqsi Parenteral packaging
Catalent Inc Editas Medicine Inc Positive Phase I/II interim results from the first four patients with sickle cell disease (SCD) treated with the drug in the RUBY trial and from the first transfusion-dependent beta thalassemia patient treated in the EdiTHAL trial EDIT-301 Parenteral manufacture 
Catalent Inc Celltrion Inc FDA approval for the treatment of Ankylosing Spondylitis, Crohn's Disease, Hidradenitis Suppurativa, Plaque Psoriasis, Polyarticular Juvenile Idiopathic Arthritis (PJIA), Psoriatic Arthritis, Rheumatoid Arthritis and Ulcerative Colitis Yuflyma Parenteral manufacture & packaging
Catalent Inc Blueprint Medicines Corp FDA expanded indication for the treatment of adults with indolent systemic mastocytosis (ISM) Ayvakit Solid dose
Catalent Inc AbbVie Inc NICE approval for the drug with venetoclax within its marketing authorisation, as an option for untreated chronic lymphocytic leukaemia (CLL) in adults. This is only if the companies provide both drugs according to the commercial arrangements Imbruvica** Small mol API & Solid dose
Dalton Pharma Services Arch Biopartners Inc Trial planned - Phase II to assess safety and efficacy of LSALT peptide versus placebo (matching drug-free saline) in subjects undergoing on-pump cardiac surgery and to evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria Metablok Parenteral manufacture 
Dottikon Exclusive Synthesis AG AstraZeneca Plc FDA expanded indication in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration resistant prostate cancer (mCRPC) Lynparza Small mol API
Esteve Pharmaceuticals SA Pfizer Inc FDA expanded indication for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Paxlovid** Small mol API
Esteve Pharmaceuticals SA Gilead Sciences Inc EMA expanded indication for the treatment of chronic hepatitis B (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg Vemlidy Small mol API
Hetero Drugs Ltd Pfizer Inc FDA expanded indication for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Paxlovid** Small mol API & solid dose
IDT Biologika GmbH Vifor Pharma Management Ltd FDA expanded indication for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity Injectafer Parenteral manufacture & packaging
IDT Biologika GmbH Merz Pharma GmbH & Co KgaA UK MHRA expanded indication for the treatment of focal spasticity of the lower limb affecting the ankle joint Xeomin Parenteral manufacture & packaging
Jetpharma SA AstraZeneca Plc FDA expanded indication in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration resistant prostate cancer (mCRPC) Lynparza Small mol API
Konapharma AG Novartis AG EMA expanded indication in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction Entresto Solid dose packaging
Lonza Group Ltd Shanghai Junshi Biomedical Technology Co Ltd Trial planned - Phase II to investigate the efficacy and safety of therapeutic regimen of toripalimab and the drug plus chemotherapy in stage III non-small cell lung cancer Tifcemalimab Biologic API
Lonza Group Ltd Merck & Co Inc FDA expanded indication to reduce recurrence of Clostridioides difficile infection (CDI) in pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence Zinplava Biologic API
Lonza Group Ltd AstraZeneca Plc FDA expanded indication in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration resistant prostate cancer (mCRPC) Lynparza Small mol API
Lonza Group Ltd Gilead Sciences Inc NICE approval for the drug to use within the Cancer Drugs Fund as an option for treating diffuse large B‑cell lymphoma in adults when an autologous stem cell transplant is suitable if it has relapsed within 12 months after first-line chemoimmunotherapy or is refractory to first-line chemoimmunotherapy Yescarta Parenteral manufacture
Lonza Group Ltd AbbVie Inc NICE approval for the drug with venetoclax within its marketing authorisation, as an option for untreated chronic lymphocytic leukaemia (CLL) in adults. This is only if the companies provide both drugs according to the commercial arrangements Imbruvica** Small mol API
Lyocontract GmbH Gilead Sciences Inc NICE approval for the drug as an option for treating chronic hepatitis D in adults with compensated liver disease only if there is evidence of significant fibrosis (METAVIR stage F2 or above or Ishak stage 3 or above) and their hepatitis has not responded to peginterferon alfa‑2a (PEG‑IFN) or they cannot have interferon-based therapy Hepcludex Parenteral manufacture & packaging
MIAS Pharma Ltd Fennec Pharmaceuticals Inc EMA approval for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours Pedmarqsi Parenteral manufacture
NortecQuimica SA Pfizer Inc FDA expanded indication for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Paxlovid** Small mol API
Novasep Holding SAS Pfizer Inc FDA expanded indication for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Paxlovid** Small mol API
Organon & Co Merck & Co Inc FDA expanded indication to reduce recurrence of Clostridioides difficile infection (CDI) in pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence Zinplava Parenteral packaging
Patheon NV Pfizer Inc FDA expanded indication for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Paxlovid** Solid dose
Patheon NV AstraZeneca Plc FDA expanded indication in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration resistant prostate cancer (mCRPC) Lynparza Solid dose & packaging
Patheon NV Samsung Bioepis Co Ltd EMA approval for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and children Epysqli Biologic API
Patheon NV Melinta Therapeutics LLC EMA expanded indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older Tenkasi Parenteral manufacture
Patheon NV Gilead Sciences Inc EMA expanded indication for the treatment of chronic hepatitis B (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg Vemlidy Solid dose & packaging
Patheon NV Cara Therapeutics Inc NICE approval for the drug within its marketing authorisation, for treating moderate to severe pruritus in adults with chronic kidney disease (CKD) having in-centre haemodialysis. The drug is only recommended if the company provides it according to the commercial arrangement Kapruvia Parenteral manufacture & packaging
PCI Pharma Services Celltrion Inc FDA approval for the treatment of Ankylosing Spondylitis, Crohn's Disease, Hidradenitis Suppurativa, Plaque Psoriasis, Polyarticular Juvenile Idiopathic Arthritis (PJIA), Psoriatic Arthritis, Rheumatoid Arthritis and Ulcerative Colitis Yuflyma Parenteral packaging
PCI Pharma Services Blueprint Medicines Corp FDA expanded indication for the treatment of adults with indolent systemic mastocytosis (ISM) Ayvakit Solid dose packaging
PCI Pharma Services Pfizer Inc FDA expanded indication for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Paxlovid** Solid dose packaging
PCI Pharma Services Melinta Therapeutics LLC EMA expanded indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older Tenkasi Parenteral packaging
PCI Pharma Services Gilead Sciences Inc EMA expanded indication for the treatment of chronic hepatitis B (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg Vemlidy Solid dose packaging
PCI Pharma Services LFB SA EMA approval for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features Briumvi Parenteral packaging
PCI Pharma Services Johnson & Johnson NICE approval for the drug with bortezomib and dexamethasone as an option for treating multiple myeloma in adults, only if they have had just 1 previous line of treatment and it included lenalidomide or lenalidomide is unsuitable as a second-line treatment and the company provides it according to the commercial arrangement Darzalex Parenteral packaging
PCI Pharma Services AbbVie Inc NICE approval for the drug with venetoclax within its marketing authorisation, as an option for untreated chronic lymphocytic leukaemia (CLL) in adults. This is only if the companies provide both drugs according to the commercial arrangements Imbruvica** Small mol API
PolyPeptide Group AG Cara Therapeutics Inc NICE approval for the drug within its marketing authorisation, for treating moderate to severe pruritus in adults with chronic kidney disease (CKD) having in-centre haemodialysis. The drug is only recommended if the company provides it according to the commercial arrangement Kapruvia Small mol API
Rechon Life Science AB Camurus AB FDA approval for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal drug or who are already being treated with the drug Brixadi Parenteral manufacture & packaging
Rentschler Biopharma SE UCB SA EMA expanded indication for the treatment of adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA), ankylosing spondylitis (AS), also known as radiographic axSpA and active psoriatic arthritis  Bimzelx Biologic API
Samsung Biologics Co Ltd UCB SA EMA expanded indication for the treatment of adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA), ankylosing spondylitis (AS), also known as radiographic axSpA and active psoriatic arthritis  Bimzelx Biologic API
Samsung Biologics Co Ltd LFB SA EMA approval for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features Briumvi Biologic API & parenteral manufacture
Samsung Biologics Co Ltd Johnson & Johnson NICE approval for the drug with bortezomib and dexamethasone as an option for treating multiple myeloma in adults, only if they have had just 1 previous line of treatment and it included lenalidomide or lenalidomide is unsuitable as a second-line treatment and the company provides it according to the commercial arrangement Darzalex Biologic API
Sharp Packaging Services Pfizer Inc FDA expanded indication for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Paxlovid** Solid dose packaging
Sharp Packaging Services Nobelpharma Co Ltd EMA approval for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older Hyftor Non-sterile liquid packaging
Siegfried Holding AG Camurus AB FDA approval for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal drug or who are already being treated with the drug Brixadi Small mol API
Siegfried Holding AG Novaliq GmbH FDA approval for the treatment of the signs and symptoms of dry eye disease Vevye Sterile liquid manufacture
TOYO Pharmaceutical Co Ltd Nobelpharma Co Ltd EMA approval for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older Hyftor Non-sterile liquid manufacture
Vetter Pharma-Fertigung GmbH & Co KG Johnson & Johnson NICE approval for the drug with bortezomib and dexamethasone as an option for treating multiple myeloma in adults, only if they have had just 1 previous line of treatment and it included lenalidomide or lenalidomide is unsuitable as a second-line treatment and the company provides it according to the commercial arrangement Darzalex Parenteral manufacture
WuXi STA (Shanghai) Co Ltd Pfizer Inc FDA expanded indication for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Paxlovid** Small mol API
WuXi STA (Shanghai) Co Ltd AbbVie Inc NICE approval for the drug with venetoclax within its marketing authorisation, as an option for untreated chronic lymphocytic leukaemia (CLL) in adults. This is only if the companies provide both drugs according to the commercial arrangements Imbruvica** Small mol API

POTENTIALLY NEGATIVE
Lonza Group Ltd Gilead Sciences Inc NICE rejection for the drug within its marketing authorisation, for treating relapsed or refractory follicular lymphoma after 3 or more systemic treatments in adults. This recommendation is not intended to affect treatment with axicabtagene ciloleucel that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop Yescarta Parenteral manufacture
Renaissance Lakewood LLC Johnson & Johnson NICE is unable to make a recommendation on drug for treating major depressive disorder in adults at imminent risk of suicide because Janssen did not provide an evidence submission. We will review this decision if the company decides to make a submission Spravato Inhalational manufacture & packaging
SEQENS Johnson & Johnson NICE is unable to make a recommendation on drug for treating major depressive disorder in adults at imminent risk of suicide because Janssen did not provide an evidence submission. We will review this decision if the company decides to make a submission Spravato Small mol API

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