October 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 Takeda Pharmaceutical Co Ltd FDA expanded indication for the maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with drug intravenous Entyvio Biologic API 
AGC Biologics Inc Jazz Pharmaceuticals Plc EMA approval for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month and older who have developed hypersensitivity to E. coli-derived asparaginase  Enrylaze  Biologic API 
Almac Group Ltd Pfizer Inc FDA expanded indication of the drug in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test Braftovi Solid dose packaging
Alvogen Inc Endo International Plc UK MHRA expanded indication for the treatment of multiple sclerosis in adults and children over the age of 5 years old weighing 25 kg or more Dantrium Parenteral manufacture & packaging
AMPAC Fine Chemicals LLC Merck & Co Inc FDA expanded indication for the treatment of adults with refractory anaplastic astrocytoma Temodar Small mol API
AstraZeneca Plc Merck & Co Inc NICE approval for the drug as an option for treating tumours with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency in adults with: advanced or recurrent endometrial cancer that has progressed during or after a platinum-based therapy, who cannot have curative surgery or radiotherapy unresectable or metastatic gastric, small intestine or biliary cancer that has progressed during or after 1 therapy colorectal cancer after fluoropyrimidine combination therapy, only if they cannot have nivolumab with ipilimumab. It is only recommended if: pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier if the cancer progresses, and the company provides it according to the commercial arrangement. Keytruda** Biologic API 
Boehringer Ingelheim Biopharmaceuticals GmbH BeiGene Ltd EMA approval for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy Tevimbra Biologic API 
Boehringer Ingelheim Biopharmaceuticals GmbH Merck & Co Inc NICE approval for the drug as an option for treating tumours with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency in adults with: advanced or recurrent endometrial cancer that has progressed during or after a platinum-based therapy, who cannot have curative surgery or radiotherapy unresectable or metastatic gastric, small intestine or biliary cancer that has progressed during or after 1 therapy colorectal cancer after fluoropyrimidine combination therapy, only if they cannot have nivolumab with ipilimumab. It is only recommended if: pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier if the cancer progresses, and the company provides it according to the commercial arrangement. Keytruda** Biologic API 
Catalent Inc Moderna Inc EMA approval for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older Spikevax Omicron XBB.1.5**  Parenteral manufacture & packaging
Catalent Inc Pfizer Inc FDA expanded indication of the drug in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test Braftovi Solid dose 
Cell and Gene Therapy Catapult Freeline Therapeutics Holdings Plc Positive Phase I/II Interim results for the treatment of Gaucher disease FLT-201 Biologic API 
Curia Global Inc Soleno Therapeutics Inc Positive Phase III top-line results  for the treatment of Prader-Willi syndrome diazoxide choline CR Small mol API
Curia Global Inc Small Pharma Inc Positive Phase I top-line results for the treatment of Major Depressive Disorder SPL-026 Small mol API
Delpharm SAS Takeda Pharmaceutical Co Ltd FDA expanded indication for the maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with drug intravenous Entyvio Parenteral manufacture
EMD Serono Inc Fresenius SE & Co KGaA FDA expanded indication to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome (H-ARS) Stimufend Parenteral manufacture
Esteve Pharmaceuticals SA Pfizer Inc FDA expanded indication for the treatment of adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy Bosulif Small mol API
Excella GmbH & Co KG Pfizer Inc FDA expanded indication for the treatment of adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy Bosulif Solid dose 
FUJIFILM Diosynth Biotechnologies USA Inc  Fresenius SE & Co KGaA FDA expanded indication to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome (H-ARS) Stimufend Biologic API 
HAS Healthcare Advanced Synthesis SA Endo International Plc UK MHRA expanded indication for the treatment of multiple sclerosis in adults and children over the age of 5 years old weighing 25 kg or more Dantrium Small mol API
Hikma Pharmaceuticals Plc Boehringer Ingelheim International GmbH UK MHRA expanded indication in adults for the treatment of chronic kidney disease Jardiance Solid dose packaging
IDT Biologika GmbH Helocyte Biosciences Inc Trial planned - Phase II to determine whether drug is safe and effective in protecting against CMV events defined as viremia requiring antiviral preemptive therapy (PET) or CMV end organ disease Triplex Parenteral manufacture
KBI Biopharma Inc ALX Oncology Holdings Inc Positive Phase  II/III Interim results of the drug in combination With trastuzumab, ramucirumab, and paclitaxel in patients with Advanced HER2-overexpressing gastric/gastroesophageal junction (GEJ) adenocarcinoma evorpacept Biologic API 
Laboratorios Farmaceuticos Rovi SA Moderna Inc EMA approval for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older Spikevax Omicron XBB.1.5**  Parenteral manufacture & packaging
Lonza Group Ltd Takeda Pharmaceutical Co Ltd FDA expanded indication for the maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with drug intravenous Entyvio Biologic API 
Lyophilization Services of New England Inc ALX Oncology Holdings Inc Positive Phase  II/III Interim results of the drug in combination With trastuzumab, ramucirumab, and paclitaxel in patients with Advanced HER2-overexpressing gastric/gastroesophageal junction (GEJ) adenocarcinoma evorpacept Parenteral manufacture
Metrics Contract Services Soleno Therapeutics Inc Positive Phase III top-line results  for the treatment of Prader-Willi syndrome diazoxide choline CR Solid dose 
MilliporeSigma Fresenius SE & Co KGaA FDA expanded indication to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome (H-ARS) Stimufend Biologic API 
Onyx Scientific Ltd Small Pharma Inc Positive Phase I top-line results for the treatment of Major Depressive Disorder SPL-026 Small mol API
Organon & Co Merck & Co Inc FDA expanded indication for the treatment of adults with refractory anaplastic astrocytoma Temodar Parenteral packaging
Organon & Co Merck & Co Inc NICE approval for the drug as an option for treating tumours with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency in adults with: advanced or recurrent endometrial cancer that has progressed during or after a platinum-based therapy, who cannot have curative surgery or radiotherapy unresectable or metastatic gastric, small intestine or biliary cancer that has progressed during or after 1 therapy colorectal cancer after fluoropyrimidine combination therapy, only if they cannot have nivolumab with ipilimumab. It is only recommended if: pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier if the cancer progresses, and the company provides it according to the commercial arrangement. Keytruda** Parenteral packaging
Orion Corp Merck & Co Inc FDA expanded indication for the treatment of adults with refractory anaplastic astrocytoma Temodar Parenteral manufacture
Patheon NV Jazz Pharmaceuticals Plc EMA approval for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month and older who have developed hypersensitivity to E. coli-derived asparaginase  Enrylaze  Parenteral manufacture & packaging
Patheon NV Endo International Plc UK MHRA expanded indication for the treatment of multiple sclerosis in adults and children over the age of 5 years old weighing 25 kg or more Dantrium Parenteral manufacture & packaging
Patheon NV Vifor Pharma Management Ltd FDA expanded indication for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older Veltassa Non-sterile liquid manufacture & packaging
Patheon NV Takeda Pharmaceutical Co Ltd FDA expanded indication for the maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with drug intravenous Entyvio Parenteral manufacture & packaging
Praxis Packaging Solutions Boehringer Ingelheim International GmbH UK MHRA expanded indication in adults for the treatment of chronic kidney disease Jardiance Solid dose packaging
PYRAMID Laboratories Inc Novo Nordisk AS FDA approval to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function Rivfloza Parenteral manufacture
Rentschler Biopharma SE Genmab AS EMA approval as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy Tepkinly Biologic API 
Rentschler Biopharma SE UCB SA NICE approval for the drug as an option in adults for treating active ankylosing spondylitis (AS) when conventional therapy has not worked well enough or is not tolerated, or active non‑radiographic axial spondyloarthritis (nr‑axSpA) with objective signs of inflammation (shown by elevated C‑reactive protein or MRI) when non-steroidal anti‑inflammatory drugs (NSAIDs), have not worked well enough or are not tolerated. It is recommended only if: tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and the company provides it according to the commercial arrangement. The drug alone or with methotrexate is recommended as an option for treating active psoriatic arthritis (defined as peripheral arthritis with 3 or more tender joints and 3 or more swollen joints) in adults whose condition has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have had 2 conventional DMARDs and: at least 1 biological DMARD or tumour necrosis factor (TNF)-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis). Bimzelx Biologic API 
Saltigo GmbH Vifor Pharma Management Ltd FDA expanded indication for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older Veltassa Biologic API 
Samsung Biologics Co Ltd UCB SA NICE approval for the drug as an option in adults for treating active ankylosing spondylitis (AS) when conventional therapy has not worked well enough or is not tolerated, or active non‑radiographic axial spondyloarthritis (nr‑axSpA) with objective signs of inflammation (shown by elevated C‑reactive protein or MRI) when non-steroidal anti‑inflammatory drugs (NSAIDs), have not worked well enough or are not tolerated. It is recommended only if: tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and the company provides it according to the commercial arrangement. The drug alone or with methotrexate is recommended as an option for treating active psoriatic arthritis (defined as peripheral arthritis with 3 or more tender joints and 3 or more swollen joints) in adults whose condition has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have had 2 conventional DMARDs and: at least 1 biological DMARD or tumour necrosis factor (TNF)-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis). Bimzelx Biologic API 
Sandoz International GmbH Novartis AG FDA expanded indication for adults with active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation Cosentyx Parenteral manufacture & packaging
Simtra BioPharma Solutions Merck & Co Inc FDA expanded indication for the treatment of adults with refractory anaplastic astrocytoma Temodar Parenteral manufacture & packaging
Societal CDMO Inc Otsuka Pharmaceutical Co Ltd EMA approval as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy Inqovi Solid dose 
Symbiosis Pharmaceutical Services Ltd Freeline Therapeutics Holdings Plc Positive Phase I/II Interim results for the treatment of Gaucher disease FLT-201 Parenteral manufacture & packaging
WuXi Biologics Cayman Inc Viatris Inc EMA approval 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), myopic choroidal neovascularisation (myopic CNV) Yesafili Biologic API 

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