February 2021 – 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 |
||||
| Contractor | BioPharma Company | Event Description | Product* | Relationship |
| AGC Biologics Inc | Kuur Therapeutics Ltd | NICE approval as an option for treating wet age-related macular degeneration in adults | Beovu | Large molecule API manufacture |
| AGC Biologics Inc | ImmunityBio Inc | Positive Phase II results on survival rates in metastatic pancreatic cancer patients | Nogapendekin alfa | Large molecule API manufacture |
| Alcami Corp | A Menarini Industrie Farmaceutiche Riunite Srl | EMA approval as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) | Elzonris | Parenteral manufacture |
| Alcami Corp | Johnson & Johnson | Trial planned - Phase I/II combination study of EPI-7386 with the drug plus Prednisone in subjects with Mcrpc who have failed a current second-generation antiandrogen therapy | Zytiga | Small molecule API manufacture |
| Almac Group Ltd | BioNTech SE | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | Comirnaty** | Parenteral packaging |
| Amgen Inc | Eli Lilly and Co | FDA grants emergency use authorization for mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization | Bamlanivimab** | Large molecule API manufacture |
| Amgen Inc | Shanghai Junshi Bioscience Co Ltd | FDA grants emergency use authorization for mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization | Etesevimab** | Large molecule API manufacture |
| Aspen Pharmacare Holdings Ltd | Johnson & Johnson | Positive Phase III results the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older | JNJ-78436735** | Parenteral manufacture and packaging |
| Aspen Pharmacare Holdings Ltd | Johnson & Johnson | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | JNJ-78436735** | Parenteral manufacture and packaging |
| AstraZeneca Plc | Merck & Co Inc | EMA expanded indication for the first-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults | Keytruda | Large molecule API manufacture |
| AstraZeneca Plc | Merck & Co Inc | Trial planned - Phase II to study the drug in combination with quavonlimab (MK-1308A) in combination with lenvatinib (E7080/MK-7902) in advanced hepatocellular carcinoma (MK-1308A-004) | Keytruda | Large molecule API manufacture |
| Baxter Biopharma Solutions | Novavax Inc | Trial planned - Phase II to study the drug for the prevention of coronavirus disease 2019 (COVID-19) | NVX-CoV2373** | Parenteral manufacture |
| Baxter Biopharma Solutions | Novavax Inc | Positive Phase III results for UK variant, COVID-19 virus, efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant | NVX-CoV2373** | Parenteral manufacture |
| Biofabri SL | Novavax Inc | Trial planned - Phase II to study the drug for the prevention of coronavirus disease 2019 (COVID-19) | NVX-CoV2373** | Large molecule API manufacture |
| Biofabri SL | Novavax Inc | Positive Phase III results for UK variant, COVID-19 virus, efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant | NVX-CoV2373** | Large molecule API manufacture |
| Biogen Inc | Johnson & Johnson | FDA expanded indication for the treatment of adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant, combination with bortezomib, cyclophosphamide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis | Darzalex Faspro | Large molecule API manufacture |
| Biological E Ltd | Johnson & Johnson | Positive Phase III results the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older | JNJ-78436735** | Large molecule API and parenteral manufacture |
| Biological E Ltd | Johnson & Johnson | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | JNJ-78436735** | Large molecule API and parenteral manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | EMA expanded indication for the first-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults | Keytruda | Large molecule API manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | Trial planned - Phase II to study the drug in combination with quavonlimab (MK-1308A) in combination with lenvatinib (E7080/MK-7902) in advanced hepatocellular carcinoma (MK-1308A-004) | Keytruda | Large molecule API manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | BeiGene Ltd | Positive Phase III results for global trial for esophageal squamous cell carcinoma | Tislelizumab | Parenteral manufacture |
| Catalent Inc | Johnson & Johnson | FDA expanded indication for the treatment of adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant, combination with bortezomib, cyclophosphamide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis | Darzalex Faspro | Large molecule API manufacture |
| Catalent Inc | Adamas Pharmaceuticals Inc | FDA expanded indication as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes | Gocovri | Solid dose manufacture |
| Catalent Inc | Bristol-Myers Squibb Co | FDA expanded indication in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced Renal Cell Carcinoma | Opdivo | Parenteral manufacture and packaging |
| Catalent Inc | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Large molecule API manufacture |
| Catalent Inc | AstraZeneca Plc | EMA expanded indication as a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT) | Imfinzi | Parenteral manufacture and packaging |
| Catalent Inc | Johnson & Johnson | Trial planned - Phase I/II combination study of EPI-7386 with the drug plus Prednisone in subjects with Mcrpc who have failed a current second-generation antiandrogen therapy | Zytiga | Small molecule API manufacture |
| Catalent Inc | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Large molecule API manufacture |
| Catalent Inc | Johnson & Johnson | Positive Phase III results the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older | JNJ-78436735** | Large molecule API manufacture |
| Catalent Inc | AstraZeneca Plc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Large molecule API manufacture |
| Catalent Inc | Johnson & Johnson | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | JNJ-78436735** | Large molecule API manufacture |
| Catalent Inc | Moderna Inc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Parenteral manufacture |
| Cenexi SAS | Nordic Group BV | EMA expanded indication for the treatment of induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate | Nordimet | Parenteral manufacture and packaging |
| Charles River Laboratories International Inc | Johnson & Johnson | FDA expanded indication for the treatment of adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant, combination with bortezomib, cyclophosphamide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis | Darzalex Faspro | Large molecule API manufacture |
| Cobra Biologics Ltd | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Large molecule API manufacture |
| Cobra Biologics Ltd | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Large molecule API manufacture |
| Cobra Biologics Ltd | AstraZeneca Plc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Large molecule API manufacture |
| Daiichi Sankyo Biotech Co Ltd | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Parenteral manufacture |
| Daiichi Sankyo Biotech Co Ltd | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Parenteral manufacture |
| Daiichi Sankyo Biotech Co Ltd | AstraZeneca Plc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Parenteral manufacture |
| Delpharm SAS | BioNTech SE | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | Comirnaty** | Parenteral manufacture |
| Eisai Co Ltd | Swedish Orphan Biovitrum AB | EMA expanded indication for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (eg corticosteroids, immunoglobulins) | Doptelet | Small molecule API and solid dose manufacture |
| Emergent BioSolutions Inc | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Large molecule API manufacture |
| Emergent BioSolutions Inc | Novavax Inc | Trial planned - Phase II to study the drug for the prevention of coronavirus disease 2019 (COVID-19) | NVX-CoV2373** | Large molecule API manufacture |
| Emergent BioSolutions Inc | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Large molecule API manufacture |
| Emergent BioSolutions Inc | Johnson & Johnson | Positive Phase III results the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older | JNJ-78436735** | Large molecule API manufacture |
| Emergent BioSolutions Inc | Novavax Inc | Positive Phase III results for UK variant, COVID-19 virus, efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant | NVX-CoV2373** | Large molecule API manufacture |
| Emergent BioSolutions Inc | AstraZeneca Plc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Large molecule API manufacture |
| Emergent BioSolutions Inc | Johnson & Johnson | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | JNJ-78436735** | Large molecule API manufacture |
| Fujifilm Diosynth Biotechnologies USA Inc | Samsung Bioepis Co Ltd | EMA expanded indication for Cervical Cancer,Colorectal Cancer,Epithelial Ovarian Cancer,Fallopian Tube Cancer,Metastatic Breast Cancer,Metastatic Renal Cell Carcinoma,Non-Small Cell Lung Cancer,Peritoneal Cancer | Onbevzi | Parenteral manufacture and packaging |
| Fujifilm Diosynth Biotechnologies USA Inc | Novavax Inc | Trial planned - Phase II to study the drug for the prevention of coronavirus disease 2019 (COVID-19) | NVX-CoV2373** | Large molecule API manufacture |
| Fujifilm Diosynth Biotechnologies USA Inc | Eli Lilly and Co | FDA grants emergency use authorization for mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization | Bamlanivimab** | Large molecule API manufacture |
| Fujifilm Diosynth Biotechnologies USA Inc | Novavax Inc | Positive Phase III results for UK variant, COVID-19 virus, efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant | NVX-CoV2373** | Large molecule API manufacture |
| Fujifilm Diosynth Biotechnologies USA Inc | Johnson & Johnson | FDA expanded indication for the treatment of adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant, combination with bortezomib, cyclophosphamide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis | Darzalex Faspro | Large molecule API manufacture |
| Grand River Aseptic Manufacturing Inc | Johnson & Johnson | Positive Phase III results the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older | JNJ-78436735** | Parenteral manufacture |
| Grand River Aseptic Manufacturing Inc | Johnson & Johnson | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | JNJ-78436735** | Parenteral manufacture |
| Groupe Synerlab SAS | Recordati SpA | FDA expanded indication in pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to Propionic Acidemia (PA) or Methylmalonic Acidemia (MMA) | Carbaglu | Solid dose manufacture and packaging |
| Halix BV | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Large molecule API manufacture |
| Halix BV | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Large molecule API manufacture |
| Halix BV | AstraZeneca Plc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Large molecule API manufacture |
| Janssen-Cilag SpA | BioCryst Pharmaceuticals Inc | FDA expanded indication for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days | Rapivab | Small molecule API manufacture |
| JCR Pharmaceuticals Co Ltd | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Large molecule API manufacture |
| JCR Pharmaceuticals Co Ltd | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Large molecule API manufacture |
| JCR Pharmaceuticals Co Ltd | AstraZeneca Plc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Large molecule API manufacture |
| Jubilant HollisterStier LLC | BioCryst Pharmaceuticals Inc | FDA expanded indication for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days | Rapivab | Parenteral manufacture and packaging |
| Laboratorio Reig Jofre SA | Johnson & Johnson | Positive Phase III results the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older | JNJ-78436735** | Parenteral manufacture and packaging |
| Laboratorio Reig Jofre SA | Johnson & Johnson | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | JNJ-78436735** | Parenteral manufacture and packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Parenteral manufacture and packaging |
| Lonza Group Ltd | Bristol-Myers Squibb Co | FDA expanded indication in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced Renal Cell Carcinoma | Opdivo | Large molecule API manufacture |
| Lonza Group Ltd | Aurinia Pharmaceuticals Inc | FDA Approval in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN) | Lupkynis | Small molecule API manufacture |
| Lonza Group Ltd | Kuur Therapeutics Ltd | NICE approval as an option for treating wet age-related macular degeneration in adults | Beovu | Large molecule API manufacture |
| Lonza Group Ltd | Moderna Inc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Large molecule API manufacture |
| MIAS Pharma Ltd | A Menarini Industrie Farmaceutiche Riunite Srl | EMA approval as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) | Elzonris | Parenteral manufacture and packaging |
| MilliporeSigma | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Large molecule API manufacture |
| MilliporeSigma | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Large molecule API manufacture |
| MilliporeSigma | AstraZeneca Plc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Large molecule API manufacture |
| Moehs Iberica SL | Adamas Pharmaceuticals Inc | FDA expanded indication as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes | Gocovri | Small molecule API manufacture |
| Novasep Holding SAS | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Large molecule API manufacture |
| Novasep Holding SAS | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Large molecule API manufacture |
| Novasep Holding SAS | AstraZeneca Plc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Large molecule API manufacture |
| Oxford BioMedica Plc | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Large molecule API manufacture |
| Oxford BioMedica Plc | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Large molecule API manufacture |
| Oxford BioMedica Plc | AstraZeneca Plc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Large molecule API manufacture |
| Par Sterile Products LLC | Novavax Inc | Trial planned - Phase II to study the drug for the prevention of coronavirus disease 2019 (COVID-19) | NVX-CoV2373** | Parenteral manufacture |
| Par Sterile Products LLC | Novavax Inc | Positive Phase III results for UK variant, COVID-19 virus, efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant | NVX-CoV2373** | Parenteral manufacture |
| Patheon NV | Exelixis Inc | FDA expanded indication in combination with nivolumab, is indicated for the first-line treatment of patients with advanced Renal Cell Carcinoma | Cabometyx | Solid dose manufacture and packaging |
| Patheon NV | Exelixis Inc | FDA expanded indication in combination with nivolumab, is indicated for the first-line treatment of patients with advanced Renal Cell Carcinoma | Cabometyx | Solid dose manufacture and packaging |
| Patheon NV | Amgen Inc | FDA expanded indication to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation | Nplate | Parenteral manufacture and packaging |
| Patheon NV | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Large molecule API manufacture |
| Patheon NV | Johnson & Johnson | Trial planned - Phase I/II combination study of EPI-7386 with the drug plus Prednisone in subjects with Mcrpc who have failed a current second-generation antiandrogen therapy | Zytiga | Solid dose manufacture and packaging |
| Patheon NV | Amicus Therapeutics Inc | Positive Phase I/II results for CLN3 Batten Disease Gene Therapy | ATGTX-502 | Large molecule API manufacture |
| Patheon NV | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Large molecule API manufacture |
| Patheon NV | AstraZeneca Plc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Large molecule API manufacture |
| PCI Pharma Services | Millennium Pharmaceuticals Inc | NICE approval as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor in adults | Alunbrig | Solid dose manufacture and packaging |
| Pharmstandard | F Hoffmann-La Roche Ltd | Trial planned - Phase II for relapse/refractory lymphomas after CAR T-cells therapy | Gaziva | Parenteral manufacture |
| Polymun Scientific Immunbiologische Forschung GmbH | BioNTech SE | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | Comirnaty** | Parenteral manufacture |
| Recipharm AB | Recordati SpA | FDA expanded indication in pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to Propionic Acidemia (PA) or Methylmalonic Acidemia (MMA) | Carbaglu | Solid dose manufacture and packaging |
| Recipharm AB | Moderna Inc | COVID-19 vaccine may need to be administered annually to address variants, states JnJ CEO | COVID-19 Vaccine** | Parenteral manufacture |
| Renaissance Lakewood LLC | DURECT Corp | FDA approval of the drug in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression | Posimir | Parenteral manufacture |
| Renaissance Lakewood LLC | Johnson & Johnson | EMA expanded indication for co-administering with oral antidepressant therapy, in adults with a moderate to severe episode of Major Depressive Disorder, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency | Spravato | Inhalation dose manufacture and packaging |
| Rentschler Biopharma SE | BioNTech SE | May need annual administration to address variants*** | Comirnaty** | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Co | FDA expanded indication in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced Renal Cell Carcinoma | Opdivo | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Eli Lilly and Co | FDA grants emergency use authorization for mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization | Bamlanivimab** | Large molecule API manufacture |
| SEQENS | Johnson & Johnson | EMA expanded indication for co-administering with oral antidepressant therapy, in adults with a moderate to severe episode of Major Depressive Disorder, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency | Spravato | Small molecule API manufacture |
| Sharp Packaging Services | Adamas Pharmaceuticals Inc | FDA expanded indication as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes | Gocovri | Solid dose packaging |
| Siegfried Holding AG | BioCryst Pharmaceuticals Inc | FDA expanded indication for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days | Rapivab | Small molecule API manufacture |
| Siegfried Holding AG | Novavax Inc | Trial planned - Phase II to study the drug for the prevention of coronavirus disease 2019 (COVID-19) | NVX-CoV2373** | Parenteral manufacture |
| Siegfried Holding AG | Novavax Inc | Positive Phase III results for UK variant, COVID-19 virus, efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant | NVX-CoV2373** | Parenteral manufacture |
| Siegfried Holding AG | BioNTech SE | May need annual administration to address variants*** | Comirnaty** | Parenteral manufacture and packaging |
| SK Bioscience | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Large molecule API manufacture |
| SK Bioscience | Novavax Inc | Trial planned - Phase II to study the drug for the prevention of coronavirus disease 2019 (COVID-19) | NVX-CoV2373** | Large molecule API manufacture |
| SK Bioscience | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Large molecule API manufacture |
| SK Bioscience | Novavax Inc | Positive Phase III results for UK variant, COVID-19 virus, efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant | NVX-CoV2373** | Large molecule API manufacture |
| SK Bioscience | AstraZeneca Plc | May need annual administration to address variants*** | COVID-19 Vaccine** | Large molecule API manufacture |
| Symbiosis Pharmaceutical Services Ltd | AstraZeneca Plc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older | COVID-19 Vaccine** | Parenteral manufacture |
| Symbiosis Pharmaceutical Services Ltd | AstraZeneca Plc | WHO recommends the use of vaccine for all adults | COVID-19 Vaccine** | Parenteral manufacture |
| Symbiosis Pharmaceutical Services Ltd | AstraZeneca Plc | May need annual administration to address variants*** | COVID-19 Vaccine** | Parenteral manufacture |
| Synth-Innove Laboratories | Recordati SpA | FDA expanded indication in pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to Propionic Acidemia (PA) or Methylmalonic Acidemia (MMA) | Carbaglu | Small molecule API manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | EMA expanded indication as a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT) | Imfinzi | Parenteral manufacture |
| Vibalogics GmbH | Johnson & Johnson | Positive Phase III results the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older | JNJ-78436735** | Large molecule API manufacture |
| Vibalogics GmbH | Johnson & Johnson | May need annual administration to address variants*** | JNJ-78436735** | Large molecule API manufacture |
| WuXi Biologics Cayman Inc | Hbm Holdings Ltd | Trial planned - Phase I antitumor activities of drug combined with toripalimab | HBM-4003 | Large molecule API manufacture |
POTENTIALLY NEGATIVE |
||||
| Advanced BioScience Laboratories Inc | Themis Bioscience GmbH | Withdrawal/Discontinuation in Phase I due to insufficient immune responses for COVID-19 | V-591** | Large molecule API manufacture |
| Batavia Biosciences BV | International AIDS Vaccine Initiative | Withdrawal/Discontinuation in Phase I due to insufficient immune responses for COVID-19 | V-590** | Large molecule API manufacture |
| PCI Pharma Services | Taiho Oncology Inc | NICE rejection for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in adults who have had 2 or more systemic treatment regimens | Lonsurf | Solid dose packaging |
| Yuki Gosei Kogyo Co Ltd | Taiho Oncology Inc | NICE rejection for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in adults who have had 2 or more systemic treatment regimens | Lonsurf | Small molecule API manufacture |
Notes:
Source: GlobalData, Pharma Intelligence Center (Accessed February 10, 2020) ©GlobalData
EMA = European Medicines Agency; NICE = National Institute for Health and Care Excellence; WHO = World Health Organization
* New molecular entities are in bold
** Denotes product being marketed or in the pipeline for COVID-19 therapy area
*** According to comments made by Johnson & Johnson CEO Alex Gorsky on February 9, 2021
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