April 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 |
||||
| 3P Biopharmaceuticals SL | Affibody AB | Trial planned - Phase II to assess the efficacy of the drug in ankylosing spondylitis(AS) | ABY-035 | Large molecule API manufacture |
| Abzena Ltd | Telix Pharmaceuticals Ltd | Trial planned - Phase I to assess the safety, tolerability, biodistribution, dosimetry and efficacy study with best standard of care in subjects with PSMA expressing metastatic castration-resistant prostate cancer | TLX-591 | Large molecule API manufacture |
| Aenova Holding GmbH | SK Biopharmaceuticals Co Ltd | EMA approval for the adjunctive treatment of focal-onset seizures with or without secondary generalization in adult patients who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products | Ontozry | Solid dose manufacture and packaging |
| AGC Biologics Inc | Swedish Orphan Biovitrum AB | NICE approval for treating Still's disease with moderate to high disease activity, or continued disease activity after non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids | Kineret | Large molecule API manufacture |
| AGC Biologics Inc | ImmunityBio Inc | Trial planned - Phase I to evaluate the effect on B Cell follicles in antiretroviral treated HIV disease | nogapendekin alfa | Large molecule API manufacture |
| Ajinomoto Bio-Pharma Services | Humanigen Inc | Positive Phase III results in patients hospitalized with COVID-22 | lenzilumab** | Parenteral manufacture |
| Albany Molecular Research Inc | Eli Lilly and Co | FDA expanded indication in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN); in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN and as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. It is also indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment; in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. and as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan | Erbitux | Parenteral manufacture and packaging |
| Almac Group Ltd | Johnson & Johnson | Trial planned - Phase I to evaluate the safety, tolerability, and pharmacokinetics (PK) after single- and multiple-dose oral administration in healthy Japanese adult male subjects | aticaprant | Solid dose manufacture |
| Almac Group Ltd | BioNTech SE | Positive Phase III results in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses | Comirnaty** | Parenteral packaging |
| Amgen Inc | Eli Lilly and Co | Positive Phase II results for trial the drug with VIR-7831 in low-risk adults with COVID-19 | bamlanivimab** | Large molecule API manufacture |
| Asahi Kasei Finechem Co Ltd | Jazz Pharmaceuticals Plc | FDA expanded indication for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older | Vyxeos | Small molecule API manufacture |
| Aspen Pharmacare Holdings Ltd | Johnson & Johnson | 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 and packaging |
| AstraZeneca Plc | Merck & Co Inc | Trial planned - Phase II | Keytruda | Large molecule API manufacture |
| AstraZeneca Plc | Merck & Co Inc | FDA expanded indication for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy, or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test | Keytruda | Large molecule API manufacture |
| Avara Pharmaceutical Services Inc | Astellas Pharma Inc | FDA expanded indication for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq Granules (mirabegronfor extended-release oral suspension) for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older | Myrbetriq | Solid dose manufacture |
| Avid Bioservices Inc | Humanigen Inc | Positive Phase III results in patients hospitalized with COVID-19 | lenzilumab** | Large molecule API manufacture |
| BASF SE | Amarin Corp Plc | EMA approval to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor | Vazkepa | Small molecule API manufacture |
| Baxter Biopharma Solutions | Pharma Mar SA | Trial planned - Phase I/II to identify the maximum tolerated dose (MTD) in phase I and to assess the efficacy with respect to clinical response rate of a combination with berzosertib in previously treated subjects with SCLC and HGNECs in phase II | Zepzelca | Small molecule API manufacture and parenteral packaging |
| Baxter Biopharma Solutions | BioNTech SE | Positive Phase III results in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses | Comirnaty** | Parenteral manufacture |
| Baxter Biopharma Solutions | Jazz Pharmaceuticals Plc | FDA expanded indication for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older | Vyxeos | Parenteral manufacture and packaging |
| Biogen Inc | Vir Biotechnology Inc | Positive Phase II results for trial the drug with bamlanivimab in low-risk adults with COVID-20 | sotrovimab** | Large molecule API manufacture |
| Biological E Ltd | Johnson & Johnson | 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 |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | Trial planned - Phase II | Keytruda | Large molecule API manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Amgen Inc | FDA expanded indication for B-Cell Acute Lymphocytic Leukemia (B-Cell Acute Lymphoblastic Leukaemia) | Blincyto | Parenteral manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Eli Lilly and Co | FDA expanded indication in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN); in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN and as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. It is also indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment; in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. and as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan | Erbitux | Large molecule API, parenteral manufacture and packaging |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | FDA expanded indication for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy, or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test | Keytruda | Large molecule API manufacture |
| Boehringer Ingelheim RCV GmbH & Co KG | Swedish Orphan Biovitrum AB | NICE approval for treating Still's disease with moderate to high disease activity, or continued disease activity after non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids | Kineret | Large molecule API manufacture |
| Bristol-Myers Squibb Co | AstraZeneca Plc | Trial planned - Phase I to evaluate relative bioavailability of the drug | Forxiga | Small molecule API manufacture |
| BSP Pharmaceuticals SpA | Gilead Sciences Inc | Trial planned - Phase I/II to identify maximum tolerated dose (MTD) in phase I trial, assessing the efficacy with respect to clinical response rate of a combination of the drug and berzosertib as treatment of subjects with recurrent SCLC and HRD positive tumors in a phase II trial | Trodelvy | Parenteral manufacture |
| Cambrex Corp | Pacira BioSciences Inc | FDA expanded indication in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia | Exparel | Small molecule API manufacture |
| Cambrex Corp | Paion AG | EMA approval for procedural sedation | Byfavo | Small molecule API manufacture |
| Capsugel Inc | Amarin Corp Plc | EMA approval to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor | Vazkepa | Solid dose manufacture |
| Catalent Inc | Bristol-Myers Squibb Co | NICE approval for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease | Opdivo | Parenteral manufacture and packaging |
| Catalent Inc | AstraZeneca Plc | Trial planned - Phase I to evaluate relative bioavailability of the drug | Forxiga | Small molecule API manufacture |
| Catalent Inc | Humanigen Inc | Positive Phase III results in patients hospitalized with COVID-23 | lenzilumab** | Large molecule API, parenteral manufacture and packaging |
| Catalent Inc | Supernus Pharmaceuticals Inc | FDA approval for the treatment of Attention-Deficit Hyperactivity Disorder in pediatric patients 6 to 17 years of age | Qelbree | Solid dose manufacture |
| Catalent Inc | United Therapeutics Corp | FDA expanded indication for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability | Tyvaso | Inhalation dose manufacture |
| Catalent Inc | Exelixis Inc | EMA expanded indication in combination with OPDIVO is used (nivolumab) as a first-line treatment for advanced renal cell carcinoma (RCC) | Cabometyx | Solid dose manufacture and packaging |
| Catalent Inc | Johnson & Johnson | 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, parenteral manufacture and packaging |
| Catalent Inc | Amarin Corp Plc | EMA approval to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor | Vazkepa | Solid dose manufacture |
| Catalent Inc | Karyopharm Therapeutics Inc | EMA approval for combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy | Nexpovio | Solid dose manufacture |
| Chemport Inc | Amarin Corp Plc | EMA approval to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor | Vazkepa | Small molecule API manufacture |
| Cosmo Pharmaceuticals NV | Paion AG | EMA approval for procedural sedation | Byfavo | Parenteral packaging |
| Delpharm SAS | BioNTech SE | Positive Phase III results in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses | Comirnaty** | Parenteral manufacture |
| DPT Laboratories Ltd | Bausch Health Companies Inc | FDA expanded indication for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older | Diastat | Semi solid dose manufacture |
| EMD Serono Inc | Eli Lilly and Co | FDA expanded indication in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN); in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN and as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. It is also indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment; in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. and as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan | Erbitux | Large molecule API manufacture |
| Emergent BioSolutions Inc | Humanigen Inc | Positive Phase III results in patients hospitalized with COVID-20 | lenzilumab** | Parenteral manufacture |
| Emergent BioSolutions Inc | Johnson & Johnson | 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 |
| Excella GmbH & Co KG | Pacira BioSciences Inc | FDA expanded indication in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia | Exparel | Small molecule API manufacture |
| Fujifilm Diosynth Biotechnologies USA Inc | Outlook Therapeutics Inc | Positive Phase III results from open-label safety study evaluating drug to treat retinal diseases. | Lytenava | Large molecule API manufacture |
| Fujifilm Diosynth Biotechnologies USA Inc | Eli Lilly and Co | Positive Phase II results for trial the drug with VIR-7831 in low-risk adults with COVID-19 | bamlanivimab** | Large molecule API manufacture |
| Grand River Aseptic Manufacturing Inc | Johnson & Johnson | 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 and packaging |
| IDT Biologika GmbH | Johnson & Johnson | 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 |
| Jubilant HollisterStier LLC | Eli Lilly and Co | FDA expanded indication in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN); in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN and as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. It is also indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment; in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. and as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan | Erbitux | Parenteral manufacture and packaging |
| Jubilant HollisterStier LLC | Eli Lilly and Co | Positive Phase II results for trial the drug with VIR-7831 in low-risk adults with COVID-19 | bamlanivimab** | Parenteral manufacture |
| Laboratorio Reig Jofre SA | Johnson & Johnson | 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 and packaging |
| Lonza Group Ltd | Bristol-Myers Squibb Co | NICE approval for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease | Opdivo | Large molecule API manufacture |
| Lonza Group Ltd | Humanigen Inc | Positive Phase III results in patients hospitalized with COVID-24 | lenzilumab** | Large molecule API manufacture |
| Lonza Group Ltd | Amgen Inc | FDA expanded indication for B-Cell Acute Lymphocytic Leukemia (B-Cell Acute Lymphoblastic Leukaemia) | Blincyto | Large molecule API manufacture |
| Lonza Group Ltd | Novartis AG | EMA approval for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features | Kesimpta | Large molecule API manufacture |
| Merck & Co Inc | Johnson & Johnson | 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, parenteral manufacture and packaging |
| Merck KGaA | Eli Lilly and Co | FDA expanded indication in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN); in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN and as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. It is also indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment; in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. and as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan | Erbitux | Large molecule API, parenteral manufacture and packaging |
| MIAS Pharma Ltd | Amarin Corp Plc | EMA approval to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor | Vazkepa | Solid dose manufacture and packaging |
| MIAS Pharma Ltd | Karyopharm Therapeutics Inc | EMA approval for combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy | Nexpovio | Solid dose manufacture |
| Mibe GmbH Arzneimittel | BioNTech SE | Positive Phase III results in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses | Comirnaty** | Parenteral manufacture |
| Nisshin Pharma Inc | Amarin Corp Plc | EMA approval to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor | Vazkepa | Small molecule API manufacture |
| Novartis AG | BioNTech SE | Positive Phase III results in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses | Comirnaty** | Parenteral manufacture and packaging |
| Novasep Holding SAS | Amarin Corp Plc | EMA approval to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor | Vazkepa | Small molecule API manufacture |
| Patheon NV | Swedish Orphan Biovitrum AB | NICE approval for treating Still's disease with moderate to high disease activity, or continued disease activity after non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids | Kineret | Parenteral manufacture |
| Patheon NV | Frontier Biotechnologies Inc | Trial planned - Phase II to evaluate the safety and tolerability of combination therapy with 3BNC117 in virologically suppressed subjects with HIV-1 infection and explore the potential of viral suppression and viral reservoir clearance after analytical treatment interruption (ATI) | Aikening | Large molecule API manufacture |
| Patheon NV | A. Menarini Industrie Farmaceutiche Riunite Srl | Trial planned - Phase I to evaluate the effect on proliferation after 4 weeks of treatment in postmenopausal women with Estrogen Receptor-positive (ER+) and Human Epidermal Growth Factor Receptor 2-negative (HER2-negative) early breast cancer (BC) amenable to surgery | elacestrant hydrochloride | Small molecule API and solid dose manufacture |
| Patheon NV | Humanigen Inc | Positive Phase III results in patients hospitalized with COVID-21 | lenzilumab** | Large molecule API manufacture |
| Patheon NV | Pacira BioSciences Inc | FDA expanded indication in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia | Exparel | Parenteral manufacture |
| Patheon NV | Exelixis Inc | EMA expanded indication in combination with OPDIVO is used (nivolumab) as a first-line treatment for advanced renal cell carcinoma (RCC) | Cabometyx | Solid dose manufacture and packaging |
| Patheon NV | Amarin Corp Plc | EMA approval to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor | Vazkepa | Solid dose manufacture |
| Patheon NV | Paion AG | EMA approval for procedural sedation | Byfavo | Parenteral manufacture and packaging |
| PCI Pharma Services | Pharma Mar SA | Trial planned - Phase I/II to identify the maximum tolerated dose (MTD) in phase I and to assess the efficacy with respect to clinical response rate of a combination with berzosertib in previously treated subjects with SCLC and HGNECs in phase II | Zepzelca | Parenteral packaging |
| PCI Pharma Services | Pacira BioSciences Inc | FDA expanded indication in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia | Exparel | Parenteral packaging |
| PCI Pharma Services | Regeneron Pharmaceuticals Inc | FDA expanded indication for the treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older | Arcalyst | Parenteral packaging |
| PCI Pharma Services | Amarin Corp Plc | EMA approval to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor | Vazkepa | Solid dose packaging |
| Pfizer Inc | Swedish Orphan Biovitrum AB | NICE approval for treating Still's disease with moderate to high disease activity, or continued disease activity after non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids | Kineret | Large molecule API manufacture |
| Pfizer Inc | Sanofi | FDA expanded indication for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease | Fabrazyme | Parenteral manufacture |
| Pharma Packaging Solutions | Karyopharm Therapeutics Inc | EMA approval for combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy | Nexpovio | Solid dose packaging |
| Piramal Pharma Solutions Inc | Althera Inc | FDA approval as an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol and also indicated for alone or an adjunct to other LDL-C lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C in adults | Roszet | Solid dose manufacture |
| Polymun Scientific ImmunbiologischeForschung GmbH | BioNTech SE | Positive Phase III results in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses | Comirnaty** | Parenteral manufacture |
| Rechon Life Science AB | Swedish Orphan Biovitrum AB | NICE approval for treating Still's disease with moderate to high disease activity, or continued disease activity after non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids | Kineret | Parenteral packaging |
| Reed-Lane Inc | Amarin Corp Plc | EMA approval to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor | Vazkepa | Solid dose packaging |
| Rentschler Biopharma SE | BioNTech SE | Positive Phase III results in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses | Comirnaty** | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Co | NICE approval for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease | Opdivo | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Gilead Sciences Inc | Trial planned - Phase I/II to identify maximum tolerated dose (MTD) in phase I trial, assessing the efficacy with respect to clinical response rate of a combination of the drug and berzosertib as treatment of subjects with recurrent SCLC and HRD positive tumors in a phase II trial | Trodelvy | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Eli Lilly and Co | Positive Phase II results for trial the drug with VIR-7831 in low-risk adults with COVID-19 | bamlanivimab** | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Vir Biotechnology Inc | Positive Phase II results for trial the drug with bamlanivimab in low-risk adults with COVID-19 | sotrovimab** | Large molecule API manufacture |
| Sanofi | BioNTech SE | Positive Phase III results in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses | Comirnaty** | Parenteral manufacture |
| Sanofi | Johnson & Johnson | 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 and packaging |
| Siegfried Holding AG | Novartis AG | Trial planned - Phase I to assess the safety, tolerability and confirm the dose for select single agents and combinations in subjects with lower risk (very low, low, and intermediate risk) Myelodysplastic Syndromes (MDS) | Ilaris | Parenteral manufacture |
| Siegfried Holding AG | BioNTech SE | Positive Phase III results in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses | Comirnaty** | Parenteral manufacture and packaging |
| Siegfried Holding AG | Novartis AG | EMA approval for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features | Kesimpta | Parenteral manufacture and packaging |
| SK Biotek Co Ltd | AstraZeneca Plc | Trial planned - Phase I to evaluate relative bioavailability of the drug | Forxiga | Small molecule API manufacture |
| SK Biotek Co Ltd | SK Biopharmaceuticals Co Ltd | EMA approval for the adjunctive treatment of focal-onset seizures with or without secondary generalization in adult patients who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products | Ontozry | Small molecule API manufacture |
| Tjoapack BV | Incyte Corp | EMA approval for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy | Pemazyre | Solid dose packaging |
| Vibalogics GmbH | Johnson & Johnson | 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 and packaging |
| WuXi Biologics Cayman Inc | Vir Biotechnology Inc | Positive Phase II results for trial the drug with bamlanivimab in low-risk adults with COVID-21 | sotrovimab** | Large molecule API manufacture |
| Zhejiang Hisun Pharmaceutical Co Ltd | Jazz Pharmaceuticals Plc | FDA expanded indication for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older | Vyxeos | Small molecule API manufacture |
POTENTIALLY NEGATIVE |
||||
| Boehringer Ingelheim Biopharmaceuticals GmbH | Amgen Inc | NICE rejection for previously treated Philadelphia-chromosome-positive acute lymphoblastic leukaemia in adults | Blincyto | Parenteral manufacture |
| Lonza Group Ltd | Amgen Inc | NICE rejection for previously treated Philadelphia-chromosome-positive acute lymphoblastic leukaemia in adults | Blincyto | Large molecule API manufacture |
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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