May 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 |
||||
| AbbVie Inc | AstraZeneca Plc | NICE approval for advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer | Lynparza | Solid dose manufacture and packaging |
| Albany Molecular Research Inc | Panbela Therapeutics Inc | Trial planned - Phase I for combination study for treatment of subjects with metastatic pancreatic ductal adenocarcinoma | SBP-101 | Parenteral manufacture |
| Albany Molecular Research Inc | Pfizer Inc | EMA expanded indication for the treatment of adult men with high-risk, non-metastatic castration-resistant prostate cancer | Xtandi | Small molecule API manufacture |
| Allpack Group AG | Jazz Pharmaceuticals Plc | EMA expanded indication as an adjunctive treatment of seizures associated with tuberous sclerosis complex (TSC), for patients two years of age and older | Epidyolex | Liquid dose packaging |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | EMA expanded indication for the treatment of cystic fibrosis (CF) in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Solid dose manufacture and packaging |
| AstraZeneca Plc | Merck & Co Inc | FDA expanded indication in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma | Keytruda | Large molecule API manufacture |
| Baxter Biopharma Solutions | Amgen Inc | NICE approval for treating multiple myeloma | Kyprolis | Parenteral manufacture and packaging |
| Baxter Biopharma Solutions | Moderna Inc | Positive Phase II results for booster dose to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 | COVID-19 Vaccine** | Parenteral manufacture and packaging |
| Baxter Biopharma Solutions | Moderna Inc | Moderna announces supply agreement with GAVI for up to 500 million doses of COVID-19 vaccine for COVAX to help end COVID-19 pandemic in lowest income countries | COVID-19 Vaccine** | Parenteral manufacture and packaging |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | FDA expanded indication in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma | Keytruda | Large molecule API manufacture |
| Bristol-Myers Squibb Co | AstraZeneca Plc | FDA expanded indication to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression | Farxiga | Small molecule API manufacture |
| BSP Pharmaceuticals SpA | Gilead Sciences Inc | FDA expanded indication for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor | Trodelvy | Parenteral manufacture |
| Cambrex Corp | BioCryst Pharmaceuticals Inc | EMA approval for the prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older | Orladeyo | Small molecule API manufacture |
| Catalent Inc | AstraZeneca Plc | NICE approval for untreated chronic lymphocytic leukaemia | Calquence | Solid dose manufacture and packaging |
| Catalent Inc | Moderna Inc | Positive Phase II results for booster dose to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 | COVID-19 Vaccine** | Parenteral manufacture and packaging |
| Catalent Inc | Trillium Therapeutics Inc | Trial planned - Phase I/II in combination with azacitidine and venetoclax in elderly or unfit p53 wild type acute myelocytic leukemia | TTI-622 | Large molecule API and parenteral manufacture |
| Catalent Inc | AstraZeneca Plc | FDA expanded indication to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression | Farxiga | Small molecule API manufacture |
| Catalent Inc | Ono Pharmaceutical Co Ltd | FDA expanded indication in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma | Opdivo | Parenteral manufacture and packaging |
| Catalent Inc | ALK-Abello AS | FDA expanded indication as immunotherapy for the treatment of short ragweed pollen induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen in persons 5 to 17 years of age | Ragwitek | Solid dose manufacture and packaging |
| Catalent Inc | BioCryst Pharmaceuticals Inc | EMA approval for the prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older | Orladeyo | Solid dose manufacture and packaging |
| Catalent Inc | Pfizer Inc | EMA expanded indication for the treatment of adult men with high-risk, non-metastatic castration-resistant prostate cancer | Xtandi | Solid dose manufacture |
| Catalent Inc | Moderna Inc | Moderna announces supply agreement with GAVI for up to 500 million doses of COVID-19 vaccine for COVAX to help end COVID-19 pandemic in lowest income countries | COVID-19 Vaccine** | Parenteral manufacture and packaging |
| Cipla Ltd | Viatris Inc | FDA expanded indication for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older | Dymista | Semi solid dose manufacture |
| Fabbrica Italiana Sintetici SpA | Vertex Pharmaceuticals Inc | EMA expanded indication for the treatment of cystic fibrosis (CF) in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Small molecule API manufacture |
| Gland Pharma Ltd | Novo Nordisk AS | FDA expanded indication for Injection is indicated for the treatment of pediatric patients (1 to 17 years of age) with Staphylococcus aureus bloodstream infections (bacteremia), Complicated Skin And Skin Structure Infections (cSSSI) | Daptomycin | Parenteral manufacture and packaging |
| H. Lundbeck AS | Advicenne SA | EMA approval for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older | Sibnayal | Solid dose manufacture and packaging |
| Helsinn Group | Amgen Inc | NICE approval for treating multiple myeloma | Kyprolis | Small molecule API manufacture |
| Hovione FarmaCiencia SA | Amgen Inc | NICE approval for treating multiple myeloma | Kyprolis | Small molecule API manufacture |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | EMA expanded indication for the treatment of cystic fibrosis (CF) in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Solid dose manufacture |
| Jetpharma SA | AstraZeneca Plc | NICE approval for advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer | Lynparza | Small molecule API manufacture |
| Johnson Matthey Plc | Pfizer Inc | FDA expanded indication in adult and pediatric patients for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate | morphine sulfate | Small molecule API manufacture |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | Positive Phase II results for booster dose to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 | COVID-19 Vaccine** | Large molecule API, parenteral manufacture and packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | Moderna announces supply agreement with GAVI for up to 500 million doses of COVID-19 vaccine for COVAX to help end COVID-19 pandemic in lowest income countries | COVID-19 Vaccine** | Large molecule API, parenteral manufacture and packaging |
| Lonza Group Ltd | AstraZeneca Plc | NICE approval for advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer | Lynparza | Small molecule API manufacture |
| Lonza Group Ltd | Moderna Inc | Positive Phase II results for booster dose to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 | COVID-19 Vaccine** | Large molecule API manufacture |
| Lonza Group Ltd | Gilead Sciences Inc | Trial planned - Phase II for the combination therapy in participants with head and neck squamous cell carcinoma | magrolimab | Large molecule API manufacture |
| Lonza Group Ltd | Ono Pharmaceutical Co Ltd | FDA expanded indication in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma | Opdivo | Large molecule API manufacture |
| Lonza Group Ltd | Novartis AG | FDA expanded indication for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older | Diovan | Solid dose manufacture and packaging |
| Lonza Group Ltd | Moderna Inc | Moderna announces supply agreement with GAVI for up to 500 million doses of COVID-19 vaccine for COVAX to help end COVID-19 pandemic in lowest income countries | COVID-19 Vaccine** | Large molecule API manufacture |
| Mikart LLC | Arbor Pharmaceuticals LLC | FDA expanded indication for the treatment of attention deficit hyperactivity disorder in pediatric patients 3 to 5 years of age | Evekeo | Solid dose manufacture |
| Patheon NV | AstraZeneca Plc | NICE approval for advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer | Lynparza | Solid dose manufacture and packaging |
| Patheon NV | Amgen Inc | NICE approval for treating multiple myeloma | Kyprolis | Parenteral manufacture |
| Patheon NV | Rigel Pharmaceuticals Inc | Positive Phase II results for the treatment of hospitalized patients with COVID-19 | Tavlesse** | Solid dose manufacture and packaging |
| Patheon NV | Zosano Pharma Corp | Trial planned - Phase I to evaluate the drug in healthy subjects | Qtrypta | Parenteral manufacture and packaging |
| Patheon NV | BioCryst Pharmaceuticals Inc | EMA approval for the prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older | Orladeyo | Solid dose manufacture |
| PCI Pharma Services | Esperion Therapeutics Inc | NICE approval for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia | Nilemdo | Solid dose packaging |
| PCI Pharma Services | Esperion Therapeutics Inc | NICE approval for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia | Nustendi | Solid dose packaging |
| PCI Pharma Services | BioCryst Pharmaceuticals Inc | EMA approval for the prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older | Orladeyo | Solid dose packaging |
| PCI Pharma Services | Pfizer Inc | EMA expanded indication for the treatment of adult men with high-risk, non-metastatic castration-resistant prostate cancer | Xtandi | Solid dose packaging |
| Pfizer Inc | GlaxoSmithKline Plc | EMA expanded indication in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis | Benlysta | Parenteral manufacture and packaging |
| Piramal Pharma Solutions Inc | Esperion Therapeutics Inc | NICE approval for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia | Nilemdo | Solid dose manufacture and packaging |
| Piramal Pharma Solutions Inc | Esperion Therapeutics Inc | NICE approval for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia | Nustendi | Solid dose manufacture and packaging |
| QPS Holdings LLC | Rigel Pharmaceuticals Inc | Positive Phase II results for the treatment of hospitalized patients with COVID-19 | Tavlesse** | Solid dose manufacture |
| Recipharm AB | Moderna Inc | Positive Phase II results for booster dose to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 | COVID-19 Vaccine** | Parenteral manufacture |
| Recipharm AB | Moderna Inc | Moderna announces supply agreement with GAVI for up to 500 million doses of COVID-19 vaccine for COVAX to help end COVID-19 pandemic in lowest income countries | COVID-19 Vaccine** | Parenteral manufacture |
| Samsung Biologics Co Ltd | Ono Pharmaceutical Co Ltd | FDA expanded indication in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma | Opdivo | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Gilead Sciences Inc | FDA expanded indication for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor | Trodelvy | Large molecule API manufacture |
| Sanofi | Moderna Inc | Positive Phase II results for booster dose to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 | COVID-19 Vaccine** | Parenteral manufacture |
| Sanofi | Moderna Inc | Moderna announces supply agreement with GAVI for up to 500 million doses of COVID-19 vaccine for COVAX to help end COVID-19 pandemic in lowest income countries | COVID-19 Vaccine** | Parenteral manufacture |
| Sharp Packaging Services | Amgen Inc | NICE approval for treating multiple myeloma | Kyprolis | Parenteral packaging |
| Siegfried Holding AG | Pfizer Inc | FDA expanded indication in adult and pediatric patients for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate | morphine sulfate | Parenteral manufacture and packaging |
| SK Biotek Co Ltd | AstraZeneca Plc | FDA expanded indication to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression | Farxiga | Small molecule API manufacture |
| Srini Pharmaceuticals Pvt Ltd | Chiesi Farmaceutici SpA | FDA expanded indication for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes and sickle cell disease or other anemias | Ferriprox | Small molecule API manufacture |
| STA Pharmaceutical Co Ltd | Vertex Pharmaceuticals Inc | EMA expanded indication for the treatment of cystic fibrosis (CF) in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kaftrio | Small molecule API manufacture |
| Sterling Pharma Solutions Ltd | Amgen Inc | NICE approval for treating multiple myeloma | Kyprolis | Small molecule API manufacture |
| Sterling Pharma Solutions Ltd | ADC Therapeutics SA | FDA approval for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma | Zynlonta | Large molecule API manufacture |
| Syngene International Ltd | Panbela Therapeutics Inc | Trial planned - Phase I for combination study for treatment of subjects with metastatic pancreatic ductal adenocarcinoma | SBP-101 | Small molecule API manufacture |
| WuXi Biologics Cayman Inc | Hbm Holdings Ltd | Trial planned - Phase I to evaluate the drug in combination with pembrolizumab in subjects with advanced NSCLC and other solid tumors | HBM-4003 | Large molecule API manufacture |
POTENTIALLY NEGATIVE |
||||
| Almac Group Ltd | Takeda Pharmaceutical Co Ltd | NICE rejection for short bowel syndrome | Revestive | Parenteral packaging |
| AstraZeneca Plc | Merck & Co Inc | NICE rejection for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy | Keytruda | Large molecule API manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | NICE rejection for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy | Keytruda | Large molecule API manufacture |
| Boehringer Ingelheim RCV GmbH & Co KG | Takeda Pharmaceutical Co Ltd | NICE rejection for short bowel syndrome | Revestive | Large molecule API, parenteral manufacture and packaging |
| Patheon NV | Takeda Pharmaceutical Co Ltd | NICE rejection for short bowel syndrome | Revestive | Parenteral manufacture and packaging |
| Pfizer Inc | Takeda Pharmaceutical Co Ltd | NICE rejection for short bowel syndrome | Revestive | Parenteral manufacture and packaging |
| Sharp Packaging Services | Takeda Pharmaceutical Co Ltd | NICE rejection for short bowel syndrome | Revestive | Parenteral packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Takeda Pharmaceutical Co Ltd | NICE rejection for short bowel syndrome | Revestive | Parenteral manufacture and packaging |
Notes:
Source: GlobalData, Pharma Intelligence Center ©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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