January 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 | AstraZeneca Plc | EMA expanded indications | Lynparza | Solid dose & packaging |
| ACS Dobfar SpA | Pfizer Inc | FDA expanded indications for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in pediatric patients aged 3 months to less than 18 years caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae | Avycaz | Parenteral manufacture & packaging |
| AGC Biologics SpA | Chemomab Therapeutics Ltd | Positive Phase II top-line results for Non Alcoholic Fatty Liver Disease | CM-101 | Biologic API |
| Almac Group Ltd | Clovis Oncology Inc | FDA expanded indication for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy | Rubraca | Solid dose & packaging |
| Almac Group Ltd | AbbVie Inc | EMA expanded indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older | Xydalba | Parenteral packaging |
| AstraZeneca Plc | Merck & Co Inc | NICE approval as an option for neoadjuvant and adjuvant treatment of triple-negative early or locally advanced breast cancer in adults | Keytruda | Biologic API |
| Avid Bioservices Inc | ADC Therapeutics SA | EMA approval for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) | Zynlonta | Biologic API |
| Baxter Biopharma Solutions | Daiichi Sankyo Co Ltd | EMA expanded indication for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab based regimen | Enhertu | Parenteral manufacture & packaging |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | NICE approval as an option for neoadjuvant and adjuvant treatment of triple-negative early or locally advanced breast cancer in adults | Keytruda | Biologic API |
| Cambrex Corp | Mirum Pharmaceuticals Inc | EMA approval for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older | Livmarli | Non-sterile liquid manufacturing & packaging |
| Catalent Inc | Ono Pharmaceutical Co Ltd | NICE approval for the drug plus platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric, gastro-oesophageal junction or oesophageal adenocarcinoma in adults | Opdivo | Biologic API |
| Catalent Inc | Exelixis Inc | NICE approval as an option for advanced hepatocellular carcinoma in adults who have had sorafenib | Cabometyx | Solid dose packaging |
| Catalent Inc | Handa Pharmaceuticals LLC | FDA expanded indication for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older | Tascenso ODT | Solid dose |
| Catalent Inc | Novo Nordisk AS | FDA expanded indication as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater standardized for age and sex (obesity) | Wegovy | Parenteral manufacture |
| Catalent Inc | Regeneron Pharmaceuticals Inc | EMA expanded indication for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy | Dupixent | Parenteral manufacture & packaging |
| Catalent Inc | AstraZeneca Plc | EMA expanded indication of the drug in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC) | Imfinzi | Parenteral manufacture & packaging |
| Challenge Bioproducts Co Ltd | MediWound Ltd | FDA approval for eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns | NexoBrid | Biologic API |
| Charles River Laboratories International Inc | Atara Biotherapeutics Inc | EMA approval as monotherapy for the treatment of adult and paediatric patients 2 years of age and older with post-transplant lymphoproliferative disease (EBV+ PTLD) and relapsed or refractory Epstein-Barr virus positive, who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate | Ebvallo | Biologic API |
| Cobra Biologics Ltd | Alligator Bioscience AB | Positive Phase I/II interim results for 1st line metastatic pancreatic cancer | ADC1013 | Biologic API |
| Corden Pharma International GmbH | Slayback Pharma LLC | FDA approval for B-Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia (CLL) | Vivimusta | Parenteral manufacture & packaging |
| Dottikon Exclusive Synthesis AG | AstraZeneca Plc | EMA expanded indications | Lynparza | Small mol API |
| Eisai Co Ltd | Swedish Orphan Biovitrum AB | NICE approval as an option for treating primary chronic immune thrombocytopenia in adults | Doptelet | Small mol API |
| Eisai Co Ltd | Swedish Orphan Biovitrum AB | NICE approval as an option for treating primary chronic immune thrombocytopenia in adults | Doptelet | Solid dose |
| Fareva SA | Novartis AG | FDA approval for metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer | Cabazitaxel | Parenteral manufacture |
| Fareva SA | Laboratoires Thea SA | FDA approval for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension | Iyuzeh | Sterile liquid manufacture & packaging |
| FinVector Oy | FKD Therapies Oy | FDA approval for the treatment of adult patients with high-risk Bacillus CalmetteGuerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors | Adstiladrin | Parenteral manufacture |
| Gland Pharma Ltd | Pfizer Inc | FDA expanded indications for the treatment of adult patients with mantle cell lymphoma | Bortezomib | Parenteral manufacture & packaging |
| Glatt GmbH | Acer Therapeutics Inc | FDA approval as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS) | Olpruva | Non-sterile liquid manufacturing |
| Gnosis by Lesaffre | AbbVie Inc | EMA expanded indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older | Xydalba | Small mol API |
| Hikma Pharmaceuticals Plc | Boehringer Ingelheim International GmbH | EMA approval for Generalized Pustular Psoriasis (GPP) | Spevigo | Parenteral packaging |
| Jetpharma SA | AstraZeneca Plc | EMA expanded indications | Lynparza | Small mol API |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least primary vaccination course against COVID-19 | Spikevax Bivalent Original/Omicron BA.1** | Parenteral manufacture & packaging |
| Lonza Group Ltd | Ono Pharmaceutical Co Ltd | NICE approval for the drug plus platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric, gastro-oesophageal junction or oesophageal adenocarcinoma in adults | Opdivo | Biologic API |
| Lonza Group Ltd | Takeda Pharmaceutical Co Ltd | NICE approval as an option for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy in adults | Exkivity | Solid dose |
| Lonza Group Ltd | Clovis Oncology Inc | FDA expanded indication for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy | Rubraca | Small mol API |
| Lonza Group Ltd | Gilead Sciences Inc | UK MHRA expanded indication for the treatment of adult patients with diffuse large B cell lymphoma and high-grade B-cell lymphoma that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy and has been granted an orphan designation | Yescarta | Parenteral manufacture |
| Lonza Group Ltd | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least primary vaccination course against COVID-19 | Spikevax Bivalent Original/Omicron BA.1** | Biologic API |
| Lonza Group Ltd | AstraZeneca Plc | EMA expanded indications | Lynparza | Small mol API |
| Organon & Co | Merck & Co Inc | NICE approval as an option for neoadjuvant and adjuvant treatment of triple-negative early or locally advanced breast cancer in adults | Keytruda | Parenteral packaging |
| Patheon NV | Eisai Co Ltd | NICE approval for the drug plus pembrolizumab (Keytruda) for untreated advanced renal cell carcinoma in adults | Kisplyx | Solid dose & packaging |
| Patheon NV | Exelixis Inc | NICE approval as an option for advanced hepatocellular carcinoma in adults who have had sorafenib | Cabometyx | Solid dose packaging |
| Patheon NV | F. Hoffmann-La Roche Ltd | FDA expanded indication for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen, adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen and also for treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen | Xeloda | Small mol API |
| Patheon NV | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least primary vaccination course against COVID-19 | Spikevax Bivalent Original/Omicron BA.1** | Parenteral manufacture |
| Patheon NV | AstraZeneca Plc | EMA expanded indications | Lynparza | Solid dose & packaging |
| PCI Pharma Services | Takeda Pharmaceutical Co Ltd | NICE approval as an option for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy in adults | Exkivity | Solid dose packaging |
| PCI Pharma Services | Taiho Oncology Inc | NICE approval as an option for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in adults after 2 or more treatments | Lonsurf | Solid dose packaging |
| PCI Pharma Services | Mirum Pharmaceuticals Inc | EMA approval for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older | Livmarli | Non-sterile liquid packaging |
| Pfizer Inc | AbbVie Inc | EMA expanded indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older | Xydalba | Parenteral manufacture & packaging |
| Pharmstandard | Eisai Co Ltd | NICE approval for the drug plus pembrolizumab (Keytruda) for untreated advanced renal cell carcinoma in adults | Kisplyx | Solid dose |
| Piramal Pharma Solutions Inc | Takeda Pharmaceutical Co Ltd | NICE approval as an option for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy in adults | Exkivity | Small mol API |
| Piramal Pharma Solutions Inc | Exelixis Inc | NICE approval as an option for advanced hepatocellular carcinoma in adults who have had sorafenib | Cabometyx | Small mol API |
| PolyPeptide Group AG | Ipsen SA | EMA approval for the treatment of osteoporosis in postmenopausal women at increased risk of fracture | Eladynos | Small mol API |
| ProBioGen AG | Zymeworks Inc | Positive Phase II top-line results for metastatic biliary tract cancer | ZW25 | Biologic API |
| Recipharm AB | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least primary vaccination course against COVID-19 | Spikevax Bivalent Original/Omicron BA.1** | Parenteral manufacture & packaging |
| Renaissance Lakewood LLC | Johnson & Johnson | NICE approval as an option for treatment-resistant depression in adults | Spravato | Inhalational manufacture & packaging |
| Samsung Biologics Co Ltd | Ono Pharmaceutical Co Ltd | NICE approval for the drug plus platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric, gastro-oesophageal junction or oesophageal adenocarcinoma in adults | Opdivo | Biologic API |
| Sciarra Laboratories Inc | Tiziana Life Sciences Plc | Positive Phase III interim results for secondary progressive multiple sclerosis (SPMS) | TZLS401 | Biologic API |
| SEQENS | Acer Therapeutics Inc | FDA approval as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS) | Olpruva | Small mol API |
| SEQENS | Johnson & Johnson | NICE approval as an option for treatment-resistant depression in adults | Spravato | Small mol API |
| Sharp Packaging Services | Acer Therapeutics Inc | FDA approval as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS) | Olpruva | Non-sterile liquid packaging |
| Sterling Pharma Solutions Ltd | ADC Therapeutics SA | EMA approval for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) | Zynlonta | Biologic API |
| Vetter Pharma-Fertigung GmbH & Co KG | Ono Pharmaceutical Co Ltd | NICE approval for the drug plus platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric, gastro-oesophageal junction or oesophageal adenocarcinoma in adults | Opdivo | Biologic API |
| Vetter Pharma-Fertigung GmbH & Co KG | Ipsen SA | EMA approval for the treatment of osteoporosis in postmenopausal women at increased risk of fracture | Eladynos | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Regeneron Pharmaceuticals Inc | EMA expanded indication for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease in preterm infants | Eylea | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | EMA expanded indication of the drug in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC) | Imfinzi | Parenteral manufacture |
| WuXi AppTec Co Ltd | Dizal (Jiangsu) Pharmaceutical Co Ltd | Trial planned - Phase III to assess the efficacy and safety of the drug versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage | Sunvozertinib | Small mol API |
| Yuki Gosei Kogyo Co Ltd | Taiho Oncology Inc | NICE approval as an option for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in adults after 2 or more treatments | Lonsurf | Small mol 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