November 2024 — CDMO Opportunities And Threats Report
By GlobalData
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 |
||||
| Piramal Pharma Solutions Inc | Acurx Pharmaceuticals Inc | Trial planned - Phase III to demonstrate non-inferiority of drug to vancomycin for clostridioides difficile infections (clostridium difficile associated disease) | ibezapolstat | Small mol API, Solid dose manufacture |
| Alchem Laboratories Corp | Atossa Therapeutics Inc | Positive Phase II top-line results of the drug for the treatment in Premenopausal Women with mammographic breast density | endoxifen | Solid dose manufacture |
| Patheon NV | AbbVie Inc | FDA approval of the drug for the treatment of motor fluctuations in adults with advanced Parkinson’s disease | Vyalev | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Pfizer Inc | FDA expanded indication of the drug for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients” indication from 1 month down to birth (gestational age at least 35 weeks) | Fragmin | Parenteral manufacture |
| Catalent France Limoges SAS | Pfizer Inc | FDA expanded indication of the drug for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients” indication from 1 month down to birth (gestational age at least 35 weeks) | Fragmin | Parenteral manufacture & packaging |
| IDT Biologika GmbH | Sandoz Inc | FDA expanded indication of the drug to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) | Zarxio | Parenteral manufacture & packaging |
| Bayer AG | Sandoz Inc | FDA expanded indication of the drug to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) | Zarxio | Parenteral manufacture & packaging |
| SGS Quay Pharmaceuticals Ltd | Shorla Oncology | FDA expanded indication of the drug for the treatment of Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia),Polyarticular Juvenile Idiopathic Arthritis (PJIA) | Jylamvo | Solid dose manufacture & packaging |
| Patheon NV | Astellas US LLC | FDA approval of the drug in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test | Vyloy | Biologic API |
| ACS Dobfar SpA | Pfizer Inc | EMA expanded indication of the drug in adults and paediatric patients from birth for the treatment of complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), including pyelonephritis, hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) | Zavicefta | Parenteral manufacture & packaging |
| Catalent Indiana LLC | Johnson & Johnson | EMA expanded indication of the drug in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant | Darzalex | Biologic API |
| Biogen Inc | Johnson & Johnson | EMA expanded indication of the drug in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant | Darzalex | Biologic API |
| Charles River Laboratories International Inc | Johnson & Johnson | EMA expanded indication of the drug in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant | Darzalex | Biologic API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Johnson & Johnson | EMA expanded indication of the drug in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant | Darzalex | Biologic API |
| Catalent Indiana LLC | AstraZeneca AB | EMA expanded indication of the drug has been approved as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA) | Fasenra | Parenteral manufacture & packaging |
| Catalent Indiana LLC | Sanofi Winthrop Industrie SA | EMA expanded indication of the drug for the treatment of eosinophilic esophagitis (EoE) in children as young as 1 year of age | Dupixent | Parenteral manufacture & packaging |
| Cambrex Corp | Neuraxpharm UK Ltd | UK MHRA approval of the drug for the treatment of prolonged, acute, convulsive seizures only in adolescents, children and infants aged ≥3 months | Buccolam | Small mol API |
| Wasdell Packaging Group | Neuraxpharm UK Ltd | UK MHRA approval of the drug for the treatment of prolonged, acute, convulsive seizures only in adolescents, children and infants aged ≥3 months | Buccolam | Parenteral packaging |
| AstraZeneca Plc | Merck & Co Inc | EMA expanded indication of the drug in combination with carboplatin and paclitaxel, for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy; in combination with chemoradiotherapy (CRT), for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | EMA expanded indication of the drug in combination with carboplatin and paclitaxel, for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy; in combination with chemoradiotherapy (CRT), for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy | Keytruda | Biologic API |
| Organon & Co | Merck & Co Inc | EMA expanded indication of the drug in combination with carboplatin and paclitaxel, for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy; in combination with chemoradiotherapy (CRT), for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy | Keytruda | Parenteral packaging |
| WuXi Biologics Co Ltd | SFL Pharma GmbH | UK MHRA approval of the drug in combination with platinum-based chemotherapy is indicated for the firstline treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations | Eqjubi | Biologic API |
| Sharp Packaging Services | SFL Pharma GmbH | UK MHRA approval of the drug in combination with platinum-based chemotherapy is indicated for the firstline treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations | Eqjubi | Parenteral packaging |
| Catalent Nottingham Ltd | Blueprint Medicines Corp | NICE recommended the drug within its marketing authorisation, as an option for treating advanced systemic mastocytosis (including aggressive systemic mastocytosis, systemic mastocytosis with an associated haematological neoplasm and mast cell leukaemia) in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Ayvakyt | Solid dose manufacture |
| PCI Pharma Services | Blueprint Medicines Corp | NICE recommended the drug within its marketing authorisation, as an option for treating advanced systemic mastocytosis (including aggressive systemic mastocytosis, systemic mastocytosis with an associated haematological neoplasm and mast cell leukaemia) in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Ayvakyt | Solid dose packaging |
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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