October 2022 – 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 |
||||
| AGC Biologics Inc | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Biologic API |
| Ajinomoto Bio-Pharma Services | Pfizer Inc | Trial planned - Phase I to evaluate the safety, tolerability and pharmacokinetics of the drug, a single agent in Japanese subjects with relapsed or refractory lymphoma | PF-07901801 | Parenteral manufacture |
| Alcami Corp | Heron Therapeutics Inc | FDA expanded indications for the prevention of postoperative nausea and vomiting (PONV) in adults | Aponvie | Parenteral manufacture |
| Alcami Corp | Sentynl Therapeutics Inc | EMA approval for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A | Nulibry | Parenteral manufacture & packaging |
| Aldevron LLC | Moderna Inc | UK MHRA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older | Spikevax** | Biologic API |
| Allergopharma GmbH & Co KG | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture & packaging |
| Bachem Holding AG | Eli Lilly and Co | Trial planned - Phase II to determine the efficacy and safety of the drug in adults with elevated lipoprotein(a) | LY-3819469 | Small mol API |
| Baxter Biopharma Solutions | YES Pharma Services GmbH | EMA expanded indications for the treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease | Celdoxome | Parenteral manufacture & packaging |
| Baxter Biopharma Solutions | Moderna Inc | UK MHRA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Baxter Biopharma Solutions | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture & packaging |
| Bellwyck Packaging Solutions Inc | BioMarin Pharmaceutical Inc | FDA expanded indications for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) for pediatric patients from age 6 to less than 17 years | Firdapse | Solid dose packaging |
| BioReliance Corp | bluebird bio Inc | FDA approval to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD) | Skysona | Biologic API |
| Cambrex Corp | NLS Pharmaceutics AG | Positive Phase II top-line results for Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy | Mazindol ER | Small mol API |
| Carbogen Amcis AG | Johnson & Johnson | UK MHRA expanded indications for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis in adult and paediatric patients (5 years to <18 years of age and weighing ≥15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability | Sirturo | Small mol API |
| Carbogen Amcis AG | Bristol-Myers Squibb Co | NICE approval as an option for treating moderately to severely active ulcerative colitis in adults, only if conventional treatment cannot be tolerated or is not working well enough and infliximab is not suitable, or biological treatment cannot be tolerated or is not working well enough. The company provides it according to the commercial arrangement | Zeposia | Small mol API |
| Catalent Inc | Pfizer Inc | Trial planned - Phase I to evaluate the safety, tolerability and pharmacokinetics of the drug, a single agent in Japanese subjects with relapsed or refractory lymphoma | PF-07901801 | Biologic API |
| Catalent Inc | BioMarin Pharmaceutical Inc | FDA expanded indications for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) for pediatric patients from age 6 to less than 17 years | Firdapse | Small mol API |
| Catalent Inc | Regeneron Pharmaceuticals Inc | FDA expanded indications for the treatment of adult patients with prurigo nodularis (PN) | Dupixent | Parenteral manufacture & packaging |
| Catalent Inc | Aurinia Pharmaceuticals Inc | EMA approval in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN) | Lupkynis | Solid dose & packaging |
| Catalent Inc | Moderna Inc | UK MHRA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Catalent Inc | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture |
| Curia Inc | Heron Therapeutics Inc | FDA expanded indications for the prevention of postoperative nausea and vomiting (PONV) in adults | Aponvie | Parenteral manufacture |
| Delpharm SAS | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture & packaging |
| EuroAPI | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture |
| EuroAPI SAS | AbbVie Inc | NICE approval as an option for treating visual impairment caused by diabetic macular oedema in adults only if their condition has not responded well enough to, or if they cannot have non-corticosteroid therapy | Ozurdex | Small mol API |
| Eurofins Scientific SE | Sentynl Therapeutics Inc | EMA approval for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A | Nulibry | Small mol API |
| Excella GmbH & Co KG | BioMarin Pharmaceutical Inc | FDA expanded indications for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) for pediatric patients from age 6 to less than 17 years | Firdapse | Solid dose & packaging |
| Exelead Inc | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture |
| FUJIFILM Diosynth Biotechnologies USA Inc | Alexion Pharmaceuticals Inc | EMA expanded indications for Myasthenia Gravis | Ultomiris | Biologic API |
| Hovione FarmaCiencia SA | ChemoCentryx Inc | NICE approval for the drug plus cyclophosphamide or rituximab regimen is recommended, within its marketing authorisation, as an option for treating severe active granulomatosis with polyangiitis or microscopic polyangiitis in adults. It is recommended only if the company provides it according to the commercial arrangement | Tavneos | Small mol API |
| Kemwell Biopharma Pvt Ltd | Johnson & Johnson | UK MHRA expanded indications for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis in adult and paediatric patients (5 years to <18 years of age and weighing ≥15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability | Sirturo | Small mol API, solid dose & packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | UK MHRA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older | Spikevax** | Biologic API, parenteral manufacture & packaging |
| Lek dd | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture & packaging |
| Lonza Group Ltd | Aerovate Therapeutics Inc | Trial planned - Phase II/III to assess the long-term safety and efficacy of the drug in subjects with pulmonary arterial hypertension (PAH) | Imatinib | Small mol API, inhalational manufacture & packaging |
| Lonza Group Ltd | bluebird bio Inc | FDA approval to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD) | Skysona | Biologic API |
| Lonza Group Ltd | AstraZeneca Plc | EMA expanded indications for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID-19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 | Evusheld** | Biologic API |
| Lonza Group Ltd | Aurinia Pharmaceuticals Inc | EMA approval in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN) | Lupkynis | Small mol API |
| Lonza Group Ltd | Moderna Inc | UK MHRA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older | Spikevax** | Biologic API |
| Lonza Group Ltd | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture & packaging |
| Lonza Group Ltd | Trevi Therapeutics Inc | Positive Phase II results for Chronic Cough in Idiopathic Pulmonary Fibrosis | Nalbuphine hydrochloride ER | Solid dose |
| Mibe GmbH Arzneimittel | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture & packaging |
| Minaris Regenerative Medicine LLC | bluebird bio Inc | FDA approval to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD) | Skysona | Biologic API, parenteral manufacture & packaging |
| National Resilience Inc | Moderna Inc | UK MHRA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older | Spikevax** | Biologic API |
| Novartis AG | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture & packaging |
| Patheon NV | BioMarin Pharmaceutical Inc | FDA expanded indications for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) for pediatric patients from age 6 to less than 17 years | Firdapse | Small mol API, solid dose & packaging |
| Patheon NV | Alexion Pharmaceuticals Inc | EMA expanded indications for Myasthenia Gravis | Ultomiris | Biologic API |
| Patheon NV | Moderna Inc | UK MHRA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Patheon NV | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture & packaging |
| Patheon NV | Bristol-Myers Squibb Co | NICE approval as an option for treating moderately to severely active ulcerative colitis in adults, only if conventional treatment cannot be tolerated or is not working well enough and infliximab is not suitable, or biological treatment cannot be tolerated or is not working well enough. The company provides it according to the commercial arrangement | Zeposia | Small mol API |
| Patheon NV | Bristol-Myers Squibb Co | NICE approval as an option for treating moderately to severely active ulcerative colitis in adults, only if conventional treatment cannot be tolerated or is not working well enough and infliximab is not suitable, or biological treatment cannot be tolerated or is not working well enough. The company provides it according to the commercial arrangement | Zeposia | Solid dose & packaging |
| Patheon NV | ChemoCentryx Inc | NICE approval for the drug plus cyclophosphamide or rituximab regimen is recommended, within its marketing authorisation, as an option for treating severe active granulomatosis with polyangiitis or microscopic polyangiitis in adults. It is recommended only if the company provides it according to the commercial arrangement | Tavneos | Solid dose & packaging |
| PCI Pharma Services | Sentynl Therapeutics Inc | EMA approval for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A | Nulibry | Parenteral packaging |
| PCI Pharma Services | Aurinia Pharmaceuticals Inc | EMA approval in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN) | Lupkynis | Solid dose packaging |
| Pharmaceutics International Inc | BioMarin Pharmaceutical Inc | FDA expanded indications for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) for pediatric patients from age 6 to less than 17 years | Firdapse | Solid dose |
| Polymun Scientific ImmunbiologischeForschung GmbH | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture |
| Recipharm AB | Moderna Inc | UK MHRA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Rentschler Biopharma SE | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Biologic API |
| Samsung Biologics Co Ltd | AstraZeneca Plc | EMA expanded indications for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID-19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 | Evusheld** | Biologic API, parenteral manufacture & packaging |
| Samsung Biologics Co Ltd | Moderna Inc | UK MHRA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Sanofi | Moderna Inc | UK MHRA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Sharp Packaging Services | Heron Therapeutics Inc | FDA expanded indications for the prevention of postoperative nausea and vomiting (PONV) in adults | Aponvie | Parenteral packaging |
| Siegfried Holding AG | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture & packaging |
| The Biovac Institute | Pfizer Inc/BioNTech SE | Swissmedic has temporarily authorised the vaccine Bivalent Original / Omicron BA.1 from Pfizer authorised from age 18 | Comirnaty** | Parenteral manufacture |
| Unither Pharmaceuticals SAS | Sintetica SA | FDA approval for ocular surface anesthesia | Iheezo | Semi-solid sterile manufacture |
| Uquifa SA | Aerovate Therapeutics Inc | Trial planned - Phase II/III to assess the long-term safety and efficacy of the drug in subjects with pulmonary arterial hypertension (PAH) | Imatinib | Small mol API |
| Vetter Pharma-Fertigung GmbH & Co KG | Alnylam Pharmaceuticals Inc | FDA expanded indications for the treatment of lowering of plasma oxalate levels in adult and pediatric patients with primary hyperoxaluria type 1 (PH1) | Oxlumo | Parenteral manufacture |
| Woodstock Sterile Solutions | Santen Pharmaceutical Co Ltd | FDA approval for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension | Omlonti | Liquid sterile manufacture |
POTENTIALLY NEGATIVE |
||||
| AbbVie Inc | AstraZeneca Plc | NICE rejection for treating hormone-relapsed metastatic prostate cancer with BRCA1 or BRCA2 mutations that has progressed after a newer hormonal treatment (such as abiraterone or enzalutamide) | Lynparza | Solid dose & packaging |
| AbbVie Inc | Takeda Pharmaceutical Co Ltd | NICE rejection for treating chronic refractory pouchitis after surgery for ulcerative colitis in adults. This is because Takeda did not provide an evidence submission | Entyvio | Biologic API |
| Delpharm SAS | Takeda Pharmaceutical Co Ltd | NICE rejection for treating chronic refractory pouchitis after surgery for ulcerative colitis in adults. This is because Takeda did not provide an evidence submission | Entyvio | Parenteral manufacture |
| Dottikon Exclusive Synthesis AG | AstraZeneca Plc | NICE rejection for treating hormone-relapsed metastatic prostate cancer with BRCA1 or BRCA2 mutations that has progressed after a newer hormonal treatment (such as abiraterone or enzalutamide) | Lynparza | Small mol API |
| Jetpharma SA | AstraZeneca Plc | NICE rejection for treating hormone-relapsed metastatic prostate cancer with BRCA1 or BRCA2 mutations that has progressed after a newer hormonal treatment (such as abiraterone or enzalutamide) | Lynparza | Small mol API |
| Lonza Group Ltd | AstraZeneca Plc | NICE rejection for treating hormone-relapsed metastatic prostate cancer with BRCA1 or BRCA2 mutations that has progressed after a newer hormonal treatment (such as abiraterone or enzalutamide) | Lynparza | Small mol API |
| Lonza Group Ltd | Takeda Pharmaceutical Co Ltd | NICE rejection for treating chronic refractory pouchitis after surgery for ulcerative colitis in adults. This is because Takeda did not provide an evidence submission | Entyvio | Biologic API |
| NerPharma Srl | Adienne Pharma & Biotech SA | NICE rejection for treating haematological diseases before allogeneic haematopoietic stem cell transplant because ADIENNE did not provide an evidence submission | Phelinun | Parenteral manufacture & packaging |
| Patheon NV | AstraZeneca Plc | NICE rejection for treating hormone-relapsed metastatic prostate cancer with BRCA1 or BRCA2 mutations that has progressed after a newer hormonal treatment (such as abiraterone or enzalutamide) | Lynparza | Solid dose & packaging |
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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