November 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 |
||||
| Aldevron LLC | Moderna Inc | Positive Phase II/III results | Spikevax** | Large molecule API manufacture |
| Aldevron LLC | Moderna Inc | FDA approval (booster) | Spikevax** | Large molecule API manufacture |
| Aspen Pharmacare Holdings Ltd | Johnson & Johnson | FDA approval (booster) | COVID-19 vaccine** | Parenteral manufacture and packaging |
| AstraZeneca Plc | Merck & Co Inc | EMA expanded indications | Keytruda | Large molecule API manufacture |
| Bausch & Lomb Pharmaceuticals Inc | Aerie Pharmaceuticals Inc | Positive Phase III results | Rhokiinsa | Sterile liquid manufacture and packaging |
| Baxter Biopharma Solutions | Moderna Inc | Positive Phase II/III results | Spikevax** | Parenteral manufacture and packaging |
| Baxter Biopharma Solutions | Moderna Inc | FDA approval (booster) | Spikevax** | Parenteral manufacture and packaging |
| Biological E Ltd | Johnson & Johnson | FDA approval (booster) | COVID-19 vaccine** | Parenteral manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | EMA expanded indications | Keytruda | Large molecule API manufacture |
| Catalent Inc | Moderna Inc | Positive Phase II/III results | Spikevax** | Parenteral manufacture and packaging |
| Catalent Inc | Phathom Pharmaceuticals Inc | Positive Phase III results | Vocinti | Solid dose manufacture and packaging |
| Catalent Inc | Regeneron Pharmaceuticals Inc | FDA expanded indications | Dupixent | Parenteral manufacture and packaging |
| Catalent Inc | Ono Pharmaceutical Co Ltd | EMA expanded indications | Opdivo | Parenteral manufacture and packaging |
| Catalent Inc | AstraZeneca Plc | Positive Phase III results | Imfinzi | Parenteral manufacture and packaging |
| Catalent Inc | Moderna Inc | FDA approval (booster) | Spikevax** | Parenteral manufacture and packaging |
| Catalent Inc | Johnson & Johnson | FDA approval (booster) | COVID-19 vaccine** | Large molecule API, parenteral manufacture and packaging |
| Divi's Laboratories Ltd | Merck & Co Inc | UK MHRA approval | Lagevrio** | Small molecule API manufacture |
| Emergent BioSolutions Inc | Johnson & Johnson | FDA approval (booster) | COVID-19 vaccine** | Large molecule API and parenteral manufacture |
| Grand River Aseptic Manufacturing Inc | Johnson & Johnson | FDA approval (booster) | COVID-19 vaccine** | Parenteral manufacture |
| IDT Biologika GmbH | Johnson & Johnson | FDA approval (booster) | COVID-19 vaccine** | Parenteral manufacture |
| Intravacc BV | Provention Bio Inc | Positive Phase I results | PRV-101 | Parenteral manufacture |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | Positive Phase II/III results | Spikevax** | Large molecule API, parenteral manufacture and packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | FDA approval (booster) | Spikevax** | Large molecule API, parenteral manufacture and packaging |
| Lonza Group Ltd | Moderna Inc | Positive Phase II/III results | Spikevax** | Large molecule API manufacture |
| Lonza Group Ltd | Ono Pharmaceutical Co Ltd | EMA expanded indications | Opdivo | Large molecule API manufacture |
| Lonza Group Ltd | Moderna Inc | FDA approval (booster) | Spikevax** | Large molecule API manufacture |
| National Resilience Inc | Moderna Inc | Positive Phase II/III results | Spikevax** | Large molecule API manufacture |
| National Resilience Inc | Moderna Inc | FDA approval (booster) | Spikevax** | Large molecule API manufacture |
| Organon & Co | Merck & Co Inc | EMA expanded indications | Keytruda | Parenteral packaging |
| Patheon NV | Moderna Inc | Positive Phase II/III results | Spikevax** | Parenteral manufacture and packaging |
| Patheon NV | Radius Health Inc | Positive Phase III results | Elacestrant hydrochloride | Large molecule API and parenteral manufacture |
| Patheon NV | Moderna Inc | FDA approval (booster) | Spikevax** | Parenteral manufacture and packaging |
| PCI Pharma Services | Johnson & Johnson | Positive Phase III results | Edurant | Solid dose packaging |
| PCI Pharma Services | Johnson & Johnson | FDA approval (booster) | COVID-19 vaccine** | Parenteral packaging |
| Pharmaron Beijing Co Ltd | Entasis Therapeutics Holdings Inc | Positive Phase III results | Durlobactam sodium + sulbactam | Parenteral manufacture |
| Pharmstandard | F. Hoffmann-La Roche Ltd | EMA expanded indications | Gazyvaro | Parenteral manufacture and packaging |
| PolyPeptide Group AG | Radius Health Inc | Positive Phase III results | Tymlos | Small molecule API manufacture |
| Recipharm AB | Moderna Inc | Positive Phase II/III results | Spikevax** | Parenteral manufacture |
| Recipharm AB | Moderna Inc | FDA approval (booster) | Spikevax** | Parenteral manufacture |
| Samsung Biologics Co Ltd | Moderna Inc | Positive Phase II/III results | Spikevax** | Parenteral manufacture and packaging |
| Samsung Biologics Co Ltd | Ono Pharmaceutical Co Ltd | EMA expanded indications | Opdivo | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Moderna Inc | FDA approval (booster) | Spikevax** | Parenteral manufacture and packaging |
| Sanofi | Moderna Inc | Positive Phase II/III results | Spikevax** | Parenteral manufacture |
| Sanofi | Moderna Inc | FDA approval (booster) | Spikevax** | Parenteral manufacture |
| Sanofi | Johnson & Johnson | FDA approval (booster) | COVID-19 vaccine** | Parenteral manufacture and packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Radius Health Inc | Positive Phase III results | Tymlos | Parenteral manufacture and packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | Positive Phase III results | Imfinzi | Parenteral manufacture |
| Viela Bio Inc | AstraZeneca Plc | Positive Phase III results | Imfinzi | Large molecule API manufacture |
POTENTIALLY NEGATIVE |
||||
| Aldevron LLC | Moderna Inc | FDA extends adolescent EUA assessment | Spikevax** | Large molecule API manufacture |
| Aldevron LLC | Moderna Inc | Moderna delays filing request for pediatric emergency use authorization | Spikevax** | Large molecule API manufacture |
| Baxter Biopharma Solutions | Moderna Inc | FDA extends adolescent EUA assessment | Spikevax** | Parenteral manufacture and packaging |
| Baxter Biopharma Solutions | Moderna Inc | Moderna delays filing request for pediatric emergency use authorization | Spikevax** | Parenteral manufacture and packaging |
| Catalent Inc | Moderna Inc | FDA extends adolescent EUA assessment | Spikevax** | Parenteral manufacture and packaging |
| Catalent Inc | Moderna Inc | Moderna delays filing request for pediatric emergency use authorization | Spikevax** | Parenteral manufacture and packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | FDA extends adolescent EUA assessment | Spikevax** | Large molecule API, parenteral manufacture and packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | Moderna delays filing request for pediatric emergency use authorization | Spikevax** | Large molecule API, parenteral manufacture and packaging |
| Lonza Group Ltd | Novartis AG | Negative Phase III results | Lasprona | Parenteral manufacture and packaging |
| Lonza Group Ltd | Moderna Inc | FDA extends adolescent EUA assessment | Spikevax** | Large molecule API manufacture |
| Lonza Group Ltd | Moderna Inc | Moderna delays filing request for pediatric emergency use authorization | Spikevax** | Large molecule API manufacture |
| National Resilience Inc | Moderna Inc | FDA extends adolescent EUA assessment | Spikevax** | Large molecule API manufacture |
| National Resilience Inc | Moderna Inc | Moderna delays filing request for pediatric emergency use authorization | Spikevax** | Large molecule API manufacture |
| Patheon NV | Moderna Inc | FDA extends adolescent EUA assessment | Spikevax** | Parenteral manufacture and packaging |
| Patheon NV | Moderna Inc | Moderna delays filing request for pediatric emergency use authorization | Spikevax** | Parenteral manufacture and packaging |
| Patheon NV | GlaxoSmithKline Plc |
Development Discontinued for severe pulmonary COVID-19 related disease in patients 70 years and older | Otilimab** | Large molecule API manufacture |
| Recipharm AB | Moderna Inc | FDA extends adolescent EUA assessment | Spikevax** | Parenteral manufacture |
| Recipharm AB | Moderna Inc | Moderna delays filing request for pediatric emergency use authorization | Spikevax** | Parenteral manufacture |
| Samsung Biologics Co Ltd | Moderna Inc | FDA extends adolescent EUA assessment | Spikevax** | Parenteral manufacture and packaging |
| Samsung Biologics Co Ltd | Moderna Inc | Moderna delays filing request for pediatric emergency use authorization | Spikevax** | Parenteral manufacture and packaging |
| Sanofi | Moderna Inc | FDA extends adolescent EUA assessment | Spikevax** | Parenteral manufacture |
| Sanofi | Moderna Inc | Moderna delays filing request for pediatric emergency use authorization | Spikevax** | Parenteral manufacture |
| Siegfried Holding AG | Novartis AG | Negative Phase III results | Lasprona | Parenteral 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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