May 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
ACS Dobfar SpA Merck & Co Inc FDA expanded indications Zerbaxa Small Mol API
Ajinomoto Bio Pharma Services Incyte Corp Trial planned - Phase II Zynyz Parenteral manufacture
Aldevron LLC Moderna Inc EMA expanded indications Spikevax** Biologic API
Alfasigma SpA Windtree Therapeutics Inc Positive Phase II topline results Istaroxime  Small mol API
AMPAC Fine Chemicals LLC Incyte Corp EMA expanded indications Jakavi Small mol API
AstraZeneca Plc Merck & Co Inc EMA expanded indications Keytruda Biologic API
Bachem Holding AG Supernus Pharmaceuticals Inc FDA expanded indications Qelbree Small mol API
Baxter Biopharma Solutions Johnson & Johnson NICE approval Darzalex Parenteral manufacture
Baxter Biopharma Solutions Astellas Pharma Inc EMA approval Padcev Parenteral manufacture & packaging
Baxter Biopharma Solutions Moderna Inc EMA expanded indications Spikevax** Parenteral manufacture & packaging
Baxter Biopharma Solutions Daiichi Sankyo Co Ltd FDA expanded indications Enhertu Parenteral manufacture & packaging
Baxter International Inc Incyte Corp Trial planned - Phase II Zynyz Parenteral manufacture
Bioconnection BV Nykode Therapeutics AS Positive Phase II interim results VB-1016 Parenteral manufacture
Biogen Inc Johnson & Johnson NICE approval Darzalex Biologic API
Biokey Inc Turning Point Therapeutics Inc Positive Phase I/II topline results Repotrectinib Solid dose
Boehringer Ingelheim Biopharmaceuticals GmbH Merck & Co Inc EMA expanded indications Keytruda Biologic API
Bristol-Myers Squibb Co AstraZeneca Plc FDA expanded indications Xigduo XR Solid dose
Bushu Pharmaceuticals Ltd Takeda Pharmaceutical Co Ltd EMA approval Orgovyx Solid dose & packaging
Cambrex Corp Gilead Sciences Inc FDA expanded indications Veklury** Small mol API
Catalent Inc AstraZeneca Plc FDA expanded indications Xigduo XR Solid dose packaging
Catalent Inc Exelixis Inc EMA expanded indications Cabometyx Solid dose & packaging
Catalent Inc Moderna Inc EMA expanded indications Spikevax** Parenteral manufacture & packaging
Catalent Inc Biohaven Pharmaceutical Holding Company Ltd EMA approval Vydura Small mol API
Catalent Inc Supernus Pharmaceuticals Inc FDA expanded indications Qelbree Solid dose
Cell Therapies Pty Ltd Novartis AG EMA expanded indications Kymriah Biologic API
Corden Pharma International GmbH Seagen Inc NICE approval Tukysa Solid dose
Corden Pharma International GmbH GlaxoSmithKline Plc NICE approval Zejula Small Mol API
Delpharm SAS GMP-Orphan SA FDA approval Cuvrior Solid dose & packaging
Esteve Huayi Pharmaceutical Co Ltd Gilead Sciences Inc FDA expanded indications Veklury** Small mol API
Esteve Pharmaceuticals SA Seagen Inc NICE approval Tukysa Small Mol API
Excella GmbH & Co KG Takeda Pharmaceutical Co Ltd EMA approval Orgovyx Small Mol API
Fareva SA Gilead Sciences Inc FDA expanded indications Veklury** Parenteral manufacture
Farmabios SpA Windtree Therapeutics Inc Positive Phase II topline results Istaroxime  Small mol API
Flamma SpA Gilead Sciences Inc FDA expanded indications Veklury** Small mol API
Fraunhofer-Gesellschaft zur Forderung der Angewandten Forschung eV Novartis AG EMA expanded indications Kymriah Biologic API
Fujifilm Diosynth Biotechnologies USA Inc Alexion Pharmaceuticals Inc FDA expanded indications Ultomiris Biologic API
Hikma Pharmaceuticals Plc Gilead Sciences Inc FDA expanded indications Veklury** Parenteral manufacture
Jubilant HollisterStier LLC Gilead Sciences Inc FDA expanded indications Veklury** Parenteral manufacture & packaging
Jubilant HollisterStier LLC AIM ImmunoTech Inc Positive Phase I results Ampligen Parenteral manufacture & packaging
Laboratorios Farmaceuticos Rovi SA Moderna Inc EMA expanded indications Spikevax** Biologic API, parenteral manufacture & packaging
Lonza Group Ltd Astellas Pharma Inc EMA approval Padcev Biologic API
Lonza Group Ltd Moderna Inc EMA expanded indications Spikevax** Biologic API
Lonza Group Ltd Iovance Biotherapeutics Inc Trial planned - Phase I/II IOV-4001 Biologic API
Mabxience Holding SL Insud Pharma FDA approval Alymsys Parenteral manufacture
Merck KGaA AstraZeneca Plc FDA expanded indications Xigduo XR Small mol API
MIAS Pharma Ltd VBI Vaccines Inc EMA approval PreHevbri Parenteral manufacture & packaging
National Resilience Inc Moderna Inc EMA expanded indications Spikevax** Biologic API
Nitto Avecia Pharma Services Inc AIM ImmunoTech Inc Positive Phase I results Ampligen Parenteral manufacture & packaging
Organon & Co Merck & Co Inc EMA expanded indications Keytruda Parenteral packaging
Oxford BioMedica Plc Novartis AG EMA expanded indications Kymriah Biologic API
Patheon NV Exelixis Inc EMA expanded indications Cabometyx Solid dose & packaging
Patheon NV Cara Therapeutics Inc EMA approval Kapruvia Parenteral manufacture & packaging
Patheon NV Moderna Inc EMA expanded indications Spikevax** Parenteral manufacture & packaging
Patheon NV Alexion Pharmaceuticals Inc FDA expanded indications Ultomiris Biologic API
Patheon NV Gilead Sciences Inc FDA expanded indications Veklury** Parenteral manufacture & packaging
Patheon NV Seelos Therapeutics, Inc Trial planned - Phase II Cabaletta Small mol API & parenteral manufacture
PCI Pharma Services Johnson & Johnson NICE approval Darzalex Parenteral packaging
PCI Pharma Services Takeda Pharmaceutical Co Ltd EMA approval Orgovyx Solid dose packaging
PCI Pharma Services Gilead Sciences Inc FDA expanded indications Veklury** Parenteral packaging
PCI Pharma Services Supernus Pharmaceuticals Inc FDA expanded indications Qelbree Solid dose packaging
Pfizer Inc Gilead Sciences Inc FDA expanded indications Veklury** Parenteral manufacture
Pharmaceutics International Inc AIM ImmunoTech Inc Positive Phase I results Ampligen Parenteral manufacture & packaging
PharmaKorell GmbH Idorsia Pharmaceutical Ltd EMA approval Quviviq Solid dose packaging
Piramal Pharma Solutions Inc Exelixis Inc EMA expanded indications Cabometyx Small Mol API
PolyPeptide Group AG Cara Therapeutics Inc EMA approval Kapruvia Biologic API
Qilu Antibiotics Pharmaceutical Co Ltd Merck & Co Inc FDA expanded indications Zerbaxa Small Mol API
Quotient Sciences Ltd GlaxoSmithKline Plc NICE approval Zejula Solid dose
Recipharm AB Moderna Inc EMA expanded indications Spikevax** Parenteral manufacture & packaging
Recipharm AB Opiant Pharmaceuticals Inc Positive Phase I topline results Nalmefene Inhalation manufacture & packaging
Samsung Biologics Co Ltd Johnson & Johnson NICE approval Darzalex Biologic API
Samsung Biologics Co Ltd Moderna Inc EMA expanded indications Spikevax** Parenteral manufacture & packaging
Sanofi Moderna Inc EMA expanded indications Spikevax** Parenteral manufacture & packaging
ScinoPharm Taiwan Ltd Windtree Therapeutics Inc Positive Phase II topline results Istaroxime  Small mol API
SEQENS GMP-Orphan SA FDA approval Cuvrior Small mol API
Sharp Packaging Services GlaxoSmithKline Plc NICE approval Zejula Solid dose & packaging
Steri-Pharma LLC Merck & Co Inc FDA expanded indications Zerbaxa Parenteral manufacture & packaging
Summit Biosciences Inc Opiant Pharmaceuticals Inc Positive Phase I topline results Nalmefene Inhalation manufacture & packaging
Takeda Pharmaceutical Co Ltd Baxter International Inc EMA approval Inpremzia Parenteral manufacture
Vetter Pharma-Fertigung GmbH & Co KG Johnson & Johnson NICE approval Darzalex Parenteral manufacture
WuXi STA (Shanghai) Co Ltd GlaxoSmithKline Plc NICE approval Zejula Small Mol API
Xellia Pharmaceuticals ApS Gilead Sciences Inc FDA expanded indications Veklury** Parenteral manufacture

POTENTIALLY NEGATIVE
Aspen Pharmacare Holdings Ltd Johnson & Johnson FDA limits use COVID-19 vaccine** Parenteral manufacture & packaging
Biological E Ltd Johnson & Johnson FDA limits use COVID-19 vaccine** Biologic API & parenteral manufacture
Catalent Inc Ono Pharmaceutical Co Ltd NICE rejection Opdivo Parenteral manufacture & packaging
Catalent Inc Johnson & Johnson FDA limits use COVID-19 vaccine** Biologic API, parenteral manufacture & packaging
Emergent BioSolutions Inc Johnson & Johnson FDA limits use COVID-19 vaccine** Biologic API & parenteral manufacture
Grand River Aseptic Manufacturing Inc Johnson & Johnson FDA limits use COVID-19 vaccine** Parenteral manufacture & packaging
IDT Biologika GmbH Johnson & Johnson FDA limits use COVID-19 vaccine** Parenteral manufacture
Laboratorio Reig Jofre SA  Johnson & Johnson FDA limits use COVID-19 vaccine** Parenteral manufacture & packaging
Lonza Group Ltd Ono Pharmaceutical Co Ltd NICE rejection Opdivo Biologic API
Merck & Co Inc Johnson & Johnson FDA limits use COVID-19 vaccine** Biologic API, parenteral manufacture & packaging
PCI Pharma Services Johnson & Johnson FDA limits use COVID-19 vaccine** Parenteral packaging
Samsung Biologics Co Ltd Ono Pharmaceutical Co Ltd NICE rejection Opdivo Biologic API
Sanofi Johnson & Johnson FDA limits use COVID-19 vaccine** Parenteral manufacture & packaging
Vibalogics GmbH Johnson & Johnson FDA limits use COVID-19 vaccine** 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