August 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 |
||||
| Agilent Technologies Inc | IVERIC bio Inc | FDA approval for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) | Izervay | Small mol API |
| Ajinomoto Bio-Pharma Services | Bio-Path Holdings Inc | Positive Phase II results of the drug in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) | Prexigebersen | Parenteral manufacture |
| Ajinomoto Bio-Pharma Services | IVERIC bio Inc | FDA approval for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) | Izervay | Intravitreal |
| Almac Group Ltd | Alexion Pharmaceuticals Inc | EMA expanded indication for the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged 6 to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+) | Soliris | Parenteral manufacture & packaging |
| BSP Pharmaceuticals SpA | Gilead Sciences Inc | EMA expanded indication as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting | Trodelvy | Biologic API & Parenteral manufacture |
| Catalent Inc | Regeneron Pharmaceuticals Inc | UK MHRA 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 | UK MHRA expanded indication of the drug in combination with tremelimumab for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma | Imfinzi | Parenteral manufacture & packaging |
| Esteve Pharmaceuticals SA | Gilead Sciences Inc | UK MHRA expanded indication for the treatment of human immunodeficiency virus-1 infection adults and paediatric patients aged ≥2 years and weighing ≥14kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir | Biktarvy | Small mol API |
| Evonik Industries AG | Gilead Sciences Inc | UK MHRA expanded indication for the treatment of human immunodeficiency virus-1 infection adults and paediatric patients aged ≥2 years and weighing ≥14kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir | Biktarvy | Small mol API |
| F. Hoffmann-La Roche Ltd | Harm Reduction Therapeutics Inc | FDA approval for the emergency treatment of known or suspected opioid overdose | Rivive | Inhalational manufacture |
| Hikma Pharmaceuticals Plc | Boehringer Ingelheim International GmbH | EMA expanded indication in adults for the treatment of chronic kidney disease | Jardiance | Solid dose packaging |
| Juzen Chemical Corp | Sage Therapeutics Inc | FDA approval for the treatment of postpartum depression (PPD) in adults | Zurzuvae | Small mol API |
| Lonza Group Ltd | Shanghai Junshi Biomedical Technology Co Ltd | Trial planned - Phase III to evaluate pharmacokinetic characteristics, Psoriasis Area and Severity Index (PASI 90) and Static Physician's Global Assessment (sPGA) of at least 90% improvement from baseline, other efficacy indicators and safety of the drug in the treatment of adult subjects with moderate to severe chronic plaque psoriasis | JS-005 | Biologic API |
| Lonza Group Ltd | Trevi Therapeutics Inc | Trial planned - Phase II to evaluate the efficacy and safety of the drug for the treatment of refractory chronic cough | nalbuphine hydrochloride ER | Solid dose |
| Lonza Group Ltd | Alexion Pharmaceuticals Inc | EMA expanded indication for the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged 6 to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+) | Soliris | Biologic API |
| Organon & Co | Merck & Co Inc | FDA expanded indication of the drug in combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia; in combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH; in combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH) | Zetia | Solid dose packaging |
| Patheon NV | SpringWorks Therapeutics Inc | Trial planned - Phase II to assess the targeted therapies for subjects with slow-flow or fast-flow vascular malformations | mirdametinib | Small mol API & Solid dose |
| Patheon NV | Acumen Pharmaceuticals Inc | Positive Phase I top line results from the INTERCEPT-AD trial, the first clinical-stage AβO targeting antibody therapy in early alzheimer's disease | ACU-193 | Parenteral manufacture |
| Patheon NV | Alexion Pharmaceuticals Inc | EMA expanded indication for the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged 6 to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+) | Soliris | Parenteral manufacture & packaging |
| PCI Pharma Services | Gilead Sciences Inc | UK MHRA expanded indication for the treatment of human immunodeficiency virus-1 infection adults and paediatric patients aged ≥2 years and weighing ≥14kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir | Biktarvy | Solid dose packaging |
| PCI Pharma Services | Taiho Oncology Inc | EMA expanded indication of the drug in combination with bevacizumab, for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have received two prior anti-cancer treatments including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents | Lonsurf | Solid dose packaging |
| Praxis Packaging Solutions | Boehringer Ingelheim International GmbH | EMA expanded indication in adults for the treatment of chronic kidney disease | Jardiance | Solid dose packaging |
| Rottendorf Pharma GmbH | Gilead Sciences Inc | UK MHRA expanded indication for the treatment of human immunodeficiency virus-1 infection adults and paediatric patients aged ≥2 years and weighing ≥14kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir | Biktarvy | Solid dose |
| Samsung Biologics Co Ltd | Gilead Sciences Inc | EMA expanded indication as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting | Trodelvy | Biologic API |
| Uquifa SA | Gilead Sciences Inc | UK MHRA expanded indication for the treatment of human immunodeficiency virus-1 infection adults and paediatric patients aged ≥2 years and weighing ≥14kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir | Biktarvy | Small mol API |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | UK MHRA expanded indication of the drug in combination with tremelimumab for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma | Imfinzi | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Novo Nordisk AS | EMA expanded indication for treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). It can be used for all age groups | Refixia | Parenteral manufacture & packaging |
| Yuhan Chemical Inc | Gilead Sciences Inc | UK MHRA expanded indication for the treatment of human immunodeficiency virus-1 infection adults and paediatric patients aged ≥2 years and weighing ≥14kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir | Biktarvy | Small mol API |
| Yuki Gosei Kogyo Co Ltd | Taiho Oncology Inc | EMA expanded indication of the drug in combination with bevacizumab, for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have received two prior anti-cancer treatments including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents | Lonsurf | Small mol API |
POTENTIALLY NEGATIVE |
||||
| IDT Biologika GmbH | German Center for Infection Research | Trial withdrawn - Phase II to assess the safety, tolerability and immunogenicity of two doses of the drug in adults aged 18 to 64 and 65 and older because of unknown reason | Coronavirus Disease 2019 (COVID-19) vaccine** | Parenteral manufacture |
| Lonza Group Ltd | Forty Seven Inc | Trial withdrawn - Phase II of the drug and radiation as bridging strategy before CAR T-Cell Therapy in patients with Relapsed or Refractory Large B-cell Lymphoma due to per Principal Investigator request | magrolimab | Biologic 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