November 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 |
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| AGC Biologics Inc | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Biologic API |
| Aldevron LLC | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. | Spikevax** | Biologic API |
| Allergopharma GmbH & Co KG | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture & packaging |
| AstraZeneca Plc | Merck & Co Inc | NICE approval as an option for the adjuvant treatment of completely resected stage 2B or 2C melanoma in people 12 years and over, and as an option for the adjuvant treatment of renal cell carcinoma at increased risk of recurrence after nephrectomy, with or without metastatic lesion resection, in adults. It is recommended only if the company provides it according to the commercial arrangement | Keytruda | Biologic API |
| Baxter Biopharma Solutions | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. | Spikevax** | Parenteral manufacture & packaging |
| Baxter Biopharma Solutions | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture & packaging |
| BioNet-Asia Co Ltd | Chula VRC | Trial planned - Phase II to assess the safety, tolerability and immunogenicity of a single dose of the vaccine as a booster dose, given at least 3 months after receipt of a previous booster dose of any authorized/approved COVID-19 vaccine. | Coronavirus Disease 2019 (COVID-19) vaccine** | Biologic API |
| Boehringer Ingelheim Biopharmaceuticals GmbH | AbbVie Inc | UK MHRA expanded indication for the treatment of patients 16 years and older with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable | Skyrizi | Biologic API & parenteral manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | NICE approval as an option for the adjuvant treatment of completely resected stage 2B or 2C melanoma in people 12 years and over, and as an option for the adjuvant treatment of renal cell carcinoma at increased risk of recurrence after nephrectomy, with or without metastatic lesion resection, in adults. It is recommended only if the company provides it according to the commercial arrangement | Keytruda | Biologic API |
| Catalent Inc | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. | Spikevax** | Parenteral manufacture & packaging |
| Catalent Inc | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture |
| Catalent Inc | AstraZeneca Plc | EMA expanded indication for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy | Adtralza | Parenteral manufacture & packaging |
| Catalent Inc | BeiGene Ltd | EMA expanded indication for the treatment of adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy | Brukinsa | Solid dose |
| Catalent Inc | AstraZeneca Plc | FDA expanded indication in combination with tremelimumab-actl for the treatment of adult patients with unresectable hepatocellular carcinoma | Imfinzi | Parenteral manufacture & packaging |
| Catalent Inc | BeiGene Ltd | NICE approval as an option for treating Waldenstrom's macroglobulinaemia in adults who have had at least 1 treatment, only if bendamustine plus rituximab is also suitable and the company provides it according to the commercial arrangement | Brukinsa | Solid dose |
| Dalton Pharma Services | GLyPharma Therapeutic Inc | Positive Phase II Interim results for Short Bowel Syndrome with Intestinal Failure (SBS-IF), and Colon-in-continuity (CIC) | Apraglutide | Parenteral manufacture |
| Delpharm SAS | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture & packaging |
| Delpharm SAS | F. Hoffmann-La Roche Ltd | FDA expanded indication as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms | Cotellic | Solid dose packaging |
| Emergent BioSolutions Inc | Providence Therapeutics Inc | Positive Phase II top-line results for Coronavirus Disease 2019 (COVID-19) | PTXCOVID-19B** | Biologic API & parenteral manufacture |
| EuroAPI | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture |
| Excella GmbH & Co KG | F. Hoffmann-La Roche Ltd | FDA expanded indication as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms | Cotellic | Solid dose |
| Excella GmbH & Co KG | Myovant Sciences Ltd | NICE approval as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age | Ryeqo | Small mol API |
| Exelead Inc | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture |
| FUJIFILM Diosynth Biotechnologies USA Inc | Ascendis Pharma AS | UK MHRA approval for growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]) | Skytrofa | Biologic API |
| Goodwin Biotechnology Inc | Actinium Pharmaceuticals Inc | Positive Phase III top-line results for Relapsed or Refractory Acute Myeloid Leukemia | Iomab-B | Parenteral manufacture |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. | Spikevax** | Biologic API, parenteral manufacture & packaging |
| Lek dd | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture & packaging |
| Lonza Group Ltd | Gilead Sciences Inc | EMA expanded indication for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy | Yescarta | Parenteral manufacture |
| Lonza Group Ltd | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. | Spikevax** | Biologic API |
| Lonza Group Ltd | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture & packaging |
| Lonza Group Ltd | Ascendis Pharma AS | UK MHRA approval for growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]) | Skytrofa | Biologic API |
| Lonza Group Ltd | Vaxcyte Inc | Positive Phase I/II top-line results for Invasive Pneumococcal Disease in Adults Aged 18-64 | VAX-24 | Solid dose |
| Mibe GmbH Arzneimittel | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture & packaging |
| Minaris Regenerative Medicine LLC | Mendus AB | Positive Phase I Interim results for Ovarian Cancer | DCP-001 | Biologic API |
| National Resilience Inc | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. | Spikevax** | Biologic API |
| Northern RNA Inc | Providence Therapeutics Inc | Positive Phase II top-line results for Coronavirus Disease 2019 (COVID-19) | PTXCOVID-19B** | Biologic API |
| Novartis AG | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture & packaging |
| Organon & Co | Merck & Co Inc | NICE approval as an option for the adjuvant treatment of completely resected stage 2B or 2C melanoma in people 12 years and over, and as an option for the adjuvant treatment of renal cell carcinoma at increased risk of recurrence after nephrectomy, with or without metastatic lesion resection, in adults. It is recommended only if the company provides it according to the commercial arrangement | Keytruda | Parenteral packaging |
| Patheon NV | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. | Spikevax** | Parenteral manufacture & packaging |
| Patheon NV | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture & packaging |
| Patheon NV | Myovant Sciences Ltd | NICE approval as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age | Ryeqo | Solid dose |
| Patheon NV | Rigel Pharmaceuticals Inc | NICE approval as an option for treating refractory chronic immune thrombocytopenia (ITP) in adults, only if they have previously had a thrombopoietin receptor agonist (TPO‑RA), or a TPO‑RA is unsuitable the company provides the drug according to the commercial arrangement | Tavlesse | Solid dose & packaging |
| PCI Pharma Services | BeiGene Ltd | EMA expanded indication for the treatment of adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy | Brukinsa | Solid dose packaging |
| PCI Pharma Services | Myovant Sciences Ltd | NICE approval as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age | Ryeqo | Solid dose packaging |
| PCI Pharma Services | BeiGene Ltd | NICE approval as an option for treating Waldenstrom's macroglobulinaemia in adults who have had at least 1 treatment, only if bendamustine plus rituximab is also suitable and the company provides it according to the commercial arrangement | Brukinsa | Solid dose packaging |
| Polymun Scientific ImmunbiologischeForschung GmbH | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture |
| Procos SpA | Karuna Therapeutics Inc | Trial planned - Phase III to evaluate the safety, tolerability, and efficacy of the drug as a monotherapy in adults with schizophrenia | (trospium chloride + xanomeline) | Small mol API |
| QPS Holdings LLC | Rigel Pharmaceuticals Inc | NICE approval as an option for treating refractory chronic immune thrombocytopenia (ITP) in adults, only if they have previously had a thrombopoietin receptor agonist (TPO‑RA), or a TPO‑RA is unsuitable the company provides the drug according to the commercial arrangement | Tavlesse | Solid dose |
| Recipharm AB | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. | Spikevax** | Parenteral manufacture & packaging |
| Regis Technologies Inc | Karuna Therapeutics Inc | Trial planned - Phase III to evaluate the safety, tolerability, and efficacy of the drug as a monotherapy in adults with schizophrenia | (trospium chloride + xanomeline) | Small mol API |
| Rentschler Biopharma SE | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Biologic API |
| Samsung Biologics Co Ltd | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. | Spikevax** | Parenteral manufacture & packaging |
| Sanofi | Moderna Inc | EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. | Spikevax** | Parenteral manufacture & packaging |
| Siegfried Holding AG | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture & packaging |
| Societal CDMO Inc | Ensysce Biosciences Inc | Positive Phase I top-line results for Substance (Drug) Abuse | PF-614 | Solid dose |
| The Biovac Institute | Pfizer Inc/BioNTech SE | EMA expanded indication of 3 micrograms/dose concentrate for dispersion as injection for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years | Comirnaty** | Parenteral manufacture |
| TriLink BioTechnologies Inc | Chula VRC | Trial planned - Phase II to assess the safety, tolerability and immunogenicity of a single dose of the vaccine as a booster dose, given at least 3 months after receipt of a previous booster dose of any authorized/approved COVID-19 vaccine. | Coronavirus Disease 2019 (COVID-19) vaccine** | Biologic API |
| Vetter Pharma-Fertigung GmbH & Co KG | Ascendis Pharma AS | UK MHRA approval for growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]) | Skytrofa | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | FDA expanded indication in combination with tremelimumab-actl for the treatment of adult patients with unresectable hepatocellular carcinoma | Imfinzi | Parenteral manufacture |
| Viela Bio Inc | AstraZeneca Plc | FDA expanded indication in combination with tremelimumab-actl for the treatment of adult patients with unresectable hepatocellular carcinoma | Imfinzi | Biologic API |
| WuXi STA (Shanghai) Co Ltd | BioNova Pharmaceuticals Ltd | Trial planned - Phase I to evaluate the efficacy, safety and pharmacokinetics of the drug in subjects with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma. | Rezurock | Small mol API |
POTENTIALLY NEGATIVE |
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| Catalent Inc | ALK-Abello AS | NICE rejection for treating allergic rhinitis and allergic asthma in adults caused by house dust mites. This is because ALK-Abello did not provide an evidence submission | Acarizax | Solid dose & packaging |
| H. Lundbeck AS | Advicenne SA | NICE rejection on the slow-release varient of drug for treating distal renal tubular acidosis in people 1 year and over. This is because Advicenne withdrew its evidence submission | Sibnayal | 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