February 2024 — CDMO Opportunities And Threats Report

Source: Outsourced Pharma

By GlobalData

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
AbbVie Inc AstraZeneca Plc NICE recommended the drug with bevacizumab, within its marketing authorisation, for maintenance treatment of high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose cancer: has completely or partially responded after first-line platinum-based chemotherapy with bevacizumab is advanced (International Federation of Gynecology and Obstetrics [FIGO] stages 3 and 4) and is homologous recombination deficiency (HRD) positive (defined as having either a BRCA1 or BRCA2 mutation, or genomic instability). NICE recommended the drug with abiraterone and prednisone or prednisolone, within its marketing authorisation, as an option for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy. It is only recommended if the company provides it according to the commercial arrangements Lynparza Solid dose manufacture & packaging
ACS Dobfar SpA Pfizer Inc FDA expanded indication of the drug in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections(cIAI) in adult and pediatric patients(at least 31 weeks gestational age) caused by the following susceptible gram-negative microorganisms; for the treatment of complicated urinary tract infections (cUTI)including pyelonephritis in adult and pediatric patients(at least 31 weeks gestational age)caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Citrobacter freundii complex, Proteusmirabilis, and Pseudomonasaeruginosa; for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia(HABP/VABP)in adult and pediatric patients(at least 31 weeks gestational age)caused by the following susceptible gram-negative microorganisms Avycaz Parenteral manufacture & packaging
ACS Dobfar SpA Baxter International Inc FDA expanded indication of the drug is indicated for the pediatric patients aged 10-17 years to the approved indication for perioperative prophylaxis Cefazolin Sodium Parenteral packaging
AstraZeneca Plc Merck & Co Inc FDA expanded indication of the drug in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by a validated test; in combination with chemoradiotherapy (CRT), indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer; indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1- containing regimen; in combination with gemcitabine and cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic biliary cancer (BTC); as monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy; in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by a validated test Keytruda Biologic API
Aurobindo Pharma Ltd Heron Therapeutics Inc FDA expanded indication in adults for postsurgical analgesia for up to 72 hours after soft tissue surgical procedure, orthopedic surgical procedures, foot and ankle procedures and other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided Zynrelef Small mol API
Avid Bioservices Inc ADC Therapeutics SA NICE recommended the drug as an option for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) after 2 or more systemic treatments in adults, only if: they have previously had polatuzumab vedotin, or if polatuzumab vedotin is contraindicated or not tolerated, and the company provides it according to the commercial arrangement. This recommendation is not intended to affect treatment with loncastuximab tesirine that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop Zynlonta Biologic API
Boehringer Ingelheim Biopharmaceuticals GmbH Merck & Co Inc FDA expanded indication of the drug in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by a validated test; in combination with chemoradiotherapy (CRT), indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer; indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1- containing regimen; in combination with gemcitabine and cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic biliary cancer (BTC); as monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy; in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by a validated test Keytruda Biologic API
BSP Pharmaceuticals SpA ADC Therapeutics SA NICE recommended the drug as an option for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) after 2 or more systemic treatments in adults, only if: they have previously had polatuzumab vedotin, or if polatuzumab vedotin is contraindicated or not tolerated, and the company provides it according to the commercial arrangement. This recommendation is not intended to affect treatment with loncastuximab tesirine that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop Zynlonta Biologic API
Cambrex Corp Heron Therapeutics Inc FDA expanded indication in adults for postsurgical analgesia for up to 72 hours after soft tissue surgical procedure, orthopedic surgical procedures, foot and ankle procedures and other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided Zynrelef Small mol API
Catalent Inc Regeneron Pharmaceuticals Inc FDA expanded indication of the drug for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE) Dupixent Parenteral manufacture & packaging
Catalent Inc Bristol-Myers Squibb Co NICE recommended the drug as an option for untreated advanced (unresectable or metastatic) melanoma in people 12 years and over, only if: the drug is stopped after 2 years of treatment, or earlier if the cancer progresses, and the company provides it according to the commercial arrangement. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. Anyone having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. For children or young people, this decision should be made jointly by the clinician, the child or young person, and their parents or carers Opdualag Parenteral manufacture & packaging
Catalent Inc AstraZeneca Plc NICE recommended the drug with gemcitabine and cisplatin, within its marketing authorisation, as an option for treating locally advanced, unresectable, or metastatic biliary tract cancer in adults. It is only recommended if the company provides the drug according to the commercial arrangement Imfinzi Parenteral manufacture & packaging
Dottikon Exclusive Synthesis AG Les Laboratoires Servier SAS NICE is recommended the drug within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation in adults after 1 or more systemic treatments. It is only recommended if the company provides it according to the commercial arrangement Tibsovo Small mol API
Dottikon Exclusive Synthesis AG AstraZeneca Plc NICE recommended the drug with bevacizumab, within its marketing authorisation, for maintenance treatment of high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose cancer: has completely or partially responded after first-line platinum-based chemotherapy with bevacizumab is advanced (International Federation of Gynecology and Obstetrics [FIGO] stages 3 and 4) and is homologous recombination deficiency (HRD) positive (defined as having either a BRCA1 or BRCA2 mutation, or genomic instability). NICE recommended the drug with abiraterone and prednisone or prednisolone, within its marketing authorisation, as an option for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy. It is only recommended if the company provides it according to the commercial arrangements Lynparza Small mol API
Dr. Reddy's Laboratories Ltd Kadmon Holdings Inc NICE recommended the drug as an option within its marketing authorization, for treating chronic graft-versus-host disease in people 12 years and over after 2 or more systemic treatments. It is recommended only if the company provides it according to the commercial arrangement Rezurock Small mol API
Hanford Pharmaceuticals Baxter International Inc FDA expanded indication of the drug is indicated for the pediatric patients aged 10-17 years to the approved indication for perioperative prophylaxis Cefazolin Sodium Parenteral manufacture & packaging
Jetpharma SA AstraZeneca Plc NICE recommended the drug with bevacizumab, within its marketing authorisation, for maintenance treatment of high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose cancer: has completely or partially responded after first-line platinum-based chemotherapy with bevacizumab is advanced (International Federation of Gynecology and Obstetrics [FIGO] stages 3 and 4) and is homologous recombination deficiency (HRD) positive (defined as having either a BRCA1 or BRCA2 mutation, or genomic instability). NICE recommended the drug with abiraterone and prednisone or prednisolone, within its marketing authorisation, as an option for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy. It is only recommended if the company provides it according to the commercial arrangements Lynparza Small mol API
Jubilant HollisterStier LLC AIM ImmunoTech Inc Positive Phase II top-line results of the drug for the treatment of post-COVID condition of fatigue rintatolimod Biologic API & Parenteral manufacture 
Lifecore Biomedical LLC Heron Therapeutics Inc FDA expanded indication in adults for postsurgical analgesia for up to 72 hours after soft tissue surgical procedure, orthopedic surgical procedures, foot and ankle procedures and other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided Zynrelef Parenteral manufacture
Lonza Group Ltd Eiger BioPharmaceuticals Inc Trial planned - Phase I to assess the safety and explore the efficacy of the drug  administered as a one-time antegrade epicardial coronary artery infusion for the treatment of subjects with cardiomyopathy secondary to DMD Mydicar Parenteral manufacture
Lonza Group Ltd Merck & Co Inc EMA expanded indication of the drug indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in paediatric patients 1 year of age and older at high risk for recurrence of CDI Zinplava Biologic API
Lonza Group Ltd AstraZeneca Plc NICE recommended the drug with bevacizumab, within its marketing authorisation, for maintenance treatment of high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose cancer: has completely or partially responded after first-line platinum-based chemotherapy with bevacizumab is advanced (International Federation of Gynecology and Obstetrics [FIGO] stages 3 and 4) and is homologous recombination deficiency (HRD) positive (defined as having either a BRCA1 or BRCA2 mutation, or genomic instability). NICE recommended the drug with abiraterone and prednisone or prednisolone, within its marketing authorisation, as an option for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy. It is only recommended if the company provides it according to the commercial arrangements Lynparza Small mol API
Nitto Avecia Pharma Services Inc AIM ImmunoTech Inc Positive Phase II top-line results of the drug for the treatment of post-COVID condition of fatigue rintatolimod Parenteral manufacture
Novasep Holding SAS Eiger BioPharmaceuticals Inc Trial planned - Phase I to assess the safety and explore the efficacy of the drug  administered as a one-time antegrade epicardial coronary artery infusion for the treatment of subjects with cardiomyopathy secondary to DMD Mydicar Biologic API
Organon & Co Merck & Co Inc FDA expanded indication of the drug in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by a validated test; in combination with chemoradiotherapy (CRT), indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer; indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1- containing regimen; in combination with gemcitabine and cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic biliary cancer (BTC); as monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy; in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by a validated test Keytruda Parenteral packaging
Organon & Co Merck & Co Inc EMA expanded indication of the drug indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in paediatric patients 1 year of age and older at high risk for recurrence of CDI Zinplava Parenteral packaging
Patheon NV AstraZeneca Plc NICE recommended the drug with bevacizumab, within its marketing authorisation, for maintenance treatment of high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose cancer: has completely or partially responded after first-line platinum-based chemotherapy with bevacizumab is advanced (International Federation of Gynecology and Obstetrics [FIGO] stages 3 and 4) and is homologous recombination deficiency (HRD) positive (defined as having either a BRCA1 or BRCA2 mutation, or genomic instability). NICE recommended the drug with abiraterone and prednisone or prednisolone, within its marketing authorisation, as an option for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy. It is only recommended if the company provides it according to the commercial arrangements Lynparza Solid dose manufacture & packaging
PCI Pharma Services Heron Therapeutics Inc FDA expanded indication in adults for postsurgical analgesia for up to 72 hours after soft tissue surgical procedure, orthopedic surgical procedures, foot and ankle procedures and other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided Zynrelef Parenteral packaging
PCI Pharma Services Johnson & Johnson FDA expanded indication of the drug for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy Balversa Solid dose packaging
Pharma Packaging Solutions Kadmon Holdings Inc NICE recommended the drug as an option within its marketing authorization, for treating chronic graft-versus-host disease in people 12 years and over after 2 or more systemic treatments. It is recommended only if the company provides it according to the commercial arrangement Rezurock Solid dose packaging
Pharmaceutics International Inc AIM ImmunoTech Inc Positive Phase II top-line results of the drug for the treatment of post-COVID condition of fatigue rintatolimod Parenteral manufacture
Roslin Cell Therapies Ltd Vertex Pharmaceuticals Inc FDA expanded indication of the drug for the treatment of transfusion-dependent β-thalassemia in patients 12 years of age and older Casgevy Biologic API
Simtra BioPharma Solutions Takeda Pharmaceutical Co Ltd FDA expanded indication for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults HyQvia Parenteral manufacture
Sterling Pharma Solutions Ltd ADC Therapeutics SA NICE recommended the drug as an option for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) after 2 or more systemic treatments in adults, only if: they have previously had polatuzumab vedotin, or if polatuzumab vedotin is contraindicated or not tolerated, and the company provides it according to the commercial arrangement. This recommendation is not intended to affect treatment with loncastuximab tesirine that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop Zynlonta Biologic API
Swedish Orphan Biovitrum AB ADC Therapeutics SA NICE recommended the drug as an option for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) after 2 or more systemic treatments in adults, only if: they have previously had polatuzumab vedotin, or if polatuzumab vedotin is contraindicated or not tolerated, and the company provides it according to the commercial arrangement. This recommendation is not intended to affect treatment with loncastuximab tesirine that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop Zynlonta Biologic API
Theragent Inc CellVax Therapeutics Inc Trial planned - Phase II to elevate the efficacy of the drug in subjects with high-risk prostate cancer post-radical prostatectomy FKPC-101 Parenteral manufacture
UPM Pharmaceuticals Inc Kadmon Holdings Inc NICE recommended the drug as an option within its marketing authorization, for treating chronic graft-versus-host disease in people 12 years and over after 2 or more systemic treatments. It is recommended only if the company provides it according to the commercial arrangement Rezurock Solid dose manufacture & packaging
Vetter Pharma-Fertigung GmbH & Co KG AstraZeneca Plc NICE recommended the drug with gemcitabine and cisplatin, within its marketing authorisation, as an option for treating locally advanced, unresectable, or metastatic biliary tract cancer in adults. It is only recommended if the company provides the drug according to the commercial arrangement Imfinzi Parenteral manufacture
Wasdell Packaging Group Kadmon Holdings Inc NICE recommended the drug as an option within its marketing authorization, for treating chronic graft-versus-host disease in people 12 years and over after 2 or more systemic treatments. It is recommended only if the company provides it according to the commercial arrangement Rezurock Solid dose packaging
WuXi AppTec Co Ltd RegenxBio Inc Positive Phase II/III top-line results of the drug for the treatment of patients up to 5 years old diagnosed with Mucopolysaccharidosis Type II (MPS II) RGX-121 Biologic API

POTENTIALLY NEGATIVE
Cenexi SAS AbbVie Inc EMA withdrawal/discontinuation at the MAH's request Rapilysin Parenteral manufacture & packaging
F. Hoffmann-La Roche Ltd AbbVie Inc EMA withdrawal/discontinuation at the MAH's request Rapilysin Biologic API, Parenteral manufacture & packaging
Fabbrica Italiana Sintetici SpA Bristol-Myers Squibb Co EMA withdrawal/discontinuation at the MAH's request Sustiva Small mol API
Vetter Pharma-Fertigung GmbH & Co KG AbbVie Inc EMA withdrawal/discontinuation at the MAH's request Rapilysin Parenteral manufacture
Wacker Chemie AG AbbVie Inc EMA withdrawal/discontinuation at the MAH's request Rapilysin Biologic API
Zhejiang Huahai Pharmaceutical Co Ltd  Bristol-Myers Squibb Co EMA withdrawal/discontinuation at the MAH's request Sustiva Solid dose manufacture & packaging

Notes:

Source: GlobalData, Pharma Intelligence Center ©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