June 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
Aenova Holding GmbH Mithra Pharmaceuticals SA EMA approval for female contraception Lydisilka Solid dose manufacture and packaging
Albany Molecular Research Inc Verastem Inc EMA approval for the treatment of adult patients with Relapsed or refractory chronic lymphocytic leukaemia  (CLL) and refractory Follicular lymphoma (FL) after at least two prior therapies Copiktra Small molecule API and solid dose manufacture
Almac Group Ltd BioNTech SE EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 to 15 years of age Comirnaty** Parenteral packaging
Almac Group Ltd Nabriva Therapeutics Plc Positive Phase III results for Community Acquired Bacterial Pneumonia Xenleta Solid dose manufacture
Almac Group Ltd BioNTech SE US government purchases 500 million doses to donate to COVAX Comirnaty** Parenteral packaging
AMPAC Fine Chemicals LLC Incyte Corp Positive Phase III results for vitiligo in adolescent and adult patients Jakafi Small molecule API manufacture
Bachem Holding AG Apellis Pharmaceuticals Inc Positive Phase III results for paroxysmal nocturnal hemoglobinuria in adults Empaveli Large molecule API manufacture
Baxter Biopharma Solutions Bristol-Myers Squibb Co FDA expanded indication for the treatment of unresectable or metastatic melanoma in adult patients Yervoy Parenteral manufacture
Baxter Biopharma Solutions BioNTech SE EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 to 15 years of age Comirnaty** Parenteral manufacture
Baxter Biopharma Solutions Alexion Pharmaceuticals Inc NICE approval for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding Ondexxya Parenteral manufacture
Baxter Biopharma Solutions BioNTech SE US government purchases 500 million doses to donate to COVAX Comirnaty** Parenteral manufacture
Boehringer Ingelheim International GmbH Hikma Pharmaceuticals USA Inc FDA expanded indication for the management of adults and pediatric patients weighing at least 50 kg or pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate Morphine Sulfate Solid dose manufacture and packaging
Catalent Inc Assertio Therapeutics Inc FDA expanded indication for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older Zipsor Solid dose manufacture
Catalent Inc Verastem Inc EMA approval for the treatment of adult patients with Relapsed or refractory chronic lymphocytic leukaemia  (CLL) and refractory Follicular lymphoma (FL) after at least two prior therapies Copiktra Solid dose manufacture
Catalent Inc Bristol-Myers Squibb Co FDA expanded indication for the treatment of unresectable or metastatic melanoma in adult patients Yervoy Parenteral manufacture and packaging
Catalent Inc Bristol-Myers Squibb Co EMA expanded indication for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM Opdivo + Yervoy Parenteral manufacture and packaging
Catalent Inc Bristol-Myers Squibb Co FDA expanded indication for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with  residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT) Opdivo Parenteral manufacture and packaging
Catalent Inc Biohaven Pharmaceutical Holding Company Ltd FDA expanded indication for the preventive treatment of episodic migraine in adults Nurtec Small molecule API manufacture
Catalent Inc Novo Nordisk Inc FDA approval adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of  30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia) Wegovy Parenteral manufacture
Delpharm SAS BioNTech SE EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 to 15 years of age Comirnaty** Parenteral manufacture
Delpharm SAS BioNTech SE US government purchases 500 million doses to donate to COVAX Comirnaty** Parenteral manufacture
Excella GmbH & Co KG Myovant Sciences Inc FDA approval for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women Myfembree Small molecule API manufacture
Fareva SA Hikma Pharmaceuticals USA Inc FDA expanded indication for the management of adults and pediatric patients weighing at least 50 kg or pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate Morphine Sulfate Solid dose manufacture and packaging
Fresenius Kabi Contract Manufacturing Nabriva Therapeutics Plc Positive Phase III results for Community Acquired Bacterial Pneumonia Xenleta Solid dose manufacture
Fujifilm Diosynth Biotechnologies USA Inc Alexion Pharmaceuticals Inc NICE approval for treating paroxysmal nocturnal haemoglobinuria in adults Ultomiris Large molecule API manufacture
Hovione FarmaCiencia SA Nabriva Therapeutics Plc Positive Phase III results for Community Acquired Bacterial Pneumonia Xenleta Small molecule API manufacture
Johnson Matthey Plc  Hikma Pharmaceuticals USA Inc FDA expanded indication for the management of adults and pediatric patients weighing at least 50 kg or pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate Morphine Sulfate Small molecule API manufacture
Konapharma AG Johnson & Johnson EMA approval for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features Ponvory Solid dose packaging
Lonza Group Ltd Bristol-Myers Squibb Co FDA expanded indication for the treatment of unresectable or metastatic melanoma in adult patients Yervoy Large molecule API manufacture
Lonza Group Ltd Bristol-Myers Squibb Co EMA expanded indication for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM Opdivo + Yervoy Large molecule API manufacture
Lonza Group Ltd Bristol-Myers Squibb Co FDA expanded indication for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with  residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT) Opdivo Large molecule API manufacture
Lonza Group Ltd AstraZeneca Plc EMA expanded indication for the adjuvant treatment of adult patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent, EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations Tagrisso Small molecule API manufacture
Lonza Group Ltd Novartis AG NICE approval for treating relapsing–remitting multiple sclerosis in adults with active disease defined by clinical or imaging features Kesimpta Large molecule API manufacture
Lonza Group Ltd Alexion Pharmaceuticals Inc NICE approval for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding Ondexxya Large molecule API manufacture
Mibe GmbH Arzneimittel BioNTech SE EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 to 15 years of age Comirnaty** Parenteral manufacture
Mibe GmbH Arzneimittel BioNTech SE US government purchases 500 million doses to donate to COVAX Comirnaty** Parenteral manufacture
Mikart LLC Assertio Therapeutics Inc FDA expanded indication for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older Zipsor Solid dose packaging
Novartis AG BioNTech SE EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 to 15 years of age Comirnaty** Parenteral manufacture and packaging
Novartis AG BioNTech SE US government purchases 500 million doses to donate to COVAX Comirnaty** Parenteral manufacture and packaging
Novartis AG Chugai Pharmaceutical Co Ltd Trial planned - Phase I for activity of drug in participants with relapsed or refractory multiple myeloma Actemra Large molecule API manufacture
Patheon NV Alexion Pharmaceuticals Inc NICE approval for treating paroxysmal nocturnal haemoglobinuria in adults Ultomiris Large molecule API manufacture
Patheon NV Nabriva Therapeutics Plc Positive Phase III results for Community Acquired Bacterial Pneumonia Xenleta Solid dose manufacture
Patheon NV  Myovant Sciences Inc FDA approval for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women Myfembree Solid dose manufacture
Patheon NV  Johnson & Johnson EMA approval for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features Ponvory Small molecule API, solid dose manufacture and packaging
PCI Pharma Services Heron Therapeutics Inc FDA approval for the treatment of adults for soft tissue or periarticular instillation to produce post surgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. Zynrelef Parenteral manufacture and packaging
PCI Pharma Services Verastem Inc EMA approval for the treatment of adult patients with Relapsed or refractory chronic lymphocytic leukaemia  (CLL) and refractory Follicular lymphoma (FL) after at least two prior therapies Copiktra Solid dose packaging
PCI Pharma Services Alexion Pharmaceuticals Inc NICE approval for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding Ondexxya Parenteral manufacture and packaging
PharmaBlock Sciences Nanjing Inc Ascentage Pharma Group International Trial planned - Phase I for neuroendocrine tumors Pelcitoclax Parenteral manufacture
Polymun Scientific ImmunbiologischeForschung GmbH BioNTech SE EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 to 15 years of age Comirnaty** Parenteral manufacture
Polymun Scientific ImmunbiologischeForschung GmbH BioNTech SE US government purchases 500 million doses to donate to COVAX Comirnaty** Parenteral manufacture
Redx Pharma Plc Quay Pharmaceuticals Ltd Trial planned - Phase II for advanced solid tumours after progression on Standard of Care (SoC) therapy (PORCUPINE2) RXC-004 Solid dose manufacture
Rentschler Biopharma SE BioNTech SE EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 to 15 years of age Comirnaty** Large molecule API manufacture
Rentschler Biopharma SE BioNTech SE US government purchases 500 million doses to donate to COVAX Comirnaty** Large molecule API manufacture
Samsung Biologics Co Ltd Bristol-Myers Squibb Co FDA expanded indication for the treatment of unresectable or metastatic melanoma in adult patients Yervoy Large molecule API manufacture
Samsung Biologics Co Ltd Bristol-Myers Squibb Co EMA expanded indication for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM Opdivo + Yervoy Large molecule API manufacture
Samsung Biologics Co Ltd Bristol-Myers Squibb Co FDA expanded indication for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with  residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT) Opdivo Large molecule API manufacture
Sanofi BioNTech SE EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 to 15 years of age Comirnaty** Parenteral manufacture
Sanofi BioNTech SE US government purchases 500 million doses to donate to COVAX Comirnaty** Parenteral manufacture
Sharp Packaging Services Nabriva Therapeutics Plc Positive Phase III results for Community Acquired Bacterial Pneumonia Xenleta Solid dose packaging
Siegfried Holding AG BioNTech SE EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 to 15 years of age Comirnaty** Parenteral manufacture and packaging
Siegfried Holding AG Novartis AG NICE approval for treating relapsing–remitting multiple sclerosis in adults with active disease defined by clinical or imaging features Kesimpta Parenteral manufacture and packaging
Siegfried Holding AG BioNTech SE US government purchases 500 million doses to donate to COVAX Comirnaty** Parenteral manufacture and packaging
Vetter Pharma-Fertigung GmbH & Co KG Chugai Pharmaceutical Co Ltd Trial planned - Phase I for activity of drug in participants with relapsed or refractory multiple myeloma Actemra Parenteral manufacture and packaging
WuXi Biologics Cayman Inc I-Mab Trial planned - Phase I with or without oral/IV Dexamethasone and in combination with oral/IV/subcutaneous anti-myeloma regimens in adult participants with multiple myeloma TJC-4 Large molecule API manufacture

POTENTIALLY NEGATIVE
Baxter Biopharma Solutions Bristol-Myers Squibb Co Withdrawal/Discontinuation of the marketing authorisation for the product at the marketing holder's request Azacitidine Parenteral manufacture and packaging
BSP Pharmaceuticals SpA Bristol-Myers Squibb Co Withdrawal/Discontinuation of the marketing authorisation for the product at the marketing holder's request Azacitidine Parenteral manufacture and packaging
Carbogen Amcis AG Bristol-Myers Squibb Co Withdrawal/Discontinuation of the marketing authorisation for the product at the marketing holder's request Azacitidine Small molecule API manufacture
Catalent Inc AbbVie Inc NICE rejection for the drug with obinutuzumab untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma in adults Imbruvica Small molecule API and solid dose manufacture
Catalent Inc Karyopharm Therapeutics Inc NICE rejection for the drug with low-dose dexamethasone for treating refractory multiple myeloma in adults Nexpovio Solid dose manufacture
Catalent Inc Pfizer Inc NICE rejection for treating wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR‑CM) in adults Vyndaqel Solid dose manufacture
DPT Laboratories Ltd Pfizer Inc NICE rejection for treating mild to moderate atopic dermatitis in people 2 years and older Staquis Semi-solid dose manufacture
Lonza Group Ltd AbbVie Inc NICE rejection for the drug with obinutuzumab untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma in adults Imbruvica Small molecule API manufacture
MIAS Pharma Ltd Karyopharm Therapeutics Inc NICE rejection for the drug with low-dose dexamethasone for treating refractory multiple myeloma in adults Nexpovio Solid dose manufacture
PCI Pharma Services AbbVie Inc NICE rejection for the drug with obinutuzumab untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma in adults Imbruvica Solid dose packaging
PCI Pharma Services Pfizer Inc NICE rejection for treating wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR‑CM) in adults Vyndaqel Solid dose packaging
Pharma Packaging Solutions Karyopharm Therapeutics Inc NICE rejection for the drug with low-dose dexamethasone for treating refractory multiple myeloma in adults Nexpovio Solid dose packaging
Piramal Pharma Solutions Inc Bristol-Myers Squibb Co Withdrawal/Discontinuation of the marketing authorisation for the product at the marketing holder's request Azacitidine Small molecule API manufacture

 

Notes:

Source: GlobalData, Pharma Intelligence Center ©GlobalData
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