December 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
AbbVie Inc Seagen Inc FDA expanded indication for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy Adcetris Biologic API
Almac Group Ltd Amryt Pharma Plc EMA approval for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues Mycapssa Solid dose packaging
Aptuit LLC X4 Pharmaceuticals Inc Positive Phase III top-line results for Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome Mavorixafor Small mol API
Baxter Biopharma Solutions Seagen Inc FDA expanded indication for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy Adcetris Parenteral manufacture
Bayer AG AbbVie Inc FDA expanded indication for prevention of pregnancy for up to 8 years Liletta Small mol API
Biogen Inc Sanofi EMA expanded indication for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (CAD) Enjaymo Biologic API
BioReliance Corp Seagen Inc FDA expanded indication for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy Adcetris Biologic API
Biotechpharma UAB Xbrane Biopharma AB EMA approval for Choroidal Neovascularization,Diabetic Macular Edema,Macular Edema,Proliferative Diabetic Retinopathy (PDR),Retinal Vein Occlusion,Wet (Neovascular / Exudative) Macular Degeneration Ximluci Biologic API
Boehringer Ingelheim Biopharmaceuticals GmbH Apexigen Inc Positive Phase II interim results for evaluating the drug in combination with doxorubicin in patients with Liposarcoma Sotigalimab Biologic API & parenteral manufacture
Boehringer Ingelheim Biopharmaceuticals GmbH AbbVie Inc EMA expanded indication for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy Skyrizi Biologic API & parenteral manufacture
BSP Pharmaceuticals SpA Seagen Inc FDA expanded indication for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy Adcetris Biologic API & parenteral manufacture
Carbogen Amcis AG GSK plc EMA approval for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) Livtencity Small mol API
Catalent Inc Editas Medicine Inc Positive Phase I/II interim results for the treatment of severe sickle cell disease EDIT-301 Biologic API
Catalent Inc GSK plc EMA approval for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) Livtencity Solid dose & packaging
Catalent Inc BeiGene Ltd EMA expanded indication for the treatment of adult patients with treatment-naive or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) Brukinsa Solid dose
Catalent Inc Aurinia Pharmaceuticals Inc UK MHRA approval for Lupus Nephritis Lupkynis Solid dose & packaging
Catalent Inc AstraZeneca Plc FDA expanded indication in combination with tremelimumab-actl and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations Imfinzi Parenteral manufacture & packaging
Catalent Inc Rigel Pharmaceuticals Inc FDA approval for the treatment of adult patients with refractory acute myeloid leukemia (AML) and relapsed acute myeloid leukemia with a susceptible IDH1 mutation Rezlidhia Solid dose
Delpharm SAS Seagen Inc FDA expanded indication for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy Adcetris Parenteral manufacture & packaging
Esteve Pharmaceuticals SA Gilead Sciences Inc EMA expanded indication for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg without present or past evidence of viral resistance to the integrase inhibitor class Biktarvy Small mol API
Evonik Industries AG Gilead Sciences Inc EMA expanded indication for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg without present or past evidence of viral resistance to the integrase inhibitor class Biktarvy Small mol API
Fareva SA Seagen Inc FDA expanded indication for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy Adcetris Parenteral manufacture
HJBBIO Transcenta Holding Ltd Trial planned - Phase I/II to evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types Osemitamab Biologic API
KBI Biopharma Inc Sanofi EMA expanded indication for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (CAD) Enjaymo Biologic API
KBI Biopharma Inc Coherus BioSciences Inc FDA expanded indication to increase survival in patients acutely exposed to myelosuppressive doses of radiation Udenyca Biologic API
Lonza Group Ltd Aurinia Pharmaceuticals Inc UK MHRA approval for Lupus Nephritis Lupkynis Small mol API
Lonza Group Ltd Seagen Inc FDA expanded indication for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy Adcetris Biologic API
Lyophilization Services of New England Inc Amryt Pharma Plc EMA approval for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues Mycapssa Solid dose
Mayne Pharma Group Ltd X4 Pharmaceuticals Inc Positive Phase III top-line results for Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome Mavorixafor Solid dose
NextPharma Technologies Holding Ltd Amryt Pharma Plc EMA approval for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues Mycapssa Solid dose & packaging
PCI Pharma Services Gilead Sciences Inc EMA expanded indication for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg without present or past evidence of viral resistance to the integrase inhibitor class Biktarvy Solid dose packaging
PCI Pharma Services BeiGene Ltd EMA expanded indication for the treatment of adult patients with treatment-naive or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) Brukinsa Solid dose packaging
PCI Pharma Services Aurinia Pharmaceuticals Inc UK MHRA approval for Lupus Nephritis Lupkynis Solid dose packaging
PCI Pharma Services Coherus BioSciences Inc FDA expanded indication to increase survival in patients acutely exposed to myelosuppressive doses of radiation Udenyca Parenteral manufacture & packaging
Piramal Pharma Solutions Inc Seagen Inc FDA expanded indication for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy Adcetris Biologic API
Quay Pharmaceuticals Ltd Therakind Ltd FDA approval for the treatment of adults with rheumatoid arthritis, severe psoriasis, acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen,  mycosis fungoides; and relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen Jylamvo Non-sterile liquid manufacture & packaging
Rentschler Biopharma SE BioNTech SE EMA expanded indication for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years who have previously received at least a primary vaccination course against COVID-19 Comirnaty Original/Omicron BA.4-5** Biologic API
Rottendorf Pharma GmbH Gilead Sciences Inc EMA expanded indication for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg without present or past evidence of viral resistance to the integrase inhibitor class Biktarvy Solid dose
Sharp Packaging Services Seagen Inc FDA expanded indication for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy Adcetris Parenteral packaging
Sichuan Huiyu Pharmaceutical Co Ltd Meridian Laboratories Inc FDA approval for Metastatic Breast Cancer, Non-Small Cell Lung Cancer, Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer, Adenocarcinoma Of The Gastroesophageal Junction, Head And Neck Cancer Squamous Cell Carcinoma Docetaxel Parenteral manufacture
Takeda Pharmaceutical Co Ltd Seagen Inc FDA expanded indication for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy Adcetris Parenteral manufacture
Uquifa SA Gilead Sciences Inc EMA expanded indication for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg without present or past evidence of viral resistance to the integrase inhibitor class Biktarvy Small mol API
Vetter Pharma-Fertigung GmbH & Co KG Sanofi EMA expanded indication for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (CAD) Enjaymo Parenteral manufacture
Vetter Pharma-Fertigung GmbH & Co KG Eli Lilly and Co FDA expanded indication as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus Trulicity Parenteral manufacture & packaging
Vetter Pharma-Fertigung GmbH & Co KG AstraZeneca Plc FDA expanded indication in combination with tremelimumab-actl and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations Imfinzi Parenteral manufacture
Wasdell Packaging Group Therakind Ltd FDA approval for the treatment of adults with rheumatoid arthritis, severe psoriasis, acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen,  mycosis fungoides; and relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen Jylamvo Non-sterile liquid packaging
Yuhan Chemical Inc Gilead Sciences Inc EMA expanded indication for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg without present or past evidence of viral resistance to the integrase inhibitor class Biktarvy Small mol API

POTENTIALLY NEGATIVE
AMPAC Fine Chemicals LLC Incyte Corp NICE rejection for treating acute graft versus host disease refractory to corticosteroids in people aged 12 and over. This is because Novartis has confirmed that it does not intend to make an evidence submission for the appraisal Jakafi Small mol API
Baxter Biopharma Solutions Amgen Inc NICE rejection for treating relapsed or refractory multiple myeloma in adults. This is because Amgen did not provide an evidence submission Kyprolis Parenteral manufacture & packaging
Cell Therapies Pty Ltd Novartis AG NICE rejection for treating relapsed or refractory follicular lymphoma in adults after 2 or more therapies. This is because Novartis did not provide an evidence submission Kymriah Biologic API
Fraunhofer Society for the Promotion of Applied Research eV Novartis AG NICE rejection for treating relapsed or refractory follicular lymphoma in adults after 2 or more therapies. This is because Novartis did not provide an evidence submission Kymriah Biologic API
HAS Healthcare Advanced Synthesis SA Amgen Inc NICE rejection for treating relapsed or refractory multiple myeloma in adults. This is because Amgen did not provide an evidence submission Kyprolis Small mol API
Hovione FarmaCiencia SA Amgen Inc NICE rejection for treating relapsed or refractory multiple myeloma in adults. This is because Amgen did not provide an evidence submission Kyprolis Small mol API
Lonza Group Ltd Novartis AG NICE rejection for treating relapsed or refractory follicular lymphoma in adults after 2 or more therapies. This is because Novartis did not provide an evidence submission Kymriah Biologic API
Oxford BioMedica Plc Novartis AG NICE rejection for treating relapsed or refractory follicular lymphoma in adults after 2 or more therapies. This is because Novartis did not provide an evidence submission Kymriah Biologic API
Patheon NV Amgen Inc NICE rejection for treating relapsed or refractory multiple myeloma in adults. This is because Amgen did not provide an evidence submission Kyprolis Parenteral manufacture
Sharp Packaging Services Amgen Inc NICE rejection for treating relapsed or refractory multiple myeloma in adults. This is because Amgen did not provide an evidence submission Kyprolis Parenteral packaging
Sterling Pharma Solutions Ltd Amgen Inc NICE rejection for treating relapsed or refractory multiple myeloma in adults. This is because Amgen did not provide an evidence submission Kyprolis Small mol 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