August 2020 – 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
Groupe Parima Inc Hatchtech Pty Ltd FDA Approval for the topical treatment of head lice infestation in patients 6 months of age and older Xeglyze Topical dose manufacture
Ajinomoto Co Inc Nippon Shinyaku Co Ltd FDA Approval for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. Viltepso Small molecule API manufacture
Fuji Yakuhin Co Ltd Nippon Shinyaku Co Ltd FDA Approval for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. Viltepso Parenteral manufacture
Hovione FarmaCiencia SA Nabriva Therapeutics Plc EMA Approval for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. Xenleta Small molecule API manufacture
Almac Group Ltd Nabriva Therapeutics Plc EMA Approval for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. Xenleta Solid dose and parenteral manufacture
Fresenius Kabi Contract Manufacturing Nabriva Therapeutics Plc EMA Approval for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. Xenleta Solid dose and parenteral manufacture
Patheon NV Nabriva Therapeutics Plc EMA Approval for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. Xenleta Solid dose and parenteral manufacture
Lyocontract GmbH MYR GmbH EMA Approval for the treatment of chronic hepatitis delta virus (HDV) infection in adult patients with compensated liver disease. Hepcludex Parenteral manufacture and packaging
Xellia Pharmaceuticals ApS Eli Lilly and Co FDA expanded indications for the treatment of Clostridioides difficile-associated diarrhea and also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age Vancocin Small molecule API manufacture
Norwich Pharma Services Eli Lilly and Co FDA expanded indications for the treatment of Clostridioides difficile-associated diarrhea and also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age Vancocin Solid dose manufacture and packaging
Yuhan Chemical Inc Bristol-Myers Squibb Co FDA expanded indications in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in the following populations adults and pediatric patients weighing at least 35 kg Evotaz Small molecule API manufacture
Esteve Pharmaceuticals SA Bristol-Myers Squibb Co FDA expanded indications in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in the following populations adults and pediatric patients weighing at least 35 kg Evotaz Small molecule API manufacture
Gilead Sciences Inc Bristol-Myers Squibb Co FDA expanded indications in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in the following populations adults and pediatric patients weighing at least 35 kg Evotaz Small molecule API, solid dose manufacture and packager
AstraZeneca Plc Bristol-Myers Squibb Co FDA expanded indications in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in the following populations adults and pediatric patients weighing at least 35 kg Evotaz Solid dose manufacture
Patheon NV Bristol-Myers Squibb Co FDA expanded indications in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in the following populations adults and pediatric patients weighing at least 35 kg. Evotaz Solid dose manufacture
Yuhan Chemical Inc Johnson & Johnson FDA expanded indications in combination with other antiretroviral agents  for the treatment of human immunodeficiency virus (HIV-1 ) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) Prezcobix Small molecule API manufacture
Esteve Pharmaceuticals SA Johnson & Johnson FDA expanded indications in combination with other antiretroviral agents  for the treatment of human immunodeficiency virus (HIV-1 ) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) Prezcobix Small molecule API manufacture
Gilead Sciences Inc Johnson & Johnson FDA expanded indications in combination with other antiretroviral agents  for the treatment of human immunodeficiency virus (HIV-1 ) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) Prezcobix Small molecule API manufacture and packaging
Patheon NV Johnson & Johnson FDA expanded indications in combination with other antiretroviral agents  for the treatment of human immunodeficiency virus (HIV-1 ) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) Prezcobix Solid dose manufacture and packaging
Formosa Laboratories Inc Grunenthal GmbH FDA expanded indications for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults Qutenza Small molecule API manufacture
LTS Lohmann Therapie-Systeme AG Grunenthal GmbH FDA expanded indications for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults Qutenza Topical dose manufacture
Contract Pharmaceuticals Ltd Grunenthal GmbH FDA expanded indications for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults Qutenza Topical dose manufacture
SEQENS Johnson & Johnson FDA expanded indications in conjunction with an oral antidepressant, for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior Spravato Small molecule API manufacture
Renaissance Lakewood LLC Johnson & Johnson FDA expanded indications in conjunction with an oral antidepressant, for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior Spravato Inhalation dose manufacture and packaging
PCI Pharma Services Celltrion Inc EMA expanded indications for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis Remsima SC Parenteral manufacture and packaging
BioReliance Corp Celltrion Inc EMA expanded indications for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis Remsima SC Parenteral manufacture
Mustafa Nevzat Ilac Sanayii AS Celltrion Inc EMA expanded indications for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis Remsima SC Parenteral manufacture
Rentschler Biopharma SE Celltrion Inc EMA expanded indications for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis Remsima SC Parenteral manufacture and packaging
Takeda Pharmaceutical Co Ltd F. Hoffmann-La Roche Ltd EMA expanded indications as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with INC does not provide adequate disease control Xolair Parenteral manufacture
AMPAC Fine Chemicals LLC Novartis AG Positive Phase III results for overall response rate in patients with chronic graft-versus-host disease (GvHD) compared to best available therapy, building on previous positive findings in acute GvHD and met key secondary endpoints, significantly improving failure-free survival and patient-reported symptoms Jakavi Small molecule API manufacture
DSM Pharmaceuticals Inc Novartis AG Positive Phase III results for overall response rate in patients with chronic graft-versus-host disease (GvHD) compared to best available therapy, building on previous positive findings in acute GvHD and met key secondary endpoints, significantly improving failure-free survival and patient-reported symptoms Jakavi Solid dose manufacture
Ube Industries Ltd Daiichi Sankyo Co Ltd Positive Phase III results in the Japan PRASTRO-III phase 3 study (hereafter, the study) of the antiplatelet agent, prasugrel hydrochloride (hereafter, prasugrel), in thrombotic stroke patients Effient Small molecule API manufacture
Oxford BioMedica Plc Novartis AG Positive Phase II results from the ELARA trial in patients with relapsed or refractory (r/r) follicular lymphoma (FL) Kymriah Large molecule API manufacture
Fraunhofer-Gesellschaft zur Forderung der Angewandten Forschung eV Novartis AG Positive Phase II results from the ELARA trial in patients with relapsed or refractory (r/r) follicular lymphoma (FL) Kymriah Large molecule API manufacture
Lonza Group Ltd Seattle Genetics Inc NICE approval in compbination with cyclophosphamide, doxorubicin and prednisone (CHP) is recommended, within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults Adcetris Large molecule API manufacture
Piramal Pharma Solutions Inc Seattle Genetics Inc NICE approval in compbination with cyclophosphamide, doxorubicin and prednisone (CHP) is recommended, within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults Adcetris Large molecule API manufacture
AbbVie Inc Seattle Genetics Inc NICE approval in compbination with cyclophosphamide, doxorubicin and prednisone (CHP) is recommended, within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults Adcetris Large molecule API manufacture
Albany Molecular Research Inc Seattle Genetics Inc NICE approval in compbination with cyclophosphamide, doxorubicin and prednisone (CHP) is recommended, within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults Adcetris Large molecule API manufacture
BioReliance Corp Seattle Genetics Inc NICE approval in compbination with cyclophosphamide, doxorubicin and prednisone (CHP) is recommended, within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults Adcetris Large molecule API manufacture
Delpharm SAS Seattle Genetics Inc NICE approval in compbination with cyclophosphamide, doxorubicin and prednisone (CHP) is recommended, within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults Adcetris Parenteral manufacture and packaging
Laboratoires Pierre Fabre SA Seattle Genetics Inc NICE approval in compbination with cyclophosphamide, doxorubicin and prednisone (CHP) is recommended, within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults Adcetris Parenteral manufacture
Baxter Biopharma Solutions Seattle Genetics Inc NICE approval in compbination with cyclophosphamide, doxorubicin and prednisone (CHP) is recommended, within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults Adcetris Parenteral manufacture
BSP Pharmaceuticals SpA Seattle Genetics Inc NICE approval in compbination with cyclophosphamide, doxorubicin and prednisone (CHP) is recommended, within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults Adcetris Parenteral manufacture
Takeda Pharmaceutical Co Ltd Seattle Genetics Inc NICE approval in compbination with cyclophosphamide, doxorubicin and prednisone (CHP) is recommended, within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults Adcetris Parenteral manufacture

POTENTIALLY NEGATIVE
Patheon NV AstraZeneca Plc Development discontinued for Vaso-Occlusive Crisis Associated With Sickle Cell Disease due to business/strategic decision Brilique Small molecule API manufacture
Ajinomoto Bio-Pharma Services AstraZeneca Plc Development discontinued for Vaso-Occlusive Crisis Associated With Sickle Cell Disease due to business/strategic decision Brilique Small molecule API manufacture
Hovione FarmaCiencia SA AstraZeneca Plc EMA has withdrawn the marketing authorisation at the request of the marketing-authorisation holder "Grunenthal GmbH", request is a business decision and is not related to any efficacy, safety or clinical concerns. Duzallo Small molecule API manufacture
Grunenthal GmbH AstraZeneca Plc EMA has withdrawn the marketing authorisation at the request of the marketing-authorisation holder "Grunenthal GmbH", request is a business decision and is not related to any efficacy, safety or clinical concerns. Duzallo Solid dose manufacture