September 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 Description Product Relationship

POTENTIALLY POSITIVE
Fabbrica Italiana Sintetici SpA Vertex Pharmaceuticals Inc EMA Approval for a combination regimen with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del in the CFTR gene with a minimal function (MF) mutation. Kaftrio Small molecule API manufacture
STA Pharmaceutical Co Ltd Vertex Pharmaceuticals Inc EMA Approval for a combination regimen with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del in the CFTR gene with a minimal function (MF) mutation. Kaftrio Small molecule API manufacture
Almac Group Ltd Vertex Pharmaceuticals Inc EMA Approval for a combination regimen with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del in the CFTR gene with a minimal function (MF) mutation. Kaftrio Solid dose manufacture and packaging
Hovione FarmaCiencia SA Vertex Pharmaceuticals Inc EMA Approval for a combination regimen with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del in the CFTR gene with a minimal function (MF) mutation. Kaftrio Solid dose manufacture
MilliporeSigma GlaxoSmithKline Plc EMA Approval for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. Blenrep Large molecule API manufacture
DAU Laboratory Intas Pharmaceuticals Ltd EMA Approval for combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing regimen. Cabazitaxel Parenteral manufacture
Cenexi SAS Gennisium Pharma EMA Approval for the treatment of primary apnea of premature newborns. Gencebok Parenteral manufacture and packaging
Biotechpharma UAB Hansa Biopharma AB EMA Approval for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. Idefirix Large molecule API, Parenteral manufacture and packaging 
Cytovance Biologics Inc Pfenex Inc EMA Approval for treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture and in treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. Livogiva Large molecule API manufacture
Eurofins Sinensis Pfenex Inc EMA Approval for treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture and in treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. Livogiva Parenteral manufacture
Alcami Corp Amgen Inc FDA expanded indications for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with lenalidomide and/or dexamethasone. Kyprolis Small molecule API manufacture
Hovione FarmaCiencia SA Amgen Inc FDA expanded indications for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with lenalidomide and/or dexamethasone. Kyprolis Small molecule API manufacture
Helsinn Group Amgen Inc FDA expanded indications for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with lenalidomide and/or dexamethasone. Kyprolis Small molecule API manufacture
Baxter Biopharma Solutions Amgen Inc FDA expanded indications for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with lenalidomide and/or dexamethasone. Kyprolis Parenteral manufacture and packaging
Patheon NV Amgen Inc FDA expanded indications for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with lenalidomide and/or dexamethasone. Kyprolis Parenteral manufacture
Samsung Biologics Co Ltd Johnson & Johnson FDA expanded indication in combination with dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. Darzalex Large molecule API manufacture
Biogen Inc Johnson & Johnson FDA expanded indication in combination with dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. Darzalex Large molecule API manufacture
Vetter Pharma-Fertigung GmbH & Co KG Johnson & Johnson FDA expanded indication in combination with dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy Darzalex Parenteral manufacture
Baxter Biopharma Solutions Johnson & Johnson FDA expanded indication in combination with dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. Darzalex Parenteral manufacture
IDT Biologika GmbH Merz Pharma GmbH & Co KgaA FDA expanded indication for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. Xeomin Parenteral manufacture and packaging
Catalent Inc Novartis AG FDA expanded indication for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy, adults with advanced renal cell carcinoma (rcc). Votrient Small molecule API manufacture
Catalent Inc AstraZeneca Plc EMA expanded indication for the first line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. Imfinzi Parenteral manufacture and packaging
Vetter Pharma-Fertigung GmbH & Co KG AstraZeneca Plc EMA expanded indication for the first line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. Imfinzi Parenteral manufacture
Siegfried Holding AG  Intra-Cellular Therapies Inc Positive Phase III results for the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder. Caplyta Small molecule API manufacture
Fabbrica Italiana Sintetici SpA Vertex Pharmaceuticals Inc Positive Phase III results for study in children ages 6 through 11 years old with cystic fibrosis (CF) who have either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation Trikafta Small molecule API manufacture
STA Pharmaceutical Co Ltd Vertex Pharmaceuticals Inc Positive Phase III results for study in children ages 6 through 11 years old with cystic fibrosis (CF) who have either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation. Trikafta Small molecule API manufacture
Almac Group Ltd Vertex Pharmaceuticals Inc Positive Phase III results for study in children ages 6 through 11 years old with cystic fibrosis (CF) who have either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation Trikafta Solid dose manufacture and packaging
Hovione FarmaCiencia SA Vertex Pharmaceuticals Inc Positive Phase III results for study in children ages 6 through 11 years old with cystic fibrosis (CF) who have either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation. Trikafta Solid dose manufacture

POTENTIALLY NEGATIVE
Catalent Inc Regeneron Pharmaceuticals Inc NICE rejection for treating chronic rhinosinusitis with nasal polyps because Sanofi did not provide an evidence submission. Dupixent Parenteral manufacture and packaging
Lonza Group Ltd Alexion Pharmaceuticals Inc NICE rejection for treating relapsing neuromyelitis optica because Alexion Pharma UK did not provide an evidence submission.  Soliris Large molecule API manufacture
Almac Group Ltd Alexion Pharmaceuticals Inc NICE rejection for treating relapsing neuromyelitis optica because Alexion Pharma UK did not provide an evidence submission.  Soliris Parenteral manufacture and packaging
Patheon NV Alexion Pharmaceuticals Inc NICE rejection for treating relapsing neuromyelitis optica because Alexion Pharma UK did not provide an evidence submission.  Soliris Parenteral manufacture and packaging
NextPharma Technologies Holding Ltd Pfizer Inc FDA has withdrawn the marketing authorisation at the request of the marketing-authorisation holder, and product was not discontinued or withdrawn for safety or efficacy reasons. Atarax Solid dose manufacture
Pharmaceutics International Inc Eli Lilly and Co FDA has withdrawn the marketing authorisation at the request of the marketing-authorisation holder, and product was not discontinued or withdrawn for safety or efficacy reasons. Sarafem Solid dose manufacture
Richter Gedeon Nyrt Johnson & Johnson FDA has withdrawn the marketing authorisation at the request of the marketing-authorisation holder, and product was not discontinued or withdrawn for safety or efficacy reasons. Ortho Tri-Cyclen Lo Small molecule API manufacture
JCR Pharmaceuticals Co Ltd AstraZeneca Plc Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1222 Large molecule API manufacture and packaging
SK Bioscience AstraZeneca Plc Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1223 Large molecule API manufacture
SGS Life Science Services AstraZeneca Plc Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1224 Large molecule API manufacture and analytical services
Catalent Inc AstraZeneca Plc Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1225 Large molecule API, parenteral manufacture and packaging
Novasep Holding SAS AstraZeneca Plc Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1226 Large molecule API manufacture
Emergent BioSolutions Inc AstraZeneca Plc Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1227 Large molecule API manufacture
Oxford BioMedica Plc Vaccines Manufacturing and Innovation Centre UK Ltd Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1228 Large molecule API manufacture
Halix BV University of Oxford Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1229 Large molecule API manufacture
Merck KGaA Jenner Institute Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1230 Large molecule API manufacture
Oxford BioMedica Plc AstraZeneca Plc Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1231 Analytical Services
Cobra Biologics Ltd AstraZeneca Plc Clinical Trial Suspension Due to Suspected Adverse Event** AZD-1232 Large molecule API manufacture