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 |
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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 |
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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 |
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