October 2024 — CDMO Opportunities And Threats Report
By GlobalData
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 |
||||
| Alfasigma SpA | Windtree Therapeutics Inc | Positive Phase II top-line results of the drug in early cardiogenic shock and Acute Heart Failure | istaroxime | Small mol API |
| Almac Group Ltd | Pharmaand GmbH | NICE recommended the drug within its marketing authorisation, as an option for the maintenance treatment of relapsed platinum-sensitive high-grade epithelial, ovarian, fallopian tube or primary peritoneal cancer that has completely or partially responded to platinum-based chemotherapy in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Rubraca | Solid dose manufacture & packaging |
| Almac Group Ltd | Janssen-Cilag International NV | EMA approval of the drug as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of drug given concurrently as separate tablets | Yuvanci | Solid dose packaging |
| Almac Group Ltd | Ipsen SA | EMA expanded indication of the drug for the treatment of cholestatic pruritus in Alagille Syndrome (ALGS) in patients aged 6 months or older | kayfanda | Solid dose manufacture & packaging |
| AstraZeneca Plc | Merck Sharp & Dohme Corp | FDA expanded indication of the drug in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM); in combination with Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with radically unresectable urothelial carcinoma in adults; in combination with chemotherapy as a neoadjuvant treatment for patients with non-small cell lung carcinoma (NSCLC); monotherapy in patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy; as monotherapy as an adjuvant treatment, for patients with non-small cell lung carcinoma (NSCLC) | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme Corp | FDA expanded indication of the drug in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM); in combination with Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with radically unresectable urothelial carcinoma in adults; in combination with chemotherapy as a neoadjuvant treatment for patients with non-small cell lung carcinoma (NSCLC); monotherapy in patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy; as monotherapy as an adjuvant treatment, for patients with non-small cell lung carcinoma (NSCLC) | Keytruda | Biologic API |
| BSP Pharmaceuticals SpA | Takeda UK Ltd | UK MHRA expanded indication of the drug for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine | Adcetris | Biologic API, Parenteral packaging |
| Catalent Indiana LLC | Sanofi UK | UK MHRA expanded indication of the drug in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate | Dupixent | Parenteral manufacture & packaging |
| Catalent Indiana LLC | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) | Fasenra | Parenteral manufacture & packaging |
| Corden Pharma International GmbH | Cereno Scientific AB | Positive Phase II top-line results of the drug for the treatment with lead candidate CS1 in Pulmonary Arterial Hypertension | valproic acid | Solid dose manufacture |
| Curia Global Inc | Novaliq GmbH | EMA approval of the drug for the treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes | Vevizye | Small mol API |
| Delpharm SAS | Ipsen SA | EMA approval of the drug indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA | Iqirvo | Solid dose manufacture & packaging |
| Delpharm SAS | Takeda UK Ltd | UK MHRA expanded indication of the drug for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine | Adcetris | Parenteral manufacture & packaging |
| Dottikon Exclusive Synthesis AG | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test | Tagrisso | Small mol API |
| Fareva SA | Takeda UK Ltd | UK MHRA expanded indication of the drug for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine | Adcetris | Parenteral packaging |
| Farmabios SpA | Windtree Therapeutics Inc | Positive Phase II top-line results of the drug in early cardiogenic shock and Acute Heart Failure | istaroxime | Small mol API |
| HWI pharma services GmbH | Novaliq GmbH | EMA approval of the drug for the treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes | Vevizye | Sterile liquid manufacture |
| IDT Biologika GmbH | Bavarian Nordic AS | EMA expanded indication of the drug for the treatment of smallpox, monkeypox and disease caused by vaccinia virus in individuals 12 years of age and older | Imvanex | Parenteral manufacture & packaging |
| Jetpharma SA | Janssen-Cilag International NV | EMA approval of the drug as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of drug given concurrently as separate tablets | Yuvanci | Small mol API |
| Kymos Pharma Services SL | Prestige BioPharma Ltd | EMA approval of the drug for the treatment of adult patients with breast cancer; gastric cancer; in combination with capecitabine is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease; in combination with 5-fluorouracil is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease; in combination with cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease; HER2 positive metastatic breast cancer as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments; HER2 positive metastatic breast cancer in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable; HER2 positive metastatic breast cancer in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable; HER2 positive metastatic breast cancer in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with drug | Tuznue | Parenteral manufacture |
| Laboratorio Reig Jofre SA | Prestige BioPharma Ltd | EMA approval of the drug for the treatment of adult patients with breast cancer; gastric cancer; in combination with capecitabine is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease; in combination with 5-fluorouracil is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease; in combination with cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease; HER2 positive metastatic breast cancer as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments; HER2 positive metastatic breast cancer in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable; HER2 positive metastatic breast cancer in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable; HER2 positive metastatic breast cancer in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with drug | Tuznue | Parenteral manufacture & packaging |
| Lonza Group Ltd | Pharmaand GmbH | NICE recommended the drug within its marketing authorisation, as an option for the maintenance treatment of relapsed platinum-sensitive high-grade epithelial, ovarian, fallopian tube or primary peritoneal cancer that has completely or partially responded to platinum-based chemotherapy in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Rubraca | Small mol API |
| Lonza Group Ltd | Janssen-Cilag International NV | EMA approval of the drug as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of drug given concurrently as separate tablets | Yuvanci | Small mol API |
| Lonza Group Ltd | Astellas Pharma Ltd | UK MHRA expanded indication of the drug in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy | Padcev | Biologic API |
| Lonza Group Ltd | Novartis Pharmaceuticals Corp | FDA expanded indication of the drug for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence | Kisqali Femara | Solid dose manufacture & packaging |
| Lonza Group Ltd | Bristol-Myers Squibb Co | FDA expanded indication of the drug in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma; adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy and have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent Opdivo as adjuvant treatment after surgery | Opdivo | Biologic API |
| Lonza Group Ltd | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test | Tagrisso | Small mol API |
| Lonza Group Ltd | Takeda UK Ltd | UK MHRA expanded indication of the drug for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine | Adcetris | Biologic API |
| Novasep Holding SAS | Sensorion SA | Positive Phase I/II Interim results of the drug for the treatment of hearing loss disorders |
SENS-501 | Biologic API, Parenteral manufacture |
| Organon & Co | Merck Sharp & Dohme Corp | FDA expanded indication of the drug in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM); in combination with Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with radically unresectable urothelial carcinoma in adults; in combination with chemotherapy as a neoadjuvant treatment for patients with non-small cell lung carcinoma (NSCLC); monotherapy in patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy; as monotherapy as an adjuvant treatment, for patients with non-small cell lung carcinoma (NSCLC) | Keytruda | Parenteral packaging |
| Patheon NV | IntraBio Ltd | FDA approval of the drug for the treatment of neurological manifestations of niemann-pick disease type c (NPC) in adults and pediatric patients weighing ≥15 kg | Aqneursa | Small mol API, Non-sterile liquid manufacture & packaging |
| PCI Pharma Services | Servier Laboratories Ltd | NICE recommended the drug with bevacizumab, within its marketing authorisation, for treating metastatic colorectal cancer in adults who have had 2 lines of treatment (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, antivascular endothelial growth factor or anti-epidermal growth factor receptor treatments). Drug with bevacizumab is only recommended if the company provides trifluridine–tipiracil according to the commercial arrangement | Lonsurf | Solid dose packaging |
| PCI Pharma Services | Janssen-Cilag International NV | EMA approval of the drug as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of drug given concurrently as separate tablets | Yuvanci | Solid dose manufacture |
| PCI Pharma Services | IntraBio Ltd | FDA approval of the drug for the treatment of neurological manifestations of niemann-pick disease type c (NPC) in adults and pediatric patients weighing ≥15 kg | Aqneursa | Non-sterile liquid packaging |
| Pharmathen Global BV | InvaGen Pharmaceuticals Inc | FDA expanded indication of the drug for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy | Lanreotide | Parenteral manufacture & packaging |
| Piramal Pharma Solutions Inc | Takeda UK Ltd | UK MHRA expanded indication of the drug for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine | Adcetris | Biologic API |
| Polpharma Biologics SA | Midas Pharma GmbH | EMA approval of the drug for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion and choroidal neovascularization in adults | Ranibizumab | Biologic API |
| Rentschler Biopharma SE | Formycon AG | EMA approval of the drug for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tnfα antagonist or have medical contraindications to such therapies; in combination with mtx, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (dmard) therapy has been inadequate; moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (mtx) or puva (psoralen and ultraviolet a); moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies; moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies; in combination with mtx, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (dmard) therapy has been inadequate; moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA; moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies | Fymskina | Biologic API |
| Rentschler Biopharma SE | UCB Inc | FDA expanded indication of the drug for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation; adult patients with active psoriatic arthritis; adult patients with active ankylosing spondylitis | Bimzelx | Biologic API |
| Samsung Biologics Co Ltd | UCB Inc | FDA expanded indication of the drug for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation; adult patients with active psoriatic arthritis; adult patients with active ankylosing spondylitis | Bimzelx | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Co | FDA expanded indication of the drug in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma; adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy and have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent Opdivo as adjuvant treatment after surgery | Opdivo | Biologic API |
| ScinoPharm Taiwan Ltd | Windtree Therapeutics Inc | Positive Phase II top-line results of the drug in early cardiogenic shock and Acute Heart Failure | istaroxime | Small mol API |
| SEQENS | Ipsen SA | EMA approval of the drug indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA | Iqirvo | Small mol API |
| Serum Institute of India Pvt Ltd | Novavax Inc | EMA approval of the drug for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older | Nuvaxovid JN.1 | Biologic API |
| Siegfried Holding AG | Novaliq GmbH | EMA approval of the drug for the treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes | Vevizye | Sterile liquid manufacture |
| Simtra BioPharma Solutions | Astellas Pharma Ltd | UK MHRA expanded indication of the drug in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy | Padcev | Parenteral manufacture & packaging |
| Skyepharma Production SAS | Pharming Group NV | UK MHRA approval of the drug for the treatment of activated phosphoinositide 3-kinase delta (P13Kδ) syndrome (APDS) in adult and paediatric patients 12 years of age and older | Joenja | Solid dose manufacture & packaging |
| SMS Pharmaceuticals Ltd | Janssen-Cilag International NV | EMA approval of the drug as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of drug given concurrently as separate tablets | Yuvanci | Small mol API |
| Vetter Pharma-Fertigung GmbH & Co KG | Bristol-Myers Squibb Co | FDA expanded indication of the drug in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma; adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy and have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent Opdivo as adjuvant treatment after surgery | Opdivo | Parenteral manufacture & packaging |
| Yuki Gosei Kogyo Co Ltd | Servier Laboratories Ltd | NICE recommended the drug with bevacizumab, within its marketing authorisation, for treating metastatic colorectal cancer in adults who have had 2 lines of treatment (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, antivascular endothelial growth factor or anti-epidermal growth factor receptor treatments). Drug with bevacizumab is only recommended if the company provides trifluridine–tipiracil according to the commercial arrangement | Lonsurf | Small mol API |
| Zhejiang Raybow Pharmaceutical Co Ltd | Novartis Pharmaceuticals Corp | FDA expanded indication of the drug for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence | Kisqali Femara | Small mol API |
| Zhejiang Raybow Pharmaceutical Co Ltd | Novartis Pharmaceuticals Corp | FDA expanded indication of the drug for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy | Kisqali | 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
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