July 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 |
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| AGC Biologics Inc | Sandoz Inc | FDA approval of the drug for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis; for the treatment of adult patients with moderately to severely active Crohn's disease; for the treatment of adult patients with moderately to severely active ulcerative colitis | Pyzchiva | Biologic API |
| AqVida GmbH | Shorla Oncology | FDA approval of the drug for treatment of adenocarcinoma of the breast and the ovary | Tepylute | Parenteral manufacture & packaging |
| AstraZeneca Plc | Merck Sharp & Dohme Corp | FDA expanded indication of the drug in combination with carboplatin and paclitaxel, followed by drug as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma | Keytruda | Biologic API |
| Biogen Inc | Swedish Orphan Biovitrum AB | EMA approval of the drug for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) | Altuvoct | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Amgen Inc | FDA expanded indication of the drug for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older | Blincyto | Parenteral manufacture |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme Corp | FDA expanded indication of the drug in combination with carboplatin and paclitaxel, followed by drug as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AbbVie Inc | FDA expanded indication of the drug for the treatment of moderately to severely active ulcerative colitis in adults | Skyrizi | Biologic API, Parenteral manufacture |
| Bristol-Myers Squibb Co | AstraZeneca Plc | FDA expanded indication of the drug for the treatment as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus | Xigduo XR | Solid dose manufacture |
| Bristol-Myers Squibb Co | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug for the treatment as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus | Farxiga | Solid dose manufacture |
| Carbogen Amcis AG | Janssen-Cilag International NV | EMA expanded indication of the drug for use as part of an appropriate combination regimen in adult and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) with pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid | Sirturo | Small mol API |
| Catalent Anagni Srl | AstraZeneca Plc | FDA expanded indication of the drug for the treatment as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus | Xigduo XR | Solid dose packaging |
| Catalent Germany Schorndorf GmbH | Vifor Pharma Management Ltd | FDA expanded indication of the drug for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis in pediatric patients 9 years of age and older | Velphoro | Solid dose manufacture & packaging |
| Catalent Inc | Pfizer Inc | NICE recommended the drug within its marketing authorization, as an option for treating wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR‑CM) in adults. The drug is only recommended if the company provides it according to the commercial arrangement | Vyndaqel | Solid dose manufacture |
| Catalent Inc | Taysha Gene Therapies Inc | Positive Phase I/II Interim results of the drug for the treatment of Rett syndrome | TSHA-102 | Biologic API |
| Catalent Inc | Sarepta Therapeutics Inc | FDA expanded indication of the drug for the treatment to individuals at least 4 years of age for the treatment of Duchenne muscular dystrophy (DMD) in patients who are ambulatory and have a confirmed mutation in the DMD gene | Elevidys | Biologic API, Parenteral manufacture |
| Catalent Indiana LLC | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug in combination with carboplatin and paclitaxel is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR); for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) | Imfinzi | Parenteral manufacture & packaging |
| Catalent Indiana LLC | Sanofi Winthrop Industrie SA | EMA 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 |
| Corden Pharma International GmbH | Vifor Pharma Management Ltd | FDA expanded indication of the drug for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis in pediatric patients 9 years of age and older | Velphoro | Solid dose manufacture & packaging |
| Dottikon Exclusive Synthesis AG | AstraZeneca Plc | EMA expanded indication of the drug in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations | Tagrisso | Small mol API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Outlook Therapeutics Inc | UK MHRA approval of the drug for treatment of neovascular (wet) age-related macular degeneration (nAMD) | Lytenava | Biologic API |
| Hovione FarmaCiencia SA | Verona Pharma Inc | FDA approval of the drug for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients | Ohtuvayre | Small mol API |
| Janssen-Cilag SpA | Idorsia Pharmaceuticals Deutschland GmbH | EMA approval of the drug for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products | Jeraygo | Solid dose manufacture & packaging |
| KBI Biopharma Inc | Shattuck Labs Inc | Positive Phase I Interim results of the drug in combination with Azacitidine (AZA)for the treatment of subjects with frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) patients | SL-172154 | Biologic API |
| Kemwell Biopharma Pvt Ltd | Janssen-Cilag International NV | EMA expanded indication of the drug for use as part of an appropriate combination regimen in adult and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) with pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid | Sirturo | Small mol API, Solid dose manufacture & packaging |
| Leukocare AG | Formycon AG | FDA approval of the drug for the treatment of Diabetic Macular Edema,Diabetic Retinopathy,Macular Edema,Wet (Neovascular / Exudative) Macular Degeneration | Ahzantive | Parenteral manufacture |
| Lonza Biologics Plc | Argenx SE | FDA expanded indication of the drug for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) | Vyvgart Hytrulo | Biologic API |
| Lonza Biologics Plc | Amgen Inc | FDA expanded indication of the drug for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older | Blincyto | Biologic API |
| Lonza Group Ltd | Bluejay Therapeutics Inc | Trial planned - Phase I to evaluate the safety and tolerability, PK/PD, and antiviral activity/efficacy of drug and drug-containing combinations in Chronic Hepatitis B infected subjects who are on nucleos(t)ide therapy | BJT-778 | Biologic API, Parenteral manufacture |
| Lonza Group Ltd | Argenx SE | FDA expanded indication of the drug for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) | Vyvgart Hytrulo | Biologic API |
| Lonza Group Ltd | AstraZeneca Plc | EMA expanded indication of the drug in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations | Tagrisso | Small mol API |
| Merck KGaA | AstraZeneca Plc | FDA expanded indication of the drug for the treatment as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus | Xigduo XR | Small mol API |
| Noramco Inc | Mirum Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of progressive familial intrahepatic cholestasis in patients with 3 months of age and older | Livmarli | Non-sterile liquid manufacture & packaging |
| Organon & Co | Merck Sharp & Dohme Corp | FDA expanded indication of the drug in combination with carboplatin and paclitaxel, followed by drug as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma | Keytruda | Parenteral packaging |
| Patheon NV | Pierre Fabre Medicament SA | EMA expanded indications of the drug in symptomatic treatment of adult patients with overactive bladder (OAB) syndrome | Obgemsa | Solid dose manufacture & packaging |
| PCI Pharma Services | Pfizer Inc | NICE recommended the drug within its marketing authorization, as an option for treating wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR‑CM) in adults. The drug is only recommended if the company provides it according to the commercial arrangement | Vyndaqel | Solid dose packaging |
| PCI Pharma Services | Pfizer Inc | NICE recommended the drug as an option for treating haemolytic anaemia caused by sickle cell disease in people 12 years and over. It is recommended only if people are ineligible for, or intolerant of hydroxycarbamide, or hydroxycarbamide alone is insufficiently effective. The drug is only recommended if the company provides it according to the commercial arrangement | Oxbryta | Solid dose packaging |
| PCI Pharma Services | Takeda Pharmaceutical Co Ltd | EMA approval of the drug for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib | Fruzaqla | Solid dose packaging |
| PCI Pharma Services | Mirum Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of progressive familial intrahepatic cholestasis in patients with 3 months of age and older | Livmarli | Non-sterile liquid packaging |
| Rentschler Biopharma SE | Genmab US Inc | FDA expanded indication of the drug for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy | Epkinly | Biologic API |
| Rentschler Biopharma SE | UCB Pharma Ltd | UK MHRA expanded indication of the drug for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy | Bimzelx | Biologic API |
| Samsung Biologics Co Ltd | F. Hoffmann-La Roche Ltd | NICE recommended the drug as an option for treating moderate to severe atopic dermatitis that is suitable for systemic treatment in people 12 years and over with a body weight of 40 kg or more, only if the atopic dermatitis has not responded to at least 1 systemic immunosuppressant or these treatments are not suitable, and dupilumab or tralokinumab would otherwise be offered, and the company provides it according to the commercial arrangement | Ebglyss | Biologic API |
| Samsung Biologics Co Ltd | UCB Pharma Ltd | UK MHRA expanded indication of the drug for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy | Bimzelx | Biologic API |
| Sharp Packaging Services | Bristol-Myers Squibb Co | FDA expanded indication of the drug in combination with cetuximab is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test , who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy | Krazati | Solid dose packaging |
| Sharp Packaging Services | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug in combination with carboplatin and paclitaxel is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR); for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) | Imfinzi | Parenteral packaging |
| Shilpa Medicare Ltd | Unicycive Therapeutics Inc | Positive Phase II Top-line results of the drug in patients with hyperphosphatemia who have chronic kidney disease on dialysis | oxylanthanum carbonate | Solid dose manufacture |
| SK Biotek Co Ltd | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug for the treatment as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus | Farxiga | Small mol API |
| The Ritedose Corp | Verona Pharma Inc | FDA approval of the drug for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients | Ohtuvayre | Inhalational manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug in combination with carboplatin and paclitaxel is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR); for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) | Imfinzi | Parenteral manufacture & packaging |
| Viralgen Vector Core SL | Elpida Therapeutics | Trial planned - Phase III clinical study of drug for patients with spastic paraplegia (SPG50) | Melpida | Biologic API |
| WuXi AppTec Co Ltd | Cabaletta Bio Inc | Positive Phase I/II Interim results of the drug for the treatment of Active Idiopathic Inflammatory Myopathy | CABA-201 | Biologic API |
POTENTIALLY NEGATIVE |
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| AstraZeneca Plc | Merck & Co Inc | NICE rejection for the drug with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, within its marketing authorisation, for untreated locally advanced unresectable or metastatic HER2‑positive gastric or gastro-oesophageal junction (GOJ) adenocarcinoma in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 1 or more | Keytruda | Biologic API |
| Organon & Co | Merck & Co Inc | NICE rejection for the drug with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, within its marketing authorisation, for untreated locally advanced unresectable or metastatic HER2‑positive gastric or gastro-oesophageal junction (GOJ) adenocarcinoma in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 1 or more | Keytruda | Biologic API |
| Organon & Co | Merck & Co Inc | NICE rejection for the drug with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, within its marketing authorisation, for untreated locally advanced unresectable or metastatic HER2‑positive gastric or gastro-oesophageal junction (GOJ) adenocarcinoma in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 1 or more | Keytruda | Parenteral packaging |
| Sharp Packaging Services | BeiGene Ltd | EMA withdrawal/discontinuation at the MAH's request | Tizveni | Parenteral packaging |
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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