June 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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| Boehringer Ingelheim Pharma GmbH & Co KG | Sanofi | NICE recommended the drug within its marketing authorization, for treating highly active relapsing–remitting multiple sclerosis in adults with highly active disease despite a full and adequate course of treatment with at least 1 disease-modifying therapy, or rapidly evolving severe relapsing–remitting multiple sclerosis defined by 2 or more relapses in the previous year, and baseline MRI evidence of disease activity | Lemtrada | Biologic API, Parenteral manufacture |
| Catalent CTS LLC | Karyopharm Therapeutics Inc | NICE recommended the drug as an option for treating multiple myeloma in adults, only if they have only had 1 previous line of treatment, and their condition is refractory to both daratumumab and lenalidomide, or they have only had 2 previous lines of treatment and their condition is refractory to lenalidomide. The drug is only recommended if the company provides it according to the commercial arrangement | Nexpovio | Solid dose manufacture |
| Cell Therapies Pty Ltd | Novartis AG | NICE recommended the drug within its marketing authorization, as an option for people 25 years and under for treating B‑cell acute lymphoblastic leukemia that is relapsed after a transplant, or relapsed for a second or later time, or refractory. It is only recommended if the company provides it according to the commercial arrangement | Kymriah | Biologic API |
| Dottikon Exclusive Synthesis AG | Les Laboratoires Servier SAS | NICE recommended the drug plus azacitidine within its marketing authorisation, as an option for untreated acute myeloid leukaemia (AML) with an IDH1 R132 mutation in adults who cannot have standard intensive induction chemotherapy. It is only recommended if the company provides it according to the commercial arrangement | Tibsovo | Small mol API |
| Fraunhofer-Gesellschaft zur Forderung der Angewandten Forschung eV | Novartis AG | NICE recommended the drug within its marketing authorization, as an option for people 25 years and under for treating B‑cell acute lymphoblastic leukemia that is relapsed after a transplant, or relapsed for a second or later time, or refractory. It is only recommended if the company provides it according to the commercial arrangement | Kymriah | Biologic API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Outlook Therapeutics Inc | EMA approval of the drug for treatment of neovascular (wet) age-related macular degeneration (nAMD) | Lytenava | Biologic API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Biogen Inc | NICE recommended the drug as an option for the treatment of rapidly evolving severe relapsing–remitting multiple sclerosis (RES‑RRMS) in adults. RES‑RRMS is defined by 2 or more relapses in the previous year and baseline MRI evidence of disease activity. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS healthcare professional consider it appropriate to stop | Tysabri | Biologic API, Parenteral manufacture & packaging |
| Janssen-Cilag SpA | Merck KGaA | NICE recommended the drug as an option for treating highly active multiple sclerosis in adults, only if the person has rapidly evolving severe relapsing–remitting multiple sclerosis, defined by 2 or more relapses in the previous year, and baseline MRI evidence of disease activity, or relapsing–remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as 1 relapse in the previous year and MRI evidence of disease activity. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS healthcare professional consider it appropriate to stop | Mavenclad | Small mol API |
| Just Evotec Biologics Inc | Sandoz International GmbH | EMA approval of the drug for treatment of osteoporosis in postmenopausal women and in men, bone loss associated with hormone ablation in men with prostate cancer and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fractures, in postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures; for the prevention of skeletal related events (SRES) like pathological fracture, radiation to bone, spinal cord compression or surgery to bone in adults with advanced malignancies involving bone and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity | Jubbonti | Biologic API |
| Lek Pharmaceuticals dd | Novartis AG | NICE recommended the drug with trametinib within its marketing authorization, as an option for treating low-grade glioma (LGG) with a BRAF V600E mutation in children and young people aged 1 year and over who need systemic treatment high-grade glioma (HGG) with a BRAF V600E mutation in children and young people aged 1 year and over after at least 1 radiation or chemotherapy treatment. The drug with trametinib is only recommended if the company provides it according to the commercial arrangements | Finlee | Solid dose manufacture & packaging |
| Lonza Group Ltd | Capricor Therapeutics Inc | Positive Phase II Top-line results of the drug for the treatment of Duchenne muscular dystrophy (DMD) | CAP-1002 | Biologic API |
| Lonza Group Ltd | Ono Pharmaceutical Co Ltd | EMA expanded indication of the drug in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma | Opdivo | Biologic API |
| Lyne Laboratories Inc | AstraZeneca Plc | EMA expanded indication of the drug for the treatment in the prophylaxis of influenza in individuals 24 months to less than 18 years of age | Fluenz | Inhalational packaging |
| MIAS Pharma Ltd | Karyopharm Therapeutics Inc | NICE recommended the drug as an option for treating multiple myeloma in adults, only if they have only had 1 previous line of treatment, and their condition is refractory to both daratumumab and lenalidomide, or they have only had 2 previous lines of treatment and their condition is refractory to lenalidomide. The drug is only recommended if the company provides it according to the commercial arrangement | Nexpovio | Solid dose manufacture |
| NerPharMa Srl | Merck KGaA | NICE recommended the drug as an option for treating highly active multiple sclerosis in adults, only if the person has rapidly evolving severe relapsing–remitting multiple sclerosis, defined by 2 or more relapses in the previous year, and baseline MRI evidence of disease activity, or relapsing–remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as 1 relapse in the previous year and MRI evidence of disease activity. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS healthcare professional consider it appropriate to stop | Mavenclad | Small mol API, Solid dose manufacture & packaging |
| Novo Nordisk AS | Biogen Inc | NICE recommended the drug as an option for the treatment of rapidly evolving severe relapsing–remitting multiple sclerosis (RES‑RRMS) in adults. RES‑RRMS is defined by 2 or more relapses in the previous year and baseline MRI evidence of disease activity. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS healthcare professional consider it appropriate to stop | Tysabri | Parenteral packaging |
| NUVISAN Pharma Holding GmbH | Celltrion Inc | EMA approval of the drug for the treatment of allergic asthma in adults and adolescents (12 years and older) with convincing IgE (immunoglobulin E) mediated asthma; as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control; as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment; allergic asthma in children (6 to <12 years of age) with convincing IgE (immunoglobulin E) mediated asthma | Omlyclo | Parenteral manufacture |
| Oxford BioMedica Plc | Novartis AG | NICE recommended the drug within its marketing authorization, as an option for people 25 years and under for treating B‑cell acute lymphoblastic leukemia that is relapsed after a transplant, or relapsed for a second or later time, or refractory. It is only recommended if the company provides it according to the commercial arrangement | Kymriah | Biologic API |
| Patheon NV | MorphoSys AG | Positive Phase II Interim results of the drug for the treatment of IgA nephropathy (IgAN) | felzartamab | Biologic API |
| PCI Pharma Services | Biogen Inc | NICE recommended the drug as an option for the treatment of rapidly evolving severe relapsing–remitting multiple sclerosis (RES‑RRMS) in adults. RES‑RRMS is defined by 2 or more relapses in the previous year and baseline MRI evidence of disease activity. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS healthcare professional consider it appropriate to stop | Tysabri | Parenteral packaging |
| Pfizer Inc | Biogen Inc | NICE recommended the drug as an option for the treatment of rapidly evolving severe relapsing–remitting multiple sclerosis (RES‑RRMS) in adults. RES‑RRMS is defined by 2 or more relapses in the previous year and baseline MRI evidence of disease activity. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS healthcare professional consider it appropriate to stop | Tysabri | Parenteral manufacture & packaging |
| Pharma Packaging Solutions | Karyopharm Therapeutics Inc | NICE recommended the drug as an option for treating multiple myeloma in adults, only if they have only had 1 previous line of treatment, and their condition is refractory to both daratumumab and lenalidomide, or they have only had 2 previous lines of treatment and their condition is refractory to lenalidomide. The drug is only recommended if the company provides it according to the commercial arrangement | Nexpovio | Solid dose packaging |
| Piramal Pharma Solutions Inc | Esperion Therapeutics Inc | EMA expanded indication of the drug for the treatment to reduce the risk of adverse cardiovascular events; hypercholesterolaemia (high levels of cholesterol) | Nustendi | Solid dose manufacture & packaging |
| Piramal Pharma Solutions Inc | Esperion Therapeutics Inc | EMA expanded indication of the drug in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors in patients on a maximum tolerated dose of a statin with or without ezetimibe or alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated; hypercholesterolaemia (high levels of cholesterol) | Nilemdo | Solid dose manufacture & packaging |
| Quotient Sciences Ltd | Crinetics Pharmaceuticals Inc | Positive Phase I/II Interim results of the drug for the treatment of ACTH-Dependent Cushing’s Syndrome (ADCS) | CRN-04894 | Solid dose manufacture |
| Quotient Sciences Ltd | Crinetics Pharmaceuticals Inc | Positive Phase II Interim results of the drug for the treatment of Congenital Adrenal Hyperplasia (CAH) | CRN-04894 | Solid dose manufacture |
| R-Pharm | Merck KGaA | NICE recommended the drug as an option for treating highly active multiple sclerosis in adults, only if the person has rapidly evolving severe relapsing–remitting multiple sclerosis, defined by 2 or more relapses in the previous year, and baseline MRI evidence of disease activity, or relapsing–remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as 1 relapse in the previous year and MRI evidence of disease activity. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS healthcare professional consider it appropriate to stop | Mavenclad | Solid dose manufacture & packaging |
| Samsung Biologics Co Ltd | Ono Pharmaceutical Co Ltd | EMA expanded indication of the drug in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma | Opdivo | Biologic API |
| Sharp Packaging Services | Biogen Inc | NICE recommended the drug as an option for the treatment of rapidly evolving severe relapsing–remitting multiple sclerosis (RES‑RRMS) in adults. RES‑RRMS is defined by 2 or more relapses in the previous year and baseline MRI evidence of disease activity. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS healthcare professional consider it appropriate to stop | Tysabri | Parenteral packaging |
| Siegfried Holding AG | Novartis AG | NICE recommended the drug with trametinib within its marketing authorization, as an option for treating low-grade glioma (LGG) with a BRAF V600E mutation in children and young people aged 1 year and over who need systemic treatment high-grade glioma (HGG) with a BRAF V600E mutation in children and young people aged 1 year and over after at least 1 radiation or chemotherapy treatment. The drug with trametinib is only recommended if the company provides it according to the commercial arrangements | Finlee | Solid dose manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Ono Pharmaceutical Co Ltd | EMA expanded indication of the drug in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma | Opdivo | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Biogen Inc | NICE recommended the drug as an option for the treatment of rapidly evolving severe relapsing–remitting multiple sclerosis (RES‑RRMS) in adults. RES‑RRMS is defined by 2 or more relapses in the previous year and baseline MRI evidence of disease activity. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS healthcare professional consider it appropriate to stop | Tysabri | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | F. Hoffmann-La Roche Ltd | NICE recommended the drug as an option for treating visual impairment caused by macular edema following central retinal vein occlusion or following branch retinal vein occlusion only if treatment with laser photocoagulation has not been beneficial, or when laser photocoagulation is not suitable because of the extent of macular hemorrhage and only if the manufacturers of the drug provide it at a discount level no lower than the discount agreed in the patient access scheme. People currently receiving the drug whose disease does not meet the criteria in 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop. The drug is recommended as an option for wet age-related macular degeneration if all of the following circumstances apply in the eye to be treated the best-corrected visual acuity is between 6/12 and 6/96 there is no permanent structural damage to the central fovea the lesion size is less than or equal to 12 disc areas in greatest linear dimension there is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, or recent visual acuity changes)and the manufacturers of the drug only provide it at a discount level no lower than the discount agreed in the patient access scheme. The treatment with the drug should be continued only in people who maintain adequate response to therapy. Criteria for discontinuation should include persistent deterioration in visual acuity and identification of anatomical changes in the retina that indicate inadequate response to therapy. It is recommended that a national protocol specifying criteria for discontinuation is developed. The drug is also recommended for treating visual impairment due to choroidal neovascularisation secondary to pathological myopia only if the manufacturers of the drug provide it at a discount level no lower than the discount agreed in the patient access scheme | Lucentis | Parenteral manufacture & packaging |
| WuXi AppTec Co Ltd | Capricor Therapeutics Inc | Positive Phase II Top-line results of the drug for the treatment of Duchenne muscular dystrophy (DMD) | CAP-1002 | Parenteral manufacture |
| WuXi Biologics Co Ltd | Viatris Inc | FDA approval of the drug for the treatment of Diabetic Macular Edema; Diabetic Retinopathy; Macular Edema; Wet (Neovascular / Exudative) Macular Degeneration | Yesafili | Biologic API |
| WuXi XDC Cayman Inc | AbbVie Inc | NICE recommended the drug as an option for preventing migraine in adults who have at least 4 migraine days per month, only if at least 3 preventive medicines have failed. Stop the drug after 12 weeks if the frequency of migraines does not reduce by at least 50% in episodic migraine (defined as fewer than 15 headache days per month) at least 30% in chronic migraine (defined as 15 or more headache days per month, with at least 8 of those having features of migraine). If people with the condition and their healthcare professionals consider the drug to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose, and commercial arrangements. This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS healthcare professional consider it appropriate to stop | Aquipta | Solid dose manufacture |
| Zhejiang Raybow Pharmaceutical Co Ltd | Novartis AG | NICE recommended the drug with trametinib within its marketing authorization, as an option for treating low-grade glioma (LGG) with a BRAF V600E mutation in children and young people aged 1 year and over who need systemic treatment high-grade glioma (HGG) with a BRAF V600E mutation in children and young people aged 1 year and over after at least 1 radiation or chemotherapy treatment. The drug with trametinib is only recommended if the company provides it according to the commercial arrangements | Finlee | Small mol API |
POTENTIALLY NEGATIVE |
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| Catalent CTS LLC | BeiGene Ltd | NICE is unable to make a recommendation for the drug with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma in adults after 2 or more treatments. This is because BeiGene has requested a delay in the evidence submission. We will review this decision if the company decides to make a submission | Brukinsa | Solid dose manufacture |
| Gilead Sciences Inc | Bausch Health Companies Inc | NICE rejection of the drug for the treatment of wet age-related macular degeneration. People who are currently receiving the drug for any lesion type should have the option to continue therapy until they and their clinicians consider it appropriate to stop | Macugen | Parenteral manufacture |
| Lonza Group Ltd | Ono Pharmaceutical Co Ltd | NICE is unable to make a recommendation for the drug for treating completely resected melanoma at high risk of recurrence in people 12 years and over. This is because Bristol-Myers Squibb did not provide an evidence submission. We will review this decision if the company decides to make a submission | Opdivo | Biologic API |
| PCI Pharma Services | BeiGene Ltd | NICE is unable to make a recommendation for the drug with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma in adults after 2 or more treatments. This is because BeiGene has requested a delay in the evidence submission. We will review this decision if the company decides to make a submission | Brukinsa | Solid dose packaging |
| PCI Pharma Services | Bausch Health Companies Inc | NICE rejection of the drug for the treatment of wet age-related macular degeneration. People who are currently receiving the drug for any lesion type should have the option to continue therapy until they and their clinicians consider it appropriate to stop | Macugen | Parenteral packaging |
| Samsung Biologics Co Ltd | Ono Pharmaceutical Co Ltd | NICE is unable to make a recommendation for the drug for treating completely resected melanoma at high risk of recurrence in people 12 years and over. This is because Bristol-Myers Squibb did not provide an evidence submission. We will review this decision if the company decides to make a submission | Opdivo | Biologic API |
| Sharp Packaging Services | Nobelpharma Co Ltd | NICE is unable to make a recommendation for the drug for treating facial angiofibroma caused by tuberous sclerosis complex in people 6 years and over. This is because Plusultra pharma did not provide an evidence submission. We will review this decision if the company decides to make a submission | Hyftor | Semi-solid dose packaging |
| Simtra BioPharma Solutions | Daiichi Sankyo Co Ltd | NICE is unable to make a recommendation for the drug for treating HER2-mutated advanced non-small-cell lung cancer in adults after platinum-based chemotherapy. This is because Daiichi Sankyo did not provide an evidence submission. We will review this decision if the company decides to make a submission | Enhertu | Parenteral manufacture & packaging |
| TOYO Pharmaceutical Co Ltd | Nobelpharma Co Ltd | NICE is unable to make a recommendation for the drug for treating facial angiofibroma caused by tuberous sclerosis complex in people 6 years and over. This is because Plusultra pharma did not provide an evidence submission. We will review this decision if the company decides to make a submission | Hyftor | Semi-solid dose manuufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Ono Pharmaceutical Co Ltd | NICE is unable to make a recommendation for the drug for treating completely resected melanoma at high risk of recurrence in people 12 years and over. This is because Bristol-Myers Squibb did not provide an evidence submission. We will review this decision if the company decides to make a submission | Opdivo | Parenteral manufacture |
| WuXi XDC Cayman Inc | BeiGene Ltd | NICE is unable to make a recommendation for the drug with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma in adults after 2 or more treatments. This is because BeiGene has requested a delay in the evidence submission. We will review this decision if the company decides to make a submission | Brukinsa | 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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