March 2023 – 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 Product Relationship

POTENTIALLY POSITIVE
Aenova Holding GmbH Millennium Pharmaceuticals Inc NICE approval for the drug with lenalidomide and dexamethasone, is recommended as an option for treating multiple myeloma in adults, only if they have had 2 or 3 lines of therapy and if the company provides ixazomib according to the commercial arrangement Ninlaro Solid dose
Ajinomoto Bio-Pharma Services H. Lundbeck AS NICE approval as an option for preventing migraine in adults, only if they have 4 or more migraine days a month, or at least 3 preventive drug treatments have failed and the company provides it according to the commercial arrangement Vyepti Biologic API & parenteral manufacture
Allpack Group AG Jazz Pharmaceuticals Plc NICE approval as an add-on treatment option for seizures caused by tuberous sclerosis complex in people aged 2 years and over, only if their seizures are not controlled well enough by 2 or more antiseizure medications (either used alone or in combination) or these treatments were not tolerated, if the seizure frequency is checked every 6 months, and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment, or if the company provides cannabidiol according to the commercial arrangement Epidyolex Non-sterile liquid packaging
AmbioPharm Inc Ariceum Therapeutics GmbH Trial planned - Phase I to assess the safety and tolerability of two new drugs in subjects with extensive stage small cell lung cancer (ES SCLC) SOMther Small mol API
Asymchem Inc BeyondSpring Inc Trial planned - Phase II to investigate that the efficacy and safety of the drug in combination with pembrolizumab, plus etoposide and platinum as first-line therapy for small cell lung cancer extensive stage (ES-SCLC) Plinabulin Small mol API
Baxter Biopharma Solutions Bristol-Myers Squibb Co FDA expanded indication of the drug as a single agent or in combination with nivolumab, for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older Yervoy Parenteral manufacture
BSP Pharmaceuticals SpA Genentech USA Inc NICE approval for the drug with rituximab, cyclophosphamide, doxorubicin and prednisolone (R‑CHP) is recommended for untreated diffuse large B-cell lymphoma (DLBCL) in adults, only if they have an International Prognostic Index (IPI) score of 2 to 5 or if the company provides it according to the commercial arrangement Polivy Parenteral manufacture & packaging
Catalent Inc Pfizer Inc UK MHRA expanded indication for symptomatic venous thromboembolism (VTE) in paediatric patients 1 month of age and older Fragmin Parenteral manufacture & packaging
Catalent Inc Moderna Inc UK MHRA approval as a booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 Spikevax bivalent Original/Omicron BA.4-5** Parenteral manufacture & packaging
Catalent Inc Karyopharm Therapeutics Inc UK MHRA expanded indication for Multiple Myeloma (Kahler Disease) Nexpovio Solid dose
Catalent Inc Stada Arzneimittel AG FDA approval in adults for the short-term management of mild to moderate acute pain Combogesic Solid dose
Catalent Inc Bristol-Myers Squibb Co FDA expanded indication of the drug as a single agent or in combination with nivolumab, for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older Yervoy Parenteral manufacture & packaging
Catalent Inc Ono Pharmaceutical Co Ltd FDA expanded indication for Metastatic Melanoma, Non-Small Cell Lung Cancer for 12 years and over Opdivo Parenteral manufacture & packaging
Catalent Inc Cybin Inc Positive Phase I/IIa final results for the study with the drug at 1 mg, 3mg, 8mg, and 10mg, respectively and all doses were well-tolerated with no serious adverse events reported and maintained a safe and well-tolerated therapeutic profile for major depressive disorder CYB-003 Solid dose
Catalent Inc Novo Nordisk AS NICE approval as an option for weight management, including weight loss and weight maintenance, alongside a reduced-calorie diet and increased physical activity in adults, only if it is used for a maximum of 2 years, and within a specialist weight management service providing multidisciplinary management of overweight or obesity (including but not limited to tiers 3 and 4), and they have at least 1 weight-related comorbidity and a body mass index (BMI) of at least 35.0 kg/m2, or a BMI of 30.0 kg/m2 to 34.9 kg/m2 and meet the criteria for referral to specialist weight management services in NICE's guideline on obesity: identification, assessment and management Wegovy Parenteral manufacture
Dottikon Exclusive Synthesis AG AstraZeneca Plc EMA expanded indication for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) Calquence Small mol API
Evonik Industries AG Eli Lilly and Co EMA expanded indication for the treatment of pediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III Adcirca Small mol API
Johnson Matthey Plc BeyondSpring Inc Trial planned - Phase II to investigate that the efficacy and safety of the drug in combination with pembrolizumab, plus etoposide and platinum as first-line therapy for small cell lung cancer extensive stage (ES-SCLC) Plinabulin Small mol API
Laboratorios Farmaceuticos Rovi SA Moderna Inc UK MHRA approval as a booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 Spikevax bivalent Original/Omicron BA.4-5** Parenteral manufacture
Lonza Group Ltd Shanghai Junshi Bioscience Co Ltd Trial planned - Phase I/II to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of the drug as monotherapy and in combination with toripalimab in subjects with advanced solid tumors JS-006 Biologic API
Lonza Group Ltd Gilead Sciences Inc Trial planned - Phase I to evaluate the safety and efficacy of combining the drug with standard first line platinum-based chemotherapy (with cisplatin / gemcitabine) in advanced urothelial carcinoma Magrolimab Biologic API
Lonza Group Ltd Moderna Inc UK MHRA approval as a booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 Spikevax bivalent Original/Omicron BA.4-5** Biologic API
Lonza Group Ltd Bristol-Myers Squibb Co FDA expanded indication of the drug as a single agent or in combination with nivolumab, for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older Yervoy Biologic API
Lonza Group Ltd Ono Pharmaceutical Co Ltd FDA expanded indication for Metastatic Melanoma, Non-Small Cell Lung Cancer for 12 years and over Opdivo Biologic API
Lonza Group Ltd Genentech USA Inc NICE approval for the drug with rituximab, cyclophosphamide, doxorubicin and prednisolone (R‑CHP) is recommended for untreated diffuse large B-cell lymphoma (DLBCL) in adults, only if they have an International Prognostic Index (IPI) score of 2 to 5 or if the company provides it according to the commercial arrangement Polivy Biologic API
Lonza Group Ltd Gilead Sciences Inc NICE approval for the drug within its marketing authorisation, as an option for treating relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma in adults after 2 or more systemic therapies. It is recommended only if the company provides axicabtagene ciloleucel according to the commercial arrangement Yescarta Parenteral manufacture
MIAS Pharma Ltd Karyopharm Therapeutics Inc UK MHRA expanded indication for Multiple Myeloma (Kahler Disease) Nexpovio Solid dose
Patheon NV Moderna Inc UK MHRA approval as a booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 Spikevax bivalent Original/Omicron BA.4-5** Parenteral manufacture & packaging
Patheon NV Chiesi Farmaceutici SpA FDA approval for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients Lamzede Parenteral manufacture & packaging
PCI Pharma Services Millennium Pharmaceuticals Inc NICE approval for the drug with lenalidomide and dexamethasone, is recommended as an option for treating multiple myeloma in adults, only if they have had 2 or 3 lines of therapy and if the company provides ixazomib according to the commercial arrangement Ninlaro Solid dose packaging
Pharma Packaging Solutions Karyopharm Therapeutics Inc UK MHRA expanded indication for Multiple Myeloma (Kahler Disease) Nexpovio Solid dose packaging
Pharmaceutical Manufacturing Research Services Inc Cingulate Inc Positive Phase I top-line results for the study assessing the effect of food on absorption and the trial demonstrated that CTx-1301 can be taken with or without food for attention deficit/hyperactivity disorder (ADHD) Dexmethylphenidate hydrochloride Solid dose
Pharmaceutics International Inc BeyondSpring Inc Trial planned - Phase II to investigate that the efficacy and safety of the drug in combination with pembrolizumab, plus etoposide and platinum as first-line therapy for small cell lung cancer extensive stage (ES-SCLC) Plinabulin Parenteral manufacture
Piramal Pharma Solutions Inc Millennium Pharmaceuticals Inc NICE approval for the drug with lenalidomide and dexamethasone, is recommended as an option for treating multiple myeloma in adults, only if they have had 2 or 3 lines of therapy and if the company provides ixazomib according to the commercial arrangement Ninlaro Small mol API
Recipharm AB Moderna Inc UK MHRA approval as a booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 Spikevax bivalent Original/Omicron BA.4-5** Parenteral manufacture
Rentschler Biopharma SE Chiesi Farmaceutici SpA FDA approval for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients Lamzede Biologic API
Samsung Biologics Co Ltd Bristol-Myers Squibb Co FDA expanded indication of the drug as a single agent or in combination with nivolumab, for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older Yervoy Biologic API
Samsung Biologics Co Ltd Ono Pharmaceutical Co Ltd FDA expanded indication for Metastatic Melanoma, Non-Small Cell Lung Cancer for 12 years and over Opdivo Biologic API
Sandoz International GmbH H. Lundbeck AS NICE approval as an option for preventing migraine in adults, only if they have 4 or more migraine days a month, or at least 3 preventive drug treatments have failed and the company provides it according to the commercial arrangement Vyepti Biologic API
Sharp Packaging Services Orion Corp EMA expanded indication in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) Nubeqa Solid dose packaging
Societal CDMO Inc Cingulate Inc Positive Phase I top-line results for the study assessing the effect of food on absorption and the trial demonstrated that CTx-1301 can be taken with or without food for attention deficit/hyperactivity disorder (ADHD) Dexmethylphenidate hydrochloride Solid dose
Vetter Pharma-Fertigung GmbH & Co KG Eli Lilly and Co EMA expanded indication for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
as monotherapy when metformin is considered inappropriate due to intolerance or contraindications or in addition to other medicinal products for the treatment of diabetes		 Trulicity Parenteral manufacture & packaging
Vetter Pharma-Fertigung GmbH & Co KG Regeneron Pharmaceuticals Inc UK MHRA expanded indication in preterm infants for the treatment of  retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease Eylea Parenteral manufacture & packaging
Vetter Pharma-Fertigung GmbH & Co KG Pfizer Inc UK MHRA expanded indication for symptomatic venous thromboembolism (VTE) in paediatric patients 1 month of age and older Fragmin Parenteral manufacture & packaging
Vetter Pharma-Fertigung GmbH & Co KG Ono Pharmaceutical Co Ltd FDA expanded indication for Metastatic Melanoma, Non-Small Cell Lung Cancer for 12 years and over Opdivo Parenteral manufacture

POTENTIALLY NEGATIVE
Almac Group Ltd Agios Pharmaceuticals Inc NICE rejection for treating pyruvate kinase deficiency in adults because Agios did not provide an evidence submission. We will review this decision if the company decides to make a submission Pyrukynd Solid dose & packaging
Biogen Inc Johnson & Johnson NICE rejection Tecvayli Biologic API
Patheon NV Johnson & Johnson NICE rejection Tecvayli Parenteral manufacture & packaging
PCI Pharma Services Johnson & Johnson NICE rejection Tecvayli 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