February 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
AstraZeneca Plc Merck & Co Inc FDA expanded indication as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC Keytruda Biologic API
Bachem Holding AG AC Immune SA Positive Phase I/II interim results for Alzheimer's Disease ACI-24 Parenteral manufacture
Baxter Biopharma Solutions Daiichi Sankyo Co Ltd NICE approval as an option for treating HER2-positive unresectable or metastatic breast cancer after 1 or more anti-HER2 treatments in adults Enhertu Parenteral manufacture & packaging
Baxter Biopharma Solutions Daiichi Sankyo Co Ltd EMA expanded indication as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy Enhertu Parenteral manufacture & packaging
BioCentriq Tevogen Bio Inc Positive Phase I results for Coronavirus Disease 2019 (COVID-19) TVGN-489** Biologic API
Biogen Inc Sanofi FDA expanded indication for the first and only treatment of hemolysis in adults with cold agglutinin disease (CAD), to include patients with or without a history of transfusions Enjaymo Biologic API
Boehringer Ingelheim Biopharmaceuticals GmbH Merck & Co Inc FDA expanded indication as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC Keytruda Biologic API
Bristol-Myers Squibb Co AstraZeneca Plc EMA expanded indication for the treatment of heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction Forxiga Solid dose
BSP Pharmaceuticals SpA Gilead Sciences Inc FDA expanded indication for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting Trodelvy Biologic API & parenteral manufacture
Cambrex Corp Pacira BioSciences Inc EMA expanded indication in adults and children aged ≥6 years as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds Exparel Small mol API
Carbogen Amcis AG GSK plc NICE approval as an option for treating refractory cytomegalovirus infection after transplant Livtencity* Small mol API
Catalent Inc Aridis Pharmaceuticals Inc Positive Phase III results for Ventilator Associated Pneumonia (VAP) AR 301 Parenteral manufacture
Catalent Inc Ono Pharmaceutical Co Ltd NICE approval for the drug plus fluoropyrimidine- and platinum-based chemotherapy for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma Opdivo Parenteral manufacture & packaging
Catalent Inc AstraZeneca Plc EMA expanded indication for the treatment of heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction Forxiga Solid dose & packaging
Catalent Inc Regeneron Pharmaceuticals Inc EMA expanded indication for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy Dupixent Parenteral manufacture & packaging
Catalent Inc AstraZeneca Plc EMA expanded indication in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer Imfinzi Parenteral manufacture & packaging
Catalent Inc AstraZeneca Plc UK MHRA expanded indication for Acid Indigestion (Heartburn/Pyrosis) Nexium Solid dose & packaging
Catalent Inc AbbVie Inc UK MHRA expanded indication as a single agent or in combination with venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia Imbruvica Small mol API & solid dose
Catalent Inc BeiGene Ltd UK MHRA expanded indication for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy Brukinsa Solid dose
Catalent Inc Takeda Pharmaceutical Co Ltd FDA expanded indication in pediatric patients 2 to < 12 years of age for prophylaxis to prevent attacks of hereditary angioedema (HAE) Takhzyro Parenteral manufacture & packaging
Catalent Inc ALK-Abello AS FDA expanded indication for the treatment of house dust mite (HDM)-induced allergic rhinitis in persons ages 12 through 17 Odactra Solid dose & packaging
Catalent Inc  Boehringer Ingelheim International GmbH NICE approval as an option for treating idiopathic pulmonary fibrosis in adults when forced vital capacity is above 80% predicted Ofev Solid dose
Catalent Inc  GSK plc NICE approval as an option for treating refractory cytomegalovirus infection after transplant Livtencity* Solid dose packaging
Corden Pharma International GmbH AstraZeneca Plc UK MHRA expanded indication for Acid Indigestion (Heartburn/Pyrosis) Nexium Solid dose packaging
Corden Pharma International GmbH Seagen Inc FDA expanded indication in combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy Tukysa Solid dose
Curia Global Inc Small Pharma Inc Positive Phase I/II results for Major Depressive Disorder SPL-026 Small mol API
Dalton Pharma Services VectivBio Holding AG Trial planned - Phase I to assess the effects, safety and tolerability of a single subcutaneous administration of apraglutide in healthy Japanese adult males and female compared with placebo Apraglutide Parenteral manufacture
Evotec SE Zogenix Inc EMA expanded indication for the treatment of seizures associated with Dravet syndrome and Lennox Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older Fintepla Small mol API
Excella GmbH & Co KG Pacira BioSciences Inc EMA expanded indication in adults and children aged ≥6 years as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds Exparel Small mol API
Fareva SA Viatris Inc FDA expanded indication for pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (who group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise Revatio Solid dose & packaging
Hikma Pharmaceuticals Plc Boehringer Ingelheim International GmbH FDA expanded indication reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure Synjardy Solid dose packaging
Hikma Pharmaceuticals Plc  Boehringer Ingelheim International GmbH NICE approval as an option for treating idiopathic pulmonary fibrosis in adults when forced vital capacity is above 80% predicted Ofev Solid dose packaging
KBI Biopharma Inc Sanofi FDA expanded indication for the first and only treatment of hemolysis in adults with cold agglutinin disease (CAD), to include patients with or without a history of transfusions Enjaymo Biologic API
Lonza Group Ltd Ono Pharmaceutical Co Ltd NICE approval for the drug plus fluoropyrimidine- and platinum-based chemotherapy for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma Opdivo Biologic API
Lonza Group Ltd AbbVie Inc UK MHRA expanded indication as a single agent or in combination with venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia Imbruvica Small mol API
Minakem SAS AstraZeneca Plc UK MHRA expanded indication for Acid Indigestion (Heartburn/Pyrosis) Nexium Small mol API
Onyx Scientific Ltd Small Pharma Inc Positive Phase I/II results for Major Depressive Disorder SPL-026 Small mol API
Organon & Co Merck & Co Inc FDA expanded indication as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC Keytruda Parenteral packaging
Patheon NV Biophytis SA Positive Phase II/III final results for Coronavirus Disease 2019 (COVID-19) related respiratory  failure BIO-101** Solid dose
Patheon NV Pacira BioSciences Inc EMA expanded indication in adults and children aged ≥6 years as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds Exparel Parenteral manufacture
Patheon NV Boehringer Ingelheim International GmbH FDA expanded indication to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure Synjardy XR Solid dose & packaging
PCI Pharma Services Zogenix Inc EMA expanded indication for the treatment of seizures associated with Dravet syndrome and Lennox Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older Fintepla Non-sterile liquid manufacturing & packaging
PCI Pharma Services Pacira BioSciences Inc EMA expanded indication in adults and children aged ≥6 years as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds Exparel Parenteral packaging
PCI Pharma Services AbbVie Inc UK MHRA expanded indication as a single agent or in combination with venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia Imbruvica Solid dose packaging
PCI Pharma Services BeiGene Ltd UK MHRA expanded indication for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy Brukinsa Solid dose packaging
Polymun Scientific Immunbiologische Forschung GmbH AC Immune SA Positive Phase I/II interim results for Alzheimer's Disease ACI-24 Parenteral manufacture
Praxis Packaging Solutions Boehringer Ingelheim International GmbH FDA expanded indication reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure Synjardy Solid dose packaging
Recipharm AB AstraZeneca Plc UK MHRA expanded indication for Acid Indigestion (Heartburn/Pyrosis) Nexium Solid dose packaging
Rentschler Biopharma SE Takeda Pharmaceutical Co Ltd FDA expanded indication in pediatric patients 2 to < 12 years of age for prophylaxis to prevent attacks of hereditary angioedema (HAE) Takhzyro Biologic API
Samsung Biologics Co Ltd Ono Pharmaceutical Co Ltd NICE approval for the drug plus fluoropyrimidine- and platinum-based chemotherapy for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma Opdivo Biologic API
Samsung Biologics Co Ltd Chugai Pharmaceutical Co Ltd EMA expanded indication for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors and without factor VIII inhibitors who have severe disease (FVIII < 1%) and moderate disease (FVIII ≥ 1% and ≤ 5%) with severe bleeding phenotype Hemlibra Parenteral manufacture
Samsung Biologics Co Ltd Gilead Sciences Inc FDA expanded indication for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting Trodelvy Biologic API
Sharp Packaging Services Shionogi & Co Ltd EMA expanded indication in children aged one year and above for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza Xofluza Solid dose packaging
SK Biotek Co Ltd AstraZeneca Plc EMA expanded indication for the treatment of heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction Forxiga Small mol API
Sun Pharmaceutical Industries Ltd AstraZeneca Plc UK MHRA expanded indication for Acid Indigestion (Heartburn/Pyrosis) Nexium Solid dose
Vetter Pharma-Fertigung GmbH & Co KG AstraZeneca Plc EMA expanded indication in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer Imfinzi Parenteral manufacture
Vetter Pharma-Fertigung GmbH & Co KG Regeneron Pharmaceuticals Inc FDA expanded indication for the treatment preterm infants with retinopathy of prematurity (ROP) Eylea Parenteral manufacture & packaging
Vetter Pharma-Fertigung GmbH & Co KG Takeda Pharmaceutical Co Ltd FDA expanded indication in pediatric patients 2 to < 12 years of age for prophylaxis to prevent attacks of hereditary angioedema (HAE) Takhzyro Parenteral manufacture & packaging
Vetter Pharma-Fertigung GmbH & Co KG Sanofi FDA expanded indication for the first and only treatment of hemolysis in adults with cold agglutinin disease (CAD), to include patients with or without a history of transfusions Enjaymo Parenteral manufacture
Vetter Pharma-Fertigung GmbH & Co KG  Ono Pharmaceutical Co Ltd NICE approval for the drug plus fluoropyrimidine- and platinum-based chemotherapy for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma Opdivo Parenteral manufacture
Vistin Pharma AS Boehringer Ingelheim International GmbH FDA expanded indication to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure Synjardy XR Small mol API
Vistin Pharma AS Boehringer Ingelheim International GmbH FDA expanded indication reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure Synjardy Small mol API
WuXi Biologics Cayman Inc AC Immune SA Positive Phase I/II interim results for Alzheimer's Disease ACI-24 Biologic API
WuXi STA (Shanghai) Co Ltd AbbVie Inc UK MHRA expanded indication as a single agent or in combination with venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia Imbruvica Small mol API

POTENTIALLY NEGATIVE
Emergent BioSolutions Inc La Jolla Pharmaceutical Company NICE rejection for treating vasosuppressor-resistant hypotension caused by septic or distributive shock Giapreza Parenteral manufacture
Lonza Group Ltd AstraZeneca Plc FDA unauthorized emergency use of the drug in the US for treating Coronavirus Disease 2019 (COVID-19) Evusheld** Biologic API
PCI Pharma Services La Jolla Pharmaceutical Company NICE rejection for treating vasosuppressor-resistant hypotension caused by septic or distributive shock Giapreza Parenteral manufacture & packaging
PolyPeptide Group AG La Jolla Pharmaceutical Company NICE rejection for treating vasosuppressor-resistant hypotension caused by septic or distributive shock Giapreza Small mol API
Samsung Biologics Co Ltd AstraZeneca Plc FDA unauthorized emergency use of the drug in the US for treating Coronavirus Disease 2019 (COVID-19) Evusheld** Biologic API, parenteral manufacture & packaging
WuXi Biologics Cayman Inc AstraZeneca Plc FDA unauthorized emergency use of the drug in the US for treating Coronavirus Disease 2019 (COVID-19) Evusheld** Biologic 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