The Pipeline Contenders: What Drugs Are Making the Mark?By
What are the key developments from the large pharmaceutical companies’ pipelines expected for later this year? Which new drugs or additional indications for existing drugs have blockbuster potential? DCAT Value Chain Insights takes an inside look.
Inside Big Pharma’s pipeline
What are some of the key developments expected this year from the large pharmaceutical companies’ pipelines? A recent analysis by Evaluate Vantage, using EvaluatePharma data, highlights select candidates from the large pharmaceutical companies with key recent/upcoming clinical catalysts and their market potential, including some with blockbuster potential, based on 2026 estimates from clinical development thus far (see Table 1 at the end of the article). Highlights are outlined below.
AbbVie. A key upcoming development for AbbVie relates to results from Phase III clinical trials for Skyrizi (risankizumab) for treating Crohn’s disease and psoriatic arthritis. Skyrizi is now approved for treating moderate-to-severe plaque psoriasis. In the first-half of 2020, it posted sales of $630 million. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. The additional indications for treating Crohn’s disease and psoriatic arthritis are important to potential revenues. EvaluatePharma projects estimated 2026 revenues of $2.4 billion for the indications of Crohn’s disease and psoriatic arthritis, which would represent more than one-third of Skyrizi’s projected 2026 sales.
Amgen/AstraZeneca. AstraZeneca and Amgen are targeting tezepelumab as a potential blockbuster for treating severe non-eosinophilic asthma. Tezepelumab is one of five monoclonal antibodies from Amgen’s clinical inflammation portfolio that were part of a pact that Amgen and AstraZeneca formed in 2012. Tezepelumab is positioned in the asthma drug market by targeting severe non-eosinophilic asthma. Eosinophilia, high levels of white blood cells, is present in approximately 50% of severe asthma cases. Most monoclonal antibodies, including Sanofi’s Dupixent (dupilumab), the expected market leader by 2026, Astra’Zenca’s Fasenra (benralizumab), and GlaxoSmithKline’s Nucala (mepolizumab), primarily target the eosinophilic phenotype, and Amgen/AstraZeneca hope to carve out a space in the asthma market with a new treatment for non-eosinophilic asthma with tezepelumab. EvaluatePharma projects estimated 2026 sales of tezepelumab for this indication (severe non-eosinophilic asthma) of $1 billion.
AstraZeneca. AstraZeneca’s immunotherapy, Imfinzi (durvalumab) is seeking to further its position for treating non-small-cell lung cancer (NSCLC). Imfinzi is approved in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy in the US, Japan, China, across the European Union (EU) and in many other countries. It is also approved for previously treated patients with advanced bladder cancer in the US and several other countries. Additionally, it is approved in the US, the EU, Japan and other countries for extensive-stage small-cell lung cancer (ES-SCLC).
Imfinzi is well-stablished in Stage III NSCLC, but only after chemoradiotherapy (CRT). Data from a Phase III trial with results released in late September (September 2020) evaluated Imfinzi with CRT versus CRT alone with a primary endpoint of progression-free survival. AstraZeneca reported updated results from a Phase III trial that showed Imfinzi demonstrated a sustained, clinically meaningful overall survival and progression-free-survival benefit in patients with unresectable, Stage III NSCLC who had not progressed following concurrent CRT. The results from the updated post-hoc analyses showed an estimated four-year overall survival rate of 49.6% for Imfinzi versus 36.3% for placebo after CRT. EvaluatePharma projects 2026 estimated sales of Imfinzi of nearly $3.3 billion for this indication (Stage III non-small-cell lung cancer with CRT).
As part of a broad development program, Imfinzi is also being tested as a monotherapy and in combinations, including with AstraZeneca’s tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer, endometrial cancer, and other solid tumors.
Bristol-Myers Squibb. Bristol-Myers Squibb (BMS) is banking on BMS-986165, an oral tyrosine kinase 2 (TYK2) inhibitor for treating moderate-to-severe plaque psoriasis. BMS-986165 is the heir apparent for BMS for Otelza, which Celgene divested to Amgen for $13.4 billion as a condition for US regulatory approval of BMS’s $74-billion acquisition of Celgene in 2019. Data from a Phase III trial are expected later this year (2020). EvaluatePharma projects estimated 2026 sales of $1.8 billion.
Eli Lilly and Company. Eli Lilly and Company is progressing a potential blockbuster, tirzepatide, for treating Type 2 diabetes. Tirzepatide is a combined GIP/GLP-1 agonist that would be the heir apparent to Lilly’s Trulicity (dulaglutide), which has compound patent protection in the US until 2027 and until 2029 in major European countries and Japan. Trulicity, which posted 2019 sales of $4.1 billion, competes with other drugs in the GLP-1 class, such as Novo Nordisk’s Ozempic (semaglutide). In June (June 2020), Lilly began Phase III clinical trials for cardiovascular outcomes, expected to be completed in four years, to evaluate whether tirzepatide can equal or improve on Trulicity in reducing cardiovascular death, myocardial infarction or stroke. EvaluatePharma projects estimated 2026 sales of $2.2 billion.
GlaxoSmithKline. GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf), a drug for treating multiple myeloma, also has blockbuster potential. In August (August 2020), the US Food and Drug Administration (FDA) granted Blenrep accelerated approval for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The drug was approved with a black-box warning for ocular risks and is part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, which was developed to ensure appropriate use of medicines and requires education for all physicians prescribing the drug and their patients on the ocular risks. Blenrep is an antibody drug conjugate comprising a humanized anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug-linker technology is licensed from Seattle Genetics; the monoclonal antibody is produced using technology licensed from BioWa, a US subsidiary of Kyowa Kirin. EvaluatePharma projects estimated 2026 sales of $1.2 billion.
Roche. Roche is progressing faricimab, a bispecific antibody for treating retinal eye diseases and that has potential blockbuster. The drug would compete against two other drugs that face near-term generic competition: Roche’s Lucentis (ranibizumab), which is approved for treating wet age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, and diabetic retinopathy, and Bayer’s/Regeneron Pharmaceuticals’ Eylea (aflibercept), which is also approved for those indications. The EvaluatePharma analysis projects estimated 2026 sales of faricimab for the indication of diabetic macular edema at $610 million.
|Table I: Select Upcoming Pipeline Highlights from the Large Pharma Companies (Fourth Quarter 2020 Clinical Catalysts)|
|Company||Product||Indication; Phase of Development||Estimated 2026 Sales for Indication Specified|
|AbbVie||Skyrizi (risankizumab-rzaa)||Crohn’s disease and psoriatic arthritis; Phase III||$2.440 Bn|
|Amgen/Cytokinetics||Omecamtiv mecarbil + standard of care||Chronic heart failure with reduced ejection fraction; Phase III||$422 M|
|AstraZeneca||Imfinzi (durvalumab) + platinum-based chemo-radiotherapy||Stage III non-small-cell lung cancer; Phase II||$3.296 Bn|
|AstraZeneca||Imfinzi (durvalumab) +/- tremelimumab||First-line liver cancer||$129 M|
|AstraZeneca/Amgen||tezepelumab||Severe non-eosinophilic asthma; Phase III||$1.021 Bn|
|Bristol-Myers Squibb||BMS-986165||Psoriasis; Phase III||$1.810 Bn|
|Eli Lilly and Company||tirzepatide||Type 2 diabetes||$2.202 Bn|
|Gilead Sciences/Arcus||AB154 + zimberelimab +/- AB928||First-line non-small-cell lung cancer; Phase II||$460 M|
|Gilead Sciences||Magrolimab + Rituxan (rituximab)||Diffuse large B-cell lymphoma; Phase I/II||$72 M|
|GlaxoSmithKline||Blenrep (belantamab mafodotin-blmf) + 2 standard-of-care regimens||Second line multiple myeloma||$1.213 Bn|
|Pfizer||PF-06826647||Psoriasis; Phase II proof of concept||N/A|
|Roche||faricimab||Diabetic macular edema; Phase III||$610 million|
|Roche||gantenerumab||Alzheimer’s disease (prodromal); Phase III||$72 M|
|Roche||gantenerumab (brain shuttle) / RG6102||Healthy volunteers; Phase I||N/A|
|Roche||Pentraxin-2 (RG6354, PRM-151)||Myelofibrosis; Phase II||N/A|
|Takeda||Pevonedistat +/- azacitidine||Higher-risk myelodysplastic syndromes; Phase III||$634 M|
Sources: Evaluate Vantage based on EvaluatePharma data (September 2020 analysis); clinicaltrials.gov, company releases and analysts’ notes.