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Q3 The latest financial report: What breakthroughs have Novartis and Eli Lilly have in the development of innovative therapies?

 Last Update: 2021-11-15
 Source: Internet
 Author: User

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Today, Novartis and Eli Lilly and Company announced their financial results for the third quarter of 2021
.

The WuXi AppTec content team will share with readers the latest developments in innovative therapies in the R&D pipelines of these two companies

Novartis

Novartis CEO Dr.
Vasant Narasimhan focused on an investigational therapy that is a potential "best-in-class" Bruton's tyrosine kinase (BTK) inhibitor remibrutinib
.

This is a covalent BTK inhibitor that can irreversibly bind to BTK in B cells and myeloid cells

The potential "best-in-class" Bruton's tyrosine kinase (BTK) inhibitor remibrutinib produces a strong inhibitory effect while reducing the systemic exposure of the drug, thereby minimizing the risk of adverse events and drug interactions

Remibrutinib significantly improved the patient's symptoms after 1 week of treatment, and in the following 12 weeks, more patients achieved complete control of the disease symptoms

▲Remibrutinib has shown good benefit/risk characteristics in clinical trials for the treatment of patients with chronic spontaneous urticaria (picture source: Novartis official website)

Based on this result, Novartis expects to start a phase 3 clinical trial of remibrutinib in the treatment of chronic spontaneous urticaria in the fourth quarter of this year
.

At the same time, the company will directly initiate a phase 3 clinical trial in the fourth quarter to test the effect of remibrutinib in the treatment of patients with relapsing multiple sclerosis

The company will directly initiate a phase 3 clinical trial in the fourth quarter to test the effect of remibrutinib in the treatment of patients with relapsing multiple sclerosis

Image source: Novartis official website

In addition, Novartis’s CDK4/6 inhibitor Kisqali (ribociclib) combined with letrozole (letrozole) significantly prolonged the patient’s life in a phase 3 clinical trial in the treatment of HR-positive, HER2-negative postmenopausal advanced or metastatic breast cancer patients.
Overall survival
.

When the median follow-up time exceeded 6.

Kisqali (ribociclib) combined with letrozole (letrozole) compared with the active control group, the Kisqali combination prolonged the patient's median overall survival by 12.

▲Kisqali significantly prolongs the overall survival of patients with advanced breast cancer (picture source: Novartis official website)

Currently, Kisqali is being used as an adjuvant therapy in a phase 3 clinical trial to treat patients with early HR-positive and HER2-negative breast cancer .
This clinical trial has completed patient registration and is expected to receive results later next year
.

Kisqali is being used as an adjuvant therapy in phase 3 clinical trials to treat patients with early HR-positive and HER2-negative breast cancer

In addition, the ABL1 allosteric inhibitor asciminib developed by the company has been granted priority review by the US FDA for the treatment of patients with Philadelphia (Ph) chromosome-positive chronic myeloid leukemia (CML)
.

Asciminib binds to the myristoyl pocket of ABL1 and inhibits the activity of BCR-ABL1

The ABL1 allosteric inhibitor asciminib has been granted priority review by the U.

▲Asciminib has a unique mechanism of action (picture source: Novartis official website)

The company's radioligand therapy 177Lu-PSMA-617 has also been granted priority review by the FDA for the treatment of metastatic castration-resistant prostate cancer
.

Novartis expects both it and asciminib to be approved in the first half of next year
.

177Lu-PSMA-617 has also been granted priority review by the FDA.
Novartis expects that both it and asciminib are expected to be approved in the first half of next year
.

The company's potential "first-in-class" TGFβ antibody therapy NIS793 aims to regulate the tumor microenvironment by inhibiting the TGFβ signaling pathway
.
In the first human clinical trial conducted in patients with advanced solid tumors, it has obtained verification of its mechanism of action and exhibited acceptable safety characteristics
.
The US FDA has granted it an orphan drug designation for the treatment of pancreatic cancer
.
It is currently being tested in phase 2 clinical trials, and it is expected that phase 3 clinical trials for the first-line treatment of patients with metastatic pancreatic cancer are expected to start this year
.

Potential "first-in-class" TGFβ antibody therapy NIS793 The US FDA has granted it an orphan drug designation for the treatment of pancreatic cancer
.
Phase 3 clinical trials for the first-line treatment of patients with metastatic pancreatic cancer are expected to start this year
.

▲Partial progress of Novartis' innovative drug development in the third quarter (Image source: Novartis official website)

Eli Lilly

Tirzepatide, a dual agonist of glucose-dependent insulin-promoting polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, is the result of a phase 3 clinical trial in the treatment of patients with type 2 diabetes.
Published on
.
Compared with insulin glargine, the three doses of tirzepatide showed better curative effect, and reduced the level of glycosylated hemoglobin (A1C) and body weight to a greater extent
.

Compared with insulin glargine, the three doses of tirzepatide showed better curative effect, and reduced the level of glycosylated hemoglobin (A1C) and body weight to a greater extent.

▲Tirzepatide significantly reduces A1C levels in patients with type 2 diabetes (picture source: Eli Lilly's official website)

Eli Lilly announced today that it has used the priority review voucher to submit a new drug application for tirzepatide to the US FDA for the treatment of patients with type 2 diabetes
.
This will speed up the review of tirzepatide
.

The priority review voucher has been used to submit a new drug application for tirzepatide to the US FDA for the treatment of patients with type 2 diabetes

In addition, the company has also initiated a rolling application for anti-amyloid antibody therapy donanemab based on the accelerated approval channel for the treatment of early-stage Alzheimer's disease
.

Based on the accelerated approval channel, a rolling application for the anti-amyloid antibody therapy donanemab was initiated for the treatment of early Alzheimer's disease
.

In the third quarter, the company and Boehringer Ingelheim (Boehringer Ingelheim) jointly developed the SGLT2 inhibitor empagliflozin (empagliflozin, English trade name Jardiance), in the treatment of adult patients with preserved ejection fraction heart failure (HFpEF) In the phase 3 clinical trial, the relative risk of patients with cardiovascular death or hospitalization for heart failure was reduced by 21%
.
Based on this result, the two companies have submitted a regulatory application for empagliflozin in the treatment of HFpEF to regulatory agencies in the United States and the European Union
.

SGLT2 inhibitor Enpagliflozin 21%
.
The two companies have submitted regulatory applications for the treatment of HFpEF with empagliflozin to regulatory agencies in the United States and the European Union
.

In addition, the imlunestrant (formerly known as LY3484356) developed by Eli Lilly is an oral selective estrogen receptor degrading agent (SERD)
.
It has shown good safety and preliminary anti-cancer activity in the first human clinical trials for the treatment of ER-positive advanced breast cancer and endometrial cancer
.
Eli Lilly has launched a phase 3 clinical trial to test its efficacy in ER-positive and HER2-negative breast cancer patients
.

imlunestrant (formerly known as LY3484356) is an oral selective estrogen receptor degrading agent (SERD) to initiate a phase 3 clinical trial to test its efficacy in patients with ER-positive and HER2-negative breast cancer
.

▲Imlunestrant's early clinical trial results (picture source: Eli Lilly's official website)

In the Q3 financial report, Novartis and Eli Lilly also introduced the company's operations.
Due to space limitations, this article will not introduce them one by one
.
Reply "Novartis financial report" to WuXi AppTec WeChat account to get Novartis Q3 financial report PPT, and reply to "Lilly financial report" to get Eli Lilly Q3 financial report PPT
.

Reply "Novartis financial report" to WuXi AppTec WeChat account to get Novartis Q3 financial report PPT, and reply to "Lilly financial report" to get Eli Lilly Q3 financial report PPT
.

Reference materials:

[1] Novartis delivers solid Q3 results, with strong growth in Innovative Medicines.
Announces strategic review of Sandoz.
Retrieved October 26, 2021, from https:// -q3-results-strong-growth-innovative-medicines-announces-strategic-review-sandoz

[2] Novartis Q3 2021 Results Investor presentation.
Retrieved October 26, 2021, from https:// Novartis Q3 2021 Results Investor presentation.
Retrieved October 26, 2021, from https:// [3] Lilly Reports Robust Third-Quarter 2021 Financial Results as Pipeline Success Strengthens Future Growth Potential.
Retrieved October 26, 2021, from https://investor.
lilly.
com/news-releases/news-release-details/lilly-reports -robust-third-quarter-2021-financial-results

[3] Lilly Reports Robust Third-Quarter 2021 Financial Results as Pipeline Success Strengthens Future Growth Potential.
Retrieved October 26, 2021, from https://investor.
lilly.
com/news-releases/news-release-details/lilly-reports -robust-third-quarter-2021-financial-results

[4] Lilly Q3 2021 Earnings Call.
Retrieved October 26, 2021.
Retrieved October 26, 2021, from https://investor.
lilly.
com/static-files/3c93ae38-a621-42a0-9964-826778a6daca

[5] Lilly Announces Updated Verzenio® (abemaciclib) Phase 3 monarchE Trial Data Presented at ESMO Virtual Plenary and Simultaneously Published in the Annals of Oncology.
Retrieved October 26, 2021, from https://investor.
lilly.
com/news-releases /news-release-details/lilly-announces-updated-verzenior-abemaciclib-phase-3-monarche

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