Global Pharma Briefs: News from AstraZeneca, Eisai, Gilead, Merck & Co.By
A roundup of news from Germany (Takeda, Evotec), Italy (Sanofi), Japan (Takeda, Eisai), the UK (AstraZeneca), and the US (Gilead, Merck & Co., BMS, Novo Nordisk, and Sagent).
Takeda, Evotec in Pact for RNA-targeting Drug Discovery, Development
Takeda Pharmaceutical and Evotec, a Hamburg, Germany-based drug-discovery and development company, have entered into a multi-RNA target alliance to discover and develop RNA-targeting small-molecule therapeutics.
Evotec and Takeda will jointly identify and develop small molecules targeting a range of RNA targets aligned with Takeda’s research and development areas. The collaboration will use Evotec’s RNA-targeting platform to identify promising RNA sequences to target with small molecule ligands that can be developed into potentially therapeutics.
Under the agreement, Evotec will receive research funding and will be eligible to receive discovery, preclinical, clinical, commercial, and sales milestone payments of up to $160 million per program. Additionally, Evotec is entitled to tiered royalties on net sales of any products resulting from the collaboration.
Sanofi Divests Anti-inflammatory Drugs to Fidia Farmaceutici
Sanofi has concluded an agreement to divest a portfolio of its anti-inflammatory drugs to Fidia Farmaceutici, a Bologna, Italy-based pharmaceutical company.
The agreement covers the registrations, trademarks, and related commercial rights of seven products, including four corticosteroids and one non-steroidal anti-inflammatory drug, across Europe and emerging markets.
Eisai Breaks Ground for New Research Building for Injectables
Eisai broke ground for a new research building for injectable at the Kawashima Industrial Park in Gifu Prefecture, Japan.
The current research building at Kawashima Industrial Park has served as a base for formulation research since its completion in 1980. In recent years, Eisai’s drug-discovery targets have expanded to include new modalities such as antibodies, antibody drug conjugates, and nucleic acid drugs, in addition to conventional small-molecule compounds.
Through its new building, the Eisai Medicine Innovation Technology Solutions (EMITS), Eisai will transfer its formulation research function from the current research building and enhance its manufacturing process development function for injection formulations.
Additionally, Eisai will install an injection manufacturing facility and is aiming for the in-house manufacturing of investigational injection drugs. The company also says there are plans for installation of systems for development of formulation technology, such as liposome and lipid nanoparticle preparations, as well as creation of space for collaborative research with external partners. The completion of the building is scheduled for the second quarter of fiscal year 2022.
Takeda Updates on Japan Pharma Business Unit President Transition
Takeda Pharmaceutical has announced that Milano Furuta, the company’s current Global Corporate Strategy Officer and Chief of Staff, has been appointed as President of the Japan Pharma Business Unit, effective April 1, 2021.
Mr. Furuta joined Takeda in 2010, serving in a range of corporate strategy and planning and global business development roles, including multiple international functions in several countries, including Japan, Switzerland, Mexico and Sweden. He has also led projects to optimize Takeda’s commercial organization and launch products in the areas of oncology, diabetes, cardiovascular and metabolism. Prior to joining Takeda, Mr. Furuta was engaged in investment and banking at an investment management firm in the US and a financial institution in Japan.
Masato Iwasaki will transition from the role on March 31, 2021. Mr. Iwasaki, who started with Takeda in 1985, will remain on Takeda’s Board of Directors and shift to a Japan general affairs role.
AstraZeneca Completes Divestment of 26.7% Ownership in Viela Bio for $775-M
AstraZeneca has completed the divestment of its 26.7% ownership in Viela Bio, a Gaithersburg, Maryland-based biopharmaceutical company, as part of the proposed acquisition of Viela by Horizon Therapeutics.
AstraZeneca received cash proceeds and profit of $775 million from the divestment, which was first announced last month (February 2021).
Viela was founded in 2018 as a spinout from AstraZeneca, with clinical and preclinical projects from AstraZeneca’s inflammation and autoimmunity pipeline. In 2020, Viela Bio received approval by the US Food and Drug Administration’s Center for Uplizna (inebilizumab-cdon) for treating neuromyelitis optica spectrum disorder, a chronic disorder of the brain and spinal cord dominated by inflammation of the optic nerve and inflammation of the spinal cord.
Gilead, Merck & Co. in Pact To Co-Develop HIV Combo Treatment
Gilead Sciences and Merck & Co. have entered into an agreement to co-develop and co-commercialize long-acting treatments in HIV.
The treatments will combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen with the potential to provide new treatment options for HIV.
Islatravir and lenacapavir are both in late-stage clinical trials. Both medicines have long half-lives and have demonstrated activity at low dosages in clinical studies, which support development as an investigational combination regimen with long-acting formulations, both oral and injectable. The first clinical studies of the oral combination are expected to begin in the second half of 2021.
Under the agreement, Gilead and Merck will work as partners, sharing operational responsibilities, as well as development, commercialization, and marketing costs, and any future revenues. The collaboration will initially focus on long-acting oral formulations and long-acting injectable formulations of these combination products, with other formulations potentially added to the collaboration as mutually agreed.
Across the oral and injectable formulation programs, Gilead and Merck will share global development and commercialization costs 60%/40%, respectively. For long-acting oral products, Gilead will lead commercialization in the US and Merck will lead commercialization in the EU and globally. For long-acting injectable products, Merck will lead commercialization in the US and Gilead will lead commercialization in the EU and globally.
Gilead and Merck will co-promote in the US and other certain major markets. Merck and Gilead will share global product revenues equally until product revenues surpass certain pre-agreed per formulation revenue tiers. Upon passing $2 billion a year in net product sales for the oral combination, the revenue split will adjust to 65% Gilead and 35% Merck for any revenues above the threshold. Upon passing $3.5 billion a year in net product sales for the injectable combination, the revenue split will adjust to 65% Gilead and 35% Merck for any revenues above the threshold.
Beyond the potential combinations of lenacapavir and islatravir, Gilead will have the option to license certain of Merck’s investigational oral integrase inhibitors to develop in combination with lenacapavir. Reciprocally, Merck will have the option to license certain of Gilead’s investigational oral integrase inhibitors to develop in combination with islatravir. Each company may exercise its option for an investigational oral integrase inhibitor of the other company following completion of the first Phase I clinical trial of that integrase inhibitor. Upon exercise of an option, the companies will split development cost and revenues, unless the non-exercising company decides to opt-out. Both companies currently have oral once-weekly integrase inhibitors in preclinical development.
Gilead, Novo Nordisk Expand Clinical NASH Pact
Gilead Sciences and Novo Nordisk have expanded their clinical collaboration in non-alcoholic steatohepatitis (NASH), a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring or fibrosis, that impairs liver function.
The companies will conduct a Phase IIb double-blind, placebo-controlled study to investigate the safety and efficacy of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist, and a fixed-dose combination of Gilead’s investigational FXR agonist cilofexor and investigational ACC inhibitor firsocostat, alone and in combination in people with compensated cirrhosis (F4) due to NASH. The four-arm study in approximately 440 patients will evaluate the treatments’ impact on liver fibrosis improvement and NASH resolution and will begin recruitment in the second half of 2021.
Cilofexor and firsocostat are investigational compounds and are not approved by the US Food & Drug Administration (FDA) or any other regulatory authority. Semaglutide has not been approved by the FDA or any other regulatory authority for the treatment of patients with NASH but has been approved for treat Type 2 diabetes.
Source: Gilead Sciences
Novo Nordisk Receives Refusal to File Letter for Type 2 Diabetes Treatment
The US Food and Drug Administration (FDA) has issued a Refusal to File letter covering the label expansion application for Novo Nordisk’s semaglutide 2.0 mg for treating Type II diabetes.
A refusal to file letter is received when the FDA determines additional information is required to review a complete application. The application for the once-weekly 2.0-mg treatment was filed on January 20, 2021.
In the letter, the FDA requested additional information, including data relating to a proposed new manufacturing site. While additional information needs to be included in the resubmission, Novo Nordisk says it believes the already completed clinical trial program will be sufficient for approval of the label expansion application. Novo Nordisk expects to resubmit the application to the FDA during the second quarter of 2021.
The semaglutide injection was approved in the US in 2017 for once-weekly 0.5-mg and 1-mg doses.
Source: Novo Nordisk
FDA To Hold Meeting on BMS’ Opdivo Hepatocellular Carcinoma Indication in US
Bristol Myers Squibb (BMS) will meet with the US Food and Drug Administration’s Oncologic Drugs Advisory Committee on April 29, 2021 to discuss the hepatocellular carcinoma (HCC) indication for Opdivo (nivolumab), its immuno-oncology drug.
In 2017, Opdivo was granted accelerated approval by the FDA as a single agent for patients with HCC who have been previously treated with sorafenib. The accelerated approval was based on tumor responses from the Phase I/II trial. CheckMate-459, the subsequent confirmatory randomized study of Opdivo versus sorafenib in the first-line setting, did not achieve statistical significance for its primary endpoint of overall survival per the pre-specified analysis.
Opdivo and Opdivo-based combinations have been approved for multiple cancers, including metastatic melanoma, renal cell carcinoma, and non-small cell lung cancer.
Source: Bristol-Myers Squibb
Sagent Pharmaceuticals Issues Voluntary Recall of Hypotension Injection
Sagent Pharmaceuticals, a subsidiary of the Nichi-Iko Group and manufacturer of pharmaceutical injectables and biosimilars, is voluntarily recalling three lots of phenylephrine hydrochloride injection, USP (10 mg/mL) to the user level as the result of a customer complaint due to potentially loose crimped vial overseals.
Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important low blood pressure resulting primarily from the dilation of blood vessels, which decreases blood pressure in the setting of anesthesia.
This product was manufactured by Indoco Remedies, a Mumbai, India-headquartered active pharmaceutical ingredient and finished dosage form manufacturer, and distributed by Sagent Pharmaceuticals. The product is supplied in 3-mL glass tubular vials.
Source: US Food and Drug Administration