Global Briefs: Merck & Co., Novartis, Eisai & More

A roundup of news from Merck & Co. Daiichi Sankyo, Novartis, Novo Nordisk/Ventus Therapeutics, AstraZeneca/LogicBio Therapeutics, and Emergent BioSolutions/Chimerix. Highlights below.

* Merck & Co. Gets Favorable Court Ruling in Diabetes Drug Patent Case
* Daiichi Gets Favorable Ruling in Patent Case Against Novartis
* Eisai Completes Construction of Injectables Formulation Research Facility
* Novo Nordisk, Ventus in $700-M Cardiometabolic Drug Pact
* AstraZeneca To Acquire Genetic Medicines Company Logic Bio for $68 M
* Emergent BioSolutions Completes Acquisition of Smallpox Drug

Merck & Co. Gets Favorable Court Ruling in Diabetes Drug Patent Case
Merck & Co. has received a favorable court ruling from a federal district court in patent- infringement litigation relating to sitagliptin, the active ingredient in Merck’s diabetes drugs, Januvia and combination drugs, Janumet (sitagliptin and metformin) and Janumet XR (sitagliptin and metformin. Combined, Januvia, Janumet, and Janumet XR are a blockbuster franchise of Merck with 2021 sales of $1.39 billion. The court found that two Merck patents at issue were valid and infringed. The decision is subject to appeal. The litigation had been brought by Viatris over generic versions of sitagliptin.

Two Merck & Co. patents were involved in the suit. The first patent, (US Patent No. 7,326,708), covers the dihydrogen phosphate salt of sitagliptin and is set to expire on Nov. 24, 2026, with pediatric exclusivity extending to May 24, 2027. The second patent, (US Patent No. 8,414,921), covers the co-formulation of sitagliptin and metformin found in Janumet and is set to expire Jan. 21, 2029, with pediatric exclusivity extending to July 21, 2029. Merck & Co. had filed infringement actions against Viatris under both patents, for which Viatris alleged non-infringement and/or invalidity. Viatris is seeking US Food and Drug Administration approval to market generic versions of Januvia and Janumet in the US.

Viatris had previously challenged validity of the salt patent in an inter parties review before the US Patent Office. In May 2021, the Patent Office issued a decision in Merck & Co.’s favor, finding all challenged claims valid. Viatris has appealed that decision in a federal appeals court, with the case still pending.

Additionally, Merck & Co. has entered into patent-ligation settlement agreements with multiple generic companies to allow them to bring their generic versions of Januvia and Janumet to the market in the US in May 2026 or earlier under certain circumstances, and their generic versions of Janumet XR to the market in July 2026 or earlier under certain circumstances.

Source: Merck & Co.

Daiichi Gets Favorable Ruling in Patent Case Against Novartis
Novartis has received a favorable ruling from a federal district court that sustains a jury verdict of patent infringement under which the company is directed to pay $177.8 million in damages and a 9% royalty on US sales of the company’s Tafinlar (dabrafenib), an oncology drug, to Plexxikon, a subsidiary of Daiichi Sankyo. The royalty payments last until the expiration of the patents of Plexxikon. Tafinlar + Mekinist (dabrafenib + trametinib) is an oral combination therapy and had combined global sales of $1.69 billion in 2021.

Plexxikon filed the case in 2017, claiming that Novartis’ BRAF inhibitor, Tafinlar infringes two US patents of Plexxikon (US Patents 9,469,640 and 9,844.539). The federal district court making the ruling, the U.S. District Court for the Northern District of California reversed the jury’s finding of willful infringement by Novartis.

Daiichi Sankyo closed the offices of its research and development subsidiary, Plexxikon, based in South San Francisco, California, earlier this year (March 2022). Plexxikon was engaged in research and development in oncology and neurology and had been part of Daiichi Sankyo since 2011.

Source: Daiichi Sankyo

Eisai Completes Construction of Injectables Formulation Research Facility
Eisai has completed construction of a JPY 10 billion ($69 million) building for injectable drug formulation development research in Kawashima Industrial Park located in Gifu Prefecture, Japan.

The facility will be Eisai’s global base for drug formulation development research function and drug- delivery system development function, including liposomal and lipid nanoparticle formulations, and address the development of various modalities.

The following initiatives will be implemented at the facility: (1) elevating the quality and speed of formulation process research through the introduction of a manufacturing data-management system and utilization of artificial intelligence; (2) installation of facilities that also enable the manufacturing of clinical trial materials in order to manufacture investigational injection drugs in-house; (3) introduction of rapid microbial testing methods for advanced microbiological control and sterility assurance; (4) enhancing collaboration with the creation of flexible space that can also be used for collaborative research with external partners and technologies.

Source: Eisai

Novo Nordisk, Ventus in $700-M Cardiometabolic Drug Pact
Novo Nordisk and Ventus Therapeutics, a Waltham, Massachusetts-based bio/pharmaceutical company, have entered into an exclusive worldwide license agreement to develop and commercialize candidates from Ventus’ portfolio of peripherally-restricted NLRP3 inhibitors, in a deal worth up to $700 million ($70 million upfront and $633 million in milestone payments).

Ventus uses structural biology and a proprietary computational chemistry platform to identify and develop small-molecule therapeutics across a broad range of diseases. NLRP3 is a biologically relevant target with potential across a number of liver, kidney, and cardiometabolic diseases.

Novo Nordisk will receive exclusive worldwide rights to develop and commercialize Ventus’ lead NLRP3 inhibitor program for a broad range of diseases, including nonalcoholic steatohepatitis (NASH), chronic kidney disease, and other cardiometabolic conditions. NLRP3 is a member of a family of proteins known as inflammasome receptors and is integral in the formation of the NLRP3 inflammasome. Inflammasomes are multiprotein complexes that regulate the innate immune system and are involved in intracellular surveillance of signals that trigger an intense inflammatory response.

Ventus retains the right to develop NLRP3 inhibitors for certain systemic diseases, including specific inflammatory and respiratory diseases. In addition, Ventus retains worldwide rights to the company’s brain-penetrant NLRP3 inhibitor program.

Under the terms of the agreement, Novo Nordisk will make an upfront payment of $70 million in cash to Ventus and provide research and development funding. In addition, Ventus will be eligible to receive up to an additional $633 million in potential clinical, regulatory, and commercial milestones as well as tiered royalties.

Source: Ventus Therapeutics

AstraZeneca To Acquire Genetic Medicines Company Logic Bio for $68 M
AstraZeneca  has agreed to acquire LogicBio Therapeutics, a Lexington, Massachusetts-based clinical-stage gene-therapy company, for $68 million. The acquisition is through Alexion, AstraZeneca’s rare-disease dur business.

LogicBio has developed technology platforms for the delivery and insertion of genes to address genetic diseasesas well as a platform designed to improve viral vector manufacturing processes.

Under the agreement, Alexion, through a subsidiary, will initiate a cash tender offer to acquire all outstanding shares of LogicBio for $2.07 per share for a total value of approximately $68 million. Both boards have unanimously approved the transaction. The deal is expected to close the deal in four to six weeks (as reported on October 3, 2022), subject to the tender of at least a majority of the outstanding shares of LogicBio common stock and satisfaction of other closing conditions. Upon closing, AstraZeneca plans to retain LogicBio employees at their current location.

Source: LogicBio Therapeutics

Emergent BioSolutions Completes Acquisition of Smallpox Drug
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, has completed its acquisition of exclusive worldwide rights to Tembexa (brincidofovir), an oral antiviral for the treatment of smallpox, from Chimerix, a Durham, North Carolina-based bio/pharmaceutical company, in a deal worth up to $378 million ($238 million upfront and $140 million in milestones). With the acquisition of the rights to Tembexa, Emergent gains a 10-year supply contract for the drug with the US government, worth up to $689 million ($115 million upfront, $551 in procurement options and $12million in post-marketing activities).

Tembexa was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.

Under the terms of the acquisition of Tembexa, Emergent is expected to pay Chimerix the following: (1) an upfront payment of $238 million; (2) potential milestone payments of up to $124 million contingent on the potential exercise by the US government of procurement options following the base period; (3) 15% royalty on gross profit from sales of Tembexa outside the US; (4) 20% royalty on gross profit from sales of Tembexa in the US that are in excess of the 1.7 million treatment courses in the existing agreement with the US government and; (5) up to an additional $12.5 million upon achievement of certain development-based milestones.

The 10-year contract to supply up to 1.7 million treatment courses of tablet and suspension formulations of Tembexa to the US government was awarded to Chimerix on August 29, 2022. The contract includes an initial product procurement valued at approximately $115 million, with optional future procurement, valued at up to approximately $551 million. In addition to product procurement, the contract includes reimbursed post-marketing activities of approximately $12 million.

Source: Emergent BioSolutions