Global Briefs: AstraZeneca, Gilead, Teva, & Endo

A roundup of news from AstraZeneca, Gilead Sciences, Teva Pharmaceutical Industries, Lupin, Endo International, and Nevakar. Highlights below.

* AstraZeneca Plans New R&D Hub in Massachusetts
* Endo Acquires Injectable Products from Nevakar
* Gilead, Dragonfly in $300-M Deal for Immunotherapies
* Teva, Lupin Settle Patent Dispute for CNS Drug

AstraZeneca Plans New R&D Hub in Massachusetts
AstraZeneca has announced plans to open a new life-sciences and innovation hub in Cambridge, Massachusetts, which will include an R&D center for AstraZeneca and new corporate headquarters for Alexion, the company’s rare-disease business. AstraZeneca acquired Alexion, a Cambridge, Massachusetts-based bio/pharma company focused on developing treatments for rare diseases, for $39 billion in 2021.

The site will bring together approximately 1,500 R&D, commercial, and corporate employees into a single purpose-built space. The site, scheduled for completion in 2026, includes 570,000 square feet of R&D and commercial space, and room for future expansion

Source: AstraZeneca

Endo Acquires Injectable Products from Nevakar
Endo International, a generics and specialty branded pharmaceuticals company, has acquired six injectable drug product candidates from Nevakar Injectables Inc., a subsidiary of Nevakar, a bio/pharmaceutical company with a portfolio of products in the ophthalmic and injectable areas. The drug candidates are ready-to-use products, meaning they eliminate the need for hospitals to prepare or transfer the product before patient administration.

The product candidates are in various stages of development, with the first launch expected in 2025. With the acquisition, Endo controls all remaining development, approval, launch and commercialization activities for these product candidates. Endo’s Par Sterile Products business will commercialize the products in the US.

Under the agreement, Endo International’s subsidiary, Endo Ventures Limited (EVL), purchased the six product candidates from Nevakar Injectables for a one-time payment of $35 million.

This acquisition is separate from a 2018 licensing agreement in which Nevakar licensed five sterile-injectable products in various stages of development and commercialization to Endo.

Source: Endo International and Nevakar Injectables

Gilead, Dragonfly in $300-M Deal for Immunotherapies
Gilead Sciences and Dragonfly Therapeutics, a Waltham, Massachusetts-based company specializing in cancer immunotherapies, have formed a collaboration to advance a number of Dragonfly’s natural killer (NK) cell-engager-based immunotherapies for oncology and inflammation indications.

Under the agreement, Gilead will receive an exclusive, global license from Dragonfly for DF7001, a preclinical immunotherapy for which an investigational new drug (IND) application is on track to be filed in the first half of 2023.

The agreement also grants Gilead options, after the completion of certain preclinical activities, to license exclusive, global rights to develop and commercialize additional NK cell-engager programs using the Dragonfly Tri-specific NK Engager (TriNKET) platform. TriNKETs are activators of the innate and adaptive immune systems, recruiting NK and cytotoxic T cells into the tumor microenvironment.

Under the agreement, Gilead will make a $300-million upfront payment to Dragonfly. In addition, Dragonfly is eligible to receive potential opt-in payments and performance-based development, regulatory and commercial milestone payments. Dragonfly will also be eligible to receive royalties of up to 20% on global net sales.

The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Source: Gilead Sciences

Teva, Lupin Settle Patent Dispute for CNS Drug
Teva Pharmaceutical Industries and Lupin, a Mumbai-based bio/pharmaceutical company, have settled a patent dispute over Teva’s Austedo (deutetrabenazine), a drug approved for treating tardive dyskinesia, a hyperkinetic movement disorder, and for chorea (involuntary movements) associated with Huntington’s disease. The drug posted 2021 revenues of $802 million.

Under the settlement, Lupin will have a license to sell its a generic deutetrabenazine product to treat moderate-to-severe tardive dyskinesia, beginning in April 2033, or earlier under certain circumstances. Will the settlement, litigation between the companies in the US District Court for the District of New Jersey will be ended.

Source: Teva Pharmaceuticals