Global Briefs: Takeda, GSK, Pfizer, Novartis & More

A roundup of news from Takeda, GSK, Pfizer/Valneva, Novartis, Organon/Henlius, Takeda, and ICH/MHRA.

* Takeda To Build New R&D Campus in US
* GSK Opens New Hybrid HQ in Canada
* Sandoz Seeks EU OK for High Concentration Biosimilar of AbbVie’s Humira
* Pfizer Takes $95-M Stake in Vaccine Company Valneva
* Novartis To Invest $250 M in R&D for Tropical Diseases, Malaria
* Organon, Henlius in Biosimilars Pact
* UK’s MHRA Accepted into ICH

Takeda To Build New R&D Campus in US
Takeda has signed a 15-year lease for approximately 600,000 square feet of research and development (R&D) and office space for a new facility to be built in Cambridge, Massachusetts. The new facility will have flexible workspaces for a hybrid working model to accommodate in-person and virtual collaboration.

Construction of the campus is scheduled to begin in 2023, and Takeda plans to occupy the building starting in 2026.

The company will also expand its existing space in Cambridge to include two additional floors, making Takeda the sole laboratory and office tenant in that building.

Takeda says it will eventually transition teams to Cambridge over time. Takeda will maintain a presence in Lexington, Massachusetts, as its suburban location.

Source: Takeda

GSK Opens New Hybrid HQ in Canada
GlaxoSmithKline (GSK) Canada has opened a new headquarters in Mississauga, Ontario, Canada, built with hybrid style to accommodate both in-person and virtual employees.

GSK employees were central to the project and engaged in various aspects of the creation of their new work environment for both in-person and virtual collaboration. Employees were provided the opportunity to vote and share their ideas on design, amenities and equipment. To ensure consistency in function across all working styles, GSK employees are being provided access to modern equipment, such as interactive whiteboards, to enable them to brainstorm and collaborate either in-person or virtually, in real time.

Source: GSK Canada

Sandoz Seeks EU OK for High Concentration Biosimilar of AbbVie’s Humira
The European Medicines Agency has accepted an application from Sandoz, the generics and biosimilars business of Novartis, for a high concentration formulation (100 mg/mL) of Hyrimoz (adalimumab), a proposed biosimilar of AbbVie’s Humira (adalimumab). The application includes all indications covered by AbbVie’s Humira, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and uveitis. Humira is AbbVie’s top-selling drug, with 2021 global sales of $20.69 billion.

Sandoz received approval of a lower concentration (50 mg/mL) of Hyrimoz 50 mg/mL from the European Commission in July 2018, and the biosimilar was launched in several European countries shortly thereafter.

Source: Sandoz

Pfizer Takes $95-M Stake in Vaccine Company Valneva
Pfizer has taken a 8.1% equity stake for $95 million in Valneva, a Saint-Herblain, France-based vaccine company and has updated the terms of the companies’ previous collaboration for developing a vaccine against Lyme disease.

Valneva and Pfizer entered into a development and commercialization agreement in 2020 to co-develop the vaccine candidate, VLA15. The vaccine candidate was granted fast-track designation by the US Food and Drug Administration in 2017. In April (April 2022), the companies reported positive Phase II results in pediatric subjects 5 years of age and above. Pfizer plans to initiate a Phase III study in both adults and pediatric subjects in the third quarter of 2022.

In addition to taking an equity stake in Valneva, the companies updated the terms of their collaboration and license agreement, which was worth up to $308 million ($130 million upfront, $35 million in development milestones, and $143 million in early commercialization milestones). The companies adjusted the deal to have Valneva fund 40% of the remaining shared development costs instead of 30%. Pfizer will pay tiered royalties ranging from 14% to 22% instead of 19%, and the royalties will have an additional $100 million in milestone payments to Valneva based on cumulative sales.

Other development and early commercialization milestones are unchanged, of which $168 million remain, including a $25 million payment to Valneva upon Pfizer’s initiation of the Phase III study.

Source: Pfizer and Valneva

Novartis To Invest $250 M in R&D for Tropical Diseases, Malaria
Novartis has announced a five-year financial commitment of $250 million for research and development of new treatments for neglected tropical diseases and malaria.

The investment includes $100 million to advance R&D of four neglected tropical disease programs for Chagas disease, visceral leishmaniasis, dengue fever, and cryptosporidium infection.

In addition, the company is committing $150 million to advance drug candidates to combat emerging resistance to artemisinin, a malaria drug. It will also continue development of an optimized formulation for neonates and infants under 5 kg, for whom no treatment currently exists.

Source: Novartis

Organon, Henlius in Biosimilars Pact
Organon, the former biosimilars, women’s health and certain legacy products businesses spun off from Merck & Co. in 2021 and now a separate stand-alone company, has entered into a commercialization agreement with Shanghai Henlius Biotech, a Shanghai, China-based bio/pharmaceutical company, for several biosimilars of innovator blockbusters in select Asian countries.

Under the agreement, Organon will license commercialization rights for biosimilar candidates referencing Roche’s Perjeta (pertuzumab), a drug to treat breast cancer with 2021 global sales of CHF 3.96 billion ($4.09 billion), and Amgen’s Prolia/Xgeva (denosumab), a drug for treating osteoporosis and bone metastases in certain cancers, with 2021 combined global sales of $5.27 billion. Organon will acquire exclusive global commercialization rights except for China, including Hong Kong, Macau, and Taiwan.

The agreement also includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Bristol-Myers Squibb’s Yervoy (ipilimumab), an anticancer drug with 2021 global sales of $2.03 billion.

Under the agreement, Merck & Co. will make an upfront payment of $73 million as well as additional payments upon the achievement of certain development, regulatory, and commercial milestones. Henlius will be responsible for development and, if approved, will supply the products to Organon.

Source: Organon

UK’s MHRA Accepted into ICH
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has been accepted as a full member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH is focused on the harmonization of pharmaceutical regulations, including for those relating to quality and manufacturing, globally.

Source: UK Government