Lonza, Takeda reach regulatory milestone in oncology tie-up

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Oatawa)
(Image: Getty/Oatawa)

Related tags: Oncology, Clinical development, Packaging, Supply chain, Supply chain management, marketing authorization, Marketing

Lonza provided development, manufacturing, and clinical packaging services for Takeda’s Alunbrig, which has received EMA marketing authorization.

Alunbrig (brigatinib), indicated for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC), received marketing authorization by the European Medicines Agency (EMA).

Ben Sahacic, director of commercial development at Lonza told us, “Lonza provided validation and regulatory submission support with Takeda leveraging benefits of a simplified supply chain with development, manufacturing, and clinical packaging in a single location in Tampa, Florida for both US and EU submissions.”

Lonza’s FL-based facility provided services for both US and EU submissions. Additionally, it produced clinical material for Phase I, II and II studies.

“Lonza will provide ongoing manufacturing product-resupply activities for brigatinib, while, in parallel, engaging in assessment of further collaboration on new oncology programs,”​ Sahacic stated.

According to Sahacic, Takeda is a “strategic client”​ for the advancement of oncology platforms for both clinical and commercial settings. 

Related news

Related products

show more

What do big pharma companies spend on R&D?

What do big pharma companies spend on R&D?

Zymewire | 15-Aug-2019 | Technical / White Paper

The free Big Pharma R&D Spend report examines the financial performance and research & development investments of the top 25 pharmaceutical companies...

Import Risks & Clinical Supply Depots

Import Risks & Clinical Supply Depots

Catalent Pharma Solutions | 07-Nov-2018 | Case Study

A sponsor running a clinical trial in Israel arranged to ship their clinical trial product from Europe to a depot in Israel. With the protocol based in...

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 05-Nov-2018 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

Related suppliers

Follow us

Products

View more

Webinars