In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|August 7, 2017
Seattle Genetics Acquires Pharma Manufacturing Facility from BMS
Author(s)BioPharm International Editors
The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline.
Advertisement
On August 1, 2017, biotechnology company Seattle Genetics announced that it signed definitive agreements to purchase Bristol-Myers Squibb’s (BMS) pharmaceutical manufacturing facility in Bothell, Washington. The facility, known as the Monte Villa Parkway Research Center, is a 51,000-square-foot manufacturing and laboratory space built in 2014. Seattle Genetics plans to use the facility primarily for antibody production for current and future pipeline programs.
As part of the transaction, the company intends to offer employment to the manufacturing facility’s current employees. The transaction is expected to close in the second half of 2017.
Under one of the agreements, Seattle Genetics purchased the manufacturing facility site location for $17.8 million, according to a company filing with the US Securities and Exchange Commission (SEC). Under a separate agreement, Seattle Genetics will acquire certain plant equipment and improvements from BMS for approximately $25.5 million. Also, under a clinical manufacturing services agreement, Seattle Genetics will agree to manufacture certain BMS clinical product candidates in accordance with prescribed production schedules and quantities through to late December 31, 2018, or when certain technical transfer activities have been completed, according to the SEC filing.
“This turnkey manufacturing facility provides the capability, capacity, and skilled workforce needed to support our expanding antibody-drug conjugate and immuno-oncology pipeline, and complements our existing outsourced manufacturing model,” said Vaughn Himes, PhD, chief technical officer of Seattle Genetics, in a company press release. “In addition, its location near our corporate headquarters will provide operational synergies with our current technical operations team and underscores our strategy for continued growth in Washington state.”
Source:
Advertisement
Related to this article
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.
Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
3
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
4
The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
5