July 24, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Boehringer Ingelheim, based in Ingelheim am Rhein, Germany, plans to invest $217 million in upgrading and expanding its manufacturing plant in Fremont, Calif.
The company indicates that this will create 300 new high-wage and high-skill positions to the city. The State of California recently awarded Beohringer Ingelheim two separate tax credits totaling $25.5 million.
The expansion will allow the company to increase manufacturing capacity by a third. It primarily manufactures drugs for immunology, rheumatology and oncology.
“The Bay Area is the largest biotech cluster in the world,” said Jens Vogel, president and chief executive officer of Boehringer Ingelheim Fremont, in a statement. “We are happy to have made Fremont our home and are grateful for the support we have received from the community and the State of California. We have made a commitment to the region and are excited to continue to invest in the Bay Area and expand our workforce to help increase patient access to high-quality medicines.”
On July 11, the company announced final results from its RE-VERSE AD Phase III clinical trial of Praxbind (idarucizumab), showing that it immediately and completely reversed the anticoagulant effect of Pradaxa (dabigatran etexilate) in emergency situations. The data was presented at the International Society on Thrombosis and Haemostasis (ISTH) 26th Biennial Congress held in Berlin, Germany, while simultaneously published in the New England Journal of Medicine.
“Emergencies or accidents can happen to anyone,” said Charles Pollack, lead investigator and professor of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, in a statement. “RE-VERSE AD has shown that idarucizumab reverses the anticoagulant effect of dabigatran within minutes and provides immediate, complete and sustained reversal of dabigatran, so that treating physicians can fully focus on dealing with the emergency at hand.”
And on June 14, the company released data from its Phase III VOLTAIRE-RA study, confirming that its candidate, BI 695501, a biosimilar to Humira, has similar efficacy, safety and immunogenicity in patients with moderate to severe active rheumatoid arthritis.
“The result that Boehringer Ingelheim’s adalimumab biosimilar candidate delivers the same clinical benefits and safety profile as Humira is great news for patients and physicians,” said Karsten Kiseel, Boehringer Ingelheim’s head of Global Medical Affairs Biosimilars, in a statement. “If approved by regulatory authorities it will increase the treatment options for patients with autoimmune diseases, while contributing to the long-term sustainability of healthcare system.”
The trial wrapped up the company’s biosimilar assessment, and results have been submitted to regulators with the required non-clinical and clinical data for biosimilar registration.
The company’s Fremont, Calif. facility focuses on human biologics manufacturing. California State Treasurer John Chiang said in a statement, “The State Treasurer’s Office is excited to play a role in helping Boehringer Ingelheim expand and create nearly 300 permanent, high-paying jobs right here in California. The incentives my office provides ensure that California will retain and create jobs, bolster the economy and clean the environment, today and into the future.”
