AGC Biologics in Bothell to produce new diabetes treatment

BOTHELL — A new treatment shown to delay the onset of Type 1 diabetes by two years will be manufactured at a biotech’s campus in Bothell.

Provention Bio, a New Jersey based pharmaceutical company, developed the treatment known as Tzield (teplizumab-mzwv).

AC Biologics, which is headquartered in Bothell, will produce it for commercial distribution.

AGC is a contract development and manufacturing company that provides drug development and manufacturing services to pharmaceutical companies.

Pharmaceutical firms typically partner with contract producers, like AGC, to outsource drug development and drug manufacturing.

Tzield, which is given intravenously, received Food and Drug Administration approval last year.

Studies show that the treatment delayed the onset of stage 3, Type 1 diabetes in patients older than age eight by about 24 months, the company said. Patients with stage three diabetes require insulin injections for the rest of their lives.

“The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease,” said Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA Center for Drug Evaluation and Research.

Others say that delaying the disease in younger children “would enable the pancreas to grow to adult size, giving better disease outcomes,” according to the UK’s Juvenile Diabetes Research Foundation.

Type 1 diabetes occurs when a person’s immune system attacks and destroys the cells that make insulin.

People with a type 1 diabetes have increased glucose that requires insulin shots to survive and must check their blood sugar levels regularly throughout the day.

Tzield binds to specific immune system cells and delays progression to stage 3 type 1 diabetes. The treatment may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that moderate the immune response, according to the FDA.

Delaying the onset of the disease gives patients and families “more time to live without and, when necessary, prepare for the burdens, complications and risks associated with Stage 3 disease” said Ashleigh Palmer, Provention’s CEO and co-founder.

Nearly two million Americans have Type 1 diabetes.

Scientists at AGC Biologics have been working with Provention for several years to develop and bring the new therapy “to market and navigate through every clinical phase,” an AGC spokesman said.

The company is a member of the AGC Group in Japan. Its headquarters are in Bothell, where it employs 300. AGC also has facilities in California, Japan, Germany and Denmark. In all, the company employs more than 2,000 people at facilities in Washington, California, Japan, Germany and Denmark.

AGC’s local plans includes opening a new 67,750 square foot warehouse and storage facility at 6200 23rd Drive in Everett, a former Boeing facility.

The facility is slated to open by the end of March, a company spokesman said.

Provention worked closely with AGC to develop a commercial production process for Tzield that would meet FDA approval, said Provention CEO Palmer.

“This is an important milestone for the Type 1 Diabetes community, and we hope the launch of this therapy can truly make an impact on patients and families seeking innovative treatments for the delay of Stage 3 T1D,” Palmer said.

“We at AGC Biologics are proud to have helped develop this innovative new medicine and to be manufacturing it for commercial distribution,” said Kevin Ingham, general manager of AGC’s Bothell site.

“This achievement demonstrates our Seattle site’s increasing track record in commercial manufacturing, which is aligned with AGC Biologic’s purpose of bringing hope to life.”

Janice Podsada: 425-339-3097; jpodsada@heraldnet.com; Twitter: @JanicePods.