Almac Pharma Services and Provention Bio, Inc Celebrate Rapid Launch of TZIELD™ (teplizumab-mzwv)

Audubon, PA, USA – 8 February 2023 – Almac Pharma Services was delighted to welcome the Provention Bio Inc’s management team to celebrate the successful packaging and rapid launch of Provention Bio Inc’s first biologic treatment, TZIELD™ (teplizumab-mzwv) into the US market.

TZIELD* was approved on November 17 by the U.S. Food and Drug Administration for intravenous use as the first and only immunomodulatory treatment to delay the onset of Stage 3 Type I diabetes (T1D) in adult and pediatric patients aged 8 years and older with stage 2 T1D. Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening.

The Provention Bio Inc’s team toured the Almac Pharma Services’ Audubon, PA facility and met with some of the team who have been key to ensuring their product had a smooth and successful launch. Culminating in a celebratory lunch and presentation to the operational staff, sharing insights into the patient journeys that have been key in the development and delivery of TZIELD™. The visit was proposed by Provention Bio Inc as an opportunity to recognise and thank the operational teams who work so hard on packaging and preparing their drug product for market.

The Almac Pharma Services’ Pennsylvanian based team began its partnership with Provention Bio, Inc. to support the packaging of the TZIELD product for commercial supply in 2020. Together they agreed on an appropriate strategic programme to efficiently, and effectively, prepare the specialised treatment for distribution including expediting all aspects of packaging and labelling to distribute TZIELD to patients within weeks of FDA approval. This visit further solidifies the by Almac Pharma Services and Provention Bio Inc, to advance the treatment of T1D to patients.

Harry Lindenmuth, VP Operations Audubon, Almac Pharma Services commented: “We are pleased to have Provention Bio, Inc join our teams on site to celebrate the successful launch of their first biologic treatment. Almac Pharma Services is delighted to have played a role in packaging this key advancement. Being able to mark this occasion with Christina and the Provention Bio Inc management team has been very meaningful to our own team. Seeing the patient journeys has been particularly impactful.”

Almac Pharma Service’s commitment to partnering to advance human health is most visible through key partnerships with companies such as Provention Bio, Inc., who are working to advance life-changing treatments and therapies to patients.

*TZIELD may cause serious side effects, including Cytokine Release Syndrome and a decrease in white blood cells. Please see Important Safety Information http://bit.ly/3VgvSjX and Medication Guide and Prescribing Information http://bit.ly/3hZZiEK.