Almac Pharma Services Supports Rapid Launch of Provention Bio, Inc.’s Treatment TZIELD™ (teplizumab-mzwv)
December 13, 2022
First and only treatment indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and paediatric patients aged eight years and older with Stage 2 T1D
Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services, has successfully supported the packaging and rapid launch of Provention Bio Inc’s product, TZIELD™ (teplizumab-mzwv) into the US market.
TZIELD* was approved on 17th November by the United States Food and Drug Administration for intravenous use as the first and only immunomodulatory treatment to delay the onset of Stage 3 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.
T1D is an autoimmune disease that occurs when the immune system attacks and destroys the cells that make insulin. People with Stage 3 T1D have increased glucose levels, eventually requiring insulin shots (or wearing an insulin pump) to survive and must check their blood sugar levels regularly throughout the day. Although it can appear at any age, T1D is usually diagnosed in children and young adults.
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.
“At Provention, we look to our manufacturing and operational partners for their strong industry expertise, infrastructure and compliance to regulatory standards to help execute a successful commercial launch,” noted Christina Yi, Chief Operations Officer at Provention Bio. “That’s why we partnered with Almac – our operational partnership supports TZIELD reaching patients across the US and helps us accelerate the depth and breadth of its launch.”
Harry Lindenmuth, Audubon Site Director, Almac Pharma Services commented: “We are pleased to have supported the launch of Provention Bio, Inc.’s first biologic treatment. Our team is delighted to have played a role in packaging this key advancement in delaying the onset of stage 3 type 1 diabetes. Through our relationship with Provention Bio, Inc., the teams worked diligently to develop a plan and implement the most appropriate robust and timely processes, protecting the integrity of TZIELD whilst ensuring it was delivered shortly after FDA approval. Many congratulations to our partners at Provention Bio, Inc. on the development of this treatment.”
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.
About Provention Bio, Inc.
Provention Bio, Inc. (Nasdaq: PRVB) is a commercial-stage biopharmaceutical company focused on advancing the development and commercialization of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Company’s pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including T1D, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.
About Almac Pharma Services
Tailormade pharmaceutical development and commercial solutions
With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.
Employing over 1,600 highly skilled individuals across 4 locations in Europe and the US, the company provides tailored, quality-led and timely solutions from early and late phase pharmaceutical development, clinical and commercial drug product manufacture, product launch through to commercial packaging and global distribution.
About Almac Group
A unique culture delivering exceptional solutions
The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.
Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation which has grown organically over the past five decades now employing over 6,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.