Durham, NC (USA) – June 13, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, today announced the expanded deployment of its Extended Workbench laboratory services program to support the ongoing manufacturing and development of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension). ZILRETTA is the first U.S. Food and Drug Administration (FDA) approved product from Flexion Therapeutics, Inc., a Massachusetts-based biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA). Flexion utilized Alcami’s Extended Workbench to support ZILRETTA from Phase 2 clinical trials through commercial launch and is using the program for the release and stability testing of commercial batches.
Alcami's Extended Workbench is a full-time equivalent (FTE) comprehensive service program customized to a client’s specific project. It dedicates Alcami staff to a particular project, granting clients additional flexibility, freedom, and consistent control over their outsourced laboratory needs. Extended Workbench can vary in size, management type, and scope, and can be effective across any pharmaceutical platform. The fixed-cost service can meet every laboratory necessity, from method development and validation to full quality control support.
“Our versatile Extended Workbench solution was an excellent fit for our partners at Flexion, whose accelerated timeline, robust clinical trial program, and specific testing requirements mandated dedicated laboratory resources to get their product to market,” said Alcami Chief Commercial Officer, Syed T. Husain. “It was a privilege to have collaborated with Flexion, leading to the approval of ZILRETTA, and we are pleased our Extended Workbench will continue to support their product.”
“For the past four years, Alcami has been one of our most trusted collaborators,” said Mike Clayman, M.D., President and Chief Executive Officer of Flexion. “They have been able to both respond to and anticipate our needs as Flexion has transitioned into a commercial organization, and we look forward to their ongoing support.”
ZILRETTA is the first and only FDA-approved extended-release intra-articular therapy for patients confronting OA-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide – a commonly administered, short-acting corticosteroid – with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief over 12 weeks.
Alcami began work on ZILRETTA in the fall of 2014. The company helped Flexion meet demanding requirements from the FDA during the review of the New Drug Application, which ultimately resulted in the U.S. approval of ZILRETTA for the treatment of OA-related knee pain on October 6, 2017. The product was officially launched nationwide in late November of 2017.
Alcami is a world-class fully-integrated end-to-end contract development and manufacturing organization (CDMO) headquartered in North Carolina, with executive offices in Durham and Wilmington. With approximately 1,000 employees operating at 10 global locations, Alcami provides customizable and innovative services to small and mid-size pharmaceutical and biotechnology companies by offering individualized and integrated services across multiple areas. We connect our clients with innovative solutions for API development and manufacturing, solid-state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services. For more information, please visit alcaminow.com.
INDICATION AND SELECT IMPORTANT SAFETY INFORMATION FOR ZILRETTA (triamcinolone acetonide extended-release injectable suspension)
Indication: ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is not intended for repeat administration.
Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.
Warnings and Precautions:
- Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
- Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
- Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
- Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment.
Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.
Please see ZilrettaLabel.com for full Prescribing Information.
ABOUT FLEXION THERAPEUTICS
Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis. The company's core values are focus, ingenuity, tenacity, transparency and fun. For the past two years, Flexion has been named one of the Best Places to Work by the Boston Business Journal, and Flexion was also recognized as a Top Place to Work in Massachusetts by The Boston Globe in 2017.