BOONTON, N.J., May 3, 2021 — Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH), today announced the expansion of its Boonton, NJ manufacturing facility and the launch of its CDMO business segment, providing custom solutions for the formulation, development and manufacturing of solid oral doses for difficult to formulate BCS III and IV compounds, including peptides and highly potent compounds. Enteris now provides bench to market services, including the development, manufacture, testing and release of Phase 1 to Phase 3 clinical trial supplies, and commercial production.
The expanded 32,000-square-foot facility includes 6,000 square feet of cleanroom space with approximately 2,500 square feet dedicated to the containment and processing of high potency API (HPAPI).
“This is a significant accomplishment for Enteris that plays a key role in our future growth plans,” said Rajiv Khosla, Ph.D., Chief Executive Officer of Enteris. “Our purpose-built manufacturing facility now has the wherewithal to produce CTM through to Phase 3, as well as product for commercial launch. These enhanced capabilities position Enteris to take advantage of a variety of growth opportunities, and it is our intent to maximize this potential to the fullest. The expansion allows Enteris to seek deeper development and manufacturing relationships with partners by providing custom solutions from bench to market.”
The manufacturing plant’s HPAPI containment area is designed to safely handle highly potent APIs. Depending on the solid oral dosage unit’s physical characteristics, batch sizes can vary from a few hundred to hundreds of thousands of dosage units. The facility also includes 1,700 square feet of flexible suite space that can be adapted to a partner’s development and manufacturing needs.
“Delivering on a construction timetable amid the COVD-19 pandemic was no easy feat, and the team at Enteris is to be congratulated for meeting the challenge,” stated Paul Shields, Ph.D., Chief Operating Officer for Enteris. “We look forward to leveraging the enhanced manufacturing capabilities to deepen existing manufacturing relationships and bolster our ability to secure new high-value relationships with companies seeking CDMO capabilities in the U.S., regardless of whether the product is a solid oral formulation using our proprietary oral formulation technologies, Peptelligence® or ProPerma™, or other tablet technology.”
Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH) offering total integrated contract development and manufacturing (CDMO) services including innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence® and ProPerma™. The technologies have been the subject of numerous feasibility studies and active development programs, several of which are in late-stage clinical development. Additionally, Enteris BioPharma is advancing an internal product pipeline of oral tablet reformulations of drug products that address significant treatment opportunities for which there is no oral delivery option. Enteris BioPharma’s most advanced internal product candidate, Ovarest® (oral leuprolide tablet), is an oral peptide being developed for the treatment of endocrine disorders. TobrateTM (oral tobramycin tablet) is also being developed by Enteris BioPharma for the treatment of uncomplicated urinary tract infection (uUTI). For more information on Enteris BioPharma and its proprietary oral delivery technology, please visit https://www.EnterisBioPharma.com.
Amos J. Sanchez
Director, Business Development and Partnering