West Annouces Significant Agreements With Swissfillon & scPharmaceuticals

West recently announced it has commenced discussions with Swissfillon AG, a provider of aseptic fill and finish services to pharmaceutical and biotechnology companies that are intended to lead to a non-exclusive global collaboration to provide fill-finish capabilities to customers using West’s proprietary SmartDose drug delivery platform for complex molecules.

Through the collaboration, it is anticipated that West will be able to deliver an integrated solution with filled Daikyo Crystal Zenith cartridges for the SmartDose wearable injector, which is expected to accelerate clinical development and enable customers to bring their innovative injectable drugs to market quickly. This new collaboration is expected to offer customers a robust clinical fill-finish capability later this year.

“We are very pleased to partner with Swissfillon and expand our ability to offer a fully innovative drug delivery solution supporting our customers’ journey from molecule to market. It combines Swissfillon’s fill-finish expertise with West’s proprietary drug delivery technology to deliver a streamlined solution that meets the unique needs of pharmaceutical manufacturers around the world,” said Karen Flynn, SVP & Chief Commercial Officer, West.

“We are excited to work with West to bring our fill-finish capabilities to West’s SmartDose platform offering,” added Daniel Kehl, Chief Executive Officer, Swissfillon AG. “We look forward to partnering together to support pharmaceutical and biotech customers to deliver innovative combination drug products to patients.”

West’s SmartDose drug delivery platform enables patients to self-administer medication in accordance with their prescribed treatment. West developed the SmartDose platform with extensive human factors testing and analysis to understand the interaction between the patient and the delivery system. An integrated solution for the containment and delivery of injectable medications, the SmartDose platform feature a silicone-free Daikyo Crystal Zenith cartridge and a Flurotec barrier film coated piston primary containment system.

Clinical fill-finish services are part of West’s new Integrated Solutions Program. The Program offers customers the opportunity to Simplify the Journey™ from molecule to market with containment and delivery solutions for combination products; analytical testing services; regulatory support; and device manufacturing, assembly and drug handling designed for any stage of the drug development lifecycle.

West also announced an agreement  with scPharmaceuticals Inc to incorporate West’s SmartDose Drug Delivery System with FUROSCIX. FUROSCIX is scPharmaceuticals’ lead program for the treatment of edema in patients with heart failure.

“We are pleased to announce the successful completion of preliminary feasibility studies of FUROSCIX with the SmartDose Drug Delivery System and the execution of a development agreement with West. We look forward to advancing FUROSCIX with the West on-body drug delivery system technology,” said John Tucker, President and Chief Executive Officer of scPharmaceuticals. “We believe the features and functionality of the SmartDose system improves the overall patient experience with FUROSCIX. Heart failure remains a large market opportunity with high unmet patient need and significant associated healthcare costs. We anticipate filing a New Drug Application for FUROSCIX with the next-generation technology in 2020, subject to meeting with the FDA to define the regulatory path.”

Based on the company’s interactions with the FDA since June 2018, including the previously disclosed clarifications on additional human factors and validation studies necessary to advance FUROSCIX using the existing delivery technology, scPharmaceuticals elected to expedite the advancement of a next-generation on-body delivery system with a pre-filled cartridge. The development agreement with West represents an important milestone in advancing the FUROSCIX program.

scPharmaceuticals recently completed preliminary feasibility studies on the West SmartDose drug delivery system, confirming its ability to successfully deliver FUROSCIX. scPharmaceuticals’ feasibility testing included drug stability in the pre-filled cartridge, drug compatibility, and overall performance within FUROSCIX delivery specifications. The West SmartDose drug delivery system, previously approved by the FDA for use in the US with another combination product, allows patients to self-administer medication in accordance with their prescribed treatment. West developed this wearable technology with extensive human factors testing and analysis to understand the interaction between the patient and the delivery system. The SmartDose drug delivery system adheres to the patient’s body enabling the patient to be hands free during administration.

“West and scPharmaceuticals have a shared objective to deliver injectable medicines to improve patient lives, so we are excited to announce this development agreement today,” said Karen Flynn. “West is very pleased that scPharmaceuticals has selected the SmartDose drug delivery system for FUROSCIX and looks forward to working together on this project.”

FUROSCIX is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via a wearable, pre-programed drug delivery system that is applied to the abdomen for subcutaneous drug administration. FUROSCIX is being developed for treatment of edema, or fluid overload, in patients with heart failure. FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to edema.