• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Clearside Biomedical inks $76m licensing deal with Bausch for Xipere

October 23, 2019 By Sean Whooley

Clearside Biomedical logo - updatedClearside Biomedical (NSDQ:CLSD) said yesterday that it entered into a license agreement with Bausch Health Ireland (NYSE:BHC) worth up to $76 million for the Xipere device for the treatment of macular edema associated with uveitis.

The agreement grants Bausch an exclusive license to develop, manufacture, distribute, promote, market and commercialize the suprachoroidal injection device.

Bausch agreed to pay $5 million upfront, plus additional payments worth up to $15 million after achieving specified pre-launch development and regulatory milestones. And there’s another $56 million on the line in other milestone payments pegged to regulatory approvals for additional indications and sales goals, according to a regulatory filing.

Clearside is also entitled to receive tiered royalties at increasing percentages during the applicable royalty term after reaching the $30 million cumulative sales mark, according to the filing.

Under the agreement, Alpharetta, Ga.-based Clearside is responsible for all of Xipere’s development expenses until the company’s new drug application is approved by the FDA. It is also responsible for clinical and development expenses put toward the FDA’s requests in a complete response letter. If the FDA approves Xipere, Bausch holds responsibility for all expenses after the approval.

Last week, the FDA sent its CRL, saying it found no efficacy issues with Xipere and will not ask for further clinical efficacy studies. Clearside said it expects to address the recommendations in the CRL in a manner that would allow the company to resubmit its NDA in the first quarter of 2020.

Clearside also agreed not to develop or commercialize Xipere alone or with another device in the licensed field in the U.S. or Canada. Bausch has the right to terminate the agreement and have its $5 million upfront payment refunded if the FDA has not approved the Xipere NDA by February 28, 2021.

Shares of CLSD were up 8.9% at 86¢ per share while shares of BHC were down -0.2% at $22.53 per share in early-morning trading today.

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: Bausch Health, Clearside Biomedical

IN CASE YOU MISSED IT

  • Embecta stock soars on first full-quarter results after BD spinoff
  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
  • Study backs Fluidx embolic device for vessel filling
  • Senseonics stock is up as it sticks by revenue guidance

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS