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

Drug Delivery Business

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

More trouble for United’s Remodulin

April 4, 2017 By Sarah Faulkner

More trouble for United's RemodulinThe Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled yesterday that the claims of United Therapeutics‘s (NSDQ:UTHR) patent, which covers Remodulin, are unpatenable due to obviousness. SteadyMed (NSDQ:STDY) challenged the patent in October last year.

The patent, No. 8,497,393, relates to the process to purify prostacyclin derivatives, including treprostinil, which is the active ingredient in United’s Remodulin and SteadyMed’s Trevyent. Both candidates are designed to treat pulmonary arterial hypertension.

“We are very pleased with this decision by the [Patent Trial and Appeal Board], which confirms our position that the claims in the … patent were invalid, and the patent should not have been issued to United Therapeutics,” SteadyMed president & CEO Jonathan Rigby said in prepared remarks. “We have a growing body of market research data that we believe strongly indicates a significant need for Trevyent that, if approved, has the potential to take a meaningful share of the PAH market.”

SteadyMed’s shares jumped 40% premarket on robust volume yesterday, but today is trading at $6.65 apiece, down -11.3%. The company said it plans to file a New Drug Application for Trevyent with the FDA this quarter.

This is the latest in a slew of problems for United. Yesterday, shares in United Therapeutics (NSDQ:UTHR) fell after the company said that the U.S. commercial launch of Remosynch, Medtronic‘s (NYSE:MDT) implantable infusion pump for Remodulin, will be delayed until 2018.

In March, the FDA updated Medtronic’s Class I recall for the company’s SynchroMed II and EL implantable drug pumps over a priming bolus issue. which Medtronic said it can fix with a software update. But analysts are concerned that any delay in debuting an alternative delivery option for Remodulin will make it harder for United to protect its sales as it faces generic competition in the year ahead.

“United Therapeutics’ commitment to bringing better therapies to patients transcends temporary delays or setbacks,” United chairman & CEO Martine Rothblatt said in prepared remarks. “We are sorry to have missed our 2017 launch target, but it is a small miss in the context of our providing more U.S. pulmonary arterial hypertension patients with helpful medicines than any other company.”

Shares in United were trading at $124.22 apiece in mid-morning activity today, up 0.2%.

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics, United Therapeutics

IN CASE YOU MISSED IT

  • Medtronic to separate Diabetes business unit
  • Tandem Diabetes Care wins CE mark for Mobi insulin pump with Control-IQ+ technology
  • Glooko adds chief strategy officer to chief medical officer’s title
  • Cordis launches 10,000-patient registry for drug-eluting balloon
  • Senseonics opens $50M public offering, $25M private placement with Abbott

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

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.

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

Copyright © 2025 · 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.

Privacy Policy | RSS