Ascelia Pharma receives conditional FDA acceptance for brand name Orviglance

2021-08-10
Download

Ascelia Pharma AB (publ) (ticker: ACE) today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted Orviglance® as the proposed brand name for manganese chloride tetrahydrate (Mangoral), the company's novel first-in-class MRI contrast agent for use in liver MR imaging in adults with severely impaired kidney function.

The name Orviglance was developed in accordance with FDA’s guidance for the submission and evaluation of proprietary names and the name selection included a research study of healthcare practitioners across the U.S. to ensure accurate prescription and safety interpretation of the name.

In addition, Orviglance previously received an invented name approval from the European Medicines Agency (EMA).

 “This is yet another important step towards making Orviglance available to patients as our U.S. and global commercialization preparations progress. We continue to focus on the completion of the ongoing Phase 3 program and subsequent regulatory submission, approval and launch of this first-in-class MRI contrast agent”, said Julie Waras Brogren, Chief Commercial Officer of Ascelia Pharma.

Orviglance (previously referred to as Mangoral), which entered pivotal clinical studies in 2020, has been granted an Orphan Drug Designation (ODD) by the FDA and is targeted patients with poor kidney function who undergo an MRI scan of the liver to detect cancer.

As part of the launch plans for Orviglance*, Ascelia Pharma opened its US office in New Jersey earlier this year.

*Trademark is registered in Europe and several other markets and submitted for registration in the US.

2021-09-21

Ascelia Pharma Signs Clinical Collaboration Agreement With Taiho Oncology, Inc. for the Development of Oncoral in Combination with LONSURF®

Ascelia Pharma AB (publ) (ticker: ACE) today announced that it has signed a clinical collaboration agreement with Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. The collaboration concerns an upcoming global Phase 2 clinical study in gastric cancer. In this all-oral combination study, Ascelia Pharma’s irinotecan chemotherapy tablet Oncoral (ASC-201) will be evaluated in combination with Taiho Oncology’s LONSURF® (trifluri ...
2021-08-19

Quarterly Report Q2 2021: Preparing Oncoral for the next level

Ascelia Pharma AB (publ) (ticker: ACE) today published its quarterly financial report for Q2 2021 (April – June 2021), which is now available on the company’s website: https://www.ascelia.com/ir-media/reports-presentations/
2021-08-18

Covid-19 extends recruitment period of SPARKLE study

Ascelia Pharma AB (publ) (ticker: ACE) today announced that the continued global impact of the Covid-19 pandemic could extend the recruitment period of the clinical phase 3 study SPARKLE with up to 6 months. The recruitment is now expected to be completed during H1 2022. Ascelia Pharma has a solid cash position supporting operations well into 2023.