Delta-Fly Pharma, Inc. received orphan drug designation for DFP-10917 from the US Food and Drug Administration

8 December 2022

Delta-Fly Pharma, Inc. reports that the US Food and Drug Administration has received orphan drug designation for DFP-10917, a lead pipeline of the company of acute myeloid leukemia.

With the ODD, Delta-Fly Pharma, Inc. could claim a seven-year market exclusivity and some benefits such as research and development credits in view of regulatory approval.

DFP-10917 is an investigational anticancer compound for the treatment of patients with refractory/relapsed AML. A Phase 3 clinical trial is ongoing at the MD Anderson Cancer Center in Texas and other major sites for hematologic cancer therapies in the United States. The company expects the patient recruitment plan to be completed soon.

Delta-Fly Pharma, Inc. focuses not only on the cancer itself, but on the overall context factors of cancer patients and aims to provide medicines that are recommended for cancer patients and their families.

company profile

Company Name

Delta-Fly Pharma, Inc. [Tokyo:4598]

Capital

3352 million Japanese yen

Representative's name and title

Kiyoshi Eshima, PhD, President

Date of company incorporation

December 6, 2010

Description of business

Research and development, manufacturing and marketing of pharmaceuticals

corporate headquarters

37-5, Nishikino, Miyajima, Kawauchi-cho, Tokushima 771-0116, Japan

branches

Tokyo, Beijing, Vancouver

The source language in which the original text is published is the official and authorized version. Translations will be included for a better understanding. Only the language version that was originally published is legally valid. Therefore, compare translations with the original language version of the publication.

Contacts
Delta-Fly Pharma, Inc.
Inquiries: Yasuo Matsueda
Tel: +81-(0)3-6231-1278
ymatsueda1206@delta-flypharma.co.jp
https://www.delta-flypharma.co.jp/en/

 

Source:businesswire.com