Acquired ODD status for liver cancer and intrahepatic bile duct cancer and License-In for additional Indications
As of April 24, 2020, NewG Lab Pharma received the status of Orphan Drug Designation (ODD) for liver cancer and intrahepatic bile duct cancer from KoDiscovery. This acquisition of ODD status is based on a joint agreement with KoDiscovery. and Primocure. Primocure Inc., a 100% subsidiary of KoDiscovery, already received an Orphan Drug designation from the FDA for the treatment of liver and intrahepatic bile duct cancer in 2013.
In addition to obtaining ODD status, NewG Lab Pharma signed an in-licensing contract to commercialize KAT (Kodiscovery Anti-cancer therapeutics) for gallbladder and intrahepatic bile duct cancer. Therefore, NewG Lab Pharma has received the commercialization right for a total of 6 indications including liver cancer, breast cancer, bladder cancer, and melanoma.
In September 2019, NewG Lab Pharma signed a pre-clinical research contract including the ODD Program with Covance, a global contract research organization. Currently, a GLP-Tox Study on an investigational metabolic cancer drug, KAT, is in progress. In parallel with pre-clinical trials, NewG Lab Pharma and Covance have applied for an Orphan Drug in a subgroup of melanoma this February and waited for the result.
Orphan drugs are drugs that :
(A) treat diseases and conditions affecting fewer than 200,000 patients in the United States, or
(B) shows no reasonable expectation that costs of development and marketing of the drug can be recovered by selling medicines for the disease or symptom that affect more than 200,000 people in the United States.
ODD qualifies the sponsor company for various incentives such as
1) Eligibility for 7 years of marketing exclusivity regardless of patent period
2) Up to 50% Tax credit on the cost of clinical trials
3) Exemption of fees for registration
4) Support of Office of Orphan Products Development (OOPD) during the development period
5) Eligibility for applications for clinical development cost assistance programs.
It also offers eligibility for a fast track drug development program, priority review, and accelerated approval.