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FDA GRANTS ORPHAN DRUG DESIGNATION FOR PROPANC BIOPHARMA

Propanc Biopharma Inc. (PPCB) announced yesterday that the FDA approved their Orphan Drug Designation (ODD) for the use of its lead product, PRP. PPCB is a clinical stage biopharmaceutical company focused on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian, and colorectal cancers. Under the Orphan Drug Act (ODA), drugs, vaccines, and diagnostic agents qualify for orphan status if they are intended to treat a disease affecting less than 200,000 American citizens.

Under the ODA, orphan drug sponsors qualify for seven-year FDA-administered market Orphan Drug Exclusivity (ODE), tax credits of up to 50% of R&D costs, R&D grants, waived FDA fees, protocol assistance, and may get clinical trial tax incentives. This designation helps crucial drug treatments, such as PRP, move to the medical market faster, increasing the chance to save lives, whilst also providing exclusivity in the marketplace for their drug which maximizes their returns.

ENDING THE THREAT OF PANCREATIC CANCER

Pancreatic cancer is one of the deadliest, if not the deadliest, cancer. This diagnosis gives patients a median survival rate of 6 months and less than 5% of patients live up to 5 more years. PRP is making headway through the cancer research world as a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen, for the treatment of pancreatic cancer. As PRP moves toward First-In-Human Studies, the goal is to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. The World Health Organization stated that 8.2 million people died from cancer in 2012. A recent report published by IMS Health, stated that innovative therapies are driving the global oncology market to meet demand. The market expected to reach $150 Billion by 2020.

“PRP is truly a unique and exciting technology, and I am really pleased we achieved this important milestone,” said Dr Julian Kenyon, Propanc Biopharma’s Chief Scientific Officer. “My experience tells me that our drug has the potential to extend life meaningfully, free from the severe side effects inflicted by standard treatment approaches.”

IN OTHER BIOTECH NEWS

Moleculin (MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, announced this morning they’ll be hosting a conference call on Thursday, June 29, 2017 at 4:30 PM ET to discuss the recent new discovery of a metabolic inhibitor with the potential to treat pancreatic cancer as well as to provide a business update.
CARA Therapeutics, Inc. (CARA) announced last week that the FDA has granted Breakthrough Therapy designation to I.V. CR845 for the treatment of moderate-to-severe uremic pruritus (UP) in chronic kidney disease (CKD) patients undergoing hemodialysis.

NantKwest (NK) announced earlier this month they’ll be expanding the company’s existing NANT Cancer Vaccine program in pancreatic cance3r to target a number of additional tumor types.

Arena Pharmaceuticals (ARNA)’s CEO, Amit Munshi, presented a corporate update at the JMP Securities Life Sciences Conference last Wednesday, June 21st. You can find the audio webcast on Arena’s website at www.arenapharm.com.

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