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Immunotherapies for Life

Priority Review Program Extended Through 2022

12-02-2016

House of Representatives approve the 21st Century Cures Act to increase funding of the FDA and the National Institutes of Health, including a long-term reauthorization of the Priority Review Program to encourage Treatments for Rare Pediatric Diseases

NEW YORK, December 2, 2016 – Y-mAbs Therapeutics, Inc. (YmAbs), an immunotherapy company discovering and developing innovative treatments for patients with cancer, today announced that the House of Representatives has approved the 21st Century Cures Act, which among other initiatives reauthorizes the Priority Review Voucher (PRV) program for rare pediatric diseases until 2020. A drug that receives a Rare Pediatric Disease Designation (RPDD) before October 1, 2020 continues to be electable for a voucher if the drug is approved before October 1, 2022.

“This long-term reauthorization of the PRV program is very important to YmAbs, and is potentially unlocking very significant future value. YmAbs was recently granted a second Rare Pediatric Disease Designation by the FDA, and could potentially be eligible for additional Rare Pediatric Disease Designations in the near future, as we continue working on our pipeline of pediatric assets”, said Thomas Gad, Founder, Executive Chairman and President of YmAbs.

Dr. Claus Møller, Chief Executive Officer further notes, “We are extremely pleased with the PRV program, which helps companies like YmAbs to continue focusing on development of new treatments for pediatric diseases, such as rare solid tumors with very poor prognoses, while utilizing the government programs in place.”
 

About Rare Pediatric Disease Program
In 2012, the United States Congress effectuated a Rare Pediatric Disease Priority Review Voucher Program to incentivize pharmaceutical sponsors to develop drugs for rare pediatric diseases. A sponsor who obtains approval of a new drug application (NDA) or biologics license application (BLA) for a rare pediatric disease may be eligible for a Priority Review Voucher (PRV), which may be redeemed to obtain priority review of a marketing application by the owner of such PRV. A PRV is fully transferrable and can be sold to any sponsor, who in turn can redeem the PRV for priority review of a marketing application in six months, compared to the standard timeframe of approximately ten months. Since the Priority Review Voucher Program was initiated, the FDA has granted eleven PRVs of which five have been transferred to third parties. The first transferred Rare Disease Priority Review Voucher was granted to BioMarin Pharmaceuticals in February 2014, who sold it to Regeneron Pharmaceuticals and Sanofi SA for $67.5 million. The most recent PRV was bought by AbbVie Ltd from United Therapeutics, Inc. for $350 million.
 

About YmAbs
YmAbs is a clinical stage biopharmaceutical company focused on developing new cancer treatments through immunotherapies. In addition, YmAbs utilizes its platform technologies to create next-generation humanized, affinity matured bispecific antibodies targeting GD2 and B7H3. To further improve our bispecific antibodies, we are collaborating on the development of a novel human protein tag that dimerizes T-cell engaging bispecific antibodies, which enables higher tumor binding and results in a longer serum half-life and a significantly greater T-cell mediated killing of tumor cells. Our treatments could potentially reduce longer-term toxicities associated with current chemotherapeutics and provide the potential for curative therapy even for patients with widespread disease. YmAbs’ goal is to drive multiple product candidates in select solid tumor cancers to FDA licensure. Each candidate has the potential to treat a variety of high-risk cancers. To learn more, visit www.ymabs.com.

 

SOURCE:

Y-mAbs Therapeutics, Inc.

 

CONTACT:

 Y-mabs Therapeutics, Inc.

 750 Third Avenue, 9th Floor

 New York, NY 10017

 USA

 +1 212 847 9844

 E-mail: info@ymabs.com

     Y-mAbs Therapeutics A/S

     Rungsted Strandvej 113

     2960 Rungsted Kyst

     Denmark

     +45 70 26 14 14

     E-mail: info@ymabs.com