BEKINDA™ (RHB-102) is a proprietary, oral, extended-release, once-daily formulation of the antiemetic drug ondansetron. Ondansetron is marketed under various trade names including GSK’s Zofran®.
RHB-102 was licensed from SCOLR Pharma, Inc. [Amex: DDD] in May 2010. In March 2014 RedHill secured the direct rights to the original RHB-102 patents from Temple University, following SCOLR’s announcement that the they had ceased their business operations. RHB-102 has received the brand name BEKINDA™.
As Zofran®, BEKINDA™ is a 5-HT3 receptor antagonist and is planned to be indicated for prevention of nausea and vomiting for cancer patients. Two clinical PK studies were conducted.
After obtaining both an IND (Investigational New Drug Application) approval from the FDA and a CTA (Clinical Trial Application) approval from the Canadian Health Authority, In April 2012, RedHill announced positive results in a pivotal bioequivalence clinical trial with BEKINDA™. Following a Type B meeting held with the FDA in February 2013, RedHill announced in October 2013 that it had received positive results in two supplementary pharmacokinetic studies with BEKINDA™.
In December 2014 RedHill submitted a Marketing Authorization Application (MAA) seeking European marketing approval of BEKINDA™ for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting. The MAA was submitted to the UK MHRA and several other European member states and is supported by a number of pharmacokinetic studies comparing BEKINDA™ to several approved regimens of Zofran®, including a comparative bioavailability study with the European reference drug, Zofran® suppositories. RedHill expects to receive feedback from the MHRA regarding the European marketing application during the second half of 2015.
In March 2014 RedHill announced that it had held a pre-NDA meeting with the FDA, and is currently in discussions with the FDA regarding the submission of the U.S. NDA for BEKINDA™.