Israeli biopharmaceutical company Kitov Pharma Ltd. (NASDAQ: KTOV; TASE:KTOV), announced last night that the US Food and Drug Administration (FDA) has approved Consensi oral tablets for marketing. Consensi has been approved for once daily use in three dosage forms, corresponding to approved dosages of amlodipine (2.5, 5, and 10 mg) for hypertension and a 200 mg dose of celecoxib for the treatment of osteoarthritis pain.
The company’s share price rose 41% on Nasdaq yesterday, giving Kitov a market cap of $41 million.
Kitov chairman and CMO Dr. Paul Waymack said, “Consensi provides a safe and effective combination treatment option for the millions of Americans who suffer from osteoarthritis pain and hypertension.”
He added, “Now that Consensi has been approved for marketing, our clinical and regulatory teams will focus on leveraging their drug development expertise to advance NT219, an exciting investigational new drug candidate currently in development for various oncology indications.” Kitov CEO Isaac Israel said, “This approval demonstrates the Kitov team’s ability and experience in expertly guiding Consensi through clinical trials and regulatory review, from Investigational New Drug (IND) submission to FDA approval in less than four years.
He continued, “Over 50 million Americans suffer from osteoarthritis. About 1 of 3 US adults or about 75 million people have high blood pressure, known as the “silent killer” due to the absence of noticeable symptoms. As a result, patients’ adherence to the hypertension treatment regimen is low. We believe that Consensi, as a single pill combination treatment for osteoarthritis and hypertension, presents a unique value proposition of potentially increasing treatment adherence.
“We recently expanded our commercialization network for Consensi by securing a second licensing agreement in Asia with a major Chinese pharmaceutical company. The FDA approval of Consensi puts us in a stronger position towards securing commercial partnerships for the US and other key territories.”
The FDA-approved Consensi™ New Drug Application included the positive results from the Company’s Phase III clinical trial. These data demonstrated that the study met its primary endpoint of showing that the drug lowers daytime systolic blood pressure by at least 50%.
Published by Globes [online], Israel business news – www.globes-online.com – on June 1, 2018
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