Today, the share price of Kitov Pharmaceutical Holdings Ltd. (TASE: KTOV)(Nasdaq: KTOV) has risen 8% after the company announced that its flagship product, the KIT-302 integrated drug for pain relief and lowering blood pressure, has successfully completed another pharmacokinetic bioequivalence (BE) study and met the U.S. Food and Drug Administration’s (FDA) standards. The trial’s success brings the company one step closer to applying for a final FDA marketing approval.
Kitov’s combination drug KIT-302 consists of two drugs: amlodipine, for the treatment of high blood pressure and celecoxib, indicated for osteoarthritis and causing hypertension.
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The last trial tested a lower dosage (2.5 mg) of amlodipine, compared with the previous pharmacokinetic trial, which tested bioequivalence in a 10 mg amlodipine dosage.
In August, the company received an FDA patent approval for this drug, which will enable it to market it exclusively in the US until May 22, 2029.
Following the publication of the results, Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer said, “We are pleased with the results of our additional pharmacokinetic BE study, which brings us closer towards submitting our New Drug Application to the FDA for KIT-302 as planned.”
Kitov is traded at a market cap of $28 million. Yesterday, its share price leaped 15% on Wall Street and today it has risen 8% on the Tel Aviv Stock Exchange, in addition to a high trade turnover. In the past year, the company’s share has dropped 60%.
Published by Globes [online], Israel business news – www.globes-online.com – on September 28, 2016
Copyright of Globes Publisher Itonut (1983) Ltd. 2016