Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

[JB3729]

I've been wondering what KTOV would do with the anticipated earnings from KIT-302. IMO, they have plenty of money for a phase 1 on this new drug and earnings should be coming in from KIT-302 in time to pay for the other trials.

From sticky -

KTOV a very professional report (link inside)-"patient population for KIT-302 of approximately 12 million patients in the US". "Figure 6 shows our estimates for US sales of KIT-302 based on the assumptions above. Our scenario includes a modest launch and peak penetration of 2%. This yields estimated peak sales of $513 million in 2022"
http://www.baystreet.ca/articles/research_reports/lifesci/Kitov092116.pdf


I don't think too many KTOV investors were fooled by the Pfizer trial. From SA -

http://seekingalpha.com/article/4032938-kitov-pharmaceuticals-precision-study-shelf-registration-create-buying-opportunity

From an article at the American Heart Association (my emphasis):

"The trial was so poorly designed that the conclusions are unsupportable," said Garret FitzGerald, M.D., director of the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania, who wrote about the study in an editorial published in Circulation.
"The trial is called PRECISION, and that's the last thing it delivers," he said. "It provides us no useful information to influence practice."
[…]
"Doctors may have been nervous about giving people with high cardiovascular risk a COX-2 inhibitor, so they never enrolled them in the trial," said Elliott Antman, M.D., a cardiologist at Brigham and Women's Hospital in Boston and associate dean for clinical/translational research at Harvard Medical School, who was not involved in the study.
And from an article at the Cardiology Advisor (my emphasis):

During the trial, 68.8% of patients discontinued taking the study agent, and 27.4% of patients were lost to follow-up. "The principal limitation was the low retention and nonadherence rates," Nissen said. "This is more typical in pain trials than in CV outcome trials."
A second limitation he noted was that, due to regulatory restrictions on the doses of celecoxib, "we used doses considered to be moderate-100 mg twice a day, which could be increased to 200 mg twice a day for those with RA. But patients with RA were only 10% of the total number of participants." By contrast, those taking naproxen or ibuprofen were allowed to escalate doses without restriction.
In an interview with Cardiology Advisor, Elliot Antman, MD, professor of medicine, Cardiovascular Division, Brigham and Women's Hospital and associate dean for Clinical and Translational Research at Harvard Medical School in Boston concurred that these were important limitations.
"Poor adherence and low retention challenge the claim of noninferiority since the proportion of individuals who discontinued the drug was significantly higher in celecoxib, as compared to ibuprofen or naproxen, suggesting that the dose of celecoxib was too low to achieve pain reduction," Dr Antman said. By contrast, "those who discontinued ibuprofen or naproxen did so because of adverse reactions, and were receiving comparatively higher doses."
He expressed additional concerns: "Previous data showed that high doses of celecoxib were associated with risk of [CV] events, and this study utilized relatively low doses."
"Moreover, since a relatively small percentage of participants had known heart disease, the population can be considered low-risk. The low dose of celecoxib administered to a low-risk population calls into question the statement of noninferiority," Dr Antman said.

My take is that the low dosage of celecoxib administered during the study will render the chances of the FDA removing the black box label on celecoxib - based on this study alone - to essentially zero (For example, the PRECISION study used a 100 mg dosage of celecoxib while all three of KIT-302's titrations use 200 mg of celecoxib). Thus KTOV's advantage for KIT-302 still stands. Moreover, the target population for KIT-302 is patients known to be suffering hypertension. For these patients, not only does the issue of liability suggest that physicians will prescribe the combination drug which will have a huge labeling advantage, but KIT-302's synergistic effects on blood pressure will also cause doctors to choose KIT-302 over prescribing separate arthritis pain medications and anti-hypertensive drugs.