Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

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DD 16-Feb-2016: KTOV completed P3. 15 times market cap($9m current cap) might be equal to only one year net income. calculate PV and you ended up with a present value of $1B+. a major pharma can waste $200m- $300m on a buyout for a billion dollar risk reward,imo. Celebrex has $1.8B in rev every year (with all the risks!!!), if we take only 10% of their market share alone,on 70% profit margin(don't forget,almost no more expenses) will brings us to $130 net income per year.Market cap is about $9m now (under Cash on hand).

There is never 100% guarantee with bio(s),but risk/reward here is very impressive.

Risk is limited for several reasons:

1. I would think BIG PHARM will be falling all over themselves to get the rights to distribute this multi BILLION dollar drug.

2. CMC Work Plan already got FDA approval.the FDA has approved an expedited approval process for Kitov products. "Only a single phase III study will be required as opposed to the usual two phase III studies". (P3 already completed). "The FDA has approved the Phase III clinical trial design for KIT-302, in a Special
Protocol Assessment, in accordance with the shortened regulatory pathway,
Section 505(b)(2)"-more info on Presentation( note no.6 below).

3. Dr. Waymack is a former academic transplant surgeon and a former FDA medical officer, with over fifteen years of experience in drug development as a consultant to major pharmaceutical companies, including Pfizer, Roche, Pharmacia, Warner Lambert and Searle.

4. drug is a combo of 2 approved drugs.

5. no debt and no need to raise more Cash,no expenses as well till hit the market (2017). Because the trial target was fully achieved, there is no need to recruit additional patients, and the trial results have been declared final.
Even with a fully diluted market cap will be about $25M ( Warrants can be executed till 2020),this is still a killer deal relating market potential of billions.

6. Celebrex alone has many risks,while KTOV found much better safe way to use it. It might be a life changer drug.
If Celebrex has $1.8B in rev every year, and we take only 10% of their market share alone,on 70% profit margin(don't forget,almost no expenses,2 approval drugs) will brings us to $130 net income per year.Market cap is about $10m now (same as Cash on hand).
i believe it's a very conservative estimation,the combination works way better then the drugs by themselves.

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
Cardiovascular Risk
Celebrex may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All nonsteroidal anti-inflammatory drugs (NSAIDs) may have a similar risk. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (5.1,14.6)
Celebrex is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1)
Gastrointestinal Risk
NSAIDs, including Celebrex, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
http://www.drugs.com/pro/celebrex.html

As you can see(below) the combination works way better then the drugs by themselves.."Upon further review of its Phase III clinical results, Kitov has determined that the blood pressure reduction synergy seen with combining celecoxib and amlodipine, is seen not only in the study’s primary efficacy endpoint of daytime systolic blood pressure, but was also present in all other blood pressure variables. This beneficial effect of celecoxib on blood pressure was not present when celecoxib was administered alone, rather celecoxib was shown to elevate blood pressure relative to placebo, when administered by itself".

"The blood pressure reduction synergy was also seen for daytime diastolic blood pressure measurements. After two weeks of treatment the reduction for this variable with amlodipine alone was 5.5 mm Hg, while for patients treated with KIT-302's components the reduction was 7.6 mm Hg. For nighttime systolic blood pressure after two weeks of treatment the reduction with amlodipine therapy alone was 6.3 mm Hg, while for patients treated with KIT-302's components the reduction was 10.7 mm Hg. For nighttime diastolic blood pressure after two weeks of treatment the reduction with amlodipine alone was 3.1 mm Hg, while for patients treated with KIT-302's components the reduction was 7.2 mm Hg.

To summarize, the synergy in blood pressure reduction demonstrated with KIT-302’s two components was present at all times of day and with both blood pressure measures. Although celecoxib when combined with amlodipine appears to have a synergistic effect and lowers blood pressure, it has the opposite effect when administered by itself".

7. Presentation,more info here: http://maya.tase.co.il/bursa/report.asp?report_cd=1008139

8. PT + Coverage 11-Feb,2016,confirmed Marketing in 2017,"Kitov saves time and money by filing combo pill through 505(b)(2) pathway":
http://www.in-pharmatechnologist.com/Regulatory-Safety/Kitov-saves-time-and-money?utm_source=RSS_text_news&utm_medium=RSS_feed&utm_campaign=RSS_Text_News

16-Feb-2016: Price target $10:
http://www.losangelesmirror.net/201602/16/kitov-pharmaceuticals-holdings-ltd-adr-ktov-is-initiated-by-rodman-renshaw-to-buy-price-target-at-10-312250/