Opko Health Inc (OPK)

[WiseFool]

Opko Health’s Rayaldee (CTAP101) Is A Game Changer

OPKO Health Inc.:OPK’s Rayaldee Is Best in Class

Rayaldee Will Penetrate And Take Share In The Prescription Vitamin D Market

>Chronic kidney disease (CKD) affects nearly 14% of the US population and is a leading cause of morbidity and mortality.

>CKD-related Medicare expenditures were estimated to total $45 billion in 2012.

>The CKD patient population is large and growing as a result of: Obesity, Hypertension and Diabetes.

>Stage 3 (Moderate impairment) CKD Prevalence 18.7 Million> Vitamin D Insufficiency 70%

>Stage 4 (Severe impairment) CKD Prevalence 1.4 Million> Vitamin D Insufficiency 80%

>Stage 5 (Failure) CKD Prevalence 0.5 Million>Vitamin D Insufficiency 90%

>Rayaldee is going to be the first with the indication of treating Secondary Hyperparathyroidism that arises from Vitamin D Insufficiency in this patient population. No other product has this indication.

>There are no other drugs currently on the market or under development that simultaneously control secondary hyperparathyroidism pre-dialysis patients and correct the most frequent underlying cause of the disease which is vitamin D insufficiency.

>Rayaldee will be a game changer for pre-dialysis patients.

>Rayaldee achieves Vitamin D sufficiency much more readily than any other product that is available. It lowers PTH as well as any product that is in the market. It does two things that Physician’s want to do. Rayaldee allows Physician’s to use one drug to get those two things done more effectively and safely.

>Opko expected to submit the New Drug Application for Rayaldee to the FDA by the last week of May 2015.

>Rayaldee is expected to take significant market share in Stage 3 and 4 CKD patients suffering from SHPT – a potential $12 Billion Revenue Opportunity.

>Market for Rayaldee is large. Millions of patients that we target with Stage 3 & 4 CKD, one quarter are treated with active Vitamin D Hormones and one third are treated with Nutritional Vitamin D. Because neither of these options are very good about one half of the patient’s are not treated at all. We believe Rayaldee can take share from all three of these categories and in fact expand the market.

>With Rayaldee’s target pricing at about $10,000 per year, you can see with every million patient’s we have under treatment we will have a major financial opportunity.

>Over half of the CKD population can be reached with a small sales force targeting nephrologists and endocrinologists

>Rayaldee US patents issued, protected through 2028. Additional global patents allowed or pending.

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