OPKO Health (OPK) I felt I needed to update you in the most recent developments pertaining to OPKO Health
OPKO Health has received from the FDA Orphan Drug Status!
Here are the headlines : This came out a day ahead of the companies Press Release from the stock news service theflyonthewall.com
OPKO Health unit gets orphan designation for hemophilia treatment
According to a post on the FDA's website, PROLOR Biotech, a unit of OPKO Health, received orphan designation for its long acting recombinant Factor VIIa-CTP3 for the treatment and prophylaxis of bleeding episodes in patients with hemophilia A or B with inhibitors to factor VIII or factor IX.
One of todays PR’s dated 2/28/14 came from Business Wire and they elaborated on the news.
Patients affected with this condition are currently being treated by commercially-available Factor VIIa, with estimated 2013 worldwide sales of $1.7 billion. Ill write that down again in bigger font.
2014 estimated worldwide sales of $1.7
Here is more about what this special designation means
FDA's Orphan Drug Act of 1983 was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect 200,000 persons or less in the U.S. The orphan drug designation provides for seven years of market exclusivity, reduction in regulatory fees, certain tax credits and additional regulatory support for R&D initiatives.
The thing that makes OPKO Health a great investment is it has Dr. Frost as the CEO. Google Dr Frost for his list of achievements.
Dr. Phillip Frost, CEO of OPKO, commented, “We are pleased with the new orphan drug designation for Factor VIIa-CTP in the U.S., as it would allow OPKO seven years of marketing exclusivity upon commercialization of the drug. We have previously presented data in animal models of hemophilia showing that Factor Vlla-CTP demonstrates superiority across key efficacy and safety parameters compared to current Factor VIIa therapy. We are enthused about the potential for SC administration due to its improved bioavailability compared to presently available Factor VIIa IV therapy. Expecting to initiate a Phase IIa trial with our IV formulation in hemophilia patients in late 2014, we believe that we are in a unique position to be first to market with a longer acting Factor VIIa product.”
Now what does the Empower Network mean for you? If you easily found this article to do some of your stock research then you found this because this blog post is written on the Empower Network. If you want to take your blog writing to a higher level then click on one of my bannors and sign up. Comment or email me
For the purpose of Full disclosure. I have long positions in OPKO Health because I believe this stock and company could be a huge winner. I said Huge!