Getting in on the ground floor of Microsoft (MSFT) or Apple (AAPL) stock years ago would make someone a very rich investor right now. In the biotechnology field, publicly traded companies periodically reach a point where all the research and sacrifice starts to pay off with revenue producing drugs entering the pipeline. At this point, revenue increases and so does the value of the stock. PROLOR Biotech (PBTH) is about to enter that stage in 2012.
The pipeline for the company is full with possibilities this year. 2012 brings with it a Phase III project; two Phase II projects; and one Phase I candidate -- all moving simultaneously! The company has a twelve month price target of 16 and is financially secure enough to finance itself through the year seeing a better loss per share estimate that went from ($0.37) to ($0.30). It might be a good time to consider accumulating shares of this stock!
Main (hGH-CTP) Product
The advantage of PROLOR's technology platform was introduced this year and respect grew for its (gHG-CTP) program because of the trailblazing data gathered last summer in the Phase II research. The company plans to do more research in pediatric patients. It is filing for approval for Phase II trials in the fourth quarter. Researchers will look for between 52 to 56 patients and run the study for a year that will focus upon the velocity of height increase as its efficacy point.
The second half of this year the company will file for Phase III approval in its continued study for adults. 120 to 150 patients will be involved in this 12 month study. Focus will be on safety and effectiveness over the trial period. The results from this trial should be available by mid 2014 and the availability of the drug a short time thereafter. One of the nice things about this type of technology is that the hGH-CTP drug is based upon an existing market already so the likelihood of having to create multiple Phase III trials may not be necessary to reach approval.
Understanding Risk Factors
Investment in a company like PROLOR does have its risks and it is important to know what they are before hand. As an investor you may be interested in long term growth and this company may look like a potential candidate. But as you research and read on the company's plans and projections, some important considerations are needed.
Possible Regulatory Concerns
Drugs that are currently in research and in the process of being submitted for review from regulatory committees may not reach the market at projected times. There could be some regulatory concerns that may forestall the drug.
Diluted Share Value
It is not impossible for a research company like PROLOR to need additional funding to work through its research. If this is the case, additional offerings of shares could be given diluting the value of any present investment in the company.
Competition is always a factor and how reimbursement takes place by government entities as well as private insurance carriers will always have an affect upon the purchasing decisions of the public and medical community.
With the pipeline filling up nicely, this may be a stock worth research for a long term investment.