PROLOR Biotech, Inc. (PBTH)

[dshade]

shorts winning a bit here. adding

[someconcerns]

IMHO, I personally think an addition now would be fine. You would be, in essence, buying OPK shares cheaply if the acquisition by OPK goes through. If PBTH remains independent, there are exciting events on the horizon as they further prove their technology and monetize one or more of the applications.

[dshade]

maybe add time

[someconcerns]

Good. I've been in OPK since the mid $4 range and in PBTH since just under $5.

[abc1938]

yes I am in. also in opko

[someconcerns]

ABC, Have you bought in yet?

[abc1938]

MR.FROST CEO OF OPK HAS THE MONEY POWER to give pbth a push upward.

[abc1938]

I have put this stock on my watch list today.

[abc1938]

this is like a great love affair made in heaven. I expect pbth willtag along for a great ride.

[abc1938]

Opk CEO has been buying shares of pbth every day as he has with opk

[dshade]

Up well from that guys selling and bailing as mod. The Frost is hard to bet against.

[someconcerns]

PBTH price seems to have decoupled from the offer by OPK.

If you recall, OPK offered 0.9951 shares for each share of PBTH. Yet PBTH closed at 6.49 today while OPK closed at $7.16. The price for PBTH should be $7.12, implying either: (1) some arbitrage opportunity to buy PBTH and short the same number of shares of OPK; or (2) that the market assumes that the deal will not go through and that PBTH will not receive a higher offer.

Disclosure: I am long both OPK and PBTH. No short holdings.

[someconcerns]

If you look at the comments at the end of the article I referenced in the preceding post, there is extensive discussion of what the possible outcome of the offer by OPK to purchase PBTH might be. Comments were added even today.

[someconcerns]

Article on Seeking Alpha: http://seekingalpha.com/article/1391461-a-sweeter-deal-on-the-horizon-for-prolor-biotech?source=email_rt_article_title

".... As of 4/26/13, Prolor shares trade at $6.30, an 11.1% upside to $7.00 and a 12.5% premium to what shares traded at in the beginning of the week. The deal currently offers a total premium of about 25% on $5.60. Despite a 25% total gain and a current gain of about 11%, this current premium is not as delightful as the possible future profits Prolor could have in store for it. Some analysts have projected a share price of about $10 to $15 for Prolor. Deerpath Capital indicated that the Company is worth more than $10.00 per share. The overall point here is that the company has been deemed undervalued compared to the current buyout price. So there are a few things investors can do now to take advantage of the situation. Currently, there's about an 11% upside as I am writing this, and so an arbitrage play is defiantly a possibility; but 11% may not be all you get. Considering the current shareholder backlash and analyst valuation of the company, there could be further gains (assuming Opko raises its offer). If Prolor is offered $10 per share; (about 58.73% upside from $6.30) valuing the company at about $634 million and if at $15 per share (138% upside from $6.30), the company would be valued at about $951 million.

Worst Case Scenario For Now

Even if the deal didn't go through at $7.00 per share, and if an investor were to purchase shares now at $6.30, the probable scenario would be that the shares fall back to their $5.50 levels. This drop would propose a 12.7% downside from $6.30. This is not the end of the world either, because even if this acquisition doesn't work out, Prolor still has the possibility of being a profitable and very successful company in the future.

Conclusion

Although I can't tell the future, at the current valuation and possibilities, I believe it's safe to say that Prolor offers a nice arbitrage play with a speculative bonus. Based on the possible upside and limited downside as addressed above, I personally feel comfortable increasing my shares. In fact, I have already increased my position as of 4/26/13, and have the intention of increasing it further.

Please feel free to express your opinions below as I greatly appreciate opinions and criticism. I understand everyone is different in their views towards particular subjects of interests and whether or not you agree with my views, I still appreciate your feedback. I only hope my article provided some insight and help in your investing analysis. Please also keep in mind I address my opinions and views in this article and encourage readers to forge their own opinions when considering trades and investments."

[someconcerns]

I find the technology to dramatically extend the efficacy (to a week) of medicines which otherwise require daily injections fascinating. Has anyone estimated the market potential of all the different existing treatments to which this technology could be applied?

[someconcerns]

Does anyone see a likely prospect of the ambulance-chasing attorneys getting shareholders a higher price from OPK?

[someconcerns]

If you see the acquisition of PBTH by OPK as synergystic and that OPK can better bring the PBTH products to market, you might take the share swap and stay for the ride. After all, it would not be a taxable event.

OTOH, if you feel PBTH is fully valued or that OPK can't add value, then sell. You both appear to have adopted that stance.

While it is possible that one of the ambulance-chasing lawyers can extract more value for PBTH shareholders, I think it may be more likely that other entities might try to make a higher offer and snatch PBTH away. Frost only has around a 20% interest in PBTH and may be compelled to recuse himself anyway.

As I have OPK shares as well and find the Prolor technology exciting, I may just stick around for a while.

[starbuxsux]

agree

[surf1944]

I would take the money & run!! I am out, little chance this goes higher....

Another biotech gets a buyout, dropping the MOD position.....

[starbuxsux]

Prolor shareholders mull blocking Opka acquisition

http://www.globes.co.il/serveen/globes/docview.asp?did=1000839171

[surf1944]

8:44AM PROLOR Biotech to be acquired by OPKO Health (OPK) for $7.00 per share; trading 12% higher this morning (PBTH) 5.83 : OPKO Health (OPK) and PROLOR Biotech (PBTH) announced that the companies have signed a definitive merger agreement under which OPKO will acquire PROLOR, a biopharmaceutical company focused on developing and commercializing longer-acting proprietary versions of already approved therapeutic proteins, in an all-stock transaction.

Under the terms of the agreement, which has been approved by the boards of directors of both companies, holders of PROLOR common stock will receive 0.9951 shares of OPKO common stock for each share of PROLOR common stock. Based on a price of $7.03 per share of OPKO common stock, the transaction is valued at ~$480 mln, or $7.00 per share of PROLOR common stock. The companies expect the transaction to be completed during the second half of 2013.

For OPK, the acquisition adds promising late stage product hGH-CTP targeting growth hormone deficiency and preclinical products targeting hemophilia, obesity & diabetes. Additionally, PBTH complementary drug development technologies strengthen OPKO's innovation leadership

[someconcerns]

Prolor being acquired by OPKO for OPKO stock valuing PBTH at $7 per share. 0.9951 shares of OPKO for each share of PBTH.

I have been wondering when Dr. Frost would roll both of these into one company.

[JomMengGu]

Prolor Said to Hire Jefferies to Evaluate Alternatives

http://www.bloomberg.com/news/2013-04-11/prolor-said-to-hire-jefferies-to-evaluate-alternatives.html

[JomMengGu]

Prolor hired Jeffreys to purchase worth $ 800 million

hormone, which produces BioMed indexes beginning versions: Pfizer, nobortis, ??????????'?????? and nature. The last Chairman, Philip Frost, holds 19.8% stake in prolor. Jeffreys led to the call-up of prolor on NASDAQ last year

other Israeli BioMed Corp. is in preliminary negotiations for sale. Property "was informed that Chairman of prolor biotech company headed by nature Philip Frost hired u.s. Investment Bank Jeffreys, to examine various strategies and options, including the sale of the company, as well as formulating an analysis of each of the three become products.
Read more lectures at HR seminar:
Searching medicine organize the future
The real heroes of the high-tech industry: leading BioMed indexes beginning companies
Another unknown property "that four companies contemplating the purchase of prolor-Pfizer, Novartis, ??????????'?????? and nature, and that the price to which the shareholders of the company is aiming at up to 800 million dollars, although the company is worth $ 322 million. However, due to its primary product--the vast potential for growth hormone. Recently it was reported that nature was for purchasing contacts protalix however these were discontinued.


In may 2012, the Bank has led the recruitment of Jeffreys 37 million dollars on NASDAQ, lprolor and costs 5 dollars per share, the price at which the stock trades today. Reference ??'???? now was made after the company has received inquiries from major companies who have expressed interest in various collaborations with respect to its products and commercial agreements with prolor.

3 billion market

Adult growth hormone market rolls about 1 billion dollars worldwide, and the treatment of children rolling ??2 billion. While children with hormone deficiency are treated to high, old symptoms in adults causes scarcity, such as increased risk of heart disease, increased levels of fat and bone hbtani, and the company hopes to get approval for the product ??2015.

Frost holds a 19.8% interest in prolor, and Dr. Jane hsiao, former Vice Chairman and Vice Chairman of the aioox-controlled company opko Frost that is controlled by the Frost, which holds about 3.4%. Frost holds a 1.5 percent stake in another nature worth $ 578 million.

Prolor is using the patented CTP technology, especially the development of long-range versions of existing drugs. The company's flagship product is an advanced clinical stages is a long-range version of human growth hormone. The company also is developing long-range versions of factors for bamopilia, vbashmant, vglokgon for diabetes, all of which are in clinical development phase violation.

The main asset of both development and commercialization rights to prolor that received from the University of Washington in St. Louis ?????"? on the CTP technology, which tie short protein (peptide) proteins in blood cultures, drug them and extends the duration of their activity without increasing the damage they cause to the body and reduce their biological activity.


http://www.calcalist.co.il/markets/articles/0,7340,L-3599818,00.html

[zullo1]

Would love to see some continued buying on this beast!

[surf1944]

7:33AM PROLOR Biotech receives notice of allowance for new U.S. Patent covering long-acting coagulation factors VII and IX (PBTH) 4.86 : Co announced that it received a notice of allowance from the U.S. Patent and Trademark Office for a new patent application covering the company's proprietary long-acting CTP-enhanced coagulation factors for the treatment of hemophilia: Factor VIIa-CTP, Factor Vll-CTP and Factor IX-CTP. The allowed claims cover both product composition and treatment methods.

[zullo1]

Thanks-continues to be a good long term speculative investment.

Zullo

[surf1944]

7:32AM PROLOR Biotech receives notice of allowance for new u.s. patent covering methods for decreasing body fat with hGH-CTP (PBTH) 5.00 : Co announced that it has received a notice of allowance from the U.S. Patent and Trademark Office for a new patent application covering the company's long-acting CTP-enhanced human growth hormone. Upon issuance, the new patent will provide PROLOR with additional intellectual property protection that covers methods for decreasing body fat in humans through the use of hGH-CTP therapy.

[surf1944]

7:35AM PROLOR Biotech's longer-acting human growth hormone receives orphan drug designation in Europe (PBTH) 4.99 : Co announced that the European Commission and the European Medicines Agency (EMA) have granted orphan drug designation to hGH-CTP, PROLOR's longer-acting version of human growth hormone in development for the treatment of growth hormone deficiency. PROLOR will receive 10 years of marketing exclusivity in Europe for hGH-CTP, beginning at product launch. This is the first time a growth hormone product has received orphan drug designation in Europe.

"In Phase II studies in growth hormone-deficient adults, hGH-CTP was safe and well tolerated, and it demonstrated the potential to be administered once-weekly, replacing seven daily injections of currently marketed human growth hormone. These results enabled PROLOR to initiate a Phase II trial in children with growth hormone deficiency and to proceed with plans for a Phase III trial in growth hormone-deficient adults, which is scheduled to begin later this year."

[surf1944]

7:38AM PROLOR Biotech receives notice of allowance for new U.S. patent covering broad applications of its CTP Platform for long acting therapeutic proteins (PBTH) 4.86 : Co announced that it received a notice of allowance from the U.S. Patent and Trademark Office for a patent application covering the company's CTP platform, which has the potential to extend the duration of activity of therapeutic proteins. This new U.S. patent is expected to be issued in the next few months.

[surf1944]

7:36AM PROLOR Biotech announced that the company will present preclinical data on its long-acting clotting Factor VIIa; demonstrated a markedly enhanced pharmacokinetic profile and increased exposure (PBTH) 4.86 : Top-line results of the Factor Vlla-CTP studies have been previously reported by PROLOR. The results show that when compared to commercially available Factor VIIa, Factor VIIa-CTP in hemophilic mice demonstrated a markedly enhanced pharmacokinetic profile and increased exposure, as evidenced by a prolonged hemostatic effect and improved recovery, which is a measure of clotting activity. Compared to commercially available Factor VIIa, Factor VIIa-CTP in hemophilic mice demonstrated superior thrombin generation parameters, and it resulted in greater survival of the subjects. In these studies, the specific activity of Factor VIIa-CTP was comparable to commercial Factor VIIa. The study data also show that administration of Factor Vlla-CTP by subcutaneous injection resulted in improved bioavailability and prolonged exposure compared to intravenous administration of Factor Vlla-CTP.

[surf1944]

8:24AM On The Wires (WIRES) : PROLOR Biotech (PBTH) announced that the U.S. Patent and Trademark Office issued a notice of allowance for a patent application covering the company's long-acting reversible-pegylation technology.

[surf1944]

7:32AM PROLOR Biotech reports positive results from preclinical toxicology study of its reversible-pegylation platform technology (PBTH) 5.10 : Co announces positive results from a preclinical toxicology study designed to assess the safety and tolerability of PROLOR's proprietary long-acting reversible-pegylation technology. The study results demonstrate that RPeg was safe and well-tolerated at high doses following repeated administration in rats. The RPeg platform has been utilized to develop PROLOR's preclinical drug candidate MOD-6030, a GLP-1/Glucagon dual receptor agonist peptide in development for the dual indications of obesity and type 2 diabetes. RPeg can also potentially be applied to a range of peptide and small molecule drugs to increase their duration of action, and it is expected to be especially well suited for use with drugs that must cross the blood-brain barrier.

[surf1944]

7:31AM PROLOR Biotech Receives Notice of Allowance for New U.S. Patent for Its Long-Acting Human Growth Hormone (PBTH) 5.06 : Co announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent application covering the company's long-acting CTP-enhanced human growth hormone (hGH-CTP). Upon issuance, the new patent would provide PROLOR with additional intellectual property protection covering methods for the induction of growth in growth hormone deficient patients. This new patent is the fourth hGH-CTP patent that has been allowed by the USPTO.

[surf1944]

Prolor Biotech (PBTH) which closed trading on Wednesday at $4.88/share had its coverage initiated by Oppenheimer who initiated the stock with an Outperform rating and a $7.00/share price target. The Nes Ziona, Israel-based firm, is a development stage biopharmaceutical company, engages in the development of proprietary versions of already-approved therapeutic proteins. Its technology, Carboxyl Terminal Peptide technology could be attached to an array of existing therapeutic proteins, stabilizing the therapeutic protein in the bloodstream and extending its life span without additional toxicity or loss of desired biological activity.

I think there are two key long-term catalysts for PBTH going forward. The first catalyst is going to be the continued development its therapeutic proteins and more specifically the development of its Carboxyl Terminal Peptide technologies and how those technologies can apply to a larger portfolio of previously-approved proteins in the future. The second catalyst in terms of PBTH is going to be the company's total-debt to total-cash ratio and how that ratio outpaces some of the company's industry based counterparts. Over the last 12 months PBTH has managed to demonstrate a total debt to total cash ratio of 0.00, due largely in part to the fact the company hasn't had any debt over the last 12 months, whereas biotech companies such as Ariad Pharmaceuticals (ARIA) and Nektar Therapeutics (NKTR) carry total debt to total cash ratios of 0.045 and 0.527, respectively.

http://seekingalpha.com/article/837721-2-healthcare-companies-with-new-analyst-coverage-growth-investors-should-consider?source=yahoo

[surf1944]

7:39AM PROLOR Biotech: data from Phase II trial of co's long-acting human growth hormone presented at Endo 2012; previously reported data confirm that hGH-CTP has the potential to be administered once weekly and appears to be safe and well tolerated (PBTH) 4.75 : Co reported that researchers at ENDO 2012 presented data from the company's Phase II trial of its long acting human growth hormone, hGH-CTP, in growth hormone deficient adults. The data, which were previously reported by the company, confirm that hGH-CTP has the potential to be administered once weekly to adults with growth hormone deficiency and that it appears to be safe and well tolerated. "ENDO 2012 represents a great opportunity to share the encouraging data we have reported from our completed Phase II trial of hGH-CTP with leading endocrinologists from North America and around the world," noted Dr. Abraham Havron, CEO of PROLOR Biotech. "These data further confirm the potential of our long acting version of human growth hormone to be administered once-weekly, in contrast to the daily injections currently required. We believe that informing the broader endocrinology community about our progress with hGH-CTP is timely as we continue to enroll subjects in our Phase II trial in growth hormone deficient children and prepare to initiate a Phase III trial in growth hormone deficient adults, expected later this year."

[surf1944]

8:49AM PROLOR Biotech prices underwritten public offering of 6.5 mln shares of its common stock at $5.00 per share (PBTH) 5.69 :

This is the way a biotech company should do a secondary offering, near the top of its price range.

[mlkrborn]

PROLOR Biotech announces top-line results from four-month treatment extension of its long-acting human growth hormone Phase 2 trial: reaffirms prior phase 2 findings showing a single weekly injection of hGH-CTP has potential to replace seven daily injections of commercial hGH (PBTH) 5.24 : Co reported top-line results from a Phase II four-month treatment extension study of hGH-CTP, its long-acting version of human growth hormone, in growth hormone deficient adults. The data reaffirms the company's prior Phase II findings showing that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone (hGH), and further validates the dosing regimen for the company's planned Phase III trial.

[surf1944]

7:33AM PROLOR Biotech announces 'positive' results of its obesity/diabetes drug candidate in preclinical weight loss study (PBTH) 5.46 : Co reported positive preclinical results from an animal study of its long-acting obesity/Type II diabetes drug candidate MOD-6030. The study was designed to measure the potential therapeutic effect of MOD-6030 injected once weekly as measured by weight loss, reduction in food intake, glycemic control and cholesterol levels MOD-6030 administered to diet-induced obese mice once weekly over a 30-day period demonstrated significant efficacy in reducing weight, lowering blood glucose levels, increasing insulin sensitivity and reducing cholesterol levels as compared to a group that received placebo. Animals in the placebo group showed minimal changes in the study parameters, while the animals receiving MOD-6030 achieved on average a 28% reduction in weight, a 29% reduction in food intake, a 19% reduction in blood glucose levels and a 57% reduction in cholesterol levels. Body composition analysis showed that the weight loss resulted specifically from reductions in body fat.

[surf1944]

7:44AM On The Wires (WIRES) : PROLOR Biotech (PBTH) announced initiation of a Phase II clinical trial of its long-acting CTP-modified version of human growth hormone in children with growth hormone deficiency.

[surf1944]

7:33AM PROLOR Biotech announces 'positive' preclinical results from comparative study of its long-acting clotting factor VIIa (PBTH) 6.65 : Co reported positive results from a comparative study of its biobetter longer-acting version of the hemophilia drug Factor VIIa (Factor VIIa-CTP) in hemophilic mice. The study was designed to measure the potential increase in survival rates, thrombin levels and in vivo recovery of Factor VIIa-CTP when compared with commercially available recombinant Factor VIIa. The new study showed that compared to commercially available Factor VIIa, hemophilic mice receiving PROLOR's Factor VIIa-CTP demonstrated: A superior survival rate over a longer time period following a bleeding challenge; Superior and longer-lasting generation of thrombin, a key pro-clotting enzyme; Significantly higher in vivo recovery.

[surf1944]

Shares of PROLOR Biotech, Inc. (PBTH) have been on the move since we told readers about the company in January and jumped another 5.2% this past week. Read More

The biopharmaceutical company which utilizes patented technology to develop longer-acting, proprietary versions of already approved therapeutic proteins led gains on the Bloomberg Israel-U.S. Index in January with a 45 percent surge after dropping 34 percent last year.

Just days after we told our premium subscribers that we were hearing positive clinical data chatter from various analysts and others at healthcare conferences in San Francisco, the company announced positive top-line results from their pilot study of their Long-Acting Human Growth Hormone Injected Twice Per Month. Dr. Avri Havron, Chief Executive Officer of PROLOR was very encouraged by the findings and hinted that hGH-CTP can potentially provide a safe and effective new therapeutic option for adults with growth hormone deficiency when injected once-weekly, versus the daily injections of conventional hGH that are currently required.

"The results from this new pilot study indicate that hGH-CTP may be able to achieve an even better administration regimen-requiring injections just twice per month," said Dr. Havron. "This is encouraging news for growth hormone deficient patients who would like to minimize their injection regimen."

We aren't the only ones we continue to expect some very positive developments from this company. Earlier in the week, Raghuram Selvaraju, Ph.D.-- an analyst at Morgan Joseph TriArtisan reminded clients that they would be well-advised to take note of PROLOR's recent progress and the prospects for future appreciation of the stock given the achievement of several notable near-term milestones. Selvaraju reiterated his firm's Buy rating and 12-month price target of $16.00 on PROLOR shares.

I continue to agree with the analyst that PROLOR continues to represent a compelling investment in the life sciences sector. They are taking a substantially risk-mitigated approach to drug development, focusing on validated targets and making improvements to existing drugs. We would not be surprised to see PROLOR's value continuing to rise, especially in the eyes of Big Pharma entities like Teva Pharmaceutical Industries Ltd. (TEVA).

PROLOR is 21 percent owned by Teva's Chairman Philip Frost and there is little doubt that may come into play for PROLOR's valuation as more data and study results from key are revealed going forward.

Keep in mind also that Teva announced recently that Jeremy Levin, formerly of drugmaker Bristol-Myers Squibb Co. (BMY), would be joining the firm as its CEO. Investors have been concerned that Teva's U.S.-traded shares plunged 23 percent last year, the most since 2006 and that the Big Pharma needs to find new sources of revenue.

"Levin's background will enable Teva to buy companies like Prolor that would fold particularly well with the company," Selvaraju told Bloomberg last week.

http://seekingalpha.com/article/343151-2-biotechs-on-teva-s-radar-screen?source=yahoo

[surf1944]

PROLOR Biotech (PBTH)

From positive clinical results to growing takeover potential, PROLOR has appreciated by nearly 50% for the year to date. As the pipeline marches forward, 2012 is gearing up to be an inflection point for the biotech firm. Based on attractive peer comparisons, previous buyouts, and earnings potential, I believe that PROLOR has considerable upside from here.

With a net cash position of $17.6M, the company has solid liquidity to fund operations and offers the certainty that other emerging biotech firms frequently lack. Its lead product, hGH-CTP, has more than proceeded smoothly - it has exceeded both management and analyst expectations. In the post-Phase II clinical trial, hGH-CTP indicated that it could be injected just twice monthly instead of daily like what is currently available. Previously, we were bullish on the product allowing for weekly injections - now, the growth story has become even brighter.

hGH-CTP will be the first long-acting version of human growth hormone that is FDA-approved. It will target a $3B market that is compounding 7% annually. Assuming that it could penetrate 35% of the market through partnerships and receive 20% in royalties, PROLOR's take comes out to more than $200M. At a price-to-sales multiple of 5x, this product is thus worth more than $1B. Eli Lilly (LLY), Pfizer (PFE), and Roche (RHHBY.PK) are all in need of pipeline upgrades and a partnership with PROLOR would be a significant way to catalyze earnings. As a result of strong IP protection and extensive capital requirements, the barriers to entry virtually preclude competition over PROLOR's reign in the human growth hormone market.

As much as hGH-CTP is a value driver, it is just one piece to the puzzle. MOD-6030, a long-acting version of oxyntomodulin, targets the diabetes type II market and is significantly undervalued when one considers past buyouts. When factoring in possible milestone payments, Roche acquired Marcadia for $537M to gain rights to a simple preclinical GLP-1/Glucagon dual receptor agonist. Having already demonstrated superiority in weight loss to oxyntomodulin, MOD-6030 only further enhances PROLOR's takeover potential. Accordingly, the company merits its "strong buy" rating on the Street.

http://seekingalpha.com/article/320839-why-prolor-biotech-is-rising-and-other-attractive-prospects?source=yahoo

[gym gravity]

Cool.

[mlkrborn]

PROLOR Biotech announces 'positive' top-line results from pilot study of its long-acting human growth hormone injected twice per month (PBTH) 6.16 : Co announced positive top-line results from a post-Phase II clinical study of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults. The data show that two injections of hGH-CTP per month have the potential to replace 30 consecutive daily injections of currently marketed human growth hormone. " The results from this new pilot study indicate that hGH-CTP may be able to achieve an even better administration regimen--requiring injections just twice per month. This is encouraging news for growth hormone deficient patients who would like to minimize their injection regimen."

[someconcerns]

Up 9+ percent this a.m. Something must be up.

[gym gravity]

Strong volume heading towards resistance.

http://stockcharts.com/h-sc/ui?s=PBTH&p=D&yr=0&mn=6&dy=0&id=p71126041241

[surf1944]

Prolor Biotech: Set Up For Success

Part of what makes any particular developmental or clinical stage company into a success story is its ability to develop and eventually commercialize a pipeline that brings a unique angle to the table. That angle could be, for example, a breakthrough medical discovery, an answer to an ongoing medical dilemma or unmet medical need, or a new approach that improves on an already-approved product or technology.

It's that last example where Israel-based Prolor Biotech (PBTH) may excel.

Prolor possesses world wide rights to the naturally-occurring Carboxyl Terminal Peptide (CTP). When CTP is attached to already-existing therapeutic proteins, it stabilizes the proteins in the bloodstream and, by slowing the process in which the protein is removed from the body, it creates an extended life span for the therapeutic treatment without adding toxicity or sacrificing the desired biological activity.

In short, CTP extends the life of existing protein-based treatments, and therefore has the potential to significantly reduce the amount of injections a patient needs to receive for treatment.

Only two companies currently hold licenses to the CTP technology. Merck (MRK) holds a license for four fertility-related proteins while Prolor holds a license for "all other human therapeutics of natural or non-natural sequence," according to a recent company presentation.

Merck has already successfully implemented the technology on the European market. One injection of Merck's fertility treatment Elonva replaces seven daily FSH injections that would otherwise be needed for treatment. Merck's ability to commercialize its CTP product in Europe validates the technology, as does a successful Phase II trial that Prolor conducted for its own lead product candidate, hGH-CTP.

HGH-CTP is being developed as a long-lasting substitute for the once-daily injection of hGH that is currently prescribed for patients with hormone deficiencies. An already-completed Phase II trial in adults demonstrated that one weekly injection of hGH-CTP could replace seven daily injections. No safety concerns were noted in this trial and the positive results justified a quick move into a Phase III, which is planned for 2012 to confirm the positive results from the Phase II.

Another trial, a Phase II to test hGH-CTP in hormone deficient children, is also slated to start next year.

The hormone-deficiency market, combined for both children and adults, targeted by Prolor with hGH-CTP reaches an estimated three billion dollars. That number is growing annually and could signify a very lucrative future for the company, should it even garner a small foothold in the worldwide market.

Additionally, Prolor expects to be the first to bring such an extended-life hGH treatment to market, at its current rate of clinical development, giving it a leg up on any potential competitors in being able to quickly achieve significant market share. The company also has the advantage of already being granted an Orphan Drug Designation for hGH-CTP in both children and adults.

Analysts began taking notice of the company this year as well, given the successful Phase II trial and market potential of hGH-CTP. PBTH was slapped with a tag of 'Buy' earlier this year, with price targets significantly higher than where shares are currently trading. Some high-profile investors also started rolling in, most notably by Dr. Philip Frost of Teva Pharmaceutical Industries (TEVA).

Mr. Frost's interest, which establishes an intriguing connection with Teva, also puts Prolor on the watch list as a potential buyout candidate. Generally the big players like to see later-stage results before turning a buyout idea into actuality, but by the time Prolor is on the cusp of bringing its first product to market, any deal would most likely be a lot more expensive than it would be now. The Prolor-Teva-Frost connection will be one to keep an eye on. With a significant interest in Prolor already, and future success of the company will turn into a personal boon for Dr. Frost.

In addition to hGH-CTP, Prolor still has more in the pipeline.

Long-acting versions of two hemophilia drugs (Factor IX and Factor VIIa) enhanced with CTP are in preclinical studies, while a naturally-occurring drug to treat type II diabetes/obesity is also being prepped for Phase I. The markets for each of the indications targeted with these products is estimated to be in excess of a billion dollars, laying the groundwork for significant opportunity for all of this company's products, should they make it to market.

On the financial front, a recent company presentation notes that there is enough cash in the coffers to last through 2012, leaving Prolor on sound footing for the time being. The possibilities also exist that Prolor could land a partner or two through licensing deals that would help fund the remainder of its development phase. Companies may look to utilize the CTP technology to create longer-acting versions of other already existing proteins, peptides or small molecule drugs.

The analysts and big money have already started to notice this growing success story, and with multiple catalysts planned for 2012 - and with a technology that could prove very valuable on the open market - this has quickly become a story to watch.

Stay tuned.

http://seekingalpha.com/article/312134-prolor-biotech-set-up-for-success?source=yahoo

[zomniac]

This is keeping up with the pop in OPK today

[surf1944]

7:41AM On The Wires (WIRES) : PROLOR Biotech (PBTH) announces that it has received a notice of allowance from the U.S. Patent and Trademark Office for a patent application covering the co's long-acting CTP-enhanced human growth hormone.