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It also discussed in detail here https://opkodd.proboards.com/thread/2568/bcda-frost-sold-13
Correct. Sold to OPKO. Recently filed 13g shows an increase that reflects the aquistion. Confirmed by SEC Form4. Sold to OPKO at 0.13. Happened once before with Zebra. https://www.sec.gov/Archives/edgar/data/925741/000119312517000819/d280841dsc13g.htm
Translation not so good, take it for what it's worth. No guarantee on the translation accuracy.
Mizuho Securities. 4/13/2016
http://kabutan.jp/
U.S. Athersys shows efficacy against acute cerebral infarction in the Phase 2 study. Conservative stock spread originates from a new field of cell medicine.
Current point, there is no choice of other treatments for this serious life threatening disease. In that, this will change the way of thinking with more and more use, that can be expected.
Domestic health care costs are rising, tailwind in early treatment promotion of this disease is necessary to long-term care, such as cerebral infarction.
"BUY" rating and raised the target price to 1660 yen ($15.19 usd) to 1960 yen ($17.94).
"MK" Kabusagu News
A Forbes August 2015 article showed in 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as “new molecular entities,” faced rejection 66% of the time. In 2015 the FDA rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%. Those numbers come from a new analysis commissioned by Forbes from BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry.
Eliminating BioMedTracker’s counting of multiple uses for the same drug means FDA approved 23 drugs and rejected 1, Merck ’s anesthesia antidote, Bridion. Again, that means 19 of 20 new drug applications were approved. So in reality, the FDA approval rate is more like 96%.
As far as Rayaldee, The SPA with the FDA active involvement throughout the NDA review process speaks volumes.
As far as a prediction percentage, sorry, I am not in a position to comment.
I will tell you this. Pre 2013 OPKO Rayaldee acquisition from Cytochroma, CTAP101 (Rayaldee) commenced dosing in a Phase I/II clinical trial in 2007. Multiple trials later, all meeting primary efficacy and safety endpoints, Rayaldee showed no adverse effect on serum calcium or phosphorus, the key drivers of vascular calcification. Vascular Calcification is the killer of patients with Chronic Kidney Disease.
With a drug over nine years in the making that met all Phase 3 Primary Endpoints. With no other drugs currently on the market or under development that simultaneously control secondary hyperparathyroidism pre-dialysis patients, and corrects the Vitamin D insufficiency. You be the judge.
The completed and current progress with the FDA on Rayaldee has been active throughout the NDA review process.
Initially focused primarily on issues related to chemistry, manufacturing and controls (known as CMC), but has recently focused on product labeling and the proposed package insert. This would appear to bode well for a Rayaldee approval on their anticipated March 29, 2016 PDUFA date.
The proposed product labeling and package insert regulation required for an NDA are provided in 21 CFR 314 Subpart B.
The above aforementioned culminates the end process pre-approval, you may find primary items to include...safety and efficacy, components, description of methods and controls, etc...
One thing to keep in mind. Rayaldee Two Pivotal Phase 3 Trials were the subject of a Special Protocol Assessment (SPA) established with the United States (U.S.) Food and Drug Administration (FDA).
The Special Protocol Assessment (SPA) provided a mechanism for the FDA and OPKO to reach agreement on the design, size, execution and analysis of the two pivotal phase 3 trials with Rayaldee. The FDA agreed that the design and planned analysis of these studies adequately addressed the objectives necessary to support an NDA submission.
SPA in a nutshell. Representatives of GSK at the Drug Information Association’s (DIA) 45th annual meeting explained.
An SPA, they explained, is a declaration from the FDA that an uncompleted Phase III trial’s design, clinical endpoints, and statistical analyses are acceptable for support of regulatory approval later, after the trial has concluded. It’s the FDA’s way of saying: If you execute this trial exactly as you promise you will, and the data are there, this drug will get approved.
And that’s bind. Unless the science around the research changes or a new public health concern emerges that impacts the agreement, the FDA has to honor it once the Phase III trial is done. That is, as long as the sponsor has followed the agreed-upon protocol to the letter, and the data support the efficacy and safety of the product.
“It’s an opportunity to take some specific steps under SPA to cement some agreements as best as can be done during the dynamic development process,” said David Cocchetto, V.P. of U.S. regulatory affairs for GSK. During the session, he quoted a blogger as saying, “An SPA is about as binding a deal as you can get with a government agency.” Cocchetto laughed, and agreed.
Opko Health could turn out to be one of 2016's biotech winners
3 Predictions for Opko Health Inc. in 2016
What does the new year hold for this up-and-coming biotech?
TheMotleyFool
Keith Speights
Dec 5, 2015 at 9:03AM
"Prediction is very difficult, especially if it's about the future."
While that sounds like something Yogi Berra might have said, the quote actually comes from renowned physicist Niels Bohr. And Bohr was right -- predicting is a tough business. That's particularly true when it comes to prognosticating what might happen with biotech stocks like Opko Health (NYSE:OPK).
Opko has experienced a tumultuous 2015. The stock more than doubled by mid-year, then lost nearly all of those gains by October. Shares are now up around 30% year-to-date. What will 2016 have in store for the biotech? Here are three predictions.
1. Bio-Reference buyout benefits
Opko completed its buyout of Bio-Reference Laboratories in August, which has resulted in good news already. The company announced a surprise profit in November thanks largely to a $93 million tax benefit stemming from the acquisition. While this was a one-time benefit, I think Opko will continue to reap rewards from the Bio-Reference buyout in 2016.
Opko's shares fell in the aftermath of the announcement of its Bio-Reference acquisition back in June. My view is that these early worries from investors underestimated the long-term opportunity for Opko as a result of the buyout.
In the past, Opko primarily targeted urologists in promoting its 4Kscore prostate cancer genetic test. Access to Bio-Reference Laboratories' significantly larger sales team allows Opko to go after primary care physicians and internists -- who order 93% of PSA tests in the U.S. With inclusion of 4Kscore in national guidelines for early detection of prostate cancer, I think this expanded sales force will achieve considerable success in 2016.
2. Victory for Varubi
Tesaro (NASDAQ:TSRO) received good news in September when the FDA approved Varubi. Opko licensed the anti-nausea and anti-vomiting drug used by cancer patients in 2010. Next year should be a big one for both Tesaro and Opko as marketing for Varubi kicks into high gear.
My Motley Fool colleague Todd Campbell recently provided a great analysis on the financial potential of Varubi. Todd projects that the drug could generate somewhere between $50 million and $100 million annually for Opko from royalties. I think he's right -- and I suspect the actual figure could ultimately come close to the upper end of that range.
Even better, Opko is eligible for up to $110 million in milestone payments from Tesaro. We don't have the details related to those milestones, but I wouldn't be surprised if some money began flowing soon and extended into 2016.
3. Regulators reward Rayaldee
Could Opko Health score another FDA win soon? I think it just might. The regulator is due to make a decision on Rayaldee by March 29, 2016.
Opko conducted two phase 3 clinical studies evaluating the efficacy and safety of Rayaldee as a treatment for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. Both studies achieved positive results. While nothing is a given when it comes to FDA decisions, I'd say Rayaldee has a very good shot at winning approval.
There isn't currently a drug on the market that effectively corrects vitamin D insufficiency for CKD patients. And with over 20 million patients suffering from moderate (stages 3 or 4) and severe (stage 5) forms of CKD, the potential market is huge.
Foresight isn't 20/20
Hindsight might be 20/20, but foresight surely isn't. Any or all of the three predictions above could prove to be off the mark. Maybe the Bio-Reference deal won't pan out nearly as well as I think it will. Maybe the Varubi launch will fall flat. Maybe the FDA will give a thumbs-down to Rayaldee. On the other hand, if my predictions are right, Opko Health could turn out to be one of 2016's biotech winners.
I think this time next year, I'll be proven right. However, when it comes to predicting, I tend to agree with another statement from Niels Bohr: "Every sentence I utter must be understood not as an affirmation, but as a question."
More
Good Classification Model as a Whole Reveals Preliminary Study of the Ability of the 4Kscore Test
OpkoDD.Wordpress.com
Actas Urol Esp. 2015 Nov 17. pii: S0210-4806(15)00246-6. doi: 10.1016/j.acuro.2015.09.006. [Epub ahead of print]
A Preliminary Study of the Ability of the 4Kscore test, the Prostate Cancer Prevention Trial-Risk Calculator and the European Research Screening Prostate-Risk Calculator for Predicting High-Grade Prostate Cancer.
[Article in English, Spanish]
Borque-Fernando Á1, Esteban-Escaño LM2, Rubio-Briones J3, Lou-Mercadé AC4, García-Ruiz R5, Tejero-Sánchez A5, Muñoz-Rivero MV5, Cabañuz-Plo T5, Alfaro-Torres J6, Marquina-Ibáñez IM6, Hakim-Alonso S6, Mejía-Urbáez E6, Gil-Fabra J5, Gil-Martínez P5, Ávarez-Alegret R6, Sanz-Saiz G7, Gil-Sanz MJ5.
Abstract
INTRODUCTION:
To prevent the overdiagnosis and overtreatment of prostate cancer (PC), therapeutic strategies have been established such as active surveillance and focal therapy, as well as methods for clarifying the diagnosis of high-grade prostate cancer (HGPC) (defined as a Gleason score ≥7), such as multiparametric magnetic resonance imaging and new markers such as the 4Kscore test (4KsT). By means of a pilot study, we aim to test the ability of the 4KsT to identify HGPC in prostate biopsies (Bx) and compare the test with other multivariate prognostic models such as the Prostate Cancer Prevention Trial Risk Calculator 2.0 (PCPTRC 2.0) and the European Research Screening Prostate Cancer Risk Calculator 4 (ERSPC-RC 4).
MATERIAL AND METHODS:
Fifty-one patients underwent a prostate Bx according to standard clinical practice, with a minimum of 10 cores. The diagnosis of HGPC was agreed upon by 4 uropathologists. We compared the predictions from the various models by using the Mann-Whitney U test, area under the ROC curve (AUC) (DeLong test), probability density function (PDF), box plots and clinical utility curves.
RESULTS:
Forty-three percent of the patients had PC, and 23.5% had HGPC. The medians of probability for the 4KsT, PCPTRC 2.0 and ERSPC-RC 4 were significantly different between the patients with HGPC and those without HGPC (p≤.022) and were more differentiated in the case of 4KsT (51.5% for HGPC [25-75 percentile: 25-80.5%] vs. 16% [P 25-75: 8-26.5%] for non-HGPC; p=.002). All models presented AUCs above 0.7, with no significant differences between any of them and 4KsT (p≥.20). The PDF and box plots showed good discriminative ability, especially in the ERSPC-RC 4 and 4KsT models. The utility curves showed how a cutoff of 9% for 4KsT identified all cases of HGPC and provided a 22% savings in biopsies, which is similar to what occurs with the ERSPC-RC 4 models and a cutoff of 3%.
CONCLUSIONS:
The assessed predictive models offer good discriminative ability for HGPCs in Bx. The 4KsT is a good classification model as a whole, followed by ERSPC-RC 4 and PCPTRC 2.0. The clinical utility curves help suggest cutoff points for clinical decisions: 9% for 4KsT and 3% for ERSPC-RC 4. This preliminary study should be interpreted with caution due to its limited sample size.
DR. DAVID SAMADI: ‘NEW BLOOD TESTS BEING DEVELOPED TO REPLACE THE PSA TEST SUCH AS THE 4KSCORE’
With fewer PSA screenings, will more men die of prostate cancer?
NEW YORK, Nov. 24, 2015 /PRNewswire/ — According to two new studies, fewer men are having PSA tests today than in 2005. This is something that many doctors, scientists, and public health experts have been pushing for a long time. One questions remains: with fewer PSA tests being done, will there be more men dying of prostate cancer?
According to Dr. David Samadi, “Despite the efforts made in regards to early detection for prostate cancer, the disease remains the second leading cancer cause of death in men, killing approximately 27,500 men this year. Tens of thousands of additional men suffer from the burden of painful metastatic prostate cancer, which can lead to bone fractures, the inability to urinate, spinal cord compression and renal failure. The evidence remains that since PSA screening became widely recognized in the early 1990’s, there has been a 39 percent reduction in prostate cancer mortality rates.”
However, not everyone agrees with his finding. Others say that fewer PSA tests will not cause more prostate cancer deaths. According to Dr. Kenneth Lin, a family medicine physician at Georgetown University School of Medicine, the claim that fewer PSA tests will cause more prostate cancer deaths is based on “putting all your faith” on a European study that found a mortality benefit from PSA screening. Dr, Lin said “It’s not right to ignore the other trials,” which he claims did not show the PSA blood test saves men’s lives.
There has been controversy over PSA screening for a number of years. The evidence began piling up about a decade ago that the PSA test leads to overdiagnosis and overtreatment. It is true that an elevated PSA may indicate prostate cancer. However, the PSA is not specific for prostate cancer and could also indicate other prostate related conditions. Many argue that prostate cancers are so slow growing that they may never even put a man’s health or life at risk, and that many men with prostate cancer will die with it, not of it.
The PSA test is not perfect, and there are a few new blood tests being developed to replace the PSA test such as the 4KScore and the PHI test, both of which are prostate cancer. In the meantime, rather than getting rid of PSA screening, there are other things that can be done to optimize the benefit of the PSA test while reducing overdiagnosis and overtreatment. It is important that that PSA test not be looked at as a single test result. Physicians must also take into account the PSA trends, co-morbid conditions, overall life expectancy, and understand patients’ treatment goals.
According to Dr. Samadi, “The controversy over PSA screening exposes the importance of the need for physicians to put more emphasis on treating their patients as individuals, and not just as a population. Because the PSA test is not always the best measurement for all patients, the decisions made for diagnosing and treating each patient should be based on the individual. Until then, and until we have a better test for diagnosis prostate cancer, it is simply too dangerous to tell men to stop having PSA tests.”
Patients newly diagnosed with prostate cancer can contact world renowned prostate cancer surgeon and urologic oncologist, Dr. David Samadi, for a free phone consultation and to learn more about PSA screening. Call 212.365.5000 to set up your consultation.
SOURCE:opkodd.wordpress.com
David B. Samadi, MD
Chairman of Urology,
Chief of Robotic Surgery at Lenox Hill Hospital
Professor of Urology at Hofstra North Shore-LIJ
School of Medicine
Dr. Samadi is a board certified urologic oncologist trained in open traditional and laparoscopic surgery and is an expert in robotic prostate surgery. He is Chairman of Urology, Chief of Robotic Surgery at Lenox Hill Hospital, Professor of Urology at Hofstra North Shore-LIJ School of Medicine. He has dedicated his distinguished career to the early detection, diagnosis and treatment of prostate cancer and is considered one of the most prominent surgeons in his field.
OPKO CEO Dr. Phillip Frost Bloomberg Interview Transcript & Audio
OPKO CEO Dr. Phillip Frost and President of Urology of OPKO Health Dr. Mitchell Steiner on Bloomberg Radio with Kathleen Hays and Pimm Fox.
Transcript
Oct 14, 2015
Lightning Round Recap
Mad Money w/Jim Cramer:
Cramer: ‘This Stock is a BUY, Right Here – Right Now!’
Caller:
Louis In Minnesota
My Stock is Opko Health
Cramer:
I thought that Dr. Phil Frost when he came on acquitted himself well, including about the Bio-Reference Lab and that acquisition. I think this stock is a BUY, Right Here – Right Now! I’m not afraid to stick my neck out for Phil Frost, he’s made too much money for people.
Highly Esteemed, E. David Crawford, MD “4Kscore is unique in that you find cancers that probably need to be treated”
Excerpt:
How do we improve the performance of the tests and find cancers that need to be treated?
There are these new PSA isoforms already mentioned by Mitch Sokoloff. We have PHI, we have PCA3. This is a study that Dr. Shalken didn’t mention that we had done with PCA3. This is one with David Boswick with some 2,000 men where there was a very nice, and these were the first biopsies of men. This was a very nice linear relationship between PCA3 and the positive biopsy. 4Kscore, we heard about that already the value of this test and the 4Kscore is unique in that you find cancers that probably need to be treated, in other words, Gleason 7s and above.
Audio / Video Slide Presentation + Transcript
Prostate Conditions Education Council Increases Prostate Cancer Marker Awareness on Opko Health’s 4Kscore
The Prostate Cancer Biomarkers website is brought to you by Prostate Conditions Education Council.
New Current Standard Screening Methods introduces the Emergence of Genetic Tests Such as the 4Kscore
Gaps in Prostate Cancer Research and How Governor Cuomo’s Funding Will Help
Dr. Samadi
prWeb
NEW YORK, NEW YORK
OCTOBER 06, 2015
Last week, New York State Governor, Andrew Cuomo, announced major funding for prostate cancer. With a total of $3 million in funding, 20 research institutions across the state will now be exploring new and innovate concepts around prostate cancer detection, diagnosis and treatment.
In the state of New York alone, Prostate Cancer is the second most common cancer in men.
“Over 233,000 men are diagnosed with Prostate Cancer across the United States each year with thousands being diagnosed in New York State alone. This issue is important and it’s wonderful to see a political figure supporting the need for more research,” stressed Dr. Samadi.
There are many gaps around what we know about prostate cancer and more research is needed even in areas that have advanced over the past decade. Arguably, the most important need for more research is around current standard screenings such as the PSA blood test and genetic tests like the 4Kscore.
“Obviously the PSA blood test is non-specific, however new genetic testing methods have improved this process but we continue to need more clinical trials to see how and when these tests should be recommended to an individual patient in order to pinpoint their exact risk for prostate cancer,” said Dr. Samadi.
Another area that needs more support is evaluating the side effects of each treatment method more carefully and over a longer period of time. Surgery versus radiation has long been debated for prostate cancer but there still remains many gaps in research when it comes to the actual quality of life men experience after these procedures.
Lastly, we still don’t really know what causes prostate cancer. We know the risk factors which range from family history to race, but we still don’t fully understand why and how it develops in some men and especially why it progresses much faster in some patients as opposed to others who have a slower growing disease.
“Genome sequencing and genetic testing has helped advance our overall understanding but we need to get inside this disease and really understand its inception and growth,” stressed Dr. Samadi.
A paramount study was released this year from Vanderbilt University Medical Center that showed the impact of the United States Preventive Task Force Services guidelines on prostate cancer detection rates. The study showed that there is a decrease in the number of prostate cancer cases being diagnosed and correlated it to the U.S. Task Force recommending against the PSA screening for men in their 40s. This is dangerous but a great example of how research can help identify these patterns to work toward a solution.
Past research has led us to understand just how unique this disease is along with uncovering many breakthroughs in diagnosis and treatment. A few key research highlights we’ve seen in the last 3 years are:
>Vitamin D shows promise to slow prostate cancer growth
>Prostate Cancer is more aggressive when it occurs in younger men
>MRI Fusion-Guided Biopsy better detects aggressive prostate cancer
>Researchers identify 5 different types of prostate cancer
>Androgen Deprivation Therapy associated with increased risk of fatal heart attack in men with prostate cancer
“Research and funding has also led to our advanced understanding of the genetic nuances in how prostate cancer develops. The emergence of genetic tests such as the 4Kscore, PCA3 and Oncotype DX came from institutions investing in the cause for better prostate cancer detection methods. We are fortunate that prostate cancer was at the forefront of many of these discoveries, but of course we need more,” noted Dr. Samadi.
Contrarily, we do also see confusion coming out of certain research findings. A recent example came from a study published in the journal Cancer, which showed that low PSA levels were associated with an increased risk of dying of prostate cancer.
“These types of findings are what lead us to believe this disease is much more complicated than previously thought. Just because this type of cancer resides in one gland that can be removed, doesn’t make it any less of a complicated form of the disease,” explained Dr. Samadi.
Video
Washington Regional says new blood tests on the market like the 4Kscore test can help
NWA Northwest Arkansas News
KNWA
10/01/2015 4:43 PM
Fayetteville, AR
For years the standard method of testing for prostate cancer was a rectal exam and a PSA test. The test for Prostate Specific Antigen or PSA comes with many limitations and can often show a false positive.
Dr. Adam Childs is a urologist with Washington Regional says new blood tests on the market like the 4Kscore test and the Prostate Health Index can help. Reverse engineered from patients with prostate cancer, these tests are designed to catch prostate cancer earlier by looking for certain markers in the blood.
"If there's one thing I could tell men during the month of September, which is National Prostate Awareness Month, it would be that if you are between the ages of 50 and 75 I would recommend that you talk with your doctor about getting a digital rectal exam and considerations for prostate cancer screening with one of the several blood tests that are now available."
View Video
Opko Health Europe Events
OPKO Health present at the congress of the Spanish Society of Ophthalmology
From 23 to 26 September OPKO Health attended the last congress of the Spanish Society of Ophthalmology in Sevilla. In their own stand, equipment medical representatives reported the new line of ophthalmic products, focusing on VisNeurox and CitoNeurox.
OPKO Health is Positioned for Strength and Growth in Large Markets with Significant Unmet Needs
OpkoDD.wordpress.com
By: UncleTlzz
Sep 28, 2015
OPKO Health’s Advancing Deep Pipeline
Cramer Said:‘BUY More Opko Health’…Your on the Wrong Side of the Trade to Bet Against the Doctor
Mad Money w/ Jim Cramer
CNBC.com
September 17, 2015
Caller: Andrew in Massachusetts
Hi Jim. I bought Opko Health a few years back on your recommendation. The stock has recently dropped back for the share for share purchase of Bio Reference Labs. I believe the buyout was a great investment for Opko but the stock has fallen. 55 million shares are held short, but yet the CEO who owns 180 million shares and since the beginning of August has added an additional 20 plus million dollars worth of stock seems to think otherwise. Should I buy more now or do you think I have a chance to buy at a lower price?
Mad Money: Cramer
I think you should buy more. I think Phil Frost has done a great job. Yes, the stock ran up a great deal and was opportunistic in making that acquisition. But you know what, that stock has come down Way to Much! For those that don’t believe in Phil Frost, they ought to study history. It’s been the wrong side of the trade to bet against the doctor.
Eisenhower Medical Center Now Offers Opko Health’s Cutting Edge Lab Test 4Kscore™
THE CUTTING EDGE
THE LATEST DIAGNOSIS AND TREATMENT OPTIONS FOR PROSTATE CANCER AVAILABLE AT EISENHOWER
Eisenhower Medical Center
By: Roxanne Jones
Sept 15, 2015
About one man in seven will be diagnosed with prostate cancer in his lifetime, making it the most common cancer in American men, after skin cancer. The average age at the time of diagnosis is 66.
While prostate cancer can be serious, most men diagnosed with the disease don’t die from it. In fact, more than 2.5 million U.S. men who have been diagnosed with prostate cancer are still alive today, according to the American Cancer Society®.
This encouraging fact is due largely to the advanced diagnostic and treatment resources available today, including the resources available at Eisenhower Medical Center.
The UroNav Fusion Biopsy System is one example. This diagnostic technology fuses magnetic resonance imaging (MRI) and ultrasound images to create a detailed, three-dimensional view of the prostate, which doctors can use to guide exceptionally precise biopsies.
“Traditionally, we do biopsies by taking six tissue samples from each side of the prostate, for a total of 12 samples,” explains Board Certified Urologist William Page, MD, referring to what’s called a pattern biopsy. “But this can miss hard-to-find and sometimes aggressive prostate cancer.
“With UroNav, we’re able to more precisely pinpoint what are called regions of interest (ROIs) or targets in the prostate that look suspicious,” he continues. “This way, you can do the standard pattern biopsy plus test these highly suspicious ROIs. We’re hopeful that this will help us find the really bad stuff sooner.”
Dr. Page notes that the UroNav system isn’t appropriate for every patient.
“Right now, it’s typically being used with patients who already have a diagnosis of prostate cancer and we want to rebiopsy any highly suspicious areas,” he says, “or someone who had a biopsy a year ago and it was negative, but his PSA is going up and we need to take another look.” PSA (prostate-specific antigen) is a protein that circulates in the blood that may indicate the presence of prostate cancer.
Eisenhower acquired the UroNav system in June and is the first and, to date, only hospital in the desert to offer it. “We’re very much at the forefront, even compared to other hospitals around the country,” Dr. Page says. “There’s really no need to leave the desert for advanced diagnostic imaging.”
Eisenhower also is on the cutting edge when it comes to lab tests for detecting prostate cancer. Two new blood tests, the Prostate Health Index (PHI) and the 4Kscore™ test, bring a new level of diagnostic sophistication to PSA testing.
“These tests help us sort out if an abnormal PSA number requires a biopsy, or if watchful waiting is appropriate,” Dr. Page explains. “The 4Kscore test can help us predict if someone has an aggressive form of prostate cancer that requires treatment.”
When treatment is necessary, Eisenhower offers a range of options, including the latest advance in radiation therapy called volumetric modulated arc therapy (VMAT).
“VMAT delivers very precise radiation to the prostate gland with a minimal dose to surrounding normal tissues,” says Robert Johnson, MD, a Board Certified Radiation Oncologist at Eisenhower. “But what really makes it unique is that patients can be treated in a couple of minutes, compared to traditional radiation therapy that takes 15 to 20 minutes per treatment.”
Dr. Johnson notes that a variety of prostate cancer treatment options are available today, which can feel overwhelming for someone who’s newly diagnosed.
“We spend up to an hour with each patient, explaining his treatment options,” he says. “All treatment paths have similar outcomes, but there are different risks relative to side effects, and we make sure patients understand these before they make a decision.
“The upshot is, just about everyone diagnosed with prostate cancer today can expect a positive outcome,” Dr. Johnson adds. “It just comes down to how you get there.”
Full Article
Lowenthal Capital Partners: ‘Does heavy insider trading in Opko signal an impending breakout?’
Healthcare Insider Roundup: Opko Health And More
Summary
Top news on insider activity in healthcare.
What are today’s hottest insider stocks?
Does heavy insider trading in Opko signal an impending breakout?
To put it simply, my investment strategy focuses on tracking insider and hedge fund trading. Before committing to an investment, I research whether or not key financial actors have put some skin in the game. So to speak, I ask, “is their money where their mouth is?”
In conjunction, I assess the timing of major investments in relation to important company catalysts. I believe that well-timed buys from key financial players can indicate optimism toward a products’ and/or the company’s outlook; on the flip side, I believe that well-timed sells from key financial players can indicate pessimism toward a product’s and/or the company’s outlook.
This is the working assumption that has guided much of my research over the last few months. Generally, I piggyback on informative insider purchases and sales in healthcare, as it has proven to produce sizable returns as compared to more conventional strategies that I have employed. I hope you find the contents of this Healthcare Insider Roundup as useful as I do.
Focus Ticker: OPK
In my three healthcare Roundups, I noted as postscript that Opko Health (NYSE:OPK) was one of a number of particularly interesting long opportunities to watch in the coming weeks. After updating that list on several occasions, accounting for daily changes and so forth, Opko Health is one of the few still on that list.
From the outset, I admit that I have been watching and covering Opko stock for some time now. Most recently, I published an article on Seeking Alpha titled, “Poor Earnings, A Questionable Acquisition, A Disastrous August, But I’m Still Betting on Opko,” whose bullish thesis is self-evident. In the article, I sought to explain why Opko stock has plummeted since June 2015, why many analysts believed that share price would level out around 10$/share, and why a rebound was imminent. Now I’ve found the perfect opportunity to expand on that analysis in my Healthcare Insider Roundup. Specifically, I follow up by covering recent insider events, and finally, and by exploring potential catalysts that could drive share price in the near future.
For those who are not familiar with the company, Opko Health is a mid-cap ($6 billion) biopharmaceutical company focused on point-of-care diagnostics, novel molecular diagnostics, as well as pharmaceutical and vaccine products. Following the announced $1.47 billion acquisition of Bio-Reference Laboratories (NASDAQ:BRLI) last month, the Opko stock has suffered dramatically. The stock plummeted from 52-week highs of around $19/share to nearly $10.00/share in August. While the acquisition of Bio-Reference provides Opko with a number of valuable opportunities, the market consensus was that the company overpaid. As a result of this, as well as a worse-than-expected Q2 earnings report, Opko stock has undergone a major sell-off.
Criterion #1 – Insider Buying
Despite the rapid decline in the share price, or perhaps, because of the rapid decline in the share price, corporate insiders have made large purchases of cheap company stock. Opko CEO, Dr. Philip Frost, has led this recent spending spree. Over the past 18 days alone, Frost has purchased over $6.8 million worth of stock in the company at near-$10/share mark.
Here, I turn to TipRanks, a service which tracks and ranks corporate insiders, analysts and investors based on their purchases and buy/sell recommendations. Frost, who was long-time Chairman of Teva (NYSE:TEVA), the largest generic manufacturer in the world, is currently ranked 1 out of all 34,001 corporate insiders tracked by TipRanks, having achieved a 41.4% ROI for a 77% success rate on all investments since 2009.
Simply put, this an incredibly promising sign for Opko investors. Frost, with his incredible track record, continues to funnel investments into the company, despite the declining earnings per share. This has generated positive sentiment for the long-term outlook of Opko, but it is also already turning heads in the financial industry. Frost is an incredibly well-respected investor, and hedge funds have responded well to his optimism. Despite declining share price, hedge funds have actually increased their holdings 331,600 shares in the last quarter. Most recently, Paul Tudor Jones at Tudor Investment Corp upped his position $2.53 million; David Costen Haley at HBK Investments initiated a new position worth $445,040; and Joel Greenblatt at Gotham Asset Management initiated a new position worth $453,090. These are the last three major transactions – all buys.
Although I do not trust any actor alone, there is a tidal wave of investment coming from insiders, who have bought shares worth $32.6 million in the last 3 months, as well as hedge funds. As a result, analysts are beginning to update their projections for the share price. The vast majority are now leaning bull on Opko, including Brady Hawke, Chris Sester, Alexis Barley, and Kurtis Sibley.
Criterion #2 – Catalysts
Much has occurred of late for Opko. In my last article on Opko, I focused on the acquisition of Bio-Reference and its implications for the commercialization for the 4Kscore Test. I argued, and maintain, that the acquisition will have incredible long-term benefit for Opko. Here, however, I want to focus on a more recent which, I believe, is yet to be reflected in the share price: the recent approval of Varubi (rolapitant).
Rolapitant is used to prevent delayed-phase chemotherapy-induced nausea and vomiting. Opko has a license agreement for Rolapitant with Tesaro (NASDAQ:TSRO), (another Healthcare Roundup company on my watch list), which entitles Opko to up to $121 million in upfront and milestone payments, double-digit tiered royalties on sales, an undisclosed share of future profits in Japan, and an option to market Rolapitant in Latin America. Opko has established an equity position in Tesaro, so it will benefit greatly from the Rolapitant approval.
Unfortunately, the approval of Rolapitant has not catalyzed a rebound in the share price, but it is still very possible that it has stabilized the situation – that, or investors are yet to fully appreciate the opportunity that the approval has presented Opko with. Much is still to be seen.
Another positive development (albeit, in no way a game changer) was Opko’s September 9 announcement of a global license agreement with the Scripps Research Institute for the development and commercialization of Lsp inhibitors developed and discovered using technology funded and licensed by Opko from Scripps. The parties aim to develop a novel antimicrobial agent through their expanded collaboration. Opko agreed to fund work from Dr. Dennis Wolan at the Institute in order to move rapidly into clinical trials. Obviously, what comes from this collaboration is yet to be seen, but regardless, the expanded efforts seem promising. Stay tuned.
My Takeaway
Although Opko Health has received major insider and hedge fund investment over the last few weeks, public sentiment is yet to turn. Recent developments that might have catalyzed share price appreciation in the past are currently being met with skepticism. As a result, the share price continues to plateau, or decline very mildly. Based on the continued investment from key financial players, and in light of the recent approval of rolapitant, it seems like the bleeding will soon stop. At least this is the notion of the vast majority of analysts who have upgraded their position on Opko. Again, bullish sentiment seems to dominate the conversation.
Full Article
David Coleman of Vickers Insider Weekly Top Pick is Opko Health Inc
5 reasons to double-down and buy stocks today
Excerpt
A top pick of Coleman’s is Opko Health Inc. OPK, +2.84% It’s an unusual biotech company in that it recently sold off sharply, despite the persistent strength in the group, most likely because it announced the purchase of another biotech company. Investors often sell the shares of the buyer in mergers, because of doubts about acquisitions, which so often fail to pan out. But in this case, the insider buying suggests the buyout adds to the product pipeline in a favorable way, one reason I have also suggested Opko in the recent weakness in my stock letter, Brush Up on Stocks.
Full Article
Very good read on OPKO’s out-licensed Rolapitant and how it could give Merck's Drug Emend a run for it's Money...
I’m not telling you it’s going to be easy – I’m telling you it’s going to be worth it
OPKO – Performing Consistently
Samreen Agha
Small-cap, value, growth, healthcare
Aug. 31, 2015 1:15 PM ET
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Summary
OPKO is successfully performing on its business model with pipeline advancement, revenue generation and strategic investments.
According to estimates, it is expected to turn profitable by next year.
Multiple important catalysts approaching, including PDUFA date of Rolapitant, conferences, and trials.
OPKO Health (NYSE:OPK) has had a good year, so far. It has risen almost 13.7% since I last wrote about it, and declined a lot more during the year; however, it still has a number of catalysts left for the year. The catalysts throughout the year and into 2016 are instrumental for turning the company profitable in a year or so. Yes, OPKO is this close to turning profitable and the business model is soon going to pay off. Dr. Frost’s able management, strategic investments and consistent insider buying has only increased the trust in the company.
Recent Investments
OPKO on June 3, 2015 entered into a merger agreement to acquire Bio-Reference Laboratories, Inc. following which the company’s shares declined. The share decline was attributed to the fact that OPKO is overpaying for this acquisition. However, the long-term benefit that this acquisition will unlock is substantial, since it provides a remarkable sales force to better market its 4Kscore test. The value that this deal adds is best explained in Dr. Frost’s letter to shareholders as:
“The strategy behind the recent Bio-Reference acquisition is twofold. First, it is a business whose revenues and profits have grown consistently since its launch by Dr. Marc Grodman in the 1980s, primarily through organic growth, to become the third largest full service reference laboratory in the United States. It has built a reputation of innovation with recognized franchises in women’s health, cancer and, more recently, genetics, helping physicians worldwide to diagnose rare genetic disorders and to identify special features of a patients genetic material to select more effective chemotherapy. Second, it provides an infrastructure for marketing and sales that reaches approximately 10 million patients a year. Reimbursement is an important factor for the success of diagnostic products and Bio-Reference has a large team of experts who can complement our efforts to be sure that payors recognize the value of our tests for reimbursement purposes.”
Another significant investment made by OPKO is that of EirGen Company in Ireland. EirGen has a very rich pipeline with 10 applications filed with the FDA, 3 of which have been approved, an additional 4 filings in Europe all of which are approved, and 4 out of 5 approved in Japan. Not only this, the company has 24 drugs in development. From the strategic point of view, this acquisition is the first of OPKO’s investment in Ireland, and Dr. Frost did emphasize that Ireland is a good place to concentrate the company’s efforts, thus more investments in Ireland are expected. The benefits of investing in Ireland include the low tax rate and the government paying for the R&D work going on.
Oxyntomodulin (MOD-6031) on to Phase I
OPKO is expected to begin the Phase I clinical trial for its obesity and diabetes drug – the long acting Oxyntomodulin (OXM) MOD-6031 – by early 2016. OXM is a peptide hormone which is secreted following food intake and induces fullness after reaching the brain. Thus, it is a powerful appetite suppressant, which also increases glucose tolerance. The reduction in food intake is also accompanied with an increase in energy expenditure.
In addition, OXM also activates the glucagon receptor (GCGR) and the glucagon-like-peptide-1 receptor (GLP1R). Activation of GCGR increases the production of glucose which may pose as a hyperglycemic risk; however, the simultaneous activation of GLP1R counters the effect by release of insulin. Thus, these two receptors together can provide a superior treatment option for diabetes and obesity. However, the benefits of OXM have been limited due to its relatively short life, which requires frequent administration. This is where OPKO is working by linking the natural OXM to a proprietary hydrolysable linker and substance to increase biological half-life, thus, forming a long-acting OXM which will require weekly injections. In preclinical trials, the candidate MOD-6031 was administered to obese mice and rats, and they shed almost 20% of their weight without any worrisome side effects. OPKO expects to begin human trials for this candidate early next year. Earlier, the Phase I trials were expected to begin in the second half of 2015; however, in the recent letter to shareholders by Dr. Frost, it is mentioned that the trials will be beginning early 2016.
Various studies evidence the weight-shedding effect OXM has on the subjects, but thus far the utility was limited due to the short life of OXM. OPKO got the drug when it acquired Prolor Biotech in 2013. Dr. Frost believes that the drug can achieve $100 billion potential, and that OPKO will be able to tweak it to be a successful obesity drug. Dr. Frost even went on to claim that the companh may be able to control obesity. His exact words are:
“We are taking technology that extends the life of the hormone, which itself has already been proved in previous studies to reduce weight. With a single injection a week, we think we can control obesity.”
Obesity Drugs
To date, an effective treatment for obesity eludes pharmaceutical companies. Those drugs already in the market claimed of blockbuster potential, but are nowhere near proving that potential. Obesity drugs are tricky because they must be free from serious adverse events and also must be fast-acting to keep the patients on the drug. However, the drugs already approved do not fulfill these criteria, as can be seen in the table below. And it is early for OPKO even to expect that MOD-6031 may come out without any glitches, but with Dr. Frost and his history with re-engineering drugs, there is a fair chance of success.
As evidenced from the table, the already approved obesity drugs require frequent doses and their mechanism of action is varying. Not only this, they have a number of side effects, which may be responsible for the lower uptake of the drugs. However, OXM in mice has shown marked weight loss and also decreased the food intake. The native OXM reduced food intake for around one hour; however, OXM-5CTP maintained this inhibition for about 80 hours or 3 days. This not only means that the biobetter OXM is effective but also increases the prospects of the candidate.
Competition in OXM Space
There are a few other pharmaceutical companies which are using the dual GLP-1 and GCG agonists to develop candidates for obesity, and are already in advanced stages of development.
Zealand Pharma (OTCPK:ZLDPF) (OTCPK:ZLDPY) requires administration of its candidate on a daily basis, which in a way excludes it from the competition. As for Hamni Pharmaceutical, it is administrating once weekly, and expects to file NDA for the obesity indication by 2020, if all goes without glitches. The trials in mice showed a 23% decrease in body weight, which was driven by fat mass reduction and not by body lean mass. Furthermore, blood glucose levels also witnessed a decrease; however, the food intake inhibition was not measured. As for Eli Lilly’s (NYSE:LLY) TT401, the Phase I trial reported body weight loss and glucose levels reduction. However, it also reported mild side effects such as nausea and vomiting, which is a common side effect of GLP-1 activation. The results of the Phase II trial have an estimated completion date of August 2015. Given the positive results of the trial, it should be able to commence Phase III trials pretty soon. Thus, it is not entirely out of question that the drug may be in the market in the next 3-4 years.
Updated Pipeline
OPKO has included two preclinical candidates in the updated pipeline. One is the AntagoNAT platform aimed for the indications cancer, CV, metabolic and orphan diseases. The animal models have shown that these AntagoNATs have enhanced the mRNAs expression that are responsible for certain genes transcriptions into functional proteins. The most advanced program is CUR-1916 for SCN1A (sodium channel protein) for treating Dravet Syndrome, and OPKO aims to file an IND once the toxicity studies in animals are completed. And an orphan designation for the candidate will also be requested from the FDA.
The other program is the CYP24 inhibitors being developed for the indications Secondary Hyperparathyroidism (SHPT), Chronic Kidney Disease (CKD) and cancer. A Phase I trial is targeted for the fourth quarter of 2016, and the market size is estimated by OPKO at $1 billion.
Upcoming Catalysts
The PDUFA date for Rolapitant, the treatment for chemotherapy induced nausea and vomiting (CINV), is set at September 5, 2015. Rolapitant will be competing in a $1.5 billion market, and in my previous article, I put a modest estimation that it should be able to capture about 15% of the market, which brings the estimated potential to about $0.23 billion. OPKO will receive milestone payments and double digit royalties from Tesaro (NASDAQ:TSRO) upon approval and commercialization. An approval is extremely likely, and will result in a price hike for OPKO.
OPKO will be participating in the Barrington Research Fall Investment Conference on September 1, 2015. These meetings have a positive impact on share price and the general investment sentiment. Additionally, OPKO will be presenting reports in the 54th Annual Meeting of the European Society for Pediatric Endocrinology (ESPE) on October 3, 2015. Two abstracts accepted for presentation are the additional data for hGH-CTP pediatric Phase II trials. One is for the pre-pubertal growth hormone deficient children, while the other is for the Growth Hormone Deficient (GHD) children. These oral presentations will have a positive impact on the stock price based on the news relayed.
The Phase IIa trials for Factor VIIa-CTP for Hemophilia is also expected to begin dosing in the next few months. The candidate has been granted orphan drug status in the US and Europe, and has a market size of $1.7 billion. The current product for hemophilia, NovoSeven, requires 3-4 doses a day during bleeding episodes, and 1-2 times a day for prophylactic treatment. However, OPKO’s candidate demonstrated in the pharmacological studies a dosage frequency for prophylactic treatment 2-3 times a week.
OPKO’s 4Kscore test was included in the National Comprehensive Cancer Network (NCCN) guidelines, which was a notable feat for the test. The company is fervently pursuing its effort to gain reimbursement by targeting highest CPT code i.e. a category 1 CPT code, which will further solidify the position of 4Kscore. The application submitted to the AMA CPT Editorial Board on July 15 will be reviewed by October, and OPKO expects a favorableresponse by the beginning of 2016. This catalyst is of importance not only for the 4Kscore test’s validation but also for the revenues the increased insurance coverage will bring.
Another major NDA related catalyst is that of the PDUFA date for Rayaldee on March 29, 2016. OPKO will be submitting the 120 safety updates to FDA by September 25, 2016. Rayaldee is a blockbuster potential drug and its approval will result in a price hike. On the contrary, any negative comments or delays from the FDA will obviously be detrimental to OPKO’s stock price. However, my bet is on the approval of the NDA and the subsequent commercialization will take place as expected.
Other catalysts for 2016 include the expected 510(k) filing of the Claros 1 platform for the testosterone testing, and a PMA filing for PSA testing, both in the first half. The PSA test will complement the 4Kscore test and will be marketed by the Bio-Reference sales force. A PSA test result raising suspicion will call for a 4Kscore test to help the physician in making a decision as to the condition and subsequent treatment. Furthermore, the final global Phase III study protocol for Fermagate, the calcium phosphate binder, is also expected in the first half of 2016.
Financial Condition
Financially, OPKO is stable given the various revenue generators, including the diagnostic tests and the approved candidates. A major chunk of the revenue will come from the 4Kscore test, given its strong uptake and the reimbursements. The recent acquisitions of Bio-Reference Laboratories and EirGen are also set to bring in healthy revenues. Bio-Reference alone had $432 million of revenue in the first half of 2015, with an operating profit of $30.9 million. As for EirGen, it reported a profit of $1.1 million in 2014. This will bring in healthy revenues for OPKO over the years. Analysts estimate that OPKO would turn profitable by 2016, with an estimated EPS of $0.03.
OPKO had a cash balance of $221 million at the end of quarter 2, which also included the upfront payment from Pfizer (NYSE:PFE) of $295 million, and excluding the acquisition made of EirGen. The cash position of OPKO is expected to stay stable, as the company will again be eligible to receive a $110 million milestone payment from Tesaro on the expected approval of Rolapitant’s NDA next month. Tesaro expects annual sales of over $1 billion for Rolapitant, of which OPKO will receive double digit royalties.
Insider Buying and Market Performance
Management, led by Dr. Frost, has consistently purchased shares of OPKO, and in the last three months there have been a total of 29 buys, and 127 in twelve months.
OPKO has a year-to-date performance of approximately 14.3%, with a year high of $19.12. However, Friday’s closing price was at $11.42 and, in my opinion, OPKO is significantly undervalued. The price declined following the Q2 financial results, as OPKO didn’t meet the expectation of the analysts. Further price decline was owed to the general market correction that took place. And OPKO has now started to recover, and is expected to witness significant price increase. In addition, looking at the technical charts, it is slowly exiting the previous oversold territory with an RSI of 30.93.
Additionally, OPKO has a consensus price target of $17.67, which represents an upside of almost 55% from Friday’s close. The consensus rating is a Buy, and the highest price target is $22 by Laidlaw.
Risks
There have been a number of instances where OPKO has delayed the already announced timelines by a few months or so. This has a negative impact not only on the stock price but also on the investor sentiment in general. The company ultimately does perform on the new set timelines, and this is not a risk in itself, but rather a matter that may impact the stock price and sentiment.
MOD-6031, the obesity drug, is in very early stages of development and is targeting a condition which has previously not generated a blockbuster drug. Though Dr. Frost is sure of his re-engineering and believes the drug will be a success, but there are still chances of either failure of the drug achieving its target or serious side effects that may render the drug not fit for approval. Although OXM has already proven to be safe and effective in various studies, both on mice and humans, the inherent risk of trial failure still exists.
OPKO has two NDAs pending approval, one is for Rolapitant PDUFA on September 5, 2015, and the other is for Rayaldee with PDUFA date of March 29, 2016. Approval is highly likely for the both the candidates since they have strong clinical data. However, a negative response from the FDA in either delay, additional data or clinical trials will result in negative price reaction.
Conclusion
All in all, OPKO still remains an excellent investment, and the current dip in the price is merely an opportunity to invest more for the long run. The company is on its way to profitability and will keep growing under Dr. Frost’s able management. OPKO is financially sound, has remarkable products in the pipeline, equally remarkable subsidiaries and acquisitions, and an excellent business model. Thus, I remain bullish on the prospects of OPKO.
Full Article With Images Can Be Found Here
'Opko Health's micro-device highlights the appeal of this market'
3 Stocks to Watch in Medical Diagnostics
There’s super-cool science at work here, as well as multiple opportunities for investors.
Cheryl Swanson
The Motley Fool
Aug 30, 2015 at 10:22AM
Picture a small wireless device that can determine in minutes whether you have a serious disease, versus having to endure the agony of waiting day after day to hear back from your doctor. Now imagine that this device is located not in a remote laboratory, but rather in your local pharmacy, on your doctor’s desk, or even in the backpacks of healthcare personnel working in disaster zones.
Pretty cool, huh?
It’s not sci-fi; it’s a rapidly approaching reality. Thanks to advances in wireless technologies and low-cost biosensors, the floodgates are opening for sophisticated point-of-care diagnostics, or POC.
POC is already in use for simple applications such as glucose monitoring, but the latest micro-devices are being used on people who show symptoms of diseases such as Ebola. The payoff is that having results quickly can minimize the need for quarantining. There are also applications coming for cancer, where enormously accelerated turnaround times could facilitate much faster treatment.
But that’s just the beginning. Since POC is spot-on with the goals of personalized medicine, it’s an industry that has enormous potential and presents multiple intriguing opportunities for investors.
Let’s dig into three companies to watch in this space. The first is Abbott Laboratories (NYSE:ABT), an oft-overlooked healthcare stock that is the surprising market leader in POC. Next comes pure play Cepheid (NASDAQ:CPHD). The California-based small cap sports significantly higher risk, but its technology is at the heart of where the POC industry is going. Last but not least, Opko Health (NYSE:OPK) is developing a fascinating platform for POC that could catalyze its shares.
Abbott is the stealth play in POC
Abbott Pharmaceuticals is composed of four subsidiaries: medical devices, pharmaceuticals, nutrition, and diagnostics. Abbott’s overall medical-device sales were a big yawn as usual last quarter. (Sales were up 3.1% to $1.3 billion.) But slice and dice the numbers a bit further, and you’ll see diagnostics gained 8.7% to reach sales of $1.2 billion in Q2. That makes it this second best-performing unit in the company after established pharmaceuticals. Sharpen your knife a bit further, and Abbott’s POC segment jumps out from within their diagnostics business, posting an 11.5% increase in sales year over year.
Diagnostics now account for 25% of Abbott’s valuation. Abbott CEO Miles White sees increased market penetration in POC as an important growth driver. Profitability is expected to remain steady for Abbott overall (gross margins were at 58% last quarter), and White said he expects high-single-digit operational growth for diagnostics to continue.
The company’s market leadership in POC is based on the company’s i-Stat handheld device, which is now found in one in three emergency rooms in the country.The blood analyzer provides lab-quality results in a situation where every minute counts. Abbott also gained FDA clearance last quarter for a first-of-its kind i-Stat test to detect pregnancy status in emergencies.
Cepheid’s new laboratory in a box
California-based Cepheid recently unveiled a DNA-reading diagnostic device called the Omni, which is expected to be available outside the U.S. during the first half of 2016. CEO John Bishop said the company will soon be applying for FDA approval to put the device directly in drugstore clinics or doctors’ offices, rather than confined to laboratories.
The Omni is the latest in the company’s GeneXpert devices. The company showed solid 13.7% year-over-year growth in revenues of $132.5 million last quarter, which exceeded estimates. On the flip side, the company’s net loss was slightly higher than expected, $0.23 per share versus the expected $0.21 per share. Still, on a non-GAAP basis, the company is projecting itself to be profitable for the year, with net income in the range of $0.25 to $0.29 per share.
While questions have been raised about the quality of POC tests, the GeneXpert system passed several independent evaluations for clinical applications and cost-effectiveness, as reported in peer-reviewed journals such as the American Journal of Clinical Pathology. Cepheid has nearly $300 million in cash and is operating cash-flow positive. While I think there is plenty that distinguishes Cepheid from the competition, as validated by continued sales growth, Cepheid is only for investors with an extremely high risk tolerance.
Opko Health’s micro-device highlights the appeal of this market
Rounding out the list of companies is Opko Health, a stock that colleague Sean Williams recently appropriately described as one that “pulls on the heartstrings of bulls and bears.” Specifically, the stock took it on the chin recently after a double-miss in the second quarter.
While investors in Opko tend to focus on CEO Philip Frost, who has a track record of developing strong companies, or the company’s promising drugs, it’s worth remembering that Opko has a powerful possible catalyst in POC. The company’s platform technology, the Claros 1, could potentially define the course of patient treatment for several diseases in a single office visit. The Claros 1 uses an in-office finger-stick blood analysis to address the large prostate specific antigen (PSA), testosterone, and Vitamin D testing market. The company claims the potential in PSA is $750 million, $525 million in testosterone, and a whopping $3.5 billion in Vitamin D testing for its POC analyzer.
As a Motley Fool Industry Focus interview pointed out, Opko isn’t the kind of company where the investing opportunity is going to disappear today, tomorrow, this month, or even this year. But as highly accurate medical devices migrate out of remote laboratories, the potential of POC diagnostics is something investors ought not to ignore.
The global market for POC should reach $19.3 billion by 2018, according to figures from BCC Research. The United States is advancing at nearly a 5% compounded annual growth rate. Globally, the CAGR is 4.5%. In terms of POC for infectious diseases, research firm TechNavio forecasts a CAGR of 7.5% over the period 2014-2019.
While there are major opportunities ahead, the real payoff I’m hoping for lies elsewhere. POC will allow diagnosis and treatment to happen in the same doctor visit for many more diseases, spelling the end of a lot of patient anxiety. And the value of that goes far beyond compelling — it’s priceless.
NEW Competitor to Aprepitant, Opko's Rolapitant Effectively Reduces Chemotherapy-Induced Nausea and Vomiting
Published Online: 10 August 2015, The Lancet Oncology latest Opko Rolapitant publication is titled, “Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial.”
This publication caught the eye of one Axel Grothey MD.
Dr. Grothey serves in journal review and editorial activities for numerous medical journals and is editor for Clinical Colorectal Cancer, Emerging Cancer Therapeutics, PracticeUpdate Oncology, and Therapeutic Advances in Medical Oncology.
Axel Grothey, MD, is a consultant in the Division of Medical Oncology, Department of Oncology, at Mayo Clinic. He holds the academic rank of professor of oncology and has teaching/examining privileges in Clinical and Translational Science at Mayo Graduate School. He is a member of Mayo Clinic’s Cancer Center.
In educational activities, he has served as a teacher, and he is a five-time recipient of Teacher of the Year recognition at Mayo Clinic. Dr. Grothey has given numerous international, national and regional presentations, as well as invited and visiting professor presentations. He has co-authored more than 250 articles, books, book chapters, editorials, abstracts, and letters. The Good Doctor’s Full Bio can be found at PracticeUpdate.com.
Let’s take a look on what Dr. Grothey had to say about Opko’s Rolapitant.
Note# Rolapitant is an NK-1 inhibitor developed to treat nausea and vomiting related to cancer chemotherapy. This was a Phase 3 ready drug obtained from Schering as part of its merger with Merck. After a year of evaluation, Opko Health licensed the product to Tesaro, Inc., who successfully completed three Phase 3 studies, meeting all safety and efficacy endpoints, and then submitted an NDA to the FDA. This is expected to be approved early in September 2015, triggering milestone and double digit royalty payments to us. The highly experienced Tesaro team anticipates eventual annual sales of more than $1 billion.
UncleTlzz Full Article
Rolapitant Effectively Reduces Chemotherapy-Induced Nausea and Vomiting
Oncology Expert Comment
Written by Axel Grothey MD
Chemotherapy-induced nausea and vomiting still has major adverse effects on quality of life among cancer therapy patients. With the introduction of 5-HT3 antagonists, such as ondansetron, into cancer treatment regimens more than 20 years ago, acute nausea and vomiting on the day of chemotherapy administration has become much better controlled compared with prior anti-emetic regimens; former regimens mainly used high doses of dopamine antagonists.
Delayed nausea and vomiting, however, was much more difficult to address until the advent of NK-1 antagonists. The first in-class agent, aprepitant, showed remarkable activity in the prevention of delayed nausea and vomiting after highly and moderately emetogenic chemotherapy.
Aprepitant was initially developed as an antidepressant, but as soon as the usefulness of this agent in an oncologic setting was realized, its price was set at a point that made it more expensive than some of the cytotoxic therapies (eg, cisplatin) it was used with.
Rolapitant, another NK-1 antagonist, has now emerged as a competitor to aprepitant. In contrast to aprepitant, rolapitant neither induces nor inhibits CYP3A4, which may reduce its drug–drug interaction risk. In a cross-trial comparison, the efficacy of rolapitant seemed to be comparable to that of aprepitant. It remains to be seen whether the introduction of a competitor to aprepitant will lead to more affordable NK-1 antiemetics.
Breaking News; ASCO POST: ‘OPKO Health’s Rolapitant Significantly Improved Complete Response Rates’
Rolapitant Reduced Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Cisplatin-Based Chemotherapy
Rolapitant Reduced Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy or Anthracycline/Cyclophosphamide
Key Points:
Rolapitant treatment was associated with a higher complete response rate during the delayed phase in both trials and in the pooled population.
Rolapitant was associated with a higher complete response rate over the total phase in the pooled population.
Rolapitant significantly improved the complete response rate during the delayed phase.
An overall preventive benefit was also observed over 0 to 120 hours.
Full Article
Single dose of Opko Health's Rolapitant with standard anti-emetic therapy "provides protection for the entire at-risk period" for CINV
Rolapitant Effective Add-on Prophylactic for Chemo-Induced Emesis
Medscape
By Reuters Staff
August 21, 2015
NEW YORK (Reuters Health) – A single oral dose of the investigational anti-emetic rolapitant (Tesaro) helps prevent chemotherapy-induced nausea and vomiting (CINV) when combined with granisetron and dexamethasone, the current standard of care for CINV, according to results of three large phase 3 randomized controlled studies.
Rolapitant is a potent, highly-selective long-acting neurokinin-1 (NK-1) receptor antagonist currently under review at the US Food and Drug Administration.
Findings from the three multinational studies funded by Tesaro appeared online August 11 in Lancet Oncology. Two of the studies involved more than 1000 cancer patients receiving cisplatin-based highly emetogenic chemotherapy and one involved more than 1300 cancer patients receiving moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens.
In both trials, patients received a single dose of rolapitant or identical placebo plus standard granisetron and dexamethasone before chemotherapy. The primary endpoint of both trials was patient-reported complete control of emesis and no need for rescue medication in acute (zero to 24 hours after treatment) and delayed (>24 to 120 hours) phases of emesis.
In the moderately emetogenic trial, significantly more patients receiving rolapitant than placebo had complete responses in the delayed phase (475 patients, 71% vs 410 patients, 62%; odds ratio 1.6, P=0.0002), the investigators report.
The same was true in the two highly emetogenic trials. Based on pooled data from the trials, 382 patients (71%) in the rolapitant arm had a complete response in the delayed phase, compared with 322 patients (60%) in the placebo arm (OR 1.6; P=0.0001).
These two studies show that a single dose of rolapitant with standard anti-emetic therapy “provides protection for the entire at-risk period” for CINV, write the investigators, led by Dr Bernardo Rapoport, of the Medical Oncology Centre of Rosebank, Johannesburg, South Africa.
“These trials are among the first to show that addition of an NK-1 receptor antagonist to a 5-HT3 receptor antagonist and a steroid improves prevention of CINV more than 24 h after treatment with moderately emetogenic chemotherapy,” notes Dr. Ian Olver, of the Sansom Institute for Cancer Research, University of South Australia in Adelaide, in a Comment published with the studies.
There was “less consistency” in the acute phase CINV in the moderately emetogenic trial and one of the highly emetogenic studies failed to show a difference between treatment groups in acute emesis, he points out, “although with better control than placebo over the whole 120 h at-risk period. This benefit in delayed emesis is achieved without any relevant additional toxicity.”
Dr. Olver says rolapitant “represents the next generation of NK-1 receptor antagonists, with a long half-life and NK-1 receptor binding for up to five days, suggesting that it will also have a longer duration of action. One advantage of rolapitant over other NK-1 receptor antagonists is that it is not metabolized by CYP3A4, “thereby reducing the chance for possible drug-drug interactions.”
While these three studies show that rolapitant “adds efficacy, particularly in the delayed phase of emesis with moderately and highly emetogenic chemotherapy, rolapitant’s place in routine antiemetic care is yet to be determined,” Dr. Olver concludes.
Full Article Here
OPKO “EirGen Pharma is a stand-out example of an ambitious, innovation-led Irish company that is achieving strong export-led growth.”
A story full of success
BUSINESS | FRI 21 AUG | Author – Niamh Mac Sweeney
BREATHING LIFE INTO SCIENCE
There is no shortage of life science companies setting up in Ireland, and while global multinationals are the cornerstone of the industry here, indigenous science-based enterprises are preforming strongly and holding their own too.
Building a hugely successful pharma company from start-up status 10 years ago, to its recent sale worth $135m, Patsy Carney and Tom Brennan, co-founders of EirGen, have shown their commitment to investing in Ireland, its people and the industry in general.
Last year EirGen created 40 new jobs following a €4m investment, and this year the company has been sold to US-based Opko for $135m (€120m). Opko’s CEO, Philip Frost said the main reason they were interested in EirGen was because it is one of the leading developers and suppliers of high-potency niche pharmaceutical products in the world.
Co-founder and chief technical officer, Tom Brennan, said: “Official figures show that the life sciences sector is the fastest growing area of Ireland’s export industry.
“We hope that our continuing efforts will inspire other high-end technology companies to invest – and re-invest – in the region, providing further opportunities for employment growth while driving forward efforts to secure Ireland’s future as the location-of-choice for world-leading research and manufacturing industries,” he continued.
Julie Sinnamon, CEO, Enterprise Ireland said: “EirGen Pharma is a stand-out example of an ambitious, innovation-led Irish company that is achieving strong export-led growth.”
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A Massive Buy from CEO Phil Frost Today.....
PHILLIP FROST MD CEO Opko Health Inc just picked up 544,000 shares
Merger a Done Deal
BIO REFERENCE LABORATORIES INC Files Form 25-NSE
NOTIFICATION OF REMOVAL FROM LISTING AND/OR REGISTRATION UNDER SECTION 12(b) OF THE SECURITIES EXCHANGE ACT OF 1934
Form 25-NSE
Update: Laidlaw & Co ‘OPK initiated with “buy”, target $22’
Laidlaw & Co
Aug 12, 2015
Analysts at Laidlaw initiate coverage of Opko Health Inc (OPK) with a “buy” rating. The target price is $22.
Laidlaw notes, “The recent Bio-Reference Laboratories acquisition brings additional revenue plus a large sales force to support OPKs 4Kscore test sales. Coupled with three drugs in OPK’s pipeline that potentially could be approved and enter the market over the next 24 months; the company is in a transformative stage in our opinion. We estimate OPK could become cash positive starting 2016 with continued margin improvements going forward as product mix improves.”
Laidlaw & Co Initiates Coverage on Opko Health to Buy with Price Target $22.00
Laidlaw & Co Initiates Coverage on Opko Health (NYSE:OPK). In a research note issued to the investors, the brokerage major Announces a price-target of $22.00 per share. The shares have been rated Buy. The rating by Laidlaw & Co was issued on Aug 12, 2015.
Laidlaw & Co Initiates Coverage Link
Opko Licensee Tesaro Biotech Grows as Drugs Move Towards Market
Waltham oncology biotech grows as drugs move towards market
Jessica Bartlett
Boston Business Journal
Aug 11, 2015, 2:05pm EDT
Waltham-based oncology biotech Tesaro is eyeing regulatory approval of its first drug within the next month, and has begun a hiring spree in preparation.
The drug, rolapitant, prevents chemotherapy-induced nausea and vomiting by binding to receptors in the brain that receive signals for those sensations. The Food and Drug Administration will review Tesaro’s (Nasdaq: TSRO) drug by Sept. 5.
In clinical trials, 10 to 20 percent of patients, who were already taking existing drugs to try to prevent nausea and vomiting, had relief from symptoms.
While Tesaro executives said they couldn’t comment on conversations with the FDA, their actions to grow the company in the interim appeared optimistic.
The company has grown from 100 employees at the end of 2014 to upwards of 200 today. By the end of the year, Tesaro expects to add another 100, 40 of which will be added to its 80,000-square-foot headquarters in Waltham.
“We’re in the process of expanding our commercial organization,” said Tesaro co-founder and president Mary Lynne Hedley. “We probably have 95 percent of our commercial organization in place and we’re preparing our pre-launch activity, so if rolapitant is approved on Sept. 5, we’ll be prepared to launch the drug in the fourth quarter.”
That growth will mean the company will start to look for new space around Boston in the next year.
“We’re enthusiastic about the drugs we’re developing and making a difference for patients. With that comes growth and new opportunity,” Hedley said.
Clinical trial success and subsequent employee growth marks a stunning development for a company only five years old, one that is relatively quiet despite its $1.97 billion market cap and significant size.
Rolapitant is just the beginning for the company’s more public push. Tesaro is also advancing Phase III clinical trials of its ovarian and breast cancer chemotherapy drug niraparib. The company expects to report data from the 100-site trial by the end of the year.
Despite a recent public confrontation with a patient who wanted to be removed from the study due to her declining health, executives were optimistic about the trial.
“We were able to see in a Phase I clinical trial, 75 percent of patients had their tumors shrink,” Hedley said. “What was even more interesting is the duration of response is very long. We’re able to keep those tumors in remission for 15 months, which is very rare.”
Promising results will mean the company will submit the drug to the FDA for regulatory approval in 2016.
Additionally, Tesaro hopes to begin clinical trials in the first of five cancer antibodies by the end of the year, with an Investigational New Drug application to the FDA.
Tesaro acquired the rights to the antibodies from AnaptyzBio in March 2014, a deal valued at up to $125 million. Analysts at the time said the deal would be transformative for Tesaro in the long run.
“These preclinical assets add significant breadth to Tesaro’s existing pipeline … (and) has improved its long-term investment proposition,” said analysts from Edison.
Few analysts have continued to follow the company since, but they may start paying attention again soon. Lonnie Moulder, the co-founder and CEO of the company, said the company is only getting started.
“We’re just getting started with our product launching in the fourth quarter followed by the product launch next year,” he said. “We’re enthusiastic, but not predicting any specific stock price.”
OpkoDD Note
Acquisition of Rolapitant
In October 2009, OPKO acquired Rolapitant, a potent and selective competitive antagonist of the NK-1 receptor, in addition to other neurokinin-1 (NK-1) assets from Schering Plough Corporation. In December 2010, OPKO exclusively out-licensed the development, manufacture, and commercialization of Rolapitant to biopharmaceutical company TESARO, Inc. Rolapitant. In December 2010, we entered into a license agreement with OPKO to obtain exclusive worldwide rights to research, develop, manufacture, market and sell rolapitant. The license agreement also extended to an additional, backup compound, SCH900978, to which we have similar rights and obligations as rolapitant, but which we are not currently advancing. In consideration for this license, we paid OPKO $6.0 million upon signing the agreement and issued 1,500,000 shares of our Series O convertible preferred stock. At the time of this transaction, the fair value of the Series O convertible preferred stock was determined to be $0.6 million.
We are also required to make development milestone payments to OPKO of up to an aggregate of $30.0 million, of which we have paid $5.0 million to date, if specified regulatory and initial commercial sales milestones are achieved in the U.S. and Europe. In addition, we are required to make milestone payments to OPKO of up to an aggregate of $85.0 million if specified levels of annual net sales of rolapitant are achieved. If commercial sales of rolapitant commence, we are required to pay OPKO tiered royalties on the amount of annual net sales achieved in the United States and Europe at percentage rates that range from the low teens to the low twenties, which we expect will result in an effective royalty rate in the low teens. The royalty rate on annual net sales outside of the United States and Europe is slightly above the single digits.
We will pay royalties on rolapitant until the later of: (i) the date that all of the patent rights licensed from OPKO and covering rolapitant expire, are invalidated or are not enforceable, and (ii) 12 years from the first commercial sale of the product, in each case, on a country-by-country and product-by-product basis. If we elect to develop and commercialize rolapitant in Japan through a third-party licensee, we will share equally with OPKO all amounts received by us in connection with such activities under our agreement with such third party, subject to certain exceptions and deductions. OPKO also retains an option to become the exclusive distributor of such products in Latin America, provided that OPKO exercises that option within a defined period following specified regulatory approvals in the United States.
We are responsible for all preclinical, clinical, regulatory and other activities necessary to develop and commercialize rolapitant. There were no ongoing clinical trials for rolapitant or SCH900978 at the time of our acquisition of these rights. As of the date of acquisition, none of the assets acquired had alternative future uses, nor had they reached a stage of technological feasibility. We accounted for this transaction as an asset acquisition because we did not acquire any processes or activities that would constitute a “business” in addition to the license. Accordingly, we recorded the entire purchase price of $6.6 million as acquired in-process research and development expense in 2010.
Rolapitant — Intravenous Formulation. We are also developing a single dose intravenous rolapitant formulation with respect to which we have selected a dose of 185mg for further development. We have also completed a multiple ascending dose study of intravenous rolapitant that confirmed the safety and tolerability profiles and linear pharmacokinetics of repeat daily doses. As part of a registration program for IV rolapitant we have initiated a clinical study comparing the exposure of the IV and oral formulations of rolapitant and we plan to initiate clinical studies in the first quarter of 2015 to evaluate the safety of IV rolapitant to support an NDA submission, which we expect to submit in the fourth quarter of 2015.
New owner of Eirgen speaks about Irish operation
The Chief Executive of a US multinational which acquired a Waterford pharma company says he plans to bolster operations in Ireland. EirGen was bought by US drugs company Opko for 135 million dollars in May.100 people are employed at the Waterford facility which manufactures high potent drugs for cancer chemotherapy. Phillip Frost spoke about EirGen during a recent investor conference call.
Irelands Local Station WLR FM Reports on Opko Phillip Frost and EirGen
BREAKING NEWS ‘Rolapitant Approval on Track, says Mizuho’
TESARO Q2 shows Rolapitant approval on track, says Mizuho
Mizuho analyst Peter Lawson reiterates a Buy rating on TESARO with a $67 price target following the company’s Q2 results. A September 5 FDA action date for the oral version of rolapitant is upcoming, Lawson tells investors. He expects FDA approval with commercialization in Q4 for the NK-1 receptor antagonist.
Note# In October 2009, OPKO acquired Rolapitant