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Opko EirGen Product Approvals
EIRGEN PHARMA ONCOLOGY PRODUCT EIR-080
EirGen Pharma oncology molecule ‘Eir-080' product was developed for treatment of adults with newly-diagnosed glioblastoma multiforme, and also for the treatment of children 3 years and older and adult patients with malignant glioma.
RECEIVES APPROVAL IN:
UKRAINE
UK
HUNGARY
SWITZERLAND
SERBIA
EIRGEN PHARMA ONCOLOGY PRODUCT EIR-050
EirGen Pharma molecule ‘Eir-050' product was developed for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer.
RECEIVES APPROVAL IN:
U.S.
BOSNIA HERZEGOVINA
UKRAINE
SINGAPORE
TAIWAN
HONG KONG
KOSOVO
EIRGEN PHARMA ONCOLOGY PRODUCT EIR-012
EirGen Pharma oncology molecule ‘Eir-012' product was developed for first line treatment in postmenopausal women with hormone-dependent breast cancer.
RECEIVES APPROVAL IN:
SWITZERLAND
HONG KONG
CROATIA
EIRGEN PHARMA BREAST CANCER PRODUCT EIR-070 PASSES CLINICAL TRIAL
EirGen Pharma oncology molecule ‘Eir-070' has successfully passed clinical trial studies in Japan in November 2013 . This product was developed as an treatment for postmenopausal women with estrogen-receptor postive early breast cancer and represents the fifth successful clinical trial for EirGen Pharma in Japan.
EIRGEN PHARMA REGISTERS ONCOLOGY PRODUCT EIR-050 WITH SFDA
EirGen Pharma oncology molecule Eir-050 was submitted to the Saudi Food and Drug Authority (SFDA) in July 2013. This product was developed as an adjuvant treatment of postmenopausal women with estrogen-receptor postive early breast cancer and represents the first of several planned marketing authorisation applications in the Gulf Region. Company Co-Founder and Chief Technical Officer Tom Brennan commented “This marks another key milestone for our organisation as we continue to grow and expand into new territories and is another significant achievement for our company”.
EIRGEN PHARMA PRODUCT EIR-115 APPROVED BY PMDA
EirGen Pharma ‘Letrozole’ Japan application has been approved by the PMDA (the Japanese Health Authority) after the application being filed in February 2014. Letrozole was developed for first line treatment in postmenopausal women with hormone-dependent breast cancer.
EIRGEN PHARMA PRODUCT EIR-111 SUBMITTED FOR LICENSE APPROVAL
EirGen Pharma product Eir-111 submitted for license approval in the European Union. This product is a corticosteroid which successfully passed its Bioequivalence Study in Q4 2014.
Reference OpkoDD Post
Opko A Solid Candidate That May Be Offering Investors Big Gains
4 Biotech Stocks Could Have Big Upside Before Russell Index Changes
24/7 Wall St
By Lee Jackson May 12, 2015 8:20 am EDT
Typically when we cover index rebalancing or reconstitutions, they are happening within a few days of when our story is posted. Investors may have a huge head start as, even though the Russell Indexes will not reconstitute until late in June, there are some solid candidates that may be offering investors big gains now.
A new report from Credit Suisse points out that stocks that are moving up the market cap ladder from the Russell 2000 to the Russell 1000 tend to outperform ahead of the changes and underperform in the six months after. They also expect that biotech stocks will see the most promotions. We highlight the four biotech and health care stocks that Credit Suisse feels will be moving on up.
DexCom
DexCom Inc. (NASDAQ: DXCM) is a medical device company headquartered in San Diego, Calif., that is developing and marketing continuous glucose monitoring systems for ambulatory use by patients and by health care providers in the hospital. The company has made its G4 PLATINUM CGM System with Share app available on the Apple Watch.
Being one of the first companies in the category to be approved by the U.S. Food and Drug Administration (FDA), DexCom’s app will allow diabetic patients to track their blood glucose statistics right from their wrist. The app will also allow them to share this information with caregivers, parents, doctors or other authorized individuals and send an alert when the glucose levels are beyond the normal range.
The Thomson/First Call consensus price target for the stock is $70.36. Shares closed on Monday at $67.60.
Isis Pharmaceuticals
Isis Pharmaceuticals Inc. (NASDAQ: ISIS) engages in the discovery and development of antisense drugs using a novel drug discovery platform. The company’s flagship product includes the Kynamro injection, which is an apo-B synthesis inhibitor for patients with homozygous familial hypercholesterolemia, and for the reduction of low-density lipoprotein cholesterol. It also has a pipeline of 38 drugs in development for the treatment of various diseases, including cardiovascular and metabolic diseases; severe and rare diseases, which include neurological disorders; and cancer.
The company recently agreed to license its developmental blood-thinning drug to a unit of Bayer. It expects an upfront payment of $100 million on the drug, called ISIS-FRXI, and an additional $55 million following a Phase 2 study in patients with compromised kidney function.
The consensus price target is $68.11, and the shares ended trading on Monday at $62.12.
Opko Health
This company is a multinational biopharmaceutical and diagnostics participant. Opko Health Inc. (NYSE: OPK) seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. Shareholders will be glad to know that the chairman of the board has consistently been a buyer of the stock.
The company announced last week the acquisition of EirGen Pharma, a growing, profitable and cash flow positive specialty pharmaceutical company focused on the development and commercial supply of high potency, high barrier to entry, pharmaceutical products for sale in the United States, Canada, Japan, Australia, most European countries, and more than 40 others around the world.
The company reported less than stellar earnings this week, and investors may have a good chance to buy shares at a discounted price. The consensus price target is $14.88, and shares closed on Monday at $14.30.
Puma Biotechnology
This stock has had a huge run over the past year. Puma Biotechnology Inc. (NASDAQ: PBYI) is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. It focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use.
The company is initially focused on the development of PB272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation. A cocktail of drugs containing Puma’s neratinib given before surgery eliminated evidence of cancer in the breast and lymph nodes in 55.6% of women, compared with 32.6% of those given standard drug therapy in data released last year.
The consensus price target is a whopping $276.80. The stock closed Monday at $200.98 per share.
It is important to remember that these are all very aggressive stocks and only suitable for high risk-tolerant accounts. With that in mind, if history is any guide, investors that buy these stocks now and sell before the actual Russell changes may be well rewarded.
By Lee Jackson
“IF THEY DO TO OPKO WHAT THEY DID PREVIOUSLY WITH IVAX THERE’S A VERY POSITIVE FUTURE THERE FOR THE COMPANY.”
From a 40-foot container to a $135m pharma sell-out
Patsy Carney and Tom Brennan “bootstrapped” their Waterford EirGen biotech firm. Last week they sold it for $135m
Gavin McLoughlin
PUBLISHED
Sunday, May 10, 2015 | 02:30
Ten years ago, Patsy Carney and Tom Brennan founded EirGen, a Waterford-based company that makes chemotherapy drugs. On Monday they sold it to US-based Opko for $135m (€120m) – netting each of them about €15m.
Part of the deal was that the Irishmen would get to stay on, and they’ve got lots of plans.
“As would be expected that’s an important part of the deal, we’re in this for the longer haul. It’s about taking EirGen on now to the next level, and that’s something we’re both motivated to do,” Carney told the Sunday Independent.
But it hasn’t all been plain-sailing.
“We kind of bootstrapped it in terms of raising cash. Fair enough, we were raising money in what was supposedly the boom in 2005, but the boom was for bricks and mortar and building houses and all sorts of mad stuff like that.
“For two lads from down the South East who wanted to build themselves a pharmaceutical plant, VCs and so on weren’t really interested. The idea of putting money into capital expenditure didn’t float their boat, so we raised our money from private investors and BES (Business Expansion Scheme) as it was at the time”.
At one point some of the company’s most important staff were working in a 40-foot container – though Carney quips that at least the container had windows. Others worked in Portakabins, with Carney describing the place as a “shanty town”.
Now things are very different, and Carney is excited about EirGen’s future.
“What we’re looking at is overlaying a layer of products in a similar kind of area to ourselves, these high-potency products, coming through the Opko pipeline.
“The difference being that the majority of products we develop at the moment are actually generic products whereas quite a number of the products coming through the Opko pipeline are actually new chemical entities, new products.
“So that’s exciting and quite different from what we’ve been doing. And the other part is that they already have in their portfolio of companies a company that makes the active raw materials that we use in our products, and there’s the potential there for vertical integration, with the raw material coming from their site in Israel, into the Waterford site for manufacture and distribution into the market,” Carney says.
And there’s no fear of the company leaving Waterford either. EirGen’s manufacturing licence to supply products to the market is linked to the facility, and Carney says it will remain at the centre of the company’s operations.
The deal was done after EirGen quietly put out the feelers to see what kind of takeover interest there was in the market. Why did they do that?
“Three years ago we took in substantial investment from a pharma company in Saudi Arabia, and we made use of those funds to basically build out our facility, and also invest more in our R&D pipeline.
“We’ve got it to a stage now where it’s a profitable business, and we said, ‘Right, what’s the next stage for the company?’.
“The pharmaceutical market as it is at the moment in terms of mergers and acquisitions and so on, is actually very buoyant, and certainly in the last couple of years.
“So we began looking at this and saying, ‘A lot of our business is actually in to the US, that’s the direction our business is going, very clearly that’s one of our key markets, so therefore one of the things that would make sense would be to look to the market from the point of view of attracting the right company to bring us on to the next level in terms of access to the market, in terms of R&D portfolio, and in terms of complimenting what we were already doing.’
“We had a number of unsolicited approaches, so we then went and had a look at some of those approaches, and then from that came effectively quite a completable offer, let’s say, from Opko.”
Mr Carney wouldn’t reveal who the other interested companies were, saying only that there was “a range”.
“Companies in the same space as us, much larger organisations that are looking to acquire. It’s happening every day of the week, there’s more news about who’s making an offer for who and so on.
“The kind of business that we are, and the niche that we’re in, it was quite attractive because it could be bolted on immediately to any organisation. There’s a range of products already there, it’s a profitable business, it’s cash-flow positive and so on.”
Carney and Brennan previously worked for an American plc called Ivax, which was built by the founders of Opko. Carney said the “added attraction” of the Opko deal was that they had known the bigwigs at Opko for a long time. Ironically, the idea to start a company of their own came when the two men were sent to do an MBA by Ivax.
“We wouldn’t be the poster boys for multinationals to send their staff on MBA programmes, because they could actually just up and leave and start their own company,” Carney quips.
“If they do to Opko what they did previously with Ivax there’s a very positive future there for the company.”
Three years ago, Saudi Pharmaceuticals Industries and Medical Appliances Corporation, one of the biggest pharmaceuticals companies in the Middle East, bought a 48pc stake in EirGen for €19m.
They’ll have trousered €58m this week.
Opk Mad Money Lightning Round
Lightning Round: Cramer Wants You To Own OPK
Mad Money w/ Jim Cramer ‘Lightning Round’
Friday, 08 May 2015
Caller Dean from Illinois:
What are your thoughts on OPK prior to the earnings call next week?
Cramer:
You want to own OPK, and if the stock comes in on the earnings call you’ll want to do some buying. Hey I’ll tell you, I like that stock, that’s that Dr. Phil Frost.
OPKO and Licensee Tesaro ‘Rolapitant Demonstrated Significant Clinical Efficacy For Preventing CINV’
Study of rolapitant, a novel, long-acting, NK-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC).
Abstract
PURPOSE
Rolapitant is a novel, long-acting neurokinin-1 (NK-1) receptor antagonist. This study evaluated the safety and efficacy of four different doses of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC).
METHODS
This randomized, double-blind, active-controlled, global study was conducted in patients receiving cisplatin-based chemotherapy =70 mg/m(2). Patients received a 9, 22.5, 90, or 180 mg oral dose of rolapitant or placebo with ondansetron and dexamethasone on day 1 of chemotherapy. The primary end point was complete response (CR; no emesis and no use of rescue medication) in the overall (0 to 120 h) phase of cycle 1. Other assessments were CR in delayed (24-120 h) and acute (0-24 h) phases, no emesis, no significant nausea, and no nausea.
RESULTS
Four hundred fifty-four patients were randomized. All doses of rolapitant improved CR with the greatest benefit observed with rolapitant 180 mg vs. active control in the overall phase (62.5 and 46.7 %, p?=?0.032) and in the acute (87.6 vs. 66.7 %, p?=?0.001) and delayed (63.6 vs. 48.9 %, p?=?0.045) phases. Rates for no emesis and no significant nausea were significantly (p?<?0.05) higher with rolapitant 180 mg vs. active control in the overall, acute, and delayed phases. Treatment-related adverse events were largely considered related to the chemotherapy and included constipation, headache, fatigue, and dizziness which were mostly mild or moderate and were similar across treatment groups.
CONCLUSION
All doses of rolapitant were well tolerated and showed greater CR rates than active control. Rolapitant 180 mg demonstrated significant clinical efficacy for preventing CINV in the overall, delayed, and acute phases for patients receiving HEC.
Full Text
Irish Independent & Irish Times Report On Opko's Acquisition Of EirGen
US drug company buys EirGen for $135m
Waterford-based pharmaceutical company EirGen has been acquired by US drugs company Opko for $135 million. Founded by Tom Brennan and Patsy Carney 10 years ago, the company employs 100 people and manufactures high potency drugs for cancer chemotherapy.
Opko – which is listed on the New York Stock Exchange and based in Miami – is paying $100 million in cash and €35 million in shares for the business. “We wanted to build to the next level and the focus had to be in the US. We made a relatively soft approach to the market in February to gauge interest,” EirGen’s chief executive Mr Carney explained yesterday.
Niche
The deal with Opko closed yesterday and was facilitated by the fact that both Mr Carney and Mr Brennan, who is chief technology officer, were familiar with the executive team behind the US company led by Philip Frost, he added.
Mr Frost sold Key Pharmaceuticals to Schering-Plough in 1986 for €600 million before establishing Ivax which was sold to Israel-based Teva Pharmaceuticals in 2006 for $7.5 billion.
He is chairman of Teva and established Opko in 2007 by merging three smaller drugs companies. It is currently valued at $6.3 billion.
Mr Carney and Mr Brennan worked for Ivax – which has a plant in Waterford – for 14 and 10 years respectively before establishing EirGen when they spotted an opportunity to manufacture generic chemotherapy drugs.
“EirGen Pharma is one of the leading developers and suppliers of high potency niche pharmaceutical products in the world,” Mr Frost said in a statement yesterday.
Mr Carney and Mr Brennan will remain with the company which will operate as a subsidiary of Opko. It has a research and development portfolio of more than 20 of its own drugs and will also be involved in developing other drugs in Opko’s “pipeline”.
Opko owns a pharmaceutical ingredients manufacturing business in Israel and the potential exists to integrate it into the Waterford manufacturing plant.
The EirGen facility is approved by the US, European and Japanese regulators.
“The superb management, research and development, manufacturing and product distribution teams, along with state of the art facilities, together, will create an important, tax efficient base of operations for Opko,” said Mr Frost
Middle East
Opko will be investing in Ireland but it is to early to predict if additional jobs will be created, said Mr Carney. “It will have to be a bigger organisation,” he said.
In 2012 Saudi Pharmaceutical Industries and Medical Appliances Corp, one of the largest pharmaceutical companies in the Middle East, took a 48 per cent stake in EirGen for €19 million. The other shareholders in the business are Mr Carney, Mr Brennan, a number of a individual investors and Enterprise Ireland.
4Kscore Test Represents a Major Step in The Right Direction, says Andrew Stephenson, MD
New Blood Test Helps You Avoid Unnecessary Prostate Cancer Biopsies
Can be used in conjunction with PSA blood test
By Urinary & Kidney Team | 5/6/15 9:00 a.m.
A new screening tool for prostate cancer has been shown to offer better accuracy than the test currently used by most physicians in the United States. The new test, called the 4Kscore™ test (OPKO Lab), offers various advantages over the more commonly used prostate specific antigen (PSA) blood test.
The new test improves on these common issues with the PSA blood test:
>Isn’t specific to cancer; detects a variety of prostate issues
>Doesn’t account for a natural tendency for PSA levels to rise with age
These factors increase the PSA blood test’s false positive results, says Andrew Stephenson, MD, Director of the Center of Urologic Oncology at Cleveland Clinic’s Glickman Urological and Kidney Institute. They are the reason why many men go on to have a prostate biopsy when they don’t really need one.
Avoiding unnecessary biopsies
Biopsies are unpleasant for patients. Also, they carry a small risk of infection and bleeding. Sometimes, they detect cancers that are minor and that do not need treatment. Still, when patients learn about these minor cancers, it can cause them needless stress, Dr. Stephenson says.
“The promise of the new 4Kscore test is that it is more specific for prostate cancer. It appears to identify patients at risk for high-grade cancers more efficiently than the PSA,” he says.
Best way to use the new test
Dr. Stephenson says the best way to use the new test is not as a replacement of the PSA test. Rather, it is to use the new test as a follow-up to a positive PSA test, but before undergoing a biopsy. Using it this way, physicians can reduce the need for prostate biopsy by 30 to 50 percent. Doctors at Cleveland Clinic have already started using the new test.
The test’s performance is quite good across many patient populations, Dr. Stephenson says. There is no one type of patient who benefits more than others.
According to 4Kscore’s manufacturer, the test has undergone extensive clinical review. The company cites more than a decade of research involving more than 20,000 men in Europe and the United States.
Filling a need
There has been a clear need for a more accurate prostate cancer screening tool. Considering the impact of false-positive PSA results, experts have been dubious about the overall benefits of the blood test.
“The paradigm that we have used to screen patients for prostate cancer has needed to change for a while,” Dr. Stephenson says. “The U.S. Preventive Service Task Force gave PSA screening a grade of D in 2012. They said the harm it brings outweighs the benefits. The 4Kscore test represents a major step in the right direction. It improves our prostate cancer screening practices.”
The new 4Kscore test can help patients avoid unnecessary worry and procedures while accurately identifying when there is a real need for treatment, he says.
America's Top Hospital Now Offering Opko Health's 4Kscore
UROLOGY May. 4, 2015 @ 7:11 a.m.
New Blood Test Is Highly Accurate in Identifying Patients at Risk for Prostate Cancer
4Kscore test helps avoid needless biopsies
Cleveland Clinic has recently begun offering a new test that is highly accurate in screening men for prostate cancer, especially for the risk of high-grade cancers that warrant aggressive treatment.
The test, called 4Kscore™, is used if a patient has an elevated prostate specific antigen (PSA) test result.
Most physicians in the United States currently use the PSA blood test as an initial screening tool. Unfortunately, PSA is not specific for prostate cancer, just for prostate issues. Also, PSA levels go up with age as the prostate enlarges, which further increases the test’s rate of false positives for cancer, says Andrew Stephenson, MD, Director for the Center of Urologic Oncology at Cleveland Clinic’s Glickman Urological & Kidney Institute.
These two factors mean that many men are referred for a prostate biopsy needlessly, and sometimes are diagnosed with unimportant cancers, Dr. Stephenson says.
“Overdiagnosis — the identification of cancers that likely pose no harm to a man’s well-being or longevity — is a big problem with the PSA test,” he says. “The promise of the new test is that it is more specific for prostate cancer and, importantly, it appears to identify patients at risk for high-grade cancers more efficiently than the PSA.”
How the test works
The 4Kscore test combines four prostate-specific kallikrein assay results with clinical information in an algorithm that calculates the individual patient’s risk for aggressive prostate cancer.
According to developer OPKO Lab, the test has undergone extensive clinical development and confirmation. The biomarkers it utilizes are based on more than a decade of research involving more than 20,000 men in Europe and the United States. The results were recently replicated in a prospective, blinded clinical study conducted at 26 urology centers across the United States involving 1,012 patients.
When using the 4Kscore test according to the specified threshold OPKO recommends, physicians can reduce the need for prostate biopsy by 30 to 50 percent while still accurately identifying high-grade cancers, Dr. Stephenson says.
“The paradigm that we have used to screen patients for prostate cancer has needed to change for a while,” Dr. Stephenson says. “The U.S. Preventive Service Task Force gave PSA screening a grade of D in 2012 because the harm it brings outweighs the benefits. The 4Kscore test represents a major step in the right direction to improve our prostate cancer screening practices.”
The test’s performance is quite good across many patient populations. There is no one demographic that benefits more than others, he says. However, it is more expensive than the PSA test and its cost is not currently covered by insurers. “I am not suggesting the 4K test should substitute for PSA as a screening test,” Dr. Stephenson says. “But using it after an elevated PSA result but before ordering a biopsy will save money and prevent many biopsies.”
Biopsy concerns
Biopsy is worth avoiding when possible, Dr. Stephenson says. It is unpleasant for patients and carries a risk of infection and bleeding. “These risks are low, occurring in 1 to 2 percent of men, but when you consider that 20 to 30 percent of all men undergo a prostate biopsy, that represents an enormous number of patients,” he says.
Other prostate cancer screening tests are available, including the Prostate Health Index; however they have not been compared in a head-to-head clinical trial, Dr. Stephenson says.
“Overall, we are getting much more refined about how we screen and diagnose for prostate cancer, and these tests offer great potential to move us in the right direction,” he concludes.
2015 Best International Hospital Brings Opko 4Kscore To Patients
Clinic HIFU Prostate Cancer Treatment Center is a modern Diagnostics and Treatment Center of Prostate Cancer in cooperation with Medicover Hospital in Warsaw.
Opko Health (OPK) – Market Recap
Posted on 04/30/2015 by Ethan Greenberger
Opko Health options set a new 90-day record for the number of call contracts that exchanged hands between the buyers and the sellers. Aggregate volume of puts was 1.95K and calls was 1.05K equating to a 1.85 put/call ratio.
Unusual volume provides reliable clues that the stock is expected to make a move. Investors can use the put/call ratio statistics to measure trader sentiment. A high put/call ratio suggests that the overall investment sentiment is bearish and that investors expect the underlying stock to decrease in value. Conversely, a low put/call ratio implies that investor sentiment is bullish based on the large amount of call options.
Opko Health (OPK) opened today at $14.38 and is currently trading at $13.76, down $0.61 (4.24%) during last trading session. Within the last week, the shares have lost -1.58% of their value. The daily low is $13.71 and the high is $14.40. The trading volume of 2.98M is above the average volume of 2.50M shares. OPK is trading above the 50 day moving average and lower than the two hundred day moving average. The technical momentum Relative Strength Index indicator shows oversold conditions. The stock’s 52 week low is $7.90 and 52 week high is $15.23.
OPKO Health, Inc. is engaged in the development and commercialization of pharmaceutical products, vaccines, diagnostic technologies, and imaging systems.
OPKO Strategic Investment> Arno Therapeutics Receives European Orphan Drug Designation
Arno Therapeutics Receives European Orphan Drug Designation for AR-12 to Treat Two Infectious Diseases
FLEMINGTON, N.J., April 30, 2015 (GLOBE NEWSWIRE) -- Arno Therapeutics, Inc. (ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for the treatment of cancer and other life threatening diseases, today announced that the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), has designated AR-12 as an orphan medicinal product for the treatment of two separate infectious diseases, cryptococcosis and tularaemia.
Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics, commented, "Following positive recommendation by the EMA's Committee for Orphan Medicinal Products, we are very pleased with the European Commission's designation of AR-12 as an orphan drug to treat two infectious diseases that continue to affect people across the globe and for which new therapeutic options are needed. This designation marks an important milestone that supports Arno's global regulatory and development strategy. We believe AR-12 has potential as a promising approach to address unmet medical needs of patients infected with cryptococcosis and tularaemia and look forward to further investigating AR-12 in these two disease areas."
The AR-12 orphan medicinal product designation was based on application packages that contained relevant data from pre-clinical models for each condition. In the application regarding cryptococcosis, results of an animal model evaluating AR-12 showed a reduction in brain fungal burden in combination with fluconazole, an antifungal medication.[1] In the application regarding tularaemia, results of an animal model evaluating AR-12 showed improved survival in combination with gentamicin.[1]
The European Commission grants orphan designations for medicines that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.
Preliminary data demonstrate that the mechanism of action of AR-12 may include induction of host cell autophagy and inhibition of fungal acetyl coenzyme A synthetase. Additional work is ongoing to further understand the mechanism of action. Based on pre-clinical research, AR-12 may have potential as an orally-available antimicrobial agent in a number of infectious diseases.
About Cryptococcosis
Cryptococcosis is an infectious disease of the lungs caused by the fungus Cryptococcus neoformans, typically found in soil and breathed in. It is most often seen in people with a weakened immune system, including those with HIV infection, organ transplants receiving immunosuppressive therapy, receiving cancer chemotherapy, or who have Hodgkin's disease. Cryptococcus is one of the most common life-threatening fungal infections in people with AIDS.[2]
About Tularaemia
Tularaemia is an infection which can be spread from animals to humans that is caused by the bacterium Francisella tularensis. Human infection can occur through a variety of mechanisms, most often of which is through bites of infected insects such as ticks, mosquitoes and flies. Following an incubation period of about 3--5 days in humans, symptoms start abruptly with high fever. Other symptoms vary with the portal of entry, and include swollen lymph glands, eye infection, throat infection, pneumonia and severe infection with blood stream infection.[3] The condition may become debilitating due to the development of lymphadenopathy, pneumonia, diarrhea, and cutaneous ulcers, with a protracted recovery.1Francisella tularensis (tularemia) is a Category A Priority Pathogen on the National Institute of Allergy and Infectious Disease (NIAID) list of Biodefense and Emerging Infectious Diseases.
About AR-12
AR-12 is an orally-available small molecule. Preliminary data demonstrate that the mechanism of action may include induction of host cell autophagy and inhibition of fungal acetyl coenzyme A synthetase. Previously, AR-12 has completed Phase 1 clinical trials in patients with cancer. Additional pre-clinical research indicates that AR-12 may have potential as an antimicrobial agent in various infectious diseases.
About Arno Therapeutics
Arno Therapeutics is a clinical stage biopharmaceutical company developing innovative products for the treatment of cancer and other life threatening diseases. Arno has exclusive worldwide rights to develop and market three innovative anti-cancer product candidates. These compounds are in clinical or preclinical development as product candidates to treat hematologic malignancies and solid tumors. For more information about the company, please visit www.arnothera.com.
References
1. Arno Therapeutics. Data on File.
2. NIH's MedlinePlus. http://www.nlm.nih.gov/medlineplus/ency/article/001328.htm
3. European Centre for Disease Prevention and Control. http://ecdc.europa.eu/en/healthtopics/Tularaemia/Pages/index.aspx
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include, without limitation, statements regarding the potential of AR-12 as a potential therapy for cryptococcosis, tularaemia, infectious diseases and cancer, the timing, progress and anticipated results of the development of AR-12, as well as Arno's strategy, future operations, outlook, milestones, future financial position, future financial results, plans and objectives. The Company may not actually achieve these plans, intentions or expectations and Arno cautions investors not to place undue reliance on its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements made. Various important factors could cause actual results or events to differ materially from the forward-looking statements. Such factors include, among others, risks that the results of further preclinical and clinical trials will not support Arno's claims or beliefs concerning the effectiveness of AR-12 or any other product candidates, the ability to finance the development of AR-12 and other product candidates, regulatory risks, and reliance on third party researchers and other collaborators. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2014. Arno is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
Contact:
The Ruth Group
Lee Roth (investors)
lroth@theruthgroup.com
(646) 536-7012
Kirsten Thomas (media)
kthomas@theruthgroup.com
(646) 536-7014
Arno Therapeutics
Lawrence Kenyon
lk@arnothera.com
(862) 703-7171
From OpkoDD
OPKO FORM 10-K Filed 02/27/15 for the Period Ending 12/31/14
In October 2013, we entered into an agreement with ARNO pursuant to which we invested $2.0 million as part of an approximate $30 million financing. In exchange for our investment, we received 833,333 shares of ARNO common stock, one -year warrants to purchase 833,333 shares of ARNO common stock, for $2.40 a share and five -year warrants to purchase an additional 833,333 shares of ARNO common stock for $4.00 a share. Other investors participating in the private financing included Frost Gamma Investments Trust, a trust affiliated with Dr. Frost (the “Gamma Trust”), Hsu Gamma Investment, L.P., an entity affiliated with Dr. Hsiao (the “Hsu Gamma”), and other members of our board of directors and management. In connection with the transaction, ARNO agreed that for so long as we continue to hold at least 3% of the total number of outstanding shares of ARNO’s common stock on a fully-diluted basis, we will have the right to appoint a non-voting observer to attend all meetings of ARNO’s board of directors and we shall have a right of first negotiation that provides us with exclusive rights to negotiate with ARNO for a 45 -day period regarding any potential strategic transactions that ARNO’s board of directors elects to pursue.
Opko Health Rose 3.69% For The Biggest Gain On The Tel Aviv 25 Index
Teva and Perrigo fell amid takeover bids but Delek and Israel Chemicals lifted the market
26/04/2015, 19:00
Globes correspondent
The Tel Aviv Stock Exchange (TASE) rose today. The Tel Aviv 25 Index rose 0.27% to 1,687.85 points, the Tel Aviv 100 Index rose 0.07% to 1,472.35 points, but the BlueTech 50 Index fell 0.25% to 383.07 points. Turnover was NIS 860.4 million.
In the foreign currency market, futures trading pointed to the shekel-dollar representative exchange rate falling 1.23% from Friday’s rate to NIS 3.903/$, while the shekel-euro rate fell 0.05% to NIS 4.247/€.
In the bond market, the corporate bond benchmark Tel-Bond 20 Index rose 0.47%.
In the stock market, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) fell 1.59% on the day’s largest trading turnover, after last week’s hostile takeover bid for generic drug rival Mylan NV. Perrigo Company (NYSE:PRGO; TASE:PRGO), itself the target of a hostile takeover bid from Mylan, fell 2.06% for the biggest fall on the Tel Aviv 25 Index. Opko Health Inc. (NYSE: OPK; TASE: OPK) rose 3.69% for the biggest gain on the Tel Aviv 25 Index.
Delek Group Ltd. (TASE: DLEKG) rose 1.77%, Azrieli Group Ltd. (TASE: AZRG) rose 2.42% but Elbit Systems Ltd. (Nasdaq: ESLT; TASE: ESLT) fell 1.57%.
Israel Chemicals (TASE: ICL: NYSE: ICL) rose 0.91% on news of potash deals with Chinese customers, despite the company’s two month strike deadlock, and parent company Israel Corporation (TASE: ILCO) rose 2.70%.
Opko / Pfizer Partnership Ready to Flourish
Wednesday April 22, 2015
Robert Borowski
Analyst Opinion
Opko has Friends in High Places; Pfizer Partnership Ready to Flourish
Opko Health, Inc. Daily: OPK saw massive share price appreciation late last year when Pfizer struck a deal with OPK to jointly develop products. Once regulatory clearance was obtained, the share price found a new support level of around the $14 mark. As this partnership flourishes, OPK’s share price should see growth.
Recent news of insider buying strengthens management’s belief that the partnership and the company will be profitable. The CEO, Dr. Frost, recently resigned from his chairman position at Teva Pharmaceuticals to focus on running his company. This is great news for current and prospective shareholders.
The long term potential for OPK is excellent having Pfizer backing the company and its products. On the short term, it is believed that the share price will hover around the $14 support and only grow as positive news is announced. Currently, there is no expected news in the short term leading to the prediction of a flat pattern.
OPK: The partnership with Pfizer is the best thing that could have happened for this little known biopharma.
A brief recap of Opko Health, Inc.: OPKO Health Inc. is a multi-national biopharmaceutical and diagnostics company. The Company is involved in developing a range of solutions to diagnose, treat and prevent various conditions, including point of-care tests, laboratory developed tests (LDTs), molecular diagnostics tests, and proprietary pharmaceuticals and vaccines. The Company operates through two divisions: Diagnostics and Pharmaceutical. It has established pharmaceutical platforms in Chile, Spain, Mexico and Uruguay. It has also established pharmaceutical operations in Brazil. The Company has developed a diagnostic instrument system that provides rapid, high performance blood test results and enables tests to be run in point-of-care
settings.
Opko Health is expected to release next quarter earnings on May 8, 2015. The street estimates an EPS of $-0.08; last quarter, OPK missed earnings estimates by $0.06. Meeting or beating estimates could be a potential catalyst to send the share price above the current resistance level of $15, which has been tested multiple times in March 2015. Investors should watch for strong volume moving the price above that resistance as a buy signal for further growth. Surpassing that resistance level may also trigger a short squeeze as stop prices for short position are likely in the $15 to $16 range; on high volume this could see the price appreciate significantly. Beating earnings estimates may be a sign of a flourishing relationship with Pfizer, which investors would view as very positive. This partnership may similarly be test of OPK as a potential acquisition target by Pfizer. The future of the company rests on its ability to take advantage of the opportunity given and only time will tell whether the company can execute. The signs, which include the CEO resigning form a chairman position at another company and purchasing more shares of OPK, suggest that the captain running the show is confident in his company, enough so that he invests his own money into it. That should give the investing community more confidence in OPK.
Summary and Conclusions:
This little known biopharmaceutical has been shining bright in the eyes of many investors when Pfizer and OPK announced a partnership to develop high value growth products. That news alone more than doubled the share price in over two months to a support level of $14; far exceeding its 200 – day SMA of $10.40. A resistance at $15 has also formed and been tested several times in the past month. If the share price can break through that resistance and cause a short squeeze, the share price should benefit significantly. As an investor, watch for the share price crossing that resistance on high volume as an opportunity for a long position entry point.
OPKO CEO Dr. Phillip Frost, MD "the Warren Buffett of biotech"
Billionaire Doctor Behind Disruptive Miner/Biotech Merger
When Miners Take on Tech
By Keith Kohl
Energy & Capital
Wednesday, April 22nd, 2015
“Mining Company Acquires Hepatitis Cure.”
Well, you definitely don’t see this headline every day.
An acquaintance from British Columbia — the capital of the world’s mining industry — emailed me a link a few weeks ago that had me scratching my head, wondering, “Is this some sort of corporate subterfuge or a budding new trend for the volatile precious metals and resource mining markets?”
In this case, the company is a silver miner — a medium microcap explorer with a 100% stake in a 122,000-acre project in Mexico’s Chihuahua State.
And this is no small project, either. With 488 million ounces of silver and 1.37 million ounces of gold indicated, the current market value of this 190-square-mile property is $9.45 billion.
That’s an 88-fold increase over today’s market capitalization of $107 million.
The problem is, with its production prices exceeding market price of the metals, it would cost the company over $11 billion just to get those metals out of the ground.
Now, this isn’t the end of the world… It happens all the time in the mining industry, and companies react to it by temporarily scaling back or halting operations in anticipation of a market turnaround.
As you well know, market turnarounds for precious metals are just as common and just as inevitable as market turnarounds for the overall economy.
Creative Hedging on a Corporate Level
For every recession, there’s a new rush to buy metals.
This company, however, decided to go another route — something I’d never heard of before…
It decided to invest in a biotech.
More specifically, it decided to buy the ownership of a commercial-stage, potentially best-in-class hepatitis B vaccine.
Big emphasis on “commercial-stage,” because that means it’s done, or almost done, having to deal with regulators.
The vaccine is called Sci-B-Vac, and it’s already on the market in Israel, where the drug was first developed, as well as 10 other countries.
The Big Name Behind the Big Deal
Now, here’s where it gets really interesting…
At the moment, parent company SciVac is private, with 45% of its shares held by another biotech company, OPKO Health, Inc. (NYSE: OPK) — a $6.4 billion giant headed by billionaire investor and industrialist Dr. Phillip Frost, MD.
Worth more than $10 billion, Dr. Frost has taken numerous biotech companies from development through product rollout to acquisition.
In fact, Jim Cramer recently referred to this man as “the Warren Buffett of biotech.”
So why would a billionaire doctor want to merge with a silver and gold producer?
Because he sees the value in it in the long term. Because he knows that eventually, when that resource is worth two or three times what it is now and production cost is still the same, share value will explode.
Whether it happens in a month or in a year makes no real difference to an investor ready to hold long term.
For short-term holders of the mining company that’s now about to start making the world’s best hepatitis B vaccine, the benefit comes in the form of shares in SciVac.
According to the company’s press releases, anybody holding shares of the mining company on April 24 — two days from now — will be granted one share of SciVac for every share of the miner.
The details of the merger are far more complicated, and you can peruse them at your leisure right here, but this information is public, so access is unlimited.
Have the Planets Aligned?
So why do I care about any of this? Well, two reasons…
The first is the current pricing of gold and silver.
Gold is just $50/ounce shy of crossing over the profit threshold for this mining company. It might sound like a lot, but just one bad month on the stock market could send investors back into hedge mode — and we’re definitely due for one of those.
Silver has $4 to go to that same threshold — admittedly a 25% gain from the current market price, but if you look back at what happened to silver during the last downturn, you’ll see just how mobile of a commodity it is.
It rose more than 400% — which would have put a company like the miner I’ve been talking about more than $10.5 billion in the black in terms of total resource value.
But the second reason has everything to do with the main name behind all of this: Dr. Phillip Frost.
Whether he really believes the chunk of a precious metals miner he’s about to own will appreciate to the tune of a few billion dollars in the next year or whether he’s got some other idea in mind, the one irrefutable fact is that shareholders of the mining company get to join forces with a serious player.
To me, that alone is pretty reassuring.
The mining company is called Levon Resources (TSX: LVN) (OTC: LVNVF), and it trades right now for less than a buck.
Check out its website right here, and do your own research… Then Google Sci-B-Vac, and you’ll start to understand what sort of potential we’re dealing with here.
So to answer my original question: Is this a legitimate new strategy of radical hedge diversification or just a billionaire pulling the strings?
I’m thinking it might be a bit of both. It usually is, after all.
I’m also thinking it might not make a difference.
Until next time,
Keith Kohl
A true insider in the energy markets, Keith is one of few financial reporters to have visited the Alberta oil sands. His research has helped thousands of investors capitalize from the rapidly changing face of energy. Keith connects with hundreds of thousands of readers as the Managing Editor of Energy & Capital as well as Investment Director of Angel Publishing’s Energy Investor. For years, Keith has been providing in-depth coverage of the Bakken, the Haynesville Shale, and the Marcellus natural gas formations — all ahead of the mainstream media. For more on Keith, go to his editor’s page.
Note# The current owners of SciVac will own 68.4% of the outstanding shares of New SciVac post-closing, with OPKO owning approximately 30% of the outstanding shares.
OPKO Investee SciVac Ltd. Enters into Transaction with Levon Resources
Clinical Oncology News Opko 4Kscore
ISSUE: APRIL 2015 | VOLUME: 10
4Kscore Can Reduce Need for Risky Prostate Biopsies
by Chase Doyle
Orlando, Fla.—Costly and invasive biopsies may soon be obsolete for most men screened for prostate cancer. According to results from a prospective clinical trial presented at the 2015 Genitourinary Cancers Symposium, a blood test called the 4Kscore can predict the personal risk of Gleason 3+4 or higher aggressive cancer with a 94% rate of accuracy (abstract 1).
“The role of the 4Kscore,” explained Sanoj Punnen, MD, an assistant professor in the Department of Urology at the University of Miami Miller School of Medicine and Sylvester Comprehensive Cancer Center, in Florida, “is to determine which patients are most likely to have an aggressive cancer and would, therefore, benefit from … biopsy. This allows us to forgo biopsies in men who are unlikely to ever suffer any serious consequences from a high-grade cancer.”
Although Dr. Punnen acknowledged the reduction in prostate cancer mortality shown in previous screening trials involving prostate-specific antigen (PSA), he was also quick to stress the costs of said reduction—namely, over-detection and overtreatment. “To save one man’s life,” Dr. Punnen said, “we need to screen over 1,000 men … ”
According to Dr. Punnen, much of this screening culminates in a prostate biopsy, which in addition to increased costs, can result in urinary complications, emotional stress and an increased trend for quinolone resistance. Additionally, he said, “75% of biopsies are either negative for cancer or show an indolent or low-grade cancer, which … is unlikely to ever affect the quantity or quality of anyone’s life.”
First Prospective Study Of Kallikrein Panel
The 4Kscore, a blood test based on the four-kallikrein panel, incorporates total PSA, free PSA, intact PSA and human kallikrein (hK2), as well as clinical information, including digital rectal exam results, prior biopsy status and the patient’s age. “When you take all of these factors together,” Dr. Punnen said, “you obtain a personalized risk prediction of a Gleason 3 or higher cancer of the prostate.”
Although a previous study, the European Randomized Study of Screening for Prostate Cancer, examined the kallikrein panel, it was a retrospective study (Lancet 2014.6;384[9959]:2027-2035, PMID: 25108889).
“This test has never been analyzed prospectively, and it’s never been performed in the United States,” Dr. Punnen said. “So that was the goal of this current study.”
From October 2013 to April 2014, Dr. Punnen and his co-investigators studied 1,012 patients from 26 different sites around the United States. All the men were referred by their urologists to undergo a biopsy of the prostate; there were no restrictions based on age or PSA values; all patients underwent a minimum of 10 core biopsies; and all patients gave samples of blood, which were tested for kallikrein levels.
Among the 1,012 men enrolled in the trial, the majority (77.2%) had either no prostate cancer or a Gleason 6 low-grade cancer; 231 men (22.8%) had a Gleason 3+4 or higher cancer.
“The idea of this test was to see how well we could predict the high-grade cancers using the 4Kscore,” said Dr. Punnen. “The calibration plot shows that the 4Kscore pretty much approximated the actual observed risk of a Gleason 3+4 cancer (area under the curve 0.82)” (Figure).
4Kscore Correlation Graph
The investigators also examined the clinical utility of the 4Kscore with a decision-curve analysis of the net benefit at various thresholds for performing a biopsy, which was useful in providing a personalized risk prediction to facilitate informed and shared decision making.
“For a very risk-averse person—a young person, for example—you may use a very low threshold in order to perform a biopsy,” he explained. “Anything 6% or higher may be your threshold. If you did that, you would avoid 30% of biopsies that you normally would [perform] and only about 1.3% of Gleason 3+4 or higher cancers would be missed. But, if you have an older man with more comorbidities, you may take a 15% threshold before you’re willing to undergo a biopsy. With this threshold, you’d avoid almost 60% of biopsies you would otherwise [perform].”
Although such a strategy carries some risk for missing high-grade cancers (4.7% with the aforementioned threshold), Dr. Punnen suggested that most of those cancers were Gleason 3+4 and unlikely to progress quickly and would probably be detected in subsequent screenings. “The likelihood of missing an actual high-grade Gleason 4+4 or higher cancer is less than 1% at all of those thresholds,” Dr. Punnen concluded.
Co-investigator Daniel W. Lin, MD, the chief of urologic oncology at the University of Washington Medical Center, in Seattle, underscored the value of the findings. He said, although “we can detect prostate cancer with PSA screening alone, the problem is it detects prostate cancers that might not need to be detected because they’re indolent. The value of the 4Kscore is to identify those men who have a higher likelihood of having high-grade prostate cancer. At the same time, it spares men the burden of having to get an unnecessary prostate biopsy.”
Oliver Sartor, MD, a professor of cancer research in the Departments of Medicine and Urology at Tulane School of Medicine, and the director of the Tulane Cancer Center, in New Orleans, commented on the study. “The study presented by Dr. Punnen helps to provide valuable new data,” Dr. Sartor said. “The 4Kscore test appears to correlate well with the presence of high-grade cancer on biopsy, much better than PSA. Though it is not perfect, it does represent a new step forward in the assessment of men at risk for prostate cancer.”
Sound Clip from April 14, 2015 Mad Money courtesy of Opkodd
MadMoney-April 14 2015 Opko Health
Opko Health Assigned Patent for Asthma Related Disorders
Title: Hypersulfated disaccharide formulations
Document Type and Number: United States Patent 9006211
Abstract:
Hypersulfated disaccharides with utility in asthma or asthma related disorders are disclosed. The compounds are formulated with agents that enhance the oral delivery of the hypersulfated disaccharides. The delivery agents are selected from the group consisting of natural or synthetic polymers having ionic side chains as well as other compounds or types of compounds that improve the bioavailability of the disaccharides relative to delivery of the drug without such agents. The hypersulfated disaccharides are made from heparin or salts thereof.
Inventors: Ahmed, Tahir (Coral Gables, FL, US)
Application Number: 14/011807
Publication Date: 04/14/2015
Filing Date: 08/28/2013
Assignee: OPKO Health, Inc. (Miami, FL, US)
Attorney, Agent or Firm: OPKO Health, Inc. Browder, Monte R.
Excerpt:
FIELD OF THE INVENTION
The present invention relates to pharmaceutical formulations comprising a hypersulfated disaccharide compound of formula I as further described below and a delivery agent selected from a pharmaceutically acceptable vehicle (additive) that facilitates/enhances oral delivery of said compounds. The formulations are useful in the treatment of a variety of inflammatory disorders and diseases in animals and people, and, in particular, pulmonary disorders selected from asthma and other conditions or diseases associated with inflammation of the lungs and airway.
BACKGROUND OF THE INVENTION
U.S. Pat. No. 7,056,898 (the ‘898 patent) discloses and claims certain hypersulfated disaccharides and methods of using same to treat certain inflammatory disorders. This patent specifically describes the use of the claimed compounds to treat pulmonary inflammations including asthma and asthma-related pathologies, such as allergic reactions or an inflammatory disease or condition. The compounds disclosed therein are described as being capable of preventing, reversing and/or alleviating the symptoms of asthma and asthma-related pathologies, particularly the late phase response in asthma patients following antigen stimulation. The examples and figures shown therein specifically relate to intravenous and inhalation means of administration of the recited disaccharides. In the ‘898 patent there is a general disclosure of the oral administration of a hypersulfated disaccharide designated as 811-25-1 at a dose of 0.5 mgs/kg to sheep, but no specific data is shown. There is also no disclosure therein of any specific oral formulation nor any specific disclosure of any data related to administration of a specific oral formulation. There is a need for an improved pulmonary or anti-inflammatory medication that can be delivered in small dosages to patients in need of treatment thereof on a convenient basis and which does not have the side effects associated with, for example, chronic administration of steroids or leukotriene receptor antagonists such as montelukast sodium.
The inventor has met this unmet need and has surprisingly found that certain formulations comprising the hypersulfated disaccharides recited herein and a delivery agent selected from the group consisting of a pharmaceutically acceptable natural or synthetic polymer as well as other vehicles that heretofore have been utilized to improve delivery of large compounds (e.g., those compounds having molecular weights of greater than 4,500 daltons as average molecular weight) have enhanced absorption/bioavailability/efficacy relative to the same compounds delivered without the claimed additives. While the literature has disclosed that certain carbomers enhance the intestinal absorption of Low Molecular Weight Heparins (LMWH) having, molecular weights of approximately 4500 daltons, there has been no teaching or suggestion of the use of such materials to enhance the absorption of low molecular weight disaccharides. In fact, as reported in Thanou et al., Pharmaceutical Research, 18 (11) 2001, such carbomers were added because of the large size of the LMWHs which, it was thought, would have difficulty permeating across the intestinal epithelium via transcellular or paracellular routes (via passage through the tight junction) albeit with less difficulty than fractions having a molecular weight of 12,000 daltons. The same would not apply to low molecular disaccharides which are, when compared to LMWHs, small molecules which can more readily permeate across the intestinal epithelium. The present inventors have unexpectedly found that low molecular weight disaccharides, in particular, low molecular weight hypersulfated disaccharides (e.g., of about 1,000 daltons), have surprisingly better efficacy when combined with a polymeric material having at least one of the chemical and/or physical properties of, for example, Carbopol 934 P and/or other carbomers. Such polymers have ionic groups such as a carboxylic acid side chain and/or hydrophilic moieties which facilitate the delivery of the hypersulfated disaccharides of the invention.
Download PDF 9006211
Mad Money Jim Cramer Not Backing Down On Opko
Mad Money w/ Jim Cramer
Tuesday, 14 Apr 2015
Caller Ron in NY:
Like to know about the Company Opko health and the Chairman, What do you think about Phillip Frost?
Cramer:
First of all I would love for Phil Frost to come back on the show, it’s been awhile.
Second, I have been recommending this stock literally since it was ten bucks, it’s at $14.75. I’m not backing down any more than he is not done buying stock. He’s still at it! Opko’s got so many irons in the fire I don’t blame Phil. He has made a lot of money for a lot of people over many years. Opko is proving to be a winner and it’s not done going higher.
George S. Mack of The Life Sciences Report (4/8/15) Interviews Maxim's Jason Kolbert on Athersys' Inc.
TLSR: Go ahead with Athersys, please.
JK: On March 2 Athersys announced a partnership with Chugai Pharmaceutical Co. Ltd. (4519:TSE), one of the premier pharma companies in Japan. Japan is not the easiest country in the world for a foreign company to launch a product in. You almost, by necessity, have to have a partner. Interestingly enough, Mesoblast also has a partner on the ground in Japan, JCR Pharmaceuticals Co. Ltd. (4552:TKY), and it was very strategic in the way it acquired that partner. It partnered with JCR by acquiring Prochymal (remestemcel-L) from Osiris Therapeutics Inc. (OSIR:NASDAQ). I'm very excited by what we'll see there.
I believe that Athersys got a very attractive deal with Chugai, for two reasons. It got an upfront payment that was nominal, but more importantly, it got the premier pharma company in Japan. Chugai has one of the top positions in the hospital market in Japan, and it's a company that understands biologics, having delivered two recombinant DNA products to the Japanese market—Neupogen (filgrastim; Amgen Inc. [AMGN:NASDAQ]) and Epogen (epoetin alfa; Amgen). Chugai is now going to develop Athersys' Phase 2 product MultiStem in ischemic stroke. Like Teva paying the freight for Mesoblast, Chugai will pay the freight—all of the developmental costs—for MultiStem to see that it's approved for stroke in Japan, which has the highest incidence and highest prevalence of stroke in the world.
TLSR: What could this MultiStem/ischemic stroke deal be worth to Athersys?
JK: There are $150–200M in development and revenue-associated milestone payments that Athersys can realize but, more importantly, there is a royalty stream associated with sales of MultiStem, as well as a manufacturing agreement at transfer pricing, which I look at as a second royalty stream. Based on our assumptions and my internal modeling, we're assuming those royalty rates will represent 30–40% of gross product sales. Athersys—nor anyone else—could not accomplish the development cheaper (or more effectively) in Japan by itself. This really is a great deal for both companies.
TLSR: I'm noting that final data collection for this 140-patient Phase 2 trial with MultiStem in ischemic stroke is supposed to occur in spring 2015. When do you expect Athersys to release top-line data?
JK: I like to have a bit of wiggle room, because the company will have to do a statistical analysis after data collection. But we believe that we'll see the data by mid-April. We are very excited. We believe that good data from this trial could be transformative for Athersys and for the landscape.
TLSR: Jason, this stock is up about 105% over the past 12 weeks. Do you see Athersys shares possibly selling off, even on good news?
JK: No, I don't. The percentages are very misleading. The stock was $4/share this time last year. I could argue that this stock is 25% below where it was a year ago. Here's the thing. The Mesoblast product is an allogeneic mesenchymal cell. The Athersys product is an allogeneic mesenchymal cell. The products are only slightly different, but the valuations are quite different. If we see that every patient in the treated arm of Athersys' Phase 2 had a better stroke recovery score versus the control arm, and the company has a p-value of 0.05 or less associated with that, then those data arguably could be good enough, with a modest bridging study, to secure the product's approval in Japan. This product could be selling in Japan in a year. I don't expect that, but it's possible.
A Phase 2 clinical trial, by design, is meant to provide information on determining the best dose, the best patients, and when patients should be treated. Phase 2 is supposed to be an informative study to help design a pivotal Phase 3 study. What I'm looking for from Athersys is Phase 2 data that will guide to a clear Phase 3 design, which, in turn, will translate into success. If we see that—and I believe we will—then I believe the stock is substantially undervalued today. Modest penetration into this market could make MultiStem more than a $1B product. Typically, I put 3–5x revenue as an expectation for market cap. If I put 1x revenue, and it's a $1B product, the company's market cap is one-quarter of that size. I believe Athersys is undervalued.
About
Jason Kolbert is Head of Healthcare Research and a Senior Biotechnology Analyst at Maxim Group, LLC. Mr. Kolbert has worked extensively in the Healthcare sector as product manager for a leading pharmaceutical company, a fund manager and as an equity analyst. Prior to joining Maxim Group, he spent seven years at Susquehanna International Group where he managed a healthcare fund and later founded SIG’s sell-side biotechnology team. Previously, Mr. Kolbert served as the healthcare strategist for Salomon Smith Barney. He is frequently quoted in Barron’s and is regularly featured on CNBC. Prior to beginning his Wall Street career, Mr. Kolbert served as a product manager for Schering-Plough in Osaka, Japan. He received a B.S. in Chemistry from SUNY New Paltz, and an MBA from the University of New Haven.
Site:
Why Investors Shouldn't Worry About Explosive New Drug Pricing: Maxim's Jason Kolbert
Opko Health Shares Could Have More Upside After Huge First Quarter Run
By Rafi Farber | 04/08/15 – 12:01 PM EDT
NEW YORK (TheStreet) — Drug-maker Opko Health (OPK – Get Report) has had a good run of late, hitting a three-year high in February, but it has room to run higher. Strong, savvy management plus an upcoming new drug application still make Opko an attractive investment opportunity.
The company is helmed by — arguably — the Warren Buffet of biotech, Dr. Phillip Frost. Let me explain.
The stock has nearly doubled since December on the news of Pfizer (PFE) offering $295 million up front to license Opko’s long-acting growth hormone, currently in development, called HGH-CTP.
That licensing deal with Pfizer for an as yet unapproved drug added some zip to Opko shares, but the interesting thing is that Opko got control of HGH-CTP when it acquired Prolor for $480 million a year-and-a-half prior. If we take into account the $275 million in milestone payments that are included in the Pfizer licensing agreement, Opko could profit on Prolor before even selling any growth hormone. More interesting still is that Frost personally owned 9.8 million shares of Prolor through his investment trust before his company put up close to half a billion to acquire it. He also chaired Prolor while chairing Opko. He owns it before he buys it and licenses it for even more. Keep that pattern in mind.
And there’s much more to come.
Looking at a chart of Opko may lead you to believe that it could run out of steam any minute, so what else can drive it higher?
Opko is on the cusp — within weeks or even days — of submitting a new drug application to the FDA for its lead candidate Rayaldee, a vitamin D formulation for patients with chronic kidney disease.
In the words of Charles Bishop, CEO of Opko’s renal division during the company’s March 2 earnings call, “We are completing the calculation of the datasets from all three trials and will proceed to submit the NDA as soon as possible expected later this month.”
That was in March. It’s now April. Two pivotal phase 3 trials already met their endpoints. All Opko has to do is collect the data and submit the papers.
Rayaldee has a target patient population of over 4 million in the United States alone, so any news on the NDA could produce yet another spike for Opko shares.
But beyond even the Pfizer deal on HGH-CTP and Rayaldee’s imminent NDA, Opko is something of a biotech holding company, with Frost handpicking the companies he wants to invest in. On the radar lately is Cocrystal Pharma (COCP), a biotech focusing on antivirals, most notably hepatitis C. Cocrystal is Opko’s second-largest holding in its biotech portfolio at 8%. While Frost himself does not chair Cocrystal, he does sit on its board along with Opko’s Executive Vice President and board member Steven Rubin. Frost owns close to half of the company and just bought more shares in late March.
The Rubin/Frost tagteam is key, as Rubin also sat on Prolor’s board prior to the acquisition.
Opko has a thing for private biotechs as well, and for bringing them public. One of the companies it has in its portfolio is SciVac, an Israeli company that like Prolor that has a third-generation hepatitis B vaccine already on the market in some countries, though not yet approved in the U.S. Frost recently took SciVac public via merger. Opko owned 45% of SciVac, and will now own 31% as a result of the deal.
So not only is Opko on the cusp of a major FDA NDA and fresh off a deal with Pfizer, it is a successful holding company for other biotechs with a penchant for acquiring them outright or merging them with other entities.
Occasionally, Frost extends his capital outside the biotech space as well. He just did this two weeks ago with Tiger Media (IDI), once a Chinese firm, now incorporated in Delaware and merged with a previously private data company. Frost owns nearly 35% of the combined company. It’s hard to say what Frost has in mind for this operation, but just as Buffet-followers track the Oracle of Omaha’s moves with great interest, biotech investors should track Frost. It will be interesting to see where he takes this one, and if it has anything to do with Opko.
Rubin, Opko’s vice president, who was also on Prolor’s board prior to the acquisition and who also sits on Cocrystal’s board, has been on the board of Tiger since 2009.
This article is commentary by an independent contributor. At the time of publication, the author held OPK.
MicroCap Daily on MabVax Private Placement Led by OPKO Health
All Hail to MABVAX THERAPEUTICS (OTCMKTS:MBVX)
MicroCap Daily
BY DAVE YOUNG ON APRIL 6, 2015
MABVAX THERAPEUTICS (OTCMKTS:MBVX) is a fascinating story developing in small caps that has a lot of Investors really excited. The stock has transformed in recent days from illiquid to one of the top most traded stocks on the entire bb exchange.
All the excitement on MBVX is about billionaire Dr. Phillip Frost $11.6 million investment in the Company; the man is a self-made billionaire with a keen eye on bb’s with big futures (check out COCP and DRNE) and he regularly receives national media attention from the likes of Bloomberg, CNBC and Barron’s.
MABVAX THERAPEUTICS (OTCMKTS:MBVX) is a cancer immunotherapy company focused on the development of vaccine and antibody-based therapies to address unmet medical needs in the treatment of cancer.
MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center. MabVax has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof of concept Phase II multi-center clinical trials, and a vaccine targeting neuroblastoma ready for Phase II clinical development.
The Company takes a unique approach to identifying the elusive cancer antigen proteins that are effective in fighting cancer. This is the holy grail of cancer research and cancer fighting monoclonal antibodies such as the ones that MBVX is creating have been some of the most significant biotechnology products in the last 10 years generating billions of dollars in sales with products such as Herceptin, Rituxan, and Avastin.
MabVax’s lead product is a monoclonal antibody called 5B1 and all results coming back have been highly promising thus far. 5B1 was derived from a patient with stage IV breast cancer who was vaccinated in 2008 and has remained disease free for over 5 years now. MBVX is quickly moving 5B1 forward as an imaging agent, a naked antibody therapeutic, and an antibody drug conjugate.
Also important to note here is that Juno Therapeutics, an oncology giant trading at a $3.5 billion plus market valuation has been evaluating MabVax’s antibody library for potential use in novel chimeric antigen receptor (CAR) T cells.
On April 6 MBVX announced it has closed on gross proceeds of approximately $11.6 million in a private placement led by OPKO Health, Inc. and Dr. Phillip Frost, CEO and Chairman of OPKO Health.
Pursuant to the Private Placement, MabVax issued a total of 15,486,001 units at $0.75 per unit for total gross proceeds of $11,614,501 before issuance costs of approximately $500,000. Each Unit consists of one share of common stock and a 30-month warrant to purchase one-half of one share of common stock (the “Warrant”). The Warrants are exercisable at $1.50 per each whole share of common stock. Laidlaw & Company (UK) Ltd. acted as an advisor on the transaction.
Mabvax CEO David Hansen said ”This financing will provide MabVax with funds to advance our pipeline of clinical products through several key milestones, and allow us to pursue additional preclinical research programs in our pipeline of which several are partnered with Memorial Sloan Kettering Cancer Center. We are proud to have OPKO Health and biotech investor and entrepreneur, Dr. Phillip Frost, lead the financing. Their input will be invaluable as MabVax advances its business plan.”
Dr. Phillip Frost said “The target for MabVax’s first novel human antibody addresses important medical problems in need of better therapeutic solutions. The early data for its HuMab 5B1 antibody are encouraging and MabVax has a pipeline of dozens of novel antibody leads on its discovery platform from which it may select promising candidates to develop through clinical trials.”
Currently trading at a $5 million market valuation MBVX might just be the most exciting opportunity in small caps today. The Company takes a unique approach to identifying the cancer antigens that are the holy grail of cancer research. Continued success of MBVX lead product 5B1 and current valuation or anywhere near it could be history. Dr. Phillip Frost $11.6 million investment is another huge vote of confidence.
Disclosure: we hold no position in MBVX either long or short and we have not been compensated for this article.
Opko 4Kscore AUA Citation Updates 'High Degree Of Accuracy Confirmed'
Opko 4Kscore AUA Citation Updates
MP6-04 THE 4KSCORE TEST PREDICTS HIGH-GRADE PROSTATE CANCER ON BIOPSY WITH PSA LESS THAN 4 NG PER MILLILITER
MP60-06 THE PERFORMANCE OF THE 4KSCORE FOR PREDICTING HIGH-GRADE CANCER ON BIOPSY OF THE PROSTATE DOES NOT DEPEND ON THE AGE OF THE PATIENT
MP77-20 AMONG MEN WITH LOW-GRADE PROSTATE CANCER ON PROSTATE BIOPSY, THE 4KSCORE PREDICTS MORE AGGRESSIVE PROSTATE CANCER AT PROSTATECTOMY.
PD38-03 THE 4KSCORE IS ASSOCIATED WITH MORE ADVANCED DISEASE AT RADICAL PROSTATECTOMY; RESULTS FROM A MULTI-INSTITUTIONAL PROSPECTIVE TRIAL.
New Screening Tool Predicts Likelihood Of Prostate Cancer
CBS Miami
April 2, 2015 4:24 PM
Each year, more than one million men in the United States have a prostate biopsy due to an elevated PSA. The majority of these biopsies show either no prostate cancer or low-risk cancer, meaning the biopsy was not necessary. Although screening for prostate cancer with serum PSA has reduced mortality from prostate cancer, it has also led to an increased number of unnecessary biopsies. A simple new test, the 4Kscore, is set to change that, and yet most men have never heard of it.
The 4Kscore, named because it measures four kallikrein proteins found in the blood, is the latest prostate cancer screening tool. It accurately predicts whether cancer is present, allowing physicians and patients to decide whether to move forward with a biopsy.
Urologists at Sylvester Comprehensive Cancer Center, Dipen J. Parekh, M.D., and Sanoj Punnen, M.D., have completed the first U.S. clinical trial of the 4Kscore. It combines measurement of the four proteins with a patient’s age, digital rectal examination findings and prior biopsy status to provide the likelihood of the patient having a high-grade cancer.
“Our trial confirmed what research in Europe had originally revealed, that the 4Kscore accurately identifies men with high-grade prostate cancer,” said Parekh, head of urology at UHealth – University of Miami Health System. “This is significant due to the ongoing criticism of PSA being used as a primary marker for prostate cancer because it leads to over-diagnosis and over-treatment. The 4Kscore rectifies that problem.”
“The 4Kscore is a useful tool in selecting men who are likely to have high-grade disease and most likely to benefit from a prostate biopsy versus those men with no cancer or indolent cancer,” added Punnen, who presented their findings at the 2015 Genitourinary Cancers Symposium.
Torsan Cowart of Boynton Beach, was one of many men who had never heard of the 4Kscore. When his PSA levels came back higher than normal, Cowart was unsure whether to move forward with a biopsy.
“In the past few years, there has been much discussion not only on the efficacy of the PSA test, but also on when biopsies should be performed. The 4Kscore resolves that dilemma,” said Parekh, who is professor and chairman of urology at the University of Miami Miller School of Medicine. “In our study we found that 43 percent of unnecessary biopsies would have been avoided with the 4Kscore.”
Doctors recommended that Cowart have the 4Kscore screening, which was as simple as ordering a blood test. “I was told it was a new test that was able to give you a risk percentage of whether you have cancer,” Cowart said. “My PSA was in a high range, so I wanted to be sure. I agreed to take it.”
After receiving his 4Kscore results, Cowart had no doubt that he needed to move forward with a biopsy, which ultimately came back positive for prostate cancer. But while many men like Cowart are receiving news that further treatment is required, just as many are determining that a biopsy is unnecessary, thanks to the 4Kscore.
Parekh and Punnen conclude that the 4Kscore will lead to a “drastic reduction” in the number of biopsies performed, potentially adding up to $1 billion in savings for the U.S. health care system. In addition, thousands of men will be spared the possible complications that are attributed to prostate biopsy, such as urinary incontinence, bleeding and emotional distress.
Published in European Urology, Parekh and Punnen showed that the 4Kscore has a near-perfect calibration in identifying patients most likely to benefit from biopsy because of a high probability of having a tumor that would require treatment. The risk of missing a high-grade cancer with the 4Kscore was minimal.
The study reviewed 1,012 men from 26 institutions around the U.S. between 2013 and 2014. The 4Kscore showed near-perfect prediction of the probability of high-grade cancer. There also was no discrepancy in results when comparing African-American and Caucasian men. The test performed equally well for both demographics.
“Physicians and patients now have a tool that will better enable them to decide whether to undergo or forgo a biopsy, and they can both walk away knowing with almost complete certainty that the decision they made was correct,” said Punnen, assistant professor of urology at the University of Miami Miller School of Medicine.
Transcript taken from opkodd site. Ceo of Renal Division talks about Opko Rayaldee as a one of a kind Game Changer. Link to original webcast should be still working. Nice conference. This could be a Block Buster Drug.
Opko CEO Renal Division Charles W. Bishop, PhD
2015 RBC Capital Markets’ Healthcare Conference
(Excerpt From Webcast February 25, 2015 at 2:35 PM (ET) 2015 RBC Capital Markets’ Healthcare Conference)
Uncle is Quoting, Paraphrasing, and Summarizing (condensed)
Click Here to listen in full CEO Renal Division Charles W. Bishop discuss Rayaldee at the 2015 RBC Capital Markets’ Healthcare Conference.
CEO Renal Division Charles W. Bishop, PhD
Five products in Phase 3. Host of products in earlier stage development. Top of the list is Rayaldee, a drug that has finished Phase 3 development. We will be submitting the NDA for Rayaldee next month. Rayaldee is a treatment for Secondary Hyperparathyroidism in patients who have pre-dialysis chronic kidney disease.
This product is going to be the first with the indication of treating Secondary Hyperparathyroidism that arises from Vitamin D Insufficiency in this patient population. No other product has this indication.
We think it will be a game changer for our pre-dialysis patients.
Rayaldee achieves Vitamin D sufficiency much more readily than any other product that is available. It lowers PTH as well as any product that is in the market. It does two things that Physician’s want to do. Rayaldee allows Physician’s to use one drug to get those two things done more effectively and safely.
Market for Rayaldee is large. Millions of patients that we target with Stage 3 & 4 CKD, one quarter are treated with active Vitamin D Hormones and one third are treated with Nutritional Vitamin D. Because neither of these options are very good about one half of the patient’s are not treated at all. We believe Rayaldee can take share from all three of these categories and in fact expand the market.
With Rayaldee’s target pricing at about $10,000 per year, you can see with every million patient’s we have under treatment we will have a major financial opportunity.
“Rayaldee will be the only product in history with this indication.” Charles W. Bishop, PhD
Arizona Urology Specialists Use Opko 4Kscore
James Daitch, MD Arizona Urology Specialists on Opko 4Kscore
Barrington Research Assumes Coverage On Opko Health
Dwight Einhorn , Benzinga Staff Writer
March 26, 2015 9:29am
In a report published Thursday, Barrington Research analyst Michael Petusky assumed coverage on Opko Health, Inc. OPK 2.95% with an Outperform rating and $19.00 price target.
In the report, Barrington Research noted, "We are assuming coverage of OPKO Health due to an analyst transition. Headquartered in Miami, Florida OPKO primarily focuses on point-of-care diagnostics, novel molecular diagnostics, and pharmaceuticals...Led by long-time healthcare executive Phillip Frost, OPKO has many additional shots on goal even beyond the opportunities within its currently commercialized product portfolio and its front-burner pipeline products, Rayaldee, and hGH-CTP. We have included information on pages 2 and 3, which illustrates key aspects of the current product portfolio as well as the depth of the product pipeline."
Opko Health closed on Wednesday at $13.88.
Michael Petusky Managing Director & Senior Investment Analyst
Barrington Research Associates
Michael Petusky, CFA
Managing Director
Michael Petusky joined Barrington Research in 2014 as Managing Director & Senior Investment Analyst covering Healthcare Services and focusing currently on the pharmacy, home infusion, rehabilitation, chronic care management and wellness, and senior housing, as well as Dental Services and select Medical Device companies. Prior to joining Barrington Research, Mr. Petusky covered healthcare services stocks and select medical device ideas for Noble Financial Group (2007-2014), Thompson Davis & Co. (2002-2007), and Branch Cabell, and its successor firms (1995-2002).
Mr. Petusky has been quoted in national publications such as Business Week, Investor’s Business Daily, Smart Money Magazine, and The Washington Post. In 2010, he received a StarMine analyst award for his stock-picking ability among analysts covering Healthcare Services.
Mr. Petusky has a B.B.A. (Finance-concentration) from the University of Richmond (1991) and also holds the Chartered Financial Analyst designation.
Barrington Coverage List
Opko 4Kscore at EAU15 MADRID, SPAIN - Session Highlights
EAU15 - Poster: Among men with low-grade prostate cancer on prostate biopsy, the 4Kscore predicts the presence of more aggressive prostate cancer
Presented by S. Punnen, M. Steiner, S. Zappala, J. Palou, D. Sjoberg, V. Mathur, R. Roberts, V. Linder, M. Reeve, D. Okrongly, J. Newmark, G. Sant, J. Morote, and D. Parekh! at the 30th Annual European Association of Urology (EAU) Congress - March 20 - 24, 2015 - IFEMA - Feria de Madrid - Madrid, Spain
MADRID, SPAIN 23 March 2015 (UroToday.com) - The appropriate identification of men with truly low-grade, indolent prostate cancer is essential to minimize the potential for disease progression on active surveillance protocols. The 4Kscore is a blood test measuring the levels of 4 kallikrein biomarkers (total PSA, free PSA, intact PSA, and human kallikrein-2) which has been demonstrated to accurately predict an increased likelihood of high-grade disease on biopsy. In this study the authors looked more specifically at the ability of the 4Kscore to predict the presence of aggressive disease in patients with low-grade disease diagnosed on biopsy, who would thus be poor candidates for active surveillance. To achieve this purpose, the study looked at the rate of disease upgrading in patients with Gleason 6 disease on biopsy who ultimately underwent radical prostatectomy.
The final cohort of this study consisted of 306 patients recruited from October 2013 to April 2014 in a prospective multi-institution study. The authors reported that higher 4Kscores significantly correlated with increasing amounts of cancer detected on biopsy, as measured by positive core number and core length. Of the 51 men who ultimately underwent radical prostatectomy, patients whose disease was upgraded to a Gleason 7 disease or greater had a significantly higher pre-biopsy 4Kscore in comparison to those patients whose disease was not upgraded (15 vs 7 respectively, p=0.02).
The authors concluded that the 4Kscore may be utilized to better risk-stratify patients to active surveillance or immediate treatment. Further investigation will be necessary to determine the optimal use of the 4Kscore in this setting. The identification of specific cutoff levels for observation vs further investigation vs intervention could prove to provide a significant clinical benefit.
Presented by S. Punnen, M. Steiner, S. Zappala, J. Palou, D. Sjoberg, V. Mathur, R. Roberts, V. Linder, M. Reeve, D. Okrongly, J. Newmark, G. Sant, J. Morote, and D. Parekh! at the 30th Annual European Association of Urology (EAU) Congress - March 20 - 24, 2015 - IFEMA - Feria de Madrid - Madrid, Spain
Sylvester Comprehensive Cancer Center/University of Miami Health System, Miami, FL USA
4Kscore Session Image Poster
Opko Health After Hours Most Active List
March 23, 2015, 04:44:46 PM EDT
Opko Health Inc ( OPK ) is unchanged at $14.93, with 4,238,464 shares traded. As reported in the last short interest update the days to cover for OPK is 14.006762; this calculation is based on the average trading volume of the stock.
Opko Health AH
Opko Health - Daily Trading Update Avafin
Posted on 03/23/2015 by Ethan Greenberger
A record number of Opko Health call contracts were traded during the busy trading session. There were 2.2 call contracts traded for each put contract yielding a 0.46 put/call ratio where 2.01K put and 4.34K call contracts exchanged hands.
Put/Call ratio is often used to measure investor sentiment, the ratio serves as a predictor of investor behavior. A high put/call ratio suggests that the investor sentiment is bearish and that investors expect the underlying stock to decrease in value. In contrast, a low put/call ratio suggests that the investor sentiment is bullish and that the underlying stock is expected to increase in value. Unusual volume provides reliable clues that the stock is expected to make a move.
The trading volume of 4.20M is above the 90 day average volume of 3.82M shares. Shares of Opko Health edged up $0.41 (2.82%) to $14.93. The price of the stock ranged between a low of $14.55 and $15.15 respectively.
OPKO Investee SciVac Ltd. Company Overview March 23, 2015
From Opkodd.wordpress.com
Today, Frost accomplished his goal, as SciVac has been officially acquired by Levon Resources (OTCMKTS:LVNVF), with 68.4% of the new company going to the former private SciVac shareholders and 31.6% going to former Levon shareholders. Since Opko already has a 45% stake in SciVac, that brings its total take in SciVac to 30.8%.
SciVac Company Overview March 2015
OPKO Investee SciVac Ltd. LVN-SciVac_Investor_Presentation-V6
Emerging Bio Markers for Prostate Cancer Detection
Opko 4Kscore Emerging Bio Marker
March 22, 2015 Dr. David Samadi
The PCA3 is a new gene-based test to aid in the diagnosis of prostate cancer. This is great news in this field because there aren’t that many screening tests for prostate cancer, a.k.a the silent killer.
How PCA3 Test Works
The PCA3 is a fairly simple test. A urine sample is collected following a DRE (digital rectal exam) for determination of the PCA3 score. Specific for prostate cancer and, unlike the PSA, the test is not affected by prostate enlargement or other non-cancerous prostate conditions.
The PCA3 score, in addition to a DRE and PSA test, provides useful information to help decide if a biopsy is needed, or can be delayed
If you have a positive biopsy, the PCA3 score may give additional information about the aggressiveness of the cancer and it may help in deciding which treatment is appropriate
Prostate Health Index (PHI):
Many researchers in the field are claiming that it gives us as doctors more accurate information on what an elevated PSA level might mean and the probability of finding cancer on a biopsy.
The PHI measures PSA, free PSA, p2PSA – all three are combined in an algorithm and give a probability for prostate cancer. It’s evaluated as being 3X more specific for prostate cancer than just a sole PSA test. The biggest improvement with the PHI is the specificity it gives and we’ve seen a substantial decrease in the number of prostate biopsies that are negative for cancer.
The PHI results are intended to be used to help distinguish between prostate cancer from benign prostatic conditions in men 50 years of age and older with total PSA results in the 4 – 10 ng/mL range and negative digital rectal examination (DRE) findings.
4K Score
This test measures four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, digital rectal exam (nodule, no nodule), and prior negative biopsy (yes, no). The test then provides a % probability on a scales from <1% to >95% for the patient having high-grade prostate cancer. Both tests measure the variance of the PSA in the blood
The 4K Score is designed to reduce the number of unnecessary negative biopsies that detect low-grade cancer. With these tests – not all men with an elevated PSA will need biopsy.
Genetic Testing: When Is It Used
1. For Biopsy
Oncotype DX: biopsy based genetic test that can be combined with other measures to predict aggressiveness of PCa
If biopsy is positive for cancer: 2 tests
The Polaris & Genomic Prostate Score
Purpose is to distinguish between aggressive cancers that need treatment and those that are slow growing and may need active surveillance
2. After surgery
Genome DX :: Decipher Prostate Cancer Test
The Decipher test predicts the probability of metastasis after surgery
Provides an independent assessment of tumor aggressiveness
Information distinct from that provided by Gleason score or PSA.
Decipher is a genomic test, which means it evaluates the activity of genes in the tumor that are shown to be involved in the development and progression of prostate cancer.
Decipher does this by measuring the expression levels of 22 RNA biomarkers involved in multiple biological pathways across the genome that are associated with aggressive prostate cancer.
Uses expression of these biomarkers to calculate the probability of clinical metastasis within 5 years of radical prostatectomy surgery, and within 3 years of successive PSA rise (biochemical recurrence).
Decipher analyzes a small tissue sample that was removed during surgery and is routinely archived or stored by the pathology laboratory.
David Samadi,M.D.@drdavidsamadi
Fox News Medical Correspondent | Chairman of Urology, Chief of Robotic Surgery at Lenox Hill Hospital. Expert in Prostate Cancer (212) 365 5000
Dr. David 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.
Dr. Dipen Parekh On Opko 4Kscore “As of today, it is the most accurate model in the entire world to predict high-grade cancer”
Prostate cancer tests, treatments an imperfect science
By Julie Landry Laviolette – Special To The Miami Herald
03/20/2015 8:00 AM 03/20/2015 12:00 PM
Screening for prostate cancer is not an exact science.
“There is not a consensus in the medical community about when or how is best,” said Dr. Rosendo Collazo, a primary care doctor with Baptist Health Primary Care in Miami. “It really depends on the physician having a sense of the patient’s risk factors.”
Men 50 and older, those with a family history, and African-American men have a higher risk.
The most common screening test, the Prostate-Specific Antigen, or PSA, is a blood test that measures a protein sometimes found in high amounts in men with prostate cancer.
“The problem with the PSA is that it’s not an accurate predictor. There isn’t a number result that tells you that you have or don’t have cancer,” Collazo said. Traditionally, the norm was set at 0-4, and anyone above 4 was referred for biopsy. But the PSA test is not reliable.
“We know there are people with prostate cancer who have PSAs below 4, and there are people without prostate cancer who have PSAs of 6 or 7,” Collazo said.
One reason is that PSA levels can be influenced by factors other than prostate cancer. It can be elevated in the bloodstream by an infection in the prostate, or lowered by medications such as aspirin or statins.
Typically patients with a high PSA level undergo a rectal exam and are referred for a biopsy. If prostate cancer is found, the patient is typically treated with surgery, radiation or hormone therapy.
But that thinking is changing.
The complicating factor is that not all prostate cancers are equal, said Dr. Akshay Bhandari, co-chief of the Columbia University Division of Urology at Mount Sinai Medical Center in Miami Beach. There are various grades of prostate cancer, from least to most aggressive. Low-grade cancers can be slow-growing and not affect quality of life for years, if at all, Bhandari said.
Dr. Dipen Parekh, chairman of the Department of Urology at the University of Miami Miller School of Medicine agrees. “But in the United States, finding cancer equates to treating cancer, even these low-grade cancers that for the most part do not harm someone,” he said.
The treatment may cause more damage to the quality of life of the patient, without increasing his survival rate, Parekh said.
Prostate cancer treatment, as much as it has advanced, is a rough ride, Collazo said. Impotence and urinary incontinence can result. “Before you go to those lengths, you’re going to want to make sure that the prostate cancer is going to impact your health,” he said.
If low-grade cancer is found, it can be monitored through repeat biopsies and imaging such as MRIs, PSAs and rectal exams, Parekh said. “If the cancer continues to grow, you treat it, and if not, you can very safely watch it for a long period of time,” he said. The University of Miami has a survivorship program to help patients cope.
Now doctors are trying to reduce unnecessary biopsies and overtreatment through more comprehensive screening methods. Parekh was a lead physician on the clinical trial of the 4Kscore, a screening method that became available last March. It is typically used after an elevated PSA has been found and a biopsy is recommended.
The 4Kscore looks at the measurement of four proteins in the blood, the results of the prostate exam, patient age and whether or not the patient has had a prior biopsy, Parekh said. “The result is a risk score that predicts the likelihood of aggressive prostate cancers,” he said.
“The ideal time to do the 4Kscore is before a biopsy. So if the score is high, your chances of finding an aggressive cancer are higher, and if the score is low, the chance of finding an aggressive cancer is lower, and you may defer the biopsy,” Parekh said.
The 4Kscore is about 82 percent accurate, he said. “As of today, it is the most accurate model in the entire world to predict high-grade cancer,” Parekh said.
The test is not covered by insurance. The out-of-pocket cost is $395-$450.
“It’s a relatively new test, but very soon, I think this test should be, and must be adopted by primary care physicians,” Parekh said.
Doctors say the best approach to prostate cancer screening is to evaluate on a case-by-case basis.
“Prostate cancer screening has come under a lot of flak because PSA testing is not the greatest test,” Bhandari said. “But we don’t want to throw out the baby with the bath water. Just because it’s not perfect, doesn’t mean it needs to be abandoned. I think for a certain age group, there is still a lot of benefit to screening.”
For example, a recent study that showed testicular cancer patients have a higher probability of getting prostate cancer is significant because it helps pinpoint those at risk, he said.
“More research needs to be done, but what we’re trying to do is isolate certain high-risk groups that would benefit from screening,” Bhandari said.
The American Urological Association recommends that men ages 55 to 69 with no family history of prostate cancer and no symptoms talk to their doctors about the risks and benefits of screening.
“But if you have a healthy 75-year-old who goes to the gym, who you think has a good chance of living the next 10 years, it’s not inappropriate to screen them,” Bhandari said.
The most common symptom of prostate cancer is nothing, Collazo said. But there are symptoms that could be caused by cancer or other issues that should be checked out. They are a sudden change in urinary flow, discomfort in urination, interrupted stream and changes in frequency — urinary tract infection symptoms that men don’t typically get.
“These are triggers that should be followed up on with a PSA, but those are the exception, they are not the norm,” Collazo said.
Opko Health Options Contracts New Ninety Day Record
Opko Health – Daily Digest
Posted on 03/20/2015 by Ethan Greenberger
Opko Health options contracts experienced a new ninety day record for call contracts where a total of 2.30K call contracts were traded in the busy trading session. The contract spread yielded a 0.77 put/call ratio where 1.3 call contracts were traded for each put contract.
Investors use options to manage risk and to speculate on price changes. Options can provide significant leverage if the stock moves in the right direction but aslo end up worthless if it doesn’t.
OPKO Health, Inc. is engaged in the development and commercialization of pharmaceutical products, vaccines, diagnostic technologies, and imaging systems.
Opko Health is trading at $14.52, down $0.15 (1.02%) in today’s trading session. The daily low is $14.39 and the high is $14.78. The trading volume of 4.46M is above the average volume of 3.97M shares. OPK is trading above the fifty day moving average and lower than the two hundred day moving average. The technical momentum Relative Strength Index indicator shows oversold conditions. The stock’s 52 week low is $7.82 and 52 week high is $15.23. Within the last quarter, the shares have gained 68.62% of their value.
OPKO Health Invests in Cardiac Device Company.
Opko Investee Neovasc $9B Massive and Virtually Unpenetrated Market Opportunity
Opko Investee Neovasc Update
EAU15 Madrid
Two abstracts have been accepted for Opko’s 4Kscore test at the European Association of Neurology in Madrid, March 22, 2015.
Opko 4Kscore abstracts at Madrid EAU15
Scripps Research Institute and OPKO Health Global License Agreement for a Novel Compound That Blocks Brain Cell Destruction in Parkinson’s Disease.
(JNK) SR-3306
MILESTONES IN MEDICAL SCIENCE:
Preventing Brain Cell Death Associated with Parkinson’s
Opko Health In ETF (XBI) Top Fund Holdings
Opko Health: SPDR® S&P® Biotech ETF (XBI) Fund Top Holdings
David Miller of Catalyst Funds Highlighted Opko in a video piece back in July titled:"Pro’s favorite insider plays: GE, DKS & OPK"
Opkodd transcript on Peter Najarian “Fast Money” Contributor & David Miller Catalyst Senior Portfolio Manager were quoted as saying...
TRANSCRIPT
Peter Najarian “Fast Money” Contributor
Opko Health, just real quick Judge. This one caught my eye because it’s one of your Buys and this is a Bio Pharma kind of play, right?
And this one where typically you see more people selling in these kinds of names, the fact is you have people buying.
It’s not at a 52 week high, but it’s a pretty good sign again, it’s an $8.00 stock but a $3 Billion Dollar Company.
David Miller Catalyst Senior Portfolio Manager
Right, so if you looked at Opko Health, you could see Phil Frost buying several Hundreds Thousands Dollars worth of stock virtually everyday for the past year.
His buying has actually continued and actually picked up in the last couple months.
He is a multi billionaire. He has enough cash personally that he could buy the entire company if he wanted to, and it seems like he is just gradually doing that, sucking up the entire float.
And it’s not just him. CTO of the firm Jane Hsiao, she’s buying as well as a few of the other directors.
It’s particularly interesting when they just keep buying more and more in such large volumes virtually everyday.
(Transcript posted with permission from Uncletlzz at opkodd.wordpress.com)
With a CPT Code already in the works for insurance coverage and inclusion in the NCCN Early Detection Guidelines expected to be announced this quarter, this bodes well for OPKO.
Some interesting points about this article.
Dipen J. Parekh, M.D Professor and Chair, Department of Urology, Director of Robotic Surgery, Dr. Victor A Politano Endowed Chair in Urology University of Miami Miller School of Medicine.
MD canididate at the University of Miami Miller School Brian Frank of Medicine tweeted: "parekh is a big deal here at UM in robotic surgery and all of urology. For him to give his praise means a lot for 4kscore"
"The 4Kscore showed a near-perfect calibration"
"The 4Kscore showed near-perfect prediction of the probability of high-grade cancer"
"There also was no discrepancy in results when comparing African-American and Caucasian men"
"Much discussion not only on the efficacy of the PSA test"
"The 4Kscore resolves that dilemma"
"Parekh and Punnen, assistant professor at the Miller School, conclude that the 4Kscore will lead to a “drastic reduction” in the number of biopsies performed, potentially adding up to $1 billion in savings for the U.S. health care system"
“Physicians and patients now have a tool that will better enable them to decide whether to undergo or forgo a biopsy,” Punnen said, “and they can both walk away knowing with almost complete certainty that the decision they made was correct.”
Opko 4Kscore Confirmed by UM Urologists
UHealth
University Of Miami
Miller School of Medicine
03/11/2015
More than one million men have a prostate biopsy each year in the United States. The majority of these biopsies show either no prostate cancer or low-risk cancer, meaning the biopsy was unnecessary. Although screening for prostate cancer with serum PSA has reduced mortality from prostate cancer, it has come at the cost of many men having to undergo further testing, such as a biopsy, and so physicians and patients have been searching for a better prostate cancer screening tool. The 4Kscore is the solution.
University of Miami urologists Dipen J. Parekh, M.D., and Sanoj Punnen, M.D., have completed the first U.S. clinical trial of the 4Kscore. This new prostate cancer screening tool combines measurement of four kallikrein proteins found in the blood with a patient’s age, digital rectal examination findings and prior biopsy status to provide the likelihood of the patient having a high-grade cancer.
Parekh and Punnen’s study, published in European Urology, found that the 4Kscore showed a near-perfect calibration in identifying patients most likely to benefit from biopsy because of a high probability of having a tumor that would require treatment. The risk of missing a high-grade cancer with the 4Kscore was minimal.
“Our trial confirmed what research in Europe had originally revealed, that the 4Kscore accurately identifies men with high-grade prostate cancer,” said Parekh, professor and Chair of the Department of Urology at the Miller School of Medicine. “This is significant due to the ongoing criticism of PSA being used as a primary marker for prostate cancer because it leads to over-diagnosis and over-treatment. The 4Kscore rectifies that problem.”
“The 4Kscore is a useful tool in selecting men who are likely to have high-grade disease and most likely to benefit from a prostate biopsy versus those men with no cancer or indolent cancer,” added Punnen, who joined Parekh in presenting their findings at the 2015 Genitourinary Cancers Symposium.
The study reviewed 1,012 men from 26 institutions around the United States between 2013 and 2014. The 4Kscore showed near-perfect prediction of the probability of high-grade cancer. There also was no discrepancy in results when comparing African-American and Caucasian men. The test performed equally well for both demographics.
“In the past few years, there has been much discussion not only on the efficacy of the PSA test, but also on when biopsies should be performed. The 4Kscore resolves that dilemma,” Parekh said. “In our study we found that 43 percent of unnecessary biopsies would have been avoided with the 4Kscore.”
Parekh and Punnen, assistant professor at the Miller School, conclude that the 4Kscore will lead to a “drastic reduction” in the number of biopsies performed, potentially adding up to $1 billion in savings for the U.S. health care system. In addition, thousands of men will be spared the possible complications that are attributed to prostate biopsy, such as urinary incontinence, bleeding and emotional distress.
“Physicians and patients now have a tool that will better enable them to decide whether to undergo or forgo a biopsy,” Punnen said, “and they can both walk away knowing with almost complete certainty that the decision they made was correct.”