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SBS
I was not surprised that the genetically modified safflower product was approved by FDA. But, somewhat like the issue with GTCB prior to approval of ATRYN there was lingering worry that a bioengineered product might meet an uncertain fate when reviewed by FDA.
Sorry, I don't know much about the other partners mentionned, except that I think Arcadia is involved with nutraceuticals and is subsidized by Canadian fed or provincial government. It was a partner in the SBS-Botaneco spinoff .
urche
ISIS, TKM.to, MRNA
I would be interested to hear more about why you are so optimistic about prospects for ISIS, esp with regards to its competition. Also, would like to hear from any one else here who has opinions about how the promising field of RNA therapeutics is likely to shake out.
I am aware of these players:
ISIS. A very complicated company to value, due to a patchwork history of deals, financings, partnerships. But thru its co-ownership of Regulus seems to have a promising pipeline developing "microRNAs", small amino acid glycoproteins that function as antisense drugs. They tout 22 drugs in their pipeline.
Tekmira (TKM.to)A very tiny Canadian company that uses RNAi, switches that interfere with RNA, essentially switching off genes. One phase 1 drug and another IND pending.
MRNAI don't follow this one, but understand the current emphasis of this reborn, preclinical company is also in RNA interference.
For all of these companies, I think that the biggest challenges are drug delivery and the related problem of unintended effects.
Thoughts or a downloadable resource on this topic would be much appreciated.
Urche (no positions)
Sembiosys--?another scam from Alberta?
I don't really view SBS as a scam, but maybe a good example of a company that should have stayed private longer before going public. It still seems to have a long road to buyout or profitability.
This story bolsters the company, however. The import, it seems to me, is not in the small , undisclosed royalty SBS will receive for food grade GLA, but, rather, in the fact that their genetically engineered safflower oil has survived scrutiny from the FDA.
urche
SemBioSys provides update on GLA-rich safflower oil
cnwgroup
*
Companies:
o Semibiosys Genetics Inc
Press Release Source: SemBioSys Genetics Inc. On Monday January 18, 2010, 7:00 am EST
TSX symbol: SBS
CALGARY, Jan. 18 /CNW/ - SemBioSys Genetics Inc. (TSX:SBS - News) today announced that its partner Arcadia Biosciences Inc., has successfully completed the U.S. Food and Drug Administration (FDA) regulatory process for SONOVA(TM) 400, a GLA-rich safflower oil. Following established procedures for New Dietary Ingredients, the FDA reviewed and acknowledged extensive data supporting the safety of SONOVA(TM) 400, allowing it to be marketed and sold as an ingredient in dietary supplements. Arcadia and its commercialization partner, Bioriginal Food and Science Corp., expect to have commercial quantities of SONOVA(TM) 400, available for sale in the first quarter of 2010 as an ingredient for dietary supplements.
In 2004, SemBioSys entered into a funded agreement with Arcadia to develop high GLA-expressing safflower plant lines using a proprietary Arcadia gene. In 2006, SemBioSys announced that it had developed safflower lines that had accumulated over 65% GLA content in the plant's oil, well in excess of the milestone target. Under the terms of the agreement, SemBioSys is entitled to receive royalties from Arcadia on GLA-associated commercial product sales, as well as milestone payments.
"This is the first product developed using SemBioSys' platform technology to complete a FDA review process, and thus represents a major milestone for SemBioSys," said James Szarko, President and Chief Executive Officer of SemBioSys. "Successful commercialization of SONOVA(TM) 400 will result in a royalty stream to SemBioSys and is an example of SemBioSys' strategy to generate revenues from existing non-pharmaceutical programs while SemBioSys focuses on the development of our BioSimilar Insulin and Apo AIMilano pharmaceutical programs."
Gamma linolenic acid or GLA, is an essential fatty acid with potential use in topical, medical food and nutrition products. Scientific studies suggest that GLA may offer benefits for sufferers of blood platelet dysfunction, atherosclerosis and rheumatoid arthritis. According to ICIS Chemical Business Americas, the U.S. market for GLA oils is currently valued at more than US$100 million. Current GLA supply is expensive, greatly limiting its use. The commercial availability of SONOVA(TM) 400, a low cost, reliable, concentrated and scalable source of GLA, should not only reduce these limitations, but significantly enhance market demand and utilization.
About SemBioSys
in other words....
I don't see any way to interpret this insider purchase (at 5 lincolns per share) of $75,000 of the company as anything except bullish.
urche
HQH/HQL---an important difference?
In addition to the strong performance of the biotech sector, HQH in particular has benefited from a “relief rally” in the health-insurance and managed-care names that it owns.
In the past, DEW, you have observed that HQH and HQL holdings have so much overlap that it might make sense to pick between them based on the discount to NAV. Has that changed? I have not compared holdings in a long time, because it is an arduous process that involves printing out both SEC filings.
Do these holdings represent a significant difference between the funds' holdings?
By the way, I don't really see a significant trend in share prices that favors HQH over HQL. Looking at 3 month performance HQH has a slight edge, but HQL actually has a similar, small edge looking at 1 yr performance. Both have been satisfying, low stress investments over the past stressful year.
urche
MYRX-JAV merger
I can't think of another takeover deal that fostered so little interest, and the little sentiment seems to be all negative from both sides of the marriage.
Since the announcement on Dec 18, JAV is up a few percent, Myriad is down about 8%, almost no enthusiasm for the deal on respective Ihub boards---and already a law firm is threatening to sue Javelin for "the potential unfairness of the price to Javelin shareholders and the process by which the Company’s Board of Directors considered and approved the transaction". This seems to be a deal that leaves no one happy.
I admit to having had a much higher perception of the value of Javelin's pipeline.
Burned again,
Urche
SBS/MDCO
McBio, I think you have a valid point.
You said,
I'm not sure where you get that Sembiosys doesn't have the intellectual property to develop ApoA1.
Upon further digging, I am concluding that Sembiosys believes it has patent on the ApoA1 Milano VARIANT it engineered in proprietary, genetically modified safflower.
From the PR this week:
...SemBioSys' Apo AI(Milano) product is different
and distinct from that in-licenced by The Medicines Company, ...
Also, from some older PR's is this explanation:
SemBioSys' proprietary
safflower-derived Apo AI(Milano) is a des-1,2- variant of Apo AI(Milano) as
previously described in the literature.
By contrast, The Medicines Co I presume owns the patent on the human form used in Esperion's early research.
So, working from the assumption that both companies have valid IP and effective drugs, I suggest the problem from an investment perspective, is whether either company can find the right path to develop a game changing approved drug . My bias at this point is that SBS is interesting as a potential acquisition, though it's a guess whether it would be as a take-over or take-out (to kill it) strategy.
Urche
20 tons of safflower is not tons of commercial grade product
Agreed. But I believe that refers to the seed, where the ApoA1 is concentrated and although I can't find the documentation, I think I recall a claim that the genetically modified safflower has been induced to produce around 10% apoA1 milano by weight. If that is correct, 20 tons is a boatload of raw material---and there is a lot more where that came from.
To put these figures in some context, the Esperion studies using ETC-642 seem to be using 10-30 mg/kg (about 1-2 gm) single doses in their phase 1 studies. That dose seems to produce clinically measurable effects 30 days later.
This comes from the SemBioSys web site, corroborating the same dose range:
If successfully commercialized, predicted high
dosing (multiple grams per course of patient treatment) coupled with a large
patient population would be expected to drive volume demand of several tons of
Apo AI(Milano) per year, underscoring the value of a highly scalable, plant
manufacturing solution
Urche
That would help explain the dismal performance of SBS.
If both the insulin and apo-A1 programs are hampered by serious limitations (one lacking a market and the other lacking a route to market), then that doesn't leave much value---but a mighty fine story!
Sembiosys, MDCO---seems like a desperate PR to me
After rereading the Sembiosys PR several times, it strikes me as unusual and perhaps it underscores some irony in SBS' apparent success.
The PR, IMO , comes off sounding like a weak attempt to draw attention to itself, with nothing new to say.
On first glance, the company at this point seems to have a lot going for its Apo-A1 program.
To summarize recent progress, this is from their website:
"SemBioSys has achieved commercial levels of Apo AI and Apo AIMilano accumulation in safflower and confirmed the identity of safflower Apo AIMilano through the use of mass spectrometry and protein sequencing. The function of safflower Apo AIMilano has been demonstrated through lipid clearance, cellular cholesterol efflux and whole-animal cholesterol mobilization assays. Taken together, these analyses indicate that safflower Apo AIMilano is physiologically and pharmaceutically comparable to microbially-produced Apo AI and Apo AI derived from human serum." Furthermore,the company has publicized several times that they already have stockpiled a large surplus ("more than 20 tonnes")of potent safflower.
So what's the problem and why is the stock down 90% over past 2 yrs? Despite their success at producing literally tons of commercial grade product, they don't have a route to market, they don't have a partner, and, now I gather, they don't own the intellectual property to develop apo A-1. So, it seems to me that the fate and the value of the company lies in the hands of MDCO. It could still be a home-run, but if they felt secure, I don't think they would be issuing a PR like that.
BTW, a call to IR led to a message that the offices will be closed from 12/24 to Jan 4.
Urche (former long)
This news is not really, IMO, likely to be material to Javelin, but I would not be surprised to see a signif drop in share price from the news. Maybe a buying opportunity?
The reason I don't see this as a significant negative is that the injectable form of diclofenac is intended for short term use. Also, it is an old, established drug with lots of wordlwide experience. So, it is a drug that maybe needs monitoring for long term use. But, I don't see how this would affect the safety profile or approvability for short term IV use.
All IMO.
Urche
From Medscape Medical News > Alerts, Approvals and Safety Changes > Medscape Alerts
Diclofenac Linked to Liver Failure, Death
Deborah Flapan
Posted: 12/05/2009
December 5, 2009 — Treatment with all products containing diclofenac sodium, including Voltaren Gel, may increase liver dysfunction, resulting in severe hepatic reactions and liver transplantation or death, the US Food and Drug Administration (FDA), Endo, and Novartis announced late last night.
Cases of drug-induced hepatotoxicity have been reported within the first month of treatment with diclofenac but can occur at any time during treatment.
"Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure," according to an alert sent last night by MedWatch, the FDA's safety information and adverse event reporting program. "Some of these reported cases resulted in fatalities or liver transplantation."
Physicians should discontinue diclofenac treatment immediately if patients continue to have abnormal or worsening liver test results, if liver disease symptoms develop, or if systemic manifestations occur, such as eosinophilia, rash, abdominal pain, diarrhea, or dark urine, according to a letter from Endo and Novartis to healthcare professionals.
The companies also recommend that physicians advise their patients receiving diclofenac of the signs and symptoms of hepatotoxicity, including nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and flulike symptoms, and what to do if these signs and symptoms appear.
To reduce the risk for hepatotoxicity in patients receiving diclofenac sodium, the lowest effective dose should be used for the shortest time possible.
Postmarketing Data
In their letter to healthcare professionals, Endo and Novartis advise physicians to measure transaminase levels regularly in patients receiving long-term therapy with diclofenac "because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known."
Clinical trial data and postmarketing experiences suggest that transaminase levels should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. "However, severe hepatic reactions can occur at any time during treatment with diclofenac," they note.
Transaminase levels have been elevated at borderline or higher levels in about 15% of diclofenac-treated patients, the companies say in the letter to healthcare professionals. Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase) is the recommended hepatic function marker for monitoring liver injury, they say.
However, in clinical trials, clinically important elevations (>3 times the upper limit of normal range [ULN]) of aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase) occurred in approximately 2% of about 5700 patients during diclofenac treatment (ALT was not measured in all patients). In a smaller open-label study of 3700 patients, similar elevations of ALT and/or AST levels were seen in approximately 4% of patients and "marked" elevations (>8 times the ULN) occurred in about 1% of patients. In this open-label study, "a higher incidence of borderline (<3 times the ULN), moderate (3-8 times the ULN), and marked (>8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs [nonsteroidal anti-inflammatory drugs]," the companies point out.
In addition, elevated transaminase levels were more common in patients being treated for osteoarthritis than in those with rheumatoid arthritis.
Diclofenac is a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
More information is available on the FDA's MedWatch Web site.
Novel HDL-like therapy
This interesting approach was described in the NYT yesterday.
It would be a stretch to view this approach as threatening or bearish for Merck (niacin), Sembiosys (for its apo-1 Milano synthesis technology), and Resverlogix (for its HDL analogue in development). At this point, I marvel at the cleverness of this idea but don't see near term investing or commercial angle (unless you want to see this as bullish for GOLD!)
Urche
From the Lab, a New Weapon Against Cholesterol
By ANNE EISENBERG
The particles that ferry cholesterol through the bloodstream are popularly known as “bad” or “good”: bad if they deposit cholesterol on vessel walls, potentially clogging them; good if they carry the cholesterol on to the liver for excretion.
Now scientists have created tiny particles in the laboratory that mimic those good carriers, scooping up the cholesterol before it can grow into dangerous deposits of plaque. The surfaces of these new particles are coated with fats and proteins so they can bind tightly with the sticky cholesterol to transport it through the bloodstream.
The particles may someday be important in treating cardiovascular disease, said Dr. Andre Nel, chief of the division of nanomedicine and director of the Center for Environmental Implications of Nanotechnology at the University of California, Los Angeles.
“Researchers have endowed these artificial particles with the same properties as natural particles that circulate in the blood,” called high-density lipoproteins, or HDL, he said. The artificial carriers can clean up sites where plaques can otherwise rupture, leading to strokes and heart attacks.
The particles may be useful not only in cardiovascular therapy, but also in diagnosis. The researchers have put gold and other metal cores at the center of the particles, Dr. Nel said, so that they show up well in medical imaging. Such imaging could be used, for example, to monitor plaques as they build up in blood vessels.
At the Chicago campus of Northwestern University, artificial HDL nanoparticles have been designed by Dr. C. Shad Thaxton, an assistant professor in the urology department, and Chad A. Mirkin, a professor and director of the International Institute for Nanotechnology at the university’s Evanston campus They have founded a company, AuraSense, to commercialize the technology.
The Northwestern researchers replaced the fatty core found in natural HDL with gold nanoparticles, Dr. Mirkin said. “The gold core serves as a scaffold for attaching molecules that are the same as those on the surface of naturally occurring HDL,” he said. “We have demonstrated that our synthetic version of HDL binds cholesterol very tightly, not only in the laboratory, but in animals.”
The group has done a pilot study in animals and will soon begin a larger study, also involving animals, Dr. Thaxton said
At the Mount Sinai School of Medicine in Manhattan, Willem J. M. Mulder, an assistant professor of radiology and gene and cell medicine, and his research group have developed HDL-like nanoparticles intended primarily for imaging and diagnosis. The particles have centers of gold or other materials, Dr. Mulder said, depending on the type of imaging to be used.
“One of our interests is in the imaging of the biological processes in atherosclerosis,” the hardening of the arteries caused by plaques, he said.
Gold nanocrystals show up well in one type of imaging, called computed tomography, he said, and iron oxide nanocrystals work well with magnetic resonance imaging.
The research of the Northwestern and Mount Sinai groups may one day benefit people who develop deposits of atherosclerotic plaque, said Dr. Gregory M. Lanza, a professor of medicine at the School of Medicine at Washington University in St. Louis.
“Both of these groups have shown that this HDL mimic can adsorb cholesterol,” he said. One day, the particles like those created by the groups may be included in therapies for heart disease, he said. “They may become part of good anti-atherosclerosis management, along with diet, nonsmoking and statins,” drugs that interfere with the synthesis of cholesterol.
BUT for that to happen, cautioned Dr. Nel at U.C.L.A., more study will be needed. “We will have to find out what happens when the gold nanoparticles accumulate in the body,” he said. “This is a problem for treatment of chronic diseases where you administer materials over a long time.”
Vincent M. Rotello, a professor of chemistry at the University of Massachusetts, Amherst, who does nanoparticle research, agreed. “Right now, nanoparticles are great for diagnostic and acute therapeutics,” he said, but issues lie ahead that must be solved before the particles can be prescribed.
“Gold is nontoxic,” he said. “But it does build up. We don’t know what the effects of the buildup might be.” Smaller particles are excreted, he said. But larger particles may accumulate in the liver. Dr. William O’Neill, executive dean for clinical affairs at the Miller School of Medicine at the University of Miami, welcomed the artificial particles.
“If we can prove they don’t have side effects, we could give them as a drug, causing plaque in the coronary arteries to shrink,” he said. “It could revolutionize cardiology.”
I don't get it...
I don't see anything in the quarterly report to explain the substantial bump in share price yest and today. Was there something I missed or something said in the conf call?
urche
conf call
A few notes from the conf call added to the terse statements from management in the PR.
1) Almost all the fine growth in revenue reported was from Asia, esp China. US sales (mostly BNP) have been nearly flat and disappointing.
2) However CEO expressed satisfaction with the 3M and Roche relationships and is optimistic about a new marketing strategy by Roche that will start late this year. There will be more marketing of RAMP tests directly to clinics who order the tests (such as cardiologists) rather than hospital labs.
3) New business opportunities seem to abound, with a new TB test that is being evaluated by a Swiss organization (?FIND?) that receives funding from the Gates Foundation. Roche and 3M are also evaluating some new tests. I doubt these new opportunities would affect the bottom line initially, but at least would expect the increased development costs would be funded by the partners.
4) Enough cash still exists to go to Q4 2010 which, is about the time that profitability can be projected. Although it was not said in the CC, I would still expect another dilutive financing unless a rich deal with a partner is struck.
Considering the whole story and the current price, it seems a value to me and I added to my position yesterday.
Urche
Don't think you are alone.
There is at least one other reader and long time holder of this company. Even though I think there is some promise for this company, and I think the share price does not reflect the potential, it is below the radar of most investors. So, it is hard to be optimistic about the future until substantial profits and attention from US analysts develops.
Tiny Titanium
One doesn't see much mention of titanium on this board, and tiny White Mountain Titanium is probably not on anyone's radar screen.
It caught my interest as a natural resource play that is not only tiny (last I heard, only one bona fide employee and market cap under $30 million) , but also because most of its assets and expenses are denominated in Chilean pesos. The "company" in this case seems to be essentially mineral rights to a promising mountain. Having recently announced a financing, and this PR (which is timed so closely that it can't be unrelated) announcing positive ore analysis study, this might be a time for the adventuresome to buy.
Urche (no position)
PS: I don't understand how to interpret the results in the table below.
http://finance.yahoo.com/news/White-Mountain-Progress-prnews-1747656652.html?x=0&.v=1
White Mountain Progress Report on Metallurgical Test Work Programs
* Press Release
* Source: White Mountain Titanium Corporation
* On 6:00 am EDT, Tuesday October 20, 2009
SANTIAGO, Chile, Oct. 20 /PRNewswire-FirstCall/ -- White Mountain Titanium Corporation ("White Mountain" or the "Company") (OTC Bulletin Board: WMTM - News) reports that rutile locked cycle, feldspar concentrate and Stage 2 pilot plant test work programs currently underway at SGS Lakefield ("SGS") are proceeding well. Rutile locked cycle and initial feldspar concentrate test work have been completed with encouraging results and Stage 2 pilot plant test work is scheduled for completion at the end of October 2009, with full results available to the Company by the middle-to-end of November 2009.
The primary objective of the test work is to produce a natural rutile, titanium dioxide concentrate which meets the chemical and particulate specifications of titanium pigment and metal producers. A secondary objective is to produce a co-product feldspar concentrate which meets the chemical specifications of glass and ceramics producers. For purposes of the test work, a representative bulk sample of the Las Carolinas deposit totalling 275 tonnes was shipped to SGS in late August 2009. The head grade of the bulk sample averaged in excess of 2.9% TiO2.
Drawing upon a process flow sheet and procedures which have been developed and refined over the past two years, the bulk sample is first crushed to -1/2 inch and then ground to a particle size no finer than 100 mesh. The ground sample then passes through a gravity pre-concentration circuit where non-mineralized material is rejected and mineralized material, collected. The collected mineralized material is expected to represent approximately 50% by volume of the total material passing through the gravity pre-concentration circuit, with a corresponding increase in grade. For the bulk sample, we expect the grade of the gravity pre-concentrate passing to the flotation circuit to be approximately 6% TiO2.
Based on the process flow sheet and procedures set out above, SGS has completed a number of 9 hour, locked cycle tests on bulk sample material. These tests were conducted in order to stabilize the pilot plant circuits and attain steady state conditions prior to undertaking continuous pilot plant trials of up to 48 hours at a feed rate of 1 tonne per hour. (Flotation circuit conditions mirror the optimized chemical balances reported from previous work test work.) Detailed chemical analysis of one recent locked cycle test is set out below and we view the results as very encouraging.
LCT Results - Pilot Plant Bulk Sample
Test Product Weight Assays % % Distribution
No. % TiO2 SiO2 Fe2O3 CaO TiO2 SiO2 Fe2O3 CaO
PS1 TiO2 Conc
(Non-mag) 2.57 98.36 0.61 0.81 0.07 83.2 0.03 1.4 0.2
TiO2 Total
Tails 97.43 0.52 62.06 1.53 0.88 16.8 100.0 98.6 99.8
Head (Calc) 100.00 3.04 61.9 1.52 0.87 100.0 100.0 100.0 100.0
In marketing discussions, potential buyers of our rutile concentrate have emphasized that particulate size is very important to operators of commercial chlorinators used in the production of titanium dioxide pigment. Fines reduce the yield in chlorinators as the fine material can be lost in flue gases. In order to meet the buyer's particulate specifications, we will closely monitor the Stage 2 pilot plant grinding circuit to ensure that the bulk sample is not over ground resulting in too many fines. Results from particulate analysis will be available in the final Stage 2 pilot plant report.
In associated work, SGS has completed initial test work on the recovery of a commercial grade feldspar concentrate from tailings derived from the rutile flotation circuit. Following a detailed mineralogical examination of the feldspar, SGS has been able to reduce the iron content in the final feldspar concentrate from 1.2% Fe2O3 to 0.35% Fe2O3. Feldspar test work is scheduled for completion in early December 2009.
"The Company's metallurgical test work programs are proceeding well, and I am delighted with the results obtained so far," said Michael Kurtanjek, the Company's President and CEO. "The process flow sheet and procedures developed jointly for the Cerro Blanco project by SGS and White Mountain technical staff appear to be capable of achieving rutile concentrate specifications at a time of growing concern over future concentrate feedstock supplies. A recent marketing article by the London based magazine Industrial Minerals drew attention to the fact the global supply of titanium dioxide feedstock remains tight and that prices for rutile concentrate appear to be heading to $600 per tonne FOB."
About White Mountain Titanium Corporation
low ball buyout offer is the only hope
Barring some shocking new development, when the second shoe drops and LFB takes control of GTC’s BoD, a lowball buyout offer from LFB will probably ensue in short order.
I agree and that is the only reason to hold onto shares at this point, IMO. The question is what that buyout price will be. Am I foolish to think it will be at a premium to today's price? For the IP and a drug on the market I think shareholders should be outraged at anything lower than current price. But then again, shareholders other than LFB won't really have much say about it all.
HQH/HQL
HQH/HQL finally moved to “fix” the wide discount to NAV
I don't really understand why this is such a problem that the BODs feel the need to "fix" it. From the viewpoint of a trustee, what is the problem if the share price stays below NAV for a long period? In the case of HQH and HQL NAV is a substantially imprecise value, anyway, since roughly 20% of the portfolios are in private, illiquid investments.
Maybe I am missing something here, but I had a different take home message from this announcement---- that the management of these funds don't see a biotech market with ripe investment opportunity. Relatively speaking, buying back their own shares is a more attractive use of cash.
Urche
shares of BBL currently trade at a 16% discount to shares of BHP on the NYSE!
What could possibly explain this discrepancy? One ticker (BHP) has about 2.5 times as much volume as the other, so conceivably liquidity could have something to do with it. Or, maybe BHP, being headquartered in Australia might be perceived as more the right place to be with A$ and commodities in general rising. But, these seem like flimsy reasons for such a large difference in share price. Could the dividends for BBL be any less secure? I am looking for other ideas to explain this discrepancy.
If there is no good explanation, then the question becomes, which one is priced correctly?
Urche
Good find. Keep up the good sleuthing.
urche
Arixtra---GSK, MNTA
This is a minor update on my prior post in which I shared my surprise that a medium size hospital where I worked has adopted Arixtra, deleting Lovenox from the formulary.
Dew's points are compelling why this is not likely to be significant issue for Momenta, despite my concern that just prior to generic enoxaparin hitting the market, Arixtra may be able to pull off a strong increase in market share.
One of the reasons DEW raised for being unconcerned is that Arixtra is not approved for acute coronary syndrome. Be that as it may, this NH hospital, which has a strong cardiology dep't and does PCI, is in fact using Arixtra (off label) for ACS.
Once again, the suddenness of this shift in a pretty conservative hospital took me by surprise. But, let's not lose sight of the fact that when generic enoxaparin hits the market, the cost savings will rapidly annul any market share gained by Arixtra.
urche
OT: But appropriate Sunday reading
This editorial is from Sunday NY Times, a review of the bold Massachusetts health care model.
The New York Times
August 9, 2009
Editorial
The Massachusetts Model
Massachusetts’s experiment in near universal health care coverage has become a favorite whipping boy for opponents of health care reform. They claim the program is a fiscal disaster and that the whole country will be plunged into a similar disaster if President Obama and Congress’s Democratic leaders have their way.
That is an egregious misreading of what is happening in Massachusetts. The state’s experience so far suggests that it is more than possible to insure almost all citizens and stay within planned budgets — although it will take great creativity and political will to hold down rising costs so that the program is sustainable.
Three years after the program began, 97 percent of Massachusetts residents have health insurance — by far the highest rate in the nation. That has been achieved without huge increases in state spending.
The Massachusetts Taxpayers Foundation, a non-partisan research group, recently concluded that the cost of achieving near universal coverage “has been relatively modest and well within early projections of how much the state would have to spend to implement reform.” That is heartening news given that the major features of the Massachusetts reforms are similar to those under consideration in Washington.
Massachusetts requires everyone to take out health insurance or pay a tax penalty (unless they are deemed unable to afford coverage). It requires employers to offer coverage or pay a modest fee. It has expanded Medicaid to cover more of the poor and provides subsidies to help other low- and moderate-income residents buy insurance. And it has established an exchange where people not covered at work can choose from policies offered by private insurers who compete for their business.
All told, this program has raised state and federal health care spending in Massachusetts from $1 billion a year in fiscal 2006 to a projected $1.7 billion for fiscal year 2010 — with the federal and state governments each paying half of the added costs, or about $350 million. Massachusetts’s overall budget for 2010 is $27 billion.
A remarkable and encouraging development is that employers, who faced only a modest penalty if they dropped or failed to provide coverage, have chosen instead to expand coverage, in part because their workers were clamoring for group coverage. Indeed, employers and their workers have made a greater contribution to expanding coverage than the state has.
When the Legislature recently imposed cuts that forced the program to reduce benefits for thousands of legal immigrants, critics were quick to charge that the program was unraveling. But as state tax revenues have dropped during the recession, virtually all state programs have had to accept cuts. The demand for subsidized care has also risen as people have lost jobs.
There have been growing pains and glitches. The initially generous insurance benefits had to be scaled back to keep costs manageable. Cigarette taxes had to be raised to help pay for the reform. The number of people reporting problems paying medical bills and gaining access to care, after falling sharply, has begun to rise again. Tens of thousands of people who make too much to qualify for subsidies have to be exempted from the mandate each year on the grounds that they cannot afford to buy insurance. People just above the exemption level who lack employer coverage often face what they consider very high premiums.
Such problems are a warning perhaps that subsidies need to be extended higher up the income range. Massachusetts gives subsidies to families of four earning $66,000 a year, while pending Congressional bills would provide subsidies for those earning up to $88,000. That could mean added strain on government budgets.
What Massachusetts has not yet figured out is how to slow the relentless rise in medical costs and private insurance premiums, although premiums within the exchange have been held to 5 percent annual increases. The state’s political leaders decided to expand coverage first, while postponing the hard decisions about cutting costs until lots of people, businesses and institutions had a stake in the success of the enterprise.
Now the state seems poised to tackle costs — with an approach that is far more ambitious than anything currently being contemplated on Capitol Hill.
A special commission has just recommended that the state try, within five years, to move its entire health care system away from reliance on fee-for-service medicine, in which doctors are paid more for each additional test or procedure they provide.
In its place, the commission wants a system in which groups of doctors and hospitals would receive fixed sums to deliver whatever care a patient needed over the course of a year. The hope is that doctors would be motivated to deliver only the most appropriate care, not needless and excessively costly care, with safeguards to ensure that they do not skimp on quality.
In Washington, as Congress and the administration look for ways to slow the rate of increase in health care costs, they are focusing on a range of possibilities and planning pilot projects to test them. That seems to be a more judicious approach given uncertainties as to what will work. Whatever Massachusetts chooses, Congress should keep a close eye. And the public should demand an honest assessment, from critics and supporters.
Randomized discontinuation
Thanks, Dew, for the informative explanation. This trial design sounds like it would be not be able to give statistically useful data when applied to 8 or 9 different types of cancer. The numbers for each type would be too small. But, I can imagine a few seemingly compelling anecdotal responses that would trigger interest in further study. In this case, since the expense is borne by GSK, not EXEL, I am not particularly concerned, but it would seem like a frivolous way to spend money for a development stage biotech company.
EXEL
Can anyone shed some light on what is meant by a "randomized discontinuation trial"?
I am trying to understand the transcript of the recent Exelixis Q2 earnings conf call---and therein may lie some of my problem, relying on a poor quality transcript.
http://seekingalpha.com/article/152690-exelixis-inc-q2-2009-earnings-call-transcript?source=yahoo&page=-1
This is the befuddling passage:
We and BMS also believe that XL184 has potential beyond GBM and MTC. We recently initiated a previously planned, randomized discontinuation trial of XL184 in multiple tumor types, including pancreatic, prostate, heterocellular, gastric and GE junctional, melanoma, small cell lung and small cell lung with variant and breast cancers. This trial is designed to identify potential clinical activity across multiple indications as part of our long term plan with BMS to develop XL184 for the treatment of a variety of cancers.
Other than taking a hit on this approach of conducting Phase 2 trials in a small number of tumor types, we are undertaking a more comprehensive trial that should yield information about the potential activity of XL184 across a broad array of oncology indications. We and BMS believe that this approach will provide us with the data we need to maximize both the clinical and commercial opportunities for these very promising compounds.
One of the questioners in the Q+A session asked the question I would have asked and , IMO, came away just as befuddled:
Eric Schmidt - Cowen & Company
Okay. And then in terms of the randomized discontinuation study, that's a fairly novel design as at least in my experience. It's got a bunch of tumor types in there. How do you, how do you work to separate any potential signal from the noise and what size study are we talking about?
Mike Morrissey
You know it's a trial design that I think was initially validated with sorafenib. Certainly that's where the RCC indication came from, and I believe other indications as well. So across the nine, nine different histologies that we're looking at, we project a total of 600 patients in total and again there is, as this works in the classic paradigm, there's various enrollments goals initially to see a signal along with rules for stopping either based upon success or utility in the running phase and then for patients with stable disease are then looking at a randomization to be able to generate a rough PFS [meet] out.
So, in our view and certainly in the view of working closely with BMS, this is a very efficient way to really do some very careful analysis of variety of different tumor types in a very efficient manner. So we're excited about having this trial up and running and looking forward to wrapping it most.
I have not heard of such a study type and wonder if it has any validity. My hunch is that, much like what one can learn from retrospective sub group analysis, this type of study may be useful for hypothesis generation and not much else.
Urche
MNTA/GSK: Is Arixtra still a dog?
Dew has opined repeatedly that Arixtra is a commercial dog (Reference these, among other posts):
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=28934131;
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=28934131
I wonder if the tide is turning for Arixtra(fondapirinux) and whether this may have implications for the eventual market for m-enoxaparin.
I was surprised to learn that a well-run NH hospital where I have worked is phasing out Lovenox this month, and substituting Arixtra.
Here is a portion of the letter from the Pharmacy and Therapeutics committee:
Formulary Change:
In the continued efforts to provide patients at XXXX Hospital with safe, effective and cost efficient medications, the Pharmacy and Therapeutics Committee approved the addition of Arixtra® (fondaparinux) to the hospital’s formulary in place of enoxaparin.
This decision was made based on provider requests, patient safety, drug information, once a day dosing of fondaparinux, reports in literature supporting the use of fondaparinux in the treatment or prophylaxis of thromboembolism in patients with heparin-induced thrombocytopenia (HIT), and cost savings for the organization.
Therefore, over the next several weeks the organization will be making the conversion from enoxaparin to fondaparinux. A complete conversion will be implemented no later than August 1, 2009.
I would be interested if there is other evidence from across the US that Arixtra is taking turf.
Aside from having to learn how to use a new drug, my concern as a MNTA holder is that if Arixtra is able to position itself with a significant market share just prior to generic enoxaparin being approved, it may pose a significant barrier to adoption of the generic (i.e. MNTA produced) drug.
HQH/HQL
While I agree the suspension of dividends is a positive change for investors, it will be interesting to see if the market considers this a negative move. It seems to me that the only investors likely to sell on this news would be those using the funds as a relatively safe, bond-like, income oriented investment.
If we do see a drop in share price, the opportunity is magnified by the fact that, IMO, the funds are already undervalued compared to some other benchmarks. This graph shows how HQH and HQL have lagged in the past year, though it probably exaggerates the effect by not accounting for reinvested dividends to the effect of about 10% :
http://finance.yahoo.com/q/bc?t=1y&s=HQH&l=on&z=m&q=l&c=^btk&c=^GSPC
urche
wan shareholder sentiment
FWIW, I also cast my few remaining shares wanly against the LFB proposal.
ode to y3
You must at times feel that you are preaching to an empty church on this board. But, I, for one, appreciate your stalwart , informative posts. I don't share your penchant for technical analysis and some of your estimates (like the future sales of Ereska) are rosy in my view. But, you do a fine job of keeping us silent watchers and owners informed. So, here's a toast to y3. I wish I followed this stock closely enough to be able to contribute more meaningfully to the discussion.
Urche
anyone here?
My interest is piqued in this little company. But without some inside info or special expertise, I don't see any reason to be in a rush to invest with already 32 million shares outstanding and certainty of needing more financing in near future. Can anyone shed any light on why one should invest now?
Thanks,
Urche
Dew's call is looking commendable now
I am slogging thru posts starting 3 months back and came upon this prediction by DEW that looks like a fine call at this point in time:
Today may be the proverbial day of capitulation when hordes of people decide they don’t want to own any stocks and sell everything.
If you have dry powder, you can buy shares of myriad fine companies at prices that haven’t been seen in a long, long time.
As this chart shows anyone who followed that advice is sitting on a 20% gain in less than 3 months:
http://finance.yahoo.com/q/bc?t=6m&s=^BTK&l=on&z=m&q=l&c=&c=^GSPC
Time decay
Thanks for the responses that enhance my understanding of TBT.
Could someone explain in more detail the concept of "time decay"? It seems to be an inherent problem in holding a leveraged ETF long term, even if the underlying assets move in a favorable direction.
Is this really as easy as it seems?
I'd appreciate some help understanding how TBT is structured. I tried reading the investment info, but confess that I just don't get it, esp the part about needing to rebalance every day and frictional charges.
What are you actually buying when you buy TBT?
Boatman wrote, "Interest rates have no way to go but up. "
Even if this is true, does it necessarily follow that TBT will go up? Is the relationship linear?
TIA,
Urche
I'm leery of anything that seems so easy.
The problem for me has been finding an entry point. Several limit orders have not filled because I just can't believe the ticker will keep going up day after day. Up from around 46 a month ago to 56 now. This being a market, a pull back seems inevitable.
re: B12 levels
As a practical matter, both the nasal and sublingual delivery methods have evidence of more than enough bioavailability to do the job needed. B12 levels don't need to be high for its metabolic effects , and I am not aware of any validated research that says higher levels are more beneficial. So, I think it boils down to which product is cheaper and more palatable----I daresay Pre-Histin wins on both counts.
Urche
I know a company with a better product----
and they could have bought it for a lot less than $54 million:
http://finance.yahoo.com/news/Par-pays-545-million-for-apf-14821309.html
Par pays $54.5 million for vitamin B12 drug
Par Pharmaceutical pays $54.5 million for rights to vitamin B12 deficiency treatment
* Wednesday April 1, 2009, 5:10 pm EDT
WOODCLIFF LAKE, N.J. (AP) -- Generic drug developer Par Pharmaceutical Cos. said Wednesday its Strativa unit bought worldwide rights to the vitamin B12 deficiency treatment Nascobal from QOL Medical for $54.5 million in cash.
Nascobal is a once-weekly nasal spray. Revenue exceeded $8 million in 2008.
Par also bought the facility where Nascobal is made.
Vitamin B12 deficiency can be caused by a range of conditions, including pernicious anemia, a strict vegetarian diet, and malabsorption of vitamin B12 resulting from conditions such as HIV infection, AIDS, Crohn's disease and multiple sclerosis.
Shares of Par fell 60 cents, or 6.3 percent, to close at $8.87. The stock has traded between $7.80 and $19.10 over the last 52 weeks.
Steve, Thanks for the direct info.
Are you at liberty to discuss anything about the marketing strategy? I am wondering if this is a product that someone looking for a B12 supplement would ever hear about. Or will it only get a web search hit if looking for an allergy product? What market are you trying to reach?
Timing seems good for pollen season in northern US.
Urche
That's a parochial view of allergy season.
Seems strange to launch an allergy product AFTER allergy season.
The season starts around Halloween time and ends around Valentines day.
Depends entirely on where you live.
For those of us in Northern climates, Halloween and first "killing frost" is when allergy sufferers can finally breathe a sigh of relief because there is no more pollen until April.
And the pollen is, of course, different in New England vs. Northwest where it is much more coniferous. And then consider that for most allergy sufferers pollen is not even the main allergen---pet dander, dust mites, molds are more common, with year round prevalence.
Finally, consider that even the US is a parochial viewpoint. The "allergy season" no longer exists when viewed from a global perspective encompassing East/West and Northern/Southern Hemispheres.
Expand your perspective--- the world (except Antarctica) is the market for PreHistin.
urche
IDIX-GSK deal
OK, I appreciate your response. Basically I think you are saying that the deal was expected and the deal seems favorable to IDIX. Therefore the default explanation for the price drop is the "sell on good news" strategy.
A follow on question:
Does this deal make it any more or less atrractive for Novartis to buy out the minority shareholders? I would think it makes it more attractive because a piece of the pie is carved out that strategically probably has more value to GSK than Novartis. The pie is a little smaller but presumably cheaper now.
What are the naysayers saying?
This has probably been addressed on the
BTV board, which I admit to being unable to keep up with.
But I am surprised at the drop in price on what appears to be a good deal for a phase 2 drug. And it was not really expected as far as I know, so the sell on the news investors shouldn't have built this into their strategy.
I would be interested in what the market sees as disappointing enough in this deal to send IDIX down on an up day for the market?
Urche
(cross posted on IDIX board which seems underutilized)
What are the naysayers saying?
This has probably been addressed on the
BTV board, which I admit to being unable to keep up with.
But I am surprised at the drop in price on what appears to be a good deal for a phase 2 drug. And it was not really expected as far as I know, so the sell on the news investors shouldn't have built this into their strategy.
I would be interested in what the market sees as disappointing enough in this deal to send IDIX down on an up day for the market?
Urche