When RNA interference first electrified biologists several years ago, pharmaceutical companies rushed to harness what looked like a swift and surefire way to develop new drugs.
Billions of dollars later, however, some of those same companies are now losing their enthusiasm for RNAi, as it is called. And that is raising doubts about how quickly, if at all, the Nobel Prize-winning technique for turning off specific genes will yield the promised bounty of innovative medicines.
The biggest bombshell was dropped in November, when the Swiss pharmaceutical giant Roche said it would end its efforts to develop drugs using RNAi, after it had invested half a billion dollars in the field over four years.
Just last week, as part of a broader research cutback, Pfizer decided to shut down its 100-person unit working on RNAi and related technologies. Abbott Laboratories has also quietly shelved its RNAi drug development work.
“In 2005 and 2006, there was a very sudden buildup of expectation that RNAi was going to cure many diseases in a very short time frame,” said Dr. Johannes Fruehauf, vice president for research at Aura Biosciences, a small company pursuing the field. “Some of the hype, I believe, is going away and a more realistic view is setting in.”
The issue is that while drugs working through the RNAi mechanism can indeed shut off genes, it has been difficult to deliver such drugs to the cells where they are needed. At a time when hard-pressed pharmaceutical companies are already scaling back research expenditures, RNAi is losing out to alternatives that seem closer to producing marketable drugs.
“I have no doubt that at a certain point in time RNAi will make it to the market,” said Klaus Stein, head of therapeutic modalities for Roche. But he added, “When we looked into this, we came to the conclusion that we have opportunities that have higher priorities.”
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UK-based GlaxoSmithKline was ranked as the world’s fourth largest player in 2009 (behind US-based Pfizer, France-based Sanofi-Aventis and Switzerland-based Novartis) based on prescription pharma sales. The company was founded in 2000 via the merger of Glaxo Wellcome and SmithKline Beecham and is headquartered in Brentford, London, UK. I wrote about GSK in my first PSW write-up in 2009.
In terms of its therapeutic focus, GSK owes its market-leading position in the global respiratory market to the Glaxo Laboratories legacy. Over 30 years ago, Glaxo launched Ventolin for the treatment of asthma and developed and launched Serevent and Flixotide in 1990. A combination of these two compounds—sold under the brand names Seretide/Advair ($7.8B in 2009). Similarly, GSK’s origins in the CNS market—currently its third largest therapeutic area of focus—can be traced back to the Wellcome and SmithKline scientists. Other therapeutic areas of importance include infectious disease and virology (vaccines).
The merger of Glaxo Wellcome and SmithKline Beecham created a company with a strong portfolio of blockbuster brands including Seroxat/Paxil (depression),now off patent Seretide/Advair (asthma, COPD) which dominates the respiratory arena, Wellbutrin (depression) now off patent, Augmentin (infections) now off patent, Avandia (diabetes), Imigran/Imitrex (migraine) and Lamictal (epilepsy) now off patent. However, since its creation in 2000, GSK has failed to add to its portfolio with any additional blockbuster drug launches. Instead, like its rival Pfizer, GSK has been forced to implement cost reductions in the medium term. Sales of Seroxat/Paxil have been eroded by generics (as have Augmentin and Wellbutrin ) in the US market prior to 2011. In addition, its second largest product Avandia faces declining sales as a result of concerns that have emerged regarding its side-effect profile (e.g., its association with a heightened cardiovascular risk). Many feel that the company faces pressure from investors to revive its performance. and must turn to M&A activity. Thusfar, GSK has been reluctant to make such a move. (Gilead for the HIV franchise?)
What GSK has done instead is sought to in-license product rights in order to boost the sales potential of its portfolio. Of the eight products launched by GSK since 2000, four have been in-licensed (Lexiva from Vertex, Levitra from Bayer, Boniva from Roche and Vesicare from Astellas). However,
Hola fellow PSW subscribers! The week is finally over, and the fluctuations in the market is making many of us jittery. This write up has a few picks for all, one that is conservative, one a bit more risk, and a fly-by-the-seat-of-your-pants short.
First, let’s take a look at the pharma & biotech sector in comparison to the entire market. The Healthcare Spider (XLV) and now the Biotech Spider (XBI) are now under performing the market. The most logical explanation for this is the passage of the health care bill. If the reimbursement is less, pharma and its compadres will also collect less. Many of the companies have already factored in the hit to earnings, so it is known the ramifications going forward. Drugs will always be needed, as they are one of the scientific advances for extending life (which in turn makes medical care more expensive). The population is not getting any younger, so economies of scale will kick in and increase revenue, giving incremental increases in profit (if it is a well run company). So, on to the picks.
Figure 1. Comparison of XLI & XBI against major market indices.
Merck & Company
Merck & Co. traces its origins to Friedrich Jacob Merck who purchased a drug store in Darmstadt, Germany in 1668; and Emanuel Merck who took over the store several generations later, in 1816. Emanuel and his successors gradually built up a chemical-pharmaceutical factory that produced — in addition to raw materials for pharmaceutical preparations — a multitude of other chemicals.
In 1891, George Merck established his roots in the United States and set up Merck & Co. in NY as the US arm of the family partnership, E. Merck (named for Emanuel Merck), which is now Merck KGaA. Merck & Co. was confiscated in 1917 during World War I and set up as an independent company in the United States. Between the wars and during World War II, the company was led by George W. Merck, who oversaw America’s germ-warfare research at Fort Detrick.
Figure 2. 2010 Merck stock price.
Merck has a broad therapeutic focus, with key products historically positioned within the cardiovascular (Zocor, Cozaar/Hyzaar), infectious diseases, endocrine, respiratory
This is a brief article of where the pharmaceutical industry has been, and where it could be headed in the near future. In contrast to past articles where I focused on the pipelines of GSK, LLY, MRK, BMY and ‘biotechs’ GENZ, GILD, and others, this is a summary of the industry. The overall market continues its grind up and I am gun-shy of its continued direction, but with the passage of the health care bill, biotechs that serve niche markets will be well positioned to see a rise both in stock price and potential M&A activity. In addition, as noted on Friday, March 19th on the laggers/leaders of the past month or so, Telecom and Healthcare were at the bottom of the pile. For the review of Big Pharma and some biotech picks at the end, generic companies are excluded from most data (Merck KGaA, Mylan, Teva and Watson).
From 2002 to 2009, the top pharmaceutical companies by sales had growth rates greater than 12% (compounded annually). Unfortunately, this growth is not sustainable and should move towards flat to nominal growth by 2014. The growth decline will challenge these companies to seek more profitable routes, including licensing and acquisitions. Picking the right companies based upon the science is at the forefront of good investing. Not they will all succeed because the science is sound, but understanding the molecule, target, and the disease helps guide smart decisions. Good management helps as well!
Let's start with a summary of potential acquirers. Table 1 is a list of the 15 largest pharmaceutical and biotech companies ranked by healthcare revenue. Some companies (e.g., Bayer and Johnson) have additional revenue which is not included the sales data.
Here’s another terrific post by Pharmboy, this time discussing Generic Drug Makers. – Ilene
Generic Drug Makers
Courtesy of Pharmboy
Coming to the end of a good year, and good riddance for some! Whilst the market has been irrational for some time, it is not about what we think but rather about what others that have money think. I have my notions, and here are a few companies that may do well in the New Year with a passed health care reform bill.
I really like the generic market right now. With patents expiring you can literally gauge how much a generic will make based on the patents expiring in the next few months. These generics are the vultures that follow the in a pack of lions. They have a good way of scavenging for their food and vultures have a distinct relationship with the lions. They may not come up with the drugs but they are definitely going to make a nice margin from them. But the competition is fierce these days, and competitors in the generic market include Watson (WPI), Teva (TEVA) , Dr Reddy’s Labs (RDY), Hi-Tech Pharmacal (HITK), Par Pharmaceuticals (PRX), and Caraco (CPD).
First up, Mylan Pharmaceuticals (MYL) – I know that Phil has liked Teva in the past and I have noted Mylan (#3 in generics), WPI and RDY (pre-GSK rumors). Currently, Mylan has blown through its 52 week high so is it still a buy? In short answer, yes. Mylan’s future comes from a swath of FDA approvals that have come in over the past few months.
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"We have the American Nurses Association, we have the American Medical Association on board," Obama told the weekend crowd in Grand Junction, Colo. "We have an agreement from drug companies to make prescription drugs more affordable for seniors. … The AARP supports this policy."
The drug makers went first in making a deal with the White House, agreeing to pick up $80 billion in additional costs over the next decade to help defray the expenses of the legislation. The American Hospital Association agreed to shoulder an additional $155 billion.
In exchange, both won assurances the White House would protect them against attempts in Congress to seek additional cuts in their projected Medicare and Medicaid payments.
The American Medical Association’s key issue was different. Doctors hope the legislation will allow them to avoid a looming 21 percent cut in payments under Medicare. The cost to the government for that would be about $230 billion over a decade.
Obama also agreed to require individuals to purchase insurance, reversing a position he held during his campaign. "My thinking on the issue of mandates has evolved. And I think that that is typical of most people who study this problem deeper," he said.
The more promotion there is for this package the more leery of it you should be. The reason the AMA, AARP, and now PhRMA are all lining up behind healthcare reform is because everyone of them has been bought out by sweeteners.
While everyone is concerned about rationing, I am concerned about lack of rationing. What incentives does anyone have to hold down costs?
Certainly big PhRMA has to be thinking more drugs will be prescribed or they would not have a huge ad campaign going while pledging $80 billion in lower drug costs. Here are two key questions:
Kvaerner sells its onshore construction business in North America to Matrix Service Company for an enterprise value of USD 80.3 million. The divestment enables Kvaerner to focus its efforts on further developing its upstream oil and gas business. "This transaction is an important step in our strategy to focus our operations. All of Kvaerner's operations will now be focused on delivering offshore installations and onshore plants to our upstream oil and gas customers. The sale also provides us with increased strength to further develop Kvaerner's position in our target markets," says Jan Arve Haugan, President & CEO of Kværner ASA. A definitive agreement was signed between Kværner AS and Matrix Service Company (Nasdaq: MTRX). In the tra...
The President’s speech yesterday on inequality avoided the “R” word. No politician wants to mention “redistribution” because it conjures up images of worthy “makers” forced to hand over hard-earned income to undeserving “takers.”
But as low-wage work proliferates in America, so-called takers are working as hard if not harder than anyone else, and often at more than one job.
Yet they’re still not making it because the twin forces of globalization and technological change have reduced their bargaining power and undermined their economic standing — while bestowing ever greater benefits on a comparative few with the right education and connections (and whose parents are often best able to secure these advantages for them).
From Bernanke's infamous 2008 "not forecasting a recession" call to Fannie Mae CEO Franklin Raines 2004 "subprime assets are riskless" commentary, the following 10 "predictions" - as opposed to Wien "surprises" - will go down in infamy for their degree of errant-ness...
10) Ben Bernanke, 10th January 2008 - "The Federal Reserve is currently not forecasting a recession."
A few months later, United States entered one of the wort recessions ever.
9) Herbert Hoover 1928: "The United States are nearer to the final triumph over poverty than ever before in the history of any land."
It's time again for my weekly gasoline update based on data from the Energy Information Administration (EIA). Rounded to the penny, Regular and Premium were unchanged. Regular and Premium are down 52 cents and 45 cents, respectively, from their interim highs in late February.
According to GasBuddy.com, no state is averaging above $4.00 per gallon, and only Hawaii is averaging over $3.80. Five states (Oklahoma, Missouri Kansas, Minnesota and Montana) are averaging under $3.00, up from three states last Monday.
How far are we from the interim high prices of 2011 and the all-time highs of 2008? Here's a visual answer.
Today, with very little market moving news, the S&P 500 closed at 1808.4, yet another new closing daily high. The index did touch the 1811 area on at least three distinctly different time slots creating a new resistance level. But after last week’s bevy of positive economic surprises, the sharp gain of 1.1% on Friday, leaving the index just a tiny point away from its ninth consecutive up week, we can’t be too quick to suggest today was a topping rally. For one thing, volume was quite low as traders seemed to be trying to sort out the odds on the earliest date of Fed tapering. Estimates range from this month to March and even later. But it’s going to happen…so why so much emphasis on when? Perhaps protection of end-of-the-year profits in so many fund managers portfolios? ...
Investors sent the S&P 500 to a record-high close despite speeches by Federal Reserve officials hinting that the taper could begin this month.
Monday’s trading action suggested that investors finally overcame their fear that the FOMC could vote to taper the Federal Reserve’s bond-buying on December 18. The S&P 500 reached a new, record-high close, despite the fact that three Federal Reserve officials gave speeches on Monday, suggesting that the tapering program could begin this month. Dallas FedHead Richard Fisher, Richmond FedHead Jeffrey Lacker and St. Louis FedHead James Bullard gave speeches on Monday, wherein each discussed the possibility that the cutbacks to the Fed’s bond-buying could begin in December. Is a Fe...
OSIS – OSI Systems, Inc. – Options volume on OSI Systems today is well above the average daily level for the stock, with upwards of 7,500 contracts in play as of midday in New York versus average daily volume of 57 contracts. The surge in options trading on OSI Systems coincides with a 40% decline in the price of the underlying shares to $39.00 today, the lowest level since October of 2011. The company provided an update on a recent $60 million order cancellation by the Transportation Security Administration (TSA). Call options are more active than puts, with the call/put ratio hovering near 2.0 as of 12:40 p.m. EST. Some traders appear to be selling out of the money December and January 2014 expiry calls, while others step in to buy the contracts perhaps in the expectation that shares rebound in the...
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This post is for all our live virtual trade ideas and daily comments. Please click on "comments" below to follow our live discussion. All of our current trades are listed in the spreadsheet below, with entry price (1/2 in and All in), and exit prices (1/3 out, 2/3 out, and All out).
We also indicate our stop, which is most of the time the "5 day moving average". All trades, unless indicated, are front-month ATM options.
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These rallies are becoming familiar. In early July we saw a streak of 12 of 13 sessions in a row up, early September 11 of 12, and mid October 11 of 13 (current streak). It is a bit uncanny the similarities and how the escalator goes straight up in vertical ascent as we see indexes come out of mini corrections during QE. So we are about at the same stage where the last two began to tire, so it will be interesting if this is similar or if the current consensus of the market that there is nothing to worry about until next year as the Fed and D.C. are both off the table and this 3% annual growth rate in earnings we are now seeing in the S...
Welcome to the fouth update of the IRA Virtual Portfolio. First I am going to summarize the current state of the Portfolio then I will get into all the activity we had during September expiration.
Profit and Loss – Net of closed positions the portfolio is up a total of $769
Market Commentary – Last expiration I said, "I would like to put a total of $20,000 to work by the end of SEP expiration. If the VIX pops up to around 20 I plan to put about $50,000 total to work." The market didn't quite reach the goal but I did manage to deploy $15,000 of buying power. I still feel the market is too high and expect a correction during October. If the vix pops up to around 20 I still plan to put about $50,000 to work. If a correction doesn't happen I still plan to have a total of $25,000 in buying power put to work by October expiration. Now on to the act...
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Come and get it! Read all about it! Biotechs, biotechs and more biotechs to buy buy buy for your portfolio! To date, almost 30 biotech companies have hit the market. Most of the time, there are fewer than 10-12!
For the last five years, biotechs have had issues obtaining offer prices above expectations. In 2013, that trend looks to be broken. According to BiotechNow, the offer prices are 4% above expectations! In addition, biotechs are going public with little more than a wing and a prayer (pre-clinical or Phase 1 data only). Really? What this means is that the drug or technology looks good in mice, rats, or dogs, etc, but there is no smidgen of evidence that it will work in humans. That's what is called an appitite for RISK!
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