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Bro, very helpful post. Your post and Paula's subsequent response have made me a bit more negative on Orchid's future, although I think government will always need a certified, reliable company to handle DNA assays.
Hasbro,
I agree in main with your post. However, Orchid has two items of value to a buyer:
1. An existing testing system and operations network, and
2. Tax losses that would be purchased in an acqusition, reducing the purchase price.
I'm not a financial analyst, but that might be enough to tip the scales.
Jed thanks for the referral to the new hotel. Since they renovated the old place, you can't find the rooms anymore!
So, here's my last post from the old hotel:
Orchid's SP is at historic pre-split lows. There is unlikely to be good news for at least 6-9 months, perhaps longer. The new CEO is cleaning house and is in the process of finding a new executive team to run the company. It has about one year of cash left to run the business and is currently (and has always) operated at a loss.
There is no reason therefore that, especially in a reverse speculative market (that is, one in which speculation is punished), that Orchid's SP will not continue to decline for the next 6 -9 months. Over that time, there may be a better "buying opportunity". So why not sell now and buy back if you believe the company has a decent chance at long-term recovery, which it may indeed have, assuming that the board has, in Bologna, finally found someone who can lead? My only reason for holding my shares is that I hate to rack up a large loss in my portfolio. But that's not a good reason for holding.
I would appreciate pro/con comments.
Animal models may not by suitable for determining drug safety in humans in certain genetically engineed compounds.
By Patricia Reaney
Sun Mar 19, 1:50 PM ET
LONDON (Reuters) - Differences between a cell signaling protein in humans and animals may explain the unexpectedly severe reaction in six young men given a new drug in a clinical trial in Britain, an expert said on Sunday.
The previously healthy men were the first humans to receive the drug, designed to treat leukemia and chronic inflammation disorders. Shortly after they were given the treatment last week, they suffered massive inflammation and excruciating pain.
Two are still critically ill, one is on organ support, and the other three are recovering.
Doctors are baffled about what went wrong in the trial of the antibody drug TGN1412, made by the privately-owned German company TeGenero AG, which had previously been tested in laboratories and on rabbits and monkey.
TGN1412 belongs to a class of drugs known as monoclonal antibodies, which specifically bind to target molecules. TGN1412 targets an immune system protein called CD28.
Dr David Glover, a drug industry consultant with extensive experience of antibody treatments, said the protein the drug targets may not be the same in all species.
"I suspect the antibody was designed to work against human CD28 and because it was designed to work best in humans its performance in different animals may fall short of what you might have expected in humans," Glover said in an interview.
"That is why the animal testing may have falsely provided reassuring results. It could be one of the explanations."
Dr Thomas Hanke, the chief scientific officer at TeGenero said in a statement last week that tests on animals had not produced drug related adverse advents, nor drug-related deaths.
CD28 is a protein on the surface of some white blood cells that plays a part in activating them for an immune response. Hanke said TGN1412 was designed to activate its target protein -- rather than blocking it as many antibody drugs do.
In the British trial, the administration of the drug was followed by a massive inflammation reaction.
The trial was being run by U.S. drug research company Parexel International Corp. on behalf of TeGenero AG.
Ray Nobel, a medical ethicist who sits on a committee at University College London, said Phase 1 trials, in which new compounds are tested on healthy volunteers, are a fundamental part of the ethical process.
Glover said no one should lose sight of the benefits of antibody drugs. He said the focus should not be on antibody treatments in general, or stopping clinical trials.
The breast cancer drug Herceptin, made by the Swiss pharmaceutical Roche, is an antibody treatment. It attaches itself to the HER2 receptor on the cancer cells and blocks them from receiving growth signal.
Eighteen antibody products have been approved for sale and their combined worldwide sales reached $14 billion last year.
However Glover said trials of drugs targeting the protein CD28 should be reviewed.
"Should we stop doing trials that are directed against the target CD28? I think the answer is yes, until more is known about what it going on," he said.
The Medicines Healthcare products Regulatory Agency (MHRA) is conducting and enquiry into what went wrong. Results are expected in weeks.
OT: Odd--Same phenomenon operates with the name of a frequent poster here and a well-regarded approach to investing. (Technically, I suppose, in this case the forms differ by two letters.)
Study: Most Get Mediocre Health Care
By JEFF DONN, Associated Press Writer
March 15, 2006
BOSTON - Startling research from the biggest study ever of U.S. health care quality suggests that Americans — rich, poor, black, white — get roughly equal treatment, but it's woefully mediocre for all.
"This study shows that health care has equal-opportunity defects," said Dr. Donald Berwick, who runs the nonprofit Institute for Healthcare Improvement in Cambridge, Mass.
The survey of nearly 7,000 patients, reported Thursday in the New England Journal of Medicine, considered only urban-area dwellers who sought treatment, but it still challenged some stereotypes: These blacks and Hispanics actually got slightly better medical treatment than whites.
While the researchers acknowledged separate evidence that minorities fare worse in some areas of expensive care and suffer more from some conditions than whites, their study found that once in treatment, minorities' overall care appears similar to that of whites.
"It doesn't matter who you are. It doesn't matter whether you're rich or poor, white or black, insured or uninsured," said chief author Dr. Steven Asch, at the Rand Health research institute, in Santa Monica, Calif. "We all get equally mediocre care."
The researchers, who included U.S. Veterans Affairs personnel, first published their findings for the general population in June 2003. They reported the breakdown by racial, income, and other social groups on Thursday.
They examined medical records and phone interviews from 6,712 randomly picked patients who visited a medical office within a two-year period in 12 metropolitan areas from Boston to Miami to Seattle. The group was not nationally representative but does convey a broad picture of the country's health care practices.
The survey examined whether people got the highest standard of treatment for 439 measures ranging across common chronic and acute conditions and disease prevention. It looked at whether they got the right tests, drugs and treatments.
Overall, patients received only 55 percent of recommended steps for top-quality care — and no group did much better or worse than that.
Blacks and Hispanics as a group each got 58 percent of the best care, compared to 54 percent for whites. Those with annual household income over $50,000 got 57 percent, 4 points more than people from households of less than $15,000. Patients without insurance got 54 percent of recommended steps, just one point less than those with managed care.
As to gender, women came out slightly ahead with 57 percent, compared to 52 percent for men. Young adults did slightly better than the elderly.
There were narrow snapshots of inequality: An insured white woman, for example, got 57 percent of the best standard of care, while an uninsured black man got just 51 percent.
"Though we are improving, disparities in health care still exist," said Dr. Garth Graham, director of the U.S. Office of Minority Health.
Graham, who is black, pointed to other data showing enduring inequality in care, including a large federal study last year. He also said minorities go without treatment more often than whites, and such people are missed entirely by this survey.
Some experts took heart in the relative equality within the survey. "The study did find some reassuring things," said Dr. Tim Carey, who runs a health service research center at the University of North Carolina-Chapel Hill.
But all health experts interviewed fretted about the uniformly low standard. "Regardless of who you are or what group you're in, there is a significant gap between the care you deserve and the care you receive," said Dr. Reed Tuckson, who is black and a vice president of United HealthGroup, which runs health plans and sells medical data.
Health experts blame the overall poor care on an overburdened, fragmented system that fails to keep close track of patients with an increasing number of multiple conditions.
Quality specialists said improvements can come with more public reporting of performance, more uniform training, more computerized checks and more coordination by patients themselves.
CLSC: Yes, now the big trades are showing up--strange, for all that volume, only 4 cents up.
Re Cobalis, Yahoo shows a total of only 46,500 shares sold ATT; may be a delayed quote, however.
Naked Shorting: Interesting that no one goes to jail for this type of fraud, amounting to millions stolen from investors, but if you steal a loaf of bread, you're likely to spend some time behind bars.
OT:Generics: I don't understand why they don't add more staff to the generics division at the FDA, but their hands may be tied.
You bet their hands are tied--by the lobbyists for MRK, PFE, etc.
Thanks, Dew and io_io re: TEVA. Perhaps it is also subject to the law of gravity.
Dew, with respect to TEVA, you mentioned you might get back in when the stock retraced. Do you have a target for that?
I cashed in half of my TEVA chips at around $44; intend to rebuy perhaps at 40.
Nutra Pharma Corp., (OTCBB:NPHC) discovers a gene involved in MS:
http://www.genengnews.com/news/bnitem.aspx?name=1129574XSL_NEWSML_TO_NEWSML_WEB.xml
Implications for TEVA and ELN?
Dew, thanks for the logic behind the TEVA sale. I'll hold my shares for the time being; as I wrote before, I believe the climate for generics in the U.S. especially will be dramatically improving. Too bad much of that may already be priced in!
Vieux
Re: TEVA--Dew, did you sell because you had reached a predetermined sell point or because you thought that TEVA has risen quickly and might not be able to maintain the pace in the short term?
I'm inclined to hold for the mid- to long-term, especially as the pressure will build in the U.S. for more generics as the new Medicare Part D kicks in, which directly punishes seniors for purchasing brand name drugs over generics.
RE: YMI
Briefing.com posted this strange update just now:
10:57AM YM BioSciences clarification (YMI) 2.79 +0.06:YMI has notified us that the offering we posted at 14:22 on Oct 24 is a refiling that is in the ordinary course of buisness, is a regular update, and to the knowledge of the co, does not reflect any intent by any shareholders to offer shares for sale. We have removed the original comment.
Posted at:
http://finance.yahoo.com/mp#ymi
Article on Phase II failure problems:
Interesting analysis of Phase II failure increases in the WSJ today . Sorry, I don't have the link.
FOLLOW THE MONEY
By SCOTT HENSLEY
Early Clinical Trials the Culprit
In Drug Development Slowdown
Always a game of long shots, drug research is now suffering from more-frequent failures during early clinical tests of new drugs. The pattern has implications for drug makers, investors and patients, as it threatens companies' efforts to replenish their pipelines.
The snags are surfacing during Phase II studies, or tests to determine if experimental drugs work well enough in humans to merit the large and expensive clinical trials mounted to prove their safety and effectiveness to regulators. The growing recognition of this bottleneck is prompting pharmaceutical companies to rethink their approach to drug development.
"It's a disaster," said Robert Ruffolo, president of research and development at drug maker Wyeth, in Madison, N.J. at a conference of pharmaceutical and biotech executives on strategic alliances held by Windhover Information in New York early this week. "We have a big problem that's getting worse."
Conventional wisdom within the industry has held that the roots of the current slowdown in drug development lie in earlier stages of research. A flood of information unleashed by the decoding of the human genome, this argument goes, has made scientists' work paradoxically harder and costlier by inundating them with more potential targets for research than they can handle.
But the real culprit in the deepening slowdown now appears to be Phase II studies -- the clinical tests that drug makers rely upon to determine if the science behind a potential drug is valid. Industry wide, success rates in these proof-of-concept trials have fallen to 25% from 40% in just five years, according to Dr. Ruffolo. Simultaneously, the time these studies take to reach an answer, positive or negative, has doubled to almost three years since 2000, Dr. Ruffolo said.
These are big changes from historical norms, and they're upsetting drug companies' carefully calculated business models to restock the world's medicine chest with new products. "R&D productivity is declining. People who say it's not aren't willing to accept reality," Dr. Ruffolo said.
The main reasons for the slowdown stem from traditional bugaboos: safety issues, disappointing effectiveness and regulatory concerns. But the hurdles in all these areas are higher than they used to be, he said, as standards have increased on all fronts. An emphasis on finding novel drugs, rather than me-too medicines in a well-understood class, has compounded the difficulties for drug developers. "Novelty carries a greater risk of failure," Dr. Ruffolo said.
Though the rise in failures during Phase II is sobering, early termination of ill-fated drugs is cheaper than seeing drug candidates flame out in final clinical testing called Phase III. But even those savings may be disappearing. A growing number of studies in Phase II, especially a subset of late-stage studies sometimes referred to as Phase IIb, are becoming so large that they rival the size and expense of pivotal Phase III studies conducted just a few years ago. And the fall in productivity has dashed hopes, for now anyway, that historical success rates in research might increase as scientists gained more insights into disease.
The Phase II bottleneck complicates Big Pharma's efforts to find drugs quickly to replace those losing patent protection. Soon after arriving at Wyeth in 2000, Dr. Ruffolo committed to submit at least two new drugs every year for Food and Drug Administration approval by the second half of this decade. The Phase II problem is throwing off his previous calculations on how he'll get the job done, he said. Now, he's called on his scientists to put 12 products a year into Phase II instead of eight. He's also stepping up efforts to license more early-stage experimental compounds to supplement in-house research.
This year, Wyeth submitted a novel contraceptive for FDA review, and by year-end the company expects to submit a new antidepressant as well. Meanwhile, Dr. Ruffolo's pushing for more efficient Phase II studies. "Just because there's a problem doesn't mean it can't be fixed," he says. One initiative involves the creation of five centers around the world specializing in early clinical development to cut the time it takes to run Phase II tests.
Another tack towards research improvement involves blurring the lines between the "R" and "D" of research and development -- the basic science of drug research versus drug development through human testing. Researchers at Novartis AG, Basel, Switzerland, are attempting to map a dozen or so molecular pathways common to many diseases as a way to sort through biological complexity. With these maps in hand, a drug that works in a few patients with rare diseases, for example, may prove helpful in a range of conditions.
By carefully picking the right patients for these early exploratory tests, the Novartis researchers hope to get definitive answers about their experimental drugs earlier, reducing the time to develop the medicines. "We expose the flaw of these programs very rapidly," Trevor Mundel, head of exploratory clinical development at Novartis, told the audience at the Windhover meeting. "We don't get stuck in three-year Phase II studies."
The company recently tested a drug in four patients suffering from a rare disorder that leads to rashes when exposed to environmental stress, such as cold. In a matter of hours, the drug eliminated telltale rashes in one patient, showing the medicine could block an inflammatory factor in the immune-system that is also involved in diseases ranging from asthma to rheumatoid arthritis. The other patients responded within days. With the concept validated, Novartis decided to continue development of the compound. Without the early positive result, Dr. Mundel said, Novartis would likely have discontinued the program.
Drug researchers are used to failures, but the recent problems in Phase II represent a new challenge. Efforts like these at least try to restore the odds of the game.
Google's computer warehouse?
ELN: Interesting analysis by Motley Fool:
http://www.fool.com/news/commentary/2005/commentary05081014.htm
The article discounts the likely financial results from Tysabri, but touts ELN's NanoCrystal prospects. I'd be interested in what posters think of the following:
The entire pharmaceutical industry has two big problems. The first is that it is straining under the development cost of new drugs. The second is that the patents on nearly 60% of its blockbuster drugs are set to expire in the next few years. Elan's NanoCrystal can help address both issues and it is why, as I gaze into my NanoCrystal ball, I believe Elan continues to represent a solid long-term investment opportunity.
RE ELN: Thanks,io_io, for the information on a model for figuring net present SP--and thanks to the others who weighed in. It appears to be an art, not a science, although one can improve one's odds.
Re: "What Are We Going To Do With Dad?"
Biowatch, excellent article--thanks for posting. It seems the U.S. does not have holes in its safety net for the "old old"--it has no safety net.
ELN: Does anyone have a model of the value of ELN's shares based on future sales one year out should Tysabri receive FDA and European approvals? The safety evidence is beginning to accumulate in ELN's favor and there are many multiple sclerosis patients who would like to see the drug back in trials and on the market.
Dew, you wrote: "In the meantime, I remain convinced that it is possible to beat the market in biotech without illegal access to insider information. If I weren’t convinced of this, I wouldn’t be doing it for a living."
I would put it rather differently: I am convinced that it is possible to beat the market in biotech when illegal access to insider information is eliminated or drastically curtailed. Only then will careful outside analysis yield results proportional to the money and effort required to beat the odds.
Maybe we should all write to the SEC about this issue. Anyone done it before? Any tips on to whom to write? General counsel?
io_io, thanks for your draft in the previous message.
With this news, everyone is alerted that the game is fixed and the SEC is, so far, asleep at the wheel. Small investors are left to pick up their marbles (if they haven't already been stolen) or invest in a company like JNJ where inside information doesn't move the needle very much.
Re: GTCB, does anyone have any theories on why this stock is bucking a down market and rising at this time? There is no current news. Is it:
1. A short squeeze
2. A few acting with special information
3. Manipulation by market makers
4. Hedge fund trading (to produce a later down period)
5. Just a company with superb prospects for improving revenues
6. Other
Or is this just the unknowable part of stock trading?
RBXLF.PK: Ranbaxy is an Indian hq'd primarily generic pharma. McKinsey produced a blurb on it which follows. Does anyone have an opinion on its prospects, and whether it is worth buying OTC shares?
"Ranbaxy: Affordable pharma
Ranbaxy is a good example of how companies develop distinctive capabilities in emerging markets. Before signing on to the World Trade Organization regime, at the beginning of this year, India protected only process patents—not product patents—for drugs, hoping to make them as affordable as possible for the country's poor people. In essence, Indian companies could produce any drug in the world if the chemical synthesis of the manufacturing process differed from the one that the original manufacturer used. As a result, hundreds of Indian drug companies sprang up to make drugs as soon as they were introduced in the United States or Europe and to sell them as cheaply as possible in India.
Soon Ranbaxy distinguished itself by setting up sophisticated laboratories and hiring hundreds of world-class chemists. It also invested heavily in state-of-the-art factories that could bring the manufacture of a drug up to optimal scale quickly. The distinctive advantages of the company soon proved to be its ability to identify new processes for synthesizing patented drugs and to scale up manufacturing quickly thereafter.
By the early 1990s, Ranbaxy realized that it could exploit these strengths by quickly synthesizing drugs that were going off patent in developed markets and selling them there. To pursue this strategy, it acquired Ohm Laboratories in the United States in 1994 and entered the US generics market. In the past decade, Ranbaxy has rapidly expanded its business in the United States and other international markets and currently ranks among the world's top ten generics manufacturers. It has annual revenues of $1.2 billion—78 percent from outside India, including 36 percent from the United States. The company has globalized so successfully that more than 400 of its employees now work in the United States, and more than 18 percent of its total workforce is non-Indian."
Is this eventually competitive with GTCB's approach?
------------------------------------------------------------------------
"Scientists make blood from human stem cells"
By Sonali Paul
Thu Jun 16, 5:25 AM ET
MELBOURNE (Reuters) - Australian scientists say they have found a way to make blood cells in volume out of human master cells, which could eventually lead to production of safe blood cells for transfusions and organ transplants.
Synthetically produced red blood cells would, in theory, overcome the concerns about dangerous infections that can be transmitted from blood donors to patients worldwide.
But researchers said it would probably take years for scientists to get to the stage where blood cells could be made in large enough quantities for transfusions.
"What would be nice is if it opens the possibility for the future of making large quantities of blood cells in a controlled environment which could be used to treat patients," said Andrew Elefanty, who led the research at Monash University in Melbourne.
Writing in the U.S. journal Blood, the researchers said they were able to turn human embryonic stem cells into red and white blood cells using a system that makes more blood cells more rapidly and more safely, with fewer animal ingredients, than others have done.
"The other thing we think is important is that the way we've made the cells develop into blood is something which could be applied to other types of cells as well," Elefanty told Reuters.
The team's system was able to stimulate the stem cells specifically into becoming red or white cells.
Elefanty said the research showed that the path that human embryonic stem cells take in becoming blood cells was similar to experiments done in other animals, like mice.
While other researchers have used serum from cows as the medium for growing cells, the Monash team used a cocktail of salt and electrolyte solutions with amino acids and fats.
The system was not completely free of animal proteins, as the albumin was purified from cows. The team plans to use synthetic albumin eventually when it becomes available.
The sarcasm is well-placed. Our captains of industry often shed crocodile tears for their poor departing employees while pocketing more than their share.
It's interesting to compare the ^NBI (Biotech Index) with the ^BPI (Biopharm Index).
http://finance.yahoo.com/q/bc?s=%5EBPI&t=1y&l=on&z=m&q=l&c=%5ENBI
They are similar (although the ^NBI generally underperforms) until February, when there is a larger divergence, with the ^NBI falling.
Any theories as to the cause of the divergence?
In addition to having written one of the funniest paragraphs in the annals of financial satire (your last paragraph), your comments on hedge fund activites make a lot of sense. The NYTimes has a trendy article about them:
http://www.nytimes.com/2005/03/27/business/yourmoney/27hedge.html?
Investors not only need to know about the science behind biotechs; they now must figure out what positions hedge funds will take. Seems more than a full-time job.
Anyone here compared IVAX with TEVA? IVAX is smaller, but interesting: See:
IVAX Is No Placebo
http://www.fool.com/News/mft/2005/mft05031519.htm
INVESTING
* The Motley Fool Take
IVAX Is No Placebo
By Stephen D. Simpson, CFA
March 15, 2005
If in fact the generic-drug business reached a cyclical peak in 2004, IVAX (AMEX: IVX) certainly decided to go out with a bang. This Miami-based generic-drug maker posted results that handily beat the Wall Street guesstimates for both revenue and earnings, and the market took the stock more than 12% higher in response.
Sales climbed 28% for the quarter, while operating income grew more than 61%. Though IVAX does not break out product performance for its shareholders, the company did acknowledge that new generics such as metformin ER, glyburide/metformin, and gabapentin all contributed to the company's growth. It's also probably reasonable for investors to assume that other generic products such as paclitaxel, clozapine, and verapamil also did their part.
Interestingly, IVAX showed the greatest sales growth (44%) in its largest market -- North America. The global businesses were no slouches, though; the market in Europe grew 18%, while Latin America grew 15%.
Although management's guidance for 2005 was lukewarm, there's plenty of reason to be optimistic about the future. The company has 60 Abbreviated New Drug Applications on file with the Food and Drug Administration. That makes the company, along with Teva Pharmaceuticals (Nasdaq: TEVA), one of the most prolific generics companies -- and it gives IVAX the possibility to be the first to file on 12 compounds with branded sales of roughly $14 billion.
What's more, the company has been very aggressive in challenging the patents of some pharmaceutical companies. IVAX is currently going after Lilly's (NYSE: LLY) Zyprexa (with roughly $2.5 billion in sales) patent and Forest Labs' (NYSE: FRX) Lexapro ($1.7 billion in sales) depression drug.
Although these challenges are a crapshoot and investors shouldn't expect IVAX to win, the generics companies occasionally do prevail -- as in the case of Teva's successful attack on Merck's (NYSE: MRK) Fosamax patent -- and any success would be a major boon to the company's business.
In addition, the company should get FDA approval to sell a generic version of Flonase -- GlaxoSmithKline's (NYSE: GSK) $900 million allergy drug -- sometime in 2005, and exclusivity for generics of popular drugs Zoloft and Proscar will help in 2006.
Investors considering IVAX shares may need to be patient and willing to look ahead to 2006, when the company expects between $1.35 and $1.55 in earnings -- far above the prior Wall Street guesstimate. That said, a return on equity in excess of 16%, strong insider ownership, and a robust pipeline of future generic drugs could make this a stock worth owning. For Fools who won't be rattled by what could be a turbulent 2005, IVAX merits a further look.
Genetic Cause for AMD--Anyone have any ideas how this will effect GENR and the other biotechs with candidates? Or whether GENR's drug may turn out to be a treatment for cardiovascular disease?
Gene Mutation Tied to Blindness in Elderly
Top Stories - AP
By RANDOLPH E. SCHMID, Associated Press Writer
WASHINGTON - A gene mutation has been linked to age-related macular degeneration, the leading cause of blindness in the elderly, by three sets of researchers working independently. An estimated 15 million Americans suffer from the disorder, a number expected to double as the baby boom generation ages.
Being able to relate a gene mutation to the likelihood of developing the illness may lead to better tests and eventually treatments, the scientists hope.
"I don't think it's going to be a year or two ... but I'd guess less than 10 years" before a treatment might become available, said Albert O. Edwards, the lead researcher for one group of researchers reporting on the link.
In cases of macular degeneration the central region of the eye's retina deteriorates, damaging or destroying vision. There are no broadly effective treatments, though a recently approved drug can slow the disease for some patients.
The new gene findings are reported in separate papers in this week's online issue of the journal Science. The research groups were led by Edwards, at the University of Texas Southwestern Medical Center, Josephine Hoh of Yale University School of Medicine and Margaret A. Pericak-Vance of Duke University Medical Center.
The teams studied the genes of people with AMD and others without the disease and found that people with a variation in the CFH gene were more likely to have the illness. The gene is involved in the production of a protein called complement factor H that helps regulate inflammation in a branch of the immune system.
According to the Texas-based researchers, as many as half of AMD cases in the elderly could be related to the gene variant.
Edwards, now the president of the Institute for Retina Research at Presbyterian Hospital of Dallas, noted that risk factors for AMD are similar to those for cardiovascular illness, including obesity, lack of exercise and smoking.
"There is an unexplained increased risk of cardiovascular mortality in people with AMD," he said. "This may actually go beyond eye disease ... those studies have to be done."
Pericak-Vance, director of the Duke Center for Human Genetics, said her study indicated that the gene variant could account for about 43 percent of the risk of developing AMD for older adults.
"This gene opens the door to a whole new understanding of the factors that contribute to this disease," she said in a statement. "The finding may ultimately lead to new methods for identifying those at high risk for macular degeneration and suggests new pathways for drug development."
Hoh, an assistant professor in the Department of Epidemiology and Public Health at Yale, reported that "Caucasian AMD patients are at least four times more likely to have one particular alteration in the CFH gene that produces a different form of the CFH protein, compared to individuals without the disease."
Dennis Schultz of Oregon Health and Science University, who two years ago identified a different gene involved in some cases of AMD, said the studies are an important finding, though not yet the whole story.
"It's complex, very difficult to understand, there are many genes involved and the environment plays a role as well," said Schultz, who was not part of the three study teams.
There are two forms of macular degeneration. The more common "dry" form progresses relatively slowly. The less common "wet" form, involving bleeding in the eye, can destroy vision rapidly. Both forms were associated with the CFH gene variation.
In December the Food and Drug Administration (news - web sites) approved the drug Macugen for treatment of the wet form of AMD. In studies untreated patients had about a 45 percent chance of significant vision loss in a year compared with 30 percent for patients on Macugen. In addition, supplements including zinc and vitamins E, C and A have been shown to help some AMD patients.
The researchers was funded by the Raymond and Beverly Sackler Fund for the Arts and Sciences, the National Eye Institute, the National Institute on Aging, the National Center for Research Resources and Research to Prevent Blindness.
http://story.news.yahoo.com/news?tmpl=story&cid=514&e=7&u=/ap/20050311/ap_on_he_me/blind...
Dew, many moons ago I promised you a reference to the effects of Cox-2 inhibitors on the heart; a recent news report of a statement by the FDA's David Graham reminded me of that promise:
"I'm attracted to the Cox-2 hypothesis," Graham said, referring to suggestions that the heart problems cover the class of drugs called Cox-2 inhibitors, which includes the three under review."
The reference is from the Journal of the American College of Cardiology, vol 39, #3, 2002, from the paper: "Why do Cyclo-Oxygenase-2 Inhibitors Cause Cardiovascular Events?" by Richard J Bing and Magdelana Lomnicka.
The summary:
"This report confirms evidence that selective nonsteriodal anti-inflammatory drugs (NSAIDs), such as celecoxib, can lead to thrombotic cardiovascular events. Aspirin, a nonselective COX-1 (cyclo-oxygenase) and COX-2 inhibitor may result in gastric toxicity. For this reason, selective COX-2 inhibitors have been developed to reduce erosion of the gastric mucosa. Both selective and nonselective NSAIDs reduce prostacyclin formation in the infarcted heart; they accomplish this by tipping the balance of prostacyclin/thromboxane in favor of thromboxane, a prothrombotic eicosanoid. The relative increase in thromboxane, coupled with a diminution in prostacyclin in infarcted heart muscle, can lead to the development of thrombotic cardivasuclar events. This may be prevented by the addition of a nitric oxide donor to NSAIDs"
Sorry I don't have the report in an online version.
In that same group of competitors I ran across a company called Deltagen, Inc., which appears to be in Chapter 11 but nevertheless has a healthy trailing 12 months revenues increase of 78%. Fairly good for a penny stock.
This appeared in a local Newspaper--The Times of Trenton--regarding Lexmark (LEXG). The full text can be found at:
http://www.nj.com/business/times/index.ssf?/base/business-1/1105779915131132.xml
Anyone have an option on the company? It just announced that "it has advanced two of its drug discovery programs into preclinical development in preparation for investigational new drug (IND) applications. The first, LX-1521, is a small molecule compound to be developed as a potential cancer treatment. The second, LX-5431, is a protein to be developed as a potential biotherapeutic for thrombocytopenia, a condition that results in bleeding disorders. The functions of the targets of both potential therapies were discovered in Lexicon's Genome5000(TM) gene knockout program. This program has produced more than 60 drug discovery programs to date."
Here's the first part of the newspaper story:
Gene testing gets boost from mass mouse production
Sunday, January 16, 2005
By ANDREW D. SMITH
HOPEWELL TOWNSHIP - Of all the ways to determine a particular gene's function, the most intuitive is to engineer and observe an animal, usually a mouse, that lacks the gene in question.
Researchers have been knocking out mouse genes for years now, but the time and cost of working mouse by mouse has stopped most organizations from investigating more than a handful of genes a year.
No one could make "knockout mice" fast enough or cheap enough to get any broad understanding of the roughly 25,000 genes that mice and humans share - no one, that is, until a firm called Lexicon Genetics invented mass mouse production.
The Texas-based company, which employs about 100 people in Hopewell Township, is using this system to investigate the 5,000 genes that appear most important to human health.
Lexicon researchers, who have already studied 2,000 genes, look to be three years from finishing up, but the effort has already paid off for their employer.
Lexicon has parlayed its respected technology and its work to date into lucrative partnerships with some of the world's largest drugmakers.
In addition to multimillion-dollar deals with Genentech and Takeda Pharmaceutical Co., Lexicon has signed several deals with Bristol-Myers Squibb, the most recent of which will generate a minimum of $66 million.
In addition to these partnerships, Lexicon has sublicensed its knockout mouse technology to 13 of the largest drugmakers in the world. Johnson & Johnson is the latest company to join the list.
Why are drugmakers so eager to do business with Lexicon?
"If you look at the top-selling 100 drugs in the world, they act on a total of 43 genes. If you expand to the next 100 drugs, the number of gene targets increases by four. In other words, the entire drug industry makes a living off 47 genes," said Julia Gregory, Lexicon's chief financial officer.
"Now, keeping that in mind, consider our Genome 5,000 project. We expect that something between 3 percent and 5 percent of all the genes we examine will turn out to be promising targets for drug therapy. If you take the low number, 3 percent, and multiply that by 5,000, you come up with 150 genes, triple the number that the entire pharmaceutical industry uses now . . . This is a very important project."
As Lexicon searches through its list of 5,000, the company is looking for genes that make people susceptible to everything from obesity to depression to cancer.
To find these genes, Lexicon engineers mice, submits them to endless tests and looks for abnormally healthy specimens.
Every time Lexicon identifies a supermouse, a mouse made super by the elimination of some counterproductive gene, the company discovers another potential drug target.
After finding a target gene, Lexicon figures out which proteins it leads the body to produce. Then, the company must find chemicals that bind to those proteins and nullify them.
In theory, this sounds easy. In practice, it takes a lot of time and effort.
Drug companies maintain huge "libraries" of chemical compounds, which they bombard at targets one by one. If all goes well, one of the chemicals bonds with the target.
After finding a stock chemical that bonds, the drug companies tweak the chemical's structure to optimize the effect.
Appreciate your response, Dew. Somehow I'm not surprised that you haven't found an investment book that fits your bill. Perhaps you should write one, based on your game theory (was it Backgammon?). I for one would sign up for a copy.
Thanks to many of you on this board--Dew being the first among equals--who have helped me understand some of the basics about valuing stock and looking at new prospects. Here's a question: From each of your perspectives, what's the best book or article on investing that you've read, one that has helped you properly evaluate and value stocks and their prospects? I've got to improve my record! During the past four years I've been able to earn about 10% per year from my investing, and I think I can do better. So I'd like a little book-learning.
Thanks in advance and enjoy the holidays.
Dew, this backgammon/probability analysis is most interesting. Very helpful would be an example or two of how this is applied to a "real" or exemplar buy/hold/sell decision--the simpler the better!
In my business, we use correlations and regressional analysis in the development of assessment instruments.
Dew, I know a researcher who some two years ago worked on the biochemical characteristics of Celebrex and he is convinced that the entire class of Cox-2 inhibitors is implicated. This research is not available online, but I'll get a reference.
There may be a better PFE buying opportunity after PFE withdraws Celebrex. No matter what the valuation issues, the public will sell down further.
So far as I understand the scientific issues, all Cox-2 inhibitors are implicated in the cardiac problems. I'm a bit surprised that Pfizer didn't withdraw the compound today and get it over with. As it now stands, if (and I think when) they later withdraw, they are more vulnerable to the type of lawsuits that now bedevil Merck.