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Its hard to find companies with really nice long term growth potential with low downside risk. Since KOS was aquired by ABT SRDX is the 800 lb gorilla in my portfolio. I often buy back the same thing at a lower price after profit taking. You have to follow a stock for a long time to get a feel for when its overheated and when its too cheap after getting slammed for whatever reason. I don't think its overheated yet. Wait for the plateau after the rise. That worked pretty well with KOS, anyway.
I would guess that MRK wants to get Ivation-TA out on the market ASAP without delays related to new modifications to get Eye surgeons familiar with the device while other, better products are in the pipeline. Are we finally losing the cypher millstone around SRDX' neck? I'll bet shorts were mainly of the 'one-trick' pony view that SRDX would suffer from declining Cypher sales while not adequately factoring in the rest of their stent opportunities and the major potential of owning both devices and polymers in the opthalmology arena. Orthopedics related device announcements could propel this puppy further and we still have other eye opportunities in the works. Meanwhile non stent, non eye business keeps growing. Corning revs should be more visible soon. Cypher belongs on page 3, not page 1 anymore. I may take profits over 60/shr but will hold the bulk of my position for the long haul.
I uncorked a bottle of Chateau Montelana 1997 in honor of SRDX today.
http://www.wineperspective.com/1997_chateau_montelena.htm
OT: I picked up a Bach Stradivarius B flat silver trumpet circa 1975 for $45 (with original case, wah wah hat and silver mute and C trumpet slide attachment). The valves were sticky but once once I got them lubed up it plays like a dream with the 3C mouthpiece. Mint. Too bad my chops only last for 30 - 40 seconds. I never made it as a trumpet player professionally but it was the most fun I ever had (girls like us).
Oh yes, GTC is a good buy, a real good buy.
Sciz
OK, Fibroids are walnuts compared to ED but I won't give you coconuts. Sorry to misunderestimate the importance of fibroids. I just assumed you guys pluck out the uterus - problem solved, chaching, "next".
"According to the Massachusetts Male Aging Study [MMAS], erectile dysfunction is a condition that affects an estimated 52 percent of men between the ages of 40 and 70. Erectile dysfunction, or ED as it is commonly called, affects over 30 million men in the U.S. In fact, more than half of all men between the ages of 40 and 70 experience ED to some degree. The etiology of ED, frequently associated with psychogenic and/or vascular problems, is particularly common in men with diabetes and in those who have had a radical prostatectomy for prostate cancer. ED is defined as the consistent inability to get or maintain an erection that is hard enough for sexual intercourse."
seeking alpha
Baby boomers are how old?
ED ~$3 Billion dollar market and enlarging.
BTW coated lower flush Niaspan is on the shelves. ABT.
The male products will outsell the female products by billions. Look at the ED market. It is HUGE. Fibroids are peanuts compared to ED. Look at the current market and how big it is. These guys could carve our 30% very easily. WOW!
sciz...bring it on...
LURKERS HAVEN
Welcome and be heard. It galls me that we are stuck at "The sky is falling!" post EMEA non approval price when all the news looks so inviting to savvy investors. I am patiently looking forward to un-gallment.
IMO GTCB's update of Atryn DIC revenue is a bold move and speaks volumes.
Lurkingly Yours,
Shears, formerly known as scissors, formerly known as turkey-lurker
Now that there are five companies with more than $2B in annual revenues from generic drugs, investors need a name to describe the major players in this arena. Does anyone have a suggestion?
Big Bottom Feeders
Is it possible that Atryn could receive FDA approval for DIC/sepsis concurrent with HD or earlier? What if the Leo DIC studies are highly compelling? That would get alot of attention. What else is there besides Xigris?
One of the main reasons the US life expectancy is lower is that we call a 20-24 week gestation premie a 'live birth' and fight like hell to keep him/her alive. When they don't make it we call it death at a very young age. Other countries call it a dead baby and it doesn't effect their life expectancy statistics. US citizens have access to the best health care in the world but I concede the US could be doing a much better job in preventive medicine. An 85 year old US citizen has a median survival of 5+ years. They get put on ventilators, dialysis machines, etc to keep them alive if they wish. In other countries the doctor tells the family, "Grandma's gonna die". The biggest bang for the buck is in rationing futile, end of life care. Most docs won't stand up to hand-wringing family members who want to sue someone when an 85 year old bites the dust.
It appears to me that ABT is the big winner in the HDL market. They have Niaspan and Tricor. They have Advicor and will soon have Simcor and they are coming out with a lower flush version of Niaspan very soon. There is strong outcomes data with naicin as well as niacin combinations. That will have to do for now but it will be a good thing for ABT at the expense of Pfizer and AZN. Pravastatin is the safest statin and has an excellent portfolio of outcomes data by itself. If you combine that with niaspan and zetia you get pretty impressive shifts in lipid parameters at relatively low potential toxicity. The big problem is inertia in the medical community when it comes to aggressive lipid management in high risk individuals. IMO we have a long way to go utilizing existing options to lower events and generic statins in combination with other lipid drugs could yield impressive reductions in morbidity, mortality and therefore the direct and indirect costs of the horrendous and largely preventable atherosclerotic events that put half of us in the cemetary.
Zimulti(SNY) could be the next big blockbuster in the Metabolic realm and may be approved in July.
>>HAHAHAHAHAHA. The sad truth is your broker is right. The cold hard truth is that GTCB, as a stock pick, is a POS right now.>>
That's when you accumulate for a long term POSition. Downside is virtually nil compared to the upside. I will accumulate on dips and be patient. Reminds me of KOS in the early days. Sold out my position in the 70's after beginning in the single digits. BTW I believed in the science(cold hard truth) and that worked out for this patient investor.
One would presume Atryn will be lower priced then plasma products in EU to 'show off' the manufacturing efficiencies of transgenics. Perhaps pricier in the US where there is virtually no plasma competition. I think it would be a big mistake to price Atryn non-competitively. With lower cost manufacturing and potential gains in off label use and the potential for furmulary substitution it just makes sense.
If Atryn is priced lower than plasma derived ATIII then one would assume a pressure on hospital formularies to stock the lower priced and 'safer' version and substitute it whenever the plasma product is prescribed? Just a thought. I know hospitals do that all the time in the US for conventional drugs. Why not for Atryn? Just thinking out loud, but it makes sense to me that hospitals in EU face the same economic pressures. Also, as data starts coming out on aquired AT deficiency more off label use may ensue. I'm thinking if plasma derived ATIII is currently used in aquired deficiency states Atryn (particularly if less costly) might be substituted. Perhaps just wishful thinking. Does anyone have access to the plasma derived ATIII list of indications?
I missed the first part of the CC, was Novocell mentioned?
What are the geographical limits of GTCB's current and pending patents? If bovine milk insulin/protein is made in latin america can it be sold in the US?
DOW JONES NEWSWIRES
Johnson & Johnson (JNJ) on Friday reported a 12.5% passive stake in eXegenics Inc. (EXEG), according to a filing with the Securities and Exchange Commission.
Miami-based eXegenics doesn't have active operations. The company announced last month a merger with Acuity Pharmaceuticals and Froptix Corp., two privately owned pharmaceutical companies developing drugs to treat eye diseases. The combined company will be re-named Opko Corp.
Johnson & Johnson reported its stake on a Schedule 13G, an SEC document for passive investors - those not seeking to change or influence a company's operations. Such filers aren't required to provide a reason for any changes in stake and don't have to disclose any transactions to the SEC.
Johnson & Johnson beneficially owns about 16 million eXegenics shares, which are directly owned by Johnson & Johnson Development Corp., a wholly-owned subsidiary of Johnson & Johnson, according to the SEC filing.
Shares of the company closed Thursday at $3.54 each.
-Denise Jia, Dow Jones Newswires; 202-862-1359; denise.jia@dowjones.com
Dow Jones Newswires
04-06-07 1755ET
Is this Company on anyone's radar?
EXEG.OB
http://biz.yahoo.com/seekingalpha/070418/32674_id.html?.v=1
SeekingAlpha
eXegenics Inc.: New Company; New Technology
Wednesday April 18, 6:12 am ET
Anthony Payne submits: In this article we feature a small company which is being formed as a reverse stock merger; the shell company is publicly traded eXegenics Inc. . Acuity Pharmaceuticals and Froptix, both privately owned pharmaceutical companies developing treatments for eye diseases, will merge into the shell company. The combined company will be renamed Opko Corp. and will be based in Miami. Opko intends to apply to have its shares listed on the American Stock Exchange.
Overview:
Acuity is developing an RNAi agent called Bevasiranib, which is in Phase II clinical trials as a potential treatment for wet age-related macular degeneration [AMD] and diabetic macular edema [DME] both of which can lead to blindness.
In September 2006 Acuity Pharmaceuticals announced positive results from its Phase II trial for Bevasiranib sodium. The study was a randomized, double-blinded trial that included three dose levels of Bevasiranib tested in 129 patients with wet AMD at 28 sites nationwide. The study focused on patients with serious disease, classic or active minimally classic AMD, including those patients who had failed previous treatments. There was no placebo arm. The drug is injected locally into the eye, which reduces the possibility of systemic toxicities from the drug. Local injection was shown to be very safe in the study, with all doses well tolerated and most adverse events mild and related to the administration procedure. There were no systemic adverse events observed, an important consideration in an agent targeting vascular endothelial growth factor [VEGF].
AMD is formed in the eye when blood vessels form at the back of the eye sometimes resulting in blindness. VEGF is the growth factor which produces the blood vessels. By inhibiting the growth of these vessels it has been found that diseases which require blood vessel formation such as cancer and abnormally produce these vessels locally like AMD can be treated effectively by inhibiting this factor. Avastin (NYSE: DNA - News) works by this mechanism (see below).
Unlike antibody VEGF antagonists (Avastin), which neutralize VEGF that has already been produced in the eye, Bevasiranib works by shutting down the genes that produce future VEGF. As a result, there is residual VEGF remaining in the eye during the first weeks of administration of Bevasiranib, which stops production of new VEGF but does not neutralize the residual VEGF that naturally dissipates over time. Accordingly, the impact of the drug's anti-VEGF activity becomes evident only after several weeks of therapy, after the existing VEGF dissipates. This results in a lag between starting Bevasiranib therapy and observing a therapeutic effect. This would indicate that the RNAi mechanism of Bevasiranib may also be effective in combination with Lucentis from DNA, the current monoclonal inhibitor of VEGF (see below) on the market.
Bevasiranib uses RNA interference (RNAi) to silence genes that promote the overgrowth of blood vessels that lead to vision loss in wet AMD. This shuts down the production of VEGF, which has been shown to be the central stimulus in the development of wet AMD. Bevasiranib is administered directly into the eye and does not affect the patient systemically, an important safety consideration. A Phase III clinical trial which will further examine efficacy parameters, as well as dosing and dose scheduling regimens is being planned.
The former CEO and chairman of Ivax, Dr. Phillip Frost, will become chairman and CEO of Opko. The Frost Group will provide Opko with a $12 million line of credit. Proceeds from it, along with the about $16 million of cash held by eXegenics, will fund the company's upcoming Phase-III study of Bevasiranib.
Investment Analysis:
The AMD as a therapeutic market is growing in interest, especially with the approval of the VEGF antagonist from Genentech (NYSE: DNA - News), Lucentis in mid 2006. Sales in 2006 were $380 million. The company mentioned in its recent 10K that Avastin, a VEGF inhibitor used for cancer, is also effective for this indication and is being prescribed off-label. Another marketed therapeutic is Macugen, which is a pegylated aptamer (tight binding oligonucleotide) and was developed by Eyetech and licensed to Pfizer; Eyetech was subsequently purchased by OSI Pharmaceuticals. One of the scientists at Eyetech has joined eXegenics (Opko). Sales in 2006 were $103 million.
OSI have announced that it is divesting the eye business including Macugen as it believes sales of Macugen will be severely affected by the launch of Lucentis and they will concentrate on cancer and other diseases. They are attempting to obtain full rights to Macugen from Pfizer to assist in the divestiture.
Management of the new company appears experienced with a number of past successes; they are confident that there are sufficient funds to develop the molecule through Phase III. Local eye administration of oligonucleotide therapeutics has been the only route of administration for these types of compounds which have been successful so far; Macugen mentioned above, an aptamer, and Vitravene from ISIS, an antisense oligonucleotide against CMV retinitis. Finally, valuation is reasonable at present for a company with a compound going into Phase III. Although the stock has moved significantly since November we still believe it is a good investment for investors willing to take inherent biotech investment risk. It is a Company worth watching in 2007.
My daytrading record is as miserable as my golf game, perhaps worse. I liked the kid from Iowa who won the Masters. Who had him on their list?
When it comes to investing I plod along like a farmer, walking beans, and thinking about life and machinery and fertilizer and stuff like that.
General Question for the Board
Let's say one wished to build a speculative portfolio of Stem Cell companies with a buy and hold strategy in mind, knowing that one might need to hold/sell/modify one's postions as time goes on...
Which companies seem to hold the most promise:risk ratio such that one might create such a portfolio, knowing that there is inherent high risk and yet reduce that risk with some degree of diversification?
I guess that is what I am really after: Knowlegde from the board as to where to focus the research and potentially the grandkids' money?
I suspect that posters here have a company or two that they favor for whatever reasons. If each serious poster presented a case for their favorite(s) and then let the debate begin then I think all might benefit from the group's knowledge and intercourse?
Here I go
I like Novocell, but unfortunately it is mostly privately held. They own about 15 (or 1/4) of the grandfathered true embryonic stem cell lines that are eligible for federal funding (thru aquistion of Cythera) and are well into stage I/II human studies of human cadaver beta cell transplants that are PEG coated to withstand immune assault from the host. They have reported in 'Nature' that they have differentiated hesc into beta type insulin producing precursors. They're very confident they can produce human insulin secreting cells for mass production. Treated primates have demonstrated the ability to become virtual non-diabetics with the coated subcutaneous implants of cadaver derived primate PEG coated beta cells without long term immunosupression. SRDX owns just under 5% of Novocell and will receive significant royalties on the final transplants if they come to fruition. SRDX is the number one coating specialist in the medical device industry and very profitable with or without Novocell in the pipeline. I see SRDX as a very safe 'base' to invest from in the stem cell industry and relatively low priced in the upper 30's. Of course, not the big time home run company one might wish for in the stem cell arena but a rather safe play at this point with great potential. BTW, big pharma is in the mix with JNJ owning a minority position in Novocell as well. SRDX IMO is the best low CAP minority owner of Novocell with the best potential to affect their stock price as a result of Novocell's success and yet with very little downside risk if it falls through, due to their main business in the device coating realm.
OK, I will bite my tongue. Don't mind my rants, they are just rants and nothing personal to anyone. BTW I take potshots as well as I give them. If I sound mean it is only tongue in cheek. As the board matures then I will too. Enjoy the day and happy investing to all.
Just a bunch of day traders?
on this board. BORING!!!!!!!!
Find some companies to buy and hold and say why or I'm gone!
PS: You will miss me.
I know, don't let the door kick me in the ass on the way out, etc...
...rookies
STJ - Even though I didn't own it
I told a friend of mine that it was a good company to buy and hold. I think that was around the year 2000. At the time I didn't have any funds to invest anywhere. My friend keeps thanking me every time I run into her, and I look at her quizically:
http://finance.yahoo.com/q/bc?s=STJ&t=my&l=on&z=m&q=l&c=
The next time I run into her I will suggest ABT. But I don't own ABT and I don't have any funds to invest in it right now.
I think she will absolutely love me 5 years down the road.
Study Shows Promise For Stem-Cell Treatment Of Type I Diabetes Patients
http://online.wsj.com/preview_login.html?url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB1176228246161...
I don't have the WSJ online, has anyone read the full article?
Study Shows Promise For Stem-Cell Treatment Of Type I Diabetes Patients
http://online.wsj.com/preview_login.html?url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB1176228246161...
I don't have the WSJ online, has anyone read the full article?
Peace dude,
Happy Easter. Sorry, I hit a nerve. I do know a little bit about cholesterol drugs and what they do from DD and measuring their effects on my own lipids. (Liposcience.com advanced NMR lipid tersting with particle counts, size distribution, Lp(a) etc). I have experienced side effects, too. I can't say that I fully feel your pain but I'm glad you made it thru the rhabdo. Personally I'll take that risk, some Magnesium and CoQ10 and hope I don't wind up with a premature atherosclerotic event as I see that as far, far, more likely than getting rhabdo. My CK level has remained normal but I will keep close tabs on it. My elders die with MI's, Strokes, etc. I think that's what puts about 50% of the US population in the cemetary. My last unsolicited post on this issue. I think ABT is a good big pharma company and a fairly safe investment, FWIW.
BTW, if you hate statins so much you could try Niaspan, Zetia and a bile acid sequestrant and do pretty well, I think.
My apologies to the board. And yes, life is precious!
Scissors
The only things that keep me alive and thinking are cholesterol drugs, sad to say, or rather happy to say. When I see people post things about the evils of statins and muscles and kidneys, "Oh My!", I just contemplate gravestones in my family and think about the future grandchildren I may live to see and muscles be damned, launch the torpedos, full steam ahead! I'm alive now and I wouldn't otherwise contemplate investment stratgegies from a grave nor take my money with me. Life is good and I will do what I can to defy the damn genetics, which burdon me, and may be cumbersome at times. Flushing is cool, I tell myself that it's just my vessels being cleaned out! I can handle it.
To all statin and cholesterol drug haters:
What a bunch of stupid A-holes you are to tell people they are better off dead rather than risk the potential minor side effects. Try a $10,000 casket on for size that you never paid for! Boy, won't your family be glad you quit earning that last half million you would have earned had you lived or not got stuck in a nursing home. Sheesh, good thing you never risked your muscle health on cholesterol therapy. You're a F'ing genious! Spread your theories all over the internet so other dumb asses get it too. If you care to debate me, BRING IT ON!
rfj - I reviewed your recent posts and this oldie but goodie and did a cursory bit of delving into the science (that is what always interests me). I'm mainly a casual lurker on this board so forgive me if you've covered this before but...
Is there any data on male bone density effects of Androxal?
It seems to me that the most detrimental effect of male hypogodasim in older males is the devastating consequences on bone health rather than the desire to restore virility.
Perhaps when I am an older male I will look at it differently?
Also, it seems to me that a primary endpoint for Proellex should be rates of hysterectomy for bleeding problems and endometrial cancer rates. Go for the really hard endpoints if this stuff is so great. Why should primary doctors presribe this stuff other than symptom relief?
Correct me if I'm wrong (here's my skeptical side), but I suppose that fibroid problems (since they are so common) are the number one reason for women having hysterectomy surgery and a 'bread and butter' income source for GYN surgeons.
Lastly, but not leastly, do women with symptomatic fibroids have higher rates of endometrial cancer then women who don't?
I think that this company may be on to something. The pipeline seems to be pretty good, but what is the competition up to? How is the cash position related to the burdens of proof of utility and are there dilution concerns, etc.
What is your opinion on this company in terms of management?
Sorry if you've covered this ground before but I'm really intrigued by this company as an investment possibility and you are obviously the person who has the info.
I know triple therapy with Niaspan-statin-zetia is used now. Usually Niaspan+Vytorin or Advicor+Zetia to keep down cost, pill count, copay. Those are wicked combinations for changing the numbers. Adding the Zetia drops LDL another ~18mg/dl but doesn't add much else. I am on Niaspan+Crestor and my HDL went up over 35%. My HDL had dropped on Lipitor and my Chol/HDL ratio didn't improve so I got a new doctor. I started with an LDL of 277 and a lot of family members just memories. People don't realize how potent niaspan is at reducing LDL particle numbers (much more relevant to risk than LDL content that is usually measured). It shifts the LDL pattern from small dense LDL to larger, bouyant 'fluffy' LDL that is preferred by LDL clearance mechanisms/receptors in the liver. Some believe that small dense LDL gets oxidized more easily and crosses vascular endothelium more readily than the larger version. The best evidence I can find suggests that overall LDL particle number is the most important factor in LDL risk. The LDL content of any given LDL particle is proportional to the cube of the radius so even small shifts in LDL size can produce significant changes in particle numbers for any given LDL content in blood. Niaspan at therapeutic doses reduces LDL particles on the order of 30 - 40% while only reducing LDL content 10-15% even at high doses. Statins don't do much to change LDL pattern in comparison, neither does Tricor or zetia. Everyone touts the HDL raising of Niacin and ignores its potent pattern shifting power with LDL and most doctors don't know what their patients are missing. Once you become acclimated you hardly ever flush - its getting through the initial stages that is a real pain as a patient. Most docs have been bitched at by flushers so they just say, "Screw it, take your lipitor and don't call me at 2:00 am telling me you have fire ants crawling all over you."
My best guess is that this is the 'Lower Flush' version of Niaspan that KOSP promised would be out in 2007. Interesting that they just added a coating to the outside of the ER tablet formulation. KOS had noted the flushing reports were lower with Advicor compared to equivalent doses of niacin in Niaspan. Advicor is simply a Niaspan tablet coated with lovastatin.
But more interesting is the answer to your prevous question. It doesn't look like ABT has any agenda to bury Niaspan, but rather promote it. The new formulation helps them save face from their previous assertions promoting Tricor that Niaspan was poorly tolerated due to flushing. They never could come close with outcomes data and as far as I'm concerned the FIELD trial put a fork in Tricor as an important weapon in the fight against atherosclerotic events. Tricor is just a High Trig reducer as far as I'm concerned and the secondary endpoints in the FIELD trial were spun to death but really not that impressive either. The major CETP inhibitor setback sets the stage for Niaspan coated with Zocor to be a potential blockbuster in terms of affecting all the lipid parameters in a meaningful way and zocor is better than all the older statins in terms of it's HDL effects and has solid outcomes data by itself and particularly when combined with Niacin (HATS - 89% event reduction and coronary regression, ARBITER III - carotid plaque regression). IMO ABT made a very wise move in aquiring KOS right before PFE's mucho hyped Torcetrapib turned out to have a pesky little adverse event called 'DEATH' that put it 6 feet under and cost 10,000 people their jobs. Future CETP's now have a very long row to hoe to convince the FDA that Torcetrapib's problems were not a class effect. Finally KOS' inhaled protein program and patent porfolio is potentially a very lucrative source of income for ABT down the road. I'll bet Jaharis (KOS) kicked himself in the pants about 80 times when PFE pulled out of the HDL game for the forseeable future.
Abbott Announces FDA Approval of a New Coated Niaspan Tablet
http://biz.yahoo.com/prnews/070406/clf006b.html?.v=1
ABBOTT PARK, Ill., April 6 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) has approved Abbott's new coated Niaspan® (niacin extended-release tablets). Niaspan is the leading medication for boosting HDL cholesterol -- the "good" cholesterol.
Heart disease is the leading cause of death in both men and women in the United States, and studies have shown that every 1 percent increase in HDL cholesterol is associated with a 2 percent decrease in heart disease risk.
"Niaspan has the proven ability to elevate good cholesterol, a known risk factor in cardiovascular disease," said Eugene Sun, M.D., vice president of Global Pharmaceutical Clinical Development, Abbott. "With the FDA approval of a new Niaspan coated tablet, our next step is to expand upon two published studies to determine the effect on flushing intensity. We'll do that by initiating larger clinical studies."
Niaspan is the only FDA-approved, once-daily extended-release prescription niacin formulation for the treatment of lipid disorders with an ability to significantly raise HDL cholesterol. Collective results from three major clinical studies show an average 22 percent increase of HDL for patients receiving 2000 mg of Niaspan at bedtime. Niacin is also indicated for the secondary prevention of heart attacks, and in combination with a bile acid binding resin, niacin is indicated to promote regression of coronary atherosclerosis in patients with history of coronary artery disease.
"More and more, physicians and their patients understand that good cholesterol management means trying to bring all lipid parameters to optimal levels," said Richard Karas, M.D., Ph.D., professor of medicine, Tufts-New England Medical Center, Boston, MA. "Introducing a new coated tablet that may enhance patient convenience is an important factor in improving our ability to provide good cholesterol management for our patients," he added.
About Niaspan
Available since 1997, Niaspan is the only FDA-approved, once-daily extended-release prescription formulation of niacin for treating abnormal cholesterol levels.
Indications
Niaspan is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate, to reduce elevated total cholesterol, LDL- C, Apo B, and triglyceride levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. In patients with a history of myocardial infarction and hypercholesterolemia, niacin is indicated to reduce the risk of recurrent non-fatal myocardial infarction or in patients with coronary artery disease and hypercholesterolemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Important Safety Information
Niaspan is contraindicated in patients with allergies to any of its ingredients, active peptic ulcer disease, significant or unexplained persistent liver dysfunction, or arterial bleeding. Niaspan should not be substituted for equivalent doses of immediate-release niacin. Niaspan should be prescribed with caution in patients who consume substantial amounts of alcohol and/or have a past history of liver disease. Liver function tests should be performed on all patients during therapy with Niaspan. Use of Niaspan with other lipid-altering medications called statins may increase the risk of rhabdomyolysis, a rare condition that causes muscles to breakdown. The most common side effect with Niaspan is flushing of the skin. Patients with diabetes should carefully monitor their blood sugar and report changes to their doctor. Other commonly reported side effects include indigestion, headache, pain, abdominal pain, nausea, itching, diarrhea, runny nose, vomiting and rash.
More information about Niaspan, including full prescribing information, is available on the Web site www.rxabbott.com/pdf/niaspan.pdf or by calling Abbott Medical Information at 1-800-633-9110.
About Abbott
Abbott (NYSE: ABT - News) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
Source: Abbott
Stem Cell Patents Revoked
http://www.redherring.com/Article.aspx?a=21903&hed=Stem+Cell+Patents+Revoked+
Consumer groups call embryonic stem cell patents redundant.
April 5, 2007
By Marisa Taylor
The mudslinging began after the U.S. Patent and Trademark Office (USPTO) revoked three key patents on human embryonic stem cells. The impetus: consumer groups had complained that the patents will prevent scientists from making progress in stem cell research.
Stem cell policy experts were caught by surprise. After all, the patents were based on research conducted by James Thomson, formerly of the University of Wisconsin-Madison, who isolated human embryonic stem cells in 1998. He filed three patents through the Wisconsin Alumni Research Foundation. Today, the WARF licenses the technology exclusively to Geron Corporation, based in Menlo Park, California.
Last July, though, the Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation filed challenges to the WARF/Thomson patents. They felt that patenting the process of isolating and growing embryonic stem cells limited scientific progress, particularly after $3 billion was approved for embryonic stem cell research in California.
“Patenting embryonic stem cells is like patenting food because you can cook,” FTCR stem cell project director John Simpson wrote in an op-ed piece at that time.
For now, the USPTO is siding with the consumer groups. In its preliminary decision to revoke the patents, the USPTO noted that Thomson’s work on human cells did not constitute a significant advancement beyond already-published work.
The Elephant in the Room
“It is inconceivable to us that Dr. Thomson’s discovery, which Science Magazine heralded as one of the greatest scientific discoveries in history, would be found not worthy of a patent,” shot back Carl Gulbrandsen, the managing director of the WARF, in a statement. “Our patents will [eventually] be upheld,” he added.
Meanwhile, the WARF does not expect any licensing agreements from the California Institute for Regenerative Medicine, companies that engineer embryonic neural, cardiac, or pancreatic stem cells with the aim of going to market, and must go to Geron for a licensing agreement.
As a result, some companies feel that navigating the stem cell business landscape is tricky and restrictive. “When you work on human embryonic stem cell IP, the elephant in the room is James Thomson at Geron,” said Novocell president and CEO Alan Lewis at the second annual Stem Cell Conference last March.
Amongst the hyperventilating, Christopher Scott, director of the program on stem cell research and society at Stanford’s Center for Biomedical Ethics, noted an irony. The Thomson patents will expire by the time that applications for stem cell therapies go to market.
“In a few years, this will be water under the bridge,” said Mr. Scott, who was also surprised by the USPTO’s decision.
Look at novocell.com, a private company but there are ways to invest in it by buying other companies that hold an interest.
They have 15 of the 60 or so grandfathered lines (bought out cythera)of stem cells that are eligible for federal funding and are close to taking stem cells and mature them into insulin producing beta cells for mass production. Published stuff, just look.
SRDX licenses the PEG coating technology to make these beta cells impervious to immune destruction and will receive a royalty on the final subcu implants. Human phase I/II studies are underway. Buy SRDX if you like the prospects of this stem cell company.
IREE
Hopefully the upper 90's was rock bottom and forever behind us. Glad I added more. Go goats! No reason not to add some momentum traders now that the bottom feeders are fed.
I believe SRDX current share in Novocell is under but not alot under 5% and that may be why they are not listed on Novocell's website. They used to be listed along with Becton Dickenson and some venture capitalists. With all the cash on hand you would think SRDX would have anted up a little more along the way but having a healthy royalty rate helps ease the pain. I imagine it will be a more costly procedure than putting in a stent due to the cost of materials and the material effect on the patients that are treated and eventually retreated. The cells don't live forever. I believe the expectation is 3 to 5 years after implantation. Cha-ching!
and yet SRDX still talks about their investment in Novocell every time they speak
The media blitz doesn't highlight this...
NEJM article
under secondary outcomes:
"At a median follow-up of 4.6 years, 21.1% of patients in the PCI group had additional revascularization, as compared with 32.6% of those in the medical-therapy group (hazard ratio, 0.60; 95% CI, 0.51 to 0.71; P<0.001). In the PCI group, 77 patients subsequently underwent CABG, as compared with 81 patients in the medical-therapy group. Revascularization was performed for angina that was unresponsive to maximal medical therapy or when there was objective evidence of worsening ischemia on noninvasive testing, at the discretion of the patient's physician. The median time to subsequent revascularization was 10.0 months (interquartile range, 4.5 to 28.0) in the PCI group and 10.8 months (interquartile range, 3.2 to 30.7) in the medical-therapy group.
There was a substantial reduction in the prevalence of angina in both groups during follow-up. There was a statistically significant difference in the rates of freedom from angina throughout most of the follow-up period, in favor of the PCI group (Table 2). At 5 years, 74% of patients in the PCI group and 72% of those in the medical-therapy group were free of angina (P=0.35)."
I just don't see Cardiologists dumping stents for a study that only included stable patients. Who defines stable? Who gets paid to put in stents? How could it be construed as unethical to offer freedom from chest pain? What about orthopedic interventions or many others that don't save lives?
"See you on the squash court, old chum. Mind if I bum a Viagra? I'm free of nitro, since the stenting, you know.... Is that Phoebe on the tennis courts? Nice legs"
This study will only validate what has been known all along with stable patients (who probably FAILED a stress test). Stents don't save lives, they reduce angina and improve the quality of life. Cardiologists get paid to put stents in and they are the ones who decide when they are necessary. Patients who are unstable have the choice of watching part of their heart die (and turn to permanent scar if they live through the MI) or else salvage as much myocardium as possible with a percutaneous procedure or go on to bypass. The analysts who predict the demise of stents based on this study really don't get what goes on in the real world. Imagine yourself on the table with a plug in your groin telling the cardiologist, "Thanks for not putting a stent in my clogged vessel when you had the chance, just write me a bunch of scripts and I'll call you every time I have some chest pain like the princess and the pea or the boy who cried wolf or the progeny of the two. Can I still take Viagra?"
From a fundamental perspective...
Growing Pipeline, lack of debt, ready cash with prudent use of cash, successful products with outstanding business model (virtually no cash up front to develop new products), climbing the value chain, impressive revenue growth, highly competant management, potential blockbusters galore, broad array of participation in the stent arena - no matter who wins or loses, solid patent portfolio, share price well below historical highs of YEARS AGO!!, declining PE ratio for years, etc...
Why the heck would investors be chomping on the bit to short SRDX? Pushing the envelope and the SEC rules. I just don't get it. I could think of oodles and oodles of better things to short. I thought shorts were supposed to be savvier than the average bear. Not here. I will stay fully invested, keep buying on dips and be patient. I will do just fine.
The increased risk of re-intervention is much higher than the decreased risk of late stent thrombosis when comparing BMS vs DES. It seems to me that DES should still be first choice unless there is a contraindication for short and near term combination anti-platelet therapy, ie. chronic bleeding problems or the need for impending surgery. I think its likely that restenosis with a BMS will continue to be treated with DES. If future generations of DES have late thrombosis at no greater risk than BMS and if combination anti-platelet regimens can be shortened then BMS may go the way of the dinosaur.