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Royalties on sales of ANGIOMAX (bivalirudin) by The Medicines Company (TMC) represent our [BIIB] most significant source of other revenue.
I think that patients need to pay for using the device after they are being discharged from the hospital and that might also be a problem although a minor one.
The study I've posted was not powered to demonstrate the difference in efficacy between the 2 groups (there were no worrisome findings related to efficacy) but it was shown in other clinical studies that the device is at least as effective as Lovenox in DVT prevention and still have significantly less adverse effects.
Zyvox Q2 sales were nearly $300M, so the market is there for a 2nd generation oxazolidinone if approved.
Have you considered using a device vs. anticoagulants in DVT prophylaxis for your patients?
Here is the abs. from a JBJS publication I've found in the company's site
( http://www.mcsmed.com/professionals_clinicalstudies.html )
Thrombosis Prevention After Total Hip Arthroplasty
Background
Thromboembolic disease is a common complication of total hip arthroplasty. The purpose of this study was to compare a new mobile compression device with low-molecular-weight heparin with regard to their safety and effectiveness for the prevention of venous thromboembolic disease.
Methods
Patients who had a total hip arthroplasty were randomized to receive prophylaxis with a mobile compression device or low-molecular-weight heparin for ten days. Use of the compression device began intraoperatively, and the patients in this group could receive 81 mg of aspirin daily after the surgery. The first injection of the low-molecular-weight heparin began between twelve and twenty-four hours after the surgery. After ten to twelve days, all patients underwent bilateral lower-extremity duplex ultrasonography to screen for deep venous thrombi in the calf and thigh. Any clinical symptoms of pulmonary embolism were evaluated with spiral computed tomography lung scans. Bleeding events and utilization of (i.e., compliance with) prophylactic treatment in both groups were documented. Clinical evaluation to look for evidence of deep venous thrombi and pulmonary emboli was performed at twelve weeks postoperatively.
Results
Four hundred and ten patients (414 hips) were randomized; 392 of these patients (395 of the hips) were evaluable with regard to the safety of the intervention and 386 patients (389 hips) were evaluable with regard to its efficacy. Demographics were similar clinically between the groups. The rate of major bleeding events was 0% in the compression group and 6% in the low-molecular-weight heparin group. The rates of distal and proximal deep venous thrombosis were 3% and 2%, respectively, in the compression group compared with 3% and 1% in the heparin group. The rates of pulmonary embolism were 1% in the compression group and 1% in the heparin group, and there were no fatal pulmonary emboli. Within the twelve-week follow-up period, two events (one deep venous thrombosis and one pulmonary embolus) occurred in one patient in the compression group following negative findings on duplex ultrasonography on the twelfth postoperative day. There was no difference between the groups with regard to the prevalence of venous thromboembolism.
Conclusions
When compared with low-molecular-weight heparin, use of the mobile compression device for prophylaxis against venous thromboembolic events following total hip arthroplasty resulted in a significant decrease in major bleeding events.
Allergan jumps as Botox migraine OK seems closer
http://www.reuters.com/article/idCNN0226297820100802?rpc=44
Mon Aug 2, 2010 5:23pm EDT
* FDA seeks info on Botox anti-migraine risk strategy
* FDA to delay Botox migraine decision by 3 months
* Analysts see FDA more inclined toward approval
* Shares rise 6 percent (Adds doctor comments, closing shares)
By Ransdell Pierson
NEW YORK, Aug 2 (Reuters) - U.S. regulators seem inclined to approve Allergan Inc's (AGN.N) wrinkle drug Botox to prevent migraine headaches in millions of Americans, industry analysts said, based on information the drugmaker released on Monday.
Allergan shares rose 6 percent after it said the U.S. Food and Drug Administration requested information on how to safely market Botox for the extremely painful, recurring headaches. It gave details of the request as it reported better-than-expected quarterly results.
"The stock market is thinking that the FDA's request for risk-management information is a precursor to FDA approval" for migraines, said Credit Agricole Securities analyst David Maris.
"The market is excited because it's wondering why would the FDA ask for a program for training physicians if it wasn't going to approve it."
Investors had expected the FDA's decision on Botox by Monday and see the added indication propelling sales of Allergan's biggest product. In Allergan's latest quarter, Botox sales rose 7 percent to $361 million. Analysts believe approval for the condition could boost its annual sales by $500 million or more.
About 18 percent of U.S. women and 6 percent of men have migraine headaches at some time each year, according to the Merck Manual of medical information.
Botox would be meant for the estimated three million Americans who have chronic migraines, meaning 15 or more headache days per month.
Allergan said the FDA will delay its decision for three months after asking the company for an updated Risk Evaluation and Mitigation Strategy on how to safely market Botox for potential anti-migraine use.
Allergan has already provided the FDA with the requested information, including a proposed plan on how to train physicians for the new use of Botox.
"We believe this strongly suggests that (the) FDA will approve Botox for migraine without requesting another study," Wells Fargo analyst Larry Biegelsen said in a research note.
In clinical trials, Botox was given every 12 weeks to prevent migraines, via 31 injections into seven areas of the head and neck.
In one late-stage trial, Botox failed its primary goal of reducing the number of headache episodes compared with a placebo. But it met a secondary goal, as those on Botox had headaches on average 7.8 fewer days each month, compared with a drop of 6.4 days among patients taking placebo.
In a second trial, Botox patients had nine fewer headache days compared with a drop of 6.7 days for the placebo group.
Botox seems to block brain messenger chemicals, called neurotransmitters, that transmit pain, said Dr. David Simpson, a professor of neurology at Mount Sinai Medical Center.
"Current drugs to prevent migraines are far from perfect, so this is a potential significant advance," said Simpson, who has been a consultant for Allergan on unrelated Botox studies.
BRITAIN PAVES PATH FOR NEW BOTOX USE
Britain three weeks ago became the first country to approve Botox for migraines. Wall Street expects other European countries to follow, and for the new Botox use to boost the product's sales by as much as $300 million a year in Europe.
Its approval in the larger and more lucrative U.S. market has been considered far less certain, given the FDA's greater concern with safety in recent years after the recall of Merck & Co Inc's (MRK.N) widely used Vioxx arthritis drug.
snip...
Shire has agreed to pay $565 million for Movetis, a Belgian biotech
http://www.shire.com/shireplc/en/investors/investorsnews/irshirenews?id=392
This observation is important for docs to guide them where they should test for the oncogene. It does not change the overall no of patients who should have a better therapeutic outcome from treatment with crizotinib.
NSCLC predictive biomarker
Is Pharma Running Out of Brainy Ideas?
http://www.sciencemag.org/cgi/content/full/329/5991/502
Recent cutbacks raise concerns about the future of
drug development for nervous system disorders
Greg Miller
On 4 February, GlaxoSmithKline (GSK) announced that it planned to pull the plug on drug discovery in some areas of neuroscience, including pain and depression. A few weeks later, news came that AstraZeneca was closing research facilities in the United States and Europe and ceasing drug-discovery work in schizophrenia, bipolar disorder, depression, and anxiety. These cutbacks by two of the top players in drug development for disorders of the central nervous system have raised concerns that the pharmaceutical industry is pulling out, or at least pulling back, in this area. In direct response to the cuts at GSK and AstraZeneca, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders organized a meeting in late June that brought together leaders from government, academia, and private foundations to take stock. But the biggest problem, researchers say, is that there is almost nothing in the pipeline that gives any hope for a transformation in the treatment of mental illness. That's worrying, they say, because the need for better treatments for neurological and psychiatric disorders is vast. Hundreds of millions of people are afflicted worldwide. Yet for some common disorders, like Alzheimer's disease, no truly effective treatments exist; for others, like depression, the existing drugs have limited efficacy and substantial side effects.
What’s in the pipeline?
At fi rst glance, the situation doesn’t appear to be so dire. A report released 14 July by the Pharmaceutical Research and Manufacturers of America (PhRMA) touts a recordhigh 313 drugs in the pipeline for mental health disorders such as depression, anxiety, and addiction. Another report, commissioned by IOM for the June meeting and prepared by the Tufts Center for the Study of Drug Development, identifi ed 1747 drugs in development for a much longer list of disorders, including degenerative diseases like multiple sclerosis and neurological conditions like epilepsy. Indeed, the Tufts report suggests that the pipeline has expanded rapidly for many conditions in recent years (see graph, p. 503). But a closer look tells a different story, says Steven Hyman, a psychiatrist and former NIMH director who is now provost at Harvard University. Many of the drugs in clinical trials have long been approved and are now being tested for a new indication, Hyman says. Looking over the Tufts and PhRMA reports’ lists of drugs in late-stage clinical trials for depression, he notes that both are loaded with antipsychotic drugs, including Risperdal (risperidone) and Seroquel (quetiapine), two of the fi rst “atypical antipsychotics” approved by the Food and Drug Administration in the 1990s. “People with depression can have anxiety and agitation, and low doses of antipsychotics seem to improve those symptoms,” Hyman says. “But they don’t necessarily have an independent effect on the core depressive symptoms, and they come with a real sideeffect burden.” Other treatment candidates have limitations as well. Both lists include Corlux (mifepristone, better known as RU-486, the abortion drug). Even if it proves effective for depression, it couldn’t be prescribed for women of reproductive age, Hyman notes. The Tufts list includes Agomelatine, a drug that boosts the effects of the hormone melatonin and blocks receptors for the neurotransmitter serotonin. Hyman says there’s little compelling evidence that boosting melatonin has antidepressant effects, and he notes that the drug has had mixed results in European trials for depression. “This is hardly a rich pipeline,” Hyman says. “It suggests a sad dearth of ideas and involves lots of attempts at patent extensions and new indications for old drugs.”
Risky business
The reasons for the seeming lack of innovation are partly historical, says William Potter, who retired in January from Merck, where he was vice president for neuroscience. In the 1980s and ’90s, drug companies realized that they could make billions of dollars a year off drugs that were slightly modifi ed versions of already-approved medications, particularly the SSRI antidepressants like Prozac, Potter says: “The investment in truly innovative projects was not as deep as it might have been because you could make so much money from ‘me, too,’ drugs.” The current climate for innovation may be even worse. Companies will soon lose billions of dollars in revenue as patents expire on dozens of blockbuster drugs (see fi gure, below). Meanwhile, the costs of research and development are rising. “Most companies don’t see where they’re going to be getting the cash fl ow, so they’re having to be more conservative,” Potter says. “You can’t just ask companies to throw money at something that might not pay off.” The Tufts report suggests that pharma executives have good reason to see investments in CNS drug development as riskier than investments in other areas. CNS drugs cost more and take longer to bring to market than other types of drugs (see figure, right). And only 8% of CNS drugs that make it to clinical trials end up being approved, about half the average success rate across all therapeutic areas. Moreover, when CNS drugs fail, they tend to do so in late-stage clinical trials, after a signifi cant investment has been made, says Kenneth Kaitin, director of the Tufts center. Adding to those troubles, the animal models, particularly for psychiatric disorders, are far from perfect at predicting which compounds will be effective in humans, and the clinical trials are often more complicated for CNS disorders, says Ratti. These disorders tend to be complex and intermittent, and their symptoms often defy objective measurement. “All these things together are making discovery and development in neuroscience signifi - cantly risky,” he says. Many companies see areas like oncology and autoimmune disorders as safer bets, says Steven Paul, who stepped down in February as executive vice president for science and technology for Eli Lilly and Co. “Their perception is that the science is a little richer and the odds are less daunting in some of these other areas,” he says. Even within neuroscience, Paul says, some companies may see psychiatric drugs as a bigger gamble than drugs for neurological conditions. Paul, who is a psychiatrist, says he doesn’t necessarily agree with that assessment: “I personally believe there are compelling pathways and new targets to pursue.”
Seeking a new model
Given the economic challenges, experts inside and outside pharma say the old model of drug development, in which companies assume all the risks and costs of searching for new drugs and shepherding them from test tube to clinic, is no longer viable. “Traditionally, they would have signifi cant internal research groups that would be as good as anyone at doing some of the basic research that might lead to new targets,” says Adrian Ivinson, who directs the Harvard NeuroDiscovery Center. “We’re seeing less and less of that.” Many companies are trying to reduce costs by outsourcing R&D. AstraZeneca and GSK both set up R&D centers in Shanghai, China, in 2007, for example. The GSK center focuses on developing treatments for multiple sclerosis, Parkinson’s, and Alzheimer’s diseases; its work on those disorders will continue despite the recent cutbacks in other areas of neuroscience. Another outsourcing strategy involves contracting with biotech companies and academic researchers to do some of the early drug-discovery work that was previously done in-house. “They are sending scouts out into the community to talk to groups like ours and many others to identify projects with potential for drug discovery,” Ivinson says. In a typical arrangement, a company funds a research project in exchange for the right to license any resulting compounds that show therapeutic potential. At the IOM meeting, there was much discussion about public-private partnerships. Insel notes that the U.S. National Institutes of Health (NIH) already has a drug-discovery effort that might serve as a model, the Therapeutics for Rare and Neglected Diseases project launched last year. A measure in the new U.S. health-care legislation could expand NIH’s role: It authorizes up to $500 million a year for a “Cures Acceleration Network” aimed at speeding drug development (Science, 26 March, p. 1562). “It’s a strong message from Congress that they would like to see NIH more involved in drug discovery and drug development,” says Insel. Another possibility might be a shared repository of compounds. “Pharma has thousands and thousands of compounds that are leads they’ve decided not to follow,” Insel says. “Would it make sense to put those into a resource that other people could begin to mine?” In May, GSK made public a library of potential malaria drugs, but neurology and psychiatry are far more lucrative markets. An open-access library of compounds would involve a host of challenges, not the least of which are questions about intellectual property, Insel says. “These are big and thorny issues, but we have got to grapple with them so that 10 years from now we’re not looking at the same list of compounds that we know don’t work well enough and hoping that if we just give them to a different group of patients we’ll get a better outcome.”
The phenomenon was known and is in the Post-Marketing Experience section under Immune System Disorders:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=16286
The label will probably be updated for the risk - 7 cases since 2004.
It may be routine statistical noise but the investigators did mention the difference and said they were looking at the data for the reason.
Guess AF listened to Norbert Bischofberger too :)
The virologic failure rate difference was higher in ECHO trial (11.0% vs 4.4%) than in THRIVE (7.1% vs 5.3%), and there's no explanation for this either.
One point Adam F. noted correctly in his piece - that it was also seen in the phase II trial, but difference in virologic failure rate was gone at 96-week.
On Dolly the sheep shorter telomeres - No clear answer to that. Cloning should reprogram telomerase and telomere length. All other tests and parameters didn't suggest premature aging for Dolly. However, I think it is debatable.
I think Yanai meant the FDA timing of approval.
Dolly the sheep is probably not a good example because clones are still more prone to defects in general, not because cloning per se but because of culture conditions.
Generic Wellbutrin - Biovail did file suit against the FDA and a motion for a TRO alleging that the FDA violated the Administrative Procedures Act (APA) and its right to constitutional due process.
I think Treanda also looks good in refractory MM. In small cap biotech KERX/perifosine is currently in a phase 3 trial, under an SPA in relapsed/refractory MM.
Carfilzomib achieved an ORR of 24% and a median duration of response of 7.4 months in that open label single arm phase IIb trial. Looks good enough for approval.
It doesn't sound like Teva are going to be approved soon, my hunch is the FDA wants more and might approve later.
Another MS survey was mentioned in the Israeli media this time from Merrill:
Rival MS drug or not, Merrill likes Teva
http://www.haaretz.com/print-edition/business/rival-ms-drug-or-not-merrill-likes-teva-1.303127
By Lior Zeno
Worries that multiple sclerosis drug Copaxone will lose market share are overblown, and shares of Teva Pharmaceutical Industries are still worth buying, Merrill Lynch said yesterday.
Even though there's room for investors to worry regarding the multiple sclerosis drug, the matter has lost all proportions, the investment bank said, repeating its buy recommendation for Teva and giving the stock a target price of $75. The shares started the trading day at around $54 yesterday.
While competitor Novartis plans to release a rival drug, Gilenia, a survey of 73 neurologists found that Copaxone would continue to be the treatment of choice for at least the next several years, and will maintain its market share, Merrill Lynch wrote. Gilenia will not have much of an influence on Copaxone's sales.
The doctors also said they would be interested in a newer version of Copaxone that hurts less when injected, Merrill wrote.
The issue began a month ago when a committee at the U.S. Food and Drug Administration recommended approving Gilenia for sale. Gilenia would be the first multiple sclerosis drug administered orally.
The market for multiple sclerosis drugs is worth $10 billion a year. It currently contains four drugs, including Copaxone, all of which are administered by shots or infusions, causing pain to patients. Teva is currently working on a new, more concentrated version of the drug that would reduce the quantity in each injection.
BL1020 enrollment in the extension trail
I can add what I've been told by Bioline - said it was their decision to limit the number of patients to 75 for financial reasons.
Nature Editorial on comparative studies
Effective approach
http://www.nature.com/nature/journal/v466/n7305/full/466413b.html
Date published: (22 July 2010)
The controversy surrounding diabetes drugs highlights the importance of comparative studies.
Improved diet and regular exercise may be the best way to treat type 2 diabetes, but that has not stopped the proliferation of drugs to tackle the condition. These range from the old and familiar — insulin, metformin and the sulphonylureas — to relative newcomers such as Actos (pioglitazone) and Avandia (rosiglitazone).
No drug is without risk. Some studies have suggested a link between certain formulations of insulin and an increased risk of cancer. Metformin can cause fatal complications in patients with kidney failure. Thirty years ago, US regulators placed a warning on the sulphonylureas after studies suggested they increased the possibility of death from cardiovascular complications. And both Actos and Avandia can raise the risk of heart failure, with Avandia also having the potential to trigger a heart attack.
Last week, an advisory panel of 33 scientists, clinicians and statisticians convened by the US Food and Drug Administration (FDA) picked through the evidence of Avandia's heart risks, as they debated whether or not the agency should pull the drug from the market. They recommended by majority vote that the FDA should restrict the drug's distribution (see page 420). But it was a difficult decision based on imperfect data — not least a lack of clinical comparisons between Avandia and other diabetes drugs including Actos, which is in the same chemical class but does not seem to pose the same risk of heart attack.
Few experts believe that Avandia became a blockbuster because it was demonstrably better than more established diabetes drugs. In the absence of comparative studies, many experts suggest that the drug's success was driven by an aggressive advertising campaign by its maker, the London-based pharmaceutical giant GlaxoSmithKline, and by clinicians' desire to offer their patients something 'new'. In 2006, the year before its safety risks were made public, global sales of Avandia reached £1.66 billion (some US$3 billion).
Research suggests that heavy reliance on newer, patent-protected drugs is partly responsible for driving up the cost of treating diabetes, which in the United States rose from $6.7 billion in 2001 to $12.5 billion in 2007.
That does not mean there should not be a place on the market for Avandia. Many clinicians — even those sceptical of the drug's widespread appeal — say that it is a worthwhile treatment option for patients who cannot tolerate the side effects of the older drugs.
But Avandia is a clear example of why early comparative-effectiveness studies are needed for drugs that treat conditions for which therapies are already available. It is a lesson worth remembering as the United States begins to carry out the $1.1 billion in comparative-effectiveness research mandated by the American Recovery and Reinvestment Act of 2009, and as officials ponder whether and how the data collected should inform decisions made under the nation's newly reformed health-care system.
The issue is a highly contentious one in the United States, as many politicians there equate 'comparative effectiveness' with health-care rationing. But without these comparisons, as the Avandia example demonstrates, clinicians have only intuition and their own limited experience to guide their prescriptions. And when safety issues do emerge, regulators are forced to make decisions based on incomplete data. The studies need to be done consistently and early in the approval process, before the damage is done.
Talecris stopped inhaled plasma-derived AAT trials for now:
http://www.alpha-1foundation.org/news/talecris-releases-letter-to-alpha-1-community-outlining-research-strategy-including-recombinant-alpha-1-protein
Gilead: Btripla Jury Still Out
http://www.thestreet.com/story/10810364/gilead-btripla-jury-still-out.html
Adam Feuerstein
FOSTER CITY, Calif. (TheStreet) -- Investors have shredded Gilead Sciences(GILD) in the year since the company announced last July plans to develop a new single-pill HIV treatment in a partnership with Johnson & Johnson(JNJ).
Over the weekend, new efficacy and safety data from two late-stage studies of the new pill -- nicknamed Btripla -- were released at an international AIDS meeting and largely met Street expectations.
Gilead shares are up about 3% to $33 in Monday trading, but the stock is still miles away from the $48-49 level of last July when Gilead announced Btripla's development plans. Gilead announces second-quarter earnings Tuesday afternoon.
Gilead acts like a dead stock walking mainly because investors are taking a jaundiced view towards the company's assertion that Btripla and the "Quad" (another of Gilead's new all-in-one HIV pills under development) are solutions to the challenges facing the company when patents on its key HIV drugs begin to expire around 2018.
Gilead is the first of the large-cap biotech firms to suffer significantly from the same "patent cliff" fears that have beset Big Pharma companies like Pfizer(PFE), Eli Lilly(LLY) and Merck(MRK) in recent years.
Nearly 90% of Gilead's $6.5 billion in 2009 drug sales comes from the HIV treatment market, so the company is dead in the water unless it can either come up with new patent-protected HIV medicines or diversify the company's revenue stream outside of HIV.
Btripla is a once daily, single-pill co-formulation of J&J's experimental drug TMC278 with Gilead's current HIV drug mainstay Truvada. Gilead pioneered the single-pill HIV treatment approach when it debuted Atripla in 2006, which combines Truvada with Sustiva, a pill marketed by Bristol-Myers Squibb(BMY).
Atripla sales totaled $2.4 billion in 2009 but the drug's future is clouded by looming patent expirations for both the Sustiva and Truvada components. Moreover, Gilead receives nothing financially from the Sustiva portion of Truvada. On the other hand, Gilead will receive 30% economics on the TMC278 portion of Btripla, if approved.
If Gilead can convince doctors to switch patients from Atripla to Btripla (in essence swapping Sustiva for TMC278 while keeping patients on Truvada), the company will make more money and stave off a generic threat to Atripla.
Btripla data is being presented this week from two studies that compared the efficacy and safety of TMC278 compared to Sustiva. Abstracts of the data were released over the weekend, with more complete presentations scheduled for Thursday at the International AIDS Society (IAS) meeting in Vienna, Austria
After one year of treatment, 84% of HIV patients treated with TMC-278 demonstrated a significant reduction in HIV viral load compared to 82% of patients treated with Atripla. The result showed the two drugs to be statistically non-inferior, which satisfied the primary endpoint of the two studies.
From a safety perspective, patient discontinuations due to adverse events were lower for TMC278 arm (2.2%) compared to Sustiva arm (7.2%).
One big question market from this weekend's Btripla data, however, is the 9% of TMC278 patients who experience virologic failure in the two studies compared to 4.8% of Sustiva-treated patients.
Virologic failure is a concern for HIV doctors because it means patients' HIV levels either never fall or are suppressed initially before rebounding. Virologic failure can be a sign that a patient's HIV is mutating in ways that make it more resistant to treatment.
Investors were expecting to see higher rates of virologic failure in TMC278 patients compared to Sustiva based on phase II data previously presented. But what's not yet clear from the new data are the sorts and severity of the HIV mutations being caused by TMC278.
In previous phase II studies followed for two years, the virologic failure rates for TMC278 and Sustiva equalized between the first and second years. It remains to be seen whether the same thing happens in the phase III studies, which is why investors are still viewing Btripla with some caution.
Gilead may also have to contend with competition from other, new HIV drugs in development, including a so-called integrase inhibitor from GlaxoSmithKline(GSK) that has data being presented at the same IAS meeting this week.
During a conference call with investors Monday morning, ISI Group biotech analyst Mark Schoenebaum said his initial feedback on Btripla from an HIV doctor indicated some reluctance to use Btripla over Atripla based on the virologic failure data released over the weekend.
At the same time, Schoenebaum reiterated his position that Gilead "continues to look really cheap" at these stock levels. He pegs fair value today in the $45 range.
Gilead will release second quarter earnings Tuesday afternoon. The company is expected to earn 87 cents a share on an adjusted basis on total revenue of $1.96 billion. Worldwide HIV sales are expected to reach $1.59 billion. Investors will be paying close attention to Gilead management's discussion of U.S. demand for its HIV drugs as well as efforts by some European countries to cut the price of HIV drugs.
It was the last question on the draft:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM219429.pdf
Isentress QD dose is still possible as you noted (final data collection date for primary outcome measure of the trial is October 2010) but low barrier to resistance is there to stay.
Once-daily Kaletra was approved end of Apr for treatment in experienced patients, so the downfall might slow a bit. Reyataz is already the leading PI and Prezista is a tough competitor but I think Isentress might be less of a competitor due to low barrier to resistance. On the big picture I agree with ciotera - the trend is not in favor for Kaletra.
To clarify on the former post about ISSCR (I've been asked via a PM)
Daley talked about the epigenetic memory in iPS cells, which was still unpublished. Hochedlinger, although had similar results spoke about published data. I was simply amused by the differences (anyone who knows Hochedlinger's mentor Rudi Jaenisch may have a good guess where this attitude came from).
Hochedlinger did not even mention at ISSCR that he has such data while Daley did focus on his talk about this intriguing and exciting new issue - epigenetic memory in iPSc.
Just rethinking, maybe better sack the lazy bum :)
We should tell the person who takes care of the scientific calendar s/he missed the The International AIDS Conference - http://www.aids2010.org/ where TMC278 data will also be presented.