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Indeed you did. I must have been hallucinating
Congrats on your CYPB call. Hope you did take a position.
Why didn't you post as a reply to #msg-52340768 ?
So does KUDCO Ireland except it has not launched its generic product to my knowledge. However, I'd say that while Teva is in the boat, Sun is in the dingey :)
Jbog, I find it hard to believe we'll see a withdrawal of approval. What's your impression?
[OT] Francis Collins live
The Protonix case
The ruling on the invalidity arguments shifts the outcome of the patent litigation against Teva. There is still the patent misuse arguments but I don't think it could win the case. The fact the court hasn't ordered a reset of the date of Teva's regulatory approval to sell its generic and that "Teva is not prohibited from making further sales prior to January 2011", sounds to me that Teva is now actually allowed to sell its generic without a further risk.
Generic-Protonix update:
"Teva Pharmaceutical Industries Ltd.(Nasdaq: TEVA) announced today that the U.S. District Court for the District of New Jersey denied Teva's motion to overturn an April 23, 2010, jury verdict finding the patent in suit not invalid. The Court also denied Wyeth and Nycomed's request for FDA to reset the date of Teva's final approval to January 2011, based on the fact that Teva has patent defenses remaining at the District Court, including patent misuse. Accordingly, Teva is not prohibited from making further sales prior to January 2011, the date when the pediatric exclusivity expires. The Court has not yet issued its underlying reasoning for today's decisions. Teva continues to believe the patent is invalid and unenforceable and intends to pursue all available legal remedies including appeals."
http://maya.tase.co.il/bursa/report.asp?report_cd=557091-00&CompCd=629&Type=Pdf
CBST/Cubicin patent litigation with TEVA - The trial is scheduled to begin on April 25, 2011.
http://www.cubist.com/investor_relations/management_qa.php
Except for the chubby chasers
Qnexa slightly affects the level of estrogen I am not sure if its the reason for pregnancy.
What will be an effective pregnancy prevention plan?
VVUS - I think the FDA will go with the panel recommendation and ask for a CV outcomes study before approving. Risk with SSRI can be managed via label warning.
I would like to know how VVUS is going to address that concern even with a longer study
Good call.
Re: Reference links
HIV drugs on market and in development
Merck announced July 14 that it is abandoning development of vicriviroc, the company’s CCR5-blocking HIV entry inhibitor candidate.
http://www.aidsmeds.com/articles/hiv_vicriviroc_merck_1667_18742.shtml
No worries - I dislike shooting, always use my bare hands
Such anonymous letters should be ignored imo.
LapBand is a very good product
Peter, the editorial on lorcaserin data titled - Drug Management of Obesity — Efficacy versus Safety
http://content.nejm.org/cgi/content/short/363/3/288
was also kind of positive:
Lorcaserin therapy also resulted in slight, but clinically relevant, improvements in almost all reported surrogate measures of diabetes and cardiovascular risk. These findings are important in light of the problems with drugs such as rimonabant and sibutramine, which do not produce similar reductions in blood pressure, heart rate, and levels of low-density lipoprotein cholesterol that would be expected with the weight loss achieved.
...The justification for using lorcaserin to manage obesity is not greater efficacy than currently available drugs, but rather an apparently much better safety and adverse-event profile and very clear-cut beneficial effects on risk factors for type 2 diabetes and cardiovascular disease.
The FDA is having a public meeting to discuss regulation of Laboratory Developed Tests (LDTs), Direct to Consumer (DTC) Testing, personalized medicine:
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212830.htm
Vpriv head start is nearly done in the sense of capturing Cerezyme switchers during the shortage because Shire is reaching its production capacity limit and it will take at least a year before it will be able to ramp it up. GENZ is still at half production capacity and said this should improve gradually. So, not getting a priority review is not a disaster but certainly disappointing for PLX.
Not only Effient present sales are gloomy, its future looks even worse especially if brilinta is approved, as you've noted #msg-41731834. The platelet function test - VerifyNow holds a slim chance to increases the use of Effient, imo.
Eli Lilly Pitches Blood Test to Aid Sales of Blood Thinner [Effient]
http://prescriptions.blogs.nytimes.com/2010/07/12/eli-lilly-pitches-blood-test-to-aid-sales-of-blood-thinner/
By ANDREW POLLACK, July 12, 2010, 3:11 pm
Eli Lilly is about to try a new tack to help flagging sales of its new anti-clotting drug, Effient. It will urge doctors to test patients taking a rival drug, Plavix, to see if it is working. If it isn’t, doctors would presumably switch patients to Effient.
Lilly said on Monday that its sales representatives would tell doctors about a blood test offered by Accumetrics that physically measures clotting ability after patients take anti-platelet drugs like Effient and Plavix. Daiichi Sankyo, Lilly’s partner on Effient, will also participate in the effort.
The collaboration is an example of how pharmaceutical companies and diagnostics companies can work together for mutual advantage.
“We’ve had a mutual interest in promoting the fact that many patients don’t get the appropriate level of platelet inhibition,’’ said Steve Schaefer, senior director of marketing for Lilly’s cardiovascular business unit.
Effient was expected to be a blockbuster, but in its first three quarters on the market sales have totaled just $35 million. By contrast, Plavix, sold by Bristol-Myers Squibb and Sanofi Aventis, has billions of dollars in annual sales.
Both drugs prevent platelets from clumping together to form a clot. The drugs are used by patients who have undergone artery-opening procedures like stenting. Effient was better at preventing heart attacks and strokes than Plavix in its main clinical trial, but it also caused more bleeding incidents, including fatal ones. There is also some suggestion, disputed by Lilly, that Effient is associated with a higher cancer risk than Plavix.
Timothy I. Still, president of Accumetrics, a privately held company in San Diego, said that the use of his company’s test suggests that one-third of the people taking Plavix might not be getting the full benefit of the drug in preventing heart attacks and strokes.
However, Accumetrics is only now doing a study aiming to demonstrate that patient outcomes are improved if its test is used to guide therapy. The tests, called VerifyNow, cost about $60 each, though laboratories also need a machine to run them on, which costs at least $8,000.
Mr. Schaefer of Lilly, who said Effient sales were improving, said the collaboration was not aimed at Plavix and would also urge doctors to test patients receiving Effient.
Still, since Plavix has the dominant market share, wider use of the test is likely to find far more people for whom Plavix isn’t working.
Certain genetic variations in a patient’s DNA can also diminish the effectiveness of Plavix. Lilly has said Effient will work for many of these patients. Mr. Schaefer said the Accumetrics test provides a faster answer than a genetic test.
VVUS is asking for Category C but with warnings for Category X (pregnancy is an absolute contraindication).
I doubt you'll see the Israeli product in the US in the near future.
On the mild bilirubin elevations seen in the TMC435 arms - PR doesn't say what was the conjugated bilirubin portion, so indeed too soon to opine on hepatotoxicity.
Here's a different take:
Why the FDA Will Likely Reject 3 New Weight Loss Drugs
By Jim Edwards | Jul 12, 2010
http://industry.bnet.com/pharma/10008897/why-the-fda-will-likely-reject-3-proposed-new-weight-loss-drugs/?tag=shell;content
The first of three new diet drugs — Vivus (VVUS)’s Qnexa – comes up for a vote at the FDA on July 15, and its fate will send a strong signal about the likelihood of its two rivals (Arena (ARNA)’s lorcaserin and Orexigen (OREX)’s Contrave) also getting a thumbs up. The mood surrounding lifestyle drugs has darkened at the FDA, suggesting that all three may get rejected.
The feds almost unanimously kicked out Boehringer Ingelheim’s flibanserin, a re-purposed antidepressant for female libido, on both safety and efficacy grounds even though the drug did not display any particularly worrying side effects.
As all three diet drugs have either safety or efficacy concerns, the chances of any of them getting the green light seem reduced. There are no FDA briefing documents available for any of the drugs yet — although we do know that the FDA insists any drug be at least 5 percent more effective than a placebo — so let’s recap what we know about each:
* Vivus’s Qnexa: is a combination of phentermine (a bit like speed) and the anti-seizure drug topiramate, commonly known as Topamax.
Efficacy: 59 - 84 percent in a study lost 5 percent or more of their body weight. Those on placebo lost 26 percent.
Safety: Phentermine can be habit forming and can have cardiovascular side effects. The warnings for Topiramate include kidney stones, suicide and a type of ammonia poisoning. (hyperammonemia and encephalopathy).
* Arena’s lorcaserin: This is a new drug and so much less is known about it than the combinations of existing drugs that the other two companies are proposing.
Efficacy: “More than twice as many lorcaserin patients (47.1%) achieved at least 5% body weight loss compared to placebo (22.6%),” the company says. However on average patients lost 7.9 percent of their body weight, whereas placebo-takers lost 3.9 percent. That seems to be less than the FDA’s 5 percent better standard.
Safety: The company reports few side effects. Lorcaserin seems to be the safest drug of the three. In a study of abuse potential, Arena says the drug has low abuse potential, but it tested lorcaserin against Ambien (a sleeping pill controlled by the DEA) and ketamine (a veterinary anesthetic better known as Special K to the nightclub crowd), which doesn’t seem like a tough competition to win.
* Orexigen’s Contrave: is a combination of naltrexone, used to fight alcohol and drug addiction (as Vivitrol), and the antidepressant bupropion.
Efficacy: 11.9 - 15.7 percent of patients on Contrave lost more than 10 percent of their weight. Placebo takers lost 2 - 2.4 percent.
Safety: “Seven serious adverse events were attributed by investigators as possibly related to Contrave treatment. These include cholecystitis (gallbladder inflammation) , seizure, palpitations, paresthesia and vertigo,” the company says. Most seriously, naltrexone already carries a black box warning for liver damage, with a narrow range between safe and dangerous doses. Buproprion, already on the market as Wellbutrin, carries a boxed warning for suicide.
Of the three drugs, Contrave appears least likely to be approved. Two boxed warnings equals two red flags, surely, especially for patients whose cardiovascular systems are already under stress from excessive weight. And if Qnexa, the first horse out of the gate, gets rejected, then Lorcaserin must surely be doubtful also.
Drug shortage in Israel is not that bad as far as I know because many patients switched to PLX's drug. Normally drugs are approved in Israel shortly after being approved by the FDA or the EMEA and hardly ever before, so I don't see this happens.
Ikaria filed for up to $200 mln IPO on May.
PLX/PDUFA date - they got standard review time of ten months (not a 6-month priority review), assigning a PDUFA action date of February 25, 2011.
http://finance.yahoo.com/news/Protalix-BioTherapeutics-prnews-2149859161.html?x=0&.v=1
Will be interesting and more convincing to see if diabetic retinopathy developed more slowly among patients with higher baseline TG levels.
(I haven't read the manuscript, just the abs. but I don't think they've looked at this subgroup).
Meanwhile, here are two responses to that paper:
Prof. Albert Farrugia from the Plasma Protein Therapeutics Association:
Statement on Review - Intravenous Alpha-1 Antitrypsin Augmentation Therapy
http://www.pptaglobal.org/news/news.aspx?nid=61
The authors of the ‘Review’ claim that their analysis is limited to just their two trials with a total of 140 patients because these are the only studies which were classifiable as randomized clinical trials (RCTs). The authors dismiss the meta-analysis of five trials, four of which were non-randomized, performed in 2009 by Professor Chapman in Toronto, Canada, which shows that treatment of 1500 patients confers benefit in alpha-1 antitrypsin deficiency. It has been pointed out by many eminent medical authorities that performing RCTs on small numbers of patients with rare disorders is fraught with statistical limitations and ethical problems. The use of non-randomized studies, such as in Professor Chapman’s meta-analysis, is an entirely valid approach to studying treatments in these patients. Excluding the majority of a patient population in the name of dogma is not conducive to optimal patient care.
It is interesting to note, however, that the two studies which were included by the authors of the ‘Review’ both stated that there is a benefit in AAT augmentation for patients with AAT deficiency. The investigators comment on the difficulty in getting a statistically valid result with the small number of patients at their disposal, but note that emphysema was delayed in patients on AAT, and that exacerbation severity in treated patients was reduced. The investigators also validated the use of computed tomography (CT) densitometric assessment of lung tissue, using this technique to assess lung structure and function. They show that CT analysis is a more sensitive indication of lung status, than the parameters used by the ‘Review’ authors.
In summary, this ‘Review’ represents an arbitrary and dogmatic interpretation of clinical findings in AAT augmentation therapy, much of which is challengeable by the limited studies cited and by the much wider experience in the treater community.
“This conclusion was based on retrospective analysis of published data from only two small pilot placebo-controlled studies that were not powered to evaluate the effectiveness of augmentation therapy. This flies in the face of carefully crafted guidelines from the American Thoracic Society, the European Respiratory Society, the American College of Chest Physicians, and the American Association for Respiratory Care – all prestigious organizations that recommend augmentation therapy for the treatment of patients with lung disease due to Alpha-1. The guidelines are based on the totality of the evidence, scientific understanding of the disease, correcting the biochemical defect, and a wealth of observational studies.”
I think for shorter use but in elderly as well...
Re: Researchers Say Drugs for AAT Deficiency Are Useless
I have read the review by Gotzsche and Johansen and here are a few points I would note:
They only looked at 2 studies that were not powered to show statsig efficacy, were quite different (even AAT dose was not the standard), had many dropouts in the placebo groups, they mainly looked at FEV1, which is not the best endpoint in the disease and doesn't reflect loss of lung tissue, and did not report mortality data (mortality is a very important outcome in this disease). So, while I agree that clinical trials with proper end points are needed to demonstrate efficacy of AAT augmentation therapy in alfa-1 antitrypsin deficiency, I certainly object to the authors' conclusion that the treatment is usless.
Circadin is indicated for the treatment of primary insomnia in patients who are aged 55 or over.
Not joking, it was in the Irish Times.
Circadin was approved in EU 3 years ago: #msg-23144359 and Neurim said that it has applied to the FDA and this would take at least two years. Guess it takes longer then they expected. If I were over 55 and insomniac, I'd give it a try.
Scangos wants to help Tysabri's performance by a 18.7% price hike:
http://online.wsj.com/article/BT-CO-20100702-708335.html?mod=WSJ_World_MIDDLEHeadlinesEurope
Pretty big price hike. Copaxone's last price hike was 8% on May.
That explains.
Remember the first time we've talked about the name I also thought the company must have Israeli roots since 'lev' means 'heart' in Hebrew and the company was also developing (or at least said so) C1-INH as a treatment for heart attack (AMI) at the time. Perhaps medchal's Hebrew is better than yours :)