Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
AGN’s 1Q10 Lastisse sales were surprisingly low
There's another mGluR5 antagonist in FXS but it is behind NVS' candidate
http://clinicaltrials.gov/ct2/show/NCT00965432?term=NCT00965432&rank=1
Edit:
This one started phase II last Nov. so it is also behind:
http://clinicaltrials.gov/ct2/show/NCT01015430?term=NCT01015430&rank=1
I, as you understood, meant the BENEFIT and BENEFIT-EXT studies.
One point on efficacy: belatacept was compared to cylcosporine not to tacrolimus, which is used more often, considered more potent and does not harm kidney function as much. Also, the panel highlighted safety problems seen in belatacept's clinical studies - high acute rejection rate, post-transplant lymphoproliferative disease and PML. lastly, belatacept has another commercial disadvantage as it is given iv whereas both tacrolimus and cylcosporine are given orally.
That of course came as a surprise to them, as NS5A had no enzymatic activity and an unknown function.
Patients switching from Fabryzyme to Replagal will increase even more in EU since the EMEA has recommended in Apr. to do so.
BMRN
Unfortunately, the phase III trial will probably have a primary endpoint of 6-minute walk distance :)
Shire said they have about 500 patients on Vpriv but majority are not paying yet but in time, maybe even as soon as Q2 we'll see a boost in sales. Btw, they also said Replagal has added about 400 patients during the last two quarters.
BMRN expects to initiate a pivotal Phase III trial in Morquio in the fourth quarter of 2010.
Study sharpens focus on Glaxo's heart drug (darapladib ) hope
http://www.reuters.com/article/idUSLDE63T07T20100430?type=marketsNews
* Study highlights Lp-PLA2 enzyme link to heart disease
* Link may play similar role to blood pressure, cholesterol
* Glaxo developing darapladib drug to target Lp-PLA2
(Adds comment from British Heart Foundation)
By Kate Kelland
LONDON, April 30 (Reuters) - A way of fighting heart disease being pioneered by GlaxoSmithKline <GSK.L> won a potential boost on Friday from a scientific study that stressed the significance of an artery-clogging enzyme.
A study published in The Lancet medical journal suggests that the enzyme, known as lipoprotein-associated phospholipase A2, or Lp-PLA2, plays as much of a role in the risk of heart disease as high blood pressure and bad cholesterol.
Alex Thompson and John Danesh of Cambridge University, who conducted the research, said their findings would sharpen focus on an experimental drug called darapladib being developed by Glaxo and currently being studied in two large-scale clinical trials involving 27,000 patients worldwide.
"This reinforces interest in this enzyme, and reinforces the need to see the results from these clinical trials," Thompson said in a telephone interview.
Results of the trials are expected between 2012 and 2014.
Coronary heart disease is the leading cause of death worldwide, responsible for around 7 million deaths a year.
Smoking, diabetes, high blood pressure and high levels of "bad" cholesterol known as LDL are known to cause heart disease, but they do not entirely explain its incidence, so scientists and drug companies have been investigating other links.
Glaxo discovered darapladib through the use of gene technology from Human Genome Sciences <HGSI.O>, which has an agreement with Glaxo to receive clinical development milestone and royalty payments for such compounds.
It is the first in a new class of drugs targeting Lp-PLA2 and is designed to offer something beyond the hugely successful class of cholesterol-lowering statin drugs like Pfizer's <PFE.N> Lipitor and AstraZeneca's <AZN.L> Crestor.
Darapladib seeks to cut the risk of artery-clogging plaques rupturing, blocking blood vessels and triggering heart attacks.
Peter Weissberg, medical director of the British Heart Foundation charity, said he hoped Friday's study would stimulate more research into other drugs that could reduce Lp-PLA2 level.
"The acid test will then be to find out if such drugs reduce the risk of heart attacks and strokes in large clinical trials," he said. "It will be some time yet before we have the answers." Thompson and Danesh looked at links between Lp-PLA2 and risk of heart disease, stroke and death in almost 80,000 people in 32 previous studies.
They found that higher blood levels of Lp-PLA2 were associated with increased risk. For heart disease, the size of the increased risk was similar to that from higher blood pressure or bad cholesterol, they said.
But they said their analysis, which was mostly of data for people in North America and Europe, also showed weaker than expected links between heart disease and blood pressure and bad cholesterol.
"This enzyme in this study was as strongly associated with heart disease as blood pressure and cholesterol, but we need to be cautious in interpreting that because the associations of blood pressure and cholesterol were themselves substantially lower than we would have expected," Thompson said.
He said this may be because many patients in the studies were already taking heart medications that would alter their blood pressure or cholesterol levels.
Very interesting and probably most important basic research on the mechanism of gene control:
Embryonic stem cells reveal oncogene’s secret growth formula
http://www.wi.mit.edu/news/archives/2010/ry_0429.html
CAMBRIDGE, Mass. (April 29, 2010) — A comprehensive new gene expression study in embryonic stem cells has uncovered a transcription control mechanism that is not only more pervasive than once thought but is also heavily regulated by the cancer-causing gene c-Myc.
In research published in the April 30th edition of Cell, a team of Whitehead Institute researchers describes a pausing step in the transcription process that serves to regulate expression of as many as 80% of the genes in mammalian cells.
“It’s like the engine’s running, but the transmission is not engaged on that transcription apparatus,” says Whitehead Member Richard Young. “You need something to engage that transmission.”
Scientists have long known that DNA-binding transcription factors recruit the RNA polymerase Pol II (which prompts copying of DNA into mRNA protein codes) to promoters in order to kick off the transcription process. Now researchers in the lab of Whitehead Member Richard Young have found that additional factors recruited to the promoters serve to stop transcription in its tracks shortly after it’s begun.
“It’s like the engine’s running, but the transmission is not engaged on that transcription apparatus,” says Young, who is also a professor of biology at MIT. “You need something to engage that transmission.”
It turns out that for a surprisingly large number of genes in embryonic stem cells, that “something” is the transcription factor c-Myc. This so-called pause release role for c-Myc is significant, as many of c-Myc’s targets are genes in highly proliferative cells. Over-expression of c-Myc is a hallmark of a number of tumors, and it now appears that c-Myc’s ability to release transcriptional pausing is linked with the hyper-proliferation that is characteristic of cancer cells.
“Our findings provide the molecular basis for loss of proliferation control in some cancers,” says Peter Rahl, a postdoctoral researcher in Young’s lab and first author of the Cell paper.
Armed with this new understanding of c-Myc’s role in controlling proliferation genes, Young and his colleagues have embarked on a search for drugs that could interrupt c-Myc’s pause-release activity in tumors where it’s over-expressed.
“Clearly, cancer cells are able to exploit mechanisms that normally operate in embryonic stem cells,” says Young, “so I expect further understanding of embryonic stem cell control mechanisms will give us additional insights into human disease mechanisms.”
This research was supported by the National Institutes of Health (NIH) and National Cancer Institute (NCI).
Written by Nicole Giese.
* * *
Richard Young’s primary affiliation is with Whitehead Institute for Biomedical Research, where his laboratory is located and all his research is conducted. He is also a professor of biology at Massachusetts Institute of Technology.
* * *
Full Citation:
“c-Myc regulates transcriptional pause release”
Cell, April 30, 2010.
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Added ASCO, WOC, EHA, NCDEU, EULAR, ENDO, ENS, ADA, EACR.
APRIL 2010
European Lung Cancer Conference - ESMO
Geneva, Switzerland
April 28 - May 1, 2010
http://www.esmo.org/events/lung-2010-iaslc.html
MAY 2010
American Association of Neurological Surgeons - AANS
Philadelphia, PA
May 1-5, 2010
http://www.aans.org/
Digestive Disease Week - DDW
New Orleans, LA
May 1-5, 2010
http://www.ddw.org/
Society of Thoracic Surgeons - AATS
Toronto, ON, Canada
May 1-5, 2010
http://www.aats.org/annualmeeting/
Association for Research In Vision and Ophthalmology - ARVO
Fort Lauderdale, Fl
May 2 – 6, 2010
http://www.arvo.org/EWEB/startpage.aspx?site=am2010
World Congress on Osteoporosis - IOF
Florence, Italy
May 5-8, 2010
http://www.iofwco-ecceo10.org/
International Congress on Autoimmunity
Ljubljana, Slovenia
May 5-9, 2010
http://www2.kenes.com/auto2010/Pages/Home.aspx
American Pain Society - APS
Baltimore, MD
May 6-8, 2010
http://www.ampainsoc.org/
World Stem Cells & Regenerative Medicine Congress
London, UK
May 11-13, 2010
http://www.terrapinn.com/2010/stemcells/
The Heart Rhythm Society - HRS
Denver, CO
May 12-15, 2010
http://www.hrsonline.org/Sessions/
American Thoracic Society - ATS
New Orleans, LA
May 14-19, 2010
http://conference.thoracic.org/
American College of Obstreticians & Gynecologists - ACOG
San Francisco, CA
May 15-19, 2010
http://www.acog.org/
American College of Radiology - ACR
Washington, DC
May 15-19, 2010
http://www.acr.org/
American Society of Gene & Cell Therapy - ASGCT
Washington, DC
May 19-23, 2010
http://www.asgct.org/
International Society on Thrombosis & Haemostasis - ISTH
Cairo, Egypt
May 22-25, 2010
http://www.isth.org/
American Society for Microbiology - ASM
San Diego, CA
May 23-27, 2010
http://www.asm.org/
American Urological Association - AUA
San Francisco, CA
May 29 - June 3, 2010
http://www.auanet.org/content/homepage/homepage.cfm
JUNE 2010
American Society of Clinical Oncology - ASCO
Chicago, IL
June 4-8, 2010
http://chicago2010.asco.org/Home.aspx
World Ophthalmology Congress - WOC
Berlin, Germany
June 5-9, 2010
http://www.woc2010.org/
European Hematology Association - EHA
Barcelona, Spain
June 10-13, 2010
http://www.ehaweb.org/
European Society of Human Genetics - ESHG
Gothenburg, Sweden
June 12-15, 2010
https://www.eshg.org/
Psychopharmacologic clinical research - NCDEU
Boca Raton, FL
June 14-17, 2010
http://www.ncdeumeeting.org/NCDEU%202010.htm
European League Against Rheumatism - EULAR
Rome, Italy
June 16-19, 2010
http://www.eular.org/
Endocrine Society - ENDO
San Diego, CA
June 19-22, 2010
http://www.endo-society.org/
European Neurological Society - ENS
Berlin, Germany
June 19-23, 2010
http://www.ensinfo.org/
American Diabetes Association - ADA
Orlando, FL
June 25-29, 2010
http://www.diabetes.org/
European Association for Cancer Research - EACR
Oslo, Norway
June 26-29, 2010
http://www.eacr.org/
OCTOBER 2010
American Association for the Study of Liver Diseases - AASLD
Boston, Massachusetts
October 29 - November 2, 2010
http://www.aasld.org/
NOVEMBER 2010
American Society of Human Genetics - ASHG
Washington, DC
November 2-6, 2010
http://www.ashg.org/
----
Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting any new items in chronological order.
3. Near the top of the message, give a very brief description of your changes (e.g. “Edits: Added entry for AASLD”).
4. Post the updated calendar in a new message as a reply to the message with the old calendar.
As before (#msg-46565490), Roche discloses very little information on HbA1c and AE, but data will be presented at ADA.
Makes me wonder whether a subdermal implant of a very slow release form of the drug might be preferable. Something along the lines of an insulin pump or slow release drug implants.
Good news for ACOR:
Two projects in Phase II were discontinued. Data on Nerispirdine in improving the ability to walk in multiple sclerosis patients, and on SSR411298 in major depressive disorders, did not support progression to Phase III trials.
Shire booked sales of $5.8M for Vpriv (velaglucerase for Gaucher) in 1Q.
http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201004290728dowjonesdjonline000471&title=shire-1q-net-falls-on-adderall-hit-but-newer-drugs-shine
On BCX-4208 safety
this PNP inhibitor’s ability to reduce uric acid levels in the blood
NeuroSearch/Huntexil - another one bites the dust in Huntington’s disease
NeuroSearch shares fall 41 pct on key drug study
http://www.cnbc.com/id/36820860
COPENHAGEN, April 28 (Reuters) - Shares in Danish biopharma firm NeuroSearch plunged as much as 41 percent after a new study on its Huntington's disease drug, Huntexil, heightened uncertainty about whether the drug would come to market. When NeuroSearch announced preliminary positive results from a Huntexil clinical Phase 3 study in early February, the shares almost tripled in value. On Wednesday new findings from the same study were released and they showed, contrary to the preliminary findings, results did not meet the "primary endpoint" which the company had set out for the drug to achieve. But the company said the results were still positive. "Overall, the study results confirm the unique and clinically meaningful effect and good safety profile of Huntexil," NeuroSearch said in the statement. Sydbank analyst Rune Dahl said it was bad that the study had not reached the primary endpoint. "This obviously increases the uncertainty as to whether they can get this (Huntexil) approved," he said, adding NeuroSearch may have to launch new studies, which would push forward the point in time when the company might start generating revenue. NeuroSearch Chief Executive Flemming Pedersen told a conference call that the company was not planning any new studies and was "confident about bringing Huntexil to market". "Changes in the significance level are always inconvenient but that does not change the overall picture for Huntexil," he said. On Wednesday, NeuroSearch did not give a timeline for when it hoped to get regulatory approval from the U.S. Food and Drug Administration, the European Medicines Agency, and the Pharmaceuticals and Medical Devices Agency in Japan. In February, NeuroSearch said Huntexil could win regulatory approval by end-2011 and that the drug could be launched at the start of 2012. Separately, NeuroSearch said in its first-quarter report that its capital resources totalled 907.3 million Danish crowns ($162.4 million) at end-March. It raised more than 400 million crowns through a rights issue in November. The company's shares trimmed some losses to trade 20.93 percent lower by 1036 GMT.
Novo Nordisk Q1 beats forecasts, raises outlook
http://www.forexyard.com/en/news/Novo-Nordisk-Q1-beats-forecasts-raises-outlook-2010-04-27T104412Z-UPDATE-3
* Q1 operating profit 4.38 bln DKK, beats 3.88 bln fcast ($1=5.584 Danish Crown)
* Says U.S. prescription data encouraging for Victoza sales
* Victoza Q1 sales 370 million DKK, two-thirds is stocking
* Raises 2010 operating profit, sales guidance
* Shares up 1 percent, outperform European peers
By Anna Ringstrom and Karin Jensen
COPENHAGEN, April 27 (Reuters) - World No.1 insulin maker Novo Nordisk posted forecast-beating first-quarter profits, helped by strong sales of new potential blockbuster drug Victoza and its modern insulins, and raised its outlook.
Operating profit rose to 4.38 billion Danish crowns ($784 million) from 3.81 billion a year earlier, beating all analyst estimates in a Reuters poll.
"The increasing use of our modern insulins is the primary driver of growth," Chief Executive Lars Rebien Sorensen said. "Furthermore, the roll-out of Victoza, our new treatment for type 2 diabetes, is progressing well in both the U.S. and Europe."
U.S. healthcare reform had a minor negative sales impact.
Group sales rose 9 percent to 13.7 billion crowns, beating a forecast 13.5 billion. Sales in the biggest product group, modern insulins, rose 17 percent to 5.86 billion crowns, topping a forecast 5.84 billion.
Victoza, which after delays was launched in nine European countries last year and in the United States in February, is now commercially available in 15 countries.
"The initial performance in the U.S., as measured by prescription level data, is encouraging," Novo said.
Sales of Victoza reached 370 million crowns in the quarter. But suppliers' stock building accounted for two thirds, and Deutsche Bank said in a note that suggested a weaker trend this quarter.
The bank said launch costs had been lower than expected.
Novo expects its biggest new drug hope, due for launch in Japan this quarter, to be a blockbuster, meaning it would reach $1 billion in sales within its first five years on the market, despite the U.S. approval including a boxed cancer warning.
Novo Chief Financial Officer Jesper Brandgaard told Reuters he expected Victoza sales to fall this quarter. "From there, it will grow. We'll be very disappointed if we don't exceed 1 billion crowns in Victoza sales this year."
"We see a very stable uptake of patients week for week."
Novo is however bracing for fiercer competition.
After delays, Eli Lilly and Amylin Pharmaceuticals Inc expect U.S. approval this year for Bydureon, a once-weekly version of their Byetta.
Taspoglutide, under development by Roche Holding AG and Ipsen SA, is another once-weekly GLP-1 drug for Type 2 diabetes.
Brandgaard said he hoped use of GLP-1 class drugs, to which Victoza belongs, would grow to 5 percent of the diabetes care market in the next few years from a current 3 percent.
RAISES OUTLOOK
"It's a good report with a small (outlook) upgrade. Victoza has had a really good start," said Sydbank analyst Rune Dahl.
Novo raised its 2010 outlook to see sales growth in local currencies of 7-10 percent and reported growth around 3 percentage points above that.
"This should allay any fears that the market may have had about the impact of U.S. healthcare reform," PiperJaffray said in a note.
Novo forecast operating profit growth in local currencies of more than 10 percent, with reported growth around 6 percentage points above that.
The previous guidance, given in February, had been for sales growth of 6-10 percent and profit growth of around 10 percent.
"The market had expected an upgrade and Novo delivered," said Soren Sorensen, head of equities at Amagerbanken. "The results confirm that the share price rise we have seen has been justified," he said.
Some analysts said the outlook was still conservative and there was room for more upgrades.
Shares in Novo, which have outperformed European peers this year, were up 1 percent at 1009 GMT while the STOXX 600 European healthcare index was down 1 percent.
Morgan Stanley said the value of Novo's shares still lagged improving fundamentals. "Novo is a structural growth story with limited patent risk ... and expanding margins."
Gilead Finalizes Selection of Bioequivalent Formulation for the Fixed-Dose Regimen of Truvada® and Tibotec Pharmaceuticals' TMC278
http://finance.yahoo.com/news/Gilead-Finalizes-Selection-of-bw-3098125952.html?x=0&.v=1
Gilead Sciences, Inc. (Nasdaq:GILD - News) announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg). A bioequivalence study is required to demonstrate that a co-formulated product results in the same levels of medication in the blood as achieved when the individual products are dosed simultaneously as separate pills. Gilead anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the fixed-dose combination following validation of the TMC278 NDA.
Aricept
I wonder why was the most important patent, which was also the first one issued to Eisai in Nov 1999, added to the Orange Book too late.
I think that Aricept does not have Hatch-Waxman data exclusivity protection anymore. Teva filed ANDA on Oct, 2004, with Para IV certification against ‘864, ‘321, ‘911, ‘760 and Para III against patent ‘841. Later, in Oct, 2005, Teva amended it’s ANDA with Para IV against patent ‘841 (the only one that Eisai is defending). Due to Para IV filing against product patent, Teva also got First Filer status.
Upon the April, 2008 expiration of the 30-month Hatch-Waxman stay, the prior FDA tentative approval of ANDAs could then be made a final approval.
OT
No worries aj, just get a decent firewall and an anti-hacker software
Merck: Health overhaul to cost roughly $320M
http://www.google.com/hostednews/ap/article/ALeqM5ha_-qI-b20ems8VnQZOpAqXEjyNQD9F90RO81
By LINDA A. JOHNSON (AP) – 2 days ago
TRENTON, N.J. — The drugmaker Merck & Co. said Friday the federal health care overhaul will reduce its revenue by about $170 million this year and by roughly double that amount next year — less than the impact some rivals have reported. Its shares rose on the news.
Merck also expects to take a non-cash charge of about $150 million in the first quarter, due to elimination of the tax benefit for providing prescription drug coverage to company retirees.
Merck said new rebates to the Medicaid program, required in the federal health care legislation passed last month, and other changes will reduce its revenue by about $35 million in the first quarter and $170 million for all of 2010. In 2011, the company said it expects unfavorable sales impact of about $300 million to $350 million.
Despite those costs, Merck said that it is still aiming to produce compound annual growth in the high single digits excluding one-time items through 2013 compared with its 2009 results.
"The impact is less than what we might have otherwise guessed," analyst Dr. Timothy Anderson of BernsteinResearch wrote in a note to investors.
Anderson calculated that based on the percentage of Merck sales coming from the United States, the legislation's earnings-per-share impact would be about 1 percent this year and about 2 percent next year. He previously estimated those hits would be roughly 4 percent and 6 percent for 2010 and 2011, respectively.
Merck shares rose $1.69, or 5 percent, to $35.46 in trading Friday. Other U.S. drugmakers also saw their shares rise significantly.
Merck, based in Whitehouse Station, is the maker of asthma and allergy drug Singulair and cholesterol drugs Vytorin and Zetia. It is slated to report its first-quarter results on May 4.
Numerous other major U.S. companies have been taking large charges for the lost prescription drug tax benefit as the first-quarter corporate earnings season proceeds.
On Monday, when drugmaker Eli Lilly & Co. reported its first-quarter results, it took one-time charges totaling 12 cents per share: $85 million related to retiree prescription drug coverage and $60 million for higher Medicaid rebates. It expects Medicaid-related rebates to shrink revenue by $350 million to $400 million this year.
Shares of drugmakers generally dropped the next few days as investors worried about the potential impact of the health overall on the pharmaceutical industry.
On Tuesday, Johnson & Johnson, which makes medical devices and prescription and over-the-counter drugs, said government rebates under the health care overhaul would reduce its 2010 revenue up to $500 million and its profit by about $300 million, or 10 cents per share. J&J did not take a charge related to retiree prescription benefits, however.
On Wednesday, Abbott Laboratories said the bigger Medicaid rebates had slashed its sales by about $60 million at the end of the first quarter. It also took an after-tax charge of $60 million related to the lost tax benefit for retiree prescription drug coverage.
Johnson & Johnson Chief Executive William Weldon said Tuesday he expects the health overhaul to cost the pharmaceutical industry about $4 billion this year, $11 billion next year and a total of $100 billion to $115 billion over the next decade.
Pfizer Inc., the world's biggest drugmaker, and another major U.S. drugmaker, Bristol-Myers Squibb Co., have not disclosed what impact they expect. They are set to report their first-quarter results on May 4 and April 29, respectively.
Meanwhile, Nycomed and Merck today announced that they have entered into a co-promotion agreement for Canada and certain European countries for the commercialization of Daxas.
http://www.merck.com/newsroom/news-release-archive/corporate/2010_0426.html
I didn't think silly, just improbable.
(silly and you don't match)
Sutent is so well established as the favorable 1st line in RCC and very potent in this setting that I think it would be a mission impossible for Onyx to make inroads in kidney cancer.
So, you're in?
Micromedic
Their most important test for blood levels of the CD24 protein could be approved in the EU by mid next year for identifying patients who would benefit most from colonoscopy.
Here is the ASCO abs:
Use of a simple blood test evaluating the level of CD24 protein to detect subjects with adenomas
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=72&abstractID=1774
Meeting:
2010 Gastrointestinal Cancers Symposium
Session Type and Session Title:
General Poster Session C: Cancers of the Colon and Rectum
Abstract No:
286
Background: CD24 is a cell surface protein and P-selectin ligand, involved in cell adhesion and metastasis. Using gene expression array we have shown that CD24 expression is associated with colorectal cancer (CRC) (Sagiv E, et al. Gastroenterology 2006;131:630-9). The data was confirmed by IHC staining showing expression of CD24 in ~90% of adenomas and adenocarcinomas. The aim of the study was to evaluate CD24 protein expression in peripheral blood lymphocytes (PBLs) from normal, adenoma, and CRC subjects. Methods: We initially recruited 150 consecutive subjects attending Tel Aviv Souraski Medical Center. Each consented individual underwent colonoscopy. PBLs were isolated from blood samples and protein extracts were subjected to SDS-PAGE and Western blotting using anti-CD24. The samples were also externally evaluated. A second validation trial was conducted which included 73 consecutive subjects. Band intensities were scanned and tested for statistical significance. Sensitivity and specificity for CD24 was calculated using receiver operating characteristic (ROC) curves. The study was approved by the Israel Ministry of Health. Results: Among the patients that we first analyzed, 63 had colorectal cancer (CRC), 19 had adenomas, and 68 had normal colonoscopies. The sensitivity and specificity of the CD24 test for distinguishing CRC from normal subjects was 70.5% (95% CI, 54.8-83.2%) and 83.8% (95% CI, 74.6-92.7%), respectively, and for the detection of advanced adenomas was 84.2% (95% CI, 60.4-96.4%) and 73.5% (95% CI, 61.4-83.5%), respectively. The results obtained in the external evaluation slightly varied. Improved values were achieved in the validation trial. Thus, the sensitivity for the detection of CRC was 92.3% (95% CI, 63.9-98.7%), with similar specificity, whereas the specificity for detecting adenomas was higher, 89.2% (95% CI, 74.6-96.9%). Conclusions: This blood test is the first of its kind to be able to detect adenomas. It can also successfully distinguish CRC from healthy subjects. CD24 may serve as a new potential and promising blood biomarker for the early detection and CRC surveillance.
I'll make sure you get the credit for the unforgettable pointer from #msg-44614277
Teva was down 2.4% at TASE today on these news.
I'm having hard times imagining who will play Dr. Rothblatt in OUR movie How does Robin Williams sound to you?
Generic-Protonix
Teva could conceivably be liable for treble damages
Dr. Rothblatt's determination is admirable and the story can be an even bigger Hollywood blockbuster than "Extraordinary Measures".
Novo's Victoza beats Merck drug in diabetes study
http://www.reuters.com/article/idCNLDE63L1SN20100422?rpc=44
Thu, Apr 22 2010
* Victoza lowers blood sugar levels more than Januvia
* Novo exec says uptake meets "optimistic" expectations
* Outside experts: Januvia still has advantages as oral drug
By Ben Hirschler
LONDON, April 23 (Reuters) - Novo Nordisk's <NOVOb.CO> new diabetes drug Victoza proved more effective than Merck & Co's <MRK.N> Januvia in a head-to-head study, boosting prospects for a product that has got off to a strong start in key markets.
Daily injections of both high- and low-dose Victoza reduced blood sugar levels by more than a daily tablet of Januvia in people with type 2 diabetes who had not responded adequately to the older drug metformin, researchers said on Friday.
The results may help the Danish drugmaker, which funded the study published in the Lancet journal, to differentiate its medicine in a highly competitive marketplace.
Victoza is Novo's biggest new drug hope and is expected to generate annual sales of more than $1.4 billion by 2014, according to consensus forecasts compiled by Thomson Reuters.
After a delayed path to market, prescription trends suggest it is now doing well in both Europe and the United States, in contrast to disappointing sales of some other recently launched new drugs, such as Eli Lilly's <LLY.N> bloodthinner Effient.
Mads Krogsgaard Thomsen, Novo's chief scientific officer, said the results followed other positive comparative studies and would bolster Victoza's reputation among medical experts.
"The fact that Novo Nordisk has now done most, if not all, of the major comparator studies against different classes of oral and injectable anti-diabetic drugs really shows our commitment to showing comparative efficacy in a serious way," he said in a telephone interview.
Novo demonstrated two years ago that Victoza controlled blood sugar better than Byetta, a drug from the same class of medicine that is sold by Eli Lilly and Amylin Pharmaceuticals <AMLN.O>.
PROGRESS REPORT
With investors awaiting a progress report on Victoza's sales prospects when Novo reports first-quarter results on April 27, Thomsen said demand for the new drug was following the company's own "optimistic" expectations.
"We have overtaken Byetta in several European markets in the first nine months post launch and in the U.S. we are already seeing, nine weeks into the launch, a rather sizeable uptake," he said.
In the latest study, 1.8 milligrams of Victoza, or liraglutide, lowered levels of HbA1c -- a standard blood measure that is indicative of a patient's glucose levels -- by 1.5 percentage points against 0.9 percent for Januvia, or sitagliptin.
The lower dose of 1.2 mg of Victoza cut HbA1C by 1.2 points in the six-month trial.
Researcher Dr Richard Pratley of the University of Vermont College of Medicine and colleagues said the difference was "clinically relevant", adding that patients on Victoza, which caused some nausea, also lost more weight.
In an accompanying comment, Dr Andre Scheen and Dr Regis Radermecker of Belgium's University of Liege said 1.2 mg of Victoza should be considered as a starting dose in most cases, with patients moving up to 1.8 mg if necessary.
On the downside, they noted that Januvia was cheaper, caused fewer gastrointestinal upsets and "one pill of sitagliptin daily might be judged as easier to administer than one subcutaneous injection of liraglutide daily".
EU agency backs Nycomed's Daxas after U.S. rebuff
http://www.reuters.com/article/idUSLDE63M10W20100423
* European Medicines Agency recommends Daxas for COPD
* Decision follows vote against approval by U.S. panel
* Forest Laboratories has U.S. rights to Daxas
(Adds comment from Nycomed, details on drug)
By Ben Hirschler
LONDON, April 23 (Reuters) - Privately owned Swiss drugmaker Nycomed [NYCMD.UL], which is aiming for an initial public offering (IPO) at some stage, won a consolation prize on Friday as European regulators backed a key lung drug after a recent rebuff in the United States.
The European Medicines Agency said it was recommending approval of Daxas as a maintenance treatment for severe chronic obstructive pulmonary disease (COPD) in conjunction with a bronchodilator.
Nycomed said the once-a-day tablet medicine was expected to be launched in the first European countries later this year, once it was formally given marketing authorisation by the European Commission.
Earlier this month, a U.S. Food and Drug Administration panel voted 10-5 not to recommend Daxas, dealing a blow to Nycomed and its partner Forest Laboratories <FRX.N>, which has U.S. marketing rights to the drug.
The fate of Daxas is key to its developer Nycomed, which has said in the past it wants to launch an IPO but has never given an exact timetable for listing its shares in Switzerland.
Daxas is also pivotal for Forest, which is trying to build its portfolio ahead of the 2012 patent expiration for its huge-selling antidepressant Lexapro.
Industry analysts have estimated peak annual sales could hit $500 million or more -- but the drug's setback in the U.S. has placed its commercial prospects under a cloud.
Daxas, known generically as roflumilast, works by inhibiting an enzyme called PDE4 that is linked to inflammation. Nausea, diarrhoea and weight loss are known side effects of the PDE4 inhibitors.
It could win a niche in the multibillion-dollar worldwide COPD market, alongside rivals such as GlaxoSmithKline's <GSK.L> Advair and Spiriva, marketed by Pfizer <PFE.N> and Boehringer Ingelheim, analysts believe.
HER2
Current testing methods (FISH is considered the gold standard) aren't accurate enough and better tests are definitely needed. Furthermore, we do not fully understand the link between HER2 gene copy number (which is what FISH is testing for) and Herceptin treatment since less than 50% of HER2+ metastatic breast tumors respond to Herceptin monotherapy and some HER2- do respond. So, better tests (in sequence we trust!) and their clinical relevance as well.
ACUR - the writing was on the wall (#msg-49234976)
I'm not aware of any new NRTIs in the future also because tenofovir has a favorable resistance profile (no thymidine-analog associated mutations).