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Teva attempted to have three additional Copaxone patents pertaining to molecular-weight markers [Nos. 6514938, 7074580, and 7163802] included in the litigation, but this request was denied by the Court.
I think the 600-patient trial is a Relapse-Prevention Study with different Outcome Measures than of the three Safety and Efficacy trials.
The two ongoing phase-3 trials in MDD are one larger 700 patients fixed-doses and another just like the one that failed 360 patients flexible-dose.
Discontinuing the drug in more than 6000 patients with a history of stroke also means longer time for the TRA-2P study to have power to assess the effects of vorapaxa.
Solvay did most of that [regulatory]
I am generally skeptical about oral delivery of peptides/proteins/enzymes drugs and the data, which I haven't seen yet are still preclinical, but let's wait for more results.
Interesting part on oral delivery from form 8-K:
Oral GCD for the treatment of Gaucher disease is a plant cell expressed form of GCD that is naturally encapsulated within carrot cells genetically engineered to express the GCD enzyme.
are they in need of cash?
Or are do they have some plans for a huge carrot farm or something smile.
The recovery of Cerezyme supply is on track, with currently treated patients back to full supply and bioreactor performance at the higher end of historical experience. Fabrazyme supply is improving and allocations increased 82 percent from the third quarter to the fourth. ...Fourth-quarter sales of Cerezyme were $224 million compared with $105 million in the same period in 2009, and full-year sales were $722 million compared with $793 million in 2009.
Good antennae! wonder was it safety or efficacy. My guess is more bleeding with vorapaxar.
I always thought GIVN capsules showed great promise, but seemed to fall off the news radar
GIVN Small v/large intestine: Battery life or scope?
One more unpleasant point with virtual colonoscopy scan is a small catheter is inserted into the rectum in order to pump air into the colon. GIVN’s capsule does not require that.
$250 million cash payment upon certain U.S. approval of ABRAXANE® by FDA for NSCLC with progression-free survival claim in U.S. label
Completed Interim Analysis of ABRAXANE(R) Phase III Study in Non-Small Cell Lung Cancer (NSCLC); Interim Analysis of Progression Free Survival (PFS) in the Intent-to-Treat Population, While Not Statistically Significant, Supports Submission of a Supplemental New Drug Application for the Treatment of Advanced NSCLC During the Second Half of 2011. Final Analysis, Including Subset Analyses, Expected to Be Completed and Presented During an Upcoming Medical Meeting.
ACOR reported 4Q10 sales of $55.7M for Ampyra. Sales were $52.6M in in 3Q10 and full-year revenue were $141.4M.
http://www.bloomberg.com/news/2011-01-10/acorda-reports-fourth-quarter-ampyra-sales-of-55-7-million.html?cmpid=yhoo
AUXL’s 4Q10 sales of Xiaflex were $8.4M:
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1514323&highlight=
AUXL said it believes Xiaflex may become a blockbuster drug.
This kind of thing happens a lot with JNJ’s operating divisions.
Far better to get the vaccine than to hack off your foreskin.
The first article refers to TB-403 - the anti-PlGF mAb, ThromboGenics and BioInvent partnered with Roche in June 2008. Results from phase I trial were presented in Nov. 2009 and Roche said it will conduct dose-finding study (before starting phase II, I presume), so should start phase II soon:
http://www.genengnews.com/gen-news-highlights/bioinvent-and-thrombogenics-earn-10m-as-roche-progresses-anticancer-agent/81243419/
Going down some 7-8% on "shelf registration process, we may sell shares of common stock in one or more offerings, up to a total dollar amount of $150,000,000". See page 7:
http://maya.tase.co.il/bursa/report.asp?report_cd=607864-00&CompCd=1554&Type=Pdf
Copaxone price was hiked as of January 4. I tend to think this is not the only reason for the stock to go up and that points mentioned by dewophile also counts.
Novartis gains new indication for Lucentis in EU for DME
http://www.novartis.com/newsroom/media-releases/en/2011/1477848.shtml
A prognostic (a negative predictive biomarker for response to SOC therapy) test for HCV based on plasma protein - CXCL10. Not commercial yet. Full text:
http://www.jci.org/articles/view/40594?search[article_text]=+Plasma+levels+of+the+protein+IP-10+hcv&search[authors_text]=
They usually raise the price of Copaxone twice a year but this price hike is higher (last one was 9.9% in May) probably because of the introduction of Gilenia, which costs $48K/year.
FRX announced positive top-line results of ATTAIN, a six month double-blind placebo-controlled pivotal Phase III study comparing the efficacy and safety of inhaled aclidinium bromide 200µg and 400µg twice daily (BID) versus placebo, in 828 patients with moderate to severe COPD.
http://www.frx.com/news/PressRelease.aspx?ID=1512675
Twisted sense of humor? I was just making a note to tell Given's people next time I see them
You certainly can
GIVN/JNJ
It was a marketing agreement, which JNJ terminated in Nov 2007
http://www.reuters.com/article/idUSL0884997720071108
Diagnosing AD, what good will it do to patients?
Alzheimer's blood test 'most accurate' so far
http://www.nature.com/news/2011/110106/full/news.2011.0.html
The blood of patients with the brain disease contains antibodies not found in healthy people.
By Ewen Callaway
A new blood test diagnoses Alzheimer's disease by sensing molecules produced by the immune systems of people with the neurodegenerative condition.
So far, the test has been applied to just a small number of blood samples, but if proven on a larger scale, the assay could help diagnose Alzheimer's disease in combination with other tests, says Thomas Kodadek, a professor of chemistry at the Scripps Research Institute in Jupiter, Florida. It could also be used to identify patients for trials of experimental Alzheimer's drugs, he adds. His team published its results online today in Cell1.
Currently, the only way to conclusively distinguish Alzheimer's from other dementias by examining the gnarled plaques and tangles of protein found in the brains of those with the condition. This can only be done after death. A furious search is under way for earlier, less-invasive tests using brain scans, blood draws and spinal taps, for instance.
Globally, over 35 million people suffer from Alzheimer's. There are no effective treatments for the disease or proven means of preventing it.
Most trawls for blood biomarkers typically whittle down a list of potential molecules to a few that differ between people with a condition and healthy people. For instance, Tony Wyss-Coray's team at Stanford University in California screened 120 proteins involved in cell communication and found 18 of the proteins present at higher levels in the blood of people with Alzheimer's disease than others2.
However, such 'candidate' screens rely on assumptions about which molecules are likely to be affected by a disease. They also rely on sensing vanishingly small levels of proteins and other molecules.
Slide screen
Antibodies — immune molecules in blood that stick to specific foreign and disease proteins — offer a solution, says Kodadek. If specific to a disease, they are likely to be found in high levels in those with the condition, yet be absent in healthy people.
Typically, a scientist would fish out such antibodies using the disease proteins they attack. However, Kodadek's team reasoned that antibodies should also recognize other kinds of molecules. They created glass slides coated with thousands of differently shaped peptoid molecules — chemical cousins of peptides that are likely to be recognized by antibodies.
As a proof of principle, Kodadek's team searched for antibodies produced by mice that have a multiple sclerosis-like condition caused by their antibodies attacking the fatty sheaths surrounding nerves. Among the 4,800 peptoids on the slide, several latched onto antibodies in the blood of mice with the disease, but this did not happen for controls. "It was a night-and-day difference, it wasn't a subtle thing," he says.
Next, the researchers tested the peptoid slides on blood from six likely Alzheimer's patients, six similarly aged healthy people, and six patients with a different neurodegenerative condition, Parkinson's disease.
They identified three peptoids that recognized antibodies from people suspected to have Alzheimer's. Tested against 16 different people with the condition, each peptoid proved more than 93% accurate at diagnosing Alzheimer's, meaning they missed only one Alzheimer's case out of 16.
Antibody issue
In unpublished work, Kodadek says his team has applied the test to about 300 people, correctly diagnosing 98% of the people thought to have Alzheimer's. Meanwhile, the test proved 95% accurate at distinguishing healthy people from those suspected to have Alzheimer's, yet Kodadek doubts all 5% are true false positives. "I'm really pretty sure what we're seeing is pre-symptomatic Alzheimer's," he says.
Current tests for Alzheimer's relying on brain imaging and spinal tap accurately diagnose about 90% of patients, says Kodadek. "One could imagine our test being used a cheap front line screen, and at least if you test positive there, you could go for these more expensive things that couldn't be used as a general screen."
Kaj Blennow, an expert on Alzheimer's biomarkers at Sahlgrenska University Hospital in Mölndal, Sweden, calls the findings "very promising" but says they need to be replicated in a larger group of patients, including those at early stages of Alzheimer's and with other forms of dementia.
Wyss-Coray says it is still an open question as to whether or not people with Alzheimer's produce antibodies that are specific to their condition. However, the small number of peptoids unique to those with the disease could point to a very specific immune response against an unknown disease molecule. "If true, that would most certainly change the current view of this disease."
Kodadek's team is hoping to find the molecule or molecules recognized by the Alzheimer's antibodies. They also plan to apply the peptoid screen to discovering antibodies against various cancers.
A company he is involved with, Opko Health based in Miami, Florida, plans to work with a large pharmaceutical firm to identify people suitable for its clinical trials. "If we're ever going to get an Alzheimer's drug, we need a much better early diagnostic. Otherwise these trials are doomed to failure," Kodadek adds.
*
References
1. Reddy, M. M. et al. Cell 144, 132-142 (2011).
2. Ray, S. et al. Nature Medicine 13, 1359-1362 (2007).
Who retrieves the capsule after it passes? Does the patient need to leave a deposit with the doctor to offset the risk of the capsule being inadvertently flushed?
Will the state of Israel even exist by then? but for 1Q2011, I'm still cautiously optimistic.
...Teva may provide an update during an investor presentation on Jan 10, 2011...
Perhaps not a $100B market but I think medicine and research certainly going to routinely sequence everything in the near future. I still see the problem in interpretation. Who is going to interpret? Unfortunately, interpretation is the least of their worries now. They are pushing very hard for sales of machines and technologies. You cannot sell interpretation kits…
Might be another trial before starting phase III but I don't think it's going to be another phase IIb or anything that big. Anyway, point is Merck will take the drug further after the delay announced back in Aug 2010.
...its good to see Merck backing their [CRME] oral drug hopefully that means it gets to market (sooner)!
In a convention last week, Teva’s CFO said the comp. is looking for big branded acquisitions in the range of $2B-$8B, in cancer, neurology and immunology arenas.
ENDP's testosterone gel -Fortesta approved:
http://finance.yahoo.com/news/Endo-Pharmaceuticals-Receives-prnews-2558295106.html?x=0&.v=1&.pf=retirement&mod=pf-retirement
And this trial of AstraZeneca's anti-NGF candidate, MEDI-578, in patients with osteoarthritis of the knee, has been terminated:
http://clinicaltrials.gov/ct2/show/NCT01072591
Nothing to write home about. Just another analyst's view on all known issues. I nearly quit reading when reached a part where it said: Oral Copaxone (laquinimod). Besides, I don't think analysts can have any better idea about what will happen with Teva or Momenta. It's almost entirely in the hands of the FDA and the Court.
The other analyst sent me a report he issued after meeting with Teva's management earlier this month, but there was no direct answer to the Lupenox question in it.