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No data that I'm aware of on oral vernakalant vs. amiodorone. Agree that oral vernakalant will not be as effective as amiodorone but it likely will be safer. More important imo, is how it will compare to Multaq and the FDA might ask for such a trial (head-to-head oral vernakalant vs. Multaq).
ANA598 rash
I'm a notch less skeptic than I was after the monotherapy data, as rash incidents in the ANA598+SOC treatment were all mild and the only moderate rash case was in the control arm. Of course, longer treatment and higher dose may induce more rash.
CELG/Revlimid CALGB trial in treating patients who are undergoing autologous stem cell transplant for multiple myeloma was stopped early due to superior efficacy:
http://www.reuters.com/article/idCNN1821779320091218?rpc=44
FRX just licensed LAS100977, a once-daily LABA for the treatment of COPD and asthma from Almirall.
http://finance.yahoo.com/news/Almirall-and-Forest-bw-2543222109.html?x=0&.v=1
ANA598 - data at 4 weeks for the first dose cohort, 200 mg bid, in an ongoing Phase II study:
http://www.anadyspharma.com/pr_pdfs/ana598%204-week%20interim%20results%20final%2012.17.09.pdf
Still a difference between genotypes 1a and 1b but what looks strange here is that VL change was quite similar in genotype 1b and placebo 3.7 and 3.9 (log10 IU/ml) respectively.
"...DMC has endorsed escalating to the second dose level, 400 mg bid, and this cohort is now open for enrollment."
I like their statistics about a mutation every 15 cigarettes...
Oops, Dr. Rothblatt is a she alright (the Martine part sounds like a male's name to me).
Think he was speaking of paying patients new ones and Ventavis switchers as well.
The adoption of testing has been slower than I expected down here as well but at least for KRAS things are going to get better as the test will be reimbursed soon.
yesterday i wrote about LGAL IS ONLY 1 CENT LOOK TODAY UP 35%
Tasoglutide - news release contains no details on weight loss either. Again no info on pancreatitis and calcitonin levels. Guess we have to wait till full results will be presented at a medical meeting.
I wasn't aware of the trial, thanks for the update. Think we'll have better visibility after the FDA's action on liraglutide. Anyways I'm not going to make an international call to LLY or AMLN to obtain the answers, I'm not invested just watching.
Roche is certainly pursuing this strategy see this phase III trial of Tarceva vs.chemo, in 1st line NSCLC patients with EGFR mutation positive (completion expected end of 2010).
http://clinicaltrials.gov/ct2/show/NCT00446225
On the metabolic role of Sirt1 in the brain
Controlling key enzyme in brain offers clue for future obesity treatment
http://www.eurekalert.org/pub_releases/2009-12/bu-cke121109.php
Facet Bio cuts shareholder deal as Biogen promises proxy fight
http://www.bizjournals.com/sanjose/stories/2009/12/14/daily44.html
Silicon Valley / San Jose Business Journal - by Ron Leuty
A battle for control of Facet Biotech Corp. is coming down to the 11th hour, with Facet protecting itself from hostile bidder Biogen Idec through a deal that gives its largest shareholder the right to buy additional shares.
The deal between Redwood City-based Facet (NASDAQ: FACT) and Biotechnology Value Fund LP of Chicago allows BVF to increase its ownership in Facet to between 15 percent to 20 percent without becoming an “acquiring person.”
BVF currently holds nearly 3.7 million shares of Facet common stock — about 14.7 percent — and told Facet it does not intend to tender its shares for Biogen Idec's $17.50-per-share offer. Led by Mark Lampert, BVF has increased its Facet stake from 1.8 million shares, or 7.36 percent, in mid-May.
The Facet-BVF agreement would raise the stakes for Biogen, which in advance of a midnight Wednesday deadline to tender shares, said it is prepared to launch a proxy fight for control of Facet’s board.
Biogen, the Cambridge, Mass.-based developer of multiple sclerosis drugs (NASDAQ: BIIB), told Facet shareholders Tuesday that it would replace most of Facet’s board if they tendered a majority of shares and the board “refuses to listen to the explicit wishes of its stockholders.”
Even if the majority of shares are tendered, Facet’s board, which reiterated Tuesday that it recommends that shareholders reject Biogen’s bid, would have to approve the deal.
Biogen has said its best-and-final offer, which pencils out to $493 million, would expire if shareholders don’t tender a majority of shares by the deadline.
“Our board, along with its advisers, determined that Biogen Idec’s offer is inadequate and materially undervalues the assets of the company, overstates the liabilities and demonstrates and incomplete understanding of our pipeline and technologies,” Facet CEO Faheem Hasnain said in a statement.
Facet’s portfolio consists mainly of oncology drugs and daclizumab, the multiple sclerosis drug it is developing with Biogen. The drugs are legacies of Facet’s spinout from PDL BioPharma a year ago, but a deal this summer with Trubion Pharmaceuticals Inc. was an attempt to bulk up its lineup of experimental drugs.
Biogen initially approached Facet’s board in August with an offer of $15 per share. Facet rejected that offer and moved forward with a deal to invest in Trubion (NASDAQ: TRBN) of Seattle, with which it also struck a research deal.
Biogen made another bid, at $14.50 per share, saying the lower price reflected Facet’s deal with Trubion, and Facet’s board rejected that offer as well.
Biogen went directly to Facet shareholders with the $14.50 offer in September, extended an October deadline and, earlier this month, boosted the offer to $17.50 per share.
Epigenetics research takes aim at cancer, Alzheimer's, autism, other illnesses
http://www.washingtonpost.com/wp-dyn/content/article/2009/12/14/AR2009121402894.html
Research on mice might have meaning for many human illnesses
By Rachel Saslow, Washington Post Staff Writer, Tuesday, December 15, 2009; HE05
Two mice. One weighs 20 grams and has brown fur. The other is a hefty 60 grams with yellow fur and is prone to diabetes and cancer. They're identical twins, with identical DNA.
So what accounts for the differences?
It turns out that their varying traits are controlled by a mediator between nature and nurture known as epigenetics. A group of molecules that sit atop our DNA, the epigenome (which means "above the genome") tells genes when to turn on and off. Duke University's Randy Jirtle made one of the mice brown and one yellow by altering their epigenetics in utero through diet. The mother of the brown, thin mouse was given a dietary supplement of folic acid, vitamin B12 and other nutrients while pregnant, and the mother of the obese mouse was not. (Though the mice had different mothers, they're genetically identical as a result of inbreeding.) The supplement "turned off" the agouti gene, which gives mice yellow coats and insatiable appetites.
"If you look at these animals and realize they're genetically identical but at 100 days old some of them are yellow, obese and have diabetes and you don't appreciate the importance of epigenetics in disease, there's frankly no hope for you," Jirtle says.
He offers this analogy: The genome is a computer's hardware, and the epigenome is the software that tells it what to do.
Epigenomes vary greatly among species, Jirtle explains, so we cannot assume that obesity in humans is preventable with prenatal vitamins. But his experiment is part of a growing body of research that has some scientists rethinking humans' genetic destinies. Is our hereditary fate -- bipolar disorder or cancer at age 70, for example -- sealed upon the formation of our double helices, or are there things we can do to change it? Are we recipients of our DNA, or caretakers of it?
Last year, the National Institutes of Health announced that it would invest $190 million to accelerate epigenetic research. The list of illnesses to be studied in the resulting grants reveals the scope of the emerging field: cancer, Alzheimer's disease, autism, bipolar disorder, schizophrenia, asthma, kidney disease, glaucoma, muscular dystrophy and more.
When Jirtle planned his first epigenetics conference in 1998 in Raleigh, N.C., epigenetics was such a small field that he worried nobody would come. About 160 people attended. Jirtle hosted another conference in 2005; it attracted 470.
"It's the flavor of the month," says Michael Meaney, a brain researcher at McGill University in Montreal.
When a gene is turned off epigenetically, the DNA has usually been "methylated." Biologists have known for decades that methylation is involved in cell differentiation in utero, making one cell a skin cell, another cell a liver cell, and so on. Cell differentiation is also what happens when scientists prompt an embryonic stem cell to grow into a specific type of cell. But five years ago, when Meaney submitted a paper suggesting that DNA methylation happens throughout life in response to environmental changes, he was told, "This just can't happen." (Most DNA methylation occurs prenatally and during infancy, puberty and old age, Jirtle says. Research suggests that epigenetically, humans are pretty stable during adulthood.)
Duke Department of Medicine researcher Simon Gregory described the link between DNA methylation and autism in a paper published in October in the journal BMC Medicine.
Most genetic studies of autism focus on variations in the DNA sequence itself, especially on genes that are missing. Gregory and his colleagues looked at an oxytocin receptor gene, called OXTR, and found that about 70 percent of the 119 autistic people in his study had a methylated OXTR; in a control group of people without autism, the rate was about 40 percent. Oxytocin is a hormone that affects social interaction; difficulty relating to others is common for those with autism spectrum disorders.
Because this was only a pilot study, more research is necessary. But Gregory says methylation-modifying drugs might be a new avenue for treatments. He also hopes that his findings will provide a new tool for doctors to diagnose autism.
"Methylation has been very hot in the cancer field for a number of years," Gregory says. "To find something like this associated with autism is very exciting."
Epigenetic therapy is still very inexact -- "a pretty broad brush," says Jirtle. But oncologists have seen some success in using it against leukemia. Azacitidine, sold as Vidaza and used to treat bone-marrow cancer and blood disorders, became the first FDA-approved epigenetic drug in 2004. When tumor-suppressing genes aren't doing their job, due to a genetic mutation or hypermethylation, cancer cells can replicate uncontrollably. But by manipulating the epigenetic marks, doctors can get tumor-suppressing genes to work again. Toxicologists also have a big stake in epigenetics. A 2005 study by Washington State University molecular biologist Michael Skinner generated buzz with his finding that when a pregnant rat was exposed to high doses of pesticides, her offspring plus the next three generations suffered from high rates of infertility. (Some scientists have challenged Skinner's work because they have not been able to reproduce his results in their labs.)
The potential human implications -- do the chemicals we ingest today affect our great-grandchildren? -- are tremendous. In addition to pesticides, toxicologists are studying chemicals in plastics, such as phthalates and bisphenol A, to see if they could enhance our risk of disease by altering the epigenome.
Jirtle says that he and his fellow researchers usually discuss epigenetics only on the microscopic level, but when he pulls back and looks at the big picture, he is awed.
"I've got goose bumps right now talking about it," he says. "You're looking at the book of life, how it's read and how you can change it."
If you're just a chart reader who knows nothing about the science, you should have sold when the stock spiked in early Nov.
AMLN /LAR
From whom?
Why don't you try reading the board before raising the scam argument?
Nothing on pancreatitis rate and calcitonin level?!
Thanks for the note.
(glad they agree with me on that )
Doesn't look like Pfizer is going for a disease modification claim (at least for now), judging by dimebon's phase III program.
Wow, I think you're on to something here - Pfizer is willing to make an upfront payment of $60M and additional regulatory milestone payments of up to $55M for a scam!
I'm keepink this cent in a safer place, thanks.
Efficacy is more like MTX but I think the higher infection and discontinuation seen with apremilast in this 16 weeks trial is the bigger problem as this should be worse over longer period of use.
Positive Phase IIb Topline Clinical Data for Celgene Oral Compound Apremilast (CC-10004) Reported for Patients with Moderate-to-Severe Psoriasis
http://finance.yahoo.com/news/Positive-Phase-IIb-Topline-bw-538737890.html?x=0&.v=1&.pf=personal-finance&mod=pf-personal-finance
Placebo-controlled, four-arm study met its primary endpoint at 16 weeks
Study demonstrates PASI-75 of 41% for apremilast 30mg twice daily compared to 6% for placebo (p<0.001) at 16 weeks; apremilast was also generally well-tolerated
Pivotal phase III studies evaluating apremilast in inflammatory conditions to begin in 2010
SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG - News) announced clinical data from an investigational Phase IIb, double-blind, placebo-controlled study of apremilast (CC-10004) in patients with moderate-to-severe plaque-type psoriasis (PSOR-005). This was a 352-patient, multi-center study in which patients received either 10mg, 20mg or 30mg of apremilast twice per day (BID), or placebo.
Forty-one percent of patients treated with 30mg of oral apremilast BID achieved a PASI-75 after 16 weeks (p<0.001), compared to a 6% of patients receiving placebo. In addition, a dose-dependent effect was observed between the active therapy arms of the study. Specifically, 29% of patients receiving 20mg BID of apremilast achieved a PASI-75 (p<0.001), while 11% of patients receiving 10mg BID of apremilast achieved a PASI-75.
“These results are extremely important,” said Kim Papp, M.D., Ph.D. of Probity Medical Research, Canada. “The results suggest apremilast is active and may meet a significant unmet medical need: a new oral treatment for patients with moderate-to-severe psoriasis.”
In general, common treatment-emergent adverse events were self-limited and manageable and included headache (32% of patients in the 30mg BID apremilast arm vs. 14% in the placebo arm), nausea (18% vs. 8%, respectively), upper respiratory tract infection (16% vs. 6%, respectively) and diarrhea (14% vs. 5%, respectively). Overall infections were 48% with 30mg BID compared to 33% in the placebo group, with 1% of patients in both the 30mg BID apremilast and placebo arms discontinuing treatment due to infection. In total, discontinuations due to adverse events were 14% for the 30mg BID apremilast arm and 6% for placebo. Most treatment emergent adverse events were mild to moderate (>96%), with no serious adverse events related to apremilast reported in this study.
“The 30mg bid dose of apremilast achieving a PASI-75 rate of 41%, coupled with data from the earlier psoriatic arthritis trial, supports our move to pivotal programs in moderate-to-severe psoriasis and psoriatic arthritis,” said Randall Stevens, MD, Vice President and Clinical Head, Inflammation and Immunology at Celgene. “Importantly, the results of this study suggest that apremilast may become a new oral therapy for psoriasis with a unique balance of safety, tolerability and efficacy in the range of biologic therapies.”
About Psoriasis...snip
ELN/ELND-005
I admit I didn't think scyllo-inositol will have a safety issue , thought efficacy will. Guess it is the problem now with the lower dose...
SGEN gets $60M upfront and retains full commercialization rights for SGN-35 in the US and Canada. Milestone payments to Seattle Genetics could reach $230M. Takeda will fund worldwide development costs on a 50:50 basis and all of the Japan development costs.
Seattle Genetics sells non-U.S. drug rights to Takeda
http://www.reuters.com/article/idCNTOE5BE07A20091215?rpc=44
Perhaps this will boost the use with this drug, which was very low so far.
Teva hails milder restrictions on Parkinson's drug
(AP) – 9 hours ago
NEW YORK — Teva Pharmaceutical Industries Ltd. said Monday U.S. health regulators scaled back dietary and health restrictions on its Parkinson's Disease drug Azilect.
Teva said the new labeling eases concerns about drug interactions with other medications, including over-the-counter cold medicines.
The new labeling also states that patients no longer have to follow general dietary restrictions on levels of tyramine, an amino acid found in certain foods, including air-dried and fermented meats. Because of increased sensitivity in some patients, however, the new labeling recommends against high levels of the acid.
The Food and Drug Administration approved Azilect in 2006 as a daily treatment for Parkinson's Disease.
Think Cobalt Pharmaceuticals has first-filer status on generic versions of Crestor.
Crestor's patent litigation
Inequitable Conduct Claims against AstraZeneca Survive Motion to Dismiss
http://www.law.com/jsp/tal/digestTAL.jsp?id=1202436314713
By Andrew Longstreth, December 14, 2009
What are you looking forward to in 2010? For the Anglo-Swedish drug company AstraZeneca, it's a February trial that will test its intellectual property rights to the blockbuster cholesterol drug Crestor. Seven pharmaceutical companies seeking to make generic versions of Crestor have challenged the validity and enforceability of AstraZeneca's patent on the drug. Among other things, the generic manufacturers contend that AstraZeneca committed inequitable conduct by withholding certain information from the Patent and Trademark Office when it applied for the Crestor patent.
The generics got some good news Friday, when Wilmington federal magistrate judge Leonard Stark recommended that AstraZeneca's summary judgment motion on inequitable conduct be denied. "It may well be, as [AstraZeneca asserts], that the non-disclosures here were due to mistake and inadvertence, but making a final determination on this matter will require the fact finder to assess the credibility of the witnesses," he wrote.
Neil McCrae, a spokesman for AstraZeneca, told Reuters that it still believes it will win when federal district court judge Joseph Farnan hears the case. "We remain confident that we will prevail on these issues at trial," said McCra
Cubist to acquire privately-held Calixa Therapeutics, for $92.5M in upfront cash and up to $310M in future milestones.
http://finance.yahoo.com/news/Cubist-Pharmaceuticals-pays-apf-2380367664.html?x=0&.v=2
At 6 months the dimebon treated patients showed a 4 point (not 6) advantage on the ADAS-CoG vs. about 2-3 points seen from historical aricept trials. At 12 months advantage was even greater (6.9 points) .
The litigation with Mylan went to trial last Oct, next one to settle could be Apotex as the trial should start in Jan.
There's time until 6/1/11 to have FDA approval but I have another argument for you: all settlements Wyeth has made contain condition that if another generic challenger enters the market after Jan 2011, all others can launch their generics. In such multi generics market there will be very little profit for anyone, not worth the risk of potential damages.
There is another way other companies could launch a generic before 6/1/11 - but they would want to take on potential damages and I tend to think they would rather settle.
But Teva does have 6 months exclusivity until Jan. 1, 2011.
I'm quite sure Teva has the 6 month exclusivity until the end of 2010, for being the 1st filer, but others remain in litigation and would be eligible to launch their generics in January 2011.
Wyeth has settled with generic manufacturers such as Lupin that wasn't tentatively approved by the FDA and will probably try to settle with the rest as well.
Since the Teva settlement in 2005, several other generic manufacturers have filed paragraph IV against Wyeth's Effexor XR and WYE has settled with six of them. However, there are a few more that didn't settle yet and can still launch a generic in the US in Jan 2011, as soon as Teva's exclusivity expires. So, not sure Teva will be alone for eleven months, but it's possible.
On knockoff of Effexor XR: there's the potential for Sun to launch a non-AB rated version but you're right that the UCB/Osmotica version has had limited success in the US.