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Fampridine's extension data (from all former groups of patients i.e. responders, non-responders and placebo patients as well), showed that a higher percentage of patients were still on the drug after long time. Placebo effect, which as expected was observed in the blinded clinical trials, as some 8-9% of patients taking placebo had a consistent improvement in walking speed and were classified as responders, can account for some of the 'new' responders but certainly not all. Some may be 'late' responders or simply since responder in the real world means - any patient who feels better while on the drug.
Just because someone may be considered a non responder in the context of a trial (walking speed) doesn't mean they would drop off the drug in the real world or would do so quickly.
ACOR - a note on the drug's MOA
Ampyra improves axonal signaling by reducing potassium ion flow out of impaired and demyelinated axons and so improves neurological function. Since K+ channel blockers are potent immunosuppressive agents, there's a possibility Ampyra might also (in long-term use), affect progression by inhibiting T-cell-mediated immune response (due to blockade of K+ channels on T-lymphocytes and reducing the attack on astroglia).
Re: Novazyme/Pompe enzyme
Myozyme was NOT the Enzyme from Canfields labs/Novazyme. Your article talks about Genzyme having 4 (I thought it was 3 but my memory isn't that great smile).
Semi OT - Good PR for GENZ
A review of Extraordinary Measures
http://www.the-scientist.com/blog/display/57091/
Posted by Jef Akst
Rare diseases and drug discovery don't usually make for Hollywood blockbusters. But today (January 22) a film about a genetic affliction that strikes fewer than 10,000 people worldwide hits movie screens, and it has some serious star power behind it. Harrison Ford and Brendan Fraser head up the cast of Extraordinary Measures, a new movie that may lift Pompe disease from the shadows of obscurity into the spotlight, as the focal point of an inspirational story of paternal love and scientific innovation.
"The movie is a great exposure for a rare genetic disease," said Duke University School of Medicine's Priya Kishnani, who studies Pompe and participated in much of the research that led to the first and only approved treatment for the disease -- a quest that forms the central plot of the film. "I would have never thought in my lifetime, a disease that I'm so passionate about would make it into mainstream Hollywood cinema."
Extraordinary Measures tells the tale of businessman John Crowley (played by Fraser) who makes it his mission to promote the development of an enzyme therapy to treat his two youngest children, who are sick with Pompe. Teaming up with University of Nebraska researcher Robert Stonehill (Ford), Crowley starts a small biotech company called Priozyme dedicated to his purpose. (In reality, the researcher who helped Crowley was William Canfield of the University of the Oklahoma Health Sciences Center, and the company Crowley launched was called Novazyme.)
Pompe disease is a genetic lysosomal storage disorder. Any of the nearly 300 mutations in the lysosomal enzyme acid a-glucosidase (GAA) gene that affect its function can result in either infantile- or late-onset accumulation of glycogen in muscle tissues. Pompe destroys skeletal muscle, impairing motor skills and usually relegating patients to wheelchairs. The disease also compromises lung and heart function, with most Pompe patients ending up on ventilators with inflamed and failing hearts. Infants with Pompe disease typically survive less than one year, while late onset patients can suffer only mild symptoms for years before experiencing an abrupt decline.
As the movie depicts, Novazyme was eventually bought out by Genzyme (Zymagen in the movie), a larger biotech company that was also developing a Pompe therapy and had purchased two others. Now with four different enzymes to choose from, Genzyme ran what they call the "Mother of All Experiments," pitting the four candidates against one another in blinded biochemical analyses and mouse model tests to see which held the most promise. Once the results were in, a group that included Canfield, as well as Genzyme's vice president, Robert Mattaliano, selected the winner, revealing the drug's identity by decoding the color-schemed key.
There was "this great collage of [people with] the desire to come up with something would serve the needs of this patient population," Mattaliano told The Scientist. "It was quite a team effort."
The winner -- a recombinant human form of the GAA enzyme (rhGAA) produced in a Chinese hamster ovary cell line -- was the subject of three clinical trials: one for infantile-onset Pompe patients, one for patients aged 3 months to 3.5 years, and one for the two Crowley children, who were able to receive treatment at a local New Jersey hospital near their home after their father left his position at Genzyme.
The trials showed significantly decreased mortality, and patients were able to survive longer without the aid of a ventilator, and some even demonstrated increased motor function. In 2006, the treatment, an intravenous enzyme replacement therapy dubbed Myozyme, became the first and only approved treatment for Pompe disease. While Crowley's children are still on respirators, they are responding well to their Myozyme treatments, which they continue to this day.
Extraordinary Measures tells this story with remarkable accuracy (albeit with some minor Hollywood name changes and plot tweaks), and shines a light on Pompe that rarely touches most rare diseases. But somewhere in the recounting of this emotionally driven tale, the viewer, at least the scientifically-inclined one, is alienated from the realities of the disease. The sick children, while on ventilators and in wheelchairs, speak with ease -- an overly optimistic picture of Pompe patients, who often have much more difficulty communicating. The movie also typecasts theoretical endeavors as idealistic and even useless, dismissing a branch of research that provides the basis of most bench and clinical work.
The film does a better job of representing the hard-to-swallow fiscal issues of drug development. "The movie emphasizes how these things can be monetized," University of Florida pediatric cardiologist Barry Byrne told The Scientist. "Everything cannot be done at the research level," added Byrne, who was involved in the clinical trials of Myozyme. "Without investments from a company like Genzyme to bring these products to patients there would be no benefit to patients in the long run."
Since the development of Myozyme, research on treatments for Pompe disease has continued and expanded. Most recently, Byrne opened a clinical trial to test a gene therapy supplement to the enzyme replacement therapy. A handful of biotechs are also developing new Pompe drugs, including Genzyme which is currently working on their second generation compound.
"It's really striking that for such a small community of patients that there is so much interest," Byrne said. "And [hopefully it will be] catalyzed by the public interest in the film."
Haven't you forgoten something Dovi?
Also, Pfizer Inc.'s Selzentry was approved by the FDA in August, bringing another HIV anti-viral to the market. [Selzentry is IMO a niche product.]
Why don't you ban him then?
Savella
...different people respond to different drugs,...
Milnacipran Citizen's Petition - Lyrica is similar to gabapentin and its pain reduction effect is greatly associated with sleep (majority of MFS patients suffer from insomnia). SAEs of Lyrica are different and Savella should be compared to Cymbalta as both work via similar mechanisms.
Petition to Ban Fibromyalgia Drug Milnacipran (Savella)
http://www.citizen.org/publications/release.cfm?ID=7723
On Oppenheimer's word games - bear in mind that Oppenheimer has an outperform rating for TEVA shares as well.
Re: NVS-ACL deal
Alcon Group Says Novartis Bid 'Inadequate'
http://www.thestreet.com/_yahoo/story/10663831/1/alcon-group-says-novartis-bid-inadequate.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
By Joseph Woelfel 01/20/10 - 06:50 AM EST
HUENENBERG, Switzerland (TheStreet) -- The Independent Director Committee of Alcon(ACL Quote) said Novartis'(NVS Quote) bid to acquire the minority publicly traded shares of Alcon is "grossly inadequate."
In a statement Wednesday, the group also said "the financial analysis upon which Novartis' unilateral proposal is based is fundamentally flawed."
Earlier this month, Novartis exercised its call option to buy Nestle's remaining 52% stake in eyecare company Alcon for about $28 billion in cash. Novartis is buying the Alcon shares for $180 each, raising its stake in Alcon to 77%.
The Independent Director Committee of Alcon pointed out that Novartis proposed to acquire the Alcon shares at a price of 2.8 shares of Novartis for each share of Alcon, which is valued at $151.43 as of Tuesday because of a decline in Novartis' share price.
That's "significantly below the $180 in cash that will be paid by Novartis to acquire its majority position," the committee said.
It was done:
Gene for glowing passed along to monkey offspring
http://www.newsvine.com/_news/2009/05/27/2869630-gene-for-glowing-passed-along-to-monkey-offspring
And there's this
I've posted the Nature piece because it is more balanced than Derek's, whose piece was referred to as provocative. I don't think GSK will add fluorescent peptide, we'll have to wait and see how sirtuin compounds will do in clinical trials.
Vical also had a malaria DNA vaccine program sometime in its past.
Semi OT apropos to sirtuins on red wine controversy:
Health benefits of red-wine chemical unclear
http://www.nature.com/news/2010/100119/full/news.2010.18.html
Sceptics continue to ask whether resveratrol really can delay the effects of ageing.
By Lizzie Buchen
Five years ago it seemed that resveratrol, a compound present most famously in red wine, could slow down the ageing process. But a study published on 8 January in The Journal of Biological Chemistry1 deepens the divide between those who are confident in its potential and those who think it is too good to be true.
Resveratrol's health benefits are thought to result from its activation of enzymes called sirtuins, which were linked to longevity 10 years ago when Leonard Guarente from the Massachusetts Institute of Technology in Cambridge found that yeast with additional copies of the gene that encodes sirtuin, called sir2, lived significantly longer than did those that had the usual two copies2. Four years later, Guarente's former post-doc David Sinclair published work showing that resveratrol activated sirtuins in yeast and extended the organism's lifespan3. Sinclair later went on to show that resveratrol fed to worms and flies lengthened lifespan by acting through the sirtuins4.
Then in 2007, Sinclair and Sirtris Pharmaceuticals — a company Sinclair had co-founded with venture capitalist Christoph Westphal in Cambridge, Massachusetts, to develop sirtuin activators — screened a large selection of small molecules to look for activators of SIRT1, the mammalian version of the yeast Sir2 enzyme. Their study, which was published in Nature5 found three compounds that were 1,000-fold more potent than resveratrol at activating the enzyme5. Furthermore, one of these compounds made obese mice and rats more sensitive to insulin, suggesting that the substances could be used to treat type 2 diabetes — a disease that gets more common with age. Less than a year later, the British pharmaceutical giant GlaxoSmithKline bought Sirtris for US$720 million. Two Sirtris drugs are already in Phase II clinical trials — one for cancer, and both for the treatment of type 2 diabetes.
But the excitement over the potential health benefits was tempered by reports concluding that resveratrol does not activate SIRT1 directly6,7 and that it works only when the substrates are linked to a fluorophore, as they were in the screen and in the study that first showed resveratrol activated SIRT1. Now, researchers led by biochemist Kay Ahn of Pfizer in Groton, Connecticut, have shown that the Sirtris compounds do not seem to activate SIRT1 when not attached to fluorophores either1.
"We can only replicate the Nature findings by using a fluorescent peptide, which [Sinclair and his colleagues] had used exclusively," says Ahn.
Only in real life
However, Guarente, who is now a scientific adviser to Sirtris, says that the latest findings are neither surprising nor worrisome. The compounds may work only with fluorophore-conjugated peptides in vitro, says Guarente, but the situation is different in cells and in animals. The Nature paper, among others, went beyond the test tube and indicated that SIRT1 was more active in cells and in animals after application of the Sirtris compounds. Furthermore, resveratrol administration made no difference to the lifespan of yeast that did not have Sir23, indicating that the compound's action depends on this gene.
According to a statement from GlaxoSmithKline, Ahn's conclusion "ignores any possibility of direct activation of SIRT1 that may occur in a cellular environment that is not reproduced in vitro".
But some remain unconvinced. Another former member of Guarente's lab, Brian Kennedy, now at the University of Washington in Seattle, points out that cell-based assays are difficult to interpret, particularly because resveratrol is thought to interact with many enzymes.
"It's very nonspecific," says Kennedy, who in 2005 was the first to report that resveratrol activates SIRT1 in vitro only when the substrates are conjugated to fluorophores. Although resveratrol does seem to affect animals, he says, "It's still highly unclear what the targets are that lead to those activities. I remain sceptical that SIRT1 is a key target."
Compound controversy
In the second portion of the latest study, Ahn tried, unsuccessfully, to replicate Sirtris' findings that the compounds reduced the blood-glucose levels of obese mice. A few of the mice even died, despite receiving the same dose as that given in the Nature paper. But Ahn is quick to point out that "every in vivo experiment is a little bit different". "Under our conditions we didn't see beneficial effects, but we don't want to make a big conclusion out of those results."
A possible explanation for the discrepancy, says Sinclair, is that Ahn and her colleagues did not provide information on the characterization of the compounds, which they synthesized themselves. So there is no way of knowing how pure they were or whether they're the same as those made by Sirtris. "The fact that mice died indicates that there may be an issue with purity," says Sinclair.
Sceptics of Sinclair's findings continue to voice doubt. "The enthusiasm for resveratrol and for Sirtris activators seems to have been premature," says Richard Miller at the University of Michigan Geriatrics Center in Ann Arbor, who has found that activating a different pathway extends lifespan in mammals8. "They may have health benefits, but the early evidence doesn't seem very strong and all the newer evidence suggests that the system may be more complicated."
But because of the growing number of studies showing beneficial effects of sirtuins and resveratrol, no one is willing to write them off quite yet. "If I were asked to list ten proteins that deserve a lot of attention in ageing in mammals, the sirtuins would be on that list," says Miller. "They just wouldn't be at the top of the list."
*
References
1. Pacholec, M. et al. J. Biol. Chem. advance online publication doi:10.1074/jbc.M109.088682 (2010).
2. Kaeberlein, M. , McVey, M . & Guarente, L. Genes Dev. 13, 2570-2580 (1999).
3. Howitz, K. T. et al. Nature 425, 191-196 (2003).
4. Wood, J. G. et al. Nature 430, 686-689 (2004).
5. Milne, J. C. et al. Nature 450, 712-716 (2007).
6. Kaeberlein, M. et al. J. Biol. Chem. 280, 17038-17045 (2005).
7. Beher, D. et al. Chem. Biol. Drug Des. 74, 619-624 (2009).
8. Harrison, D. E. et al. Nature 460, 392-395 (2009).
Quiz: What other company once had a malaria vaccine in its pipeline?
BRCA patent litigation
The case will probably take years and note that the suit targets 7 of MYGN' BRCA1/2 patents (there are 11 more although not COM patents). There are 2 related cases - Bilsky and Prometheus Labs
vs. Mayo Clinic. More reading:
http://www.genomicslawreport.com/index.php/2010/01/13/myriad-genetics-uspto-file-summary-judgment-motions-in-gene-patent-case/
BRCA testing
Compliance with BRACAnalysis among cancer patients is so high not only because oncs do a better job promoting the test. It is also because someone who has already been diagnosed with cancer is more willing to be tested than an unaffected person. Considering the outcomes and therapeutic alternatives, many unaffected still don't want to know. I'm also quite certain that money isn't the main issue here as testing for the 3 Ashkenazi Jewish mutations in the BRCA genes costs like $100 in Israel and still most tests come from newly diagnosed cancer patients. Soon we'll have a cheaper analysis (full sequencing) of BRCA genes here (similar to MYGN's test), and it will be interesting to see if price reduction will help push the test among unaffected women. My own view is that it takes more education and awareness of both gyns and patients and adding genetic counselors in order to have better adoption of BRCA test in the this setting. MYGN knows the Ob/Gyn market is critical to sustained growth for BRCA test as the onc segment is quite saturated. They put a lot of effort in marketing and in time it will do the trick.
if someone is already at the gyns for a pap then they are already of the mindset of screening for cancer. that type of person should be receptive to the BRCA story if it is delivered appropriately
smoking is not quite the same...
Very interesting phenomenon, wish we could adapt to nature as these slugs.
Tidbit apropos to ovarian cancer diagnosis
Abbott announces CE Mark (Conformité Européene) certification for the ARCHITECT human epididymis protein 4 (HE4) test:
http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0812.htm
Thanks, Jim. Will read the Journal of Clinical Oncology manuscript.
...it is just so irrational to me
I just don't get it
I've heard Michael McCaughan talk a few months ago in an E&Y conference and he sounded quite intelligent, but he wasn't talking about Teva’s strategy then.
My English isn't good enough to catch all these grammar and style mistakes, but the wrong spelling of Copaxone's generic name was obvious to me.
All correct of course, but the one I was thinking of is (Copaxone) "glatiramer acetate," not "glatimir."
BRCA testing
Dewophile, being a geneticist I know the figures by heart. I know women with positive BRACAnalysis tests have an 82% risk of developing breast cancer and a 54% risk of developing ovarian cancer. If asked, I tell asymptomatic subjects that the test will help them making treatment decisions that can reduce the risk for carriers of gene mutations to develop cancer. Most choose not to be tested but to be monitored more closely. That's why I am not surprised MYGN has hard times selling the test in the OB/GYN
market and think gyns and their unaffected patients need a lot more education.
Quiz: The blogger made a spelling error that stands out. What is it?
Chris Viehbacher, CEO of Sanofi-Aventis made an interesting comment at the JP Morgan conference on buybacks:
Companies resort to share repurchases when they’ve “run out of any ideas,” he said. “And the day we run out of ideas, I will retire on that day and let my successor do a share buyback.”
http://ircafe.com/2010/01/13/a-ceos-pushback-on-buybacks/
MYGN/BRACAnalysis in the OB/GYN market
Think about the options for an unaffected woman, who is a BRAC mutation carrier (try thinking like a woman):
Monitoring (more often) with clinical breast examination mammography and breast MRI screening.
Chemoprevention - Tamoxifen may reduce breast cancer risk by about 60% only in BRAC2 (not BRAC1) not to mention adverse side effects.
Removal of the ovaries and fallopian tubes reduces the risk of breast cancer by 40-70% but it's a surgery with consequences and as you said will be considered only after childbearing.
Prophylactic mastectomy is very radical for an unaffected woman.
Unaffected women who are eligible for the test (family history of breast cancer) are considered at high risk even without the genetic test and being told the test may be helpful to consider the options. No wonder many of them still do not do the test and tend to go on with more closer monitoring. I think we both agree on the bottom line which is educating gyns and patients.
How are you defining unaffected in this context?
MYGN/BRACAnalysis in the OB/GYN market
if counseled properly
they are marketing heavily
Especially since PARP inhibitors could be as effective in BRCA-related prostate and pancreatic as in breast cancer.
MYGN/BRACAnalysis in the OB/GYN market - I suspect that a meaningful part of those who qualify for insurance among the unaffected group (thse with at least one 1st degree relative under 50, with breast or ovarian cancer), select not to be tested. Also gyns don't recommend the test like oncs do.
DEALTALK-Novartis may nudge up bid for rest of Alcon
http://www.reuters.com/article/idAFLDE60B0P220100113?rpc=44
* Novartis can force deal but risks bad publicity, lawsuits
* May offer more, but not as much as it paid for majority
* Higher offer would echo Roche tactics in Genentech takeout
By Sam Cage
ZURICH, Jan 13 (Reuters) - Novartis (NOVN.VX) will likely
nudge up its lowball bid to minority shareholders in eyecare
group Alcon (ACL.N) to push a deal through cleanly, even though
it appears to hold all the trump cards.
All eyes are now on an assessment by an independent
committee of Alcon directors, widely expected to say the
Novartis price is too low. But if needs be, the Swiss drugmaker
could simply replace the committee members to force through a
deal.
"The question is: Is the offer adequate? And there I think
there is still some room for improvement," said Andrew Weiss,
analyst at Swiss bank Vontobel.
Novartis is offering 2.8 of its own shares for each
outstanding share in Alcon, valuing the outstanding 23 percent
of the U.S. group at about $147 per share, a discount to its
closing price on Tuesday of $153.46.
Both are significantly lower than the average $168 per share
Novartis is paying to buy a 77 percent stake from Nestle
(NESN.VX) and the $180 agreed for the purchase of the second
tranche of that deal. Novartis bought the first, 25 percent
stake for $143.18 per share.
"$168 -- that caps the discussion as to how much they should
be rewarded," said Weiss. "If the board does not comply then I
think Novartis are going to say: 'That's the law.'"
Alcon, though listed in New York, is incorporated in
Switzerland where the law does not require that any squeeze out
of minorities is concluded at the same price paid for the
majority.
Once the Nestle deal is concluded Novartis could -- as
majority shareholder -- simply replace the independent Alcon
directors to force through the deal.
NOT FAIR
Some investors have already cried foul and a Masschusetts
pension fund has sued Novartis, Alcon and Nestle over the deal.
"Novartis is using its de facto status as Alcon's majority
and controlling shareholder to ram the proposed merger through,"
Massachusetts Bricklayers and Masons Trust Funds said in its
court filing.
"The proposed merger, however, is the very antithesis of an
entirely fair transaction," the $95 million pension fund added.
But such lawsuits cannot actually prevent the merger and
most analysts expect Novartis will end up paying a touch more
than its initial bid, originally worth some $11.2 billion, to
push the deal through and avoid more bad publicity.
One source familiar with the deal, who declined to be named
due to direct involvement in the transaction, said replacing the
independent directors was "not a comfortable situation" and a
small increase could avoid a lot of trouble.
"Ultimately I think Novartis can push through the merger,"
the source said. "That could be -- a lowball bid to give the
possibility to the committee of independent shareholders a
chance to play their role."
GENENTECH PRECEDENT
The Alcon deal could mark the swansong of two senior
Novartis executives, CEO Daniel Vasella and finance chief
Raymund Breu, keen to push through the transaction at more
favourable terms to secure their legacy.
That would echo last year's events at Novartis' Swiss rival
Roche (ROG.VX), whose $47 billion buyout of U.S. biotech
Genentech marked a changing of the guard from experienced hands
to younger Chief Executive Severin Schwan. [ID:nL1227320]
The normally reserved Breu -- who has worked for Novartis
and one of its predecessors, Sandoz, for some 35 years -- is due
to retire in March and has had an unusually high profile since
the deal was announced earlier this month.
There is also speculation that the more garrulous Vasella, a
medical doctor who is one of the longest-serving leaders in the
European pharmaceutical industry, could soon hand over the reins
to one of the group's younger and up-and-coming executives.
"They can't totally ignore the fact that Alcon is a
U.S.-listed company," said Helvea analyst Karl-Heinz Koch. "They
could in theory push it through, but they may ultimately raise
the price to the average price Nestle received."
The Sirtris Compounds: Worthless? Really?
http://pipeline.corante.com/archives/2010/01/12/the_sirtris_compounds_worthless_really.php
Posted by Derek
As followers of the drug industry know, GlaxoSmithKline famously paid $720 million to buy Sirtris Pharmaceuticals in 2008. Sirtris is the most high-profile shop working on sirtuins and resveratrol-like pharmacology, which subject has received a massive amount of press (some accurate, some scrambled). I've been following the story with interest, since the literature has me convinced that the aging process can indeed be modified in a number of model organisms, which makes me think that it could be in humans as well. And I also feel sure that advances in this area could lead to many profound medical, social, and economic effects. (GSK, though, is going after diabetes first with the Sirtris deal, I should add - among other reasons, the FDA has no regulatory framework whatsoever for an antigeronic, if I can coin a word.)
But whatever the state of the anti-aging field, doubts have crept in about the wisdom of the Sirtris purchase. Last fall, a group at Amgen published a study suggesting that some of the SIRT1/resveratrol connections might be due an an experimental artifact caused by a particular fluorescent peptide. Now a group at Pfizer has piled on in the Journal of Biological Chemistry. They're looking over resveratrol and a series of sirtuin activators described by the Sirtris group in Nature.
And unfortunately, they also find trouble due to fluorogenic peptides. The TAMRA fluorophore on their peptide substrates seems to pervert the assay. While the Sirtris compounds looked like activators initially, switching to the native peptide substrates showed them to be worthless. Further study (calorimetry) showed that the activator compounds bind to a complex of SIRT1 and the fluorescent peptide substrate, but not to SIRT1 itself (or in the presence of native substrate without the fluorogenic group). That's not good.
But worse is to come:
"Despite a lack of evidence for the Sirtris series of compounds as direct SIRT1 activators, we investigated whether the in vivo efficacy demonstrated by SRT1720 in several rodent models diabetes could be validated and attributed to indirect activation of SIRT1. We therefore attempted to reproduce the in vivo efficacy for SRT1720 in mouse models of type 2 diabetes previously shown. . ."
That word "attempted" should tell you what comes next. The reported high dose of the compound (100 mpk) resulted in weight effects and death. The reported low dose (30 mpk) showed no effects at all on any diabetic parameters, but instead seemed to lead to increased feeding and weight gain. To complete the debacle, the Pfizer group screened the Sirtris compounds through a broad panel of assays, and found that all of them hit a number of other targets (and appear significantly worse than resvertarol itself, which is no one's idea of a clean compound to start with).
Basically, these folks have thrown down the gauntlet: they claim that the reported Sirtris compounds do not do what they are claimed to do, neither in vitro nor in vivo, and are worthless as model compounds for anything in this area of study. So what is GSK going to have to say about this? And what, if this paper is at all accurate, did they buy with their $720 million?
Biogen Says Tysabri Patient Additions Slow
http://www.thestreet.com/story/10659772/1/biogen-says-tysabri-patient-additions-slow.html
By Adam Feuerstein 01/12/10
SAN FRANCISCO (TheStreet) -- Biogen Idec(BIIB Quote) said Tuesday that sales of its multiple sclerosis drug Tysabri surpassed $1 billion in 2009, but the number of new patients starting treatment on the drug in the fourth quarter appears on the low end of Street expectations.
In advance of an afternoon presentation at the J.P. Morgan Healthcare Conference here, Biogen said that 48,800 patients were being treated with Tysabri worldwide as of the end of December.
That works out to 2,600 new patients added to Tysabri's treatment role in the fourth quarter, or 200 new net patients per week.
In a research note Monday, Deutsche Bank biotech analyst Mark Schoenebaum estimated that there would be 200 to 250 new Tysabri patients added per week in the fourth quarter.
In a note issued last week previewing his bank's healthcare conference, J.P. Morgan analyst Geoffrey Meacham said he was looking for 250 new Tysabri patients per week in the fourth quarter.
Biogen shares Tysabri revenue with Irish drugmaker Elan(ELN Quote).
The $1 billion in Tysabri global sales for 2009 were in-line with Street expectations.
Biogen shares were down 15 cents to $53.75 in early Tuesday trading.
I'm not getting in the paranoia zone.
(but hey, that doesn't mean I'm not being followed)
There's no lack of regulation, GMOs need regulatory clearance i.e to be approved for marketing. Open the links in the table.
For example:
http://californiafarmer.com/story.aspx?s=7763&c=11
http://www.reuters.com/article/idUSTRE50661V20090107