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[OT] Power E*Trade Pro
I also appreciate the tips it may help me to use more of it then I was! I need an E*Trade Pro for Dummies :)
[OT] E-trade Pro Update
FYI, I noticed it ran on my newer PC today which it didn't a day or two ago (The error message I'd get would be because of the version of Java installed). So perhaps it may be a java issue more then an E-trade programmer issue (wonder if you could have configured it to use the older version?)
I recall a while back in earlier days when working with some Java each time their would be an upgrade some of my programs would behave differently.
I haven't figure out E-trade pro yet to use it much so I didn't have any layouts set up. I am not an active trader so the basics are more then enough for me at this stage :)
He then asked me to email him my layout file so they could use it for debugging!
A familiar phrase from old work. Leave it to a former computer person to break anything new :)
FYI, I caught the last part of a segment on Good Morning America where they had the doc and one of the patients from the trial. Don't if Good Morning America has webcasts of their stories but it was this AM.
Thanks for the info Biowatch. I agree about small trial/tiny company
I am always a little leary of tiny companies and Phase 1 results and then add that it is gene therapy... That being said a disease in need of a treatment the results seem to show promise. I was curious if anyone has any thoughts on this in general or has heard of Neurologix ( http://finance.yahoo.com/q/ks?s=NRGX.OB )
Since it is pretty invasive I don't know how many would rush to get it but the results seemed promising. I guess tomorrow we'll know how much the street thinks of its potential.
http://news.yahoo.com/s/ap/20070621/ap_on_he_me/parkinson_s_treatment_1
New treatment promising for Parkinson's
By MALCOLM RITTER, AP Science Writer 14 minutes ago
NEW YORK - An experimental treatment for Parkinson's disease seemed to improve symptoms — dramatically so, for one 59-year-old man — without causing side effects in an early study of a dozen patients.
The gene therapy treatment involved slipping billions of copies of a gene into the brain to calm overactive brain circuitry.
The small study focused on testing the safety of the procedure rather than its effectiveness, and experts cautioned it's too soon to draw conclusions about how well it works. But they called the results promising and said the approach merits further studies.
"We still have quite a bit more testing to do," said Dr. Michael Kaplitt of Weill Cornell Medical College in New York, an author of the study. Still, "the initial results are extremely encouraging."
Kaplitt and collaborators report their results in this week's issue of the British medical journal, The Lancet.
They're not alone in trying gene therapy for Parkinson's. In April, another team told a medical meeting that its experiments, which delivered a different kind of gene to a different part of the brain, also appeared safe and gave a preliminary hint of benefit.
More than half a million Americans have Parkinson's. They endure symptoms that include tremors, rigidity in their limbs, slowness of movement and impaired balance and coordination. Eventually they can become severely disabled.
Nathan Klein, a 59-year-old freelance television producer in Port Washington, N.Y., said the disease left him "pretty messed up." It weakened his voice, impaired his walking and made his hand tremble so badly he couldn't hold a glass of wine without spilling it all.
Klein was the first patient to be treated with Kaplitt's gene therapy procedure in 2003, and he said his symptoms gradually subsided afterward. Nowadays, he said, apart from freezing now and then when he wants to walk, the symptoms are basically gone.
"I'm elated," said Klein, who continues to take his regular pills for the disease. "It's unbelievable."
Kaplitt, who has a financial interest in Neurologix Inc., which paid for the research, noted that the 12 patients in the study still have Parkinson's symptoms. The amount of medication they were already taking for their symptoms didn't change significantly in the year after the surgery.
Current medicines can control symptoms, but can't stop the disease from getting worse over time, and they can produce troublesome side effects like uncontrollable movement.
Some patients gain relief from a surgical treatment called deep brain stimulation, in which electrodes are placed in the brain and connected to a programmable stimulator.
Kaplitt's procedure was aimed at achieving the same goal as that surgery, calming overactive circuitry in the brain. It gets overactive because it loses the normal supply of a chemical called GABA. The gene therapy was designed to make the brain produce more GABA.
For the gene therapy surgery, a tube about the width of a hair was threaded through a hole about the size of a quarter at the top of the skull. The tube delivered a dose of a virus engineered to ferry copies of a gene into cells of a brain region called the subthalamic nucleus. The gene copies enable the cells to pump out more GABA.
The Lancet paper reports that over a year, patients showed no side effects from the procedure. What's more, they showed improvements in an overall assessment of symptoms like tremors, stiffness and walking problems.
The improvements were evident at a checkup three months after the procedure and persisted to the end of the study, one year after the surgery, researchers reported. By that time, the overall amount of improvement from before surgery was about 24 percent when measured at times that patients were off their normal medication, and 27 percent at times when they were on medication.
Most of the effect appeared on just one side of the body. Because of concerns about safety with the untested procedure, the researchers treated only the brain circuitry controlling one side of the body.
Dr. Karl Kieburtz of the University of Rochester Medical Center, who didn't participate in Kaplitt's work, said the lack of any apparent side effects is itself significant.
But he urged caution in interpreting the evidence of benefits in symptoms. Other experimental therapies that looked good at such a preliminary stage have failed to pan out in more rigorous studies, he said, so more research is needed.
Future studies could include a head-to-head test against deep brain stimulation to see which relieves symptoms better, said neurosurgeon Dr. Guy M. McKhann of the Columbia University Medical Center in New York.
Dr. J. Timothy Greenamyre of the University of Pittsburgh, who was also familiar with the results, said the new study and prior research in animals leave him "very optimistic" about Kaplitt's approach.
__
For you Bill James Fans. Todays Journal had a nice article. He has an interesting contrarian opinion on the effect of steroids on performance.
http://www.opinionjournal.com/la/?id=110010232
Sultan of Stats
How Bill James's analysis has helpd make the Red Sox into winners.
BY DAN ACKMAN
Wednesday, June 20, 2007 12:01 a.m. EDT
BOSTON--After 25 years on the outside, Bill James was invited to take a seat at the center of the baseball universe. Since his hiring by the Boston Red Sox in 2002, Mr. James, the statistical oracle and author of the Bill James Baseball Abstracts, the team has broken the Curse of the Bambino, won the World Series and is currently tearing up the American League.
As Mr. James, raised on the Kansas City Athletics, is a Yankee-hater from way back, he might be expected to take even more pleasure in the New York team's faltering start to the season. But sitting in a restaurant a long fly ball from his bare office in Fenway Park, Mr. James refuses to revel. "Who was it who wrote the book 'They Only Look Dead'?" Mr. James asks. He also refuses to take credit for the Red Sox rise. "Nothing I do leads directly to consequence, and if it did I wouldn't tell you," Mr. James says.
Indirectly, it's a different story. Starting in 1977 with his first Baseball Abstract, Mr. James transformed a century's worth of conventional wisdom and forever altered the way ballplayers are judged. Applying the scientific method to the game, he and a band of amateur analysts who Mr. James termed sabermetricians (for the Society for American Baseball Research) attempted to answer through objective statistical analysis what factors led to scoring runs and winning games--and which players contributed most to those goals. Mr. James, for instance, has long held that the ability to get on base was underrated and that the sacrifice bunt was overrated. After gaining a wide following among fans, his work started to influence at least a few baseball general managers, a process chronicled in "Moneyball," the 2003 best seller by Michael Lewis about the Oakland Athletics and General Manager Billy Beane.
Now, more than 20 books of his own later, Mr. James has a desk in Fenway Park and a title, senior baseball operations adviser. So what does he do for the team? "I see it as being my job to ensure as much as I can that we act on the basis of actual evidence."
Of course, if it weren't for hope and blind faith, interest in the Red Sox might have dried up years ago. As it is, the team, with its current eight-game lead over the Yankees, has never been more popular, and Fenway is sold out almost every night. As for the Curse of the Bambino, Mr. James says: "I didn't even believe in it before."
Mr. James, a rationalist in a church of red-blooded true believers, takes the long view: "In any given season there is an immense amount of luck in who wins the division, even if it's a lopsided race," he says. "People are made very uncomfortable by the notion that our lives are random, but there are huge random parts in everything that happens. It's uncomfortable because it's our job to drive the randomness out and make the system work."
Since Mr. James was hired by Red Sox owner John Henry in 2002, the team has yet to win the division. It did, however, win the World Series in 2004, beating the Yankees in seven games to win the pennant. A year earlier, the Sox lost to the Yankees in seven games. Two years later they had fallen to third place in the American League East.
What accounts for this year's dominance? "We think we have a good organization, and we thought we had a good organization last August when we couldn't win a game to save our soul," Mr. James says. With "Moneyball," Mr. James's style of analysis has become associated with relatively poor teams. The Red Sox, however, are one of the richest.
"There is a certain backwardness to it, yes," he concedes. But he adds that Boston is "committed to the challenge to figuring out the best way to do things. Nobody in the organization is traditional."
That would include Mr. James, who started writing his Abstracts while working as a night watchman at a pork-and-beans factory in Lawrence, Kan. Even as his fame grew as a writer, Mr. James says he never imagined working in baseball management. Unlike Theo Epstein, who interned for major-league clubs in college and was hired as the Red Sox general manager at age 28, Mr. James says he was never the type to put together a résumé and go find a job. Even today he allows that "there are very good reasons why Theo is the GM and I am not."
Now age 57, Mr. James says he does better working in an organization than he suspected. Still, even after moving to Boston two years ago, he spends a lot of time alone. "A lot of my friends think that I don't like people. The reality is I do like people--I just need time to myself to work. So I tend to turn off my cellphone," he says.
With the success of the Athletics and of "Moneyball," baseball analysts like Mr. James were given more credit for helping teams draft and trade players more intelligently. In 2006, Time magazine named Mr. James one of the 100 most influential people in the world. Inexplicably, Time dropped him from this year's list even as the Red Sox moved from third place to first. Go figure.
Mr. James is known for claiming that some statistics (such as runs batted in) are less important than was commonly believed, while others (like on-base percentage) are more important. Both are now conventional wisdom. Is there some wrongheadedness still in vogue? "I do have an answer, but I can't tell you what it is. . . . I do think we know at least some small things that not everybody in the world knows."
Even if the analytical tools he helped create are now widely employed, Mr. James says that just as some teams stay richer, others can stay smarter. "In reality, knowledge is a very dynamic universe--and what is most valuable is not the body of knowledge, but the leading edge of it."
Mr. James does allow that "when a team has resources, there is a powerful tendency to solve problems by spending money. It is less attractive to experiment." The Yankees' recent signing of pitcher Roger Clemens for $28 million a season is "probably" an illustration of the idea, he says.
"I have a lot of oddball ideas. I always have," Mr. James says, even if some of his ideas once considered odd are now popular.
His theory on baseball and steroids may or may not be odd, but it is certainly not in vogue. "I don't know," he says, when asked if steroids account for the surge in home runs in the late 1990s. "Speaking globally . . . the reality is that there are many changes in the game which could cause batting numbers to jump. And no one really knows to what extent the increase is a consequence of steroids. I strongly suspect that the influence of steroids on hitting numbers is greatly overstated by the public." Other factors include ballpark dimensions and bat design. "I've never understood why nobody writes about it, but the bats are very different now than they were 20 years ago," Mr. James says, with different woods and finishes. "[Barry] Bonds's bats are still different from everybody else's," he notes.
"People think they understand how to win in baseball much more than they really do," Mr. James says. This is true of the statisticians as much as it is of traditional scouts. While "Moneyball" treats scouts and analysts as at odds, Mr. James says he learns from the scouts all the time. "The scouts see a lot of things that I can't see. And some of the things they see I have learned to see. But some of the things they see I can't see at all. And I'm not suggesting it's not real, it's just that I can't see it," he says. "There is no reason for there to be a conflict. The conflict exists only when people think they know more than they do."
After a lifetime of studying the game, Mr. James reckons he still has plenty to learn. The internationalization of the game is one source of new wisdom, he says. "One of the great things about the Cubans and the Japanese is that they develop their own traditions and a lot of the things we think they know they don't necessarily buy into. Incorporating those other traditions is a source of wealth for baseball, and if we're smart, we'll do more of it."
Ichiro Suzuki, the Seattle Mariners centerfielder and perennial hits leader, is one example. "He's a great player while violating 48 rules about how everybody is taught to hit," Mr. James says. Orlando "El Duque" Hernandez, the wily Cuban-born New York Mets pitcher, is another case in point. "We have a set pitching pattern, and then you get a guy like El Duque doing everything wrong and he beats you. It's a wonderful object lesson for all of us."
Mr. Ackman writes for The Wall Street Journal about sports, culture and law.
Webcast Calendar
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Fix formatting (bold not turned off), username/password info for William Blair conference
June 19-20, 2007
NASDAQ 19th Investor Program - London
http://investor.shareholder.com/nasdaq/June2007.cfm
June 19-21
William Blair 27th Annual Growth Stock Conference (Some Biotech)
http://www.wsw.com/webcast/blair8/
Username: williamblair
Password: june2007
June 20-21, 2007
Piper Jaffray Second Annual London Health Care Conference
http://phx.corporate-ir.net/phoenix.zhtml?c=128690&p=conferenceAgenda&id=1543785&day=1
http://www.piperjaffray.com/conferences (or from this link if above doesn't work)
June 26-28, 2007
Jefferies Healthcare Conference
http://www.wsw.com/webcast/jeff18/
---
Procedure For Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old list. You can find a pointer to this list in the iBox at the top of the main message-board screen.
2. Make your additions or modifications, inserting any new items in alphabetical order.
3. Post the updated text in a new message in reply to the message with the old list.
While it is just being initiated, the company has indicated this program could move very fast with Phase 1 results before year end and starting Phase 2 in at least one indication shortly thereafter.
http://biz.yahoo.com/bw/070619/20070619006320.html?.v=1
Altus Pharmaceuticals Submits Investigational New Drug Application to Study ALTU-237 for the Treatment for Hyperoxalurias and the Potential Prevention of Kidney Stone Formation
Tuesday June 19, 4:05 pm ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News) today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for ALTU-237, an orally-delivered crystalline formulation of an oxalate-degrading enzyme. Altus has designed ALTU-237 for the treatment of hyperoxalurias and the possible prevention of recurrent kidney stones in individuals with a high risk or history of kidney stones. Following the FDA review period, the Company intends to initiate a Phase I human clinical trial to assess the safety of ALTU-237.
ADVERTISEMENT
"This IND submission is a significant milestone for Altus Pharmaceuticals. We are pleased to advance ALTU-237, our third clinical program based on the Company's proprietary protein crystallization technology," stated Sheldon Berkle, President and CEO of Altus Pharmaceuticals. "For the majority of patients with hyperoxalurias or recurrent kidney stones there are limited treatment options available. The ALTU-237 pre-clinical data is very encouraging and we are excited about the opportunity to bring our next product into the clinic."
About Hyperoxaluria
Hyperoxaluria is a disease characterized by excessively high levels of oxalate in the urine, which can be a precursor to forming kidney stones. Hyperoxaluria can be caused by either excessive absorption of dietary oxalate (enteric hyperoxaluria) or increased endogenous production of oxalate (primary hyperoxaluria). When untreated, primary hyperoxaluria could lead to recurrent kidney stones and could contribute to renal failure. Ultimately, patients suffering from severe primary hyperoxaluria experience calcium deposits in their organs, which, if left untreated, could lead to death.
About Altus Pharmaceuticals Inc.
Altus Pharmaceuticals, headquartered in Cambridge, MA, is a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders. The company is listed on the Nasdaq Global Market under the symbol ALTU.
Safe Harbor Statement
Certain statements in this news release concerning Altus Pharmaceuticals' business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Altus Pharmaceuticals might make or by known or unknown risks and uncertainties, including, but not limited to the pending FDA review, the timing and the initiation by the Company of the ALTU-237 Phase I clinical trial, the development risks of an early stage clinical program and the uncertainty of results in future clinical trials evaluating efficacy as well as safety. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Altus Pharmaceuticals' reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-Q for the fiscal year ended March 31, 2007, as may be updated in its quarterly and current reports. However, Altus Pharmaceuticals undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
Contact:
Altus Pharmaceuticals Inc.
John A. Jordan, 617-299-2852
Senior Director, Corporate Communications
Also in a PR by Auxilium today it was mentioned that Dr. Fuchs (the head of manufacturing) had retired in June from Altus (he is joining Auxiliums board. In this study there are many things of interest to note in comparison to Altus's Phase 3 study. Altus had said the FDA was most concerned with CFA absorption in the under 40 group. Eurand broke down the results by above/under 60.
http://biz.yahoo.com/prnews/070619/cltu042.html?.v=92
Eurand's Zentase(TM) Effective in Treating Exocrine Pancreatic Insufficiency, Studies Show
Tuesday June 19, 9:40 am ET
Zentase Improves Absorption of Fat, Protein and Other Nutrients in Patients with Mild, Moderate or Severe Malabsorption, While Controlling Symptoms of Exocrine Pancreatic Insufficiency
MILAN, Italy and DAYTON, Ohio, June 19 /PRNewswire-FirstCall/ -- Eurand N.V. (Nasdaq: EURX - News) today announced results that were presented at the recent European Cystic Fibrosis Society meeting in Antalya, Turkey, held June 13-16. Results from two phase III studies of Zentase(TM) (EUR-1008) showing a statistically and clinically significant improvement in the absorption of fat, protein and nutrients in patients suffering from Exocrine Pancreatic Insufficiency (EPI). Absorption levels were measured by coefficient of fat (CFA) and coefficient of nitrogen (CNA) absorption, common measurements for malabsorption in EPI patients. In the pivotal study, the mean CFA after Zentase was 88.3 percent and the mean CNA after Zentase was 87.2 percent. Levels under placebo were 62.8 and 65.7 percent respectively (p=0.001). Scientific evidence suggests that to normalize EPI, treatment needs to raise CFA levels to at least 85 percent.(1)
The data were the basis for the recent rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zentase as a treatment for EPI. EPI is a potentially lethal disease marked by the deficiency of digestive enzymes normally produced by the pancreas. This deficiency results in poor digestion and reduced absorption of nutrients, which, if left untreated, can lead to malnutrition, impaired growth, weakened immune response, and shortened life expectancy. Treatment with pancreatic enzyme products (PEPs) replaces enzymes lost through the disease. Currently, there are no known alternative therapies to PEPs for EPI.
EPI can occur as a complication of a variety of diseases, including cystic fibrosis, pancreatic cancer, surgery and chronic pancreatitis. There are no reliable statistics on the worldwide incidence of EPI, but in the U.S., it is estimated that more than 200,000 people suffer from EPI.
"Nutritional status, lung function and life expectancy are tightly connected in cystic fibrosis patients. In general, enhancing CFA and CNA levels improves nutrition. Good nutrition improves lung function. And, better lung function improves life expectancy," said James E. Heubi, MD, Director, General Clinical Research Center, Professor of Pediatrics, Cincinnati Children's Hospital Medical Center. "These data suggest that Zentase could provide EPI patients with an effective treatment option that would normalize CFA which could protect lung function and increase life expectancy."
Zentase is a zero-overfill, highly-stable, porcine-derived PEP. If approved by the FDA, it is expected to be available in four dose strengths, including a low-dose formulation for children that can be sprinkled on food.
"As a company, our goal is to develop products that optimize efficacy and tolerability while meeting patient needs for convenience, which is why we developed Zentase specifically with patients in mind," said Gearoid Faherty, Chief Executive Officer, Eurand. "The data presented in Turkey are an indication that with Zentase, we are well on the way toward meeting that goal."
About the Studies
The two phase III studies were designed to test Zentase in EPI patients presenting with the full range of disease severity. The studies included patients from 1-24 years of age with disease severity including mild, moderate and severe malabsorption. Half of the patients enrolled in the pivotal study had a baseline CFA greater than 65 percent and half had a baseline CFA lower than 65 percent (median CFA levels were 65.8 percent). Patients enrolled in the pivotal study had a wide range of baseline CFA levels with one patient as low as 28.7 percent (very severe disease) and five patients with CFA levels above 80 percent.
The majority of EPI patients in the pivotal study, regardless of disease severity, experienced a clinically significant response to Zentase treatment. Half of these patients had a CFA greater than 90 percent following Zentase treatment and 90 percent of patients had a CFA greater than 79 percent following Zentase treatment. Based on these study findings, Zentase may able to treat all patient types, from those requiring low levels of supplementation to those with severe disease needing high levels of enzyme supplementation.
Pivotal Study Highlights
This randomized, double-blind, placebo-controlled, cross-over study was conducted in 14 CF centers in the US and involved data from 31 patients with EPI. The average age was 15.4 years and the study was evenly split between male and female patients. After open-label dose titration, patients were randomized to receive Zentase or placebo over a week-long period. Following open-label normalization, all patients were crossed over to the alternative treatment arm. A determination of CFA and CNA on a 72-hour sample and under controlled diet in a hospital environment was performed at the end of each randomized treatment arm. No drugs affecting GI motility or pH (eg, PPIs or H2 blockers) were allowed under Zentase treatment.
-- Direct Dose Response on Improving EPI Symptoms. Increasing the Zentase
dose displayed a direct correlation on improving EPI symptoms including
stool consistency and symptom scores including measures of pain,
bloating, gas and oil visibility. A mean increase of 40 percent from
first to last dose changed the majority of patients from highly
symptomatic to normal. This was particularly notable for patients with
abnormal stool at baseline.
-- Improved Malabsorption Symptoms in Severe EPI Patients. Response to
Zentase correlated very well (r> 0.9) with disease severity. Patients
with more severe malabsorption on placebo (CFA<60 percent) experienced
significant improvements following Zentase treatment with a 43 percent
median increase in CFA.
-- Consistently Improved EPI Symptoms. Zentase treatment improved the
signs and symptoms of malabsorption even in patients with CFA values
greater than 80 percent under placebo.
-- Well Tolerated. There were no unexpected or significant differences
in adverse events (AEs) between treatment and placebo. No patient
discontinued due to an AE. Two serious AEs were considered unrelated
to study drug and resolved without discontinuation. The most commonly
reported AEs for either group were abdominal pain, flatulence,
abdominal distension, abnormal feces and steatorrhea.
Supportive Study Highlights
This open-label, multiple-dose, single-treatment study was conducted in 11 CF centers in the US and involved 19 CF patients with EPI. The average age was 3.9 years (range 1-6 years) with male patients accounting for 63 percent of the study participants. This was the first prospective study of PEPs involving children younger than 7 years of age. The study involved a seven- day dose stabilization period followed by a seven-day treatment period. Due to ethical concerns, placebo was not used and patients were switched from previous enzyme treatment without washout. No drugs affecting GI motility or pH (eg, PPIs or H2 blockers) were allowed under Zentase treatment.
-- Provided Very Good Control of Symptoms to Patients. The percentage of
responders on Zentase, defined as having less than 30 percent fecal fat
content and without signs and symptoms of malabsorption after 1 and 2
weeks of treatment, was consistent with the percentage of responders
under previous treatment (baseline). In addition, Zentase treatment
decreased stool frequency and oily stools vs baseline. The mean number
of stools per day was 1.82 at screening and 1.45 stools during
treatment (p<0.001). The mean proportion of oily stools was 11.1
percent at screening and 4.73 percent during treatment (p<0.001).
-- Improved EPI Signs and Symptoms. During Zentase treatment 37 percent
of patients were characterized as improved by physicians and 47 percent
were characterized as improved by parents, as compared to previous
therapy. No patients were characterized as worsened on treatment with
Zentase.
-- Well Tolerated. There were minimal AEs, none of which led to
discontinuation or study drug interruption. One serious AE was
considered unrelated to study drug and resolved without
discontinuation. The most commonly reported AEs were abdominal pain,
steatorrhea, discolored feces, flatulence and vomiting.
Zentase Stability on Food
With very young children with EPI, it is common practice to sprinkle the enzymes on a small amount of food, for example, on applesauce. Studies of 11 different baby and infant foods, including applesauce, evaluated which other foods were suitable for sprinkling with Zentase.
The study showed that Zentase could remain for . 1 hour without any significant deterioration of the enteric coating when sprinkled on the majority (10/11) of tested foods. Thus, with its enteric coating fully intact, even after an hour on food, Zentase remains protected from the harsh, acidic environment of the stomach and is released only when the enzymes reach the upper gastrointestinal tract - where the enzymes are needed for proper digestion of food. This study provides parents with a wider selection of foods to use in giving enzymes to their children when applesauce is not an option or when children want variety.
About Zentase
Zentase was designed to meet the US Food and Drug Administration (FDA) guidelines for PEPs(2). PEPs have been used since before the enactment of the U.S. Federal Food, Drug and Cosmetic Act in 1938 and consequently none of the currently available products are marketed under a NDA approved by the FDA. In April, 2004, the FDA mandated that all manufacturers of EPI drug products file a NDA and receive approval for their products by April 2008 or be subject to regulatory action.
One of the FDA requirements to submit an NDA for a PEP is the elimination of product overfill allowed under current guidelines. Currently, individual enzyme doses can be overfilled up to 165 percent of label claim(3) to compensate for the breakdown of enzymes over time and to ensure that each capsule contains at least 90 percent of the label claim at the end of the product's shelf life. As a result, patients taking PEPs may be unknowingly over or under treating their disease by using a product with variable potency. This variability can put patients at risk for colonic strictures with overtreatment or malnutrition with undertreatment.
As a highly-stable product, Zentase does not require overfill. It will be filled at 100 percent of label claim, with a minimum of 2-years shelf life, to ensure consistent dosage and maintain treatment levels over time.
About Eurand
Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four products approved by the FDA since 2000 and has a pipeline of product candidates in development for itself and its collaboration partners. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, customized release, taste-making/fast-dissolving formulations and drug conjugation.
Eurand is a global company with facilities in the USA and Europe. For more information, visit Eurand's website at www.eurand.com.
This release, and oral statements made with respect to information contained in this release, constitutes forward-looking statements. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact including, but not limited to our plans for our NDA filing, enrollment and future plans for our clinical trials, progress of and reports of results from clinical studies, clinical development plans and product development activities. The words "potentially", "could", "calls for" and similar expressions also identify forward-looking statements. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could affect actual results include risks associated with the possibility that the FDA refuses to approve our NDA; the outcome of any discussions with the FDA; and unexpected delays in preparation of materials for submission to the FDA as a part of our NDA filing. Forward- looking statements contained in this press release are made as of this date, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Actual events could differ materially from those anticipated in the forward- looking statements.
(1) Littlewood, James M., and Susan P. Wolfe. "Control of Malabsorption
in Cystic Fibrosis." Paediatric Drugs (2000; 2 : 205-22)
(2) Guidance for Industry Exocrine Pancreatic Insufficiency Drug Products
- Submitting NDAs. U.S. Department of Health and Human Services, Food
and Drug Administration (FDA), Center for Drug Evaluation and Research
(CDER), April 2006
(3) United States Pharmacopeia (USP) standards for pancreatic enzyme
products (will get full reference)
iwfal,
I suspect you may have a good point on ALTH. On Epix I think it was a bit trickier. If memory serves they not only met their end-point but were told not 1 but perhaps 2 additional trials would be required. I think they were pretty much up against a wall at that point and not in a position to do those trials especially with a moving target (how Michael Astrue characterized the end point/FDA requirement).
dewophile looks like you may have picked this well! I was not familiar enough with the company to do what you did though it seemed logical. They have a lymphoma drug that I had noticed a while back and that is what got me interested in following them (just a bit though).
MRCR -
They are having their annual meeting this week. Wondering if anyone has talked to Mr. Menard (or anyone else at the company). In reading the PR's and especially the Wall Street Reporter article he sounds like a very interesting person. I was curious if by phone/in person anyone has talked with him and their opinions. TIA
The short answer is 1 order does not equal 1 month revenue.
The longer answer entails looking at the company a bit deeper and realizing that year on year numbers there is triple digit growth. I don't think the current year PE is the best way to value a company growing at that rate (in general), however if that is what you wish to do you need to do a lot more work to get a guestimate. I believe gilead posted earlier projections that seemed to do some of this.
Another thing to keep in mind if the company elects to hire more sales reps and top-line and monthly orders keep increasing the bottom line effect will lag too.
If you are interested in the company (investing in it) as opposed to pointing out something from a quick read of a PR or two (sorry don't mean to sound harsh but I could see how someone could conclude that from just looking at a couple PR's and not seeing how the company's revenue is generated) then I'd suggest to not take my word but look at what Mr. Sandgaard has PR'd (or perhaps in some of the 8-k's and Q's and K) has tried to stress regarding monthly orders. If you go through them in order you can see he wasn't just talking nonsense. What he was telling the market is actually now being more easily seen in the top/bottom lines.
On the zynx board I posted something months back when he was hiring the additional reps to be honest I didn't expect this type of growth. So to say I am quite pleased is an understatement. Now to me does the company try to continue growing top-line (and have the bottom line catch up) or have it go to the bottom line now. I'd be happy with either approach!
http://www.investorshub.com/boards/read_msg.asp?message_id=16377965
Dew,
Do you know anything about the other company he mentioned (ULURU) http://finance.yahoo.com/q?s=ULUR.OB?
It sounded interesting but he sure got a sweatheart of a deal getting his shares!
TIA
ENCY:
Hope you did OK if you had a position here!
I guess running a Biotech company is a little like managing a baseball team when things go bad the manager gets fired but this time I think the manager deserves at least some of the blame.
I thought Given seemed quite knoweldgeable and credible, from about the 2nd approvable on my opinion drastically began to change on him.
evidently there was something in Encysive's data as far as safety that the FDA didn't like.
Who said anything about safety? The PR implies did not show efficacy on another board the discussion centers around probably a center or two (the one with Dr. Lawrence at least) had some/all of the data excluded and likely caused the P value to fall beyond what would have met statistical significance. This makes the most sense of anything and seems to be supported by the little wording in Encysive's PR.
The liver monitoring is being required by Gilead and likely would have been also for Thelin. Claims that Ambrisentan has a lower incidence of liver tox seemed to fall on deaf ears as they still got the black-box label. So Endothelin Receptor Antagonist safety is a class effect, at least as far as the FDA is concerned but the benefits to patients exceed the small risk so approval with liver monitoring beets no drug at all.
Here is the PR from the FDA website.
Thelin seems dead in the US. In addition to my thinking they won't be able to recruit patients for another trial some posters on iVillage pointed out several other reasons including: lack of funds/would be a couple years behind Letairis. The only chance I'd see for it if it is co-formulated with another class of drugs for PAH (the most likely candidate would be a longer acting PDE5 but Thelin is daily and Revatio and Cialis seem to have different dosing regimins).
From Gilead's PR, conference call yesterday and more so their Goldman Sachs call a couple days ago they seem all set for a launch and head-to-head competition with Tracleer/Actelion. I found it interesting they note the percent of patients not needing additional therapy after 1 year. Actelion has Ventavis (Inhaled Prostacylin) and was also studying both with PDE5's. I think it is more marketing/hype as most PAH opinion leaders think combination therapy is where treatment paradigms are heading.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01653.html
FDA News
FOR IMMEDIATE RELEASE
P07-104
June 15, 2007
Media Inquiries:
Sandy Walsh, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension
The U.S. Food and Drug Administration (FDA) today approved Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension, a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs.
"Letairis represents a valuable addition to the treatment alternatives for this orphan disease," said John Jenkins, M.D., director of FDA's Office of New Drugs. "Letairis is similar to an existing drug, but offers the potential for fewer drug interactions."
In pulmonary arterial hypertension, the small arteries in the lungs become narrowed or blocked, and the heart must work harder to pump the blood through them. Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs. Symptoms include shortness of breath, fatigue, chest pain, dizzy spells and fainting. About 100,000 people in the United States have pulmonary arterial hypertension.
Letairis, a new drug not previously approved in the United States, was granted a priority review by FDA. A priority review designation is intended for those products that address unmet medical needs. For priority drug applications, FDA sets a target date of six months after the date of receipt for the agency to complete all aspects of a review and to take action.
The safety and effectiveness of Letairis were demonstrated in two international clinical trials involving 393 patients. Letairis significantly improved physical activity capacity compared with a placebo, as shown by a six-minute walk, a standard test. Letairis also delayed the worsening of the pulmonary hypertension.
The most common side effects in patients using Letairis included swelling of legs and ankles, nasal congestion, sinusitis, and getting red in the face (flushing).
Letairis should not be used by women who are pregnant or may become pregnant because the drug may cause birth defects. Patients taking Letairis must have monthly blood tests to check for potential liver injury.
Letairis will be available in five-milligram and 10-milligram once-daily tablets.
Letairis was granted orphan drug status by FDA because it treats a rare disease and meets other criteria. Orphan designation qualifies the drug's sponsor for a tax credit and marketing incentives.
Letairis is manufactured by Gilead Sciences, Inc., Foster City, Calif. Gilead acquired the U.S. rights to ambrisentan when it acquired Myogen, Inc. in 2006. GlaxoSmithKline holds rights to ambrisentan outside of the United States.
For more information:
The Orphan Drug Act
www.fda.gov/orphan/
National Heart Lung and Blood Institute – What is Pulmonary Arterial Hypertension?
www.nhlbi.nih.gov/health/dci/Diseases/pah/pah_what.html
GILD/ENCY:
At the Goldman call the other day Gilead's COO I believe sounded extremely confident. Saying things like monday afternoon we can show you the label.
Still no word from Encysive...
ITMN:
Said think rash is not a class effect that would not be transferable to 191 but haven't done the experiments so can't be sure.
Said in animals did reach toxic dose (did not say what was observed). Believe can dose drug well within international range for safety.
ITMN:
On the GS call (happening now) Dan Welch indicated top-line results of 1B could come at October Liver Disease meeting (perhaps just the initial cohort). Other option is December meeting (didn't catch witch one).
ALTU:
As for the DNA deal, I'm not as high on crystallized growth hormone working as Im on the pancreatic insufficiency indication.
Also, there's no reason why crystals could not still retain enzyme activity in their lattice form in the stomach. hGH on other hand, cant bind to its receptor in the crystalline form and you obviously dont want protein crystals circulating in your bloodstream. How exactly the hGH in the crystal is dissolved into a bioavailable monomeric form is critical here.
Your concern is more safety then actually efficacy or both? If in fact the hGH is circulating in the bloodstream would adverse events be more noticeable only in longer term usage or something that would be noticed immediately? I don't have you background in the science so just trying to get a better understanding. TIA.
Since your handle is pre-clinical I thought you'd be interested in their pre-clinical candidates as well :)
I missed that (Pharmasset Polymerase partnered with Roche) in the presentation!
Does anyone know what type of terms they have and what it says for Roche's own Polymerase (last I recall there was talk of perhaps them trying a lower dose)?
ALTU -
Pre_Clinical,
I like them and recently became a shareholder and have been building a position. I am not a day-to-day trader so I can't say when the bottom is. I like the "value" involved. Aside from their two Phase 3 programs which derive most of the value, I really like their pre-clinical candidates especially ALTU-237 not even the larger kidney-stone indication. I think Primary hyperoxaluria and enteric hyperoxaluria could end up being a very valuable indications in and of themselves and suspect its development will be very fast.
I really like the management backgrounds. Good to see several TKT people. Interestingly their "manufacturing" (ended up not being mfg related) issues resulted in hiring the former TKT head of manufacturing which if I recall correctly Michael Astrue gave very glowing praise to on several occasions.
Not to mention the cash is more then half the stock price.
If I were to suspect on the decline (outside of someone wanting to sell and the float not being too high). I could think of a couple things:
1-Eurand is presenting info on their Pancreatic Insufficiency product (perhaps some people are thinking they'll get more of the market)
2-No word on Genentech x-US partnership for a couple months. And trial didn't start yet or get update on when it will.
3-Dr. Falk Pharma dispute and the potential patent issue.
3-
Thanks I was a little leary because of it being a new poster. I tried to engage them to post some information but haven't noticed any posts since.
ENCY had an interesting trading day yesterday. Late in the day the stock dropped about a dollar and then quickly recovered (minutes). I saw a mention that there was a rumor the FDA did not approve but apparently that was a false rumor (for now at least).
VRTX:
At the Bear Stearns Conference Today Vertex interestingly had their 950 Program lead as the main presenter (John Randle, PHD). They did mention their other products but about 90% of the presentation and 100% of the Q&A was on 950.
Don't know if its new but they pointed out the rash seems to start to occur between 4 and 8 weeks. Said some physicians characterize it as the same as the ribavirin rash and others say no its distinguishable. Don't know yet the mechanism of how its occurring. Median 62 days for those discontinuing/delaying treatment (if I heard right).
Other items I caught on the call
. Waiting for Prove 1 and 2 data but will start discussions with FDA mid year with objective of starting Phase 3 by end of year.
. Anticipation for total duration of therapy based on initial results (from EASL) that 24 weeks is a good target (for now).
. Will shortened therapy be enough with same SVR? Think will get both shorter treatment and higher SVR. From October Advisory board meeting SVR is key. Raising SVR is most important.
Webcast Calendar
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Deleted Past Entries, Adds-FTN, Bear Stearns, Goldman Sachs and Needham Conferences
Bear Stearns Biotech Confab
http://cc.talkpoint.com/BEAR002/060707a_sc/agenda.asp?day=Thursday
June 7, 2007
FTN Midwest Health Care Conference
2007 Health Care Conference The Four Seasons, New York
June 5-6, 2007
http://www.wsw.com/webcast/ftn10/ (Have to first register for link to work)
Goldman Sachs 28th Annual Global Healthcare Conference
June 12-14, 2007
http://cc.talkpoint.com/GOLD006/061107a_ma/agenda.asp?day=Tuesday
6th Annual Needham & Company, LLC Biotechnology & Medical Technology Conference
http://www.wsw.com/webcast/needham18/????
Where ???? = Company Symbol (sorry don't have the link to companies present)
June 13-14, 2007
GSK 6/18 Time TBA (Oncology R&D Day)
MATK 6/6 4:45 pm (FY2Q07)
IDIX 6/7 2:30 pm (BS); 6/12 2pm (GS)
VRTX 6/7 7:50 am (BS)
---
Procedure For Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old list. You can find a pointer to this list in the iBox at the top of the main message-board screen.
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FYI from Nature Journal Tables of Antibody Companies
1 - Antibody manufacturers, suppliers and services
2 - Antibody-based drug discovery and development
3 - Immunoassay and immuohistochemistry
4 - General
http://www.nature.com/nature/journal/v447/n7145/fig_tab/447745a_T1.html
Coffee associated with lower liver cancer risk
http://news.yahoo.com/s/nm/20070605/hl_nm/coffee_cancer_dc_1
NEW YORK (Reuters Health) - Drinking coffee appears to lower the risk of developing liver cancer, according to findings published in the medical journal Gastroenterology.
"Data on potential beneficial effects of coffee on liver function and liver diseases have accrued over the last two decades," Drs. Susanna C. Larsson and Alicja Wolk, from the Karolinska Institute, Stockholm, write. Several studies have found an inverse relationship between coffee consumption and liver enzymes levels that indicate a risk of chronic liver disease and cirrhosis.
The researchers therefore conducted a large review, or "meta-analysis," of published epidemiological studies to look at the association between coffee consumption and the risk of liver cancer. The meta-analysis included 11 studies involving 2,260 liver cancer patients and 239,146 individuals without liver cancer who served as a comparison group.
An inverse association between coffee consumption and liver cancer risk was observed in all of the studies, and this association was statistically significant in six studies.
For every 2 cups of coffee per day, the investigators observed a 43-percent reduced risk of liver cancer.
"A protective effect of coffee consumption on liver cancer is biologically plausible," Larsson and Wolk point out. "Coffee contains large amounts of antioxidants, such as chlorogenic acids," which combat oxidative stress and inhibit the formation of carcinogens. Furthermore, experimental animal studies have specifically shown that coffee and chlorogenic acids have an inhibitory effect on liver cancer.
Yeah its definitely hard to keep up with. I actually down own that many stocks trying to focus on the ones I do own and know all the public details possible. Altus seems rather interesting to me, the risk is the technology isn't yet officially proven though the Genentech collaboration adds a lot of credibility. I like the long term potential and that is generally my investment plan.
I generally hold long term.
I thought Pharmasset (VRUS) sounded interesting. I never heard of it until Dew pointed out the BOA webcast. I generally don't move quick though and wouldn't mind someone doing a write-up on them to learn more about their technology. Perhaps one of the IDIX followers as they seem to be a (potential) competitor on several fronts.
I'll have to look at JAV and KOOL not familiar with either.
Dew,
These results look unspectacular to me. I don't know median survival stats for NSCLC off hand though so can't say for sure. Do you think it speaks to the limited efficacy of Immunotherapy in general?
I noticed the patients were stage 1B/II. I know United (OvaRex) while looking at Stage III/IV Ovarian cancer wanted optimal responders to surgery and low (but present) CA-125 levels. In retrospective analysis it also seemed that certain patients had extremely long PFS and overall survival and others had no benefit.
I'm not decided yet on Immunotherapies. It seems it may have a very meaningful benefit for a subset of patients but perhaps not a majority of them.
rfj,
I've joined you in ALTU today. Been following it for some time actually.
I've been listening to their calls over and over the past few weeks and what sold me on it are (not in order):
1-Growth Hormone (ALTU-238) - On the Morgan Stanley call I believe it sure sounded like Genentech was about to get an x-US partner which would trigger milestones.
2-ALTU-237 - From the calls it seems it will move through development quickly because of high unmet need (Primary hyperoxaluria). They indicated a 250 million market, I've owned BMRN, TKT and UTHR. Lets see rare, life threatening indication with no treatment - If the drug works well it will be more than that! Then they have 2 other potential indications.
3-Protein Crystalizition technology - 70 proteins crystallized and haven't come across one yet that they couldn't. If their business development gets active I think this could offer a lot of growth potential!
OK I have a question for you or anyone that may have an ideas. The Genentech royalty all I heard is "double digits". Any hints at where is it closer to 10 or in the 20's? TIA
PS you seem to be invested/like several stocks that I follow. Any others you like?
ALTU/Genetech royalty rate:
gfp,
Do you know if they ever hinted at what the royalty rate is beyond saying "double digits"? I didn't listen to the deal call but have heard the others and never heard anything behond "double digit" which is a bit too vague for me. I'd like to know is it more like 10 or in the 20's? TIA
drugsdrugsrx,
I am curious as to why you think third time is the charm? I'll admit to being on the fence one day thinking they'll get it another day they won't. The recent draw down on their financing and todays move actually have me thinking (contrary to the price move) that they won't.
If you boil it down the FDA said do another trial. Encysive said no we can show you with existing data. The FDA said no again and oh by the way here is a Class 2 review this time.
I think there is something more we don't know (and Given isn't saying). What has changed between the second approvable (or for that matter the first) and now? No new data just "reformatting" of old data. FDA getting criticized more for safety (OK and from the other side too by DNDN supporters).
I'd be curious as to your perspective like I said I am on the fence and could be convinced with a good argument.
I think I got this one!
(What is a) Japanese Rice cooker? (from yesterdays WSJ)
EDIT: Forgot it was jeopardy :)
PHRM 7PM too (I think it is separate from GPC's since PHRM has a bunch other oncology programs but don't know for 100% certainity)
Its good to see at least one immunotharpy doing well. The PR sounds very impressive I wonder if Biogen will put more effort in getting Zevalin to be adopted. UTHR is supposed to release data from their Phase 2 OvaRex trial which was testing front-line use with SOC. Two dosing regiments were being studied in that trial one giving OvaRex w SOC during each cycle and one group giving OvaRex 8 days after each round of Carboplatin/Paclitaxel.
http://biz.yahoo.com/bw/070603/20070603005040.html?.v=2
Data Show Improved Response Rate When Zevalin Plus Rituximab Follows Short Course First-Line Treatment in Patients with Follicular Lymphoma
Sunday June 3, 6:00 pm ET
Data Presented at ASCO Show Increase in Complete Responses
CHICAGO--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) announced today that data presented at the 43rd American Society of Clinical Oncology (ASCO) annual meeting showed that adding Zevalin® (Ibritumomab tiuxetan) radioimmunotherapy to a short course first-line treatment followed by rituximab weekly for four weeks doubled the rate of complete response in patients with follicular lymphoma, from 44 percent with a standard treatment regimen to 88 percent. Additionally, the response rate (complete and partial responses) for patients in the study was 100 percent based on PET scan assessment.
"The increase in complete response rates when adding ZEVALIN radioimmunotherapy is promising," said Samuel A. Jacobs, M.D., associate director for clinical investigations at the University of Pittsburgh Cancer Institute and UPMC Cancer Centers. "These data add to the growing body of evidence that using radioimmunotherapy as part of front-line treatment may increase complete response rates."
About The Trial
In this Phase II study, patients with symptomatic, stages II-IV and grades 1-3, untreated follicular lymphoma received three cycles of R-CHOP, a standard treatment regimen, followed by ZEVALIN. One week after ZEVALIN treatment, patients received rituximab weekly for four weeks. The primary endpoint of the trial was complete response rate, which was determined by CT scan, the conventional methodology, and PET scan. Of 56 evaluable patients, 50 completed both phases of therapy and were evaluated for response.
Results evaluated by CT scan showed that 44 percent of patients had a complete response following the R-CHOP phase of treatment. After treatment with ZEVALIN and extended dose rituximab, complete response rate increased to 88 percent. Results evaluated by PET scan, a newer method of evaluation, showed a complete response rate of 68 percent with R-CHOP and 96 percent after treatment with ZEVALIN and extended dose rituximab. The response rate in patients who completed the treatment regimen was 100 percent based on PET scan assessment. Median time to progression has not yet been reached; to date, five patients have experienced disease progression. Adverse events included myelosuppression and there was one episode of febrile neutropenia after ZEVALIN and rituximab treatment.
"We believe that ZEVALIN may play an important role in the treatment of lymphoma in the front-line setting and are encouraged that data continues to underscore the impact that radioimmunotherapy can have," said David Parkinson, M.D., senior vice president, Oncology Research and Development, Biogen Idec. "In order to further understand the potential of ZEVALIN as a first-line treatment, we have recently initiated a phase III trial that will evaluate ZEVALIN as part of first-line treatment with CVP, a commonly-used chemotherapy regimen."
ZEVALIN Safety Profile
Rare deaths have occurred within 24 hours of rituximab (RITUXAN) infusions. These fatalities were associated with an infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation or cardiogenic shock. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Patients experiencing severe cutaneous and mucocutaneous reactions should not receive any further components of the ZEVALIN therapeutic regimen and should seek prompt medical evaluation. In safety data based upon 349 patients, the most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, with grade 3/4 neutropenia, thrombocytopenia, and anemia occurring in 60 percent, 63 percent and 17 percent respectively. Infusion-related toxicities were typically grade 1 or 2 and were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplastic syndrome (MDS) and/or acute myelogenous leukemia (AML) were reported in 5.2% (11/211) of patients enrolled in clinical studies and 1.5% (8/535) of patients included in the expanded-access trial, with median follow-up of 6.5 and 4.4 years, respectively. ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
About ZEVALIN
On February 19, 2002, the ZEVALIN (Ibritumomab tiuxetan) therapeutic regimen was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory low grade, follicular or transformed B-cell non Hodgkin's lymphoma (NHL), including patients with rituximab (RITUXAN) refractory follicular non-Hodgkin's lymphoma. Determination of the effectiveness of ZEVALIN in a relapsed or refractory patient population is based on overall response rates. The effects of ZEVALIN on survival are not known. Radioimmunotherapy offers an option to patients with certain types of B-cell non-Hodgkin's lymphoma who have failed to adequately respond to other cancer therapies.
The ZEVALIN therapeutic regimen combines a monoclonal antibody with a radioisotope. The monoclonal antibody in ZEVALIN recognizes and attaches to a particular cell-surface protein on B-cells called the CD20 antigen. This allows ZEVALIN to specifically target B-cells, destroying malignant NHL B-cells and also normal B-cells.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For ZEVALIN product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding ZEVALIN as a treatment for various indications. These statements are based on the companies' current beliefs and expectation. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from the companies' current expectations include: the risk that unexpected concerns may arise from additional data or analysis, that regulatory authorities may require additional information, further studies, or may fail to approve the drug, or that the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the periodic reports of Biogen Idec Inc. filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
Biogen Idec
Media Contact:
Naomi Aoki, 617-679-6284
Director, Public Affairs
or
Investor Contacts:
Eric Hoffman, 617-679-2812
Associate Director, Investor Relations
Jazz Pharma acquired Orphan medical who already had Xyrem on the (US) market at the time. If my recollection is correct there was a slight premium when they were acquired. Orphan Medical was studying it in a few larger indications I believe Fibromyalgia was one. When they were acquired I stopped following what happened to that trial.
Hmmm the more I look at it I think Spectrum has every capability to be a real thorn to GPC (and I suspect they'll probably exercise every avenue available to them).
http://www.mass.gov/legis/laws/mgl/251-7.htm
PART III. COURTS, JUDICIAL OFFICERS AND PROCEEDINGS IN CIVIL CASES
TITLE IV. CERTAIN WRITS AND PROCEEDINGS IN SPECIAL CASES
CHAPTER 251. UNIFORM ARBITRATION ACT FOR COMMERCIAL DISPUTES
Chapter 251: Section 7. Witnesses; production of documents and things; entry on land for inspection
Section 7. (a) The arbitrators may cause to be issued subpoenas for the attendance of witnesses and for the production of books, records, documents and other evidence, and shall have the power to administer oaths. Subpoenas so issued shall be served, and upon application to the court by a party or the arbitrators, enforced, in the manner provided by law for the service and enforcement of subpoenas in a civil action.
(b) On application of a party and for use as evidence, the arbitrators may permit a deposition to be taken, in the manner and upon the terms designated by the arbitrators, of a witness who cannot be subpoenaed or is unable to attend the hearing.
(c) All provisions of law compelling a person under subpoena to testify are applicable.
(d) Fees for attendance as a witness shall be the same as for a witness in the superior court.
(e) Any party in an arbitration proceeding may serve upon any other party a request for the production of documents and things and for entry upon land for inspection and other purpose as permitted by and in accordance with the procedure set forth in rule thirty-four of the Massachusetts Rules of Civil Procedure in effect at the time the request is made. The enforcement and objections of such request shall be made to the arbitrators and the arbitrators only shall issue such orders as they deem necessary on objections and on requests for enforcement of production both prior to and after the commencement of the hearing.
Actually its free for now (2 week trial). I am trying it kind a like it but don't know if I use it enough to justify the price.