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the Nasdaq biotech index is down for the year
At least he posted links to why the stock seems cheap and didn't just say its cheap
I own Pipex but whose top pick is it. Yours?
Dorb isn't getting any value for its biodefense business
Maybe it shouldn't get any value but some company's entire market caps are based on it, like cbli
dor's Orbec is a pipeline unto itself.
acute GVHD
prophylaxis gvhd
treatment for radiation therapy for cancer
IBS
tina,
what are the advantages of the accuray product vs the one produced by this company
http://www.elekta.com/
Accuray Shares Fall on Analyst Concerns
Monday June 11, 1:03 pm ET
Accuray Shares Tumble After Analyst's Downbeat Outlook Warns Key Product Lacks Versatility
what looks like great technology to someone that doesn't actually perform the procedures may not actually be that innovative. Maybe you should investigate the competitor devices this analyst spoke about. You may surprised there are better products and you overpaid for the stock, or you may think it is much better and become even more convinced it is the best, but do your homework. I don't think you have looked at the competition. Just friendly advice. Please see comments below the analyst's
NEW YORK (AP) -- Shares of medical product developer Accuray Inc. fell Monday after an analyst issued a downbeat outlook and said the company's key cancer-surgery tool lacked versatility.
Shares of the Sunnyvale, Calif.-based company fell $1.07, or 4.5 percent, to $22.62 at midday. Since going public in February, the stock has traded from $19.66 to $31.09.
CIBC World Markets analyst Amit Hazan initiated coverage of Accuray Monday with a rating of "Sector Underperfomer" and a price target of $19.
In a note to investors, Hazan wrote that the company is likely to play a smaller role in the $6 billion stereotactic radiosurgery market than expected. That is because the company's main product, the CyberKnife robotic radiology system, is equally or less versatile than competitors' cheaper tumor-targeting systems.
"Although CyberKnife should be competitive in niche markets (mainly to neurosurgeons), in our opinion, the company's order growth prospects are insufficient to justify the current valuation," he wrote.
Accuray's CyberKnife uses a robotic system to deliver targeted beams of radiation to treat cancerous tumors anywhere in the body.
Hazan also noted concern about the company's growth prospects.
"Too much attention has been paid to backlog, while 'new orders' and order growth have not been scrutinized," he wrote. "We have done that, and see lumpy unit orders for the past five quarters that do not visibly portray growth. We only model 13 percent order growth in fiscal 2008 and 9 percent for fiscal 2009."
From their last earning report I find it hard to believe the backlog numbers. If the backlog is up 9 percent from the prior quarter the backlog last quarter was about 500 million but they only produced revenue of 37 million. Backlog up 60 percent over last year which meant it must have been about 250 million last year. With backlogs like that they should be doing more in revenue
Record revenue of $37.3 million, up 129 percent from the fiscal third quarter 2006 and up 42 percent from the fiscal second quarter 2007
-- Total backlog increased to $559 million, up 60 percent from the fiscal third quarter 2006 and up 9 percent from the fiscal second quarter 2007
Dear Pipex Shareholders,
steven is certainly putting his money where his mouth is
In addition to the previously reported 10,000 shares purchased by Pipex President, Charles Bisgaier and the 143,700 shares purchased by Pipex Chairman and CEO, Steve H. Kanzer during the period from July 16th through July 24th for a total price of $827,014, on July 25th, Mr. Kanzer also purchased an additional 14,300 shares in the open market at per share prices between $7.42 to $7.09 a share and averaging $7.22 a share corresponding to an additional purchase price of $103,281. Such additional purchase by Mr. Kanzer was reported July 26th at 5:00pm ET via a Form 4 filing, a copy of which is attached. The purchase was also covered by Dow Jones as set forth below.
In addition, at the July 20th quarterly board meeting, Mr. Kanzer entered into an amended and restated employment agreement with Pipex whereby he voluntarily contributed to Pipex for no consideration $275,254, representing Mr. Kanzer’s otherwise earned and unpaid salary and bonus accrued since November 1, 2006, which Mr. Kanzer has never elected to take. In an effort to maintain the corporation’s relatively low operating costs and overhead, Mr. Kanzer also voluntarily reduced his annual salary by $100,000 annually from $295,000 to $195,000. The amended and restated July 20th employment agreement were described in an 8-K filed yesterday at 5:23pm ET, a copy of which is attached.
Thank you for your interest and continued support of Pipex. Please feel free to contact me at the contact information listed below if I can be of any assistance
Report Backs Up Warnings About Drug Avandia
By GARDINER HARRIS
Published: July 27, 2007
http://www.nytimes.com/2007/07/27/health/27gene.html
WASHINGTON, July 26 — Patients who take Avandia, a popular diabetes medicine, face an increased risk of heart attacks while those who take Actos, a similar drug, do not, federal drug reviewers conclude in a new report.
Avandia, made by GlaxoSmithKline, is particularly dangerous to patients who take insulin, the review found, a risk not found with Actos, made by Takeda.
The drugs, which increase the body’s sensitivity to insulin, were each taken by about one million patients last year.
The Food and Drug Administration should issue strict warnings about Avandia’s heart attack risk, the reviewers concluded. On Monday, the agency is planning to ask an independent panel of experts whether they agree with stronger warnings or want the drug removed from the market.
“A critical question to be resolved in determining appropriate regulatory action is whether the anticipated therapeutic benefit of rosiglitazone outweighs the demonstrated cardiovascular risk,” one agency reviewer concluded, referring to Avandia by its generic name.
Patients with heart disease and those taking insulin should not take Avandia, one review concluded.
The medicine’s global sales for 2006 were nearly $3.4 billion.
Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, said the company continued to believe Avandia was safe, noting that various reviewers at the agency had reached a range of conclusions.
“Across the extensive data we have, the science shows no increase in cardiovascular death, and does not support a difference in heart attack rates between Avandia and the other most commonly prescribed oral antidiabetics,” Ms. Rhyne said.
Barbara Ryan, an analyst for Deutsche Bank Securities, said that the agency’s report ensures that “there are going to be a lot of lawsuits.” She noted that some firms were already advertising for clients.
GlaxoSmithKline has been accused of trying to intimidate a doctor who raised questions about Avandia in 1999. And agency reviewers were sharply critical of some studies that GlaxoSmithKline has undertaken to test Avandia’s safety, dismissing results from a continuing 4,000-patient trial as unreliable and invalid.
The report also provides ammunition to critics on Capitol Hill and elsewhere who say that top drug agency officials had been slow to acknowledge Avandia’s risks.
A year ago, GlaxoSmithKline provided the agency with most of the data underlying the report and even suggested that a note be added to Avandia’s label discussing the drug’s potential to increase heart attacks.
The agency did not add the note, but European drug regulators did.
“Why has it taken the F.D.A. a year to do this?” asked Dr. Bruce M. Psaty, a drug safety expert from the University of Washington.
One safety reviewer, David Graham, concluded in part of the report that top agency officials falsely reassured the public at a May 21 news conference that at least one large Avandia study had shown it was safe.
That study, Dr. Graham concluded, provided no such reassurance.
The new, 436-page report is a compendium of reviews released in advance of an advisory panel hearing to be held on Monday. The report largely confirms concerns first raised in May by a study written by Dr. Steven Nissen, a renowned cardiologist from the Cleveland Clinic, and published in The New England Journal of Medicine. Dr. Nissen and the Journal were criticized by Republicans on Capitol Hill and others for rushing to print a study they said was flawed.
In 2000, the drug administration removed Rezulin, made by Pfizer, from the market because that drug caused more liver problems than Actos or Avandia, both of which provided similar benefits to Rezulin.
Avandia increases the risks of heart attacks by as much as 40 percent in most patients. In those taking insulin or nitrates, the risks are higher, according to the drug agency’s analysis. That means that the drug’s heart risks likely injure far more patients than Rezulin’s liver risks did. Most diabetics die of heart disease.
Indeed, a main reason for prescribing Avandia is to stave off the effects that high blood sugar levels can have on the cardiovascular system. That Avandia actually worsens patients’ heart status “denotes a serious limitation of anticipated therapeutic benefit,” the report concluded.
Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists, said that he thought it unlikely that the drug agency would ban Avandia, but he predicted that the drug’s sales would plunge, and he said that he would not prescribe it. Patients taking the drug should consult their doctors, who will probably seek other treatment options for them, he said.
Dr. Psaty said he saw no reason to prescribe Avandia.
The drug agency has been severely criticized for its handling of Avandia concerns. In February 2006, Dr. Rosemary Johann-Liang, a drug safety supervisor, recommended that the labels of both Avandia and Actos receive the agency’s most severe safety warning — called a “black box” — for their tendencies to worsen the risks of heart failure, a problem distinct from the heart attack risks seen only in Avandia.
Her recommendation was ignored and she was punished for it, Dr. Johann-Liang said in an interview last month. In June, the agency announced that it had decided to follow Dr. Johann-Liang’s advice. By then, she had tendered her resignation.
The drug agency’s oversight of Avandia has helped garner support on Capitol Hill for legislation to give the agency more resources and authority to police drug safety issues. Presently, the agency has no power after a drug is approved to require drug makers to conduct further safety assessments, and drug makers rarely finish safety assessments they have promised to do.
Senator Charles E. Grassley, Republican of Iowa, who has championed efforts to change the way the agency polices drug risks, said Avandia was proof that changes are needed.
“The F.D.A. betrays the public trust with its delayed response in this case and others,” Mr. Grassley said. “If F.D.A. leaders are asleep at the switch, it’s a dereliction of duty. But if they’re knowingly suppressing information about risks to public safety, then it’s morally corrupt.”
Jean-Pierre Garnier, GlaxoSmithKline’s chief executive, said this week that the company stands by Avandia.
“Whilst some uncertainty remains around Avandia, we stand firm in our belief that it is an effective and valuable treatment for patients with diabetes,” Mr. Garnier said.
In a down day on Wall Street, shares of GlaxoSmithKline fell more than $1.40, to $51.23.
Next Article in Health (1 of 19) »
"On the merits, the Orbec package was apparently very weak. BSR ripped it up and down."
If you watched the panel meeting you wouldn't think it was weak so where did the apparently come from. The fact that BSR ripped it up and down doesn't mean it deserved to be ripped. He was trying to read the minds of the FDA. All you can do is look at their actions in each case.
"Yet top line it seemed to help a grievously ill group. It would be nice to think that someone at FDA saw through the package to real patient benefit and pointed out a path for DORB to get Orbec approved. Nice, but totally out of character. Chances are we're being fooled by management on this new submission - fitting the essential theme of Dew's entire board."
If you watched the panel meeting you would see the comments that Richard Pazdur made and see that he saw the benefits of the drug at the meeting. I believe that before he saw the data at the meeting he was convinced that the drug was shit, and a thirty cent bulletin board company was trying to pull a fast one.
I believe the drug will be approved because of what I saw at the panel meeting and have bought more since the extension because I think the risk/reward is tremendous and the risk/benefit of the drug is all benefit and no risk
weak data package? read this
The NDA filing is supported by data from two randomized, double-blinded, placebo-controlled clinical trials. The first trial was a 129-patient pivotal Phase 3 multi-center clinical trial of orBec® conducted at 16 leading bone marrow/stem cell transplant centers in the U.S. and France. The second trial was a 60-patient Phase 2 single-center clinical trial conducted at the Fred Hutchinson Cancer Research Center. Although orBec® did not achieve statistical significance in the primary endpoint of its pivotal trial, namely median time to treatment failure through Day 50 (p-value 0.1177),
The treatment failure rate at 50 days had a p-value of .0515. I don't know why they don't include that
orBec® did achieve statistical significance in other key secondary endpoints such as median time to treatment failure through Day 80 (p-value 0.0226), as well as a 66% reduction in mortality among patients randomized to orBec® at 200 days post-transplant with only 5 patient (8%) deaths in the orBec® group compared to 16 patient (24%) deaths in the placebo group (p-value 0.0139). At one year post randomization in the pivotal Phase 3 trial, 18 patients (29%) in the orBec® group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test).
In the Phase 2 study, the primary endpoint was the clinically relevant determination of whether GI GVHD patients at Day 30 were or were not able to consume at least 70% of their daily caloric intake by mouth, as compared to intravenous parenteral nutrition administered in the hospital. The treatment response at Day 30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the orBec® and placebo groups respectively, achieving a statistically significant p-value of 0.02. Additionally, the treatment response at Day 40 was 16 of 31 (52%) vs. 5 of 29 (17%) in the orBec® and placebo groups respectively, achieving a statistically significant p-value of 0.007.
"The extension is the result of DOR's July 13, 2007 provision of supplemental information to the orBec® NDA. This information was requested by the FDA at a June 13, 2007 NDA review meeting.""
http://biz.yahoo.com/iw/070719/0280047.html
On June 13, 2007 DOR met with the FDA to review and discuss the orBec® NDA. The discussion was productive and focused on ways to more fully elucidate the clinical effect and benefit of orBec® in the treatment of GI GVHD. Based on these discussions, the FDA requested that DOR review its existing clinical data from both its randomized, double-blind, placebo-controlled trials and highlight pertinent additional data that could provide a more comprehensive picture of orBec®'s clinical effect in treating acute GI GVHD. This new presentation of data formed the basis for the recently filed supplemental submission to the orBec® NDA. Following the FDA's review of this submission, it was determined that it constituted a major amendment. Given the close proximity of the submission of additional information relative to the July 21, 2007 PDUFA date, the FDA determined that a three month extension to the PDUFA date was necessary to allow for an adequate and complete review.
"We appreciate the FDA's willingness to allow us to provide supplemental data and for taking the additional time necessary to ensure a complete and high level review of the orBec® NDA," said Christopher J. Schaber, Ph.D., President and Chief Executive Officer of DOR. "We will continue to work with the FDA in every way possible to support their review so that it may be completed as expeditiously as possible."
He wants to use biotech against Alzheimer's
By Billy Baker, Globe Correspondent | July 23, 2007
Orrie Friedman is 92 years old, and he'd like to make a billion bucks between now and the time his number is called. He figures he's got at least 10 years to do it.
"People in my family live forever," he says. "The old man didn't retire until he was 99, and lived to 104."
It's not as though Friedman needs the money. As one of the pioneers of biotechnology, he's already made -- and given away -- more money than he could spend in a couple of lifetimes. But that $1 billion would mean two things: his latest company had developed a viable treatment for Alzheimer's disease, which contributed to his brother's death three years ago; and he can fulfill his final dream to endow a biomedicine institute at Brandeis University in his name.
The plan hinges on a theory -- as yet unproven -- that a class of organic silica-based compounds has the potential to dissolve the build-up of amyloid plaques, little bundles of protein that have been found in the brains of Alzheimer's sufferers.
Friedman thinks a paper his company, Grand Pharma, has written on the subject, which has been published on line by the Journal of Alzheimer's Disease, "will create excitement" over the next few months when it hits the print edition . And, with that excitement, he hopes to interest a deep-pocketed pharmaceutical company in developing a drug and providing a grand finale to his unlikely life. Not that he thinks he needs a final act. "Considering where I started from and where I wound up," he says, "life owes me nothing."
Where he started was Grenfell, Saskatchewan, a "tiny speck on the vast plains of western Canada," before his family moved to Winnipeg. His father was in the bootleg business, and Friedman spent his early life scratching out a meager existence, sometimes in the family business, other times as the right-hand man in a rough-and-tumble gang that "got into every hell you could imagine."
He managed to graduate from the University of Manitoba in 1935, despite being what he describes as a "crappy student," and had a short career as a professional poker player during the height of the Great Depression.
He eventually grew bored with Winnipeg, and hopped a cattle train to Montreal in search of his fortune. He barely made a living. At night, he would travel to McGill University to hang out with Leo Brickman, a Winnipeg friend who was a graduate student in chemistry. It was these visits that Friedman credits with inspiring the "first quirks of intellectual curiosity" in his life, and he decided he wanted to be a chemist. "So I went to the admissions office at McGill with my crappy academic record, not expecting to be admitted, and it turned out the guy knew my father."
Friedman struggled during his first year at McGill, was a star his second, and then was accepted to the graduate school, where he did a top-secret doctorate on RDX, an explosive that was being developed for use in World War II. This led to seven years of post-doc work at Harvard Medical School, where he was a major contributor to the development of the cancer drug Cytoxan. From there, he was recruited to become a chemistry professor at a new university in Waltham called Brandeis.
In 1961, Friedman left Brandeis to open a business aimed at developing latent cancer drugs. That company, Collaborative Research Inc., which began in a small Waltham lab with 20 employees, was a pioneer in the infant field of biotechnology and, later, was among the first to study the relationship between genes and disease.
"Orrie really is the founder of biotech," said Al Kildow, a retired biomedical consultant who has been following Friedman's work for years. "His company was the first biotech company -- though they didn't even call it biotech back then -- and he set up the model that all other biotech companies followed, with an elite scientific advisory board to advise the directions they should pursue."
Friedman retired from Collaborative Research in 1992, and, shortly thereafter, opened Grand Pharma (the name is a play on Grenfell), and began his Alzheimer's research.
Friedman, who describes himself as a "restless 92-year-old cocker," is not content to sit around his luxurious apartment and tell war stories. He skied until he was 85, at which time he took up painting. A dozen of his landscapes adorn the walls of the home on Fisher Hill in Brookline that he shares with his wife of 48 years, Laurel.
And then there's his philanthropy. He's given millions to Brandeis and the Israel Institute of Technology, and he just endowed a $1.5 million children's worship room at Temple Israel in Boston in memory of his daughter, Trudy, who died a decade ago of melanoma at age 35, six months after giving birth to twins. Using his money to help others, he says, is not a bad way to spend his final years.
"I can't take it with me, and it's the least I can do ," he said.
FACT SHEET
Hometown: Born in Grenfell, Saskatchewan; grew up in Winnipeg; lives in Brookline.
Family: Four children and four grandchildren.
On why his professional poker career came to an end: "They would feed us these corn beef sandwiches while we played, and I got a case of food poisoning that almost killed me. When I recovered, the fascination with amorality had passed."
On why he only rose to No. 2 in his childhood gang in Winnipeg: "I could beat up everyone except for the No. 1 guy."
© Copyright 2007 The New York Times Company
shorts must be the guys from the last pipe.
they bought it in anticipation of the european approval. it got delayed and they have no patience.
the stock won't be registered until next month so they are shorting and will cover with the registered shares
I believe we all thought that with a large trial and strong stat sig, albeit of a result with precious little clinical value, this would be a shoo-in.
Strong statistical significance when you measure pain a certain way. from page 22 of the briefing doc you can't convince me that the trial participants on drug had less pain.
The clear message from the Pazdur/Hussain/Sher/Flemming contingent in power at the FDA is they want survival data for cancer drugs.
when all is said and done this drug will not have a survival benefit. if you don't increase survival or reduce pain what is the drug good for.
The irony is Provenge had solid survival data, yet they wanted a larger trial that was pre-specified to be "sure", or, they wanted 9902B. Why would they change their stripes for GPCB?
Intermune's actimune also had a survival benefit until they ran another trial with survival as the pre-defined endpoint. Guess what, more people died on the drug
hey doc thanks for getting my ldl's down.
whoops.................
CNBC reports on new study published in Journal of American College of Cardiology which shows lower LDL cholesterol linked to higher risk of cancer
CNBC's Mike Huckman reports that the review, of clinical trials of over 75K patients on statins, indicates that researchers saw a 3x increase in cancer risk, especially in those with a cholesterol level of 160 or below. However, the study did not show cause/effect; it is unclear if the reduced LDL (bad) cholesterol was the cause of the higher cancer risk. Researchers recommend that those on statins continue to remain on the medication, as the heart benefits still far outweigh any suspected cancer risk (StreetAccount LLC)
I was referred to this doctor. Do you think I should use him?
Troubled Miami surgeon is still on the job
BY JOHN DORSCHNER
A legal dispute involving a 69-year-old Miami heart surgeon has revealed that he has been suspended from the staff at Cedars Medical Center while the hospital investigates 24 of his cases, which include ''numerous patient deaths,'' court filings show.
Other documents say the surgeon, Alex Zakharia, suffers from memory lapses that have been worsening, and he's been charged in a criminal case with fraud and perjury for allegedly exaggerating his surgical experience.
Zakharia's lawyers insist he has done nothing wrong, and the doctor has challenged his suspension. He continues to work in at least four South Florida hospitals. One week last month, he performed 21 procedures, according to court documents.
Doctors' problems are usually closely held secrets in the healthcare industry and can persist for years before becoming public with any disciplinary action.
But in this case, Zakharia's difficulties have been disclosed by the doctor's own lawyers in documents filed in Detroit and Miami-Dade County courts.
Zakharia refused to discuss any specifics and threatened to sue anyone who wrote about his situation.
In court papers, the surgeon and his lawyers have said there are no problems. The memory lapses don't affect his work, Zakharia told his doctors. He has pleaded not guilty to the fraud charges, and he has sued Cedars to be put back on staff. The lawsuit says hospital executives suspended him ``abruptly without . . . sufficient inquiry to confirm the credibility of the allegations.''
The four hospitals where he works are Mount Sinai Medical Center in Miami Beach, Select Specialty Hospital in Miami, North Shore Medical Center in North Miami-Dade and Larkin Community Hospital. Officials for Sinai, North Shore and Larkin said they didn't have any information about performance issues involving Zakharia. Select did not respond to phone calls.
According to his résumé, Zakharia received his medical degree from the American University in Beirut in 1962, followed by surgical residencies at Baylor, Case Western, the Mayo Clinic and the University of Miami. He has practiced in Miami since 1982.
START OF TROUBLES
Zakharia's present troubles stem from a 2003 case in which he testified for a man who sued the Veteran's Administration for malpractice. In November 2006, the U.S. Attorney's Office in Detroit indicted him on charges of fraud and false declaration concerning his surgical experience.
According to the indictment, he stated in a deposition that he had wide experience in coronary artery bypass graft surgeries, but records at Cedars and Miami Heart Institute didn't back up the testimony. Zakharia told The Miami Herald at the time that the lawyers had misunderstood him and that his background wasn't relevant to the malpractice case.
That same month, Cedars suspended his surgical privileges, saying in a letter to the surgeon that it had ''credible evidence'' that his surgical care in one case was ``below the standard of care.''
Several weeks later, another Cedars letter to the doctor said the medical executive committee recommended revoking his hospital privileges because of his ''clinical performance or competence'' in two other cases. Zakharia was offered a hearing to give his side.
Lourdes Garrido, spokeswoman for the HCA hospital chain, Cedars' owner, said the hospital couldn't comment because the matter is under litigation.
Zakharia sued Cedars in Miami-Dade Circuit Court to stop the hearing, alleging it was ''tainted'' because of the hospital's prejudice against him. The hearing, which has been frequently postponed, is now set for next month.
Cedars responded that it needed to ''protect the life and well-being of patients'' and that the hospital had summarily suspended him in November ``after several of his patients died.''
The court filing said that in December the Medical Executive Committee had received ``credible information regarding his clinical performance or competence concerning the deaths of two patients.''
Later, the Cedars staff said it would present 24 cases at his hearing. ''The additional 22 cases, which cover a period of 18 months, include numerous patient deaths,'' the court filing said.
Cedars said the surgeon's actions were motivated by ''ill will and animus,'' because Cedars had provided information to a federal grand jury that ended up indicting Zakharia for perjury.
NO COMMENT
Cedars lawyer Stephen Bronis said he couldn't comment because the case involves a ``confidential and privileged peer review.''
Zakharia said if an article were published about his situation, ''I am having the biggest lawsuit The Herald has ever seen. You have demeaned me'' by calling and asking questions of hospitals and others, he said. ``I am suing for $5 million. You tell your boss that.''
Zakharia's Detroit and Miami attorneys did not respond to five calls over a two-day period.
As the Cedars case grinds on, Zakharia's Detroit lawyer has filed motions seeking to get the federal perjury case moved to Miami because he was too ill to make the trip. In support, his lawyer submitted letters from doctors who have been treating him.
In one, Guillermo Blanco, a North Miami Beach neurologist, stated Zakharia suffered ''an episode of dizziness'' during one flight to Detroit for a hearing, and a magnetic resonance imaging test revealed ''two possible TIAs.'' A TIA is a transient ischemic attack, which the National Institute of Neurological Disorders and Stroke describes as a ``stroke that lasts only a few minutes.''
From Blanco's letter: 'Dr. Zakharia today complains of progressive difficulties with his memory. He has difficulty focusing on things and although he performs surgery without any difficulties, he has noted that he forgets names of patients and he has to ask his secretary frequently about it. Again he admitted not being as `sharp' as he use[d] to be. This has been going on for several months and probably longer than a year but has been worse lately.''
Blanco recommended Zakharia not fly ''because of a high risk of a stroke,'' and he recommended the surgeon take Aricept. The drug's website says it is the only drug approved ``for all stages of Alzheimer's disease.''
Carl Eisdorfer, director of UM's Center on Aging, said Aricept ''has really one specific use -- it's used in patients with Alzheimer's disease,'' but he couldn't say why Blanco prescribed it.
Blanco said he couldn't talk about a patient's medical problems.
ADVERSE EFFECTS
Another doctor treating Zakharia, Rafael A. Soto, said the surgeon had suffered during two Detroit flights, one of which ''caused heaviness in his speech. . . . While his condition does not prevent him from doing his normal professional duties, he is strongly advised not to fly.'' Soto did not respond to a phone call seeking comment.
Florida Board of Medicine records show no disciplinary actions against the surgeon. A spokeswoman said any existing investigations concerning Zakharia would not be public until the board ruled.
Zakharia remains busy. In one week last month, he did nine procedures at Mount Sinai, 10 at Select and one each at North Shore and at Larkin.
Cardiologist William O'Neill, executive dean for clinical affairs at the University of Miami's medical school, reviewed the list of procedures for The Miami Herald and said many were relatively simple -- inserting tubes into veins -- but three (one at Sinai and two at Select) were more complicated tracheotomies -- cutting open the throat to insert a ventilator tube.
While he doesn't have firsthand knowledge of the Zakharia case, each of the elements raises issues, O'Neill said.
``I would be very concerned to find out the reason he was suspended by another hospital. I would be incredibly concerned about the accusation of perjury, and I would be even more concerned about the memory issues.
``Before I let him continue at a hospital I was associated with, I'd want to know from the physical standpoint that he's mentally competent.''
Sidney M. Wolfe, a physician with the consumer group Public Citizen in Washington, said the Zakharia case is rare. Typically, physicians' problems are handled very quietly -- if they are handled at all.
Without the court cases, ''he presumably would be treated'' for his memory problems, Wolfe said, ``and no one would know the difference.''
--------------------------------------------------------------------------------
© 2007 Miami Herald Media Company. All Rights Reserved.
http://www.miamiherald.com
jonathan acshoff on sppi
Healthcare/Biotech
SPPI – Downgrading to Sell from Buy, pt lowered to $4 from $11…ODAC briefing documents decidedly negative, in Jonathan’s view. Friday, the FDA made public the briefing document reviewing satraplatin’s data submitted in its NDA application, and although these documents tend to be negative, we believe that this document is particularly so. The documents tend to be negative, we believe that this document is particularly so. The documents highlights five points of issue: 1) progression-free survival (PFS) as defined for satraplatin has never been used by the FDA; 2) PFS reliability as measured in the trial is questionable; 3) pain progression as measured in the trial is highly questionable; 4) 51% prior docetaxel use by patients may be too low, and 5) positive overall survival (OS) data may be required for approval.
doesn't the ncst move look a little overdone
NUCRYST Pharmaceuticals receives FDA clearance of antimicrobial barrier topical cream
Thursday July 19, 4:30 pm ET
WAKEFIELD, MA, July 19 /PRNewswire-FirstCall/ - NUCRYST Pharmaceuticals Corp. today announced that the US Food & Drug Administration (FDA) has granted 510(k) clearance for a prescription topical cream containing NPI 32101, the company's patent-protected nanocrystalline silver, as a broad-spectrum antimicrobial barrier.
"NPI 32101 cream represents a new presentation of our patented nanocrystalline silver technology," said Scott H. Gillis, President & CEO, NUCRYST Pharmaceuticals Corp. "Gaining FDA clearance is a first step toward marketing our proprietary technology in this new formulation. We are actively exploring commercialization options and as part of this process, market plans and timing for this product will be determined."
In vitro studies have demonstrated that NPI 32101 cream serves as a broad-spectrum antimicrobial barrier to organisms including Pseudomonas aeruginosa and Staphylococcus aureus, including strains resistant to Methicillin (MRSA). Clinical studies involving more than 600 adults and children have also demonstrated that it has a strong safety profile.
NUCRYST Pharmaceuticals (NASDAQ: NCST - News; TSX: NCS - News) develops, manufactures and commercializes medical products that fight infection and inflammation using its patented atomically disordered nanocrystalline silver technology. Smith & Nephew plc sell a range of advanced wound care products under their Acticoat(TM) trade mark. Acticoat(TM) products incorporate NUCRYST's SILCRYST(TM) coatings and are sold in over 30 countries. NUCRYST is also developing pharmaceutical products to address medical conditions that are characterized by both infection and inflammation. The Company has developed its proprietary nanocrystalline silver in a powder form for use as an active pharmaceutical ingredient, referred to as NPI 32101.
SILCRYST(TM) is a trademark of NUCRYST Pharmaceuticals Corp. Acticoat(TM)
is a trademark of Smith & Nephew plc
the satraplatin ae's are painful
what i am saying is how could the pain have gone down so much for people on the drug if the drug doubles constipation, nausea and diahrea
dorb and the FDA extension of time
this is why the treatment failure rate at 50 days met statistical significance. The first 10 days of treatment failure before, orbec had a chance to work overweighed the median to the beginning of the trial. by the time you stretch it out to 80 days it shows significance again. The ODAC panel was not made aware of this distinction
Treatment for Intestinal Graft-versus-Host Disease (iGVHD)
DOR BioPharma to File NDA for orBec
MIAMI, April 20, 2005 - DOR BioPharma, Inc. (AMEX: DOR) ("DOR" or the "Company") announced its intention to file a new drug application (NDA) with the FDA for orBec (oral beclomethasone dipropionate) for the treatment of intestinal Graft-versus-Host Disease (iGVHD), a common serious complication of bone marrow transplantation for cancer. The decision follows recent correspondence and a pre-NDA meeting with the FDA.
I think after reviewing the data they can see that at 50 days it worked. It only failed through 50 days because the first 10 days screwed up the median time to treatment failure.
"We are very encouraged by our meeting with the FDA," stated Michael Sember, President and Chief Executive Officer of DOR. "We are excited with the results of our pivotal Phase III clinical trial. In addition to the strong positive trends on our primary endpoint of median time to treatment failure at study Day 50 in our pivotal trial, we saw a statistically significant result in median time to treatment failure at study Day 80 (p-value 0.0226). This result, combined with a highly statistically significant outcome and approximately 70% reduction in the prospectively defined secondary endpoint of mortality at 200 days post transplant (p-value 0.006), has given us confidence in the consistency and clinical durability of activity of orBec. We believe that our pivotal Phase III clinical trial of orBec and collectively all the clinical data before it, clearly demonstrate a clinical benefit to patients with no other alternative except high dose systemic corticosteroids. Our immediate priorities are to assemble a high quality data package to support the filing of an NDA as soon as possible but by the fourth quarter of 2005, and to submit the results of the pivotal trial for publication in a prominent peer-reviewed publication. We will also take steps to prepare for submission of a Marketing Authorization Application (MAA) with the European Medicines Evaluation Agency (EMEA)."
orBec has previously been granted Orphan Drug Designation and has received "Fast Track" designation from the FDA.
George B. McDonald, MD, Head of the Gastroenterology/Hepatology Section at the Fred Hutchinson Cancer Research Center in Seattle, inventor of orBec, and a consultant to DOR stated, "Those working in the field of hematopoietic cell transplantation have long recognized that prolonged exposure to prednisone in patients with iGVHD led not only to weakness, debility, and changes in body habitus, but also to viral, bacterial, and fungal infections. The pivotal Phase III study provides a clear rationale for the use of orBec in the treatment of iGVHD; control of iGVHD with an oral topical corticosteroid leads to less prednisone exposure, less systemic immunosuppression, fewer fatal infections, and possibly an enhanced graft-versus-leukemia (GVL) effect. The frequency of leukemic relapse after allogeneic hematopoietic cell transplant is lower in patients who experience GVHD after transplant, a phenomenon called the GVL effect. We hypothesize that avoidance of prolonged prednisone exposure preserves the GVL effect, resulting in fewer relapses of leukemia. orBec appears to be safe. Thus, the benefit-to-risk ratio for the use of orBec in the treatment of iGVHD seems strongly in favor of benefit. orBec addresses the unmet medical need for an effective adjunctive therapy for iGVHD with minimal side effects."
this press release says it all
this is why the treatment failure rate at 50 days met statistical significance. The first 10 days of treatment failure before, orbec had a chance to work overweighed the median to the beginning of the trial. by the time you stretch it out to 80 days it shows significance again. The ODAC panel was not made aware of this distinction
Treatment for Intestinal Graft-versus-Host Disease (iGVHD)
DOR BioPharma to File NDA for orBec
MIAMI, April 20, 2005 - DOR BioPharma, Inc. (AMEX: DOR) ("DOR" or the "Company") announced its intention to file a new drug application (NDA) with the FDA for orBec (oral beclomethasone dipropionate) for the treatment of intestinal Graft-versus-Host Disease (iGVHD), a common serious complication of bone marrow transplantation for cancer. The decision follows recent correspondence and a pre-NDA meeting with the FDA.
I think after reviewing the data they can see that at 50 days it worked. It only failed through 50 days because the first 10 days screwed up the median time to treatment failure.
"We are very encouraged by our meeting with the FDA," stated Michael Sember, President and Chief Executive Officer of DOR. "We are excited with the results of our pivotal Phase III clinical trial. In addition to the strong positive trends on our primary endpoint of median time to treatment failure at study Day 50 in our pivotal trial, we saw a statistically significant result in median time to treatment failure at study Day 80 (p-value 0.0226). This result, combined with a highly statistically significant outcome and approximately 70% reduction in the prospectively defined secondary endpoint of mortality at 200 days post transplant (p-value 0.006), has given us confidence in the consistency and clinical durability of activity of orBec. We believe that our pivotal Phase III clinical trial of orBec and collectively all the clinical data before it, clearly demonstrate a clinical benefit to patients with no other alternative except high dose systemic corticosteroids. Our immediate priorities are to assemble a high quality data package to support the filing of an NDA as soon as possible but by the fourth quarter of 2005, and to submit the results of the pivotal trial for publication in a prominent peer-reviewed publication. We will also take steps to prepare for submission of a Marketing Authorization Application (MAA) with the European Medicines Evaluation Agency (EMEA)."
orBec has previously been granted Orphan Drug Designation and has received "Fast Track" designation from the FDA.
George B. McDonald, MD, Head of the Gastroenterology/Hepatology Section at the Fred Hutchinson Cancer Research Center in Seattle, inventor of orBec, and a consultant to DOR stated, "Those working in the field of hematopoietic cell transplantation have long recognized that prolonged exposure to prednisone in patients with iGVHD led not only to weakness, debility, and changes in body habitus, but also to viral, bacterial, and fungal infections. The pivotal Phase III study provides a clear rationale for the use of orBec in the treatment of iGVHD; control of iGVHD with an oral topical corticosteroid leads to less prednisone exposure, less systemic immunosuppression, fewer fatal infections, and possibly an enhanced graft-versus-leukemia (GVL) effect. The frequency of leukemic relapse after allogeneic hematopoietic cell transplant is lower in patients who experience GVHD after transplant, a phenomenon called the GVL effect. We hypothesize that avoidance of prolonged prednisone exposure preserves the GVL effect, resulting in fewer relapses of leukemia. orBec appears to be safe. Thus, the benefit-to-risk ratio for the use of orBec in the treatment of iGVHD seems strongly in favor of benefit. orBec addresses the unmet medical need for an effective adjunctive therapy for iGVHD with minimal side effects."
Will someone please look at page 22 of the fda briefing doc and explain to me how any of that data would intimate that sppi's drug has evokes less pain than the placebo.
the GI side effects of the drug are pretty harsh at double the rate of placebo
what was the pain score used. I think that is the issue the fda has.
bladerunner briefing doc
the fda document that i posted is only 24 pages
everyone keeps looking at the company docs
If you look at page 22 of the fda doc it would seem to me that there would be on pain on the drug
I am confused on how they measure pain
Maybe this link will reduce confusion of the briefing docs
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4309b1-00-index.htm
fda briefing doc orplatna
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4309b1-04-FDA.pdf
I didn't see this posted. If it is posted you can delete
crtx, a good history
http://pubs.acs.org/cen/coverstory/83/8314pharma2.html
Can anyone tell me why the yahoo board is so interested in getting sbbum2007 to say he thinks the drug will be approved.
It doesn't matter what he thinks anymore than it matters what I think. what matters is what pazdur thinks.
Can anyone find a case when the fda has met with a company face to face prior to rendering the pdufa response after either a negative or positive panel vote.
I don't know if has ever happened. We couldn't even get a reuters article blip from a reporter in Bangolore india to report on it.
"or for that matter to reject Provenge despite it showed statistically significant OS!? "
Intermune's actimune had an overall survival benefit in the first phase 3 which led to off label use.
second phase 3 showed more people died on the drug
Dor's orbec doesn't have that problem
What I find very positive from the press release was this
" Based on these discussions, the FDA requested that DOR review its existing clinical data from both its randomized, double-blind, placebo-controlled trials and highlight pertinent additional data that could provide a more comprehensive picture of orBec®'s clinical effect in treating acute GI GVHD."
The FDA briefing document sent to the ODAC panel expressed that the data from the phase 2 shouldn't be considered because it took place 10 years ago and didn't include non-myeloablative patients so it was a different patient population.
The ODAC panel didn't focus ont he phase 2 for this reason. The FDA is going to include this data in their review. I think this bodes very well for DOR's chances. This was so far under the radar screen very few people gave it a chance. They should rethink that position.
"Also the conclusion that the FDA suggested a prophylaxis trial - this was already DOR's intent, and they said so."
that is about the only accurate part of the minutes. The question is how does the drug get approved for acute gvhd if they run trials for prophysaxis
It looks to me like they should get approval for acute under the condition that they run a prophylaxis study
Can the right food cut cost of cancer pills?
Mon Jul 16, 2007 6:32PM EDT
By Julie Steenhuysen
CHICAGO (Reuters) - Taking advantage of the power of food to boost the effectiveness of drugs could sharply lower the cost of cancer treatments, U.S. researchers said on Monday.
"We can use drug interactions to our advantage," said Dr. Ezra Cohen, a cancer drug expert at the University of Chicago Cohen, whose work appears in the Journal of Clinical Oncology.
He and colleague Mark Ratain analyzed data from a recent clinical trial showing how food affected GlaxoSmithKline's new breast cancer pill Tykerb, known generically as lapatinib.
The drug is supposed to be taken on an empty stomach. But taking it after a full meal would boost the amount of the drug circulating in the body by 167 percent, and taking it after a high-fat meal would boost it by 325 percent, the researchers found.
That might allow patients to use 40 percent less to achieve the same effect as taking it on an empty stomach. At a cost of $2,900 a month, the change could save each patient, or insurers, $1,740 or more a month, the researchers said.
And washing it down with grapefruit juice might allow patients to use as much as 80 percent less, they said. That could reduce the recommended dosage from the current five, 250 mg pills on an empty stomach to just one pill with a full meal and grapefruit juice chaser, they said.
But the researchers hastened to say they are not recommending that patients try this on their own.
"The first word of caution is 'do not try this at home.' The last thing we want is to have patients take their drug with food or change the dose on their own," Cohen said in a telephone interview. "That could be potentially dangerous."
The point, he said, is that instead of looking at drug interactions with food as something to be avoided, researchers should seek ways to benefit from them.
Food sometimes enhances the effectiveness of drugs because some foods are broken down by the same processes that the liver uses to break down drugs. If liver enzymes are all busy working on the food, they are not available to break down as much of the drug, meaning it circulates for longer in the system.
Cohen and Ratain are currently studying the effect of grapefruit juice, which is known to delay the breakdown of many drugs, on Wyeth's immune suppressant drug sirolimus or Rapamune, but there are many possibilities.
"The list can go on and on in terms of the agents that could be favorably modified to
Still, the few head-to-head clinical trials that have been conducted show that Bexxar and Zevalin are as effective as Rituxan, if not better. In a study published in The Journal of Clinical Oncology in 2002, the tumors in 80 percent of patients who received chemotherapy and Zevalin shrank, compared with 56 percent who received chemotherapy and Rituxan. Of patients who received Zevalin, 30 percent went into complete remission, compared with 16 percent who got Rituxan.
If these numbers from the NY Times article is accurate than the onclogist you spoke with is wrong about Rituxan being better. Unless the trial mentioned in the article was a trial in follicular cell lymphoma.
Mildy surprising that, with an Approvable widely expected, DOR instead commits to spending scarce cash on a GVHD-prevention trial, which is a totally separate indication. Building that pipeline for some reason.
they supply the drug, nih is funding trials, "in large part".
I am assuming nothing.
Considering that sales are not high and I don't think they will ramp quickly, the market cap seems high.
If sales were ramping quicker I would say competitors might have a problem encroaching their territory. But since the ramp is slow other competitors might give them a problem.
I have no doubt that the technology is useful and meaningful.
I believe I was the first person to mention the technology on this board.
The stock was a lot cheaper then and the sales aren't much higher now
I'll prolong the discussion for one more post. With regard to SPECIFICTY, CAMH's MTWA is near perfect, with 97-99% negative predictive value. That's exactly what one wants with a screening test, good old fashioned rule out power.
From camh website
EPS and MTWA directed strategies had comparable one year positive (11 percent and 9 percent, respectively) and negative (96 percent and 95 percent, respectively) predictive values. Event rates were higher at one year in patients with ICD therapy guided by both MTWA directed (HR=2.1, p=.03) and EPS alone (HR=2.4, p=.007) strategies. The event rates for patients with both a negative MTWA test and EPS were 2 percent.
New Clinical Trials Evaluate High-Dose AGGRASTAT(R) in High-Risk Patients
This is an old study but a quote from Eric Topol is important to explain the study that basically killed the sales of this drug when Merck owned it in the US.
Eric Topol, M.D. of the Cleveland Clinic Heart Center explains, "This study provides further support for doing a repeat large-scale trial testing tirofiban versus abciximab, since so much data now suggest the bolus dose we used (for tirofiban) in TARGET was inappropriately low." In the Do Tirofiban and ReoPro Give Similar Efficacy Outcomes Trial (TARGET) trial, tirofiban was given at 10 mcg/kg bolus followed by a 0.15 mcg/kg/min infusion for 18 to 24 hours.
Merck used the wrong dose in the target trial. Here are the results.
TARGET
In the first study to compare the effects of 2 platelet glycoprotein IIb/IIIa inhibitors, researchers compared tirofiban (Aggrastat) to abciximab (ReoPro), said Eric Topol, MD, chairman of cardiology at the Cleveland Clinic Foundation. The trial included 4812 patients at 149 hospitals in 18 countries throughout North America, Europe, and Australia who were scheduled for an interventional procedure including a stent.
In the study, 2398 patients were assigned to tirofiban and 2414 to abciximab. The end point at 30 days was death, myocardial infarction, or urgent target vessel revascularization. In the tirofiban group, 7.55% of patients reached one of the end point situations. In the abciximab group, 6.01% of patients reached the end point. Dr Topol said the difference was 26% favoring abciximab—a statistically significant finding. The study concluded that the preferred agent for coronary stenting was abciximab at the 30-day end point. In a released statement, Rick Sax, MD, senior director of clinical research at Merck Research Laboratories said, "Merck remains firm in its commitment to the use of Aggrastat when it is indicated in patients presenting to the hospital with acute coronary syndromes, including patients who subsequently go on to have an angioplasty procedure. The benefits of Aggrastat in improving outcomes in these patients were firmly established in the PRISM-PLUS study." Merck sponsored the TARGET trial.
BALTIMORE, July 29 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals,
Inc. (Nasdaq: GLFD) today announced the publication of two new clinical trials
of AGGRASTAT(R) that evaluated the safety and efficacy of high-dose
AGGRASTAT(R) Injection (tirofiban hydrochloride) in patients undergoing
primary coronary angioplasty for ST segment elevation myocardial infarction
(STEMI) and high-risk coronary angioplasty. These trials used a new dosing
regimen of AGGRASTAT(R)
(25 mcg/kg bolus over 3 minutes followed by infusion at 0.15 mcg/kg/min for
18 hours) and compared this regimen to abciximab (ReoPro(R)) or placebo.
AGGRASTAT(R), in combination with heparin and aspirin, is indicated for
the treatment of acute coronary syndrome (ACS) including patients who are to
be managed medically and those undergoing PTCA or atherectomy.
Results from the first trial known as ADVANCE, published in the Journal of
the American College of Cardiology(1) yielded a significantly reduced primary
composite end point (death, nonfatal MI, urgent TVR, and bailout GP IIb/IIIa
inhibitor therapy during follow-up) with heparin plus tirofiban over heparin
plus placebo [20% vs. 35%, respectively (hazard ratio 0.51, 95% confidence
interval 0.29 to 0.88; p = 0.01)]. This double-blind, placebo-controlled,
randomized trial included 202 high-risk patients undergoing percutaneous
coronary intervention (PCI).(2) In this trial, 98% of patients underwent
stenting. Any stent type approved by a regulatory agency could be implanted.
All patients were pretreated with aspirin (160 to 325 mg orally) and
thienopyridine (ticlopidine 500 mg as a loading dose and then 250 mg twice
daily or clopidogrel 300 mg orally as a loading dose and then 75mg/day at
least 48 or 6 hours before the procedure).
Investigators conclude that high-dose bolus tirofiban plus heparin was
safe and effective in this study. Minor bleeding was observed in both the
tirofiban and placebo arms; the difference between the two was not
statistically significant (p=0.19). There was no severe thrombocytopenia in
either treatment, and one patient in each treatment arm had mild
thrombocytopenia.
"These data suggest that high-dose tirofiban can reduce the frequency of
major adverse cardiovascular events in high-risk patients undergoing PCI,"
says Matthew Meldorf, M.D., Senior Director, Medical Affairs of Guilford
Pharmaceuticals. "We are encouraged by these data and are evaluating our
options for pursuing additional large-scale trials to confirm these results."
Findings from a randomized study of 100 patients, published in the
American Journal of Cardiology(3) suggest high-dose bolus tirofiban may be as
effective as abciximab for 30-day recovery of left ventricular function (as
the primary endpoint) in patients undergoing primary coronary angioplasty for
STEMI [mean baseline LV ejection fraction - 47 plus or minus 7%, increased to
55 plus or minus 9% similarly in both groups (p = 0.001)]. In the trial, 97%
of patients underwent stenting. Thrombolysis In Myocardial Infarction (TIMI)
grade flow (a secondary endpoint) was 0 in approximately 80% of patients prior
to the procedure. After the procedure, final TIMI 3 grade flow was achieved
in 88% of tirofiban patients vs. 86% of abciximab patients, respectively
(p = 1.0).
Investigators conclude that abciximab and tirofiban affected both initial
angiographic outcomes and 30-day recovery of LV function following primary
coronary angioplasty. With no major bleeding or severe thrombocytopenia and
no need for red blood cell transfusions, researchers say the study provides
important information about the safety of high-dose bolus tirofiban. More
abciximab-treated patients than tirofiban-treated patients [8% vs. 4%,
respectively] experienced minor bleeding, but this difference was not
significant (p=0.71). The 30-day incidence of major adverse cardiovascular
events was also greater, but not significantly so, in the abciximab group when
compared to the tirofiban group [6% vs. 4% (p = 0.74)].
Eric Topol, M.D. of the Cleveland Clinic Heart Center explains, "This
study provides further support for doing a repeat large-scale trial testing
tirofiban versus abciximab, since so much data now suggest the bolus dose we
used (for tirofiban) in TARGET was inappropriately low." In the Do Tirofiban
and ReoPro Give Similar Efficacy Outcomes Trial (TARGET) trial, tirofiban
was given at 10 mcg/kg bolus followed by a 0.15 mcg/kg/min infusion for 18 to
24 hours.
Important Information About AGGRASTAT(R) Injection
AGGRASTAT(R) was approved by the Food and Drug Administration (FDA) on
May 14, 1998. AGGRASTAT(R), in combination with heparin, and aspirin, if not
contraindicated, is indicated for the treatment of ACS including patients who
are to be managed medically and those undergoing PTCA or atherectomy. In this
setting, AGGRASTAT(R), has been shown to decrease the rate of a combined
endpoint of death, new myocardial infarction or refractory ischemia/repeat
cardiac procedure. In most patients, AGGRASTAT(R) should be administered
intravenously, at an initial rate of 0.4 mcg/kg/min for 30 minutes and then
continued at 0.1 mcg/kg/min. For complete information, please refer to the
product's prescribing information.
AGGRASTAT(R) (tirofiban hydrochloride) is contraindicated in patients with
known hypersensitivity to any component of the product; active internal
bleeding or a history of bleeding diathesis within the previous 30 days; or a
history of intracranial hemorrhage, intracranial neoplasm, arteriovenous
malformation, or aneurysm. Other contraindications to AGGRASTAT(R) include: a
history of thrombocytopenia following prior exposure to AGGRASTAT(R); history
of stroke within 30 days or any history of hemorrhagic stroke; major surgical
procedure or severe physical trauma within the previous month; or history,
symptoms, or findings suggestive of aortic dissection. AGGRASTAT(R) is
also contraindicated in patients with: severe hypertension (systolic blood
pressure >180 mmHg and/or diastolic blood pressure >110 mmHg); concomitant use
of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.
Bleeding is the most common complication encountered during therapy with
AGGRASTAT(R). Administration of AGGRASTAT(R) is associated with an increase
in bleeding events classified as both major and minor bleeding events, by
criteria developed by the Thrombolysis In Myocardial Infarction Study group
(TIMI). Most major bleeding associated with AGGRASTAT(R) occurs at the
arterial access site for cardiac catheterization. Fatal bleedings have been
reported. AGGRASTAT(R) should be used with caution in patients with platelet
count <150,000/mm3, in patients with hemorrhagic retinopathy, and in chronic
hemodialysis patients. Because AGGRASTAT(R) inhibits platelet aggregation,
caution should be employed when it is used with other drugs that affect
hemostasis. The safety of AGGRASTAT(R) when used in combination with
thrombolytic agents has not been established. During therapy with
AGGRASTAT(R), patients should be monitored for potential bleeding. When
bleeding cannot be controlled with pressure, infusion of AGGRASTAT(R) and
heparin should be discontinued.
The following additional adverse reactions have been reported in post-
marketing experience: Bleeding: intracranial bleeding, retroperitoneal
bleeding, hemopericardium, and pulmonary (alveolar) hemorrhage. Fatal
bleedings have been reported; Body as a whole: acute and/or severe decreases
in platelet counts which may be associated with chills, low grade fever, or
bleeding complications; Hypersensitivity: rash and/or hives.
Medicure Inc.: Positive AGGRASTAT(R)
Results Featured in the Journal of the American College of Cardiology
PROTOCOL FOR NEW AGGRASTAT(R) STUDY IN AMERICAN HEART JOURNAL
WINNIPEG, MANITOBA--(Marketwire - July 11, 2007) - Medicure Inc. (TSX:MPH)(AMEX:MCU), a cardiovascular focused, biopharmaceutical company, today announced that the two-year, follow-up results from the STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare Metal Stent In Acute Myocardial Infarction) study were published in the July edition of the Journal of the American College of Cardiology (JACC).
The article, titled, "Two-Year Clinical Follow-Up After Sirolimus-Eluting Versus Bare-Metal Stent Implantation Assisted by Systematic Glycoprotein IIb/IIIa Inhibitor Infusion in Patients With Myocardial Infarction", outlines the potential benefit of AGGRASTAT® (tirofiban hydrochloride) plus sirolimus-eluting stent (SES) versus Reopro® (abciximab) plus bare-metal stent (BMS) in the prevention of the cumulative incidence of death, myocardial infarction (MI), or target vessel revascularization (TVR) in acute myocardial infarction patients after two years.
At two years, the cumulative incidence of death, MI, or TVR was lower in the AGGRASTAT®-SES group compared with the Reopro®-BMS group (24.2% vs. 38.6%, p equals 0.038). This statistically significant outcome at two years is similar to the previously reported eight month results that were published in The Journal of the American Medical Association (May 2005).
The positive results from STRATEGY were the impetus for an ongoing larger factorial design study titled MULTI-STRATEGY (Multicentre Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab and Sirolimus-Eluting Stent Versus Base Metal Stent in Acute Myocardial Infarction). The MULTI-STRATEGY protocol was published in the July edition of the American Heart Journal.
This 600-patient study will further assess AGGRASTAT®-SES versus Reopro®-BMS in the prevention of the cumulative incidence of death, MI, and TVR in acute myocardial infarction patients. The results from MULTI-STRATEGY are anticipated to be presented at a prominent scientific symposium in early 2008.
"These papers highlight the ongoing interest in evaluating new investigational uses of AGGRASTAT® in the treatment of high risk cardiovascular disease patients," stated Medicure's President and CEO, Albert D. Friesen, PhD. "We believe AGGRASTAT® has significant untapped potential, and look forward to the presentation of new data from studies such as MULTI-STRATEGY in the coming year."
Medicure acquired the exclusive U.S. rights to AGGRASTAT®, in August 2006.
Important Information About AGGRASTAT®
AGGRASTAT® was approved by the Food and Drug Administration on May 14, 1998.
AGGRASTAT®, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be medically managed and those undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy. In this setting AGGRASTAT® has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. AGGRASTAT® has been studied in a setting that included aspirin and heparin.
AGGRASTAT® is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTAT® include: a history of thrombocytopenia following prior exposure to AGGRASTAT®; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; history, symptoms, or findings suggestive of aortic dissection. AGGRASTAT® is also contraindicated in patients with: severe hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.
Bleeding is the most common complication encountered during therapy with AGGRASTAT®. Administration of AGGRASTAT® is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT® occurs at the arterial access site for cardiac catherterization. Fatal bleedings have been reported. AGGRASTAT® should be used with caution in patients with platelet count less than 150,000/mm3, in patients with hemorrhagic retinopathy and in patients in chronic hemodialysis. Because AGGRASTAT® inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT® when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT®, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT® and heparin should be discontinued.
About Medicure Inc.
Medicure is a biopharmaceutical company focused on the research, development and commercialization of novel compounds to treat cardiovascular disorders. The Company's solid position in this field is highlighted by the following:
- Lead compound MC-1 in pivotal Phase 3 study for FDA approval
- Four positive Phase 2 trials completed with MC-1
- FDA Fast Track designation for MC-1
- U.S. rights to AGGRASTAT® Injection (tirofiban hydrochloride)
- Combination of MC-1 and lisinopril (MC-4232) completed Phase 2
- Dual action antithrombotic, MC-45308, with positive preclinical results
Medicure also has a medicinal chemistry based Drug Discovery program focused on discovery and advancement of novel small molecule anti-ischemics and antithrombotics towards human clinical studies.
This press release contains forward-looking statements, as defined under applicable securities legislation, that involve risks, which may cause actual results to differ materially from the statements made, and accordingly may be deemed to be forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are made as of the date hereof, and the Company disclaims any intention and has no obligation or responsibility to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise except as required by law. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, the Company's stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market the Company's products, the ability to protect its intellectual property, dependence on collaborative partners and the ability to meet its debt obligations. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Additional risks and uncertainties relating to the Company and its business can be found in the "Risk Factors" section of its Form 20F for the year ended May 31, 2006.
For more information, please contact
Medicure Inc.
Derek Reimer
Chief Financial Officer
1-888-435-2220
(204) 488-9823 (FAX)
or
Medicure Inc.
Adam Peeler
Manager of Investor & Public Relations
1-888-435-2220
(204) 488-9823 (FAX)
Email: info@medicure.com
Website: www.medicure.com
I am not telling anyone to run out an buy vicor
i am saying that camh will not have a monopoly and they are doing the heavy lifting getting the word out about the test to docs.
by the time the docs are ready to accept the test as standard of care the other test will be on the market.
I don't know if any of them will really be able to make money.
Medicure Inc.: Positive AGGRASTAT(R) Results Featured in the Journal of the American College of Cardiology
PROTOCOL FOR NEW AGGRASTAT(R) STUDY IN AMERICAN HEART JOURNAL
WINNIPEG, MANITOBA--(Marketwire - July 11, 2007) - Medicure Inc. (TSX:MPH)(AMEX:MCU), a cardiovascular focused, biopharmaceutical company, today announced that the two-year, follow-up results from the STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare Metal Stent In Acute Myocardial Infarction) study were published in the July edition of the Journal of the American College of Cardiology (JACC).
The article, titled, "Two-Year Clinical Follow-Up After Sirolimus-Eluting Versus Bare-Metal Stent Implantation Assisted by Systematic Glycoprotein IIb/IIIa Inhibitor Infusion in Patients With Myocardial Infarction", outlines the potential benefit of AGGRASTAT® (tirofiban hydrochloride) plus sirolimus-eluting stent (SES) versus Reopro® (abciximab) plus bare-metal stent (BMS) in the prevention of the cumulative incidence of death, myocardial infarction (MI), or target vessel revascularization (TVR) in acute myocardial infarction patients after two years.
At two years, the cumulative incidence of death, MI, or TVR was lower in the AGGRASTAT®-SES group compared with the Reopro®-BMS group (24.2% vs. 38.6%, p equals 0.038). This statistically significant outcome at two years is similar to the previously reported eight month results that were published in The Journal of the American Medical Association (May 2005).
The positive results from STRATEGY were the impetus for an ongoing larger factorial design study titled MULTI-STRATEGY (Multicentre Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab and Sirolimus-Eluting Stent Versus Base Metal Stent in Acute Myocardial Infarction). The MULTI-STRATEGY protocol was published in the July edition of the American Heart Journal.
This 600-patient study will further assess AGGRASTAT®-SES versus Reopro®-BMS in the prevention of the cumulative incidence of death, MI, and TVR in acute myocardial infarction patients. The results from MULTI-STRATEGY are anticipated to be presented at a prominent scientific symposium in early 2008.
"These papers highlight the ongoing interest in evaluating new investigational uses of AGGRASTAT® in the treatment of high risk cardiovascular disease patients," stated Medicure's President and CEO, Albert D. Friesen, PhD. "We believe AGGRASTAT® has significant untapped potential, and look forward to the presentation of new data from studies such as MULTI-STRATEGY in the coming year."
Medicure acquired the exclusive U.S. rights to AGGRASTAT®, in August 2006.
Important Information About AGGRASTAT®
AGGRASTAT® was approved by the Food and Drug Administration on May 14, 1998.
AGGRASTAT®, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be medically managed and those undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy. In this setting AGGRASTAT® has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. AGGRASTAT® has been studied in a setting that included aspirin and heparin.
AGGRASTAT® is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTAT® include: a history of thrombocytopenia following prior exposure to AGGRASTAT®; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; history, symptoms, or findings suggestive of aortic dissection. AGGRASTAT® is also contraindicated in patients with: severe hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.
Bleeding is the most common complication encountered during therapy with AGGRASTAT®. Administration of AGGRASTAT® is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT® occurs at the arterial access site for cardiac catherterization. Fatal bleedings have been reported. AGGRASTAT® should be used with caution in patients with platelet count less than 150,000/mm3, in patients with hemorrhagic retinopathy and in patients in chronic hemodialysis. Because AGGRASTAT® inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT® when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT®, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT® and heparin should be discontinued.
About Medicure Inc.
Medicure is a biopharmaceutical company focused on the research, development and commercialization of novel compounds to treat cardiovascular disorders. The Company's solid position in this field is highlighted by the following:
- Lead compound MC-1 in pivotal Phase 3 study for FDA approval
- Four positive Phase 2 trials completed with MC-1
- FDA Fast Track designation for MC-1
- U.S. rights to AGGRASTAT® Injection (tirofiban hydrochloride)
- Combination of MC-1 and lisinopril (MC-4232) completed Phase 2
- Dual action antithrombotic, MC-45308, with positive preclinical results
Medicure also has a medicinal chemistry based Drug Discovery program focused on discovery and advancement of novel small molecule anti-ischemics and antithrombotics towards human clinical studies.
This press release contains forward-looking statements, as defined under applicable securities legislation, that involve risks, which may cause actual results to differ materially from the statements made, and accordingly may be deemed to be forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are made as of the date hereof, and the Company disclaims any intention and has no obligation or responsibility to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise except as required by law. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, the Company's stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market the Company's products, the ability to protect its intellectual property, dependence on collaborative partners and the ability to meet its debt obligations. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Additional risks and uncertainties relating to the Company and its business can be found in the "Risk Factors" section of its Form 20F for the year ended May 31, 2006.
For more information, please contact
Medicure Inc.
Derek Reimer
Chief Financial Officer
1-888-435-2220
(204) 488-9823 (FAX)
or
Medicure Inc.
Adam Peeler
Manager of Investor & Public Relations
1-888-435-2220
(204) 488-9823 (FAX)
Email: info@medicure.com
Website: www.medicure.com
A N A L I T I K A Focus on Healthcare Medicure Inc. (MCU)
Biotechnology
Quote: $1.35 // Price Target: $6.00 (+344%)
Research Alert
Erik Danielsen
July 10th, 2007
e.danielsen@analitika.com
this was posted by balistic 117 on the yahoo message board
w w w . a n a l i t i k a . c o m
MARKET DATA
Mkt. Cap.: $157.0MM
Enterprise Value: $134.M
52Wk Hi-Low: $1.70 -$0.91
Outst. Shares: 116.26M
Fully Dil. Shares: 131.0M
Float: 105.3M
Daily Volume: 109,000
Short Position: n/a
VARIOUS METRICS
Cash : $43.4M
Cash Burn ‘07: $27.0M
LTD (MM): $11.5M
Short Position: 107,000
Insider buying: None
Insider Ownership: ~10%
Institutional
holdings: 24%
EARNINGS DATA
FY – 05/31 2006 2007E 2008E
Q1 (0.06) (0.03) (0.06)
Q2 (0.05) (0.06) (0.04)
Q3 (0.04) (0.08) (0.04)
Q4 (0.03) (0.08)E (0.04)
FY EPS (0.17) (0.17)E (0.09)
Revenue 0.3M 9.5M 20.0
VALUATION METRICS
FY – 12/31 2006 2007E 2008E
P/E NM NM NM
PEG NM NM NM
Sales Mult. NM NM NM
Medicure’s shares have continued to trend downwards since the shares set a high in February 2006, which, in our view, is in sharp contrast to the underlying fundamentals at the company. The company has implemented its business plan, reported highly positive
clinical data for both of its lead compounds and thereby built significant tangible share-holder value. Consequently, we strongly encourage investors to take advantage of the current price weakness and either build or add to their positions.
Key Investment Considerations:
•Strong Management: Medicure has a strong, proven management team that consis-tently delivers on all major corporate milestones.
•Late-Stage Product Candidates: Medicure clearly has one of the clinically most ad-vanced cardiovascular product pipelines of any biotech companies in our 900+ companies database. The company’s lead product, MC-1, is being developed as a cardioprotective agent and entered a 3000 patient Phase III registration study in December 2006. Top-line results are expected by the end of Q1-2008 and the product could be on the market by H1-2009. Medicure’s second product candidate, MC-4232 for diabetics with concomitant hypertension, has successfully concluded Phase IIb clinical testing and is now ready to enter pivotal Phase III clinical testing. These two products alone have by our estimate a combined market potential in excess of $1.5BN in the U.S. alone. Currently, Medicure own 100% worldwide rights to its product candidates.
•Near-Term Growth Opportunity: The August 2006 acquisition of Aggrastat, an FDA approved platelet aggregation inhibitor used to treat acute coronary syndromes, has catapulted the company into an exclusive, small group of biotech companies with significant near-term, sales-growth potential. Aggrastat was re-launched in the United States in late October 2006 with a 15 person dedicated sales-force. At the time of launch, Aggrastat generated ~$8M in annualized revenues equivalent to less than a 2% market share of a an estimated $450M annual market in the U.S. Aggrastat had not been actively marketed in the U.S. for some 3-4 years. By contrast, in Europe, where the product has been marketed actively in recent years, Aggrastat is the market leader of the three competing products in the therapeutic class with an estimated 35% market share. Aggrastat is not only a near-term, sales-growth opportunity, but importantly, it also allows the company to build and train a sales-force in anticipation of the approval of MC-1.
•Additional Licensing Opportunities Could Provide Near-Term Upside: We believe there is an excellent probability that the company will be announcing additional commercial initiatives over the next year that would be immediately incremental to
its revenue base. We look for either additional co-promotion and/or out-right product licensing agreements. •Significantly Undervalued: At current valuation levels, we believe Medicure’s common stock is significantly undervalued. We expect the stock to appreciate sharply in value, as the company continues to execute its business plan that we expect will result
in a strong news-flow over the next 9 months. We believe Medicure’s stock should be valued at $600-$900M today, implying a 12-18 months price target of $6-9.
Medicure Is Grossly Undervalued Relative To Other Small Cap Biotech Companies
We strongly believe that Medicure, at current valuation levels of ~US$157M (and enterprise value of less than $134M), continues to represent an extraordinary investment opportunity. The company is significantly undervalued by any valuation parameter that we use. In particular, Medicure is trading at an unjustified discount to a group of cardiovascular biotech companies, as highlighted by the table:
Company Ticker Quote Mkt Cap
Alexion Pharma ALXN $47.95 $1.774,0M
Cardiome CRME $9.20 $581.0M
CV Therapeutics CVTX $12.57 $746.2M
Average: $1.033,8
Median: $746.0
Medicure MCU $1.35 $157,0
Discount to median: 79%
We actually believe that Medicure’s commercial potential is much larger than any of the companies indicated in the table above. Furthermore, we have reviewed, not only the companies highlighted in the table, but also a number of other biotech companies in our database, in particular
with regard to:
• Management’s track record of delivering on corporate milestones in a timely fashion.
• Near-term sales-growth potential.
• Breadth, depth and clinically advanced stage of product pipeline.
• Long-term market potential of late-stage product pipeline.
• Anticipated news flow over the next 12 months.
* Current market cap in relation to the above parameters.
Based on our review, we feel very comfortable stating that Medicure ranks among the most attractively valued companies for all of the parameters reviewed. As the table above indicates, the company trades at a 79% discount to companies we feel are comparable, but at the same time have weaker fundamentals. One of the companies highlighted above is Alexion. Alexion once enjoyed a market cap of approximately $1Bn prior to reporting disappointing Phase III results for its heart-protective agent, Pexelizumab. Pexelizumab was being developed basically for the same indications Medicure is pursuing with MC-1. We mention this because we believe Alexion’s valuation at the time based entirely on the prospects of Pexelizumab.
However, in the meantime, Alexion gained FDA approval for another of its product candidates, Soliris, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), which one leading Wall Street analyst recently estimated has a peak sales potential of approximately $400M annually. This is virtually the same as Medicure’s Aggrastat’s market opportunity in the U.S. Alexion’s market cap has despite the disappointment with Pexelizumab soared from $1Bn to $1.77Bn based on the prospects of Soliris. Considering that Medicure in addition to Aggrastat has two products with blockbuster sales potential in late-stage clinical development, and that MC-1 could reach the market within the next 18 months, we conclude that Medicure must be grossly undervalued.
Medicure is currently enjoying a market cap equivalent to about 8.8% (!) of Alexion’s current market cap
Medicure Consistently Delivers Tangible Value To Shareholders
Medicure has had an impressive news flow over the past twenty four months; including the publication of two highly successful phase IIb clinical trials for MC-1 and MC-4232 and, most recently, the acquisition of Aggrastat, which we estimate has the potential to grow at least 5 times over the next 2-3 years. Aggrastat was purchased at a very reasonable price of roughly 2x its trailing twelve
months revenues.
Since Alexion’s Pexulizumab failed to show efficacy in Phase III as a cardio-protective agent, Medicure has now emerged as the leader in the field. This statement is shared by leading clinical investigators we have spoken to at the most prestigious hospitals in the U.S.
We Expect A Strong News Flow Through 2008
The next 12 months will be extremely exiting to Medicure’s shareholders as we expect the company to report top-line date from its confirmatory Phase III trial for MC-1 in CABG in early 2008. This will clearly be a crucial time in the company’s history. We believe the probability of success in the MC-1 Phase III trial is high and thus a significant revaluation of the stock is likely to occur at the latest by the end of Q1-2008.
The following table summarizes some of the value-driving events we expect to occur over the next 18 months.
Milestone Event Timing
~ Completion of patient enrollment in confirmatory Phase III trial for MC-1 in CABG Oct-2007
~ In-licensing of new commercial products H1-2008
~ Report accelerating sales growth of Aggrastat Dec-2007
~ Report Top-Line Results from MC-1 Phase III Trial Q1-2008
~ File NDA for MC-1 H1-2008
~ FDA Clearance and launch of MC-1 End-2008
~ Announce corporate partner for MC-1 H1-2008
Conclusion
We believe Medicure is significantly undervalued at current valuation levels. We believe Medicure is a “quality small-cap biotech stock” that has a broad product portfolio and a proven management team, lead by Dr. Albert Friesen. Consequently, we strongly recommend growth-oriented investors, familiar with inherent risks of investing in biotech companies, to either add to or take
new positions in Medicure at current price levels.
For more information: www.analitika.com
The author is compensated by Medicure through a consulting agreement for his business develpment services.
ANALITI KA Identifying Investment Opportunities In Healthcare
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Vicor Technologies Retains ROI Group as Investor Relations Counsel
Thursday July 12, 8:45 am ET
This company is only getting their trial together but it could be a competitor within a couple of years and I don't think camh's revenues are going to ramp that fast. I believe the difference in the test is that camh is a stress test. this company gets the data at rest.
I have no idea if the next paragraph is accurate or not.
Vicor's PD2i Cardiac Analyzer, is noninvasive and portable. It is believed to be superior to all other devices in predicting SCD, with greater than 95% sensitivity and 81% specificity. The twenty minute test can be administered in any cardiologist's office and is performed on resting patients (no potentially dangerous stress testing is required). The PD2i Cardiac Analyzer is a PC-Windows based system, is user friendly and can be acquired by the physician at a very low cost.
In Clinical Trials for Novel Medical Device to Risk Stratify Sudden Cardiac Death; Anticipate Seeking European CE Mark Clearance Late 2007 in Order to Commence Marketing Its PD2i Analyzer
BOCA RATON, FL--(MARKET WIRE)--Jul 12, 2007 -- Vicor Technologies, Inc. (OTC BB:VCRT.OB - News), developing its patented PD2i Cardiac Analyzer device for risk stratification of patients for Sudden Cardiac Death (SCD), announced it has retained ROI Group LLC as investor relations counsel.
ADVERTISEMENT
Vicor's PD2i Cardiac Analyzer addresses the growing need for the medical community to be able to risk stratify patients who are at high or low risk of suffering this fatal arrhythmic event. SCD is the leading cause of death in the United States each year, with over 500,000 cases reported annually. Vicor has undertaken a clinical trial (the VITAL Trial) to seek FDA approval for the use of its device with patients in the U.S.
President and CEO David H. Fater said, "Vicor management is rapidly moving forward on our strategies to get the PD2i Analyzer approved. We believe Vicor can achieve several important milestones in 2007 and 2008, and beyond. We expect to seek European CE Mark clearance in late 2007, to allow us to market the PD2i Analyzer in those countries. Upon successful conclusion of the VITAL Trial, which we project will be in about 18-24 months, we will seek U.S. FDA 510(k) clearance, targeting as early as late 2008, to market in the U.S. Now that we are a publicly held company we have hired ROI Group as we believe Vicor represents a compelling investment story, and now is the time to expand our efforts in sharing our story with potential investors throughout the financial community."
Mr. Robert Giordano, a Managing Director of ROI Group, said, "We believe Vicor Technologies is targeting a substantial market that has not been adequately served -- risk stratification of millions of patients subject to SCD. Importantly, the medical community may be spending billions of dollars needlessly on ICDs (Implantable Cardioverter Defibrillator) for patients who may not need one, while overlooking tens of thousands of people in need of an ICD."
"Therefore, in our opinion Vicor Technologies represents an exceptional growth opportunity. The markets they address are billions of dollars, and Vicor appears to have a technology that could not only benefit millions of people, but also better distribute the costs of medical care to those truly in need. Vicor's only competitor is Cambridge Heart, a publicly held company with a market capitalization of about $300 million, with nominal revenues, versus Vicor's market cap of only about $45 million. Vicor's PD2i Cardiac Analyzer, with appropriate FDA and CE Mark approval, could be a substantial benefit to the medical community, and in turn make Vicor a significant public company," added Mr. Giordano.
Vicor believes the PD2i Cardiac Analyzer, if approved as anticipated, will lead to a higher quality of patient care, the minimization of medical expenses, and the enhancement of patients' quality of life. Vicor believes it is uniquely positioned to address this unmet medical need.
About Sudden Cardiac Death (SCD)
SCD is a fatal arrhythmic event and is different than a heart attack. A heart attack is analogous to a plumbing problem, where the blood supply to a part of the heart is choked off, leading to the death of that portion of the heart muscle. SCD is theorized to be caused by a breakdown of the normal neurological communication pattern between the heart and brain, more like an electrical problem, which can lead to a rapid, life threatening heart rhythm that is usually fatal within minutes, if untreated. It is swift, unexpected, and often has no advance warning or symptoms.
About Vicor Technologies, Inc.
Vicor Technologies (OTC BB:VCRT.OB - News) medical device, the PD2i Cardiac Analyzer, is based on a patented, proprietary algorithm. Vicor believes the PD2i Cardiac Analyzer accurately risk stratifies patients who are at high or low risk of suffering a fatal arrhythmic event or SCD within a six-month time frame.
Vicor's PD2i Cardiac Analyzer addresses a significant health care issue involving a patient cohort of at least 12,000,000 patients. This patient cohort is composed of the MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II)/SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) patient population. Many in this patient cohort may need an ICD (Implantable Cardioverter Defibrillator) as life-saving therapy. However, recent registry studies have noted that over 70% of implanted ICDs never have an appropriate firing. This over-implantation has led to a substantial and unnecessary medical cost burden. Over-implantation of this patient cohort also puts patients at risk because of the complications that can accompany implantation surgery. There is also the risk of not identifying patients who need this life-saving therapy because current criteria does not provide physicians the ability to accurately risk stratify their patients.
For more information visit the Vicor Technologies web site www.vicortech.com.
About the VITAL Trial
Vicor's VITAL Trial (acronym for "Prospective, Multi-Center Study of the Ability of the PD2i Cardiac Analyzer to Predict Risk of VentrIcular TachyArrhytmic Events such as Sudden Cardiac Death (SCD), VentricuLar Fibrillation (VF) or Ventricular Tachycardia (VT) in High Risk Patients") was initiated in August 2006 and is being conducted by Harvard Clinical Research Institute (HCRI) which is responsible for the overall coordination and monitoring of the trial. The FDA, in pre-IDE (Investigational Device Exemption) meetings, agreed to the final PD2i protocol and study design for the pivotal VITAL study. Target Health, Inc., a full service contract research organization based in New York, is responsible for developing the electronic case report form to permit the gathering of patient data via the Internet, and will be responsible for preparing and submitting Vicor's 510(k) application.
Caution Regarding Forward-Looking Statements
Forward-looking statements in this press release are based on current plans and expectations that are subject to uncertainties and risks, which could cause our future results to differ materially. The following factors, among others, could cause our actual results to differ: our ability to continue to receive financing sufficient to complete the critical clinical trials; our ability to continue as a going concern; our ability to successfully develop products based on our technologies; our ability to obtain and maintain adequate levels of third-party reimbursement for our products; the impact of competitive products and pricing; our ability to receive regulatory approval for our products; the ability of third-party contract research organizations to perform preclinical testing and clinical trials for our technologies; the ability of third-party manufacturers to manufacture our products; our ability to retain the services of our key personnel; our ability to market and sell our products successfully; our ability to protect our intellectual property; product liability; changes in federal income tax laws and regulations; general market conditions in the medical device and pharmaceutical industries; and changes in laws and regulations. Forward-looking statements in this press release speak only as of the date of the press release, and we assume no obligation to update forward-looking statements or the reasons why actual results could differ.
Contact:
INVESTOR CONTACT:
Robert Giordano
ROI Associates
212.495.0201
rgiordano@roiny.com
COMPANY CONTACT:
David H. Fater
President & CEO
Vicor Technologies, Inc.
800.998.9964
http://www.vicortech.com
any ceo worth his salt should know better than to argue with Dew Diligence on a message board.
He deserves to be fired for that reason alone