Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Former Bush Surgeon General Says He Was Muzzled By REUTERS
how could reuters muzzle him?
RPRX has the cure for a bad
stock portfolio
an ad to become employed at pfizer
the only people that I would think would answer this ad are people that are already unemployed because the hiring would only last until the next time they need to issue a press release about job cuts
When does research
become a discovery?
Imagine what you can achieve at a biotech start-up with unrivaled global resources. Imagine applying innovative science to identify and validate novel drug discovery targets. Imagine a biotech company atmosphere within one of the world’s largest pharmaceutical organizations.
At Pfizer Research Technology Center (RTC) in Cambridge, MA, we’re not content waiting to witness the evolution of our industry. Instead, we’re applying innovative science to identify and validate novel drug discovery targets for Pfizer R&D and increase the diversity of potential drugs which may bind to these targets.
Surrounded by more than 300 biotechnology companies and world-leading research hospitals and academic institutions, a key element in the success of the RTC is the growing and dynamic portfolio of partnerships with these innovators. With them and without the constraints of a therapeutic area portfolio, we’re applying cutting-edge techniques and technologies with broad utility across different therapeutic areas -developing a deep knowledge of new drug discovery targets, novel chemical structures, and potential safety liabilities.
At the RTC, we’re balancing the strength of Pfizer R&D with the nimble feel of a small biotech, and creating an exciting and team-based scientific environment for over 150 colleagues with a wide range of scientific skills and experience. Collaboration and cooperation are the norm here. And the unique working environment – truly a small biotech with the backing of the largest research budget in the industry – is allowing science to leap forward into the future and bring to market what are miracles for many.
Now you can be a vital member of Pfizer Research Technology Center, a research center unlike any in the world, and use your talents to change the world.
Join us and help turn research into discovery. We are currently hiring the following disciplines:
ADME Biology
Biochemistry
Biophysics
Cell Biology
Computational Biology
Computational Chemistry
Enzymology
Genomics LCMS
Mathematical Modeling
Molecular Profiling
Protein Sciences/Protein Engineering
Proteomics
Synthetic/Medicinal Chemistry
Systems Biology
Text Mining
To apply now and learn more about our people, our pipeline, and our plans for the future, visit www.pfizercambridge.com
We’re proud to be an equal opportunity employer and welcome applications from people with different experiences, backgrounds and ethnic origins.
Want to reach 55,000+ FierceBiotech subscribers with your own message?
Contact jason@fiercemarkets.com or call (202) 628-8778 x10.
About this email: In order to receive FierceBiotech for free, we ask that you accept an occasional email promotion from our sponsors. We carefully screen each promotion and never sell or give away your personal information. If you do not want to receive these messages, you can unsubscribe entirely from FierceBiotech. To unsubscribe: click here .
FierceMarkets Inc. 1319 F St. NW Suite 604 Washington, DC 20004
"The ODAC panel agreed that it would be unethical to run another trial in acute GVHD"
I didn't get that from listening to the panel discussion. The PI from the trial and the inventor or Orbec made that assertion, but I don't think anybody on the panel either agreed or disagreed with him directly.
After the panel voted and were asked to give the company and the FDA guidance to how to run another trial in acute GVHD, did any of them have a suggestion. Dr. Perry said prior to the vote that he didn't think they would have any difficulty running another trial but he kept it a secret. The other panel members said prophylaxis would be the way to go. That means they were on board that you couldn't run another trial in acute"
In the panel's mind, there was doubt as to the efficacy of Orbec, which uncertainty would allow the trial to be ethically run. The presenter said he thought the published data were sufficiently strong that he didn't think his IRB would allow a randomized trial.
There may have been doubt in the panel's mind but they don't have imput on the decision. Pazdur said the drug had a different impact in his mind irrespective of the panel vote. That means more to me because he will have input on the outcome
I suspect the FDA will ask for another randomized trial in acute GVHD. If the company refuses to run one, they may just run the prevention trial they have planed, and seek that as an indication. We'll soon know.
I agree that we will no soon. You didn't say how you felt. The drug met every seconday endpoint. The drug beclomethasone is an already approved safe drug. What is the risk for the FDA to approve the drug
It is good that he didn't need more than a sprained wrist taken care of
If Alimta could get accelerated approval,why not Orbec
U.S. Food and Drug Administration has granted accelerated approval to pemetrexed for injection (Alimta, Eli Lilly and Company) on Aug 19, 2004. This drug is approved as a single-agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who has failed at least one type of prior chemotherapy. Efficiency and safety were were demonstrated in one multi-center, randomized trial conducted in 571 patients comparing single-agent Alimta versus docetaxel (Taxotere). Alimta, 500 mg/m2 intravenously, was administered over 10 minutes on day 1 of each 21-day cycle. Those patients who received Alimta also received dexamethasone for skin rash prophylaxis and vitamin B12 and folic acid supplementation. The primary efficacy endpoint of the study was survival, however Alimta failed to demonstrate superior survival compared to docetaxel. Non-inferiority for overall survival could not be demonstrated because there was only one small historical study with a total 104 patients from which to estimate docetaxel's survival effect. A meta-analysis of multiple historical studies is usually required to establish this survival effect estimation. In addition, comparison of the survival effect in this randomized trial was confounded by a 32% crossover rate of Alimta patients to docetaxel after tumor progression. The median survival time was 8.3 months for Alimta-treated patients and 7.9 months for docetaxel-treated patients. Secondary efficacy endpoints included response rate (Alimta 9.1%, docetaxel 8.8%), progression-free survival (Alimta and docetaxel, medians 2.9 months) and time-to progressive disease (Alimta, median 3.4 months; docetaxel, median 3.5 months).
Alimta has a more favorable safety profile compared to docetaxel. Alimta caused less neutropenia, febrile neutropenia, neutropenic infections and need for growth factors. Alimta causes less severe hair loss. Elevation of liver enzymes was more frequent with Alimta than docetaxel. Accelerated approval was based on the improved safety profile and effects on surrogate endpoints.
As a condition of accelerated approval, the applicant is required to conduct additional studies to demonstrate a clinical benefit, such as increased survival or improved disease-related symptoms.
Orbec additional trials would be in a prophylaxis setting since the ODAC panel agreed that it would be unethical to run another trial in acute GVHD
If Alimta could get accelerated approval,why not Orbec
U.S. Food and Drug Administration has granted accelerated approval to pemetrexed for injection (Alimta, Eli Lilly and Company) on Aug 19, 2004. This drug is approved as a single-agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who has failed at least one type of prior chemotherapy. Efficiency and safety were were demonstrated in one multi-center, randomized trial conducted in 571 patients comparing single-agent Alimta versus docetaxel (Taxotere). Alimta, 500 mg/m2 intravenously, was administered over 10 minutes on day 1 of each 21-day cycle. Those patients who received Alimta also received dexamethasone for skin rash prophylaxis and vitamin B12 and folic acid supplementation. The primary efficacy endpoint of the study was survival, however Alimta failed to demonstrate superior survival compared to docetaxel. Non-inferiority for overall survival could not be demonstrated because there was only one small historical study with a total 104 patients from which to estimate docetaxel's survival effect. A meta-analysis of multiple historical studies is usually required to establish this survival effect estimation. In addition, comparison of the survival effect in this randomized trial was confounded by a 32% crossover rate of Alimta patients to docetaxel after tumor progression. The median survival time was 8.3 months for Alimta-treated patients and 7.9 months for docetaxel-treated patients. Secondary efficacy endpoints included response rate (Alimta 9.1%, docetaxel 8.8%), progression-free survival (Alimta and docetaxel, medians 2.9 months) and time-to progressive disease (Alimta, median 3.4 months; docetaxel, median 3.5 months).
Alimta has a more favorable safety profile compared to docetaxel. Alimta caused less neutropenia, febrile neutropenia, neutropenic infections and need for growth factors. Alimta causes less severe hair loss. Elevation of liver enzymes was more frequent with Alimta than docetaxel. Accelerated approval was based on the improved safety profile and effects on surrogate endpoints.
As a condition of accelerated approval, the applicant is required to conduct additional studies to demonstrate a clinical benefit, such as increased survival or improved disease-related symptoms.
Orbec additional trials would be in a prophylaxis setting since the ODAC panel agreed that it would be unethical to run another trial in acute GVHD
My first question is: Are the nurse's statistics correct? And, if they are correct, why do private insurers have a ten times greater overhead than Medicare, certainly something that you would not expect to be the case.
the ceo's of some of these companies make outrageous salaries. they pay high dividends also.
then there are stock buybacks to keep their stock prices high so they can excersize options.
the waste in the private payor system is very high but the government would be worse
Diomed wins injunction by Roth Capital
Matt Dolan
(949) 720-5796
Price: $1.08
Mkt. Cap.(mil): $32.2
EPS P/E
2006A (0.67) NM
2007E (0.49) NM
2008E (0.28) NM
Permanent Injunction Served
Yesterday Judge Gorton granted Diomed a permanent injunction against defendants Vascular Solutions (VASC-$9.68 -NC) and AngioDynamics (ANGO-$18.02-NC). Additionally, damages were increased by $2.2 million (for pre-judgment interest and post-judgment sales) and now total $14.6 million.
Based on our initial read of the permanent injunction document, the wording of the injunction is relatively strong and broad and includes both kits and laser consoles "that are not more than a mere colorable variation of" those respective devices. The ruling includes all of the components we anticipated, as well as the inclusion of language on laser consoles in its wording. From our conversations with Diomed management, the company's legal interpretation of the injunction would impede the defendants from selling not only laser kits but also the corresponding laser consoles. Depending on the actual outcome in the marketplace, we believe the possible exclusion of laser consoles would be a significant incremental development for Diomed, as its competitors would be precluded from obtaining new account market share without substantially altering its device and would only be able to service its current installed-base (and that assumes competitive workarounds are viable).
In a related press release, it appears that Vascular Solutions will continue to sell both laser consoles and its new Bright Tip fibers under its interpretation that these products are not covered under the Court's recent rulings.
Ultimately, we believe the relatively broad language of the ordered injunction, coupled with the inclusion of laser consoles in its wording, will at least create a fair amount of uncertainty for those physicians looking to adopt endovascular laser ablation devices. Given Diomed's current legal position, we believe more physicians would be inclined to adopt Diomed's system as opposed to risking the potential legal and therefore economic ramifications of purchasing the defendants' products. Further, we believe the lack of clinical experience to date for more recently launched products may also leave some physicians cautious.
With respect to workaround kits, we understand Angiodynamics and Vascular Solutions continue to sell products, with Vascular indicating that the most recently ending quarter experienced sequential growth in its Vari-Lase business. We believe that Diomed continues to make progress in its clinical evaluation of both workaround products and expect to obtain more clarity on these devices over the next couple of quarters.
We reiterate our Buy rating on the shares of DIO.
Judge Grants Diomed Permanent Injunction in '777 Patent Case
Monday July 2, 5:25 pm ET
Total Damages increased to $14.6 Million
ANDOVER, Mass.--(BUSINESS WIRE)--Diomed Holdings, Inc. (AMEX: DIO - News), a leading developer and marketer of minimally invasive medical technologies, today announced that U.S. District Judge Nathaniel M. Gorton has granted Diomed a permanent injunction against both AngioDynamics and Vascular Solutions based on Diomed's United States Patent Number 6,398,777 regarding the endovascular laser treatment of varicose veins.
In today's ruling, Judge Gorton adopted Diomed's proposed order, granting a permanent injunction against AngioDynamics' and Vascular Solutions' infringing products and any other products that are no more than "mere colorable variations."
"We are extremely pleased with Judge Gorton's ruling which prohibits the defendants from promoting, marketing and selling their laser consoles or any disposable products that are used in the endovenous treatment method covered by our patent," said James A. Wylie, President and CEO of Diomed. "Today's ruling is a huge win for Diomed. If the defendants' recently modified products are mere colorable variations of those already determined to infringe, then we will be in a position to file a motion for a finding of contempt of court. Alternatively, if the devices do not permit contact between the fiber tip and the vein wall, then there is no long-term clinical evidence that such alternative approaches will deliver sustained vein closure."
In January 2004, Diomed commenced legal action in the United States Federal District Court for the District of Massachusetts against AngioDynamics, seeking injunctive relief and damages for infringement of Diomed's pioneering "777" patent. Diomed initiated similar infringement actions against Vascular Solutions and two other competitors later in 2004. In August 2006, Judge Gorton ruled that Diomed's '777 patent is both valid and enforceable and, in the trial ending on March 28, 2007, the jury found AngioDynamics and Vascular Solutions liable for both inducing infringement and contributory infringement of Diomed's patent, awarding Diomed a total of $12.4 million in damages. The parties have also stipulated to an additional $2.2 million representing prejudgment interest and post-judgment sales that will be added to the damages awarded by the jury.
Last month, Judge Gorton:
Denied the defendants' motion for a new trial;
Denied the defendants' motion for judgment as a matter of law to overturn the jury verdict; and
Denied the defendants' request to reduce the amount of the damages awarded by the jury.
Wylie further commented, "Normally, when a medical device company introduces a new product or procedure, the launch is based on extensive testing and sound clinical data. Any new product that is claimed to avoid contact between the fiber and the vein wall should be viewed as an entirely new procedure and thus should be subject to the same levels of clinical scrutiny as EVLT® when it was first introduced. Diomed believes that the defendants' latest products were brought to market with only one objective apparently in mind --- an attempt to get around our patent, and not because they offer proven advantages to the physician or better outcomes for the patient."
About Diomed
Diomed develops and commercializes minimal and micro-invasive medical procedures that use its proprietary laser technologies and disposable products. Diomed's EVLT® laser vein ablation procedure is used in varicose vein treatments. Diomed also provides photodynamic therapy (PDT) for use in cancer treatments, and dental and general surgical applications. The EVLT® procedure and the Company's related products were cleared by the United States FDA in January of 2002. Along with lasers and single-use procedure kits for its EVLT® laser vein treatment, the Company provides its customers with state of the art physician training and practice development support. Additional information is available on the Company's website: www.evlt.com.
EVLT®is a registered trademark of Diomed Inc., Andover, MA.
Safe Harbor
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: Statements in this news release looking forward in time involve risks and uncertainties, including the risks associated with trends in the products markets, reliance on third party distributors in various countries outside the United States, reoccurring orders under OEM contracts, market acceptance risks, technical development risks and other risk factors. These statements relate to our future plans, objectives, expectations and intentions. These statements may be identified by the use of words such as "may," "will," "should," "potential," "expects," "anticipates," "intends," "plans," "believes" and similar expressions. These statements are based on our current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties. Our actual results could differ materially from those discussed in these statements. Our 2006 Annual Report on Form SEC 10-KSB (the "Annual Report") contains a discussion of certain of the risks and uncertainties that affect our business. We refer you to the "Risk Factors" on pages 19 through 34 of the Annual Report for a discussion of certain risks, including those relating to our business as a medical device company without a significant operating record and with operating losses, our risks relating to our commercialization of our current and future products and applications and risks relating to our common stock and its market value. Diomed disclaims any obligation or duty to update or correct any of its forward-looking statements.
Contact:
Diomed Holdings, Inc.
Christopher J. Geberth, 866-4DIOMED
VP Finance
cgeberth@diomedinc.com
or
Burns McClellan
Carney Noensie, 212-213-0006
Investor Relations
cnoensie@burnsmc.com
--------------------------------------------------------------------------------
Source: Diomed Holdings, Inc.
who cares
It may increase some side effects. So far crxx is 0 for 4 in clinical trials. I never recieved an answer about their animal studies. Have they done extensive animal studies?
dndn - I don't know if this has been posted
http://www.psa-rising.com/med/immun/provenge-fda-fleming-t-r.html
Dr Bio, does the FDA go looking at safety when "the standard elderly patient," (such as my Mother) has 15 different prescriptions, some of which are clearly hazardous alone?
I have 6 or 7 myself.
what you are suggesting can be considered as part of the drug interaction warnings in the label.
you can't have a warning, if is combined in one pill.
Just as the company finds that the cardio drug increases the efficacy of prednisolone have they exhibited evidence that it doesn't also magnify its toxicity?
The fda would love to approve this drug as a chronic treatment for RA
Prednisolone impairs calcium absorption and new bone formation. Patients on prolonged treatment with prednisolone and other corticosteroids can develop osteoporosis and an increased risk of bone fractures. Supplemental calcium and vitamin D are encouraged to slow this process of bone thinning. In rare individuals, destruction of large joints can occur while undergoing treatment with prednisolone or other corticosteroids. These patients experience severe pain in the involved joints, and can require joints replacements. The reason behind such destruction is not clear.
Pfizer Will Start Meetings With Largest Investors (Update5)
http://www.bloomberg.com/apps/news?pid=20601103&sid=ajToCiEu_dzU&refer=news
These investors are so huge they want obesity drugs at a discount
By Shannon Pettypiece and Angela Zimm
Pfizer Inc. headquarters, New York June 28 (Bloomberg) -- Pfizer Inc., whose shares have lost almost a quarter of their value in the past three years, said it plans to be the first company to meet regularly with shareholders to discuss executive pay and management practices.
The first meeting will be in the third quarter with about 30 investors who together hold 35 percent of the New York-based company's shares, Pfizer spokesman Andy McCormick said in a telephone interview today. Pfizer's top shareholders include Barclays Global Investors Ltd., State Street Corp. and Vanguard Group Inc., according to data compiled by Bloomberg.
Pfizer, the world's biggest drugmaker, is initiating the meetings as investors demand more say in the direction of companies and in decisions such as executive pay. The drugmaker is trying to restore confidence as its share price declines and as it faces the loss of $21 billion in annual revenue to generic competition by 2011, analysts said.
``They are getting out ahead of the crowd to say, `We're not afraid to talk to our investors,''' said Ira Millstein, senior associate dean at Yale School of Management and an expert on corporate governance.
Pfizer's shares rose 2 cents to $25.63 as of 4:25 p.m. in New York Stock Exchange composite trading. The shares have declined 1.8 percent since the company ousted Chief Executive Officer Hank McKinnell on July 28 to help quell investor discontent.
Jobs Slashed
McKinnell's replacement, Jeffrey Kindler, has announced plans to slash 10,000 jobs, or 10 percent of Pfizer's workforce, in his first year in the job to save money and speed drug discovery. He is also seeking replacements for the company's chief financial officer and head of research.
``It will be very interesting to hear what is on their minds and what they will want to talk about,'' said Peggy Foran, Pfizer's vice president for corporate governance. ``This isn't about a dog-and-pony show or strategy. This is about listening to them and what their thoughts are.''
Topics likely to come up include executive compensation and succession planning, Foran said.
Kindler has had better rapport with investors and analysts than McKinnell, analysts say. Still, Pfizer has had major research setbacks in the past year, including ending development of the cholesterol pill torcetrapib. The drug, its most promising experimental treatment, had been expected to generate more than $13 billion in annual revenue if it were approved by regulators.
Compensation Protested
Investors, including AFL-CIO members whose pension plans own 21.8 million shares, protested the company's decision to give almost $200 million in severance, pension assets and performance awards to McKinnell. They said the exit package was excessive given that Pfizer's stock price fell almost 40 percent during McKinnell's tenure. Kindler's compensation is more closely tied to the share price.
The new meetings of Pfizer's board and the largest institutional investors, those owning more than 0.5 percent of the company's shares, will probably be held annually, Foran said.
``Pfizer wants to be at the forefront of governance issues that a lot of the institutional funds are concerned about,'' said Espen Eckbo, professor of finance at Dartmouth College's Tuck School of Business in Hanover, New Hampshire. ``One of the problems for institutional owners is the feeling that they do not have adequate representation on the board.''
To contact the reporter on this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net .
Last Updated: June 28, 2007 16:48 EDT
Email this article Printer friendly format
Advertisement: Market headed for a fall? Get forecast by Forbes columnist!
Scientists Transplant Genome of Bacteria
By NICHOLAS WADE
Correction Appended
Scientists at the institute directed by J. Craig Venter, a pioneer in sequencing the human genome, are reporting that they have successfully transplanted the genome of one species of bacteria into another, an achievement they see as a major step toward creating synthetic forms of life.
Other scientists who did not participate in the research praised the achievement, published yesterday on the Web site of the journal Science. But some expressed skepticism that it was as significant as Dr. Venter said.
His goal is to make cells that might take carbon dioxide out of the atmosphere and produce methane, used as a feedstock for other fuels. Such an achievement might reduce dependency on fossil fuels and strike a blow at global warming.
“We look forward to having the first fuels from synthetic biology certainly within the decade and possibly in half that time,” he said.
Richard Ebright, a molecular biologist at Rutgers University, said the transplantation technique, which leads to the transferred genome’s taking over the host cell, was “a landmark accomplishment.”
“It represents the complete reprogramming of an organism using only a chemical entity,” Dr. Ebright said.
Leroy Hood, a pioneer of the closely related field of systems biology, said Dr. Venter’s report was “a really marvelous kind of technical feat” but just one of a long series of steps required before synthetic chromosomes could be put to use in living cells.
“It’s a really worthy accomplishment, but I hope it doesn’t get hyped to be more than it is,” Dr. Hood said.
One reason for Dr. Venter’s optimism is that he says his institute is close to synthesizing from simple chemicals an entire genome, 580,000 DNA units in length, of a small bacterium, Mycoplasma genitalium. If that genome can be made to take over a bacterium using the method announced today, Dr. Venter should be able to claim that he has made the first synthetic life form. The bacterium would be identical to nature’s version, but would demonstrate how precise control could be achieved over every aspect of the machinery of living cells.
Biologists have long been able to move useful genes into bacteria and other organisms in a process called genetic engineering. The idea of synthetic biology is to carry out genetic engineering in a more extensive and systematic way.
Synthetic biologists, who held their third annual meeting in Zurich, Switzerland, this week, hope to create biochemical processes and then choose the gene sequences that will direct these processes and build the DNA from scratch. The scientists’ goal is to select and reorder the genetic machinery developed by evolution just as an engineer might assemble an efficient circuit board from existing components.
Dr. Venter hopes to lay the basis for a new approach to synthetic biology by first synthesizing whole genomes in the laboratory and then making them take control of, or “boot up,” a living cell. His new report accomplishes the second of the two steps, at least in Mycoplasma. His team, which includes a distinguished biologist, Hamilton Smith, purified the full DNA from one kind of Mycoplasma and showed that it could take control of another, making the host cell switch over to producing proteins specified by the inserted DNA. Dr. Smith said he was not sure whether the inserted genome destroyed the host genome or just made the cell divide, assigning the two genomes to different daughter cells.
Booting up cells with new genomes is a major limitation in synthetic biology, Dr. Venter said. With that hurdle now crossed, it will be possible to “design cells in future to manufacture new types of fuel and break our dependency on oil and do something about carbon dioxide going into the atmosphere.”
Dr. Hood, co-founder of the Institute for Systems Biology in Seattle, said the next step on Dr. Venter’s agenda, putting a functional synthetic genome into an organism, would be more significant.
“Synthesizing a whole chromosome and getting it to function will be a really remarkable step that will be much closer to the golden vision of creating new organisms,” he said.
George Church, a leading systems biologist at the Massachusetts Institute of Technology, said that the new report was “good science” but that it had been achieved in an organism, Mycoplasma, that is unsuitable for industrial uses. As for Dr. Venter’s assertion that his result is “an enabling technique,” Dr. Church said, “The door to synthetic biology is already wide open, and people are pouring through it.”
Dr. Church agreed with Dr. Venter’s forecast that synthetic biologists could produce fuels within 10 years. He noted that LS9 Inc. in San Carlos, Calif., was producing laboratory amounts of petroleumlike fuels in bacteria.
Dr. Venter is more colorful and less publicity shy than most academic biologists. But he has many solid achievements to his credit. They have so far been in sequencing, or decoding, genomes.
He pioneered methods for sequencing the first bacterium, Haemophilus influenzae, and raced the government to a draw in sequencing a draft version of the human genome in June 2000. Though unable to produce a complete version because he was forced out of Celera, the company he headed, Dr. Venter devised a better method than his government-supported rivals, one that has become the standard way to sequence genomes.
Dr. Venter has always sought academic credit by publishing his results in scientific journals and now directs a nonprofit research laboratory in Rockville, Md., the J. Craig Venter Institute. But he has another foot firmly planted in the commercial world. He has set up, and the Venter Institute largely owns, Synthetic Genomics, whose goal is to make alternative fuels to oil and coal. He has also applied for far-reaching patents on the uses of synthetic life forms.
The report today may be less significant if his research team is unable to repeat the success in more useful organisms than the Mycoplasma bacterium. Dr. Church said a quite similar experiment with Escherichia coli, a standard laboratory organism, was accomplished in 1958 by two French scientists, François Jacob and E. L. Wollman.
Dr. Venter’s next goal, creating the first synthetic bacterium, could have broader interest. At the Zurich meeting this week, his colleague Dr. Smith reported progress in synthesizing a Mycoplasma genome from scratch saying, according to a Nature blog, that he had already constructed it in the form of 101 long DNA fragments. When stuck together, they would comprise the whole genome.
Dr. Venter said Dr. Smith had traveled at least that far.
“We are weeks to months away from booting up that chromosome,” Dr. Venter said.
The longest piece of DNA synthesized so far, he explained, is 35,000 units long, whereas the Mycoplasma genome or chromosome is 580,000 units.
The synthetic Mycoplasma, if the Venter team is successful, would be identical to the natural kind and should present no conceivable hazard. But synthetic biology is a technique with potentially far-reaching consequences like environmental effects and misappropriation by terrorists. In addition, the ability to synthesize living organisms may provoke philosophical comment.
Scientists have taken the initiative in assessing the effects with the hope of staying far enough ahead of events to avoid regulation. A report on the possible dangers of synthetic biology is being prepared for the Sloan Foundation by scientists at M.I.T., the Venter Institute and the Center for Strategic and International Studies.
Dr. Venter said that he was filing for many more patents and that his team was trying to scale up methods of synthesizing DNA and “watermarking chromosomes in fun ways to make it unequivocal they are manmade.” He said he had no plans to use Mycoplasma as a production organism and was developing other bacteria.
“This is an area where things will happen at an exponential pace,” he said. “Once people know you can do chromosomal transplants, that will trigger new approaches.”
Others may already have raced ahead using old-fashion genetic engineering to put new genes into standard microbes. Steve delCardayre, vice president for research at LS9, said it had developed a strain of standard industrial microorganism that produced hydrocarbons from treated agricultural waste.
The present strain, which Dr. delCardayre called adolescent, is “very close to meeting an economic threshold” and will be tested in a pilot plant early next year. The youthful microbe already produces an ethanol-like product, at 65 percent of the cost of corn-derived ethanol, Dr. delCardayre said. LS9 fuels, he added, will meet the same diverse needs as petroleum does, can be transported in existing pipelines and be used in existing vehicles.
Correction: June 30, 2007
A picture caption yesterday with a front-page article about a scientific advance in the effort to create synthetic life forms misidentified the scientist pictured. He is J. Craig Venter, who directs the institute that made the breakthrough, not Hamilton Smith, a biologist who worked on the project. The article also misstated the educational affiliation of George Church, a biologist who commented on the research. He is at Harvard Medical School, not M.I.T.
the point i was making about avanir was not that it was two generics but that when you combine drugs the fda starts looking for the safety of each drug.
they the worry that the combination may actually cause the toxicities to be synergistic.
I believe that is why they are concerned about Trexima for migraine. I don't know if the drug will get approved because naproxin has some cardio effects as does immitrex and the fda may be concerned that combining the drugs may make the cardio effects worse. Even if it didn't show up in the trial you can't prove the negative and the fda may want more trials.
I am posting on a message board not publishing an article.
your article on crxx
For all the company’s promise and attention, though, it is far from clear that any of CombinatoRx’s drugs will reach the market. Three of the eight drugs that made it to clinical trials have since been dropped — including one on Thursday — because they did not work well enough in people, despite their effectiveness in the cell-based laboratory tests.
did they go from cell based tests directly into humans. I can't believe that. If it was tested in animals why doesn't he mention that the combinations were effective in animals. If the company isn't doing animal tests their data isn't worth a dime and neither is the company.
T
Steroids are used to treat arthritis, but they have undesirable side effects. Adding an anticoagulant seems somehow to amplify the steroid’s desirable effects, allowing use of a very low dose with greatly reduced side effects, Mr. Borisy said. The drug has shown promise in early clinical trials.
Combinations of existing drugs can enter clinical trials more quickly than totally new medicines because much is already known about their toxicity and how they behave in the body.
But some industry executives say the combinations risk encountering regulatory problems downstream. They say the Food and Drug Administration must be persuaded that a combination offers a real benefit to patients and is not just a commercial gimmick, because each additional drug a patient uses can raise the risk of safety problems, in part from interactions between the drugs
the 3 paragraphs above perfectly explain the Avanir rationale for combining quinidine and dextromethorphine. Quinidine is already approved but causes qt interval elongations. Dextromethorphine is over the counter cough medicine with a very short half life. lower than the approved dose of quinidine increases the dextro half life.
After the studies are done the fda now wants Avanir to reduce the quinidine even more. If they do that will the drug even work, do they have to increase the amount of dextromethorphine? It is back to the drawing board. I was thinking the CRXX was getting cheap but after reading this article and seeing what happened to Avanir, I wouldn't touch it with a ten foot pole.
The recent history of pharmacological treatments have not gone well. The pharmaceutical treatments do cause significant weight gain but side effects have been the rule rather than the exception. First there was Phen-Fen. While effective cardiologists at Mayo clinic observed and reported that it caused heart valve changes .
he is an idiot. he mean't weight loss.
Form 8-K for STAAR SURGICAL CO
I am not in the stock right now but it has gotten very cheap. I have a one on one with the ceo tomorrow. I may have to ask him if he is retarded
27-Jun-2007
Other Events
Item 8.01 Other Events
On June 26, 2007, the Company received a Warning Letter from the U.S. Food and Drug Administration ("FDA") citing four areas of noncompliance noted during an inspection of the Company's clinical study procedures, practices, and documentation related to the Toric Implantable Collamer Lens ("TICL"). The inspection was conducted by the Bioresearch Monitoring Program of the FDA Office of Regulatory Affairs ("BIMO") between February 15 and March 14, 2007. The Warning Letter notes deviations from FDA regulations that occurred between 2002 and 2005, which were among eight matters observed in the Inspectional Observations on FDA Form 483 received by the Company at the conclusion of the BIMO inspection. The Company described these observations in its Current Report on Form 8-K filed with the SEC on March 14, 2007, and provided the FDA with a written response to the Inspectional Observations on April 5, 2007.
Noting that the FDA staff found some of the Company's responses in the April 5 letter inadequate, the Warning Letter has instructed the Company to provide additional corrective and preventative action plans and further information on some of the corrective actions described in the Company's April 5 letter. The Company expects to provide its written response on or before July 18, 2007, the deadline for response stated in the Warning Letter.
David Bailey, President and CEO of STAAR Surgical Company, is expected to discuss the Warning Letter during a webcast presentation at the Jefferies Healthcare Conference, scheduled for 1:00 pm Eastern Time on Thursday, June 18, 2007. The webcast may be publicly accessed through the Investor Information page of the Company's website at www.staar.com.
The Company has revised key processes involved in initiating and monitoring clinical studies, and anticipates that an enhancement of its processes and procedures, a detailed discussion of their intended corrective effect, and a satisfactory projected completion date will adequately address the concerns of the FDA expressed in the Warning Letter. However, if the FDA does not find the Company's response adequate, further administrative action could follow, including actions that could delay approval of the TICL or restrict the Corporation as a sponsor of clinical investigations.
BIMO inspections are part of a program designed to ensure that data and information contained in requests for Investigational Device Exemptions (IDE), Premarket Approval (PMA) applications, and Premarket Notification submissions
(510k) are scientifically valid and accurate. Another objective of the program is to ensure that human subjects are protected from undue hazard or risk during the course of scientific investigations. While the past procedural violations noted in the Warning Letter are serious in nature and require comprehensive corrective and preventative actions, the Company does not believe that these nonconformities undermine the scientific validity and accuracy of its clinical data, or that human subjects were subjected to undue hazard or risk.
The description of the Warning Letter in this Report is qualified in its entirety by reference to the text of the Warning Letter, a copy of which is attached to this Report as Exhibit 99.1 and is incorporated herein by this reference.
All statements in this report that are not statements of historical fact are forward-looking statements, including statements about actions that may or may not be taken by the FDA, statements of the Company's expectations or belief and any statements of assumptions underlying the foregoing. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the FDA's discretion in determining the adequacy of the Company's response to the Warning Letter, the FDA's discretion to issue additional warning letters or take other regulatory action as a result of inspectional observations or other data received by the agency, the risk that for serious violations of regulations related to clinical procedures FDA enforcement actions may result in penalties, injunctions or other measures, and the general risks to the Company's business that result from FDA regulation, which are described in greater detail in our Quarterly Report on Form 10-Q filed on May 9, 2007, under the headings "Risk Factors - We are subject to extensive government regulation, which increases our costs and could prevent us from selling our products," and "Risk Factors - FDA compliance issues have harmed our reputation, and we expect to devote significant resources to maintaining compliance in the future," and the other risks describe in the Risk Factors section of that report and detailed from time to time in our other reports filed with the Securities and Exchange Commission. STAAR Surgical Company assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so.
--------------------------------------------------------------------------------
bentley
I was an investor in 2000 and one of the reasons was this insulin program. I can't believe it has taken this long to get data on 12 people. they should be ashamed of themselves. the patent on that cpe 215 I think only runs through 2009 or so. The time they wasted they cannot get back. Even if it gets approved I don't know where they will get a patent life.
Stem cells could treat diabetes
Early-stage study in mice shows potential of adult blood in yielding insulin-producing stem cells; treatment could side-step ethical debate over embryonic cells.
By Aaron Smith, CNNMoney.com staff writer
June 25 2007: 11:42 AM EDT
it is not against the law to do research on embryonic stem cells. The government just doesn't pay for the research. I agree with that, not because of morality but because the government would just be throwing money at crap. Adult stem cells and umbilical cord stems cells will work better and the funding can come from VC's and investors. I don't need my tax dollars going to causes that fit the Democratic or Republican coffers.
CHICAGO (CNNMoney.com) -- Early-stage studies in mice have shown that adult blood could be a richer source of insulin-creating stem cells than fertilized eggs, according to Dr. Yong Zhao, assistant professor at the University of Illinois.
If these test results are repeated in humans, it could possibly lead to a diabetes treatment that would avoid the controversy surrounding embryonic stem cells.
Video More video
President Bush used his veto pen again on a stem cell research bill. CNN's Ed Henry reports.
Play video
Dr. Zhao, who presented his findings at the annual conference of the American Diabetes Association, emphasized the early-stage, experimental nature of his study results, which were funded by his Chicago-based university.
Dr. Zhao said he intended to seek funding from the National Institutes of Health so he could begin human studies. But even if human studies are successful, potential treatments are years away. Dr. Zhao said it could take five years just to complete the first phase of human studies.
Merck sees long-term benefits from Januvia
In his animal studies, Dr. Zhao drew blood from diabetic mice, extracted insulin-making stem cells from the blood, condensed the stem cells into a solution and then injected that back into the mice.
As a result, the diabetic mice maintained healthy blood-sugar levels for three months without any other treatment, the scientist said.
Diabetics have difficulty producing their own insulin, which is necessary to convert blood-sugar into energy. Without insulin, diabetics often suffer dangerously low blood-sugar levels known as hypoglycemia. Diabetics control blood-sugar levels by injecting insulin, or taking various drugs like Merck's (Charts, Fortune 500) Januvia, or Byetta from Eli Lilly & Co. (Charts, Fortune 500) and Amylin Pharmaceuticals. Novo Nordisk is the world leader in insulin production.
In his human studies, Dr. Zhao intends to use adult blood and blood taken from umbilical cords. Since he does not plan to use embryonic stem cells taken from eggs fertilized in vitro, the scientist would be exempt from the current restrictions on federal funding.
President Bush vetoed a Congressional bill on June 20 that would have lifted restrictions on federal funding for embryonic stem cell research. This was Bush's second veto regarding stem cell research since he took office.
Bush opposes the use of fertilized eggs for research on pro-life grounds. But many medical experts believe that embryonic stem cell research could eventually lead to treatments for crippling traumatic injuries, like severed spines and brain damage, or debilitating diseases, like Parkinson's and Alzheimer's.
Diabetic nerve damage breakthrough seen
Biotechs involved in the fledgling industry for stem cells are engaged primarily in research, with few products on the market. Geron Corp. (Charts) and Advanced Cell Technologies focus on embryonic stem cells. Cytori Therapeutics (Charts), Aastrom Sciences (Charts), Osiris Therapeutics (Charts) and Stem Cells (Charts) Inc. derive stem cells from adult tissue.
Dr. Zhao said adult humans are a richer source of insulin-making stem cells than fertilized eggs. He found that 7 percent of human embryonic stem cells are capable of making insulin, compared to 70 percent of stem cells from adult human blood and umbilical cord blood.
"Application of these stem cells is very easy to access, culture, expand, and safe, without any ethical issues and immune [system] rejection," said Dr. Zhao, in an email to CNNMoney.com "Therefore, these stem cells possess much more advantages that application of embryonic stem cells."
As a potential treatment, the scientist said blood would be drawn from human diabetics. Then, the insulin-making stem cells would be extracted from the blood and injected back into the diabetics. The patient's own blood would be used because blood from another donor has a strong chance of being rejected.
Stephen Brozak, biotech analyst for the investment research firm WBB Securities, said the study "has the potential to advance science," but the potential was hard to gauge because the study is "early, early stage."
"It's an interesting scientific discovery," said Brozak. "That's as far as I would go with it."
Correction: An earlier version of this story incorrectly referred to hypoglycemia as high blood sugar, hypoglycemia is low blood sugar. CNNMoney regrets the error. (Back to story)
Drug makers take aim at diabetes
Stem cell breakthrough a bust on Wall Street
MS Trial Alert:
Clinical Trial of Sex Hormone Estriol Recruiting Women with MS to Participate
http://www.nationalmssociety.org/site/PageServer?pagename=HOM_RES_research_2007jun8
it is pretty amazing that Pipex is getting this trial done by the MS association. All they are supplying is the estriol and placebo
here is a story on an young lady taking the drug
This study is using estriol with copaxone but the prior studies were using estriol by itself
http://abclocal.go.com/kabc/story?section=health&id=5227091
June 8, 2007
In the first effort of its kind in MS, UCLA neurologist Dr. Rhonda Voskuhl is leading a team of investigators at seven medical centers to conduct a two-year, controlled clinical trial of a sex hormone added to standard therapy to treat MS. Investigators plan to administer either oral estriol along with Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries Ltd.) or Copaxone plus inactive placebo to 130 women with relapsing-remitting MS. If successful, this clinical trial could lay the groundwork for a larger, definitive trial that could lead to a new treatment option for women with MS.
Its results may also have implications for women with other autoimmune diseases, such as rheumatoid arthritis. Women with relapsing-remitting MS interested in the possibility of participating in the trial should consult with their physicians or contact one of the medical centers listed below.
This study, costing more than $5 million, is being funded by the National MS Society in partnership with the Society’s Southern California chapter and the National Institute of Neurological Disorders and Stroke. Pipex Pharmaceuticals, Inc., has manufactured oral estriol tablets as well as matching placebos, and is providing them for this clinical study.
Stems from National MS Society’s Gender Initiative
MS affects women two to three times as often as men. This and other gender differences became the topic of a special, five-year research initiative by the National MS Society. Among findings from the 50 projects supported through this $10 million initiative was the possibility that the female hormone estriol may help protect against the immune attacks that underlie MS. Estriol levels rise significantly during pregnancy, when most women’s MS disease activity declines. This led some to suspect that estriol may be responsible for this easing of symptoms during pregnancy.
According to Dr. Voskuhl, in using estriol they “aim to simulate some of the disease protection offered by pregnancy. We are very enthusiastic about this new agent since it has decades of known human safety experience throughout Europe and since it will be given as a pill, not a shot.”
Dr. Voskuhl (University of California, Los Angeles) and others explored this lead in mice with MS-like disease, and later, with National MS Society support, Dr. Voskuhl conducted a small, early-phase trial of estriol in 12 women with MS. The results showed decreases in disease activity during estriol treatment in women with relapsing-remitting MS.
Trial Details/Eligibility
The two-year study is a double-blind, placebo-controlled trial that will take place at seven sites in the U.S. (listed below). Investigators will administer estriol in pill form to women between the ages of 18-50 who are fairly newly diagnosed with relapsing-remitting MS. The oral treatment will be given in combination with subcutaneously injected Copaxone, a standard treatment for MS, for 2 years. The team is evaluating effects of the treatment combination on relapse rates and several clinical and magnetic resonance imaging measures of disability progression.
Seven Centers Recruiting Patients
The estriol trial is taking place at seven medical centers across the U.S. Women between 18-50 who are newly diagnosed and are interested in participating in this clinical trial should contact the nearest site to discuss their eligibility:
Institution
Coordinator
Phone
University of California, Los Angeles
Mike Montag
310-825-7313
Washington University,
St. Louis
Joanne Lauber, RN
314-362-3371
Univ. Med. & Dent. of New Jersey, New Brunswick
Yaritza Rosario
732-235-7099
Ohio State University, Columbus
Lisa Hafer
614-293-7877
University of Chicago
Mildred Valentine
773-702-9812
University of Utah, Salt Lake
Julia Klein
801-582-1565 x2014
Wayne State University, Detroit
Elisabetta Levcovici
313-966-5068
article in businessweek that doesn't mention Pipex
http://www.pipexpharma.com/press/businessweek_Trimesta.pdf
-- Research and Clinical Programs
Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
* To view or print a PDF file, Adobe Acrobat Reader is required.
from an investment perspective data on depo's formulation of gabapentin are due out soon. It strikes me as a low risk event given the proven efficacy for neurontin in post-herpetic neuralgia. I'm just trying to figure out if the street will care much based on the commercial potential of the product
Xenoport has a prodrug of gabapentin lisensed to glaxo
xenoport has a billion dollar market cap. their drug has more side effects than depo's. xnpt is in trials for restless leg.
depomed licensed a patent for hot flashes. Depomed's gabapentin gr will be on the market before xnpt.
valuation wise which one is cheaper
A very timely conference
I wonder what the turnout will be
Susquehanna Financial Group’s
Toll-Like Receptor Conference
Thursday, July 12, 2007
Conference Details
What:
Navigating the Toll Road: Understanding the Next Paradigm in Immune Modulation and its Implications in Cancer, Autoimmune and Infectious Disease
When:
Thursday, July 12, 2007
10:00am – 1:00pm
Where:
InterContinental, The Barclay NY
111 East 48th St. (Lexington/Park Ave)
New York, NY 10017
212-755-5900
The SFG Biotechnology Team is hosting this unique opportunity for investors to learn about the therapeutic potential of one of the newest and most cutting edge classes of drugs, the toll-like receptor (TLR) modulators. Hear from Key Opinion Leaders from academia as well as representatives from the industry.
Gain insight into:
The pros and cons of TLR immunomodulation compared to classical immunmodulatory pathways (cancer vaccines, interleukins and interferons)
The differential effects of targeting TLR7, TLR8 and TLR9
How formulation and pharmacokinetics affect the level of stimulation/inhibition of TLRs
The utility of targeting TLRs to treat cancer, autoimmune and infectious diseases
The advantages and disadvantages of using oligonucleotide vs. small molecule-based targeting
ATTENDING COMPANIES & EXPERTS
Anadys Pharmaceuticals
President, Pharmaceuticals, Stephen Worland, PhD
Coley Pharmaceutical Group
President & CEO, Robert Bratzler, PhD
Senior VP, R&D & Chief Scientific Officer, Arthur Krieg, MD
Dynavax Technologies Corporation
VP, Chief Business Officer & General Counsel, Michael Ostrach
VP & Chief Scientific Officer, Robert Coffman, PhD
Idera Pharmaceuticals, Inc
CEO & Chief Scientific Officer, Sudhir Agrawal, DPhil
President, Robert W. Karr, MD
Formal Invitation to follow with agenda, presenters and registration details.
To register please contact your SIG Salesperson or
Lori Aversano at Lori.Aversano@sig.com
speaking of tickers symbols
man financial just went public with the symbol MF
When pipex symbol PP is issued
now when the stock goes down people can say my PP hurts
alth
hedge funds were waiting for this to fail so they could buy the pipeline
Encysive's Date With Destiny Approaches
By Brian Lawler June 15, 2007
this does into detail of how they could have met the SPA endpoint of efficacy but how the FDA may not see it that way
Today, specialty drugmaker Encysive Pharmaceuticals (Nasdaq: ENCY) is likely to receive a regulatory decision in the U.S. for its lead drug, pulmonary arterial hypertension (PAH) treatment Thelin.
Encysive has a spotty record when it comes to bringing Thelin to market. The drug failed to receive marketing approval in the U.S. after the FDA issued two approvable letters for the compound last year. Despite these stumbles, Thelin has been approved for marketing in locales like the European Union, Canada, and Australia.
Encysive finished a full response to the FDA's last approvable letter in December and is now awaiting a reply from the agency. Let's consider the evidence and see if we can get a better handle on the likelihood that Thelin gets final approval in Encysive's third attempt.
Is another approvable letter on its way?
Betting against the FDA is generally not a good idea for investors. Here are statements from Encysive's past press releases about Thelin (emphasis mine):
The action letter contains concerns and observations that must be satisfied prior to achieving approval, including a request for additional clinical trial work.
The FDA acknowledged that the unresolved item is a matter of judgment and expressed an openness to consider new arguments to address this remaining item (in the approvable letter). The FDA again offered the alternative of conducting additional clinical work.
If the FDA is asking for more studies of Thelin and Encysive hasn't done additional clinical trial work besides the ongoing long-term study, this does not do much to instill confidence in Thelin's approvability in the near term.
What could that last approvable letter issue be? There are several theories floating about. One, proposed by a very astute reader of mine who did in-depth research on the subject, is that the FDA likely issued the approvable letters and called for more clinical trial work as a result of sloppy record-keeping by at least one of the investigators in a pivotal phase 3 study of Thelin.
This warning letter, likely sent to one of the investigators running the main Thelin efficacy and non-inferiority study against Actelion's PAH treatment, calls into doubt the accuracy of the data Thelin has produced in this study.
The exact name of the study the warning letter refers to is partially redacted in the FDA correspondence. If you look at the official title of this Thelin study and the partially redacted name of the study in the warning letter, it's easy to make the connection that the warning letter is likely about this phase 3 Thelin study.
Some of the deficiencies for which the FDA cited this investigator included a failure to "maintain adequate records of the disposition of the drug, including the dates, quantity, and use by subjects" and a failure to "follow the protocol-specified guidelines" for one of the main efficacy endpoints of a study.
When Thelin failed to gain regulatory approval by the FDA last year, I was very surprised, considering that the drug appeared to have successfully met a Special Protocol Assessment (SPA) that Encysive had with the FDA. If this theory about bad record-keeping holds, it could explain the disconnect between the drug's two approvable letters and its apparent success on the SPA objective.
The sloppy data theory may also explain why the company has been so tight-lipped about the reason for the approvable letter. For example, having to say that the FDA is unhappy about the accuracy of data from one of your clinical trials wouldn't do wonders for your stock's price, which is important when you need a higher stock price to limit dilution from the share offering that keeps the company running. These types of issues could also be used as ammunition in the marketing war that is sure to ensue between all the different PAH compounds.
This theory could also explain the FDA's call for more clinical trial data despite Encysive amassing the largest number of patients in an initial PAH regulatory filing.
All this is just speculation as to the reason for the Thelin approvable letter. There is still the chance that Encysive has rectified the one outstanding issue that has been holding up the drug's U.S. marketing. But without knowing what the last approvable letter issue is, it's incredibly difficult to place any confidence in Encysive's abilities to assuage the FDA's hesitance over Thelin, especially now that the quality of its clinical trials (and management's forthrightness) may be in doubt.
Final thoughts
It's worth mentioning that the June 15 Prescription Drug User Fee Act, or PDUFA, date for Thelin is just the goal for when the FDA will make a decision on the compound. It's not unusual to have to wait another couple of days, or even longer, for a regulatory decision. Hearing no word on a compound shortly after the PDUFA date is generally not something investors should worry about, and it doesn't decrease the odds of a drug's chances for approval.
Adding spice to the FDA regulatory decision is that a very similar compound, Ambrisentan from Gilead Sciences (Nasdaq: GILD), has its PDUFA date scheduled for Monday.
If the data can be relied upon, anyone who says that Ambrisentan has produced better efficacy or safety data than Thelin just hasn't looked at the efficacy and safety data produced for both compounds throughout all the clinical trials. While no head-to-head studies have been completed yet (since neither drug is approved for marketing), Thelin has produced better efficacy and safety data than Ambrisentan in some of its studies; the situation is reversed in others.
Nonetheless, if Ambrisentan and Thelin both get approved in the U.S., then tiny Encysive will be at a huge disadvantage in the marketing war that will occur between the drugs, because of the size and experience of Gilead's sales staff.
One important aspect of biotech investing is that it almost always pays to make your bets where the preponderance of evidence lies. In the case of Thelin, with all the evidence out there, I'm highly doubtful on its chances for approval when the FDA makes a decision on the drug this time. This doesn't necessarily mean that the stock is overvalued at these levels, but I wouldn't count on seeing Thelin marketed in the U.S. any time soon.
The FDA encouraged the Company to conduct an additional study to demonstrate the drug's effectiveness in exercise capacity as measured by change in six-minute walk distance.
This is an even more specific part of the press release concerning the issue the FDA wants Encysive to pursue in additional trials. To be honest I find it hard to believe that this is the issue that the FDA was concerned with.
below is a statement from the Encysive press release regarding the Canadian approval.
In the STRIDE program, THELIN 100 mg was shown to significantly improve exercise capacity, as measured by improvement in six-minute walk distance, including in patients with connective tissue disease. THELIN was also shown to reduce patients' PAH symptoms (improvement in WHO/NYHA functional class) and improve PAH hemodynamic status. Survival of patients was 96% at one year in the overall patient population and 98% in patients with PAH secondary to connective tissue disease.
Encysive seems to have paid a price for accepting people with connective tissue disease in their trials because they are harder to help than the other patients. Even though they showed an improvement the total improvement was weighed down by that group.
Evotec(evt.de) this afternoon announced that its lead drug EVT201 (a partial GABA agonist) reported positive results in its Phase II proof of concept (POC) study to treat patients with chronic primary insomnia (timing in line with our expectations). The two doses of the drug investigated met both co-primary endpoints of Wake After Sleep Onset (WASO) and Total Sleep Time (TST), as well as several key secondary endpoints. Both doses were also shown to be safe and well tolerated with no serious adverse events. A second Phase II study to treat 135 elderly patients with chronic insomnia is expected to readout in Q4:07/Q1:08.
2. â– In the pre-specified intention-to-treat analysis of the study, both EVT201 doses (1.5 & 2.5mg) successfully met both co-primary endpoints with a high degree of statistical significance: WASO (p<0.001) and TST (p<0.001). Furthermore, WASO during the second half of the night was also significantly (p<0.001) reduced, showing that EVT201 efficaciously maintains sleep throughout the night. Both doses of the drug also met several key secondary endpoints: latency to persistent sleep (p<0.001) and subjectively assessed quality of sleep (p<0.001). EVT201 showed no effect on subjectively assessed residual next day sedation and only a small decremental effect on the digital symbol substitution test (DSST) assessed at nine hours post dosing. Furthermore, the data showed that EVT 201 did not impair slow wave sleep unlike many benzodiazepine full agonists. The analysis of other secondary endpoints is still ongoing.
3. â– Our view: In our opinion, on the basis of these results EVT201 could potentially have a competitive profile to effectively compete with the current drugs on the market to treat insomnia. The Phase II POC data shows that the drug is effective in both inducing and maintaining sleep, while also avoiding significant next day hangover effects in patients. Evotec aims to seek a suitable licensing partner for the drug in 2008.
4. ■Valuation: We rate Evotec Outperform with a target price of €5. Following the divestment of the tools & technology element of the business (in Dec 06), we believe Evotec now offers investors a profitable, cash generative services business, a healthy cash balance (ca €66m in cash and cash equiv. as of 31 Mar 07) and a credible and growing pipeline. In our view, the company’s current stock price factors in little value for the pipeline and we believe investors will reappraise this view post EVT201’s positive Phase II results.
research team
CS Biotechnology, Biopharmaceuticals & EMEA Generics Team
ENCY/GILD - How does the FDA approve a drug with significant safety issues, but fails to approve another drug for the same indication for failure to demonstrate effectiveness when three regulatory agencies have not questioned the efficacy data? The agency even admits that the data indicates an improved exercise tolerance. Somethings wrong with this picture.
evidently there was something in Encysive's data as far as safety that the FDA didn't like. I have no idea what it was and Given claimed he wasn't going to tell for compeititive reasons. That made sense to me. The fact the Gilead was approved and doesn't seem to have the same issue leads me to believe it wasn't a class effect but something different about thelin in particular and he was lying.
Again I don't know what the problem is and I don't know if it will ever come out. I can't see European doctors prescribing Thelin without knowing what the issue is.
Zimulti panel was concerned about depression related to suicidal thoughts.
Cannaboids create the feeling of Euphoria and the "munchies".
A drug to inhibit the munchies might also lead to depression and suicide.
I don't think that is an enormous leap to make when you are considering the approval of a drug that in a clinical trial has this side effect.
If Vioxx taught the anybody anything it is that safety will be a major concern in the minds of people reviewing the risk benefit of a drug.
tannenbaum a director of crtx
sold half his position the day after the pdufa date. he was not allowed to sell on the pdufa date. Instead of just selling it all he has been selling pieces.
It apprears that he has 196 thousand left. he signaled to the market that he wants out so people were rushing out before him
I don't think you can do badly buying in now.
Mpm has distributed shares in the past. I wouldn't be surprised if he distributed two million shares to his fund investors the day of approval. that might explain all the selling.
I may buy some tomorrow
Bullish insider buy at Depomed
The cfo had options expiring at 5.25 on 06/16 and the stock is trading at 4.32
why not let the options expire and buy on the open market. He must have inside information causing a blackout in his purchase but he wants to own the stock in the short term.
http://biz.yahoo.com/t/90/6461.html
idix
dosing is causing the delay. they want to see if they can get by with higher dose than 200
dead money for a while in any case
the idix downgrades were because of the delay in start of phase 3 trial
prw
look at the heading of the last press release.
it was written in way to make it look like they were filing in NDA when in reality I think they are just filing an Ind
you be the judge