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TCT/CONR
Now, if they could just get that pesky patent infringement lawsuit out of the way....
http://home.comcast.net/~dhhinc/BSX_C_102405.pdf
“Conor had a powerful showing in its “first” TCT, as its stent is considered to be a safer DES
alternative because of its bio-absorbable polymer and low drug dose. Conor presented
consistent follow-up data from its COSTAR I trial, an Indian trial with complex patients,
with no change between 4-months and 12-months in TLR (1.8%) or MACE (7.5%) in the
10ug/30 day arm. Conor also presented data from a second arm of EuroSTAR, also with
clean results. In both of the trails presented, Conor maintained its clean safety record with
no instances of post-Plavix thrombosis.”
“On Thursday night, Conor held a symposium reviewing its clinical programs and plans for
commercialization in different markets. Despite the wind-down of TCT, Conor had a room
filled with both American and European docs, and a slew of competitors snapping photos.
Physician excitement is mounting, and a number of European interventionalists we spoke
with were eagerly awaiting the chance to get their hands on the product. We expect that CE
mark could come at anytime in the quarter. Perhaps the most impressive part of the entire
evening was that doctor most closely associated with the TAXUS program, Gregg Stone, chaired the evening and likened CoStar to a product that could perhaps be the answer to the
safety issues associated with currently marketed DES.”
Not something I can comment about right now.
NABI
In the course of my day job, I spend substantial time speaking with key opinion leaders in various therapeutic areas. I recently had an opportunity to speak with prominant physicians in the anti-infective field. Never one to waste an opportunity, I asked about StaphVax. "Revolutionary" was one choice quote.
I believe that StaphVax will become a standard vaccine for elderly patients, particularly those at high risk for surgical intervention. Provided the results of the second phase III are as good or better than those of the first phase III, which they should be, StaphVax should be very successful.
I won't get into NicVax--I'm very excited about the potential there, as well.
John
io_io,
I have a recent 300-page commercial report on MS if you (or anyone else) wants a comprehensive overview of the market.
I have it becuase I recently did some consulting work for an MS therapy that is already on the market.
John
I hope you realize I posted the FMVR article becuase it was funny, not becuase I was seriously considering purchasing shares in a internet beauty supply/virology outfit.
VSBS targets herpes viruses
That's Venus Beauty Supply, Inc, now FermaVir Research.
***************************************
Venus Beauty Supply, Inc. Announces Acquisition of FermaVir Research, Inc, Closing of Placement, and Name Change
Tuesday August 23, 7:30 am ET
NEW YORK--(BUSINESS WIRE)--Aug. 23, 2005--Venus Beauty Supply, Inc. (OTCBB:VSBS - News) today announced that its 35.28 stock split and name change to "FermaVir Pharmaceuticals, Inc." became effective August 22, 2005, as anticipated. Beginning with the opening of the OTCBB on August 23, 2005, the company's common stock will be quoted under the symbol "FMVR."
ADVERTISEMENT
FermaVir is a development stage biotechnology company that has licensed patents for a series of compounds for the treatment of viral diseases including compounds for the treatment of varicella zoster virus ("VZV"), the causative agent for shingles and chickenpox and human cytomegalovirus ("CMV"), a member of the herpes virus group which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores) and genitalis (genital herpes). FermaVir is currently performing preclinical studies on its compounds in order to select a clinical candidate for development for the treatment of shingles. In addition, FermaVir intends to identify from its proprietary anti-viral compounds, a clinical candidate for the treatment of CMV infections in transplant patients. FermaVir is also currently seeking other opportunities and technologies for in-licensing from academic, research institutions and commercial sources which would complement and enhance its business.
More Information regarding the company and its FermaVir Research, Inc. subsidiary can be found in the company's Form 8-K Report filed with the Securities and Exchange Commission on August 22, 2005.
Contact:
FermaVir Pharmaceuticals, Inc.
Geoffrey W. Henson, 212-375-2630
Could someone please explain to me what this means? I have never seen a filing for an "offering by selling shareholders."
Randy--what makes you think the selling happened already?
John
I agree with gfp927z--I would LOVE to hear other people's strategies, and I would be happy to share mine when I have time for a longer post.
CONR
Crashing The Stent Party
Conor Medsystems is trying to take on Goliaths J&J and Boston Scientific
http://yahoo.businessweek.com/magazine/content/05_44/b3957121.htm
Conor Medsystems Inc. (CONR ) is developing a new breed of stent that may have the power to swipe large swaths of business from rivals such as Johnson & Johnson (JNJ ) and Boston Scientific Corp. (BSX ) But the company's chief executive officer, Dr. Frank Litvack, has a controversial past, and there are thorny questions about potential conflicts of interest and litigation that could torpedo its fortunes.
Stents, especially the ones that are coated with drugs to prevent blockage by scar tissue, are one of the most lucrative areas of medicine. The market for such "drug-eluting" devices is expected to reach $5.1 billion by the end of this year, up from $3.9 billion in 2004, according to CIBC World Markets Corp.
J&J and Boston Scientific are the two gladiators in this field, but many physicians are keeping a close eye on Conor's product as well. Although the stent's rate of restenosis, or recurrence of arterial blockages, has been about the same as existing devices, some doctors say Conor's is easier to implant and may prove safer and more effective.
On Oct. 21, the Menlo Park (Calif.) company will release new data from clinical trials at a top cardiovascular meeting in Washington. "If it came out in the U.S. right now, the market would swing," says Dr. Dean Kereiakes, a professor of clinical medicine at Ohio State University who is serving as a co-principal investigator for Conor's U.S. clinical trial.
Yet Conor's technology is difficult to assess, in part because some doctors helping to evaluate the devices have received stock options from the company. Among the 14 doctors who sit on Conor's scientific advisory board and are participating in clinical trials of its stent, three received consulting fees and five have received options, according to documents obtained by BusinessWeek.
Such relationships are a growing source of concern in the medical-device industry, drawing increasing scrutiny from regulators and medical ethicists. Still, Wall Street is smitten with Conor's potential. Last December the company went public at $13 a share, then soared to $23 for a market cap of nearly $800 million. Conor has virtually no revenue and is not expected to make a profit until 2008, but CIBC analyst John P. Calcagnini, who has a $26 price target on the stock, believes Conor can take 11% of the market by 2009.
TREADING CAREFULLY
Before that happens, though, Conor must navigate a minefield. Its powerful rivals vastly outspend the startup on research and development. Its stent has not yet been approved in any market. And this February, Conor was sued for patent infringement in Europe by Vancouver (B.C.)-based Angiotech Pharmaceuticals (ANPI ) and Boston Scientific. Angiotech licenses a drug called paclitaxel to Boston Scientific that inhibits the growth of scar tissue. Conor uses the same drug in its clinical trials, but claims the way it incorporates and releases the drug is novel and doesn't infringe on its rivals' patents. Boston has not yet sued Conor in the U.S., but if Conor tries to crack the U.S. market, Boston is expected to do so. "We haven't even looked into other potential infringements on the catheter side," says Boston's chief technology officer, Fred A. Colen.
If Conor were to lose the patent lawsuit, it would be forced to start a new stent trial with another drug, which would delay commercialization by several years. Even if Conor's device receives government approval, there's no proof that its stent offers a clinical advantage. "There are a lot of potential advantages," says Dr. Jeffrey A. Brinker, a professor at the Johns Hopkins University School of Medicine. But how likely are they to be realized? "I don't know," Brinker says.
No one is claiming that doctors enlisted by Conor are intentionally skewing the data because of their stock options. Moreover, there is no Food & Drug Administration rule barring doctors who participate in clinical trials from obtaining compensation from a company whose devices they are evaluating. But many universities, medical organizations, and scientific conferences now require that doctors disclose these relationships.
According to the disclosure documents, five of the doctors who have received stock options are top cardiologists at Columbia University and Stanford University Medical Centers and the Scripps Clinic. The doctors named couldn't immediately be reached for comments.
Columbia, Stanford, and Scripps say that their doctors who are affiliated with Conor have not violated any rules, and Conor also says that it has done nothing improper. Company execs say they paid doctors for their expertise with options since, as a small startup, Conor had little cash.
It's difficult to specify the value of compensation that each doctor receives because Conor does not release that data. In their disclosures made to medical conferences, doctors must reveal the type of compensation they receive, such as stock ownership, but not its value.
In its financial filings, Conor said it granted options to purchase 1,137,750 shares of its stock -- valued at $26 million -- to "consultants and other non-employee service providers." However, Conor says not all of those consultants are doctors. Some are contract workers, such as engineers.
Dr. Kereiakes of Ohio State receives airfare and several thousand dollars from Conor to attend meetings. But he sees no conflict, he says, because he is taking a hefty pay cut to devote time to Conor. Conor says it forbids lead investigators from receiving options, but Kereiakes and his co-investigator would not take them anyway because they say it would harm their credibility. "I would not embarrass myself and give a presentation when I have a million dollars in stock from a company," he says. "There's nobody in the world that would say that's not a conflict of interest."
Dr. Litvack's professional background has also attracted attention. Having served as co-director of the Cardiovascular Intervention Center at Los Angeles' Cedars-Sinai Medical Center from 1986 to 2000, he was recruited by Conor co-founder and Chief Technology Officer John F. Shanley to serve as CEO in the fall of 2001. But his track record as an entrepreneur is uneven. Litvack has helped run three companies, one of which was Advanced Interventional Systems Inc. The company developed laser technology to clear up artery blockages, but it lost a patent infringement lawsuit in 1992 and never gained much traction with doctors. In 1994 it was acquired by its chief rival, Spectranetics Corp. (SPNC ), for just $12 million -- a thin sliver of the $150 million market cap it reached after going public in 1991.
Is Frank Litvack headed for a debacle like the one that burned investors more than a decade ago? CIBC's Calcagnini scoffs at the idea. "That's old news," he says."People are trying to detract from the idea that Conor has a novel design."
At least two physicians with no financial ties to Conor give its device high marks. Today's leading drug-eluting stents were designed as bare metal tubes, and the companies later added drug coatings. By contrast, Conor designed its stent from the ground up to deliver drugs to surrounding tissues. The idea comes from Conor's Shanley, who used computer-guided manufacturing techniques to create hundreds of little wells for drugs on the stent's lattice.
SLIPPERY SUCCESS
Some cardiologists say Conor may succeed because its stent, which is thinner and less sticky than existing drug-coated stents, is more easily maneuvered through a clogged artery. "If everything else was me-too, just that one feature would take the whole market," says Dr. Mitchell Krucoff, a professor of medicine and cardiology at Duke University Medical Center who is the co-principal investigator of Conor's U.S. clinical trial. Krucoff says he has received less than $10,000 in consulting fees from Conor.
If current clinical trials go well, European regulators could approve Conor's stent by yearend -- and the FDA could follow by late 2007. Still, even with approval, Conor must battle Boston Scientific, J&J, and others. Boston Scientific is spending more than $200 million a year on R&D for new stents and delivery systems -- four times what Conor has spent during its entire six-year existence.
For Litvack, the key to beating the competition is more innovation, both in devices and drugs. Conor is now developing a stent that uses anti-clotting compounds acquired from Novartis. "We believe the job of a good medical company is to make your products obsolete," he says.
SNUS
Any opinions on future potential for SNUS?
While I think SNUS may be a good short-term investment (1-2 years), I am worried about future competition: when Tocosol paclitaxel is finally approved, the market will probably include several epothilones--both natural and semisynthetic--that have an identical MOA, are as well tolerated, and are as easy to adminster.
The problem with the latter sequence (FOLFOX bevacizumab, irinotecan or FOLFIRI, irinotecan plus cetuximab) is that, at least according to RCTs, FOLFIRI is probably inferior to FOLFOX in the second-line setting. Based on the relatively poor performance of FOLFIRI second line, and the fact that FOLFIRI and FOLFOX are equivalent first line (aside from toxicities), I would argue that FOLFIRI should go first.
Anyway, I am sure that Saltz has valid clinical reasons for FOLFOX plus bevacizumab first line. We just don't have the RCT to support it yet. I would like to see a FOLFOX plus bevacizumab vs FOLFIRI plus bevacizumab trial. Then we could all stop arguing!
I did not catch Saltz's ASCO talk, but I am familiar with his opinions. However, until we have new data, the rational sequencing strategy is 1) FOLFIRI plus bevacizumab; 2) FOLFOX; 3) irinotecan plus cetuximab (in the absence of specific patient factors or preferences). Other sequences may be better, but I believe there are insufficient data to support other strategies.
I guess my point was that it is a shame that patients who would qualify for irinotecan--and who might be better off with transient diarrhea than with cumulative neurotoxicity--will receive an oxaliplatin-based regimen because of the need to genotype.
I have not been following panitumumab, I consider it a me-too and not worthy of the attention it is getting. YMI's anti-EGFR antibody is much more interesting.
No, I'm not an oncologist; however, I consult for pharmas and biotechs in oncology and other areas. I also work in my old lab for fun (DNA repair).
I agree that oxaliplatin and iriotecan are equally effective (in the metastatic setting--oxaliplatin is clearly superior in the adjuvant setting) but the fact is almost all patients who receive oxaliplatin develop cumulative neurotoxicity, which lasts a long time and is only partly reversible.
On the other hand, the diarrhea associated with irinotecan is transient, reversible, and managable, particularly if physicians educate their patients and take an aggressive approach.
In fact, if you look at the Tournigan (GERCOR) study, which randomized patients to FOLFIRI or FOLFOX or the reverse sequence, you'll see that many patients who received FOLFOX had to stop therapy before resistance because of neurotoxicity.
In addition, irinotecan has reliable data in combination with bevacizumab (Hurwitz study, first-line) and cetuximab (BOND-1, second-line) and the combination of bevacizumab and cetuximab (BOND-2, second line). Admittedly the Hurwitz study is in combination with a bolus 5-FU regimen (IFL), which is no longer in favor, but one might expect even better results with an infusional 5-FU regimen.
In contrast, oxaliplatin has the E3200 study, which assessed the combination of oxaliplatin and bevacizumab in the second-line setting, and immature first-line data from the TREE-2 add-on study.
Of course, the lack of data for oxaliplatin with targeted agents hasn't stopped physicians from using the combination.
Irinotecan news
Another blow to Pfizer?
Many physicians won't bother genotyping their advanced CRC patients and just use oxaliplatin first-line. A shame, because in my view irinotecan is inherently superior to oxaliplatin in the metastatic CRC setting--not to mention the evidence base is better for irinotecan plus targeted agents compared with oxaliplatin plus targeted agents.
John
===================================================================
FDAAdvisoryCommittee.com News Alert - October 20, 2005
-------------------------------------------------------------------
NEW TODAY on FDAAdvisoryCommittee.com
http://www.FDAAdvisoryCommittee.com
>>> Pharmacogenetic Data Integration Into Product Labeling To Be Discussed At Meeting
Translation of pharmacogenetic information into label updates will be discussed by FDA’s Clinical Pharmacology Subcommittee during a Nov. 14-15 meeting.
The agency is asking the subcommittee of the Advisory Committee for Pharmaceutical Science to “discuss and provide comments on the evidence and process for translation of pharmacogenetic information (e.g., cytochrome P 2C9 polymorphisms) into label updates for approved products.”
The issue has been of particular interest with regard to oncology agents, many of which have well-known toxicities. Genotyping patients according to metabolizing enzymes, for example, could become a primary tool in selecting the least toxic therapies for specific patients.
During the clin-pharm subcommittee’s previous two-day meeting in November 2004, the pharmacogenetic toxicity risk of Pfizer’s oncologic Camptosar (irinotecan) was discussed as an example of information to be included in the agent’s labeling.
The group voted nine to zero with three abstentions in favor of genotyping patients to find those deficient in an irinotecan metabolizing enzyme.
FDA cleared an sNDA in June to update Camptosar’s labeling to recommend a lower starting dose for such patients.
Discussion of FDA’s “Critical Path” initiative will occur on both days of the meeting. On Nov. 14, discussion will focus on “end-of-Phase IIa meetings which will include a case study.”
FDA has been pursuing the addition of a pharmacometrics branch to CDER’s Office of Clinical Pharmacology and Biopharmaceutics. As part of that effort, a pharmacometrics team has been involved in EOP2A meetings with sponsors.
On Nov. 15, the subcommittee will discuss several critical path-related topics: “the use of biomarker information in labels to facilitate individualizing pharmacotherapy”; “the analytical and clinical validation criteria for approving a clinical assay”; and “an update on the critical path biomarker-surrogate endpoint project.”
The group initially discussed the transition of biomarkers to surrogate endpoints during the November 2004 meeting. Part of the project includes a biomarker working group tasked with developing a guidance.
As part of its effort to encourage biomarker qualification, FDA is prepared to issue guidances on specific biomarkers, Deputy Commissioner of Operations Janet Woodcock said Oct. 6 at a Drug Information Association conference.
The clin-pharm subcommittee is also slated to discuss “current evidence related to the pharmacogenetics of warfarin as a potential basis for label updates.”
Yes, I am a fan of Conor. I am not particularly worried about paclitaxel-related litigation because their stent is a platform technology. Moreover, I wouldn't expect that the litigation will prevent Conor from launching in the US and Europe--by the time the courts hand down a decision Conor will probably have other compounds on line. I'm waiting for the Boston Creme-filled stent.
Caveat: I am not a lawyer; I would be interested in a professional opinion, if anyone here is qualified.
Still looking for a home for my BCRX profit....
TCT 2005--CONR
October 17, 2005
4:12 PM - TCT-16: A Pimecrolimus and Paclitaxel Dual Drug-Eluting Stent: A Synergistic Response From Drugs With Different Mechanisms and Different Release Kinetics From the COSTAR Stent Platform
Joseph Aragon, et al
October 21, 2005
8:00 AM - Extended Clinical Follow-Up
From the Dose-Ranging PISCES Trial
Patrick W. Serruys
8:10 AM - Final Results From the
EUROSTAR Clinical Trial (Arms 1 and 2)
Keith D. Dawkins
8:20 AM - Final Results From COSTAR I (India) and an Introduction to COSTAR II (US)
Upendra Kaul
PRDX
Looking for a place to invest my ill-gotten BCRX gain...
Any sense on when this phase III will complete and how many phase III trials will be required (they say at least two, I suspect more)? Any sense on what kind of data package will be required for submission?
I reviewed the labels for several approved agents for GAD. The venlafaxine (Effexor) label has a total of four studies in GAD, including two 6-week studies and two 24-week studies. I have no idea which data they used for approval.
Although cross-agent comparisons are difficult, it doesn't look like this is any more efficacious than other agents out there for GAD. It might be better tolerated, but speaking from experience APRs are a big deal for the FDA.
Also, what makes them think that this agent is deserving of a SPA?
Thanks,
John
Phase III Study Design
The Phase III trial is an eight-week, double-blind, placebo-controlled, multi-center study. The trial includes approximately 20 sites in the United States and is expected to enroll up to 310 patients with moderate-to-severe GAD who will be randomized into one of two arms, consisting of approximately 155 patients each: a placebo arm, or a PRX-00023 treatment arm, in which patients receive a dose of 40 mg administered over a three-day period followed by an 80 mg once daily for the remainder of the study. The primary objectives in this trial are to evaluate the efficacy of PRX-00023 in GAD as measured by the change from baseline in the HAM-A scale, and to assess the safety and tolerability of PRX-00023 during treatment of patients with GAD. The HAM-A scale is the only FDA accepted standard for the evaluation of anti-anxiety activity, and it is used in all pivotal trials of drug candidates for the treatment of GAD. This trial will be the first of at least two pivotal trials with PRX-00023 for the treatment of GAD.
PRDX
Looking for a place to invest my ill-gotten BCRX gain...
Any sense on when this phase III will complete and how many phase III trials will be required (they say at least two, I suspect more)? Any sense on what kind of data package will be required for submission?
I reviewed the labels for several approved agents for GAD. The venlafaxine (Effexor) label has a total of four studies in GAD, including two 6-week studies and two 24-week studies. I have no idea which data they used for approval.
Although cross-agent comparisons are difficult, it doesn't look like this is any more efficacious than other agents out there for GAD. It might be better tolerated, but speaking from experience APRs are a big deal for the FDA.
Also, what makes them think that this agent is deserving of a SPA?
Thanks,
John
Phase III Study Design
The Phase III trial is an eight-week, double-blind, placebo-controlled, multi-center study. The trial includes approximately 20 sites in the United States and is expected to enroll up to 310 patients with moderate-to-severe GAD who will be randomized into one of two arms, consisting of approximately 155 patients each: a placebo arm, or a PRX-00023 treatment arm, in which patients receive a dose of 40 mg administered over a three-day period followed by an 80 mg once daily for the remainder of the study. The primary objectives in this trial are to evaluate the efficacy of PRX-00023 in GAD as measured by the change from baseline in the HAM-A scale, and to assess the safety and tolerability of PRX-00023 during treatment of patients with GAD. The HAM-A scale is the only FDA accepted standard for the evaluation of anti-anxiety activity, and it is used in all pivotal trials of drug candidates for the treatment of GAD. This trial will be the first of at least two pivotal trials with PRX-00023 for the treatment of GAD.
Thank you!
That is correct. Just so you know, I had four molecular biologists in my lab--plus one physicist--working on the answer, and none of us got it right.
You have indirectly contributed to the advancement of science, because now I can get back to my experiment.
John
Puzzle
Having purchased BCRX a few months back--and after witnessing the recent speculative frenzy--I was inspired to buy "Mean Markets and Lizard Brains: How to Profit from the New Science of Irrationality," written by Terry Burnham.
According to Burnham, "part of the cause of our individual irrationality is that we aren't very good at doing calculations." As proof, he poses the following puzzle:
"Imagine that you are a doctor and one of your patients asks to take an HIV test. You assure her that the test is unnecesssary as only one woman out of a thousand with her age and sexual history is infected. She insists, and sadly the test result indicates viral infection. If the HIV test is 95% accurate, what is the change that your patient is actually sick?"
Anyone know the answer? If so, how did you arrive at it? When doctors were asked this question, they all got it wrong. The answer is given in the book, but I can't figure out how he arrived at it.
>>AVI BioPharma Inc. said Friday that its antisense drugs showed positive results against four lethal agents in preclinical studies conducted with Army researchers.<<
Is this ethical?
YMI
The full paper answers most of your questions--I have the PDF, if you care to read it. Let's just say I'm glad I bought more over the past few weeks.
Anyone interested send a private message.
John
I believe you are referring to the oral version of peramivir. My understanding is that it was discontinued because of insufficent oral bioavailability. When injected (the formulation everyone is excited about), peramivir should be a potent neuraminidase inhibitor and much more effective than Tamiflu.
The consensus view is that PAD, CAD, ischemic stroke, etc are all manifestations of the pathogenic progression of atherosclerosis. As such, I consider it unlikely that antibiotics will work in PAD if they had no impact on a hard clinical end point related to atherosclerosis in a 4000+ patient trial.
I would never say that this approach will not succeed, but it doesn't seem like a good bet to me. Not that we have the option, of course.
And thank you for taking the time to run this board, and to all of the participants. I've been reading it for months, and have learned a lot!
John
Infection and PAD
The idea that infection and atherosclerosis may be linked is not new. C. pneumoniae is found in about 50% of atherosclerotic lesions. Given that PAD is an atherosclerotic disease, it *was* reasonable to assume that antibiotics might have a beneficial impact.
The potential for an antibiotic to influence progression of atherosclerosis has been tested clinically. See, for example, the PROVE-IT trial, in which 4162 patients were randomized to pravastatin or atorvastatin, then rerandomized to gatifloxacin or placebo. There was no difference between gatifloxacin and placebo for the composite of all-cause death or MACE, the primary end point.
Also see: http://content.nejm.org/cgi/content/full/352/16/1706.
Based on these data, I find it rather unlikely that rifalazil will succeed in providing a clinically meaningful change in walking distance or any other PAD outcome. Even potent lipid lowering has little effect (see TREADMILL study).