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ACAD
>>Note that the drug was well tolerated. I always like that news best of all. "Hey, people, this drug won't do you any good but it won't kill you." That is surely important information.<<
My point is that these results are marginal at best.
>>Good diction and grammar are very important in writing. You should have paid attention to your English grammar.<<
Thanks for the advice. Forgive me if I don't take the time to couch information/comments/questions in a carefully crafted 500-word story on, say, cow udders.
ACAD
Trial fails to meet its primary end point and the stock goes up 17%? Anyone have an explanation?
http://news.acadia-pharm.com/phoenix.zhtml?c=125180&p=irol-newsArticle&ID=791782&highlig...
>>The whole reason I initial invested in IDEV was because Sanctura looked to be the best of class for OAB, and as far as I know it still is.<<
Physicians feel that there is little differentiation among drugs for OAB. Pharmas have invested tremendous amounts of money in trying to separate their products from the pack with few concrete results.
J
Of interest:
Evil pharma novel
http://www.slate.com/id/2131200/?nav=tap3
You have a point about the pens. I guess it would depend on how they are packaged. Anyway, the salient point here is that eltrombopag doesn't treat neutropenia.
Maybe DHHS will order 100,000 cases of whisky. Has the Jack Daniels distillery made the appropriate political contributions? If so, I'm sure they will be considered.
HEPH--one last thing
Stupid me: for obvious reasons, a pill would not be useful for ARS or in many oncology patients. Vomiting.
Duh. Should have thought of that.
Not that anyone should care, but I'm sort of tired of DNDN.
Here's my view: unless they show spectacular results, the drug is going to be a big commercial dud. Too complex.
The more I think about this, the more I believe that HEPH is a clear acquisition target. Assuming the DHHS contract is worth $300 million, Amgen could buy HEPH for far less than that, virtually guarantee the government contract, and protect their neutropenia franchise into the far future. I could also see GSK partnering or purchasing HEPH outright so that they can treat patients across the continuum from the very ill to outpatients.
HE2100, if it makes it to the clinic and safety data hold up, would shift the neutropenia treatment paradigm from why? to why not? Same goes for thrombocytopenia. So both markets would expand substantially.
The BCRX deal adds to my enthusiasm for HEPH; if companies are willing to partner on great terms for a phase I drug with a small market, HEPH has great potential given the size of the potential patient population.
I think elotrombopag sounds great, but of course it is directed only toward thrombocytopenia. There is no mechanistic reason why it shouldn't work in ARS-induced thrombocytopenia; however, according to Bioshield rules (at least as I understand them) they would have to do the non-human primate studies at lethal and near-lethal doses to qualify for a contract. My understanding is that monkey studies are nearly as expensive as human studies and we're talking hundreds of monkeys.
The pill formulation would be great for ARS, particularly if the bioavailability is not affected by food. However, I don't think a subcutaneous injection is a barrier at all in an emergency situation, for an oncology patient, or for any patient with thrombocytopenia that is severe enough to warrant treatment.
The $3 billion estimate highlights the potential for HE2100 if it should ever make it to market. Plus the neutropenia market, which it would likely dominate for pharmacoeconomic reasons (say $250 WAC vs $3000 WAC for Neulasta).
Anyway, if you think beyond a year or two, HEPH has huge potential. Right now I'm playing it for a near-term gain, but if it goes above ~$6.00 by Jun 17 I'll likely exercise and hold long-term.
Lubricious?
Characterized by lust; "eluding the lubricious embraces of her employer"; "her sensuous grace roused his lustful nature"; "prurient literature"; "prurient thoughts"; "a salacious rooster of a little man"
I realize "lubricious" can also be used scientifically. Nevertheless, I would have chosen another word.
YMI
I recently had the experience of leading a project that consisted of prioritizing a big pharma's portfolio of oncology trials to eliminate duplication, terminate trials that weren't enrolling, and redirect funding to achieve the broadest possible scope.
They had ~630 trials in progress. Simultaneously. You wouldn't believe the amount of duplication, stillborn trials (just stopped enrolling for no reason), trials that were underpowered to meet their objectives, etc. And the data was a mess. In fact, at one point I suffered the indignity of getting down on my hands and knees to dig through paper files trying to find the original proposals.
My point? BMS probably has or had a similar problem. One trial, in the context of big pharma, is trivial. They could very well have walked away without even looking at PFS.
>>He says APPX intends to show that Abraxane given with bare-metal stents can compete with existing drug-eluting stents such as Cypher and Taxus.<<
Highly unlikely. As I think I've said before, systemic approaches to preventing restenosis have a long history of failure and marginal results. Can you imagine the dosages of abraxane that will be required to prevent restenosis? Seems like the cure is worse than the disease.
John
>>"They're not getting the relief that they want. Therefore they're slapping more patches on trying to get that instantaneous relief," says toxicologist Daniel Anderson. "What they don't realize is that most of these patches are to be applied over a three-day period."<<
I would guess this would only help AeroLef. The problem with the patch is the lag between slapping it on and pain relief. Not a problem with an inhaled drug.
More YMI
Delex: perhaps I should rephrase: if all milestones are met, Delex is surprisingly cheap. I do not see much risk in AeroLef.
Regarding cash on hand, they are either going to have to partner or raise it in the market late next year. They will probably have ~17-18M at the end of the year, at a burn rate of ~4.3M they should be okay for four more quarters.
I think we agree re nimotuzumab. I believe they are seeing infusion-related events; however, I am skeptical about the relative lack of EGFR side effects. Would love to see a single-indication trial enrolling a few hundred patients. Saltz coming on board has somewhat eased my concerns surrounding this issue.
Regarding program survival bias: I would agree if the second phase 3 were a duplicate of the first; however, since they’re selecting the subset that did best in the first P3 I’m not sure it applies here.
I only know what I’ve read in news reports, but my understanding is BMS returned the rights to tesmilifene early during the first P3 because they weren’t seeing responses. As we now know, tesmilifene appears to extend survival without influencing RR. Now, the question: does BMS regret the decision or do they know something we don’t know?
I still don’t see serious skeletons. If these are the key concerns surrounding YMI, we still have fewer worries than investors in the vast majority of small-cap biotechs.
My grammar has gone to hell.
>>Well, yes. John asked for opinions, did he not?<<
I did. And I appreciate everyone's opinions greatly. Even if I disagree, I very much want my assumptions questioned. Otherwise why post?
I'd rather be rich than right.
John
Just a few comments. I can't comment on perceptions of the CEO.
>>Phase-2 results are not as good a predictor of phase-3 results as many investors seem to think<<
I would expect that the second tesmilifene phase 3 has a relatively high chance of success, considering that it is enrolling the subgroup of patients who responded best in the first phase 3.
>>The Delex acquisition in April, 2005 suggested that the company placed a relatively low valuation on its own shares, and it called into question the notion of “empire building.”<<
Not sure what you mean. I thought Delex came suprisingly cheap and was a target of opportunity.
>>The market for EGFR therapies is already crowded and is getting more so.<<
This is one thing that doesn't bother me at all. If 1) nimotizumab really doesn't cause rash, diarrhea, and conjunctivitis and 2) it is as or nearly as effective as cetuximab then it will supplant all other EGFR therapies. In this scenario, drugs already on the market are merely priming the pump for nimotuzumab.
Given that they've only treated a few hundred patients with nimotuzumab, their lack of rash story remains a bit optimistic. Also, I would call into question their strategy for nimotuzumab. I don't understand why they are hitting niche indications first if they are confident that nimotuzumab has significant benefits over SOC.
To all who read the report--
And those who have an interest. I would be very interested in hearing the negative case for YMI. Personally, I am impressed enough about the risk/reward for YMI to allocate a larger proportion of my portfolio than usual to it. I'm just worried that I'm missing something.
Same goes for any stock I tout here. Feel free to abuse me.
John
SNUS
>Do you have the same feelings about Toco Camptothecin as you do about Toco Paclitaxel?<
>>It's just a personal, general feeling about reformulations. I don't think equivalent safety / efficacy with shortened infusion time will be an effective selling point for a drug that retails at a premium. I personally don't think that the efficacy can be significantly improved by reformulation, so the decrease in safety will have to be tangible.<<
The camptothecin analog is not a reformulation of irinotecan. It is SN-38, the active metabolite of irinotecan. So it is novel. Whether it delivers more active drug is open to question, of course--preclinical studies suggest that it provides greater exposure to SN-38 at lower doses than irinotecan in monkeys, without evidence of severe diarrhea.
PANC
Not impressed yet--their maturation inhibitor yielded barely a 1 log reduction in viral load. For comparison, TMC114, a new protease inhibitor, yields ~2 log reduction, even in multiple PI-experienced patients. Fuzeon yields a ~1.7-log reduction in viral load. In fact, you can get a ~0.6-0.7 log reduction in treatment experienced patients just by optimizing their treatment regimen.
I believe 1 log reduction is usually the primary end point in clinical trials of antiretroviral agents (I only have experience with PIs, so that may not be correct for other classes). Any drug that provides <1 log reduction in yield is DOA or will be relegated to last resort, so given that we're seeing 1.03 log reduction with the maturation inhibitor, it's an iffy prospect to say the least.
There is considerable skepticism in the industry about PANC's maturation inhibitor. They'll have to show better results in phase IIb for it to go anywhere. In order to be enthusiastic about the maturation inhibitor, I'd want to see >1 log reduction in viral loads and substantially better tolerability than current agents. They might be able to do it with a >200 mg dose, but I'm not holding my breath.
One positive: PANC's maturation inhibitor is not metabolized by CYP3A4, which means it could be relatively easily integrated into current treatment regimens.
Regarding the oral fusion inhbitor: too early. Plus PANC's market cap is crazy for a company with one iffy drug in phase IIb and a couple of drugs in preclinical--aside from the fact that the maturation inhibitor will be entering an extremely crowded market with a bunch of good drugs going off patent.
That's my view--would be interested to hear the positive case. I understand that an entirely new class would extend treatment options, but frankly HIV is already considered a chronic disease becuase many patients are living a relatively normal lifespan even with today's treatments. I am not saying that PANC's maturation inhibitor does not have the potential to be a good thing, I'm just saying that the investment case, in my view, is weak. Particularly given the $400 million market cap.
John
YMI Report
I have the Griffin YMI report, if anyone is interested.
I agree completely--just looking at it from the perspective of regimens in the current paclitaxel label.
The paclitaxel label says 22% (135 mg/m2 q3w 3 h infusion) to 28% (175 mg/m2 q3w 3 h infusion) in patients who have failed adjuvant chemotherapy. Patients also received doxorubicin and cyclophosphamide, plus they had prophylactic G-CSF support and ciprofloxin. At very high q3w doses (250 mg/m2 the response rate was 57% in a phase II conducted in patients treated with a maximum of 1 prior regimen.
Here is a good table for single-agent QW paclitaxel, current as of Aug 2005. Discounting the Akerley study (which enrolled only previously untreated MBC and unresectable LABC), looks like 23% to 53% across all QW trials. For obvious reasons, I would be interested to know if patients received G-CSF in these trials--patients in the Tocosol P2B did not receive G-CSF support, presumably this will enhance RRs because patients will be able to receive more drug.
http://theoncologist.alphamedpress.org/cgi/content/full/10/9/665/T3
I didn't thoroughly think through my last post--I have that problem! Agree that we're comparing apples and oranges.
John
STAA--Dr Bio
So when do you think the ICL lens will finally be approved?
The Sonus P2b abstract shows 48%-57% response with Tocosol paclitaxel. Seems promising--if similar results are seen in larger-scale comparative trials it is possible that Tocosol paclitaxel will end up being superior. Plus tocosol paclitaxel is adminstered as a 15-min infusion vs 3-24 h with paclitaxel.
From a quick search of PubMed: the response rate for paclitaxel 175 mg/m2 q3w (24 h infusion) was ~34% in first-line MBC patients (Sledge et al 2003); in a second study conducted in first-line MBC patients, RR with paclitaxel 200 mg/m2 q3w (3 h infusion) was 25% (Paridaens et al 2000).
In CALGB 9840, there was a significant difference in response rate (40% vs 28%) and median time to disease progression (9 vs 5 months) favoring weekly vs monthly therapy with paclitaxel (175 mg/m2 for q3w and 80 mg/m2 for w). First- and second-line patients could enter this trial, however the majority (488/585) were first-line. Keep in mind, though, that all patients withHer2/neu-positive disease and half with Her2/neu-negative disease received trastuzumab.
SNUS San Antonio Abstract
Comments, anyone?
[1070] A phase 2b multicenter evaluation of the safety and efficacy of TOCOSOL paclitaxel (TOC- P) as initial treatment of patients with metastatic breast cancer (MBC).
Bogdanova N, Tjulandin S, Ognerubov N, Semiglazov V, Afanasjev B, Makhson A, Krasnozhon D, Manikhas G, Vtoraya O, Mitashok I, Astakhov V, Byakhov M, Luciano G, Moore E, Pratt J, Bolton MG. The 1074 TOCOSOL Paclitaxel Working Group, Russian Federation; Sonus Pharmaceuticals, Bothell, WA
TOC-P is a novel Cremophor-free vitamin E-based paclitaxel formulation that does not need reconstitution or dilution, is given over 15 minutes i.v. push, may result in reduced incidence and severity of infusion reactions and better patient tolerance (in particular, less neuropathy), thus enabling higher single doses and/or a higher cumulative paclitaxel dose, and, potentially, improved anti-tumor efficacy. Pre-medication with steroids is not required. 47 patients (pts) with previously untreated MBC were assigned to receive weekly TOC-P 120 mg/m2 until PD or intolerable toxicity. Median age: 57 (21 74). ECOG PS 0 = 26 pts, PS 1 = 21 pts. Chemotherapy nave: 19 pts; prior adjuvant chemotherapy: 28 pts; prior anthracycline: 18 pts. ER+: 12 pts, ER-: 4 pts, ER status ND: 31 pts. Prior hormone therapy: 14 pts. Pts were required to have measurable disease by RECIST, thus defining a population with a high tumor burden; visceral metastases: 43 pts, 3 sites of disease: 21 pts. One pt was ineligible and is not included in the efficacy analysis. Safety and Efficacy data for the first 16 weeks of treatment are available for 47 and 44 pts respectively. The mean dose delivered was 95 mg/m2/week. 27 pts remain on therapy after an average 17 weeks; 20 pts have discontinued: PD=11, toxicity =7, withdrawal not due to toxicity =2. Investigator reported RR: 22 pts (48%) confirmed PR (confirmatory CT 4 weeks after OR determination); an additional 4 pts (9%) have unconfirmed PR; 8 pts have SD at 16 wks; 9 have PD. The median TTP has not yet been reached. The most frequent toxicity reported was neutropenia (87%). Grade 3/4 neutropenia: 66% of pts, 60% of pts required a dose reduction by wk 4. Dose re-escalation was permitted. The time to return to full dose was 1 wk in >70% of pts. Grade 3 neuropathy: 11% (no grade 4). Arthralgias and myalgias: 34% (2% grade 3, no grade 4). 24 pts (51 %) had an adverse event related to infusion (event occurred within 30 minutes of end of dose). One grade 4 event (sacral pain) was reported and resulted in discontinuation of study drug after 3 occurrences. In all other pts, infusion reactions were easily managed and did not result in discontinuation of therapy. Final data will be presented. TOCOSOL paclitaxel is an active agent in the treatment of MBC. The recommended dose for Phase 3 study is 100 mg/m2 weekly.
Thursday, December 8, 2005 5:00 PM
Poster Session I: Treatment: Chemotherapy - New Drugs and Formulations (5:00 PM-7:00 PM)
Dr Bio,
Care to present the case for Staar Surgical? I owned it years ago, but for the life of me I can't remember why.
Any near-term drivers?
John
PGS--
>>And as I understand it, the excitement is over the possibility that HEPH may be awarded the contract based on proposals being solicited by HHS?<<
Yes, that's the one of the few near-term reasons to buy HEPH. Other near-term reasons are partnerships for Immunitin, a Department of Defense contract for Neumune. In fact, the DoD has already stated that Neumune is their lead candidate for field use. There is also the potential for non-US orders, but probably not within the next six months.
Longer-term, I think HEPH has substantial potential if the primate data for Neumune (which are incredibly good) extend to humans. We already know Neumune is ell tolerated in humans, so it will go straight to phase II.
>>So how solid is the funding behind this solicitation?<<
Bioshield 2 is being written right now, so I can't answer that question. I find politicians unpredictable. Positive: substantial congressional support behind HEPH and the failure of the government to do anything about ARS after 4 years; they might also want to avoid the perception that they are pulling the carpet out from underneath small companies. Negative: I don't think this adminstration ever wants to hear the acronym "WMD" again.
>>As an aside, didn't hgsi have an anthrax antibody that was supposedly being expedited through a similar initiative?<<
I believe they won the contract, not sure though.
With the political component factored in, HEPH is incredibly high risk. At current prices, I also think it has the potential for extremely high reward. We'll see what happens.
HEPH
From Briefing/In Play yesterday
Hollis-Eden Pharm: Color on acute radiation syndrome documents (HEPH) 5.91 +0.13: Rodman & Renshaw notes that on November 18, the U.S. Government Office of Public Health Emergency Preparedness issued several documents related to the procurement of medical countermeasures against acute radiation syndrome (ARS). Although the language of the current RFP has been modified to state the intention to the procure treatments that mitigate and/or treat neutropenia alone or in combination with co-morbidities associated with ARS, they say the RFP still requests acquisition of 100,000 treatment courses. They also note that the RFI brings Thrombocytopenia back into the mix. Firm believes these developments to be strongly positive for HEPH. With the drug demonstrating a mortality benefit in animal efficacy models, they believe Neumune remains the most efficacious ARS countermeasure in development. Firm's current estimates assume HEPH to receive an advanced purchase contract award for Neumune by year-end 2006/early 2007. Rates outperform .
YMI
While I normally don't pay attention to these sorts of things, someone is trying to buy 145,000 shares of YMI at 3.01.
John
Dew,
How about a best and worst small biotechs 2005 survey? Last one was last year.
J
The problem with GPCB, as I see it, is there is nothing to fall back on if satraplatin fails. On cursory review, SPPI's pipeline seems both broad and deep. Plus they have the generics business. However, there has to be a reason SPPI is at $4, so I'll keep digging. No rush.
Bladerunner,
I am looking at SPPI. Quite a pipeline; I'm trying to figure out why it has a $95 million market cap. I particularly like the activity in generics.
My concern with satraplatin is that it will not be reimbursable.
Is there some dirt on SPPI that I'm unaware of? Bad management? Keep in mind I've been looking at it for all of an hour.
John
The case for and against HEPH
Bladerunner,
The case for HEPH, at least in the short term, is relatively simple:
1) Positive: Competition for the DHHS contract is pretty much limited to Neumune and Neulasta (Amgen). Neulasta is highly impractical in the setting of ARS (needs refrigeration, short shelf life, need for platelet transfusion, need for physician adminstration monitoring, etc); moreover, Neulasta only treats neutropenia, not thrombocytopenia. 2) Negative: Neulasta has substantial human data; however, they would probably have to do extensive primate studies to determine efficacy in lethal models of radiation exposure. Given the mode of adminstration of Neulasta and the need for supportive care, I gather these studies would be difficult to perform.
2) Postive: Neumune appears highly effective in non-human primate models of acute radiation syndrome. While normally I wouldn't buy a company with drugs only tested in animals, a) obviously it is not ethical to do these studies in humans; b) primate data should extrapolate to humans. Or at least better than a mouse model. Negative: again Neulasta is proven, albeit impractical
3) Positive: Neumune appears very safe. In phase I studies, the only AE has been injection site irriation and swelling.
4) Positive: Aggressive management: Richard Hollis has done an incredible job driving Neumune forward. Negative: management has been rather antagonistic toward those who hold the purse strings.
5) Positive: Political clout. Substantial support at high levels within the Senate for Hollis-Eden's objectives. Negative: Regardless of your political leaning, most would agree that our current government and its appointees cannot be relied on to do anything right.
6) Positive: takeover candidate. Although I do not buy anything anticipating a takeover, Hollis-Eden is a particularly juicy target. Amgen might buy to protect their neutropenia franchise, plus a purchase would give them virtually a 100% chance of securing a government contract for ARS--a contract potentially worth five to six times Hollis-Eden's current market cap. Other companies might buy for an easy entry into the neutropenia/thrombocytopenia space. Neumune is a potential blockbuster and, if the data pan out in humans, a Neulasta-killer.
7) Positive: contracts beyond the DHHS. The Department of Defense is evaluating Neumune; they have already stated that it is their number one candidate for field use. Could yield 1 to 2 million doses (100-200 million in revenue, recurring every 3 years or so). Other countries may also buy.
8) According to Richard Hollis on the Q3 Conference Call, they are in daily discussions regarding partnerships for Neumune and Immunitin
In short, I believe their is the potential for huge upside here in the near-term. In fact, one brokerage has maintained a $30 target on HEPH, which I think is a bit optimistic. Downside risk is also substantial, but frankly they have a product that probably works. Fun money only--I purchased out-of-the-money Jun 06 $5 calls a while back. They are nicely in the green right now, and I will continue to hold them until a binary event or they decay out from under me.
It is old news, but the new news is the November 18 presolicitation notice, which preserves the 100,000 dose request. Again, I'm thinking of it in terms of 100,000*Neulasta WAC, which would suggest $300 million of available funds. So I'm holding.
Dew,
I guess that this study, if positive, could drive some first-line use of cetuximab + bevacizumab + 5FU/LV, but I have several objections:
1) The side effect profile will be different and potentially worse than oxaliplatin-based therapy. In BOND-2, toxicities were additive not synergistic, nevertheless more agents generally equals more toxicity. Managing all of these very different side effects will be challenging.
2) This sort of hit-hard, hit-early strategy expends all of the targeted agents up front. There is no evidence to suggest that restarting cetuximab will restore irinotecan sensitivity if it has been used in a previous line, nor is it known whether bevacizumab can be reinitiated and have an effect. I think any clinical effect associated with reinitiation will be transient, particularly given the timeframe of progression in CRC (not enough time for reversion to a bevacizumab- or cetuximab-sensitive phenotype)
In short, I do not think the results will be spectacular enough for oncologists to use this regimen off-label. But stranger things have happened.
Dew,
You might enjoy this:
http://finance.wharton.upenn.edu/~rlwctr/papers/0537.pdf
“The excess-volatility puzzle is one aspect of market inefficiency that begs for a behavioral explanation. It is natural to ascribe the excess volatility to fluctuations in irrational “sentiment”. But Shiller never indicated the way in which rational investors could cause those responsible for excess volatility to part with their wealth. The volatility of stock prices, if it is excessive relative to the volatility of fundamentals, is an indication that the financial market is not information efficient. If so, there must exist a trading strategy that allows a rational, intertemporally optimizing investor (a “risk arbitrageur”) to take advantage of this inefficiency. The main goal of our paper is to calculate and understand the strategy of rational investors and the impact of this on irrational investors responsible for excess volatility.”
Dew,
There was a message from you about a chemo lite CRC trial (I think)? Can't find it but I seem to remember having an opinion about it.
J
Bladerunner,
You asked last week why the PPS of HEPH fell from $35/share in late 2003. As far as I can see, the runup and decline was caused by failed clinical trials of HE2200 in patients with dyslipidemia. I can’t imagine why they thought it would work.
On Friday Nov 18, the DHHS posted a presolicitation notice for the acquisition of 100,000 doses of an unspecified radioprotectant plus an additional 100,000 in the future. If they based their calculations on the WAC of Amgen’s product, this means there is about $300 million on the table initially, followed by an additional $300 million in the future.
I’d be willing to bet that they are trying to keep Amgen in the running, otherwise they’d request a more sensible 10 to 20 million doses (which is a bit closer to the number of doses ordered for anthrax and smallpox vaccines).
This story isn’t over by any means. Nevertheless, I have a feeling I'm going to get whacked on Monday. And just when my portfolio recovered from NABI.
John
I suppose an ANPI purchase is possible, but why pay all that money for taxol? Really, they only need to be able to sell the taxol-eluting stent for 2 to 3 years before their next generation fillings are available.
CONR Insight
I have not reviewed this for absolute accuracy yet, but for once a logical argument. Courtesy of bglbfd on YMB.
******************************************************
I have a lot to type so I am not here for name calling and the mindless dribble that goes on in this board. I am a private investor and you must assume I am involved in many of the names mentioned.
1. Where is CONR's IP? Why wait for the company to tell you? Go to www.USPTO.gov got to patent search and do a search for Conor Medsystems. Here are the patent numbers to save you the time. CONR currently has 9 issued patents related to the special design of the stent with its unique holes and hinges. Feel free to take a read; 6,964,680 6,855,125 6,764,507 6,582,394 6,562,065 6,527,799 6,293,967 6,290,673 6,241,762. It is pretty safe to assume that CONR has a number of pending patents that have not issued and are not listed on the USPTO site.
2. Why didn't CONR purchase a license to ANPI's IP? I would guess for 2 possible reasons. First, CONR sees no value in the patents. Second, Go back to the original ANPI/BSX/Cook deal and how it was structed and BSX's role in determining the 2nd liscense. You could also go back to when GDT attempted to purchase Cooke to get into the DES game and what happened with the license. CONR was not really in business at the time the license was being offered. To say Litvack is a crook and thats why CONR is challenging the patents, well that is just ignorant.
3. Legal status: Closing arguments for the UK case will begin on Dec 12th. As a refresher since I have seen so many incorrect comments on this. CONR has sued ANPI to invalidate the ANPI Hunter patents. There are no infrindgement claims being argued in this case. The judge ruling in the UK case is judge Pelfry. This is the same judge who invalidated the JNJ Palmaz Shatz patents and most recently one of the key PFE Lipitor patents. So far the track record is in favor of the challenger. If CONR were to loose the case in the UK, BSX/ANPI would then be required to file suit against CONR in the UK for infrindgement. CONR would then argue noninfrindgement and there are many valid arguments to this and will cover later. The case in the Netherlands will have a scheduling hearing in April 2006, but the case is not expected to reach trial until late 2006/early 07. This is where BSX has filed suit against CONR for infrindgement. Australia is a case where CONR has again filed suit to invalidate the ANPI Hunter patents. What is interesting about European courts is the lack of Doctorine of Equivalence. This means BSX/ANPI must prove that CONR infrindges the patents to the T's. The case only involves the Hunter patents and not the Jang or any other BSX has to throw at them. This case I believe starts in June 2006. What is interesting with the case in Australia is that unlike the European cases, Australia much like the US permits full discovery. Seeing how this case takes place well before any US case, it will be a nice prep course for CONR in their US case as they will have full access to BSX/ANPI records in the discovery process.
4. With European approval on the way could BSX/ANPI file for an injunction? Yes, but they would be required to apply on a country by country basis as there no pan european reg body with authority to grant it. Can't really think of any pan European injunctions within the past three years - if someone does please post.
5. US patent case? First off, does BSX even own the Jang patent? Waiting for the California Court to decide on that. I would assume BSX is just trying to get CONR to spend money and waste resources with this type of case. Why not the Hunter patents in the US? CONR would love to see that so they could begin full discovery and use everything they learn for the European and Australian cases. BSX also knows that Safe Harbor in the US will have any case thrown out.
To continue on a few other points. I would first like to say without taking sides and looking at stents from a clinical stance, in my opinion CONR's stent is truly a next generation platform. Yes we wait to see data from the US trial, but the data out of Europe has been nothing short of clean. Cypher and Taxus and Taxus Liberte for that matter are 1st generation technologies. Palmaz, Multi Link, Nir, GFX and the many stainless steel offerings were all first generation stents that none of us would want placed in our body for many clinical reasons. Today we don't even mention stainless steel, its all cobalt chromium, DES, bioabsorbable, next generation technologies. While Dr.'s have theories on SAT's, deflation and stickiness issues, there are adverse events being created with the current generation platforms leaving much room for innovation and new products. We may not know the reason, but I believe it is fair to say the polymers for both Cypher and Taxus are aving some sort of negative clinical impact, since these are issues we did not see as frequently with bare metal. If A=B and B=C then A must equal C. CONR does not have a polymer, so maybe this is why we have not seen any SAT's in the European trials.
Is this something to be excited about, if it cures a problem seen in 1st generation products, yes absolutely. CONR doses taxol at 1/10th the amount of Taxol used by BSX on the Taxus and Taxus Liberte. Taxol is a highly toxic compound. I would argue that if CONR can get equivalent restenosis rates while introducing less of a highly toxic compound into the body this is also a good thing. Clinically meaningful? well we have seen allergic reactions in the adverse event reports on the FDA websites (not a lot, but a decent handful)with Taxus. Polymer stickiness leading to deflation or withdrawl issues? So far haven't heard anything out of Europe and again no Polymer for the CONR stent. The platform concept for CONR is very interesting, and I look forward to the trials showing the benefit and the next leap to help patients. I will make this argument. The Taxus Liberte is no 2nd generation offering. Same drug, same dose, same polymer and while a slightly different stent it is still open cell design. The balloon is the same, but it is not a 5 fold instead of a 4 fold design (correct me if I am wrong). Check the FDA website and search for Liberte and Liberte Taxus and you will still find deflation and withdrawl issues coming from European users. Yes, the FDA does recieve O.U.S. reports when they are filed, just not too frequent, but they are there. Cypher is far from perfect with its SAT's and not always easy to deliver. Are there any Dr.'s on this board who have used the CONR stent? I would interested in feedback. Every Dr. I have spoken with, including at the recent TCT and AHA conferences, the feedback has been very positive. While I await the US trials results I am very encouraged at the European results to date. Also the multi drug looks very interesting, but curious as to how it will improve outcomes. Isn't that what we want as potential patients, better and safer outcomes? The GDT an ABT offerings look much like the same old stuff we've got to date.
If you believe CONR will fail in its trials - which there has been no evidence of in data presented to date - that would be a great reason to be short the stock. If you believe BSX will be successful in keeping CONR off the market - yes another good reason to be short the stock. But much like the warning label on a drug lets go over some things. In 1998 MDT acquired AVEI for $3.6bil in MDT stock. At the time AVEI was facing significant litigation in Europe and the US (eventually lost most of their cases and has plagued MDT's stent business). In 1998 we were looking at a $2bil global stent business, today its closer to $6bil. US Stent market shares prior to DES introductions was highly volatile. There was a day when one player would have 60-80% share one quarter and see that fall to 20% when the next prodcut was introduced. If CONR is successful in taking the rate of SAT's closer to 0% and the efficacy profile is similar to Cypher and Taxus, why couldn't we see that share shift when CONR enters the market. When Taxus came to the US they went to 80% real quick before running into their clinical issues and the recalls. So if CONR shows positive US clinical results and wins the UK case where does this stock go? I guess for the market to decide, but why the heck would you be short an open opportunity stock unless you have insights into clinical trials and court cases. If you have such clinical and legal insights feel free to share.
HEPH
It appears that the requirement for thrombocytopenia is back in the government's RFP. However, they still request only 100,000 doses.
http://www2.eps.gov/spg/HHS/OOS/postdatePrevDays_1.html