Assembling my biofolio...
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Re: Seeking Alpha
"Regular readers of this board are presumably aware that many SeekingAlpha write-ups are utterly lacking in insight and some write-ups merely lift material from elsewhere (such as this board)."
I think it just depends on the author. I find the articles from Ohad Hammer to generally be among the better ones.
Feuerstein on BIO/Small-Cap Biotechs
He touches on CRIS and IMGN, two of my current holdings, among others.
http://www.thestreet.com/story/10460770/1/bio-ceo-09-small-biotechs-time-to-shine.html
"One of my personal favorites is ImmunoGen, which is partnered with Genentech on a very promising second-generation version of the blockbuster breast cancer drug Herceptin. (ImmunoGen is included in the model portfolio I manage as part of the Biotech Select newsletter.)
Curis is another cheap stock with a cancer drug partnered with Genentech. In fact, Genentech CEO Art Levinson spent a good bit of time at the recent J.P. Morgan Healthcare conference talking about this drug."
Re: BioMS
"How plausible is it that Dirucotide has strong efficacy in SPMS but not in RRMS?"
That's a very good question and one I meant to raise in my last post but forgot. I am by no means an MS expert so I don't know all of the differences/similarities between those two patient populations (SPMS vs. RRMS) and how a given drug should react in those two populations. But, it's another fair question that has to raise some level of doubt for the drug.
Re: BioMS
I haven't listened to the call but I wonder if there was an overreaction on the downside. The successful results, and all of the related hype to-date, for Dirucotide have occurred in secondary progressive MS. The results in that population group have clearly been positive as far as primary endpoints. I believe this was the first trial to test if the drug would work in relapsing-remitting MS.
So, if the drug shows successful results in Phase III for SPMS, similar to what it has already shown, the stock should clearly rebound. I have no skin in the game on this one as it's just too risky being essentially an all-or-nothing bet on Dirucotide.
Re: SGEN
I raised the exact same point regarding SGEN's market cap before. I compared its market cap to IMGN's (one of my largest holdings) as SGEN's is about 4x that of IMGN even though both have key partnerships with DNA involving ADCs. One of the counterpoints was that the terms of SGEN's partnership was much more lucrative than IMGN's. I do see that point but I don't think SGEN should be valued 4x that of IMGN. At the end of the day it's all about risk/reward and I like IMGN's much more than SGEN at these levels.
Re: MEDX
I'm going to have to agree with you on this one.
Re: IDX899
Thanks Dew. Appreciate the info as I continue to follow IDIX.
ACHN briefly mentioned on GILD Q4 '08 conf call
A general comment was made at one point that HCV was the "most focused research area" for GILD. Furthermore, around about the 38 minute mark of the call, GILD mentioned that it is focused on 7 different approaches to treat HCV either in-house or through "collaborations with companies such as Achillion." They also stated that these approaches have led to the discovery of "very interesting lead compounds." While this may not appear to be significant news, it's nice to hear them specifically cite ACHN as they had not done that in some time.
Re: GILD Quadro/impact on IDX899
Dew, how do the Quadro studies impact on the potential of IDX899? If Quadro is successful and becomes the future SoC in first-line HIV, which of its components would IDX899 attempt to replace?
Re: Dimebon data
The Dimebon data was from a small Russian study, correct? How much stock do you put in that? I'm anxious to see how the data stacks up after a U.S. trial. I don't have the guts to touch MDVN until then.
Re: PCOP pipeline
Fair enough rkrw. And opinion much appreciated!
Re: PCOP pipeline
I guess my point is that the pipeline consists of a large number of compounds that are partnered with several major drug companies. That doesn't guarantee success of course but the fact that they were able to attract several large pharmaceutical companies and a large biotech (Celgene) has to add some degree of validity. LGND obviously agreed and that's why the merger was proposed and ultimately consummated.
Re: LGND/PCOP
Rkrw,
I was just looking to get a little more feedback on your thoughts of PCOP's pipeline. I was a former PCOP shareholder and now own some LGND given the merger. PCOP had quite an extensive pipeline (http://www.pharmacopeia.com/wt/page/product_portfolio ) at the time of the merger with LGND along with numerous partnerships (Schering-Plough, BMS, GSK, Celgene, and Wyeth) so I'm not sure what you had against their pipeline.
PCOP's lead compound was a dual-acting angiotensin and endothelin receptor antagonist targeting hypertension. See: http://www.pharmacopeia.com/wt/page/PS433540. I'm curious if you or others have any opinions on this compound.
O/T Re: GLD vs. goldmoney.com
I believe it may be cheaper to use goldmoney.com. Note that you're investing directly in the physical holding there as opposed to holding shares in an ETF via GLD. The storage fees at goldmoney are a max of 0.18% annually and you also pay a fee on purchases, much as you would a commission on GLD. See: http://goldmoney.com/en/fees.php. What are the annual management fees for GLD? I couldn't quickly track that down.
Separately, I believe there may be tax advantages to directly holding the metal itself as opposed to holding shares in an ETF that invests in gold.
Finally, you can invest your cash balances in a wide variety of foreign currencies at goldmoney.com.
O/T: Goldmoney.com
Does anyone have any experience with this Web site and have any feedback for me? This appears to be an easy way to directly invest in gold and I was considering this for a very small portion of assets in the future. It appears reputable based on everything I've read.
Thanks for any help.
Re: PANC/message board delusion
A $30 million dollar buyout for their patents? When all they could muster was $7 million for their only drug in the clinic, which was based upon those patents? Message board delusion indeed.
Re: ARRY Web site
Good idea Biowatch and one I've taken to heart. Let's see if my e-mail has its intended effect.
Re: PANC/Bevirimat
Good call on this. I'm glad I never invested in PANC.
Re: ARRY Web site
That appears to be the case. I think they should include all of their partnered drugs/programs together with their unpartnered ones to show the breadth of the company.
Re: MITI/Seeking Alpha
"A high frequency of write-ups in SeekingAlpha is more apt to be a negative indicator than a a positive one, IMO :- )"
LOL, fair enough. Now, if only Ohad Hammer would stop writing about IMGN, one of my largest holdings.
Re: Ablynx/competition
I think Micromet (MITI) is one to keep an eye on in the antibody space. However, I'd like to see them sign a nice partnership and get a nice chunk of cash upfront as their finances are not exactly in order. They expected to sign two partnerships in 2009 and did just ink Bayer (http://finance.yahoo.com/news/Micromet-Enters-Into-prnews-14027982.html ) to a deal worth about $6 million with possibly more downstream.
There have been a lot of articles on Seeking Alpha, for better or worse (lol), during the past year about the company. See, e.g., http://seekingalpha.com/article/63379-micromet-biting-cancer and http://seekingalpha.com/article/63887-micromet-biting-cancer-part-ii.
Re: ARRY-300
Thomas, any idea why ARRY-300 isn't listed in the pipeline on ARRY's Web site? http://www.arraybiopharma.com/ProductPipeline/Default.asp
I know they don't show the partnered compounds but this one is wholly-owned at this point. I was thinking it was just too early-stage, but it is ahead of ARRY-403, which is listed.
ACHN @ Lazard (11/18/08)
http://ir.achillion.com/events.cfm
I wish companies would make relevant webcasts more prominent on their Web sites, if not on the home page. I found this buried deep on ACHN's Web site under "News Center" then "Calendar."
Anyways, Michael Kishbauch, ACHN's President & CEO, recently spoke at the Lazard Capital Markets Healthcare Conference in November. Attached is a link to the presentation (you do have to fill in registration info but it's free and you can pretty much put anything in I assume), which is a little over 20 minutes and I think makes for a good listen whether you are an ACHN shareholder like myself or not.
I think the key points from the presentation are as follows:
1. Perhaps most importantly, ACHN is funded through the end of 2010.
2. By that time, ACHN expects to have proven proof of concept for their two HCV candidates, ACH-1095 (NS4A antagonist under partnership with Gilead) and ACH-1625 (unpartnered protease inhibitor), both of which are set to enter the clinic in early 2009.
3. There was some discussion on elvucitabine, ACHN's HIV nuke, which has completed Phase II trials. Specifically, the company will only proceed with development if a partner is found and Mr. Kishbauch did state that one could assume that partnership discussions are ongoing. Notwithstanding, it's clear that ACHN's primary focus and valuation driver going forward are its HCV candidates.
4. With respect to the HCV compounds, ACH-1095 is a follow-on compound to ACH-806, which showed efficacy in a Phase 1b trial in 2007 but was discontinued due to "mild" Grade-1/Grade-2 elevations in serum creatinine. ACH-1095 is synergistic with HCV protease inhibitors and additive to polymerase inhibitors.
5. ACHN believes it has solved the safety issues that plagued ACH-806. Specifically, ACH-1095 comes from a completely different chemical scaffold (fiazole - sp?; widespread use in 3-4 dozen drugs including Tagamet) than ACH-806, which came from an arcane chemical structure found in some obscure thyroid drugs [If it was so obscure, why did you use it in the first place guys?]. Also, ACH-1095 is apparently much more stable.
6. ACHN believes that a single metabolite found in humans, but not in their pre-clinical animal models, was responsible for the side effects seen in ACH-806. They are confident that ACH-1095 avoids the prior safety issues.
7. ACHN believes that they are alone in the development of an NS4A antagonist. To play devil's advocate, one might question whether or not an NS4A antagonist is a valid approach if no one else is working in this space. However, the fact that ACH-1095 is partnered with Gilead and that the prior compound did show efficacy despite the prior safety problems, which have hopefully been solved, provides some reassurance for me.
8. ACH-1625, the protease inhibitor, is expected to be a once/day drug and an IND is expected to be filed in 1Q 09. ACHN has begun to engage in partnering discussions and they believe that they will receive formal offers to partner the drug (no timetable given).
9. ACHN believes that the toughest competition for ACH-1625 in the race to bring to market follow-on PIs behind Telaprevir and Boceprevir will be TMC435 (Medivir/JNJ).
10. Finally, Mr. Kishbauch believes that we will start to see the market for interferons decrease in 2012 with the possibility of being completely replaced in about 2015 by the direct-acting small-molecule HCV drugs due to the side-effects of interferon treatment. Again, I'm not so certain this concern is valid for ZGEN's IF-Lambda, and possibly other interferons, given that the side-effect profile appears to be much improved in IF-Lambda based upon results to-date.
Re: iHub searching
Yep, I figured that out awhile ago. Thanks though. It sure would be nice to get that fixed.
Re: BioMS
"<<I had posted something (little) on them probably a couple years ago if you have search. I don't recall much but there was a good analysts report or article I read that talked about how the drug was supposed to work and didn't like its chances which discouraged me from seriously considering it. I kept watching them though but never close to buying>>."
I wasn't able to find your post using various keywords (BioMS, bomsf, dirucotide, etc.) but perhaps that is due more to my lacking search skills than anything else. ; )
I guess as far as not liking the chances of the drug working, I wonder if the article was older and before they had released any trial results for their MS drug. I'm by no means an expert in interpreting MS trial results, but the actual clinical results so far look pretty good.
First, here's a link to their Web site: http://www.biomsmedical.com/
Second, they have press releases on their Web site going back to 2003. Here's a link back to a release on 5/23/03 where they released final Phase II results for Dirucotide in Primary or Secondary Progressive MS patients: http://www.biomsmedical.com/display-press-release.php?id=28
"BioMS Medical Corp (TSX: MS) today announced positive final results from its Phase II clinical trial for the treatment of multiple sclerosis (MS) with its synthetic peptide MBP8298. The MBP8298 peptide is designed to reduce the disease-associated production of a group of anti-MBP antibodies that are reactive with the central nervous system.
The 4 year Phase II trial enrolled 32 patients with either Primary or Secondary Progressive MS. The study had two phases, a two-year randomized double-blinded, placebo-controlled phase, followed by a two-year open label phase. During the double-blinded phase patients were given 500 mg of the MBP8298 peptide intravenously every 6 months. Data from the trial was analyzed both in terms of overall results, and in terms of a genetic sub-group of patients who carried either HLA-DR2 or HLA-DR4 immune response genes (“DR2/4”). These genes are associated with T-helper cells involved in the production of anti-MBP antibodies targeted by the MBP8298 peptide.
Whereas the incidence of DR2/4 genes in the normal population is relatively low, in the MS population patients that have either the DR2 or DR4 genes account for approximately 75% of the estimated 2 million MS patients worldwide. Of 32 patients enrolled in the double-blinded phase of the trial, there was a representative sample of 20 patients that carried either the DR2 or the DR4 genes, and these were evenly divided between patients dosed with MBP8298 (n=10) and placebo (n=10).
Statistically Significant Results in Patients with HLA-DR2 or HLA-DR4 Genes Clinical progression was measured by changes in score on the Expanded Disability Status Scale (“EDSS”), as the primary clinical indicator. EDSS is used to assess patients’ ability to function on a scale of 0 to 10. Patients were considered to have progressed if they had a confirmed change in EDSS of greater than or equal to 1.0 when their baseline score was less than or equal to 5.0, or a change of greater than or equal to 0.5 when their baseline score was greater than or equal 5.5.
At the end of the double-blinded phase, 0 out of 10 (0%) of the DR2/4 patients on MBP8298 progressed on EDSS as compared to 6 out of 10 (60%) of the patients on placebo (Fisher’s Exact test p=0.0108).
“Potentially delaying the debilitating progression of MS represents a major step forward in the treatment of MS,” said Mr. Kevin Giese. “A 100% stabilization rate over a two year period in the DR2/4 group exceeded our expectations.”
At the end of the open label phase, only three of the DR2/4 patients on MBP8298 (30%) had progressed at 42 months, meaning that the median time to confirmed progression for the MBP8298 patients is at least four years as compared to that of the placebo patients which was 2 years (Log Rank test p=0.004). The results were equally valid for both Primary and Secondary Progressive MS patients.
In terms of safety, patients on MBP8298 showed no statistically significant difference from the placebo group in terms of adverse events, use of steroids or in the results from eight different MRI tests. No treatment-related serious adverse events were recorded in the patients receiving MBP8298, providing further confirmation of the drug’s safety and tolerability.
Results in the Total Population
The 32 patients in the double blinded phase were made up of 16 patients that received MBP8298 and 16 that received placebo. In terms of EDSS, only 5 out of 16 patients on MBP8298 progressed as compared to 9 out 16 patients on placebo, which constitutes a 44% reduction in progression (Fisher’s Exact test p=0.29). Similarly, in terms of the two secondary clinical outcomes, the 22 meter Timed Walk and Foot Taps, both the overall and DR2/4 sub-group results showed patients on MBP8298 scoring better than placebo, although not with statistical significance. There were no statistically significant results on any safety parameter, nor was there any serious MBP8298-related adverse event.
My thoughts:
Admittedly, this is a very small trial as it only included 32 patients. And of these patients, only 20 carried one of two genes for whom such sub-group the drug is intended to work. These 20 were then divided to half receiving the drug and half receiving placebo.
My main question would be whether or not the Expanded Disability Status Scale that BioMS used to measure the results is the de facto standard in MS trials or is it some obscure measure. Also, I'll put some stock in the results out to two years as these were double-blind and placebo-controlled. 0 of 10 patients on the drug progressed according to EDSS compared to 6 of 10 on the placebo and this was statistically significant. However, how much can we rely on the results past two years as these are based on an open label?
Also, the results in the total population were better for the drug compared to placebo but not statistically significant. However, since the drug is targeted to the sub-group of MS patients that contain 1 of 2 specific genes, and trial results were statistically significant regarding primary outcome in this sub-group, I don't believe this would be of great concern.
I would question how important the secondary measurements of 22-meter timed walk and foot taps are as the drug results were not stasticially significant compared to placebo, even in the sub-group of MS patients for which the drug is targeted.
Re: BioMS
Dew, do you have any opinion on BioMS and its MS drug? There hasn't been a lot of chatter on here about the prospects for the company, other than news releases that have been posted. It appears to be a tiny, obscure company but they've attracted Eli Lilly and their MS drug has shown good results so far.
Re: INFORM-1/IFN-Lambda vs. Albuferon
Thanks Dew, that makes sense. It looks we will have some initial data from INFORM-1 in April. I've got ZGEN on my watch list now, but I think it might make more sense to wait and get the initial INFORM-1 data before truly considering an investment.
Separately, I want to get your specific thoughts on IFN-Lambda vs. Albuferon. I know you have Albuferon higher on your "HCV: Most Likely to Succeed" list, although that may be in part due to the fact that it's so far ahead in the clinic.
I can't say I'm too impressed with what I've seen so far in Albuferon. Albuferon was less potent than Pegasys in the latest ACHIEVE-2/3 trials, although they can claim "non-inferiorty" from those trials. With respect to safety, the Albuferon and Pegasys arms were comparable. I realize there are less injections with Albuferon but is this really a giant step forward in interferon treatment for HCV? It seems more like baby steps to me.
IFN-Lambda, by contrast, appears that it may be more potent and much more tolerable given what we have seen so far in the clinic. This would seem to me to be a much more important advancement in interferon treatment for HCV. I realize much more work has to be done, but IFN-Lambda looks much more promising to me than Albuferon. Also, from an investment standpoint, ZGEN doesn't have the trainwreck of a balance sheet that HGSI does, especially given the cash coming in soon from BMY.
One final thought regarding the future of interferon in HCV therapy. I assume the main reason for wanting to replace interferon therapy with a strictly oral small-molecule regimen is due to the side effects of interferon. Again, this may not be as much of an issue with IFN-Lambda given its potential for much improved tolerability compared to current interferon treatment.
Re: Role of interferon in HCV SoC
"The question is when, not if. Virtually everyone in the field thinks this will happen in due course."
Do you have any prediction as to when interferon treatments will be entirely replaced by small-molecule treatments for HCV? 5 years? 8 years? 10 years+?
Small molecule treatments vs. interferon for HCV
Are there any expectations that the new small molecule treatments for HCV will entirely replace interferon in the future? I'm just curious because that would obviously negatively impact HGSI and ZGEN, among others, long-term.
Re: ARRY @JP Morgan
Thanks very much for the update Thomas. With respect to the partnered pipeline, I see the range of 3-13% for royalties on those drugs. I know ITMN-191 has a potential 3% royalty rate but do we know the specific breakdown for all of the other drugs? I'm especially curious about potential royalties for the DNA drugs.
Feuerstein Re: ITMN-191 data
Feuerstein isn't too thrilled with the ITMN-191 data today. See: http://www.thestreet.com/_yahoo/newsanalysis/biotech/10457281.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
"A 600 mg dose of ITMN-191 given twice daily and combined with the current standard of care therapy for hepatitis C reduced the amount of virus below detectable levels in 13% of patients treated for 14 days.
Using a less stringent measure of efficacy, 75% of these patients had no detectable virus in their system. InterMune reported the new data on ITMN-191 ahead of the start Monday of the J.P. Morgan Healthcare Conference.
InterMune said it was pleased with the data and that the company and partner Roche plan to move ahead with new ITMN-191 studies in the second quarter. However, Wall Street's biotech investors never evaluate hepatitis C drugs in a vacuum, and in this case, Monday's ITMN-191 data doesn't stack up very well against Vertex's telaprevir.
In a similar 14-day "triple combination" study done in 2006 by Vertex, 25% of telaprevir patients had undetectable levels of virus in their system. That number jumped to 92% when using a less stringent measure of efficacy.
Now, patients in the Vertex study had to take telaprevir every 8 hours, or three times a day, which is less convenient than the twice-daily dosing for InterMune's ITMN-191. If InterMune wins on convenience, Vertex still appears ahead on potency.
The study reported Monday by InterMune also treated groups of patients with a three-times-daily dose of ITMN-191 for 14 days. In the best of these groups, 57% of patients treated with ITMN-191 and standard of care had undetectable levels of the hepatitis C virus in their system under the most stringent measures.
These data on ITMN-191 top the performance of Vertex's telaprevir, however, InterMune and Roche will have a hard time pushing ahead with a three-times-daily dose of ITMN-191 because they are well behind Vertex in the race to get new hepatitis C drugs approved.
Vertex announced Monday morning that it has already completed enrollment in two pivotal phase III studies of telaprevir in treatment-naïve patients, with data expected in 2010. InterMune and Roche, on the other hand, are still planning phase II studies to start next quarter.
Furthermore, other hepatitis C competitors such as Schering-Plough, Johnson & Johnson, Boehringer Ingelheim are also ahead of InterMune, with some of these drugs dosed once a day."
What do you all make of his arguments? I guess my takeaway is why will ITMN-191 have problems ultimately competing against Telaprevir if a similar dosing schedule for ITMN-191 (i.e. 3 times/day) ultimately proves more potent than Telaprevir? I understand it's nice to be first to market and all but if someone comes along with a more potent drug eventually, whether that's 1 year later, 3 years later, or whatever, won't the new drug be able to effectively compete given a similar (or better) safety profile?
Prayers for you and your family fudoo. Get well soon my friend.
MNTA @ J.P. Morgan Healthcare Conference next Thursday
http://finance.yahoo.com/news/Momenta-Pharmaceuticals-to-pz-14014753.html
I didn't see this posted before. I plan on listening as it will be available live on MNTA's Web site.
Is this one of the better healthcare conferences? Are there any good conferences that smaller investors can attend in person or are these usually limited to analysts and wealthy private investors?
Re: ARRY
Thomas, which of the 8 wholly-owned programs are you most intrigued by and feel may be the key driver in valuation going forward?
Re: IMGN Valuation
<"hahaha why are you asking me what I think the share price should be? I don't really care, to be blunt. I was just curious how you arrived at the 5-600 million market cap target you mentioned">
Because I was trying to see to what extent we disagreed on the upside in valuation for IMGN given T-DM1 and I thought we were headed in that direction. I've never walked through a specific DCF calculation for a biotech, am not sure of the rule of thumb of discount rates that are normally used in biotech, and was hoping to see an example of this for IMGN. This would be helpful in applying to any other biotech stock of course.
<"But I'll tell you what: if you think it is going to sell 1 billion in its first year on the market (3-4 years from now), and then it's casually going to pick up another billion in sales the next year from first line use (will this require any data?), then things are probably looking good.">
Yes, of course it will require data to pick up sales in a first-line setting. And that's precisely what DNA is in the process of obtaining given the Phase II trial specifically in the first-line setting.
<"The only question remaining then is what the sales in the 3rd year will be? Another billion to bring it to 3?">
I predicted in my prior post peak combined sales of $2 billion for all settings.
Re: ANDS results
Dew, would you say the data is not that big of a deal just because it's so preliminary? We are only talking about 8 patients with 3 days' dosing data.
Also, I think you said separately before in reference to ACHN that it's not so much the potency with HCV drugs as it is the safety. So, the fact that it was so potent after just a few days means very little given that you can't really tell much of anything about safety in 3 days. And, with respect to potency, we don't know anything about possible viral rebound at a later point. Even if it's extremely potent at the start of treatment, any type of viral rebound later would negate that I would assume. So, we just need to see longer-term results. Notwithstanding, this is certainly good news for ANDS.
Re: ANDS results in genotype 1a vs. 1b HCV patients
What is the difference between genotype 1a and 1b HCV patients as far as market size? If the bulk of patients are 1a, I might be concerned as the drug was clearly more potent in the 1b type, although it was clearly active in 1a.
Re: Crowded Hep C space
I would just add that it's only crowded in a clinical sense. A lot of these drugs under development will never even make it to market. The few big winners will indeed have a lucrative market awaiting.
New Seeking Alpha article on RIGL (partnership speculation)
http://seekingalpha.com/article/113805-rigel-still-on-track-and-has-pfizer-found-its-next-blockbuster
"The company is currently developing a validated drug with blockbuster potential, and is expected to announce major collaboration deal during the first quarter."
Re: T-DM1 in third line
Yes, DNA commenced Phase II testing in August 2008 specifically in third line. See: http://www.immunogen.com/wt/page/other