February 24, 2010
– Comments (35)
I think it might be a good idea to buy some ANDS shares now.
It is currently at around $1.76 in after-hours trading.
ANA598 200 mg bid 12 Week Results (pdf)
Q4 2009 Anadys Pharmaceuticals, Inc. Earnings Conference Call
ANA598 Demonstrates 73% cEVR in Combination With Interferon and Ribavirin
I just listened to the conference call. ANDS may be undervalued by quite a bit currently ...
Anadys hep C drug shows early 73 pct response-study
your site sucks
I will buy some shares in German trading tomorrow. I have added ANDS to my list of current favourites, which now looks like this.
ABBN:VX, AGX:GR, AIXG, ANDS, ARIA, ARRY, ATPG, BAS:GR, BAYN:GR, BION:SW, BPSG, BRCD, CDE, CRME, DAI, EMC, EXAS, FACT, GLW, HEI:GR, HLCS, ISIS, JAV, KSB3:GR, LNUX, LXRX, MAIL, MYGN, MYRX, NOVL, NOK, NZ, OMEX, ORTE:EY, PAH3:GR, PARD, QGEN, REP, SA, SGL:GR, SPPI, SQNM, STEC, SWV:GR, UCG:IM, VECO, VMW, VOW:GR, VOW3:GR, XNPT, XOMA, YAR:NO.
I have contributed a few positions to this portfolio (-> "permanent") by tigerpack. The largest positions I suggested are currently AIXG, ALNY, AMAG, ATPG, BPSG, BRCD, CRME, EMC, EXAS, LXRX, PBTH, QGEN, REP, SQNM, STD, XNPT.
That "slide 7" playing a major role in the Q&A part of that conference call.
I agree with their interpretation that the placebo curve shows an "anomaly" caused by the small sample size (number of patients in that arm). Let's hope that the blue curve will be similar for larger N in a subsequent trial ...
*At week 12, N=26 for the ANA598 group and 14 for the placebo group. Â One patient receiving ANA598 who had undetectable levels of virus at last measurement (week 4) and one patient receiving placebo who had a viral load of 150,000 IU/mL at last measurement (week 10) became unavailable and are excluded from weeks subsequent to their last measurement. Â The placebo values represent approximately half the overall placebo group, with the remainder of the placebo group being dosed presently, concurrently with patients receiving ANA598 400 mg bid.
Unless another patient or two are lost again (hehe) that placebo anomaly might be "cleared" pretty soon ...
I'm not willing to divulge the size of my jockey shorts to listen to the conference call Porty, could you post the nutshell edition?
better readable versions of the press releases.
ANA598 Demonstrates 73% cEVR in Combination with Interferon and Ribavirin (pdf)
Anadys Pharmaceuticals Reports Fourth Quarter and Year-End 2009 Financial Results and Highlights (pdf)
The nutshell edition might be presented by Feuerstein tonight or tomorrow (here). He already commented on it here.
My summary would be. If the red curve does not turn up from week 10 to week 12 and the blue curve would be similar for the 400mg group and of course in a trial with a larger number of patients ANDS should certainly have a higher enterprise value than it had when it traded at $1.76 about two hours ago.
By the way, this is just a phase 2 trial. Don't buy any shares (or short any) just because I or someone else suggests doing that. Reading the stuff linked above, listening to the conference call and having adequate "background" knowledge is probably essential. I am still working on that "background" part. oh well ...
Looks interesting. Do you have any info about the other 2 drugs in the cocktail?
... and the size of the placebo group was really small. N = 14 (half of the total placebo group, the other half is compared to the 400 mg arm). So the 71% cEVR after week 12 is simply 10/14 ≈ 0.71. Had they been able to follow up on that one patient and had he remained above the cut-off level for cEVR it would have been 9/14 ≈ 0.64. That was what that one somewhat confused analyst asked about in the Q&A part. They told her of course that you don't "add lost patients back in" but they did say that it would have gone down to around 60%. N = 14 is just a really small number, especially when you lose one along the way ...
for comparison some results for the potential "blockbuster" drug by Vertex Pharmaceuticals (VRTX).
New England Journal of Medicine Publishes Landmark Clinical Studies of the Investigational Hepatitis C Virus Protease Inhibitor Telaprevir
CAMBRIDGE, Mass., Apr 29, 2009 (BUSINESS WIRE) -- Two clinical studies published in this week's New England Journal of Medicine demonstrate that treatment with the investigational oral hepatitis C virus (HCV) protease inhibitor telaprevir dosed in combination with pegylated-interferon (peg-IFN) and ribavirin (RBV) as part of a 24-week treatment regimen resulted in a significant improvement in the rate of sustained viral response (SVR), considered a cure of the viral infection, in treatment-naïve genotype 1 HCV patients, as compared with the SVR rate for standard therapy dosed for 48 weeks. The data are from two Phase 2b (mid-stage) clinical trials of telaprevir known as PROVE 1 and PROVE 2. In these trials, patients who received a 24-week telaprevir-based treatment regimen achieved SVR rates of up to 69 percent, as compared to SVR rates of up to 46 percent in patients in the control arms of these trials who received peg-IFN and RBV for a standard duration of 48 weeks.
So they compared it to "peg-IFN and RBV" as well and they had 69% SVR rate for telaprevir dosed in combination with pegylated-interferon (peg-IFN) and ribavirin (RBV) and 46% for control arm received peg-IFN and RBV.
(it might be a good idea (for all of us but zzlangerhans) to start reading on p. 159)
I'll start some DD. You are always a wealth of information.
I've got to stop passing by those "... "headlines.
#14 I mentioned the SVR rate for telaprevir and placebo just to show what nice results after 24 weeks would look like. They only have the 12 week results (cEVR rates) so far for ANA 598 200 mg and for that half of the total placebo group.
Emerging Therapies for Chronic Hepatitis C Virus (pdf)
Hepatitis C Treatments in Current Clinical Development (pdf)
an analyst report from last November.
Piper Jaffray Upgrades Anadys Pharmaceuticals (ANDS) to Overweight
November 3, 2009 7:34 AM EST Piper Jaffray & Co. upgrades Anadys Pharmaceuticals (Nasdaq: ANDS) from Neutral to Overweight. Price target $2.50. Piper analyst says, "Early safety data and 4-week rapid viral response (RVR) rates are expected by year-end. Further data including 12-week early viral response (EVR) and the more critical safety assessment is expected to be reported in 1H:10. We are optimistic that 200mg BID ANA598 will show potent anti-viral activity without inducing rash leading to new partnering discussions. With positive 4-week efficacy data and a clean safety profile, Anadys should be able to get suitors back to the table for a partnership next year. "We are upgrading to Overweight based on a projected enterprise value of $113 million (up from $94 million) by applying the same 5x multiple to 2015 projected ANA598 sales of $156 million discounted back at 50%. To this we add $10 million for ANA773 and YE:10E net cash...Risks include developmental, clinical, and regulatory. ANA598 may fail in clinical trials. Anadys may not enter new collaborations. The company could face unforeseen litigation and will need to raise additional capital this year."
discounted back at 50%
that is 50% p.a.!
okay, now that I have done my little pseudo biotech analyst stunt I might as well give my rating.
buy, 12m price target $3.
Stay away from this sector unless you're willing to do due diligence to the third degree. Small cap biotech eats investors for breakfast.
(from comment #15 here)
Anadys shares fell 15 percent after the data were released as investors may have been disappointed by the unexpected similarity of response rates at 12 weeks between the Anadys drug arm and control group of the study.Of the 14 patients who received the standard treatment of pegylated interferon and ribavirin, the cEVR rate was a much higher-than-expected 71 percent."It doesn't look like a differentiated product on top of standard of care. There was essentially no difference between 598 on top of standard of care and standard of care," said Thinkequity analyst Brian Skorney, calling the control group response "bizarre" and "confounding."There was a much larger separation of response rates between the two treatment arms at weeks 4, 6, 8 and 10, when the ANA598 viral response was already at 73 percent, while the standard of care group response was 54 percent.Anadys said the virtually identical 12-week response rate between the two arms of its Phase II trial may be due to the small number of patients, and were likely skewed by one patient from each group who was unavailable for measurement at week 12 of the study so were not included in the data."I can buy the explanation, but I have to see more data to accept the explanation," Skorney said."If we see a repeat in the next data slice, then it's not compelling," he added."We would expect the placebo group number to regress back to more typical historical norms as the numbers of patients became larger both in this trial and in subsequent trials," Anadys Chief Executive Steve Worland said in a telephone interview.Analysts on a conference call with the company appeared to be generally impressed with the ANA598 data.
"We're very encouraged. The cEVR number, good safety and lack of rebound are all very positive for 598," Worland said, noting that the response rate was "comparable to the most advanced protease inhibitors in development."ANA598 belongs to a class of drugs called non-nucleoside inhibitors."There's a fair amount of skepticism that a non-nucleoside that even got a good number early could sustain that number between week 4 and week 12," Worland said."Everybody who experienced benefit from 598, all of that benefit is preserved through week 12," Worland said. "That's contrary to expectations and very positive for combining 558 with direct antivirals."Patients will continue to be treated through 24 or 48 weeks, with the most important data, the sustained virologic response, or SVR rates, becoming available toward the end of the year, the company said.SVR is considered tantamount to a cure for the serious liver disease. The cure rate for the current treatments is typically only between 45 percent and 60 percent.The current standard treatments require 48 weeks of dosing and are difficult to tolerate with flu-like symptoms often persisting throughout. Patients not helped by those drugs often have no alternative but an eventual liver transplant.Several companies, including Vertex Pharmaceuticals Inc(VRTX.O) and Merck & Co (MRK.N), are developing promising new antiviral medicines that have shown far higher cure rates, often with shorter treatment durations, when combined with standard drugs.The early response rate for ANA598 is comparable to what has been seen for those other promising hepatitis C treatments in clinical trials, while the control group response was far higher than what has been seen in those other studies.Discussions on a partnership deal for ANA598 are now expected to heat up."We're resuming an engaged level of dialogue with companies now that were waiting to see the 12-week data," Worland said.
HCV Protease Inhibitor Telaprevir Demonstrates Good Efficacy in Both Treatment-experienced and Treatment-naive Patients
A Phase 2b Study of Telaprevir with Peginterferon-Alfa-2a and Ribavirin in Hepatitis C Genotype 1 Null and Partial Responders and Relapsers Following a Prior Course of Peginterferon-Alfa-2a/b and Ribavirin Therapy: PROVE3 Interim Results Reported by Jules Levin AASLD Nov 3 2008 San Francisco, CA J. G. McHutchison; M. L. Shiffman; N. Terrault; M. P. Manns; A. M. Di Bisceglie; I. M. Jacobson; N. H. Afdhal; E. Heathcote; S. Zeuzem; H. W. Reesink; S. George; N. Adda; A. J. Muir PROVE3 Interim Analysis: AUTHOR SUMMARY and CONCLUSION
In a population of patients who have failed previous Peg-IFN/RBV therapy, response rates 12 weeks after end of treatment were 52% overall in the T12/PR24 arm: --73% in prior relapsers --41% in prior non-responders (they did not present data separate for null-responders) Lower response rates (21%) in T24?p24 (no RBV) arm are consistent with PROVE2 Adverse events reported more frequently in the TVR-treatment arms versus control were GI events, fatigue, headache, anemia and skin events (rash, pruritis) -- Other AEs were similar in type and frequency to those seen with Peg-IFN/RBV --Treatment discontinuations at week 36 due to AEs were: 16% in the TVR-based treatment arms 4% in the control arms
--PR48 (control): placebo + peg/IFN/RBV for 24 weeks, peg/IFN + RBV for 24 additional weeks --T12/P24 TVR + peg/RBV for 12 weeks plus 12 weeks of pegIFN/RBV --T24/P24 (no RBV) TVR + Peg/IFN for 24 weeks --T24/PR48 TVR + peg/RBV for 24 weeks, peg/RBV for additional 24 weeks
65-70% men 88-90% Caucasians 8-10% black race age 50-53 yrs BMI median 27-28 Median HCV RNA 6.7 to 6.8 logs HCV genotype: 54-62% 1a, 29-37% 1b Prior response: -non-responders 56-60% - relapsers 35-37% - breakthroughs 3-9%- Bridging fibrosis 23-29% Cirrhosis 11-20%
Week 4 T12/PR24 61% T24/PR48 50% T24/P24 (no RBV) 47% PR48 (control) Week 12 T12/PR24 (n=118) 75% T24/P24 (no RBV) (n=111) 53% T24/P48 (n=113) 66% PR48 (control) (n=114) 8% Week 24 T12/P24 70% T24/PR48 56% T24/P24 (no RBV) 48% PR48 (control) 33%
(so again not directly comparable as, among other things, those patients were not treatment-naïve)
comment #25 above, by the way, is probably the "nutshell edition" requested in comment #8 above.
would have been 9/14 ≈ 0.64
would have been 9/15 = 0.6
sorry, still wrong. here we go ...
- Two patients receiving placebo had unavailable samples for week 10 and are excluded from results at week 10 but are included at week 12. One patient receiving placebo who had consistent viral load ≥150,000 from weeks six through week ten but was then lost to follow-up is excluded from results at week 12.
(from slide 8 here (pdf)).
So if they had been able to "follow up on that patient" and that patient had not made the cut for cEVR (highly likely considering his viral load having been greater than 150,000 from weeks six through week ten) two fields of the table on slide 8 would have shown different values.
"All Patients, Placebo + SOC, Week 12 (cEVR)" would have been "67% (10/15)" instead of "71% (10/14)" and
"Genotype 1a Patients, Placebo + SOC, Week 12 (cEVR)" would have been "58% (7/12)" instead of "64% (7/11)".
So the "headline comparison" of the cEVR rates "73% in the ANA598 200 mg (*) arm vs. 67% in the placebo (*) arm" would have looked better, but the number of patients is simply too small. We will have to wait for the 12 week (cEVR) numbers for the 400 mg (*) vs. placebo (*) part of this trial, for the 24 week data (SVR rate) of both subtrials and more importantly for subsequent trials with larger N.
* in combination with SOC
We will have to wait ...
This does not keep me from recommending ANDS and from buying some shares since the 200 mg arm does have a decent number of patients (26 arriving at week 12), 73% cEVR appears to be okay, there were not "rebounds", safety and tolerability was okay and it is well known what the placebo arm will do for larger N (from other similar trials).
or the "nutshell version".
I think the blue curve will not suddenly crash in week 13 (and might be higher for the 400 mg arm), the red curve will be lower (will be where it it expected to be looking at earlier larger trials), safety and tolerability will be okay and all this makes it sufficiently likely (for me) that they will find a partner for the ANA598 program ...
I am not really satisfied with my ad hoc analyst job. I think I will refrain from this kind of behaviour for at least a few more weeks!
and now everyone knows why it is better to ignore my calls.
doesn't anybody feel bad for the monkey?
I like your JAV call, I noticed insider buying.
sounds like....Fool pumpin'....
Ahead of the Bell: Anadys hepatitis C drug Anadys study results show little difference between hepatitis C drug, placebo; shares slide
On Thursday February 25, 2010, 9:25 am EST
NEW YORK (AP) -- Development-stage drug developer Anadys Pharmaceuticals Inc. said late Wednesday its developing hepatitis C drug was only slightly more effective at treating the virus than placebo in a midstage study.
The company's shares plunged 46 cents, or 20 percent, to $1.85 in premarket trading.
Oppenheimer analyst Dr. Brian Abrahams cut his investment rating on the company's shares to "Perform" from "Outperform" and removed his $8 price target on the stock. He said the more rapid effectiveness suggest that the drug candidate has some activity, but the 12-week data is concerning.
"The fact that '598's magnitude of benefit was not sufficient to overcome this anomalous placebo response is concerning (and unusual in HCV trials) and makes interpreting '598's contribution to efficacy challenging which could complicate partnership discussions," he said, in a note to investors Thursday.
Leerink Swann Research analyst Howard Liang reaffirmed his "Outperform" rating on the stock and said his key focus is on the study's safety results. Despite one case of severe rash, he said, there is no sign that indicates it is any worse than current treatments.
Meanwhile, Anadys Pharmaceuticals Inc. said its fourth-quarter loss narrowed on lower operating expenses.
The San Diego company lost $4.2 million, or 11 cents per share, compared with a loss of $8.5 million or 30 cents per share, during the same period a year prior. There was no revenue in either period. Operating expenses fell to $5.6 million from $8.9 million.
Analysts polled by Thomson Reuters expected a loss of 17 cents per share.
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