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SPPI/GPC/PHRM:
I think Satra approval is better than 90%.
I take it that is for US approval. I know everyone thinks Pharmion will have a harder go at in Europe needing to wait for survival data, hopefully the drug makes it to market there without much delay as well.
HGSI:
I don't follow HGSI too closely. I had thought that Albuferon was not as efficacious as the PEG's just better dosing/compliance. Is this release misleading?
3:19AM Human Genome Sciences reports positive interim results of Phase 2b trial of Albuferon (HGSI) 11.51 : Co reports results at Week 12 following the completion of therapy in a Phase 2b clinical trial of Albuferon in combination with ribavirin in patients with genotype 1 chronic hepatitis C who are naive to interferon alpha-based treatment regimens. The interim results of the Phase 2b trial demonstrated that Albuferon provided at least comparable efficacy vs. Pegasys. The treatment group receiving Albuferon 900-mcg doses every two weeks achieved a 59% rate of sustained virologic response at 12 weeks following completion of therapy, vs. 54% for Pegasys administered once every week.
I don't follow options prices much but it seems to me to be harder then it looks to make money in options. If I didn't know better I'd think the same people that set betting lines set the premiums.
What Insomnia isn't an excuse? :)
GPC/SPPI:
There wasn’t any reason to think they would get a standard review, and an RTF was out of the question.
Since Cardiome/Astellas botched their filing I never take it for granted.
An interesting debate which drug has higher 2008 revenue Satraplatin or Provenge, especially if you thinks an approvable may be in one drug but not the others future.
Don't worry I only do play-by-play for baseball. I was/am curious how the market will perceive the results. Reading the boards I get the sense reaction is quite mixed. Thought you would do a poll on price :).
GPC/SPPI:
GPC is up about 7% on the German exchanges.
The way I value royalty revenue is about 1.5x - 2x higher multiple of ordinary revenue. Then one needs to consider GPC vs. Spectrum pipeline. I am only aware of GPC's antibody program (I believe for NHL) which is still early stage. SPPI has two other key drugs in EOquin and Ozarelix. They also have a number of other smaller/earlier stage products. I think SPPI-1620 may turn out to be an interesting drug candidate. Granted it is still preclinical but I believe Spectrum will enter Phase 1 later this year with it. It is an adjunct to chemotherapy. There are a couple posters at AACR on it:
ETB receptor agonist, IRL-1620, enhances the efficacy of cyclophosphamide and cisplatin in ovarian tumor bearing mice. Tuesday, Apr 17, 2007, 8:00 AM -12:00 PM
and
IRL-1620 increases the efficacy of radiation treatment in mice bearing lymphoma cell induced tumors Monday, Apr 16, 2007, 1:00 PM - 5:00 PM
VRTX: Overseas trading
For those impatient (or just fellow insomniacs) rounded numbers below
http://finance.yahoo.com/q?s=VX1.F - Up 6% 850 shares
http://finance.yahoo.com/q?s=VX1.SG - Up 4% 200 shares
http://finance.yahoo.com/q?s=VX1.HM - Down 2% 1800 shares
http://finance.yahoo.com/q?s=VX1.DE - Down 3% 50 shares
http://finance.yahoo.com/q?s=VX1.BE - Up 3% 50 shares
http://finance.yahoo.com/q?s=VX1.MU - Up 4% 3000 shares
http://finance.yahoo.com/q?s=VX1.DU - Down 3% 50 shares
VRTX:
I was out and missed the call live. I see the webcast is only 20 minutes and no Q&A was there any on the live call?
Haven't seen anything (yet) to discourage me from InterMune's 191 position. Anxiously awaiting 1B data this fall. But I am glad to see telaprevir having good (while not spectacular) efficacy. The AE's, 3x vs 2x dosing give me optimism 191 has at least 3 routes to improving on what telaprevir potentially has to offer.
In the latest InterMune investor conference Dan Welch mentioned the improved instrumentation led the company to a DDW abstract showing 3 orders of magnitude more potency in one model then telaprevir (previously had reported 2) and also abstract showing the disassociation rate is 4-5x slower then 950 in the liver.
CYBX:
Oops my mistake thanks for the correction, memory not that great and I am not really into devices just remember Skip Cummings (Did a quick lookup) being entertaining in the call :)
OT: lentiman
Sorry for the mispost (intended for another board) thanks for removing it from here. I don't have a paying membership so apologize for the reply here (feel free to delete this one as well)
CU programs:
Sorry to but in to your discussion but just a couple of thoughts. InterMune (a while back) created an early access program for Pirfenidone where a lottery system was used as the entry criteria. Also Actimmune was available (granted off-label) while the company was actively recruiting for the (since discontinued) INSPIRE study. One motivation to enroll in a trial rather then CU program could be the drug is provided free of charge for some period after the study. Yeah I guess it slows enrollment somewhat but there is still incentive for some and you get some of the benefits of getting the drug out there. Just my 2 cents.
You mention drugs and ODAC so this doesn't apply but I remember a case with a medical device for depression (Medtronics) that received a positive recommendation and then was given a non-approvable (I believe). One of the most entertaining conference calls followed where the then CEO berated the FDA (he has since been forced to resign). I believe the device was later approved despite the non-approvable.
VRTX:
Don't know if someone posted this already. From the company website:
April 14: Investor Presentation at 42nd Annual EASL Meeting @1:30pm EDT (7:30pm CEST).
OT: General Drug Safety/Review Info from NEJM
Basically more criticisms of Vioxx and why the government is so bureaucratic. OK I'll admit put me in the camp that supports easier approval and early access. I do support the enforcement of post-marketing studies (UTHR did theirs so others should too :) ) and am not all that much against making drug companies pay more fees (if it speeds up the process), maybe it will even cut down on some of the very marginal submissions? Don't know about the proposal cosponsored by the honorable Senator from Massachusetts as I am generally leery of him :)
Paying for Drug Approvals — Who's Using Whom?
Jerry Avorn, M.D.
http://content.nejm.org/cgi/content/full/NEJMp078041
Drug Safety Reform at the FDA — Pendulum Swing or Systematic Improvement?
Mark McClellan, M.D., Ph.D.
http://content.nejm.org/cgi/content/full/NEJMp078057
PDUFA Reauthorization — Drug Safety's Golden Moment of Opportunity?
Sean Hennessy, Pharm.D., Ph.D., and Brian L. Strom, M.D., M.P.H.
http://content.nejm.org/cgi/content/full/NEJMp078048
VRTX:
Does anyone know where/when we'll first hear about the late-breaker telaprevir data? Company PR mid-day (EST)?
The info I found at the EASL site (below) indicated 17:45.
17:45 RESULTS OF AN INTERIM ANALYSIS OF A PHASE 2 STUDY OF TELAPREVIR (VX-950) WITH PEGINTERFERON ALFA-2A AND RIBAVIRIN IN PREVIOUSLY UNTREATED SUBJECTS WITH HEPATITIS C
J.G. McHutchison 1, G.T. Everson 2, S. Gordon 3, I. Jacobson 4, R. Kauffman 5, L. McNair 6, A. Muir 7
1 Division of Gastroenterology, Duke University and Duke Clinical Research Institute, Durham, NC, USA; 2 Department of Hepatology, University of Colorado Health Sciences Center, Denver, CO, USA; 3 Henry Ford Health System, Detroit, MI, USA; 4 Division of Gastroenterology and Hepatology, Weill Medical College of Cornell, New York, NY, USA; 5 Vertex Pharmaceuticals, Cambridge, MA, USA; 6 Vertex Pharmaceuticals, Cambridge, MA, USA; 7 Division of Gastroenterology, Duke University and Duke Clinical Research Institute, Durham, NC, USA
Compassionate Use/Early Access for Prostate Cancer Therapies:
For what its worth GPC is doing an early access program. According to Yahoo figures (granted not always up-to-date) GPC 's market cap is 2/3 of DNDN and doesn't have much more cash. What would it cost DNDN to put this in place 500k shares (if they do this near todays close)? I also own BMRN which will be doing the same for Kuvan and in fact one analyst (I do as well) think the launch will be faster with this in place. I think an expanded access program is good for everyone patients, physician acceptance/uptake of the drug. Outside of what would be nominal cash savings, I can't think of any good reasons not to do it (just bad ones) but maybe I am missing something.
http://biz.yahoo.com/prnews/070221/clw082.html?.v=50
GPC Biotech Launches Expanded Access Program for Oncology Drug Candidate Satraplatin in the U.S.
Wednesday February 21, 4:20 am ET
MARTINSRIED/MUNICH, Germany, WALTHAM, Mass. and PRINCETON, N.J., Feb. 21 /PRNewswire-FirstCall/ -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced that the Company has launched the Satraplatin Expanded Rapid Access protocol (SPERA) in the U.S. Expanded Access Programs (EAPs) are intended to give patients access to investigational drugs to treat serious or life-threatening diseases or conditions for which there are no adequate therapies available. Under the SPERA program, satraplatin will be provided to patients free of charge.
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"There is an important medical need for treatments for hormone-refractory prostate cancer patients whose first-line chemotherapy has failed," said Martine George, M.D., Senior Vice President, Clinical Development, GPC Biotech. "We look forward to working with clinicians to make satraplatin available through the SPERA program to these patients who currently have no approved treatment options for their disease."
U.S. physicians interested in receiving more information about SPERA can contact 1-800-349-8086 or www.speratrial.com.
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and Europe. Approximately 219,000 men in the U.S. are expected to be diagnosed with the disease in 2007, and over 27,000 men are expected to die from the disease. In the European Union, over 200,000 new cases are expected to be diagnosed, and over 60,000 patients are expected to die each year. Since the incidence of prostate cancer increases with age, the aging of the overall population is expected to further increase the number of prostate cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery or radiation therapy, and some of these patients are cured. For many others, though, the disease recurs. At this point, the recurrent disease is treated with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumor cells become resistant to the hormones - or "hormone-refractory" - and the tumor again progresses. Increasingly, chemotherapy is being used as an effective first-line treatment for HRPC. However, it is not a cure, and so this is creating a need for effective therapeutic options for these patients once they have progressed.
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.
In September 2006, GPC Biotech announced topline results for the double- blinded, randomized satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The trial is evaluating satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer. GPC Biotech has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories.
Satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002. Additional information on satraplatin can be found in the Anticancer Programs section of the Company's Web site at www.gpc-biotech.com.
GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing new anticancer drugs. GPC Biotech's lead product candidate - satraplatin - is an oral platinum-based compound that is being evaluated as a second-line chemotherapy treatment in hormone-refractory prostate cancer. The U.S. FDA has granted fast track designation to satraplatin for this indication, and the rolling NDA submission process for this compound has been completed. GPC Biotech is also developing a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and has ongoing drug development and discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany), and its wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit GPC Biotech's Web site at www.gpc-biotech.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward- looking statements contained in this press release. In particular, additional information relating to the safety, efficacy or tolerability of satraplatin may be discovered upon further analysis of data from the SPARC trial or analysis of additional data from other ongoing clinical trials for satraplatin. Furthermore, even if these results are confirmed upon full analysis of the trial, we cannot guarantee that satraplatin will be approved for marketing in a timely manner, if at all, by regulatory authorities nor that, if marketed, satraplatin will be a successful commercial product. We direct you to GPC Biotech's Annual Report on Form 20-F for the fiscal year ended December 31, 2005 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the future results, performance and achievements of GPC Biotech. Forward-looking statements speak only as of the date on which they are made and GPC Biotech does not undertake any obligation to update these forward- looking statements, even if new information becomes available in the future.
The scientific information discussed in this press release related to satraplatin is preliminary and investigative. Satraplatin has not yet been approved by the FDA in the U.S., the EMEA in Europe or any other regulatory authority and no conclusions can or should be drawn regarding its safety or effectiveness. Only the relevant regulatory authorities can determine whether satraplatin is safe and effective for the use(s) being investigated.
For further information, please contact:
GPC Biotech AG
Martin Braendle
Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.: Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 781-890-9007 X267
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Noonan Russo
David Schull
Phone: +1 212-845-4271
david.schull@eurorscg.com
Appreciated your Pirfenidone Dr. Raghu summary and I'd be interested in this as well! Thanks!
Not sure how comfortable you are with computers so I'll leave this up to you.
I use Firfox and have some extensions you can get from:
https://addons.mozilla.org/en-US/firefox/browse/type:1
The main ones are Adblock Plus and Noscripts. I have a good deal of the ads blocked on my system this way.
DNDN:
Does anyone else find the volume the past couple weeks amusing
http://finance.yahoo.com/q/hp?s=DNDN
Date Open High Low Close Volume Adj Close*
11-Apr-07 20.60 20.84 18.20 18.23 50,630,000 18.23
10-Apr-07 24.85 25.25 20.26 22.15 66,675,000 22.15
9-Apr-07 20.00 24.27 19.86 23.58 78,665,100 23.58
5-Apr-07 15.10 18.28 14.84 18.05 60,174,800 18.05
4-Apr-07 15.00 15.15 14.66 15.08 13,677,800 15.08
3-Apr-07 14.47 15.40 14.47 14.65 25,813,600 14.65
2-Apr-07 13.25 14.99 13.10 14.30 43,706,300 14.30
30-Mar-07 17.92 18.05 12.00 12.93 92,499,200 12.93
29-Mar-07 5.22 5.22 5.22 5.22 0 5.22
28-Mar-07 4.85 5.34 4.48 5.22 32,840,900 5.22
27-Mar-07 4.40 4.97 4.36 4.62 10,820,800 4.62
26-Mar-07 4.74 5.23 4.46 4.54 16,196,800 4.54
23-Mar-07 4.14 4.48 4.11 4.47 9,452,200 4.47
22-Mar-07 3.72 3.98 3.69 3.95 2,352,200 3.95
21-Mar-07 3.67 3.74 3.57 3.70 3,662,500 3.70
20-Mar-07 3.78 3.80 3.65 3.70 2,261,200 3.70
19-Mar-07 3.88 3.88 3.68 3.77 2,845,700 3.77
16-Mar-07 3.79 3.84 3.62 3.65 3,622,400 3.65
15-Mar-07 3.92 3.93 3.71 3.78 3,498,300 3.78
14-Mar-07 4.10 4.10 3.82 3.89 2,619,900 3.89
13-Mar-07 4.20 4.20 3.97 4.03 3,323,100 4.03
12-Mar-07 4.14 4.39 4.10 4.16 4,833,000 4.16
FYI found the code: april07
thanks to this link http://cf.us.biz.yahoo.com/cnw/070404/cibc_biotech_conf.html?.v=1
and biowatch's comment to search company presentations
Thanks for the reply Biowatch. I have one company (UTHR) which never PR's and only sometime's webcasts investor conferences so I usually need to go to the conference website to hear it (if its even available) also I sometimes listen to other calls. If you or anyone does come up with a passcode I'd appreciate you posting it (You'd figure they would make things as easy as possible to listen to these things)!
Anyone know the passcode for the event?
http://www.veracast.com/cibcwm/biotech07/index.cfm
Biowatch this seems to be your specialty at finding these things :).
TIA
REX:
Walldriver, I agree completely. I just don't get the LONG-TERM valuation for REX there are way too many shares and they'll need to dilute more. Granted they could get a nice jump IF Ovarex IMPACT trials are positive and the recent settlement not to dilute at cheap prices is a slight positive but for my money UTHR stands to gain much more from OvaRex and quite frankly at these prices I don't think it comprises much of the Valuation of United, the stock has been under a lot of pressure because of suspected Sepsis issues with IV Remodulin. The valuation is quite cheap and then consider they have 3 phase 3 programs (OvaRex, Inhaled Remodulin and Oral Remodulin). The Inhaled program in my opinion has the best chance of three (not to say OvaRex and Oral don't have a good chance) but the Phase 2 data is extremely positive and its another formulation of Treprostinil so a lot less risk then a new chemical entity.
Thanks for the comments. It looks like now company's are in the early stages of combining polymerase and protease.
Here is InterMune's PR for EASL (they have a poster on in vitro combo with Roche's polymerase)
http://biz.yahoo.com/prnews/070411/sfw009.html?.v=90
InterMune Presents Research on ITMN-191 in Hepatitis C at EASL Annual Meeting
Wednesday April 11, 7:30 am ET
Presentations include preclinical data for potential combination therapies and details of N3/4A protease sequence variations after ITMN-191 exposure
BARCELONA, Spain, April 11 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) announced today the presentation of findings from three in vitro experiments concerning its HCV protease inhibitor ITMN-191, alone or in combination with other compounds, at the 42nd Annual Meeting of the European Association for the Study of the Liver in Barcelona, Spain.
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The first presentation concerned the activity of ITMN-191 alone or in combination with PEG-IFN-alfa-2a (Roche's Pegasys®) in an in vitro model of HCV clearance. These experiments explored the concentrations of ITMN-191 needed to achieve HCV replicon clearance from a human liver cell line during a two-week course of treatment. Complete clearance of replicon RNA was achieved with a 14-day treatment of only 45 nM of ITMN-191; a concentration well below that achieved in the liver of animal species following twice-daily oral dosing. Combination of the minimum human plasma concentration of PEG-IFN-alfa-2a with 15 nM of ITMN-191 also promoted durable replicon clearance, indicating clinical investigation of the anti-HCV activity of the two agents in combination is warranted.
The second experiment described the synergistic antiviral activity of ITMN-191 with Roche's R1479, an inhibitor of the HCV NS5B polymerase. The in vitro antiviral activity of each agent was enhanced when used in combination. Additionally, the replicon with reduced sensitivity to ITMN-191 remained fully sensitive to R1479, suggesting that the combination of these two agents could decrease the potential for the development of drug-resistant HCV variants in monotherapy treatments.
"With our continued research, we are better understanding the antiviral effects of ITMN-191, alone and in combination with other agents, such as polymerase inhibitors and interferons, and discovering important insights into possible treatment regimens for chronic hepatitis C," said Lawrence M. Blatt, Ph.D., Chief Scientific Officer of InterMune. "We anticipate that treatment regimens will involve multiple agents, and we are hopeful that these combinations will lead to improved, sustained virologic responses for patients who are in need of more optimal therapies."
The third presentation concerned NS3 sequence variations in HCV replicons after exposure to ITMN-191 at clinically relevant concentrations. The NS3 sequence was found to undergo dynamic changes when exposed to increasing concentrations of ITMN-191. As was seen in previous work, substitution at position 168 of NS3 appears to be fundamental to resistance but alone is not sufficient for HCV replicon persistence at all ITMN-191 concentrations achieved in the liver of animal species following oral dosing. This suggests that the genetic barrier to resistance in patients following clinical dosing of ITMN-191 may be significant dependent upon human liver exposure.
About ITMN-191
InterMune currently is conducting a Phase 1a clinical study of ITMN-191 for the treatment of chronic HCV. Preclinical toxicology and pharmacokinetic studies in multiple species demonstrated that ITMN-191 has a favorable toxicology profile, significant liver exposure, high in vitro potency and specificity, and an advantageous cross-resistance profile, including considerable effectiveness against variants of the NS3/4A protease that are resistant to other HCV protease inhibitors currently in development. The preclinical pharmacokinetic results support the exploration of twice-daily oral dosing. InterMune and Roche have a collaboration agreement for the research, development and commercialization of ITMN-191 (referred to as R7227 within the Roche research and development programs) and second-generation HCV protease inhibitor compounds.
About HCV and HCV Protease Inhibitors
According to the Centers for Disease Control and Prevention (CDC), an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected. It is estimated that there are 170 million people worldwide afflicted with this disease. While currently available therapies can cure many patients, there is considerable need for the development of novel therapeutic approaches. The HCV NS3/4 protease is an attractive drug target because of its potential involvement in viral replication and suppressive effects on host response to viral infection. Inhibitors of the HCV protease, such as ITMN-191, represent a promising new class of drugs for HCV.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 in Phase 1a, a second-generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
Forward-Looking Statements
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to the progress, future patient enrollment in and timing of our clinical trials and announcements of results thereof. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward- looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's annual report on Form 10-K filed with the SEC on March 30, 2007 (the "Form 10-K") and updates included in the most recent Form 10-Q filed with the SEC on November 7, 2006 (the "Form 10-Q"), and other periodic reports filed with the SEC, including the following: (i) risks related to the development of our product and product candidates; (ii) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (iii) risks related to achieving positive clinical trial results; (iv) risks related to our intellectual property rights; and (v) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC.
SGP:
Any of the people who follow the HCV space know if the info that SGP was doing in vitro studies combining Bocepevir with polymerase inhibitors has been previously released?
http://biz.yahoo.com/prnews/070411/nyw028.html?.v=82
Schering-Plough Addresses Major Milestones and Challenges in Treatment of Patients With Chronic Hepatitis C
Wednesday April 11, 2:00 am ET
Highlights key data at the 42nd annual meeting of the European Association for the Study of the Liver (EASL)
KENILWORTH, N.J., April 11 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) reaffirms its commitment to advancing the science and treatment of chronic hepatitis C virus (HCV) infection with several key data presentations at the European Association for the Study of the Liver (EASL) 42nd annual meeting in Barcelona, Spain, April 11-15. A total of 38 data presentations highlighting Schering-Plough hepatitis medications will be presented at EASL 2007.
Among these are several studies with PEGINTRON® (peginterferon alfa-2b) and REBETOL® (ribavirin) combination therapy, a current standard of care in the treatment of chronic hepatitis C, evaluating how results at important treatment milestones can help physicians make informed treatment decisions.
Schering-Plough also is exploring novel therapeutic approaches, both through targeted internal research programs and strategic collaborations. Chief among these efforts is boceprevir (SCH 503034), Schering-Plough's investigational oral HCV protease inhibitor currently in Phase II clinical development for treating chronic hepatitis C. Individual in vitro studies of boceprevir in combination with investigational oral HCV polymerase inhibitors from Wyeth/ViroPharma and Idenix/Novartis have been completed and will be presented at EASL.
"Schering-Plough is proud of its long-term role in introducing innovative treatments to the field of hepatitis," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "Our vision with PEGINTRON, our cornerstone HCV therapy, and ongoing work with boceprevir, our investigational oral HCV protease inhibitor, is to continue to advance the science and deliver additional treatment options for patients with hepatitis C infection."
PEGINTRON
Numerous studies with PEGINTRON will be presented at EASL evaluating patient response to therapy at certain treatment milestones, an approach that is aimed at individualising treatment for patients.
Schering-Plough also is exploring novel therapeutic approaches with PEGINTRON in combination with investigational antiviral agents to optimize treatment for patients with more difficult-to-treat forms of the disease, such as those with HCV genotype 1 and nonresponders to previous therapy.
Boceprevir (SCH 503034)
Schering-Plough is undertaking a large, fully integrated clinical development program for its oral HCV protease inhibitor boceprevir (SCH 503034), with the goal of developing new strategies for improving treatment outcomes for patients with hepatitis C.
As part of this effort, Schering-Plough has collaborated with Wyeth/ViroPharma and Idenix/Novartis to conduct separate in vitro studies of boceprevir in combination with their respective investigational HCV polymerase inhibitors, HCV-796, a non-nucleoside polymerase inhibitor, and NM107 (the active moiety of NM283, valopicitabine), a nucleoside polymerase inhibitor. These in vitro experiments suggest that the combination of boceprevir and either one of these polymerase inhibitors achieves additive antiviral activity and a complementary resistance profile; the combination of two agents increases the barrier for developing resistance to either drug alone.
In addition, Schering-Plough has initiated the HCV SPRINT-1 study (HCV Serine Protease Inhibitor Therapy-1), a large Phase II study that is currently enrolling 400 HCV genotype 1, treatment-naïve patients in sites across the United States, Canada and Europe. The primary objective of the study is to evaluate the safety and efficacy of boceprevir 800 mg TID in combination with PEGINTRON and REBETOL in the treatment-naïve patient population.
Schering-Plough also is conducting a large Phase II study evaluating the safety and efficacy of boceprevir 800 mg TID in combination with PEGINTRON and REBETOL in patients chronically infected with HCV genotype 1 who were nonresponders to previous peginterferon and ribavirin combination therapy. The study involves approximately 350 patients at centers in the United States and Europe. All study participants have completed treatment and are in the follow-up phase. Sustained virological response data from this study will be available later in 2007, and will help guide future clinical development of boceprevir.
Key Data Presentations at EASL
PEGINTRON
Peginterferon Alfa-2b and Ribavirin for 14 or 24 Weeks in Patients with HCV Genotype 2 or 3 and Rapid Virological Response, The North-C Trial. Dalgard, O. et al. Oral presentation, Sunday, April 15, at 13:15, General Session 4.
A Pegylated Interferon Alfa-2b Dose Reduction in HCV 1B Patients with Rapid Viral Response Does Not Affect Sustained Virological Response. Napoli, N. et al. Poster presentation, Thursday, April 12.
Comparison of Early Virologic Response Among Patients with Chronic Hepatitis C Infected with Genotype Non 2/3 Treated with Pegylated Interferon Alfa-2b and Ribavirin in Dependence with Hepatic Fibrosis Stages. Berak, H. et al. Poster presentation, Thursday, April 12.
Bocepevir (SCH 503034)
Combination of Two Hepatitis C Virus Inhibitors, SCH 503034 (Boceprevir) and NM107 (the active moiety of NM283, valopicitabine), Provides Enhanced Anti-Replicon Activity and Suppresses Emergence of Resistant Replicons. Ralston, R. et al. Late-breaker poster presentation, Thursday, April 12.
Favorable Cross-Resistance Profile of Two Novel Hepatitis C Virus Inhibitors, SCH 503034 (Boceprevir) and HCV-796, and Enhanced Anti-Replicon Activity Mediated by the Combined Use of Both Compounds. Howe, A.Y. et al. Poster presentation Thursday, April 12.
SCH 503034 (Boceprevir), an Oral HCV Protease Inhibitor, is Well Tolerated in Patients with Varying Degrees of Hepatic Impairment. Preston, R.A., et al. Poster presentation Thursday, April 12.
About PEGINTRON and REBETOL Combination Therapy
PEGINTRON is approved in the United States for use alone or with ribavirin (800 mg/day) for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age.
Important Safety Information Regarding U.S. Labeling for PEGINTRON and REBETOL
WARNING
Alpha interferons, including PEGINTRON, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEGINTRON therapy.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.
REBETOL and combination REBETOL/PEGINTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEGINTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6- month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.
PEGINTRON
There are no new adverse events specific to PEGINTRON as compared to INTRON® A (Interferon alfa-2b, recombinant) for Injection; however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON were "flu- like" symptoms, occurring in approximately 50 percent of patients, which may decrease in severity as treatment continues. Application site disorders were common (47 percent), but all were mild (44 percent) or moderate (4 percent) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2 percent of patients receiving PEGINTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEGINTRON.
Psychiatric adverse events, which include insomnia, were common (57 percent) with PEGINTRON but similar to INTRON A (58 percent). Depression was most common at 29 percent. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1 percent of patients during or shortly after completing treatment with PEGINTRON.
PEGINTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
The following serious or clinically significant adverse events have been reported at a frequency less than 1 percent with PEGINTRON or interferon alpha: severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.
In the PEGINTRON/REBETOL combination trial the incidence of serious adverse events was 17 percent in the PEGINTRON/REBETOL groups compared to 14 percent in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEGINTRON/REBETOL combination therapy trial was 23 percent in the INTRON A/REBETOL group and 31-34 percent in the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42 percent of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34 percent of those receiving INTRON A/REBETOL.
REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's strategy regarding and the potential of PEGINTRON, REBETOL and boceprevir (SCH 503034). Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward- looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item 1A, "Risk Factors" in the company's 2006 10-K.
VRTX:
Does anyone know the level of disclosure that will occur at the presentation? One item I am specifically curious about if they will indicate how many of those who did not get SVR's failed to do so because of mutations (according to Intermune presentations 950 had poor resistance against the NS3 A156T Variant).
Thanks for the info Dew. Unfortunately most of these "at cash" have poor management. Every once in a while you get lucky (TKT) but new management came in. I think Praecis Pharmaceuticals was a recent one too, but in listening to their calls I stayed away not expecting management to do the right thing so even when it turns out well it is sometimes hard to foresee that.
I was thinking they should make a rule when a biotech gets to cash they should have a fold rule and do just what you said liquidate give the shareholders something.
ADLR - From a quick look at Adolor's 10K it looks like they are now selling below cash. I know nothing on the company especially management to know if its worth a further look. Anyone have an opinion?
Thank you very much for posting that!
We should be do for news in a couple areas. Besides the initiation of the sickle cell trial, I think that the Kuvan NDA gets filed this month (my estimate) and listening to the recent presentations JJ indicated that an update on the BH4 Cardio Vascular program would occur in a few weeks/about a month which should be about mid month as well.
While the update on the cardio vascular could be negative (they could elect to drop it or even altar the PAD trial) there were some vague encouraging remarks that they had some interesting findings in subsets (though retrospective subset analysis is not one of my favorite findings).
With BH4 in sickle cell disease, PAH and Erectile dysfunction we have three completely different indications that each could be a rather significant market.
In thinking about the potential for Kuvan I think it becomes a much bigger drug for a reason some analysts aren't noting. The company keeps emphasizing the IQ benefit and that this is not a lifestyle drug. I thinking pricing ends up being in the neighborhood of what Tracleer costs, in the 35-40K range. One way they could do this with less of a hurdle is price the low dose (5mg) at around 7500/yr for a "normal" weight individual. One of the analysts pointed out that physicians they talked to planned on usage at the high end of the range (20mg). Then factor in that PKU patients are probably a bit heavier then average because of their diet/getting enough nutrients and the price could easily be in the 30K/yr annual range.
REX:
quantumdot I am not an expert in ViRexx (have a token position) I just follow them for OvaRex so I may not be the best person to answer this.
I thought I saw somewhere that the financing was on hold but am not certain about that. What I do know (through SEC filings) is that there is a dissident group that is seeking to change the board. They had a pretty significant amount of the stock (I believe in the 30% range but that is going by memory). One of the board members resigned and I believed joined the dissident group. I think management changes will occur one way or the other.
I became disenchanted actually before this financing. I thought the out licensing deal late last year for OvaRex was terrible. I could see if they got some significant upfront cash but they didn't. I didn't buy the argument about getting manufacturing ready. I did think the royalty rate was OK (not great).
ViRexx ... but think the company is cheap enough that a win in the OvaRex trials will make investors some money.
I agree with you. I think UTHR will do very well as well with OvaRex plus there is the Remodulin franchise so that's where my money is.
I was surprised that ViRexx didn't get some of the jump some of the other companies got following the DNDN panel outcome. Maybe because of all the other problems at the company and the fact that OvaRex isn't on too many people's radar screen. The IMPACT trials are PFS not overall survival too for what its worth.
Thanks for the note if you get any blurb from CIBC on the IPF conference today I'd appreciate anything you could post.
You could be right as I see Vertex is up a fair amount. I believe InterMune has 3 or 4 posters on 191. I am most curious about the one combining 191 with Roche's polymerase (in vitro).
ITMN: InterMune is up about 5% today my guess is the CIBC Conference Genisi posted info on. I couldn't get access but my guess is Dr. Raghu will speak very positively on Pirfenidone as he has been involved with previous studies for it and has published on it (I believe the Phase 2 Shionogi results were his publication).
With InterMune's shelf I wonder if CIBC is trying to position themselves to get involved with the financing (I am guessing they do investment banking work)?
David,
After reading Adam's column, I am curious if your companies interest in ViRexx is because of OvaRex being an immunotherapy or is this a pick of Allen's (I believe he did the interview)?
I don't think much of ViRexx after the bad OvaRex "licensing" deal late last year and the huge dilution this year (I am long UTHR) but I think OvaRex has a chance if Placebo is anywhere below 14 months or so.
I'd be curious on your thoughts on OvaRex and in general on immunotherapies or do I need to be a subscriber for that :)?
Appreciate the reply and the link. I just sent an e-mail to CIBC to see if it is possible to listen to the call. I'll post info if they reply in time but I don't have any business with them so may not be able to even if available.
Genisi,
Thanks for the info. Would you happen to know if this is webcast or has a call in? Any link would be greatly appreciated! TIA
In the current issue of Barrons BioMarin was mentioned favorable in an analysts report. Said Kuvan ramp may be faster then thought. "...after attending American College of Medical Genetics meeting and learning of BMRN intention to enroll physicians and clinics in expanded-access program for Kuvan..." upside to initial estimates of 1.8m, 50m, 100m 2007-2009 Kuvan revenue. Sorry don't have on-line Barrons at present its on page M10 though for those interested (in the short Research Reports section)
Hmmm not the best symbol for a stock but I still like the company :). 86.25 million no way this is the full cap. Even a tiny penetration of Cerazyme should be worth a pretty penny. I have to do more research but I got the sense Genzyme's Pompe drug left a lot to be desired and that is one of the larger lysosomal diseases. Amicus is in Phase 1 but this could potential be a huge drug too! The Fabry drug is oral I believe which would be an advantage over TKT (Shire's) and Genzyme's but I don't know much about its efficacy.
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070330:MTFH67636_2...
WASHINGTON, March 30 (Reuters) - Biopharmaceutical firm Amicus Therapeutics Inc. said on Friday it is planning an initial public offering of as much as $86.25 million in common stock.
Morgan Stanley, Merrill Lynch & Co., JPMorgan, Lazard Capital Markets and Pacific Growth Equities LLC, according to a preliminary offering document filed with the U.S. Securities and Exchange Commission.
It is seeking a Nasdaq listing under the symbol "FOLD."