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Does anyone know anything about Medivir, specifically their protease inhibitor? They will have two abstracts at AASLD according to their PR http://www.medivir.se/v3/en/ir_media/press_releases.aspx?id=137
The preclinical information I could find on them seems interesting. Their candidate TMC435350 appears to be dosed daily
http://natap.org/2007/HCV/092407_02.htm
I had not heard of the company before and they appear to be in 1B. Just wondering how serious they should be taken. Appreciate anyone's insights.
I appreciate the reply/reference. I would agree with BSR on the Coprexa potential especial for Wilsons Disease. Don't follow their other products much.
BIIB/ELN:
Is there a way to see how I voted on the survey? I thought it would do better then people thought but with no new PML cases, I think it is tracking better then I would have guessed. 17K patients at around 30K it would seem 1B+ is very realistic. Though of course a (negative) surprise can happen between now and 2009.
http://biz.yahoo.com/bw/071011/20071011005846.html?.v=1
Biogen Idec and Elan Provide Update on Utilization and Safety of TYSABRI(R) in Patients with Multiple Sclerosis
Thursday October 11, 12:10 pm ET
CAMBRIDGE, Mass. & DUBLIN--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) today announced new data on the global utilization and safety of TYSABRI® (natalizumab), citing that as of the end of September 2007 approximately 17,000 patients are on commercial and clinical therapy worldwide, and that the safety data to date continue to support a favorable benefit-risk profile for TYSABRI. These data will be presented as part of the companies' symposia being held on Friday, October 12, 2007 at 6 p.m. CEST at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.
As of the end of September 2007:
* In the US, approximately 10,500 patients are on TYSABRI commercially and over 2,100 physicians have prescribed the therapy;
* In the EU, approximately 5,500 patients are on TYSABRI therapy commercially; and
* In global clinical trials, approximately 1,000 patients are on TYSABRI therapy.
TYSABRI is available in the United States through the TOUCH(TM) Prescribing Program. All prescribers, infusion sites and patients receiving TYSABRI are required to enroll in TOUCH. Safety information is also collected through ongoing clinical trials and registries, including TYGRIS and the pregnancy registry, making this the largest long-term patient follow-up effort undertaken for any MS therapy.
According to data available to the companies as of mid-September 2007, there have been no new reports of confirmed cases of progressive multifocal leukoencephalopathy (PML). The safety data to date continue to support a favorable benefit-risk profile for TYSABRI. The companies plan to continue to provide similar updates at future medical meetings.
"Neurologists and patients are increasingly choosing TYSABRI given its significant impact on clinically meaningful and relevant endpoints, including relapses and disability progression. Ultimately, we believe the full potential of TYSABRI will be realized, making it the leading MS therapy," said Michael Panzara, MD, MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec.
"Continued patient experience and ongoing clinical research will further differentiate TYSABRI as a valuable treatment option for MS patients around the world. TYSABRI is currently approved in more than 20 countries, and we hope to offer this therapeutic alternative to more patients in the future," said Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan.
About TOUCH and TYGRIS
Before initiating treatment, all US patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious opportunistic infections (OIs), including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit-risk discussions prior to initiating TYSABRI treatment. Physicians report on PML, serious OIs, deaths and discontinuation of therapy on an ongoing basis.
TYGRIS (TYSABRI Global ObseRvation Program In Safety) is expected to enroll 5,000 patients worldwide, including approximately 3,000 patients from TOUCH. Patients in TYGRIS are evaluated at baseline and every six months thereafter for five years. Researchers will evaluate data including medical/MS history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs, and malignancies.
Adverse event reporting in the post-marketing setting is voluntary. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner.
About TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the United States and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.
In addition to the United States and European Union, TYSABRI is also approved in Switzerland, Canada, Australia, New Zealand and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.
For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.
Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements regarding TYSABRI. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may be unable to adequately address concerns or questions raised by FDA or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, or that the companies may encounter other unexpected hurdles. Drug development and commercialization involves a high degree of risk.
For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
MEDIA CONTACTS:
Biogen Idec
Amy Reilly, 617-914-6524
or
Elan
Jonathan Birt, 212-850-5664
or
Elizabeth Headon, 353 1 498 0300
or
INVESTOR CONTACTS:
Biogen Idec
Eric Hoffman, 617-679-2812
or
Elan
Chris Burns, 353 1 709 4444
800 252 3526
Source: Biogen Idec and Elan Corporation, plc
Kanzer has said that with approval of Coprexa he expects to be profitable next year.
I am very skeptical of this and would like to know more of what he said.
Do you know where he said this? Was it at a presentation? TIA.
OT
an investor that never "trades" is pretty much a loser.
I'd be happy to be as a big a loser as Mr. Buffet :)
SCND:
Not to mention the great balance sheet they have! If you back out the cash (and securities) the TRAILING PE is in the 7 range, then if you think the inventory is worth something your looking at a stock not much above book earning .27 and consistent earnings.
The blip late last year probably scarred off the 2-3 other shareholders out-there :). Good luck to anyone trying to get a decent position on the cheap.
ITMN:
After seeing Adam's interview with Cramer on the Street.com I am not expecting him to bother updating his readers with this information. I realize Cramer's audience aren't biotech investors but Adam did not have anything impressive to say other then of course revealing his bias http://www.thestreet.com/video/index.html?clipId=1373_10381372&channel=Cramer+On+Demand&cm_v...
http://biz.yahoo.com/prnews/070926/aqw071.html?.v=22
InterMune Announces Start of Phase 1b Trial of ITMN-191
Wednesday September 26, 8:00 am ET
- Reports Further Details from Phase 1a SAD Clinical Study -
BRISBANE, Calif., Sept. 26 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) announced that the company has begun dosing the first patients in their Phase 1b multiple ascending dose (MAD) clinical trial evaluating ITMN-191 (also called R7227) in patients with chronic hepatitis C. ITMN-191 is a hepatitis C virus (HCV) protease inhibitor in development by InterMune and its partner, Roche. InterMune also reported additional information from its recently completed Phase 1a clinical trial of ITMN-191.
Dan Welch, President and Chief Executive Officer of InterMune, said, "We are pleased to have successfully initiated the very important Phase 1b multiple ascending dose study of ITMN-191." Mr. Welch continued, "This is our first opportunity to evaluate the effects of ITMN-191 on viral kinetics in HCV patients, and to gather additional safety information beyond the recently completed Phase 1a SAD study. We look forward to sharing top-line results from the three treatment-naïve dose cohorts of the Phase 1b study in the first quarter of 2008."
Phase 1b Trial Design
The Phase 1b placebo-controlled study is anticipated to enroll approximately 40 HCV patients. The study will assess the effect of multiple doses of ITMN-191 given as a monotherapy on viral kinetics, viral resistance, pharmacokinetics, safety and tolerability. Patients will be administered ITMN-191 twice per day (BID) or three-times per day (TID) with a meal for a period of 14 days. Three ascending dose cohorts of treatment-naive chronic hepatitis C patients infected with HCV genotype 1 will be enrolled. In addition, a single cohort of treatment-experienced chronic hepatitis C patients infected with HCV genotype 1 will be studied. If the results of the first three dosage cohorts indicate that more information would be desirable to more fully inform the design of a planned study of ITMN-191 in combination with Pegasys® and ribavirin, the Phase 1b study will be expanded to include additional cohorts of treatment-naive patients.
Further Details on Phase 1a Study -- Safety and Pharmacokinetic Profile of ITMN-191
The Phase 1a placebo-controlled study of ITMN-191 was completed in May of 2007, enrolling a total of 64 healthy volunteers. Doses in this study ranged from less than 10% to many-fold higher than those that will be evaluated in the three dosage cohorts of the Phase 1b trial. The study results show that:
-- ITMN-191 was well tolerated in all doses evaluated in Phase 1a study.
-- No Serious Adverse Events (SAEs) were reported and no subject
discontinued the study due to an Adverse Event (AE).
-- All AEs in subjects receiving ITMN-191 were classified as mild (CTCAE
Grade 1).
-- The most common AEs reported were gastrointestinal-related and
consisted of mild diarrhea and mild abdominal pain. These mild AEs
occurred predominantly in the highest dose group, a dose many-fold
higher than the doses planned in the Phase 1b study just begun.
-- No clinically significant laboratory abnormalities or changes in
electro-cardiograms were observed.
-- Food has a significant effect on the absorption of ITMN-191, with
higher AUC in patients who took ITMN-191 with a meal.
-- The pharmacokinetics of ITMN-191 were linear over the range of doses
planned in the Phase lb study.
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 (referred to as R7227 at Roche) in Phase 1a, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. 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 most recent annual report on Form 10-K filed with the SEC on March 30, 2007 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) risks related to timely patient enrollment and retention in clinical trials. 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, all of which are available via InterMune's web site at http://www.intermune.com.
Updates: Capacity Trial Information, Protease Inhibitor Program, Financial Information, Research Projects, Timeline, IPF Competitive landscape
InterMune http://www.intermune.com/
Call Summaries
Q1 2007 #msg-19408521
Q2 2007 #msg-23131457
(See prior ReadMe’s for general information and Actimmune information)
Competitive Landscape for IPF
1. Genzyme (collaboration with what was CAT) in Phase 1
2. Bosentan (Tracleer) from Actelion, Phase 2 failed in their endpoint proceeding with Phase III (BUILD-3) 390 patients, event-driven study (131 events needed defined as decreased FVC and DLCO, acute exacerbation, or death interim analysis with 62 events) randomized 2:1.
3. Imatinib (Gleevec), I believe it failed Phase 2 not sure of status going forward.
4. Etanercept (Enbrel), Phase 2 mixed results (no effect on endpoint; trend towards reduced disease progression)
5. Sildenafil (Phase 2) http://www.clinicaltrials.gov/ct/show/NCT00352482
6. Pipex (Tetrathiomolybdate) Phase I-II completed. Company filings say plans to initiate Phase 3. Phase i-II presented results #msg-19613632
7. FivePrime (Collaboration with J&J) http://tinyurl.com/yz444l
8. Fibrogen FG-3019 (for IPF) completed Phase 1 in patients (safe and well tolerated) http://www.fibrogen.com/uses/ipf.html
9. EmphyCorp N115 (ILD) http://emphycorp.com/ild.html
10. AlsoThalidomide being looked at, Others?
Pirfenidone
(See prior ReadMe’s for general and older information on Pirfenidone)
• IP Expansion and life-cycle management efforts underway since 2005
CAPACITY Trials, http://www.capacitytrials.com/
http://www.clinicaltrials.gov/ct/show/NCT00287729
http://www.clinicaltrials.gov/ct/show/NCT00287716 - Three Arm Study
• Primary endpoint is change in forced vital capacity (FVC) after 72 weeks of treatment
• Two concurrent, multi-national trials CAPACITY 1 and CAPACITY 2
• Randomized first patient April 27, 2006. Completed enrollment May, 2007. 779 total patients in 110 centers (North America and Europe). Results expected late 2008 or early 2009. Expansion of trials was targeting to enroll 720 (320 and 400).
• Not pursuing partnership at this time
• Differences between CAPACITY and Shionogi Phase 3 (Company presentations) Shionogi 250 patients, ours 779 (in 2 320 and 400 targeted in each of the studies not disclosed actual breakdown). Length Shionogi-52 ours 72 weeks. Dosing in Shionogi low dose 400mg TID high 600 TID, CAPACITY I-800mg TID, CAPACITY II 800mg and 400mg both TID, if account for avg. body weight of US/EU vs. Japan about 30mg/kg in each. Endpoint Shionogi change in Vital Capacity ours Change in Percent Predicted Forced Vital Capacity. Comparable measures of lung volume. Other difference is the patient population, Shionogi is Japanese ours is mainly NA and EU do not know of any metabolism difference in population or Pirfenidone between two groups.
• Power: > 95% to detect 50% reduction of FVC decline and > 85% to deduct 40% reduction in FVC.
InterMune 191 / PI Program
(See prior ReadMe’s for general and older information on 191)
• Phase 1A Trial Information
1. One clinical trial site in Europe approximately 74 healthy volunteers, Single ascending dose.
2. First patient dosed early January 2007.
3. A significantly higher than anticipated plasma level of InterMune 191 was seen in patients, in dose cohorts where the drug was administered with food. We did explore the food effect purposely in the single ascending dose study. It was not explored at all doses, but at a selection of doses. And, yes, the results were consistent.
4. Plasma levels of 191 were observed in all dose groups in the SAD study
5. Range of potentially efficacious doses to examine in the multi-dose Phase Ib study identified. Doses in this range were well tolerated in the SAD study.
6. All adverse events reported in subjects receiving 191 were mild in severity, short-lived, and resolved spontaneously without intervention.
7. No serious adverse events were reported in the SAD study.
• Phase 1B Trial Information
1. 9/4/07 Announced approval of amended CTA in Europe, expect to initiate in 9/07. Initial top-line data expected in Q1 2008
2. We plan to administer 191 for a period of 14 days to three ascending dose cohorts of treatment naïve chronic hepatitis C patients infected with HCV genotype 1. Twice per day and three times per day dosing regimens will be studied. And the study may be expended to additional cohorts of treatment naive patients based on results from the first three planned cohorts. In addition, a single cohort of non-responder patients is planned.
3. Will be dosing with food. We have said repeatedly that the food effect was not something we expected to see. And I think it is fair to say, again, we didn't expect it, because we hadn't seen it in animal models. And I think it is fair to say that that was one of the most important observations in terms of thinking about the changes.
4. We really don't want to find ourselves in a situation where we're in the middle, or partially through Phase II and have to go back and sort of approach exploring different doses or differing dosage intervals. And that has happened in some instances with other therapeutic ongoing in HCV. I would just throw that out as one example of we would like to go into Phase II pretty sure that we are encompassing the range of doses and dose schedules that we want to look at.
5. On dosing changes in amendment - we didn't discuss specifically what doses we were looking at previously... will just say that for the reasons that we have talked about we did move lower.
6. Three dose cohorts of treatment naïve and one of treatment experienced planned with the possibility of additional cohorts. BID and TID dosing regimens to be studied.
Other Pipeline/Interests
• Equity interest in Targanta Therapeutics, http://www.targanta.com/ as a result of selling Oritavancin in December 2005. (http://tinyurl.com/yznhod)
• Early stage work on PEGylated version of Actimmune (with Maxygen), does not appear to have much effort as this time. (http://tinyurl.com/yn4e4z)
• PEG-Alfacon (PEGylated version of Infergen) appears unlikely to be further developed.
• Research work in both Hepatology and Pulmonology
o NiKem Research Srl collaboration in pulmonology (6/25/07 Nikem PR http://www.nikemresearch.com/news.htm)
o deCODE Biostructures collaboration (5/25/2007 deCODE Biostructures PR http://www.decodechembio.com/news_archives.php?year=2007 )
o Second generation PI’s (Roche Collaboration). Roche would have right of first refusal with terms comparable to 191 (up-front to be negotiated) if they decline InterMune can pursue other partnerships for candidate.
o Second target in Hepatology (undisclosed indication) Array collaboration. Royalty described by Array as high single digits. Array Responsible for creating clinical trial and all synthetic process. InterMune take into clinical development through commercialization. Partnership is described as met objectives and has been concluded.
Financials
• Cash/securities 208.5 million (end of Q2 2007)
• 170 million convertible. Coupon rate .25%. 2011 maturity. Conversion Price $21.63.
• Shelf registration (http://tinyurl.com/29rsqc) for up to 175 million filed 12/28/2006. 9/07 Registered to sell 3.5 million shares with over-allotment of up to 525,000 shares. Prospectus http://tinyurl.com/32mxjg
• 38.2 – 38.7 million shares outstanding (after 9/07 offering depending on over-allotment)
• 2007 Guidance
o Revenue (was 70– 90 million, removed with March INSPIRE study being stopped for futility)
o COGS (was 21-23%, removed with March INSPIRE study being stopped for futility)
o R&D 100-110 million. Including 5-10 million for est. FAS 123R.
o SG&A 25-35 million including 5-10 million for FAS 123R, excludes INSPIRE discontinuation expenses and possible contract wind-down costs (for Actimmune).
• Government settlement for past Actimmune promotion (http://tinyurl.com/y3wa8a) . The company will pay $36.9 million plus 5% interest over five years. The first annual installment of $5 million paid in 2006. Note some acceleration terms exist should InterMune receive 150 million in partnering/licensing (capped at $10 million/year).
• 10b5-1 plan entered into 9/07 http://tinyurl.com/2pok5z
Time-Line/Medical Presentations
• Q1 ’08 191 Phase 1B data
• Q4 ’08/early ‘09 Top line results from CAPACITY
A little late but for the curious here it is. Readme to follow.
Q2 2007 InterMune Earnings Call Notes
[most of the content is either a direct quote or paraphrasing something that was side items in brackets are additional observations]
Pirfenidone
. Study conduct of the CAPACITY program has been excellent, notably a very low rate of patient
dropouts have been observed to date after over fifteen months since the first patient was enrolled
191/Hepatology
. Have toxicology programs and studies up to 28 days. [no cardio tox, BI program had in 28 day animal studies]
1A Observations
. A significantly higher than anticipated plasma level of InterMune 191 was seen in patients, in dose cohorts where the drug was administered with food. We did explore the food effect purposely in the single ascending dose study. It was not explored at all doses, but at a selection of doses. And, yes, the results were consistent.
. Plasma levels of 191 were observed in all dose groups in the SAD study
. Range of potentially efficacious doses to examine in the multi-dose Phase Ib study identified. Doses in this range
were well tolerated in the SAD study.
. All adverse events reported in subjects receiving 191 were mild in severity, short-lived, and resolved spontaneously without intervention.
. No serious adverse events were reported in the SAD study.
1B Design
. We plan to administer 191 for a period of 14 days to three ascending dose cohorts of treatment naïve chronic hepatitis C patients infected with HCV genotype 1. Twice per day and three times per day dosing regimens will be studied. And the study may be expended to additional cohorts of treatment naive patients based on results from the first three planned cohorts. In addition, a single cohort of non-responder patients is planned.
. Will be dosing with food. We have said repeatedly that the food effect was not something we expected to see. And I think it is fair to say, again, we didn't expect it, because we hadn't seen it in animal models. And I think it is fair to say that that was one of the most important observations in terms of thinking about the changes.
. We really don't want to find ourselves in a situation where we're in the middle, or partially through Phase II and have to go back and sort of approach exploring different doses or differing dosage intervals. And that has happened in some instances with other therapeutic ongoing in HCV. I would just throw that out as one example of we would like to go into Phase II pretty sure that we are encompassing the range of doses and dose schedules that we want to look at.
. On dosing changes in amendment - we didn't discuss specifically what doses we were looking at previously... will just say that for the reasons that we have talked about we did move lower.
. Initial top-line data expected in Q1 2008
Financials
. Entered revised supply agreement with Boehringer Ingelheim no longer have 91.6 million in minimum purchases over next five years. 5.5 million paid to BI in 2007 to restructure agreement.
. Total revenue in the second quarter of 2007 was $25.4 million, Actimmune revenue was $14.5 million
. 2007 R&D expense expected to be in a range of approximately $100 million to $110 million, net of development cost
reimbursements under the Roche collaboration
. G&A expense expected to be in a range of $25 million to $35 million.
. $15 million more in milestone expected from Roche (15 month from when original deal signed by Roche). [Puts it around Q1 2008]
160 I don't think I could even name that many biotechs! You must be more a technical person, I don't know much about that. I follow a fair amount but only own a few biotechs. I was attracted to Amicus because of the focus of their drugs.
I am more the buy and hold, I actually got some shares the initial day of trading just so I can say I've had from day 1. The technology is a little novel (I'm not aware of any approved treatments with the same mechanism) but I've been a TKT and Biomarin shareholder and the pricing for treatments in LSD's is in the 100's of K per year and Mr. Crowley hinted that Amicus's drugs could be in the 100-250k per year range. I think even 1 of the three lead drugs makes it and the company's market cap becomes many fold (pun intended) higher.
In the short term (the next few months) we should have news on all three of the drugs in early stage trials.
I just saw this board.
FYI John Crowely presented at the Merrill Lynch conference. Very good presentation!
http://www.wsw.com/webcast/ml65/fold/
After listening I became much more impressed with Mr. Crowely. The book about him paints him as a bit more of a maverick. He comes across as extremely well informed on the science.
MAXY: I don't believe I ever called him any names but I think he is VERY arrogant! I haven't followed them as closely the past couple years but a few years ago he routinely criticized the street for "getting it wrong" on their valuation of the company (EDIT: Not that it is bad to be bullish on your stock just his manner was what are you a bunch of idiots -- not a quote). I also was a bit taken off by his criticism of InterMune for not advancing their PEG-Actimmune product. Obviously it was in Maxygen's interest since it would potentially lead to milestones and a royalty but the manner he said it was more like get off their *ss*s and advanced it (certainly not an exact quote but his tone was along those lines). It certainly didn't make much sense for InterMune to advance it. Not withstanding the failure of the INSPIRE study the patent lasts for quite some time yet.
MAXY: Appreciate the comments.
EDIT: Have you ever looked at Altus? I am biased (a shareholder) one thing that attracted me is they do not change the underlying molecule with their crystallization technology. Allen Leon (sp?), David's partner at BSR, asked on one of the calls about forming antibody's for their PKU product (preclinical) and they seemed to think it was very unlikely because of how it is absorbed (if memory serves).
MAXY:
Stock is down about 15%. They have a fair amount of cash so wouldn't expect too much further of a drop. I don't follow them too closely, I am not too big a fan of the CEO, his comments certainly sound surprised. Comments?
http://biz.yahoo.com/prnews/070921/aqf026.html?.v=25
Maxygen Announces Hold on MAXY-alpha Development Program
Friday September 21, 8:00 am ET
REDWOOD CITY, Calif., Sept. 21 /PRNewswire-FirstCall/ -- Roche has advised Maxygen, Inc. (Nasdaq: MAXY - News) that it has voluntarily placed a hold on further clinical development of MAXY-alpha, also known as R7025. MAXY-alpha is a novel interferon-alpha for the treatment of Hepatitis C and Hepatitis B virus infections and is licensed to Roche.
Preliminary observations from a Phase I trial indicate that an unexpected reduction of the pharmacodynamic and pharmacokinetic effects of MAXY-alpha occurred in the majority of subjects who received two doses of MAXY-alpha. In addition, antibodies binding to MAXY-alpha were identified in some subjects. Roche has initiated additional investigational studies in order to assess these results.
"We are all surprised by these unexpected findings," said Russell Howard, Maxygen's chief executive officer. "We don't yet know how this will impact the future timing or advancement of the program. Roche has now started additional work to assess the meaning and significance of these results. We will provide an update once all relevant information is collected and evaluated."
About the Maxygen and Roche Agreement
Maxygen and Roche entered into an agreement in 2003 to develop novel interferon alpha and beta products for a wide range of indications. Roche licensed from Maxygen worldwide commercialization rights to specific novel interferon product candidates for the treatment of Hepatitis C and B virus infections. Maxygen received an initial payment, full research and development funding for work done by Maxygen in the first two years of the collaboration, and milestone payments for the advancement of the MAXY-alpha product candidate. In addition, Maxygen is eligible to receive milestone payments and royalties based on any product sales.
About Maxygen
Maxygen is a biopharmaceutical company focused on developing improved versions of protein drugs. We look for opportunities where our proprietary protein modification technologies can address significant therapeutic needs. For more information about Maxygen's products and technologies, visit http://www.maxygen.com.
Forward-Looking Statements
This news release contains forward-looking statements about our research and business prospects, including those relating to our ability to develop any human therapeutic products suitable for commercialization; whether Roche will resume the clinical development of our MAXY-alpha product candidates or undertake any other development activities related to the MAXY-alpha development program, and the timing of any such development or activities; the nature, scope and timing of any further evaluation by Roche of the data that resulted in a voluntary hold on the clinical development of MAXY-alpha and whether any such evaluation will adequately assess the meaning or significance of such data or the suitability of MAXY-alpha for further development; the success or continuation of our MAXY-alpha development program and our existing collaboration with Roche; and, if such development program is continued, whether we will receive any future milestone payments or royalties from Roche relating to our MAXY-alpha product candidates. Such statements involve risks and uncertainties that may cause results to differ materially from those set forth in these statements. Among other things these risks and uncertainties include, but are not limited to, changing research and business priorities of Maxygen and/or Roche, the inherent uncertainties of pharmaceutical research and drug development, our ability to develop human therapeutic drugs in an increasingly competitive biotechnology industry and the uncertain timing of such development, the development of superior products by competitors, and our ability to establish and maintain our research and commercialization collaborations and manufacturing arrangements. These and other risk factors are more fully discussed in our Form 10-K for the year ended December 31, 2006, including under the caption "Risk Factors", and in our other periodic SEC reports, all of which are available from Maxygen at http://www.maxygen.com. Maxygen disclaims any obligation to update or revise any forward-looking statement contained in this release as a result of new information or future events or developments.
OT:
Well they say Açaí in addition to being very high in Antioxidant is supposed to give you a lot of energy so perhaps he had an overdose :). I've never noticed that type of reaction when having açaí (though I've not had the Jumba version)
Clinical / Regulatory / Litigation Calendar
[Please keep entries up to date! See updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: ITMN, UTHR
ACHN – See GILD
AMLN – Phase-3 LAR results: 2H07; Byetta monotherapy results any day.
ANOR / AOM.TO – pivotal AMD3100 results any day.
COR – CX-717 IND to be filed with FDA psychiatry division: summer 2007. (Dosing restriction on CX-717 lifted 7/17/07.)
CRME - IV version of RSD1235: FDA advisory panel 12/11/07.
CYT.TO - Initiated pivotal A-fib trial Oct/06. Complete enrollment 2nd/half 07. Results 2nd half 08.
DDSS – Tramadol NDA: second approvable letter received 5/31/07. New clinical trial likely.
DNA – Avastin sBLA in breast cancer action date: 2/08; Avastin adjuvant CRC interim look Q4 07; Rituxan in Primary Progressive MS Ph III Results Q1 08.
DNDN – Provenge 9902b study: interim analysis (~180 deaths) 2H08; final analysis (360 deaths) 2010.
DORB – OrBec NDA in GVHD: FDA action date was extended in July to 10/21/07.
ELN- Tysabri PDUFA date for Chron's disease 10/15/07
AAB-001 Phase III start in Alzheimer's Disease Q4 07
GILD – Viread NDA submission for HBV: 4Q07.
GILD – GS9190 polymerase inhibitor for HCV: data from phase-1: 3Q07.
GPCB – Satraplatin SPARC trial final OS data: late 2007. (FDA NDA based on PFS data was withdrawn.)
GTCB – ATryn phase-3 for HD in US: report data 4Q07, submit BLA 1Q08.
GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: enrollment complete mid 2008. (First patient enrolled 8/6/07.)
GTCB – Merrimack MM-093: results of phase-2 extension trial in RA: late 2007.
GTOP – Final MyVax results Dec 07.
IDIX – ph3b Tyzeka vs Baraclude 12-wk PK: 4Q07.
IDIX – Tyzeka ph3 data in decompensated liver disease: late 2008 (?) (enrollment completed 1Q07).
IDIX – IDX899 in HIV: Report on drug interaction w/ P450 in 4Q07; first human data 2/08 at CROI.
IDIX – Submit IND for IDX102 and/or IDX184, 2nd generation HCV nucleosides in 4Q07.
IMCL – Erbitux in 1st-line CRC: CAIRO2 (capox/bev/cet) top line results 2H07.
ISA.TO-European psoriasis P3 results 2008. Phase 2B 6&12 month renal results 2008. Phase II/III Uveitis results 2008.
ITMN – ITMN-191 Phase-1B Start dosing 9/07. Initial PK data from perhaps 1st 3 cohorts: Q1 2008
ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results Late 2008 (72 week treatment period). No interim analysis planned, though monitored for safety.
JNJ – TMC125 for HIV: FDA action date 1/18/08.
LBPFF – see DDSS
MCU/MPH.to - Medicure - MC-1 Lead drug candidate for cardiovascular reperfusion is in PH 3 trial /w 3000 patients.
Expect full enrollment Nov/07 with Data by August /08.
Medivir – ph-1 TMC453350 results in HCV at AASLD 11//07.
Merrimack: see GTCB
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2008, trial results in 2009.
NBIX - Indiplon IR PDUFA date December 12, 2007
NBIX - Indiplon IR Product launch, indiplon IR 1Q08
NBIX - NBI-56418 Complete enrollment, 6-month phase 2b endometriosis trial 4Q07
NBIX - NBI-56418 Topline data, 6-month phase 2b endometriosis trial 2Q08
Novocell – see SRDX
NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).
PHRM – Satraplatin MAA to EMEA to be filed 2/08 following analysis of final OS data.
PPHM -
Bavituximab (anti-viral): phase 1B HCV top-line info released 3/07. Final data at AALSD Nov.
Bavituximab (anti-viral): phase 1 trial in HCV/HIV coinfected patients initiated 7/07.
Bavituximab (anti-cancer): phase 2 breast cancer trial protocol submitted to reg. board 9/07
Bavituximab (anti-cancer): phase 2 lung cancer trial protocol submitted to reg. board 7/07
Bavituximab (anti-cancer): phase 1B solid tumor top-line info released 5/07.
Cotara: phase 2 glioblastoma multiforme Indian trial patient enrollment initiated 6/07.
Cotara: glioblastoma multiforme US trial sites expanded to include MUSC 6/07.
RPRX
Proellex
*Initiate US PII Endometriosis trial (Enrollment Oct 2007)
*One year extension data (Q1 2008)
*Initiate Fibroids Pivotal PIII trials (YE2007)
*Initiate Anemia Pivotal PIII trial(s) (YE2007)
ANDROXAL
*FDA Androxal PIII meeting: Oct 15; PR expected 15-31 Oct 2007
*Initiate Pivotal PIII trials (Q4 2007)
OTHER: select alternate Proellex-class compound for advancement into breast cancer studies via potential partner TBA.
SGP – Ph-2 data for SCH 503034 in HCV: 2H07
SNUS - Pivotal TOCOSOL paclitaxel Phase 3 trial in metastatic breast cancer data release due by 9/30/07; primary endpoint is objective response rate; TOCp treatment arm vs control arm of Taxol
SPPI – See GPCB.
SRDX - Novocell phase-1/2 trial in type-1 diabetes: late summer 2007 (enrollment complete 8/30/06).
SYMD- Synthemed-Circulatory System Devices Advisory Panel has been scheduled for September 19, 2007 for Repel CV.
TH.TO -Complete enrollment confirmatory TH9507 HIV Associated Lipodystropy trial 3rd qtr/07, final results 1st qtr/08.
UTHR - Viveta (Inhaled Treprostinil for PAH). July 13, 2007 enrollment closed with 235 enrolled. October 5th last patient out +/- 1 week. Early November around AHA top-line results
UTHR - OvaRex. 6/06 IMPACT II completed enrollment. Unblind when 118 recurrences reached in both IMPACT I and II. As of 6/30/07 number of recurrences: IMPACT I-128 IMPACT II-112.
UTHR - Oral Treprostinil (FREEDOM-C). 16 week combination study. Interim analysis possible at 150 (targeting to enroll 300). Enrollment as of 7/30/07 was 115.
UTHR - Oral Treprostinil (FREEDOM-M). 12 week monotherapy study. Interim analysis possible at 90 (targeting to enroll 150). Enrollment as of 7/30/07 was 62.
VRTX – Telaprevir: PROVE-1/PROVE-2/PROVE-3 phase-2 timetable: #msg-12267294; start phase-3 by end 2007.
VRUS – Ph-3 Clevudine for HBV: start phase-3 3Q07. Ph-1 R7128 in HCV full data at AASLD (top-line data were reported 9/10/07). New study of R7128 with pegifn and riba: start 4Q07, rpt data at EASL 4/08.
ZGEN – rThrombin FDA response date: 1/17/08 (was extended by 3 months.).
--
Procedure For Updating Clinical-Trials List
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old list. You can find a pointer to this list in the iBox at the top of the main message-board screen.
2. Make your additions or modifications, inserting any new items in alphabetical order.
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I haven't been following the cardinals lately but since they Pinch ran for him I imagine he still can't run. I remember a little bit ago (when the cardinals still were in the hunt and he was playing) he was under orders to take things easy forget if it was a hamstring injury or something else.
In the Cardinals Phillies Game if the Cardinals don't score here Pujols is Pinch Hitting for the pitcher. LaRussa will use his 10th pitcher in the 14th and that doesn't even count 2 others (by my count) that he has used in other roles (one as PH and one as a PR). I wonder if this is a record of some sort?
EDIT: Just used another Pitcher as a PR (Pujols walked)
ITMN/VRTX:
I am curious as to why InterMune choose now to do the filing. I have a couple theories namely to in-licensing deal or push one of their preclinical compounds forward). I imagine quite a few people may take the negative view that they are worried about negative 1B results but there are a couple problems with that:
1-Why only issue 3 million (the shelf is for 175 million)
2-Why do it at this point and not before 1A (the stock was higher, IMO the risk was greater)
3-If there were negative news known to the company I'd hardly think they could not disclose this before the offering
4-Several members of management recently put in 10b-5 plans. First again if they were aware of negative non-public info and put in a plan based on that I believe that would be a violation and second why do it before an offering that would perhaps have a negative impact on the share price.
5-I believe the underwriters are bared from giving an opinion on the company for a period of time (30 or 60 days?). Doing the offering now enables them to do so when the 1B data is available.
I am reading it now but this from InterMune's preliminary prospectus caught my eye. It is the first public disclosure of the AE's in the 1A and the most detail I have seen. I think it is quite a contrast from the FUD Mr. Feuerstein posted in his column. Interesting the dosing with food not only produced high concentrations in the plasma but could also reduce the GI AE's (which appear to be at many-fold higher doses then what is intended for the 1B)
RE Vertex on the call today I heard them say about exploring a SHORTER period of 950. Could this be an indication they are more concerned with AE's then they let on?? Also at the liver disease meeting it sounds like they will be presenting a lot of data at he liver disease meeting AASLD (November 2-6).
In May 2007, we reported that ITMN-191 had completed dosing in a Phase Ia single ascending-dose, or SAD, trial in 64 healthy volunteers. No serious adverse events were reported in the SAD trial. All adverse events were classified as mild (CTCAE Grade 1), and no volunteers were discontinued due to an adverse event. The most common adverse events were gastrointestinal-related, were all classified as mild (CTCAE Grade 1), occurred predominantly in the highest dose cohort, appeared to be attenuated in the presence of food and rapidly resolved without intervention. No clinically significant laboratory abnormalities or ECG changes were reported.. Plasma exposure was observed in all dosage cohorts. The doses given in this SAD trial ranged from less than 10% to many-fold higher than those planned to be given in the Phase 1b multiple ascending dose, or MAD, trial expected to begin in September 2007. Subjects who were administered ITMN-191 with a standard institutional meal demonstrated significantly higher plasma levels of ITMN-191 compared to subjects given the same dose of ITMN-191 without a meal.
Can anyone give me a description or have a link on what the 74 day letter from the FDA covers (my search capabilities apparently aren't good enough to find anything meaningful). TIA
Well maybe the side effects are more then managements is letting on so they are trying to minimize dropouts :)
Did anyone notice the mlb.com game tracker no longer shows a box outline of where the strike zone would be? I no the strike zone isn't exact for any two people but at least it helped give a vertical idea... If I was a conspiracy theorist I'd wonder if someone complained :)
ITMN:
My rebuttal to Mr. Feuerstein's (and the iVillage post) attack on InterMune.
For the record Feuerstein greatly distorts things and doesn't always get his facts 100% correct. I have noticed from past articles that he is obviously very chummy with the Vertex management and so he at least is somewhat biased.
E.g.
1. http://www.thestreet.com/s/vertex-drug-could-be-huge/newsanalysis/biotech/10374489_4.html
Something else helping Vertex these days is that some of the competitors developing new hepatitis C drugs are stumbling. InterMune (ITMN - Cramer's Take - Stockpickr - Rating) is developing a drug similar to telaprevir, but its clinical program has been slow out of the blocks, with delays to the start of human clinical trials.
Well my understanding was the Phase 1A trial was in humans maybe Mr. Feurstein considers Europeans something else? Yes the 1A had about a month delay but he probably was referring to the 1B trial but it sounds better [i.e. puts more doubts in people’s minds ] to word things as he did. He doesn’t bother to correct his little misstatement just glosses over it in a passing reference to the 1A trial in today’s column.
2. From http://www.thestreet.com/pf/newsanalysis/biotech/10378449.html (this week)
But it might be nice for Welch to show us some actual human data to back up his claims.
Again Mr. Feuerstein attempts to mislead his audience and put doubts about the 191 program. He makes it sound like InterMune is hiding data. The 1B trial is only now getting initiated and 1A trial was in health humans so no anti-viral data exists yet for 191 in humans. He is right in that we don't know for sure what it will do until then but he states it in a way to mislead and put doubts.
4. Again from the column this week:
Welch took some jabs at Vertex Pharmaceuticals (VRTX - Cramer's Take - Stockpickr - Rating) and its leading hepatitis C drug candidate telaprevir. Several times, Welch suggested that telaprevir had toxicity and tolerability issues that could make it an inferior drug to ITMN-191.
My take on the conference was FAR different then Mr. Feuerstein’s. He actual has said on several occasions Telaprevir is a good drug and the Protease has been validated as a good target in Hep. C. What Mr. Welch is pointing out is that a year or two ago everyone thought 950 was the perfect drug and it has since been realized that there is room for improvement (dosing, tolerability/side-effects, response rates).
4. Again from the column this week:
On the efficacy front, Welch repeated once again the company's well-worn take-home message for investors that ITMN-191 is hugely more potent than telaprevir in preclinical models.
He is there to talk about InterMune and its programs and one of them is a Protease Inhibitor so to educate the audience on differences between ours and potential competitors at this stage all InterMune has data on is preclinical so what is wrong with pointing out that? It also has a potential dosing advantage too Mr. Feuerstein .
5. Again from the column this week:
There have been rumors of toxicity issues with the drug, which InterMune denies (although they refuse to discuss any specific toxicities associated with ITMN-191 when given to healthy volunteers in a previous phase Ia study).
This is an old-worn-out-message from writers. Everybody likes to say its like the BI compound and they had cardio-toxicity. Well if Mr. Feuerstein had his ears opened he would have heard that there were no serious toxicity issues in the 1A and any adverse events quickly resolved themselves. The fact is European regulators and the centers that will do the 1B study gave their go ahead. I somehow seriously doubt they would have said OK, proceed, if there were some serious tox issue in the 1A trial. This is actually more of a validation that nothing critical (so far) has been discovered. Yes it is vague and I’d like to know more but again Mr. Feuerstein likes to make it sound like InterMune is hiding some major tox issue.
6. I am surprised he didn’t mention about the 10b5-1 plans several company employees entered into on Friday. Oh no wait then he’d have to say about Vertex sales. While not knowing the exact conditions if one notices the dates and assumes an even sale the bulk would be after 1B data and oh by the way since they are likely about to start dosing they would have to put the plans in before any material information.
Don’t get me wrong I enjoy reading Mr. Feuerstein’s columns just do your own research listen to the call yourself [the Q&A at the end at least that is the bulk of Mr. Feuerstein's reference] and judge. He is certainly more than a little biased!
OT: That article caught my eye too! Also saw this one. Hope it isn't clutter this board but good for a laugh (well maybe it isn't so funny).
http://news.yahoo.com/s/ap/20070905/ap_on_sc/wrong_fish_5
Study: Wrong fish used to save species
DENVER - A 20-year government effort to restore the population of an endangered native trout in Colorado has made little progress because biologists have been stocking some of the waterways with the wrong fish, a new study says.
Advances in genetic testing helped biologist discover the error, which was called a potential black eye, but they said there is still hope for restoring the greenback cutthroat trout.
The three-year study, led by University of Colorado researchers and published online in Molecular Ecology on Aug. 28, said that five of the nine populations believed to be descendants of the endangered trout were actually the more common Colorado River cutthroat trout, which look similar.
The study said the results imply that the effort has "failed to improve the species' status."
Lead author, Jessica Metcalf, who recently completed her doctorate in ecology and evolutionary biology at the university, was optimistic about the ongoing restoration program because four populations have been identified as "pure greenback cutthroat trout."
Bruce Rosenlund of the U.S. Fish and Wildlife Service, which is leading the recovery effort, said the agency is reviewing the study.
"The report is just a continuation of different expert input provided to the team for consideration for restoration," Rosenlund said.
Colorado and federal biologists have a goal of 20 self-sustaining populations of at least 500 fish each. The cost of the program was not available.
Greenback cutthroat trout were historically found in the drainages of the Arkansas and South Platte rivers in Colorado and a small part of Wyoming. They were declared extinct in 1937 because of overfishing, pollution from mines and competition from nonnative fish.
Researchers said remnant populations were found in the 1950s in tributaries and provided brood stock for fish raised in federal and state hatcheries and released in their native habitat.
The fish was added to the federal endangered species list in 1978.
The greenback were believed to be in 142 miles of waterways, including in Rocky Mountain National Park, Rosenlund said.
The new study, based DNA test results, found the greenback cutthroat trout's range is only 11 miles of streams.
The research results are a setback but state biologists believe the program will succeed over the long term, said Tyler Baskfield, Colorado Division of Wildlife spokesman.
"We've been moving fish around in the state since the late 1800s, and now the new science comes in and all of a sudden it's a different playing field," Baskfield said.
University of Colorado professor Andrew Martin, the study's principal investigator, said that while the findings might give the recovery program a "black eye," the hope is that biologists and agencies will move ahead on recovering the species before it goes extinct.
Phillies lose a heartbreaker.
That depends on whose perspective you have :)
2007 ASCO Presentations:
FYI for those who didn't want to pay for access the presentations are freely available today. Actually I think it was as of 9/1 but I tried the other day and couldn't access one.
http://www.asco.org/portal/site/ASCO/
:) Makes as much as anything, volume seemed high too I guess he is well enough to buy shares.
NFLD: Anyone know why the big move today?
I just like the huge work ethic that he has and he has always been a true professional.
Working PT, getting permission to not travel with the team (at least with Houston don't know the Yankee's deal), 1M+ per game pitched (even if it is only a couple innings) ...doesn't fit my idea of huge work ethic :).
OT (A little) my apologies if this has already been posted.
http://msn.foxsports.com/mlb/story/7141730
Woman rejects ballpark marriage proposal
You know things are wrong in Astro-land when even a wedding proposal can't go off smoothly.
During Monday night's 7-0 loss to the Nationals at Minute Maid Park, a fan failed in his public attempt at asking his girlfriend to marry him, the Houston Chronicle reported on its Web site.
With the couple on display on the stadium's jumbotron, the male fan got down on one knee to present the ring. The woman, wearing a replica Astros jersey, appeared to dump a bag of popcorn on the man before hastily making her way up the stairs amid a chorus of boos, the newspaper reported.
The man left after the top of the sixth inning, cheered and consoled by an apparently sympathetic crowd.
"If it was an act, she put on a good one," Astros manager Phil Garner was quoted as saying after the game. "She looked totally surprised and then totally mad. We couldn't even get a proposal right down here tonight.
"We lead the league in marriage proposals, and we couldn't get that one right tonight."
CRME:
First they (their partner actually) botched the filing and now they get a panel. Anyone have a guess as to why? I haven't kept up with them but they have an Oral version in the pipeline which I thought could be a huge drug.
http://biz.yahoo.com/prnews/070830/to385.html?.v=25
Cardiome And Astellas Announce Regulatory Extension
Thursday August 30, 8:30 am ET
VANCOUVER, and DEERFIELD, IL, Aug. 30 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that the U.S. Food and Drug Administration (FDA) has requested that Astellas and Cardiome participate in a panel review to be conducted by the Cardiovascular and Renal Drugs Advisory Committee on December 11-12, 2007. The New Drug Application (NDA) for the intravenous formulation of vernakalant hydrochloride, an investigational new drug for the acute conversion of atrial fibrillation, will be reviewed as part of a two-day meeting regarding therapies for acute conversion of heart arrhythmias.
ADVERTISEMENT
In preparation for the panel, and at the request of the FDA, Astellas has agreed to file additional information including final safety and efficacy data from the ACT 2 clinical trial, which was ongoing at the time of original NDA submission. As a result of this amendment to the NDA, the FDA has indicated that the action date under the Prescription Drug User Fee Act (PDUFA) will be extended by three months to January 19, 2008. It is expected that discussions related to the application review and labelling will continue with FDA throughout the intervening period.
The Cardiovascular and Renal Drugs Advisory Committee is convened on request of the FDA, and reviews and evaluates available data concerning the safety and effectiveness of human drug products for use in the treatment of cardiovascular and renal disorders and makes appropriate recommendations to the Commissioner of Food and Drugs. Although the Committee provides advice to the Agency and suggests a course of action, final decisions are made by FDA.
"Upon the acceptance of the NDA for filing in February, we and Astellas began preparation for an advisory panel, considering that vernakalant (iv) is a new chemical entity for the treatment of atrial fibrillation. We and our key clinical advisors welcome the opportunity to present our data on vernakalant (iv) to the Panel and the American public," stated Bob Rieder, Chief Executive Officer and Chairman of Cardiome. "Presentation of the program to the Advisory Committee is an important milestone in the NDA review before an action on the application from the FDA in January of 2008. Commercialization plans continue to move forward."
"Astellas, along with our co-development partner Cardiome, look forward to discussing the clinical safety and efficacy information for vernakalant (iv) with the Cardiovascular and Renal Drugs Advisory Committee, as a part of an overall dialogue on new pharmacological therapies for acute conversion of atrial fibrillation," stated Yoshihiko Hatanaka, President and Chief Executive Officer at Astellas. "The data from the ACT 2 trial offers both the FDA and the Advisory Committee additional insight regarding vernakalant (iv) as a potential new treatment option."
The NDA for vernakalant (iv), based on a 5-year clinical development program, was submitted in December 2006 and accepted for review by the FDA in February 2007. Upon approval, vernakalant (iv) will be marketed in the United States by Astellas Pharma US, Inc., a U.S. affiliate of Astellas Pharma Inc. In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize vernakalant (iv) in North America. The companies have co-developed vernakalant (iv) to NDA, with Astellas responsible for 75% of development costs. Cardiome has retained all rights to the intravenous formulations outside of Canada, U.S. and Mexico.
Cardiome will hold a conference call and webcast on Thursday, August 30, 2007 at 9:00am EDT (6:00am PDT). Please dial 416-340-8010 or 866-540-8136 to access the call. There will be a separate dial-in line for analysts on which we will respond to questions. The webcast can be accessed through Cardiome's website at www.cardiome.com. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through September 30, 2007. Please dial 416-695-5800 or 800-408-3053 and enter code 3233538 followed by the number sign to access the replay.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with two late-stage clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), a Phase 1 program for GED-aPC, an engineered analog of recombinant human activated Protein C, and a pre-clinical program directed at improving cardiovascular function.
Vernakalant (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation (AF). Positive top-line results from two pivotal Phase 3 trials for vernakalant (iv), called ACT 1 and ACT 3, were released in December 2004 and September 2005. Cardiome's co-development partner Astellas Pharma US, Inc. submitted a New Drug Application for vernakalant (iv) in December 2006. Positive top-line results from an additional Phase 3 study evaluating patients with post-operative atrial arrhythmia, called ACT 2, were released in June 2007. An open-label safety study evaluating recent-onset AF patients, called ACT 4, has completed.
Vernakalant (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Cardiome announced positive results from a Phase 2a pilot study for vernakalant (oral) in September 2006. A Phase 2b study for vernakalant (oral) is ongoing.
In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC for all indications. Cardiome intends to initially develop GED-aPC in cardiogenic shock, a life-threatening form of acute circulatory failure due to cardiac dysfunction, which is a leading cause of death for patients hospitalized following a heart attack.
Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME).
About Astellas Pharma US, Inc.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a US affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information about Astellas Pharma US, Inc., please visit our website at www.astellas.com/us.
Forward-Looking Statement Disclaimer
Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: we may not be able to successfully develop and obtain regulatory approval for vernakalant (iv) or vernakalant (oral) in the treatment of atrial fibrillation or any other current or future products in our targeted indications; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and sales capabilities and the costs of launching our products may be greater than anticipated; we rely on third parties for the continued supply and manufacture of vernakalant (iv) and vernakalant (oral) and we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Securities and Exchange Commission available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
CONTACT: Peter K. Hofmank, Senior Director, Investor Relations, (604) 676-6993, or Toll Free: (800) 330-9928, Email: phofman@cardiome.com; Maribeth Landwehr, Associate Director, Corporate Communications, Astellas Pharma US, Inc., (847) 317-8988
Tito tossed, arguing on JD's behalf?
Boy you are showing your age :). I saw his son play (and manage) but never saw him play.
MRCR: 1.95 - 2.50 (Though often the bid's aren't accurate as I've put bid's that don't appear) 6.3 million shares outstanding.
I posted this on SI don't know how many people know of the company. Yes it is a Pink Sheet but the company is selling at less then 1/4 of sales, they have been consistently profitable. Mr. Menard has consistently done good deals and had tremendous returns on Equity. If you go back and read the PR's and check out the financials you'll see a nice story.
http://biz.yahoo.com/bw/070829/20070829005839.html?.v=1
Moro Corporation Reports First Half 2007 EPS of $.12; Announces Planned Acquisition
Wednesday August 29, 2:06 pm ET
WAYNE, Pa.--(BUSINESS WIRE)--Moro Corporation (OTC:MRCR - News) today announced that financial results for the three and six months ended June 30, 2007 were as follows:
Three Months Ended Six Months Ended
June 30 June 30
------------------------ -----------------------
2007 2006 2007 2006
---------- ----------- ---------- ----------
Revenue $16,803,000 $ 16,041,000 $30,132,000 $25,477,000
Net income $ 571,000 $ 602,000 $ 776,000 $ 821,000
Earnings per share $ .09 $ .10 $ .12 $ .13
Average number of
common shares
outstanding 6,282,143 6,273,705 6,282,143 6,261,918
PDLI:
Dan Loeb from Third Point 31:45 into the call. Worth a listen!
http://web.servicebureau.net/conf/meta?i=1112921763&c=2343&m=was&u=/w_ccbn.xsl&date_...
PDLI:
Don’t remember the exact remark so don’t quote me.
I didn’t catch the name of the caller but I imagine it was someone from Third Point. He made a statement not too critical at first and then went on to suggest selling the company. Then someone from management said did you have a question somewhere in there (his tone was asking for a smart-alecky remark) then the caller replied Yes how can you sleep at night knowing what you’ve done to the company. Mgm’s reply was can we have the next question. Its worth a listen as its funny hearing it (I think it is about 40 minutes or so into the call)
PDL: Anyone listening to the PDL Call now. Great (funny) remark in response to mgm do you have a question comment. I leave the answer for those catching the playback
Some Items from the Neurochem Call
1. Models to review data are not reliable??? Discussions with the FDA indicated, substantial adjustment to model required and would not be appropriate to apply to the same data set.
2. Think tolerability was good, issues with concomitant meds related to 18-month trial in Alzheimer's patients
3. Think problems not unique with Alzhemed trial, will be shared by others [but did not elaborate]
4. Primary analysis for European trial can be modified (even though trial has fully enrolled). Could also alter cohorts (could divide). The duration and even trial size could also be altered. Plan to continue study as planned. In a few months (target by end of year) will have some answers on any changes.
5. Hippocampal brain volume changes noted in some/subgroups [didn't catch exactly]. Still learning don't have full understanding of this. In other studies [not Alzhemed] correlation with this and disease progression.
6. Not releasing P Value. Not releasing any results for that matter, will be released at future medical conference.
7. 80 mil US Cash, 45 million US debt, 3 mil/month burn will go down. 1.5 – 2 years cash.
In general management was very tight lipped. Sounded as if the study was poorly done with widely differing results and concomitant medication useage was a big problem. It seemed like some post-hoc subgroup analysis may show something.
The last question was a bit humorous side asking about Kiacta status and why the results would be any different third time around.
Neurochem: Anyone catch the conference call this AM? I'll probably try to get the replay today or tomorrow wondering if anything worthwhile was mentioned. Anyone know if it is available on the web or just via call in. TIA
FYI If you want to hear Mr. Myers there is a link about half way down on the right at
http://www.kyw1060.com/
http://atlanta.braves.mlb.com/news/article.jsp?ymd=20070824&content_id=2167614&vkey=news_atl...
Wickman designated for assignment
Veteran closer converted 20 of 26 save opportunities
By Mark Bowman / MLB.com
Bob Wickman has gone 63-60 with a 3.58 ERA and 267 saves in 827 career appearances. (Gene J. Puskar/AP)
ST. LOUIS -- Adam Dunn said goodbye to Bob Wickman's 12th-inning fastball on Thursday night, and the Braves said goodbye to Wickman on Friday afternoon.
Somewhat surprisingly, the Braves announced Friday that they've designated Wickman for assignment. This wasn't a move made to free up a roster spot. Instead, it's one that essentially puts an end to the veteran closer's days in Atlanta.
"I just want to try something else," said Braves manager Bobby Cox, while seemingly attempting to avoid saying anything negative about Wickman, who posted a 3.92 ERA in 49 appearances and blew six of his 26 save opportunities this year.
While Cox was diplomatic, Andruw Jones provided an indication that Wickman sometimes complained about pitching in non-save situations, like the one he entered in Thursday night's extra-inning loss to the Reds.
By the time the 12th inning arrived Thursday, the only remaining available relievers were Wickman and Oscar Villarreal, who would have pitched every inning that followed the 12th.
"We need guys who want to pitch," Jones said. "If you don't want to pitch you shouldn't be here."