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I believe others have replied for the record I emphasized the word FORWARD and my definition of the word would match most investors. I was in no way posting misleading info!
Since Zynex does not give forward projections to calculate the forward PE one would have to make their own. Obviously I believe your 4x last quarter is not accurate in this case and using .16 would be a PE 10 and IMO is extremely conservative (I would be disappointed with that for this year baring some extraordinary events).
sales/rental '07 sales/rental '06
Q1 $1,336,731.00 $505,091.00
Q2 $1,505,207.00 $560,860.00
Q3 $2,104,446.00 $743,787.00
Q4 ?????????? $747,071.00
Income (loss) '07 Income (loss) '06
Q1 $231,681.00 $(22,435.00)
Q2 $351,548.00 $(93,208.00)
Q3 $614,465.00 $22,892.00
Q4 ??????????? $(227,619.00)
Diluted EPS '07 Diluted EPS '06
Q1 .01 -
Q2 .01 -
Q3 .02 -
Q4 ???
Sales Growth Q over Y ago Q
Q1 165%
Q2 168%
Q3 183%
Sales Growth sequential Q over Q
Q1 79%
Q2 13%
Q3 40%
Earnings Growth sequential Q over Q
Q2 52%
Q3 75%
I don't know what woke up the stock today perhaps an article somewhere or it popped up on a couple people's radar when you think about it only about 250k dollars of volume happened today which isn't that much. If one thinks about how many people still never even heard of the stock if we start getting a bit more publicity (which no doubt will happen if growth continues even at a slower pace) our multiple should start getting to the level it deserves for such a rapid growth rate!
I am not really surprised we are at these levels (as I suspect many others aren't) personally I thought we should have been here at least a quarter ago and should be significantly higher. I know we are a microcap and a lot of people stay away and no doubt we have some (IMHO minor) problems, but we have over a year of substantial consecutive q on q sales and revenue (forget about year ago q growth which is tremendous). I think if one looks at past history and companies growing at triple figures annually and double digits quarter over quarter a FORWARD PE our PE of less then 10 today is ridiculously low (unless there is an extreme collapse, major change in the company or some extraordinary event).
VRTX:
If one goes by what is posted on some (other) message boards they'll get the entire pool of non-responders and untreated but diagnosed patients before any competitor reaches the market. I am not a historian but SGP had a lead over Roche and not only quickly lost market share but leadership. Given that the competitors (other then SGP) have various improvements if I were a guessing man I would think history appears likely to repeat itself should they reach market first and assuming 1 or more of the early competitors reach market as well [obviously I am a bit biased].
They did not give any additional information on 2nd generation but did say when/if they get data in patients they would release it. They also said that while Telaprevir is a great drug and hard to improve upon [paraphrasing], the next generations would improve upon it in 1 or more of efficacy or dosing (perhaps they said some other areas but notably safety/tolerability was not mentioned).
They gave a little color on the type of non-responders enrolled in the trial. I didn't catch it completely so I don't want to post inaccurate info. I believe it was in response to a question about why they think they'd achieve a better response the Boceprevir.
They seem to be pushing the line that efficacy and 24 weeks of total therapy are the two most important things. While I'ld agree on the first my guess is the FDA doesn't put the second in the top 2.
I just saw that! Do you think they are hearing footsteps and/or not as confident as they once were in their lead PI?
I thought J&J was picking up some of the development cost their R&D seems extremely high.
Substantially Revamped
InterMune http://www.intermune.com/
i-hub InterMune board: http://investorshub.advfn.com/boards/board.asp?board_id=8637
Call Summaries
Q1 2007 #msg-19408521
Q2 2007 #msg-23131457
Q3 2007 #msg-24264853
JP Morgan 26th Annual Healthcare Conference Notes #msg-25836765
Wachovia 2008 Healthcare Conference #msg-26491473
Q4 2007 #msg-26701562
Historic Jobs List #msg-26491523
Commentary on InterMune buyout of the future Pirfenidone License Obligation to Marnac #msg-24817787
Some other studies on Pirfenidone #msg-24788957
IPF/Pulmonary Fibrosis Competitive Landscape #msg-26702328
Pirfenidone Program
• IP Expansion and life-cycle management efforts underway since 2005
• Comments on Buyout of Royalty from Marnac #msg-24817787
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 (R7227)
• 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. September 26th began dosing patients. Approximately 40 HCV patients.
2. Triple combination study expected to start in Q2 2008
3. January 7th 2008 announced completed first 2 dose cohorts of up to 300mg DAILY doses. Additional commentary and information on 1/7/08 Phase 1B update PR #msg-25802407
Misc. / Early Stage Programs
• Equity interest in Targanta Therapeutics, http://www.targanta.com/ as a result of selling Oritavancin in December 2005. (http://tinyurl.com/yznhod). Now public company trading under symbol TARG. 3million shares, 600,300 available for sale.
• 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 ITMN-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 235.3 million (end of Q4 2007)
• 170 million convertible. Coupon rate .25%. 2011 maturity. Conversion Price $21.63.
• 39 million shares outstanding
• 2008 Guidance
o R&D 100-110 million, net of Roche reimbursement (they pay 2/3 of all PI development costs).
o G&A 25-30 million
Time-Line/Medical Presentations
• EASL and/or DDW All available Data on 4 cohorts of Phase 1B ITMN-191 (R7227). May also PR on or before meetings.
• After 4th cohort of treatment naïve patients in Phase 1B MAD study will have a single cohort of treatment-experienced patients
• Q2 2008 Initiate triple combinations study of ITMN-191 (R7227) in EU (14 day with Pegasus and ribavirin)
• 2nd Half 2008 Roche to file IND for ITMN-191 (R7227) in US
• January ‘09 Top line results from CAPACITY Trials
IPF/Pulmonary Fibrosis Competitive Landscape
It should be noted that some of the various programs (if successful) could be used in combination as they work on various pathways. Also some programs may not be aimed at addressing disease progress but rather some of the associated ailments (e.g. Cough). Look for future updates and opinions on various programs would also appreciate others views/updates.
Phase 3
Pirfenidone (ITMN) - http://clinicaltrials.gov/ct2/show/NCT00287716 http://clinicaltrials.gov/ct2/show/NCT00287729 http://www.capacitytrials.com/wt/page/index
See InterMune board and RMF: http://investorshub.advfn.com/boards/board.asp?board_id=8637
Bosentan [Tracleer] (Actelion) - http://clinicaltrials.gov/ct2/show/NCT00391443 http://tinyurl.com/3akama
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.
Sildenafil (National Heart, Lung, and Blood Institute (NHLBI)/Pfizer) - http://clinicaltrials.gov/ct2/show/NCT00517933
Phase 2
Gleevec (Novartis) - http://clinicaltrials.gov/ct2/show/NCT00131274
QAX576 (Novartis) - http://clinicaltrials.gov/ct2/show/NCT00532233
Thalidomide (Johns Hopkins University/Celgene) - http://clinicaltrials.gov/ct2/show/NCT00162760 http://clinicaltrials.gov/ct2/show/NCT00600028
BIBF1120 (Boehringer Ingelheim) - http://clinicaltrials.gov/ct2/show/NCT00514683
Tetrathiomolybdate [Coprexa] (U of Michigan/Pipex) - http://clinicaltrials.gov/ct2/show/NCT00189176
Phase 1/Unsure
GC1008 (CAT/Genzyme) - http://clinicaltrials.gov/ct2/show/NCT00125385
FG-3019 (Fibrogen) http://clinicaltrials.gov/ct2/show/NCT00074698 http://www.fibrogen.com/uses/ipf.html
Remodulin (UTHR) – Unsure of current status have heard mention of using the Oral formulation [Though personally I would wonder why the inhaled would not be tried].
Inhaled Actimmune (Respironics/U of Michigan) - http://tinyurl.com/35fnuv http://tinyurl.com/2kbztr
Promedior – Company doing early stage research
Gilead/Parion - Licensing deal for pulmonary disease http://www.gilead.com/pr_1040975
FPT025 (FivePrime/J&J) - http://www.fiveprime.com/index.php?option=com_content&task=view&id=41&Itemid=75
Neopharm – Unclear if they are actually moving forward or just looking for some PR.
Immuneworks – Using immune tolerance
EmphyCorp – Working in Interstitial Lung Disease
Thanks for the warning. I'ld hope everyone doing DD would double check things including what I post :). That being said I've listened to the call several times and think what I've taken is accurate (though I did not verify a word-for-word account on each quote). I have gotten transcripts from other places but usually I have to wait a couple weeks. While I had the time today I am updating the Readme and took the quick way out since it was available today.
Q4 2007 Earnings Release and Conference Call Notes
Some things cut and pasted from seeking alpha transcript http://tinyurl.com/3cjsdx
Pirfenidone/IPF
. No new information on Shionogi hearing from Japan. Not at liberty to comment if they have or have not heard anything. Based on traditional review of Orphan drug 9-15 months from data of submission (Shionogi Filed March 2007).
. November 26th announced new agreements with the licensors of pirfenidone, Marnac and KDL that eliminated all future royalty and milestone payment obligations for pirfenidone under the prior license agreement completed in 2002.
. Shiongi data sharing agreement always for purchase of data to use in regulatory submission. Did not think data could be sold to another party without InterMune permission (Did not know for absolute certainity).
. In 2008, we plan to do more of preliminary marketing, research, branding, positioning type studies, reimbursement type studies. In 2009, that would be done more robustly. And in 2009, we would be thinking about fielding sales force, management, et cetera, and then finally, around the time of approval, making the decision to hire actual sales representatives. But that wouldn't be until well down the line into 2009. But 2008, some preparation; 2009, classical pre-launch preparation, but not a big staffing infrastructure increase until well down the line towards the end of 2009. [though Pirfenidone is not technically available for partnering x-US the company is sure sounding like that is their intention].
ITMN-191 (R7227)
. January 7th reported that we had completed the first two dosage cohorts in the study with total daily doses of InterMune-191 of up to 300 milligrams administered for 14 days. The safety and tolerability results of InterMune-191 in these first two cohorts were excellent. Trial achieved its principal goals, namely the demonstration of a viral kinetic safety and tolerability profile of 191 sufficient to advance the program into a triple combination study with Pegasys and ribavirin.
. Completed enrolling cohort 3 in MAD study in late January. While blinded no reports of any signal that's
crossed up in the day-to-day monitoring of those patients. As patients go through the third cohort, we are aware of whether the significant issues develop from a safety and tolerability standpoint. And today, we continue to be extremely pleased with what we're seeing.
. In conjunction with our partner, Roche, we have decided to complete a fourth cohort of the Phase Ib MAD study to further inform the planned 14-day triple therapy study and potential direct antiviral combination studies in the future.
. Regarding the timeline for our 14-day triple combination study of 191 combined with Pegasys and ribavirin, we expect to initiate the study in the second quarter of this year. The study design and timeline will be shared at the time of study initiation. I would certainly anticipate that we will do dose range in that study and that we will explore different doses and likely different schedules as well.
. We have said all along that the design of the study includes a single cohort of treatment-experienced patients that we
would envision being enrolled after we complete the treatment-naïve experience. And so, just to be clear on that, that would be an additional cohort beyond the four that Dan was alluding to today.
. IND is expected to be filed for 191 in the second half of 2008 by our collaboration partner, Roche, to allow the compound to be studied in the United States. Phase 2 to include US expect it to be multinational like other Phase 2’s by other programs.
. Release of 1B MAD monotherapy data - It could be a press release. It could be an abstract. It could be both at either of the
conferences [EASL and DDW] or both.
, On mfg in Roche’s hands - they've made excellent progress in terms of cost of goods reductions, volumes, quantity, process improvements, et cetera. And at this time, we are extremely comfortable with the status of our manufacturing. And I'm very comfortable that at the time of commercialization, we'll be in a very strong position in terms of cost of goods and margins, for example.
. [Why the 4th cohort is mostly likely a higher dose though the company was intentional vague when asked directly] as I alluded to earlier how pleased we've been with safety and tolerability and other aspects of the program, we, along with Roche, decided to go ahead and in fact confirm that we are going to roll that fourth cohort.
. We have not seen the results of the third cohort. So we have what we had a month ago. Since a month ago, we've had quite a number of conversations with our partner, Roche, on how to bring the program forward in combination studies, potential direct antiviral combinations in the future. And the decision was jointly made that do a fourth cohort to get more data to inform the triple combination, to inform potential future studies.
. what we'd like not to do is have to go back and do more Phase I type work down the line if we decide when we start doing directly antiviral combinations that we need to go higher.
. In conjunction with our partner, Roche, we are talking about treatment-experienced patients and how we would conduct studies and engross designs or what those studies might look like in treatment-experienced and further down the line, and we have only just begun the discussions with our partner to direct antiviral combinations in treatment-experienced patients. But that's somewhat down the line, and conversation has just begun. [At a prior conference Dr. Porter indicated that Roche intended to pursue studies with various combinations of their entire Arsenal of HCV products]
Financial/Misc.
• Q4 2007 Results
o Net loss of $25.8 million, or $0.66 per share
o R&D expenses of $25.0 million
o G&A expenses were $6.6 million
o Actimmune revenue of $8.8 million (Total Revenue $9.6 million)
o $6.2 million charge for acquired R&D (related to Marnac license/royalty buyout)
o Unrealized gain of $5.7 million on 630,000 shares of Targanta
• Cash/securities 235.3 million (end of Q4 2007)
• 170 million convertible. Coupon rate .25%. 2011 maturity. Conversion Price $21.63.
• 39 million shares outstanding
• 2008 Guidance
o R&D 100-110 million, net of Roche reimbursement (they pay 2/3 of all PI development costs).
o G&A 25-30 million
Time-Line/Medical Presentations
• EASL and/or DDW All available Data on 4 cohorts of Phase 1B ITMN-191 (R7227). May also PR on or before meetings.
• After 4th cohort of treatment naïve patients in Phase 1B MAD study will have a single cohort of treatment-experienced patients
• Q2 2008 Initiate triple combinations study of ITMN-191 (R7227) in EU (14 day with Pegasus and ribavirin)
• 2nd Half 2008 Roche to file IND for ITMN-191 (R7227) in US
• January ‘09 Top line results from CAPACITY Trials
Would the Phenoptin (now called Kuvan) Phase 3 qualify in your discussion?
They had the unusual design in that only patients who demonstrated a blood phe reduction while on real drug in the Phase 2 would qualify for enrollment in the Phase 3 who were then blinded to receive drug or Placebo. It was necessary because the drug (BH4) was expected to only work on those patients with residual enzyme. What a great design you get to exclude patients who did not show a response to your drug!
http://phx.corporate-ir.net/phoenix.zhtml?c=106657&p=irol-newsArticle&ID=692848&highlight=
I posted this on the BMRN board but as a lot of it pertains to Altus I thought I would cross post it here too:
#msg-26678891
Congratulations fear I see you are no longer moderator so I guess it hit your target and your out? I've lightened my position too but still really like the company.
I've been thinking more and more about the cash they have and JJ's comments in the past year and I get the sense they may do a descent sized deal yet. Why? No reason in particular but it strikes me as an opportunistic time in biotech land as many are not much above cash and/or are cash strapped. The two deals they did were very minor in my book and I think JJ wants a more near-to-market product.
I could see a deal like the following (and I don't necessarily want it to happen as I am down a fair amount on the stock just pose it as an example)...
Take Altus Pharmaceuticals. Stock is about 6 and has 30 million shares and say about 140 million in cash/securities (this is all back-of-the-hand so give me some flexibility I know they have some debts but they also have NOL's). So basically the market is valuing the technology at 40 million. They have 3 products in human testing and several more preclinical. One product in preclinical would be a direct competitor to PEG-PAL (a.k.a. treatment for all PKU patients especially non-Kuvan responders). Their most advanced product Trizytek (ALTU-135) is a pancreatic enzyme replacement therapy used primarily by cystic fibrosis patients and interestingly Biomarin just licensed a cf product. I also think Biomarin would have strong interest ALTU-237 (hyperoxaluria).
The CEO recently left and former TKT CEO/COO replaced him. If Altus were to be broken up (aside from the technology, ALTU-238 is their other key asset) I am sure the three products I mentioned above would be worth > 100 million to BioMarin and yet the market is saying you can have them and more for 40 million.
I am familiar with both companies so this example comes readily but there are probably many other late stage drugs available for licensing by companies that don't have the cash/resources to commercialize them.
Congratulations fear I see you are no longer moderator so I guess it hit your target and your out? I've lightened my position too but still really like the company.
I've been thinking more and more about the cash they have and JJ's comments in the past year and I get the sense they may do a descent sized deal yet. Why? No reason in particular but it strikes me as an opportunistic time in biotech land as many are not much above cash and/or are cash strapped. The two deals they did were very minor in my book and I think JJ wants a more near-to-market product.
I could see a deal like the following (and I don't necessarily want it to happen as I am down a fair amount on the stock just pose it as an example)...
Take Altus Pharmaceuticals. Stock is about 6 and has 30 million shares and say about 140 million in cash/securities (this is all back-of-the-hand so give me some flexibility I know they have some debts but they also have NOL's). So basically the market is valuing the technology at 40 million. They have 3 products in human testing and several more preclinical. One product in preclinical would be a direct competitor to PEG-PAL (a.k.a. treatment for all PKU patients especially non-Kuvan responders). Their most advanced product Trizytek (ALTU-135) is a pancreatic enzyme replacement therapy used primarily by cystic fibrosis patients and interestingly Biomarin just licensed a cf product. I also think Biomarin would have strong interest ALTU-237 (hyperoxaluria).
The CEO recently left and former TKT CEO/COO replaced him. If Altus were to be broken up (aside from the technology, ALTU-238 is their other key asset) I am sure the three products I mentioned above would be worth > 100 million to BioMarin and yet the market is saying you can have them and more for 40 million.
I am familiar with both companies so this example comes readily but there are probably many other late stage drugs available for licensing by companies that don't have the cash/resources to commercialize them.
Great quarter, so much for being able to add any more shares on the cheap! I thought this quarter would be flatish but perhaps the announcement of a buy back was in part a hint at things growing.
I wonder if they'll PR it Monday and give any indication about prospects going forward.
Didn't read the full Q yet will be curious to see where the growth is.
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5442757
Edit:
Just read this part so while higher prices going forward will be good the big jump may be due to stocking
Sales also increased in the second quarter because we notified our customers of a coming price increase that took effect January 1, 2008.
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 (191 and Pirfenidone)
AMGN – Denosumab: Three-year data from phase III PMO trials (vs. alendronate) 1Q08; three-year data from phase III PMO fracture study: 2H08; Presentation of data from phase III HALT trial in breast cancer: 1H08; Data from phase III HALT trial in prostate cancer: 2H08.
AMLN – LAR NDA submission: mid 2009 if bioequivalence study needed; earlier if not needed.
BMY – Apixaban phase-3 in orthopedic surgery: fall 2008; phase-2 in ACS: Dec 2008 at ASH.
CEGE - VITAL1 GVAX prostate phase III interim "1H/'early' 2008. Final analysis ?09
- GVAX + MDX010 P1 results ?08
- oncolytic virus (bladder cancer) P1 results at AUA(5/08)
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. Ph III Trazodone results 2nd qtr/08
DNA – Avastin sBLA in breast cancer PDUFA date: 2/23/08 (advisory panel voted 5-4 against on 12/5/07); Avastin adjuvant CRC interim look Q2 08; Rituxan in Primary Progressive MS Ph III Results Q2 08.
DNDN – Provenge 9902b study: interim analysis (~180 deaths) 2H08; final analysis (360 deaths) 2010.
ELN – AAAB001- final phase II data Q3 08
AB-001 phase-3: Interim data 2H09 (est.), final data 2H10 (est.). (First patient dosed 12/21/07.)
ELN – ELND005 for AD phase-2: Interim data mid 2009 (est.), final data 1H10 (est.) (First patient dosed 12/21/07.)
GILD – Viread in HBV: FDA PDUFA date 8/11/08; EMEA action date expected 2Q08. (NDA and MAA submitted 10/11/07.)
GILD – GS9190 polymerase inhibitor for HCV: new phase-1 trial to test QT-prolongation announced 10/18/2007; no start date yet.
GTCB – ATryn in US: positive top-line phase-3 data were reported 2/4/08; BLA submission mid 2008; FDA action: late 2008/early 2009 assuming priority review.
GTCB – US Atryn partnership announcement: 1Q08.
GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: enrollment complete end 2008.
GTCB – Merrimack MM-093 results of phase-2 extension trial in RA: July 2008.
HGSI – Phase-3 Albuferon: report data from genotype-2/3 phase-3 trial: end 2008; report data from genotype-1 phase-3 trial: spring 2009; submit BLA fall 2009.
IDIX – IDX899 phase-1/2 seven-day monotherapy study: additional, lower-dose cohorts to be reported during 1H08 (800mg cohort was reported 2/6/08).
IDIX – IDX899 phase-2 six-week head-to-head vs Sustiva (IDX899+Truvada vs Sustiva+Truvada): start enrollment 1H08.
IDIX – IDX184 nucleotide polymerase inhibitor for HCV: file IND 1H08.
IDIX – Protease inhibitor for HCV: file IND in (late) 2008.
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: enrollment of 3rd dosing cohort complete end of Jan 2008. 4th Cohort to be done. After 4th cohort a cohort of non-responders will be done. On 1/7/08 announced advanced to combination study in Q2 2008. Data from all four cohorts to be reported at or before EASL and/or DDW in PR, Poster or both (Yes I know it is very wide range).
ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results January 2009 (72 week treatment period).
LBPFF – see DDSS
MCU/MPH.to - Medicure - MC-1 Lead drug candidate for cardiovascular reperfusion is in PH 3 trial /w 3000 patients, one of the largest trials in Canadian History.
Full enrollment completed Sept. 14 with Top Line Data expected by Late February /08 or Mid March at the latest.
MEDX - Ipilimumab BLA submission sometime in 2008 (phase-3 data reported 12/10/07).
Merrimack: see GTCB
MNTA – Meeting with FDA re Lovenox ANDA: date not specified, but soon.
MNTA — Lovenox patent appeal (Sanofi v Amphastar): oral arguments began 1/8/08.
MNTA – M118 phase-2 data in stable angina to be presented at unspecified medical conference in 2008.
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2008, trial results in 2009.
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).
Pharming – Rhucin in EU: appeal of EMEA rejection to be submitted by 2/11/08;
Pharming – Rhucin in US: phase-3 top-line data 1Q08; BLA submission in 2008 if warranted by data.
PHRM – Satraplatin MAA to EMEA to be filed 2/08 following analysis of final OS data.
PPHM- Bavituximab (cancer): Peregrine begins patient enrollment in phase II breast cancer trial w/docetaxel 1/08
PPHM- Bavituximab (cancer): Peregrine receives approval to conduct phase II NSC lung cancer trial w/carboplatin/paclitaxel 1/08
PPHM- Bavituximab (cancer): Peregrine receives approval to conduct phase II breast cancer trial w/carboplatin/paclitaxel 1/08
PPHM- Bavituximab (cancer): clinical update of Bavituximab anti-cancer at 10th Intl. Symp. on Anti-Angiogenic Agents. 2/08/08
PPHM- Bavituximab (cancer): phase 1 monotherapy trial adds site in Charlotte, NC. expect to complete patient enrollment 2nd Q 08
PPHM- Bavituximab (viral): phase 1 trial: HCV / HIV coinfected patients: Johns Hopkins added as additional site 12/07
PPHM- Cotara: phase 2 glioblastoma multiforme Indian trial patient enrollment initiated 6/07. Interim info in 1st Q 08
PPHM- Cotara: glioblastoma multiforme US trial sites expanded to include MUSC 6/07. Interim info in 1st Q 08
RPRX– Proellex
*Initiate US PII Endometriosis trial (Enrollment Oct 2007)
*One year extension data (Q1 2008)
*Initiate Fibroids Pivotal PIII trials (?)
*Initiate Anemia Pivotal PIII trial(s) (? – New IND required)
RPRX – Androxal
*Initiate Pivotal PIII trials (?)
RPRX – Other: select alternate Proellex-class compound for advancement into breast cancer studies via potential partner TBA.
SGP – Boceprevir ph-2 trial in treatment-naïve HCV: 12-week data reported on 10/18/07 (#msg-23788779); end-of-treatment data due in 2008 and SVR data in late 2008 or early 2009.
SRDX - Novocell phase-1/2 trial in type-1 diabetes: top-line data due in 2008 (enrollment complete 8/30/06).
TH.TO -Complete enrollment confirmatory TH9507 HIV Associated Lipodystropy trial 3rd qtr/07, final results 1st qtr/08.
VRTX – Interim data from BID-dosing phase-2 Telaprevir trial conducted by Tibotec: 2H08.
--
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OT: SPAM of RQST
Just curious if others are receiving all sorts of SPAM on this stock. I probably got at least a dozen of them (that I noticed) in the past 24 hours!
Its a little old but a nice article on the man behind Pirfenidone (I am not sure on the future of Pirfenidone for MS the results seemed encouraging from 1 small trial)
http://seniorjournal.com/NEWS/Stars/4-10-25DrMargolin.htm
Dr. Solomon Margolin, 82, Still Contributing Great Discoveries to Mankind
Dimetapp and Coricidin are just a couple of his discoveries.
Oct. 25, 2004 - Most careers span about 45 years, and if you’re lucky, there are significant accomplishments to reflect on when you retire. Then there are the uncommon examples of people who continue to work past age 65, even though they have achieved what most people consider incredible accomplishments. Dr. Solomon Margolin is one of those people.
While most of his peers retired at the usual age, Dr. Margolin continues to arrive at his Dallas office every day to continue his life’s work – discovering new drugs – so that others can benefit. At 82, he still has a passion for science and finding drugs that benefit those in need.
“Why do I keep working? There’s still more to do and we’re making breakthroughs that will help people long after my career is over. Besides, I’d be bored if I didn’t come to work every day,” says Margolin.
Margolin is founder and president of MARNAC, Inc., a biopharmaceutical company dedicated to the discovery and development of new drugs to treat autoimmune, inflammatory, and fibrotic disorders, such as multiple sclerosis (MS).
Before founding MARNAC in 1990, Dr. Margolin had a lengthy career filled with successes. He put his doctorate in physiology, biochemistry, and genetics from Rutgers University to good use as he held several research and director positions for major pharmaceutical laboratories around the United States. He also served for 15 years as professor and chairman of the pharmacology department and associate dean of the School of Medicine at St. George’s University in Grenada, West Indies.
Most people know his work best by his discoveries that are now household names. He is the inventor of more than 40 U.S. and foreign patents pertaining to medicines. Furthermore, he has developed more than 20 FDA-approved drugs, including several anti-histamines (Dimetapp®), cold remedies (Coricidin), and anti-inflammatory steroids (prednisone and prednisolone), which are prescribed and marketed worldwide. He is co-author of Harper’s Handbook of Therapeutic Pharmacology and a prolific author of professional publications describing research in the discovery and development of widely known prescription and non-prescription drugs.
“We can all look up to Dr. Margolin as a dedicated researcher and a compassionate human being. He’s a great colleague to have because he is a strong collaborator and truly cares about finding therapies that will improve the lives of patients,” said Jonathan E. Walker, M.D., associate clinical professor of neurology at the University of Texas Southwestern School of Medicine.
Talking with Margolin, one’s first impression is his enthusiasm and passion for finding better alternatives to treat disease. “I enjoy finding the puzzle pieces and then figuring out how to put them together. This puzzle has the added advantage of actually helping people,” said Margolin.
That enthusiasm is shared by his wife, Dr. Nancy Cox, also a part of the family business. Cox is accomplished in her own rite. With significant medical research experience and numerous published professional papers, she balances her duties as medical director for MARNAC while maintaining a private medical practice in Dallas.
Perhaps Margolin’s current work is his most important discovery to date. He is developing pirfenidone, used to treat secondary progressive MS. Still in clinical trials, the drug holds great promise for people with this advanced form of MS. Thus far, the drug has an unprecedented therapeutic record, as well as a notable safety record in more than 1,000 patients. Pirfenidone is the first orally effective, non-steroid hormone treatment for advanced MS.
People like Sarah Moore, 65, are grateful for his continued work. Moore has known Margolin and Cox for many years. It so happens that Moore has an advanced form of MS, which was debilitating her ability to walk or write. She was able to obtain compassionate use from the FDA to use pirfenidone. After less than three months on the drug, she had dramatic improvement in her ability to walk, go up and down stairs, and write her name legibly. “I never thought I would experience this new standard of living again, but this drug [pirfenidone] that Solomon discovered has afforded me this opportunity,” explains Moore.
Margolin has no regrets about spending his golden years on the job. The way he sees it, he still has more to contribute and he’s happier in the lab than on the golf course.
THanks for posting that link. An interesting read. I hope the FDA continues to more easily approve unmet medical needs and anti-virals/oncology.
I am wondering what the Provenge interim and perhaps more telling final results will do to the FDA/Advisory Panel debate. If the FDA is vindicated will that be the end of advisory panels? If Provenge does well I am sure a few congressmen will be very happy to criticize the FDA.
IMHO I think we have a system that doesn't encourage innovation except to some degree for very large indications and perhaps moderately rare diseases. It seems less riskier and more likely to get an approval for someone to make a nominal improvement to a drug. Perhaps if the bar were lowered (to gain approval) for novel drugs and/or longer protection from generics.
Two more vents and then I'll be quiet:
1-I read or heard Emil Kakkis (BMRN) rationalize some of the high cost for some of the MPS treatments could be averted if the FDA would approve based on smaller studies earlier on. Then there are some ultra-orphan disease that likely could get treatments but it doesn't make economic sense to develop.
2-For all those that complain about outrageous pricing PAH is a good example of what that can do for innovation. Here you have an Orphan disease that had no treatments a decade ago and now there are half a dozen and probably close to another half dozen in mid-late stage development.
In case people think pulmonary fibrosis is a disease of the elderly HPS is a much rarer disease but those afflicted suffer from many health issues including pulmonary fibrosis at a young age. The NIH is running this trial and InterMune is supporting it with drug. At one point I believe InterMune was going to run this trial and try to get a broad label for pirfenidone as a general anti-fibrotic agent.
http://news.yahoo.com/s/ap/20080202/ap_on_he_me/puerto_rico_albino_syndrome_6
Puerto Rico home of deadly syndrome
By DANICA COTO, Associated Press Writer Fri Feb 1, 7:02 PM ET
Mayra Nieves is used to being ostracized and called names as an albino in this Caribbean community. What she fears is not being able to breathe. Nieves is among hundreds of Puerto Ricans who have a rare type of albinism that leads to a deadly lung disease.
Sufferers such as Nieves, 30, a mother of three, have roughly five years to live once they've been diagnosed with the lung condition, known as pulmonary fibrosis.
The island has the world's highest incidence of this often fatal type of albinism, which was likely brought by a colonizer centuries ago and proliferated as the isolated population intermarried.
Today it is the focus of an experimental drug study at the National Institutes of Health. Researchers aim to minimize lung scarring from the disease that smothers air sacs and prevents oxygen from entering the bloodstream.
Nieves still remembers the day several years ago — before her diagnosis — when she suddenly passed out, gasping for air.
"I almost died," she said. "It was scary. I couldn't talk, but I remember thinking, 'Dear God, let me stay. My daughters need me.' "
Various genetic disorders can lead to albinism, defined by a lack of pigmentation in eyes, skin and hair. But Type 1 of the so-called Hermansky-Pudlak Syndrome is particularly deadly, said Dr. Thomas Markello, who works at the medical genetics branch of the National Institutes of Health. The syndrome, which is rare worldwide, is the leading cause of albinism in Puerto Rico, he said.
An estimated 300 to 500 albinos with the fatal strain live in Puerto Rico's northwest region, the island's largest concentration. NIH estimates that one in every 400 to 2,000 people worldwide carries the gene for the syndrome, compared with one in every 20 Puerto Ricans living in the northwest.
"All patients will need a lung transplant to stay alive unless we succeed in fixing the problem," Markello said.
Nieves flew to an NIH clinic in Bethesda, Md., several times last year for the drug study, which is aimed at people in the earliest stages of the disease. She still has a couple of visits left.
Her mother and father are albinos, and her father suffers from Hermansky-Pudlak. Two of his cousins died from it. Nieves' husband is not albino, nor are her daughters, though all three carry the gene — and the potential for continuing the syndrome.
The albinos scattered across the mountain villages here are often ridiculed. Nieves almost dropped out of school for being called "milk" and other nicknames. People warned their children to stay away from her, fearing they could "catch" her genetic condition. Albinism has even broken up marriages. People who don't know they carry the gene sometimes accuse spouses of cheating when an albino child is born.
If both parents are carriers of the syndrome, children have a 25 percent chance of developing it, said Enid Rivera, the director of epidemiology in Puerto Rico's Health Department.
Most sufferers develop lung problems in their 30s and 40s, but patients as young as 25 and old as 65 have died from the disease, Markello said.
Like Nieves, several dozen Puerto Ricans are taking the experimental drug, pirfenidone, which already has been the subject of 12 U.S. trials involving other ailments, including the scarring of kidneys spurred by diabetes.
Lung function among albino sufferers improved slightly in a previous pirfenidone study. Researchers say they need at least 40 patients for the current one, and they have enrolled about 26 so far.
There's no cost to participating in the drug study, and the known side effects seem to be as mild as heartburn. But scores of afflicted Puerto Ricans have refused. Some believe prayer alone will help, while others mistrust the idea of government research.
"I've had people on the phone praying, saying their faith will get them through," said Donna Appell, who founded the New York-based, Hermansky-Pudlak Syndrome Network and helped establish a Puerto Rican chapter.
German Acevedo, 30, is among the sufferers trying to enlist others.
"OK, they use you, but they might be saving your life," he tells the skeptics.
Lung transplants aren't an alternative for Puerto Rican sufferers, Markello said, mostly because the procedure costs around $300,000 and is not available on the island. Many sufferers do not have insurance. For those 65 and younger, Medicaid is not an option, because it does not cover off-island treatment.
No one keeps records of how many Puerto Ricans have died from the syndrome. NIH researchers suspect many deaths have been wrongly blamed on pneumonia, asthma and lung cancer.
(This version CORRECTS Corrects last name to Nieves sted Nieve. AP Video.)
2/1/08 Jobs@InterMune 9 positions http://www.intermune.com/wt/itmn/opportunities
Clinical
Executive Assistant, Clinical Operations
Manager, Data Management (Hybrid —Clinical Data Manager and SAE Reconciler)
Drug Safety
Associate Director, Drug Safety Risk Management (DSRM)
Finance
Accounts Payable Coordinator
Information Technology
Sr. Database and Application Administrator
Medical Information
Manager/Sr. Manager Medical Information
Research
Pharmacologist/Associate Director – Preclinical R&D
Scientist II—Sr. Scientist, Cell Biology
Senior Manager/ Associate Director, Pharmaceutical Development
Wachovia 2008 Healthcare Conference
Not much new from the earlier conference. Some brief points (all 191 related):
1-Dr. Porter made a passing remark that could be taken that 191 BID dosing went well (something to the effect of better dosing then other PI's)
2-4th cohort may be done based on safety/tolerability.
3-Q2 still plan for starting combination trial
4-On track to release data from first 3 cohorts around end of quarter
5-Said Roche can and will design studies with all combinations of anti-virals in their portfolio. Hinted at doing this particular in the true non-responders.
A filing today indicated Orbimed just about doubled their investment in InterMune from their last filing (about a year ago) they are now over 10%! Ordinarily I would be thrilled (and I am pleased), its just that Sam Isaly's record hasn't been that great (or at least some of the biotechs I know he's been in on). Though he did real well with BMRN and hopefully now those shares are in much stronger hands! I suspect the timing may be more due to 191 (I believe he has/had a Vertex position) though perhaps if he'ld been down on Pirfenidone he may have elected to wait a little longer.
With all the inaccuracies of past leaks I'll believe it when it happens but it'll be interesting if it does then if Clemens testifies after will be curious to see if he suddenly needs to not answer on advice of counsel due to pending litigation against McNamee
http://sports.yahoo.com/mlb/news;_ylt=?slug=ap-congress-steroids&prov=ap&type=lgns
McNamee's lawyer says Pettitte will corroborate HGH accusation against Clemens
By RONALD BLUM, and
January 29, 2008
HOWARD FENDRICH
AP Sports Writers
WASHINGTON (AP) -- A lawyer for Andy Pettitte's former personal trainer said Tuesday he believes the pitcher will tell Congress he discussed human growth hormone with Roger Clemens between the 2001 and 2002 seasons.
The lawyer, Earl Ward, said Pettitte talked about HGH with trainer Brian McNamee following a conversation with Clemens, who has denied that he used HGH or steroids. McNamee worked with both Clemens and Pettitte.
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"We're hopeful based on Andy's reputation that he will corroborate Brian's statements with regard to Roger," Ward said in a telephone interview.
Pettitte's meeting with a congressional committee investigating drug use in baseball was postponed until Monday. He originally was slated to appear for a deposition or transcribed interview Wednesday but the date was changed Tuesday by the House Oversight and Government Reform Committee.
McNamee said in last month's Mitchell Report that he injected Clemens at least 16 times with steroids or HGH in 1998, 2000 and 2001. He said he injected Pettitte two to four times with HGH.
Pettitte admitted two days after the Mitchell Report was released that he tried HGH for two days in 2002 -- before it was banned by players and owners.
Ward said the discussion he was referring to occurred at Clemens' house.
"Based on what we know, there was a situation where Andy was speaking to Roger in Brian's presence, then Andy came over to Brian and essentially said, 'Why didn't you tell me about this stuff?' He referred to HGH," Ward said. "Brian discouraged him and then several months later, when he (Pettitte) got injured, he came back and asked Brian about it, and that's when Brian injected him. We believe that based on the fact that Andy came to Brian and asked him about HGH, it was Roger who told Andy about HGH and that's why he asked Brian about it."
Richard Emery, another lawyer for McNamee, said his client and Pettitte also discussed steroids use by Clemens.
"Pettitte is certainly going to tell the truth and if he tells the truth everything will be fine," Emery said.
"There are a number of conversations where Pettitte and Brian talked about Clemens' use. I think there is everything to believe Pettitte is not a liar."
New York Yankees pitchers Roger Clemens, and Andy Pettitte, right, watch the sixth inning during a baseball game against the Tampa Bay Devil Rays in St. Petersburg, Fla., in this Sept. 26, 2007 file photo. Pettitte's meeting with a congressional committee investigating drug use in baseball was postponed until Monday, Feb. 4, 2008.
AP - Jan 29, 5:43 pm EST
More Photos
Jay Reisinger, Pettitte's lawyer, would not discuss what Pettitte would say.
"He hasn't testified yet, and I'm not going to comment on what he's going to testify about," Reisinger said.
Lanny Breuer, Clemens' new lawyer, said the seven-time Cy Young Award winner stood by his denials.
"Roger Clemens' remarkable success as a pitcher has everything to do with his extraordinary work ethic and his innate abilities, and nothing to do with HGH or steroids," Breuer said in a statement. "Let me be clear: Roger Clemens never took HGH and he never took steroids."
Ward's claims about the discussion were first reported by The New York Times on its Web site.
The delay of Pettitte's deposition or transcribed interview was the latest switch in the schedule of meetings between witnesses and staff before the Feb. 13 hearing.
"Just a mutually agreeable postponement," said Keith Ausbrook, Republican general counsel for the committee. "It give us a little more time to prepare and gives him a little more time to prepare."
Also asked to appear at next month's hearing are Clemens, McNamee, former Yankees second baseman Chuck Knoblauch, and former New York Mets clubhouse employee Kirk Radomski.
"Mr. Pettitte is cooperating voluntarily with the committee, and we look forward to his testimony on Monday," panel chairman Henry Waxman and ranking Republican Tom Davis said in a joint statement. "We appreciate Mr. Pettitte's willingness to assist the committee."
Knoblauch now is scheduled for Friday and would be the first of the five Feb. 13 witnesses to provide a deposition or transcribed interview. He agreed to appear after a subpoena was issued.
Clemens is to follow Feb. 5, with McNamee down for Feb. 7, and Radomski on Feb. 12 -- pending further changes to a repeatedly shuffled schedule.
Letters sent by Waxman and Davis to Clemens, Pettitte and Knoblauch on Jan. 16, requesting their appearances both at the hearing and a pre-hearing meeting, said: "The committee asks that you provide testimony about allegations in Senator George Mitchell's report ... that you and other Major League Baseball players used performance enhancing drugs during your professional baseball career."
New York Yankees' Chuck Knoblauch watches his game-tying eighth-inning homer against the Atlanta Braves in game 3 of the World Series in New York in this Oct. 26, 1999 file photo. Knoblauch is being subpoenaed by a congressional committee investigating steroids in baseball after he failed to respond to an invitation to give a deposition on Feb. 13, 2008.
AP - Jan 22, 5:01 pm EST
More Photos
Clemens, Pettitte and Knoblauch were among more than 80 players named in the Mitchell Report.
McNamee told Mitchell he acquired HGH from Radomski for Knoblauch in 2001, and that he injected the player with it. Knoblauch's major league career ended in 2002.
Radomski pleaded guilty in April to federal felony charges of distributing steroids and laundering money, and is scheduled to be sentenced Feb. 8.
The 35-year-old Pettitte has a 201-113 major league record and won four World Series championships with the Yankees. He also helped his hometown Houston Astros reach their first World Series.
Pettitte returned to the Yankees last season and went 15-9. This offseason, he put off retirement and agreed to a $16 million, one-year contract to play for the Yankees next season.
Blum reported from New York, Fendrich from Washington.
I thought this wire story was interesting on fighting the FDA. Sorry I don't have a link got it from brokers wire service (I think because of ENCY)
By Andy Georgiades
Of DOW JONES NEWSWIRES
TORONTO (Dow Jones)--The success rate for drug companies engaging in the U.S.
Food and Drug Administration's formal dispute-resolution process dipped well
below average last year.
According to data supplied by the regulator, of the 22 formal disputes
submitted to the FDA's Center for Drug Evaluation and Research in fiscal 2007,
only two, or 9%, were resolved in favor of the company. Since the program
started about nine years ago, 27% of all formal disputes have been granted.
On the other hand, the 22 disputes received in fiscal 2007, ended Sept. 30,
were about double the annual average and the second-highest number on record.
The FDA defines a "granted" dispute as an instance when the decision-maker
fully agrees with what was requested in the appeal.
While the number of disputes was high, the same can't be said for drug
approvals. The FDA hasn't released a final tally of new chemical entities
approved in 2007, but until Oct. 31, only 15 had received approval, down from
22 in 2006 and 20 in 2005.
John Jenkins, director of the FDA's office of new drugs, Center for Drug
Evaluation and Research, cautioned against looking at the appeal process as a
numbers game, since success rates can fluctuate widely year to year. For
instance, in 2001, only one out of nine disputes was granted, and in 2002, one
out of eight was granted, he said. In 2003, a record 24 disputes were
submitted, the highest number since the process began in 1999.
Another consideration is that there are four levels of authority that each
dispute can go to, with each round counting as a separate dispute. A key
footnote to last year's numbers is that five disputes involved one drug
application, Jenkins said. In that situation, two issues were being disputed -
one went to three levels and the other has gone to two levels so far.
Jenkins said that the data show overall that the FDA remains "open-minded."
But he stressed that the process shouldn't be viewed by drug companies as a one
in four chance of getting their way. "I'd like for this not to become simply a
game of oddsmanship," he told Dow Jones. "It's supposed to be about situations
where there's a legitimate disagreement with our decision and that we have
analyzed the data incorrectly."
The dispute-resolution process originated with the FDA Modernization ACT of
1997. Before that, the process of drug sponsors requesting a review of their
issues was informal and without timelines. "(The changes) led to a lot more
structure for the interactions between FDA and the regulated industry,
particularly with timelines for certain activities," he said.
Genta, Ista Disputes Ongoing
Most companies keep these disputes to themselves, although some are more
vocal. In the U.S., companies that are involved in formal disputes with the FDA
include Genta Inc. (GNTA) and Ista Pharmaceuticals Inc. (ISTA). Encysive
Pharmaceuticals Inc. (ENCY) also had one going but dropped it late last year.
In Canada, Labopharm Inc. (DDSS) and Cipher Pharmaceuticals Ltd. (DND.T) have
been open about their disagreements with the FDA. While Labopharm had its most
recent appeal of the FDA's approvable letter for its once-daily painkiller
tramadol denied, the FDA suggested an additional statistical analysis may be
sufficient for approval. (Please see related article under Ticker symbol DDSS.)
Cipher filed two appeals last year, one for CIP-ISOTRETINOIN, an acne
medication, and CIP-TRAMADOL ER. It said recently that the former is "on hold"
and a decision on the latter is expected by the end of this month.
Jenkins said he's noticed lately that more companies are taking disputes to
multiple levels. Indeed, he can think of a few in the past year that went to
the center director level - level three - which he said used to be a rarity.
"Anecdotally, it seems that the companies that tend to carry disputes to
multiple levels tend to be the smaller companies, not the large companies that
people think of as big pharma," he said. While he's not sure why that is, he
said there's "speculation" that the process may be used as a way to keep a
company "in play" while hoping for a ruling that eliminates the need for more
data that it may not be able to generate.
"In most situations, the company may not agree with the FDA's decision, but
they recognize that it's a legitimate position that the agency has taken and if
they want to get the drug approved, they need to go out and generate the data
that the FDA has asked for. I think that may be why we see fewer disputes from
the big companies that have more experience," he said.
In instances where companies argue that the FDA has reneged on a Special
Protocol Assessment - an agreement with the regulator that predetermines the
scientific and regulatory requirements for a new drug application before the
start of a trial - Jenkins said the devil can be in the details.
"In situations I've been involved in where a company is arguing we violated
the SPA, it's really more a question of, when we look at the data, we don't
come to the same conclusions that the sponsor comes to when they look at the
data, not that we're violating the SPA," he explained. For instance, if the
data come out differently than anticipated at the outset, that could require a
different statistical analysis. It all depends on where "the data takes you,"
he said, adding that the FDA wouldn't consider that to be a violation.
Even if the FDA grants a dispute, that doesn't mean approval is immediate,
Jenkins said. If there are multiple deficiencies listed in the application, the
ones not disputed still need to be addressed. And if there's only one dispute
that's later reversed by the FDA, that doesn't mean there isn't more work to be
done.
"They have to resubmit the application to the division to work out other
details, such as labeling," he said.
-Andy Georgiades, Dow Jones Newswires; 416-306-2031;
andy.georgiades@dowjones.com
TALK BACK: We invite readers to send us comments on this or other financial
news topics. Please email us at TalkbackAmericas@dowjones.com. Readers should
include their full names, work or home addresses and telephone numbers for
verification purposes. We reserve the right to edit and publish your comments
along with your name; we reserve the right not to publish reader comments.
(END) Dow Jones Newswires
01-29-08 1430ET
Copyright (c) 2008 Dow Jones & Company, Inc.
14:30 012908
As has been posted here this is the registration of warrants issued with a prior offering (which incidentally got the sales kick started in high gear).
By my math (probably could check an old filing) the warrant price comes out to .39 so I would think some weakness may be due to the perception of a lot of shares hitting the market.
I'm a long term shareholder and am not concerned about it. Its not a new offering. As long as orders and sales keep increasing in the long run its a bump. Perhaps we get some more good news in the not too distant future:
- Enter EU Market
- Perhaps get off the OTC
- If the sales force is this big adding another product or two through R&D and or licensing/acquisiton may not be a bad thing.
You are certainly quite a lucky individual! And for the record I did not profit in anyway or take joy in seeing others lose money. As a matter of fact I found it extremely frustrating to try to discuss the company with many of the posters here and on iVillage.
While I certainly don't claim to be anywhere near always accurate in my investments picks, Pipex seemed to offer all sorts of red flags. The science, misrepresentations, questionable financing deal, questionable CEO, etc., etc., etc.
This isn't something where there is one issue they say 8. While admittedly I haven't looked in a lot of detail missing animal tox data seems pretty basic and the fact that they are fighting this should be another red flag. One (of many) concerns I had is in another indications (namely IPF) the first couple patients required dose modifications so is there more to why they are fighting this? Hmmm this is 45 day tox some of these other (non Wilsons) indications that they claim Coprexa will work in would be chronic use.
The one redeeming thing is the CEO got stuck with a lot of shares. I was disappointing Mr. Kanzer was not more entertaining on the call, perhaps he took some Coprexa before :)
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed Old entries, Added Wachovia Healthcare Conference, Lehman Brothers Conference, Deutsche Bank Conference, Citigroup Healthcare Conference
CONFERENCES
2008 Wachovia Healthcare Conference
January 30-31, 2008
The Boston Langham Hotel, Boston, MA
http://www.wsw.com/webcast/wa48/
BIO CEO
February 11-13, 2008
New York City
http://ceo.bio.org/opencms/ceo/2008/program/PresentingCompaniesList.jsp
Lehman Brothers 11th Annual Global Healthcare Conference
March 18-20, 2008
Miami Beach, FL
Deutsche Bank Securities 33rd Annual Health Care Conference
May 5 - 7, 2008
InterContinental Boston
510 Atlantic Avenue
Boston, MA 02210
http://conferences.db.com/americas/healthcare08/
Citigroup Healthcare Conference
May 21 - 22, 2008
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Appreciate the comments.
I would think this would not be an insurmountable target for some combination of Protease/polymerase with SOC and wonder why it is not pursued more? I wonder if the Boceprevir experience along with the fear of combining too many agents has put too much doubt on this possibility in the near term.
It would be curious if telaprevir does not have stellar PROVE-3 results but goes on to have comparable Phase 3 results in terms of both efficacy and safety (as Phase 2) while along the same time-line some other combination does get compelling results in earlier (phase 2) studies for some classification of patients for fail to get an SVR while having a more favorable safety profile. Would the FDA approve both in different patient populations or put the two drugs against each other possibly delaying one till it is further developed?
http://tinyurl.com/3y4hyp
Roche got an 8% SVR rate using Pegasys in non-responders to prior Peg-Intron. This was raised to 16% when second-line therapy was continued out to 72 weeks.
SGP got a 23% SVR rate using Peg-Intron in a mixed pool of non-responders/relapsers to prior Pegasys/Intron-A.
The Roche trial above is the more applicable trial with respect to what VRTX/JNJ are trying to do.
http://tinyurl.com/2ehorv
Dew,
Do you think if Prove-3 is in the 16% range that would be compelling enough for approval for that patient population just on the 2B results? TIA
Coincidence that Pharming is up big too?
http://finance.yahoo.com/q?s=PHARM.AS
In Toronto (COM.TO) it was down about 16%. Seems it was down a lot more at the open
http://finance.yahoo.com/q?s=COM.TO
Someone with more confidence could get a good buying opportunity as there is a recent precedent for a delay and approval. Kuvan (BMRN) got a couple week delay and then approved but then again the company was very clear in a conference call to say it was just a scheduling delay and was in label discussions (didn't see any such mention in today's PR)
Thanks for the added info.
Appreciate hearing your comments I.
I recall on one of Genzyme's calls they down played the cardiac problems (Don't recall exactly what they said). They also weren't too bullish on chaperones though Henri sounded less pessimistic then some of the other Genzyme presenters I've heard. The reactions to both (cardiac problems and chaperones) are what one would expect though.
Thanks.
Aside from the IDIX 2b you mentioned and Vertex's current trial do you know of any others? Intermune will do a cohort in their 1B after they do their monotherapy cohorts.
The Pharmasset presentation has a nice set of slides. If you want an easy PDF file you can get it from their events page:
http://investor.pharmasset.com/events.cfm
I haven't followed them closely, their Polymerase (R7128) certainly seems quite impressive at this stage (not just efficacy but lack of side-effects).
Interestingly Pharmasset (Slide #30) and InterMune (slide #25) have very similar slides about the HCV landscape/Roche (Pharmasset lists other companies)
Does anyone know if any other companies have presented data of a Protease or Polymerase in the interferon failure population?
Genisi,
I know your view on pharmacological chaperones, what do you think of other (non ERT's) for LSD's?
The little I know about Zavesca is its not specifically targeted and has a fair amount of side-effects.
http://www.actelion.com/uninet/www/www_main_p.nsf/Content/Development+Zavesca%C2%AE+%28miglustat%29
I don't know a lot about Genzyme's Small Molecule's but I thought I heard they were along the lines of Zavesca in terms of mechanism of action.
http://genzyme.com/research/technology/tech_home.asp
Also curious what you think of long-range potential for gene therapy or other emerging technologies in this area.
TIA
Our product is just the injection. Going by memory I believe it is ~ $200 million.
Still (by my guestimate) our share of Profits for 6 months should be in the ~15 - 20 million range. Not bad.
Biosimilar articles in Nature:
Biotech as Bush bows out
http://www.nature.com/nbt/journal/v26/n1/pdf/nbt0108-15.pdf
or
http://www.nature.com/nbt/journal/v26/n1/full/nbt0108-15.html
Fractured European market undermines biosimilar launches
http://www.nature.com/nbt/journal/v26/n1/pdf/nbt0108-5.pdf
or
http://www.nature.com/nbt/journal/v26/n1/full/nbt0108-5.html
FWIW I haven't sold any of my shares.
I think the market isn't looking favorably on biotechs with a similar profile to SPPI right now. As a barometer I compare the negativism on the Yahoo board which is like probably at least a dozen other small biotechs I follow with similarities (losing money, no recent good news, people critical of management, etc.). It certainly is no fun now but those thinking its unique to Spectrum and see it as a reason to bail are at least not chosing the right reason.
BTW, I had a negative value assigned to Raj when I did my valuations before making any purchases :)... but then again I had significant value for satraplatin. I wouldn't mind being proved wrong on both counts!
JP Morgan 26th Annual Healthcare Conference Notes
Pulmonology/Pirfenidone
. Subtle change to no longer saying December/January but just January
. Think rapid uptake for a new IPF therapy. More reliable diagnostic tools (HRCT), consensus guidelines, patient referral and advocacy networks, growing government and political recognition
. Beyond Orphan many IP filings (acquired anti-Fibrotic and TNF-Alpha patents with Marnac deal)
. All milestones and royalties eliminated in Marnac deal. 80% of total cost only paid if successful. Unique situation at Marnac led to opportunity to consolidate and took advantage of it.
. Starting to give more details on registration and commercialization strategy (Project late '09 and Early '10 if favorable data to reach US and EU respectively). Estimate 85 person US sales force, modest advertising and promotion. x-US still undecided.
HCV/191
. In Q1 top-line viral kinetic and safety results from at least 3 naive cohorts.
. More Full data from all cohorts reported in spring conference DDW or EASL
. Continue to state believe 191 has superiority potential.
. Emphasized combination therapy.
1. Synergy of 191 with Pegasys in vitro (prior info.) expect to see same type of synergy
2. Phase 1B Monotherapy not helpful in knowing best dose in triple therapy.
3. Believe regimens in front have opportunity to improve open the tolerability and think as they go to Phase 3 more apparent
4. Talked about synergy of Pharmasset polymerase in combo therapy.
. Emphasized outstanding safety and tolerability thus far. "Frankly unfounded speculation around 191 and that pressure valve was released yesterday" (take that Adam F. et. al. :))
. Continue getting dose escalation to get dose response data in case need it later. In parallel submit to EU authorization for triple combination study to begin in Q2
. Tolerability crucial to us.
. Exclusive provider of protease inhibitors to Roche
McNamee's testimony was that Roger supplied him with the steroids that McNamee injected.
And its not reasonable the McNamee does not want to admit to being guilty of another crime so he would just lie to this?
BullNBear52, I Just saw the interview on the website do you know if they cut parts of what is on the website (the McNamee phone convestion they aired on the website is just a few minutes 3-4 maybe)? If that is all there is what is your take on why Clemens didn't tell McNamee what specifically he could do (the ESPN lawyer indicated legally no reason)?
I could be swayed with a passing (public) polygraph. A taped call that we don't get a confession and for all we know it could have been staged may put some doubt in my mind but if Clemens wants to convince me go for the polygraph.
Not sure how much of a contribution it made but Amicus presented interim Phase 2 Gaucher data today at the JP Morgan conference