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Here are some abstract titles I found for AASLD that delt with Protease Inhibitors. The list is not complete as Vertex PR'd today about Phase 2b data presented and I suspect more will be added.
InterMune
1-1909. Identification of Novel Non-Macrocyclic Inhibitors of HCV NS3/4A Serine Protease Activity. B. O. Buckman; L. Pan; L. Huang; K. Kossen; R. Rajagopalan; S. Misialek; S. K. Stevens; H. Tan; D. Ruhrmund; V. Serebryany; J. Matulik-Adamic; A. Stoycheva; S. Ammons; D. K. Fuhrer; L. M. Blatt; L. Beigelman; S. Seiwert
2-1871. A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics (PK) of Single Ascending Oral Doses of the NS3/4A Protease Inhibitor ITMN 191 in Healthy Subjects. W. Z. Bradford; C. Rubino; S. Porter; A. Forrest; L. M. Blatt; A. A. Patat
3-1847. Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Patients with the NS3/4A Protease Inhibitor ITMN-191 Leads to Rapid Reductions in Plasma HCV RNA: Results of a Phase 1b Multiple Ascending Dose (MAD) Study. N. Forestier; D. G. Larrey; D. Guyader; P. Marcellin; R. Rouzier; A. A. Patat; W. Z. Bradford; S. Porter; S. Zeuzem
4-1885. Combination of the NS3/4A Protease Inhibitor ITMN-191 (R7227) with the Active Moiety of the NS5B Inhibitors R1626 or R7128 Enhances Replicon Clearance and Reduces the Emergence of Drug Resistant Variants . H. Tan; S. Rajyaguru; T. Wu; M. McCown; S. Ali; W. Jiang; M. J. Otto; P. A. Furman; I. Najera; K. Klumpp; J. Symons; N. Cammack; L. M. Blatt; S. Seiwert
Vertex
1-1856. No Compensatory Fitness Mutations Selected in NS3/4A Protease Cleavage Sites During Treatment with Telaprevir, Peg-IFN-Alfa-2a, and Ribavirin in Phase II Studies of Treatment-Naïve HCV Genotype 1-Infected Patients. E. Z. Zhang; D. J. Bartels; J. Sullivan; M. Marcial; J. Dorrian; A. Tigges; A. D. Kwong; T. L. Kieffer
Merck
1-211. Safety, Tolerability and Antiviral Activity of MK-7009, a Novel Inhibitor of the Hepatitis C Virus NS3/4A Protease, in Patients with Chronic HCV Genotype 1 Infection. E. J. Lawitz; M. S. Sulkowski; I. M. Jacobson; S. Faruqui; W. K. Kraft; B. Maliakkal; M. Al-Ibrahim; R. H. Ghalib; S. C. Gordon; P. Kwo; J. Rockstroh; M. Miller; P. Hwang; J. Gress; E. Quirk
2-1910. Safety, Tolerability, and Pharmacokinetic Data Following Single- and Multiple-Dose Administration of MK-7009, a Hepatitis C Virus Non-structural 3/4a Protease Inhibitor, to Healthy Male Subjects. D. Wright; J. L. Miller; I. Verlinden; C. Cilissen; J. Valentine; P. Sun; M. De Smet; J. de Hoon; M. Depré; L. Cavens; J. Chodakewitz; J. A. Wagner
3-211. Safety, Tolerability and Antiviral Activity of MK-7009, a Novel Inhibitor of the Hepatitis C Virus NS3/4A Protease, in Patients with Chronic HCV Genotype 1 Infection. E. J. Lawitz; M. S. Sulkowski; I. M. Jacobson; S. Faruqui; W. K. Kraft; B. Maliakkal; M. Al-Ibrahim; R. H. Ghalib; S. C. Gordon; P. Kwo; J. Rockstroh; M. Miller; P. Hwang; J. Gress; E. Quirk
Boehringer Ingelheim
1-1849. Safety and antiviral activity of BI201335, a new HCV NS3 protease inhibitor, in treatment-naive patients with chronic hepatitis C genotype-1 infection given as monotherapy and in combination with Peginterferon alfa 2a (P) and Ribavirin (R). M. P. Manns; M. Bourliere; Y. Benhamou; S. Pol; M. Bonacini; T. Berg; C. Trepo; D. Wright; G. Steinmann; D. B. Huang; J. Mikl; G. Kukolj; J. O. Stern
2-1882. Safety and antiviral activity of BI201335, a new HCV NS3 protease inhibitor, in combination therapy with Peginterferon alfa 2a (P) and Ribavirin (R) for 28 days in P+R treatment-experienced patients with chronic hepatitis C genotype-1 infection.. M. P. Manns; M. Bourliere; Y. Benhamou; M. Schuchmann; D. Haussinger; S. Pol; M. Bonacini; J. L. Calleja; G. Steinmann; D. B. Huang; J. Mikl; G. Kukolj; J. O. Stern
Tibotec/J&J
1-1895. Pharmacokinetics of once-daily regimens of the novel HCV NS3/4A-protease inhibitor TMC435350, with and without pegIFN and ribavirin, in HCV-infected individuals. G. A. van 't Klooster; I. Vanwelkenhuysen; R. Verloes; K. Marien; P. Van Remoortere; K. Simmen
2-1912. Inhibitory activity of TMC435350 on HCV NS3/4A proteases from genotypes 1 to 6. T. Lin; B. Devogelaere; O. Lenz; O. Nyanguile; E. Van Der Helm; K. Vermeiren; G. Vandercruyssen; E. Cleiren; J. Lindberg; M. Edlund; P. J. Raboisson; H. de Kock; M. D. Cummings; G. Fanning; K. Simmen
These are the Abstracts I found at AASLD:
1- 1871. A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics (PK) of Single Ascending Oral Doses of the NS3/4A Protease Inhibitor ITMN 191 in Healthy Subjects. W. Z. Bradford; C. Rubino; S. Porter; A. Forrest; L. M. Blatt; A. A. Patat
2- 1847. Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Patients with the NS3/4A Protease Inhibitor ITMN-191 Leads to Rapid Reductions in Plasma HCV RNA: Results of a Phase 1b Multiple Ascending Dose (MAD) Study. N. Forestier; D. G. Larrey; D. Guyader; P. Marcellin; R. Rouzier; A. A. Patat; W. Z. Bradford; S. Porter; S. Zeuzem
3- 1885. Combination of the NS3/4A Protease Inhibitor ITMN-191 (R7227) with the Active Moiety of the NS5B Inhibitors R1626 or R7128 Enhances Replicon Clearance and Reduces the Emergence of Drug Resistant Variants . H. Tan; S. Rajyaguru; T. Wu; M. McCown; S. Ali; W. Jiang; M. J. Otto; P. A. Furman; I. Najera; K. Klumpp; J. Symons; N. Cammack; L. M. Blatt; S. Seiwert
4- 1861. Pharmacokinetic-Pharmacodynamic (PK-PD) Relationships for ITMN-191 in a Phase 1 Multiple Ascending Dose Trial in Patients with Genotype 1 Chronic Hepatitis C (CHC)Infection . C. Rubino; W. Z. Bradford; A. Forrest; S. Porter; L. M. Blatt; S. Seiwert; S. Zeuzem
5- 898. Interferon gamma-1b (IFN-γ1b) and inhibitors of the hepatitis B virus (HBV) polymerase display additive to synergistic effects in cell culture models: potential implications for treatment . L. M. Blatt; H. Tan; K. Kossen; S. Seiwert
6- 1580. Interferon Gamma (IFNg) Induces the Release of High Mobility Group Box (HMGB)1 from Rat Hepatocytes through JAK- and JNK-dependent signaling pathways . P. Pan; J. Cardinal; D. A. Geller; A. Tsung
7- 1894. Identification of novel HCV NS3 helicase inhibitors through the application of optimized unwinding and ATPase assays in high throughput screens (HTS). K. Kossen; J. Kraemer; D. Winkler; T. Hesterkamp; S. Misialek; R. Rajagopalan; B. O. Buckman; L. M. Blatt; S. Seiwert; L. Beigelman
No Dilution!
It was in the past Q that they were seeking a commercial line of credit now it is official.
http://www.sec.gov/Archives/edgar/data/846475/000107997408000836/zynex8k_9232008.htm
This is what will be in the PR at 9:12am :)
Zynex Announces a $3 million Line of Credit.
Zynex, Inc. ZYXI, a provider of pain management systems and electrotherapy products for medical patients with functional disability, announces that it has entered into a Loan and Security Agreement with Marquette Healthcare Finance. The Loan Agreement provides Zynex with a revolving credit facility of up to $3,000,000. The Loan is secured by a first priority security interest in all of Zynex’s assets. The term of the credit facility is 3 years.
Thomas Sandgaard, CEO, commented: “This Line of Credit allows us to continue our growth efforts. In the most recent six months ended June 30, 2008 alone, we produced $430,897 in cash from operations; and in the most recent quarter we had a net income of $1,852,212. At the same time, we have continued to show a significant increase in monthly orders compared to the past year.
Also, importantly we believe it is a strong signal to the market that we do not have current plans to raise capital by offering additional stock. We further believe that we are equipped for having our stock traded on the American Stock Exchange (AMEX).”
Mr. Sandgaard added: "We are very excited to be working with Marquette. Marquette has been responsive to our needs and has shown a solid understanding of the healthcare business."
About Zynex, Inc.
Zynex (founded in 1996) engineers, manufactures, markets and sells its own design of electrotherapy medical devices in two distinct markets: standard digital electrotherapy products for pain relief and pain management; and the NeuroMove(TM) for stroke and spinal cord injury (SCI) rehabilitation. Zynex's product lines are fully developed, FDA-cleared, commercially sold, and have been developed to uphold the Company's mission of improving the quality of life for patients suffering from impaired mobility due to stroke, spinal cord injury, or debilitating and chronic pain.
I think they'll do fine with either as president. Keep in mind the new orders and backlog is now. Did you happen to read the article I posted yesterday? Mr. Spink talks about how the US has led the world in reducing air pollution even though we (US) didn’t sign the Kyoto agreement was a country like Canada who is more outspoken about it and did support it does less! He also pointed out that other factors affected sales such as esthetic concerns (tourism).
Also I suspect they believe a lot of growth will come from Europe and that is why they opened the office in Italy.
I thought they would do in the 4MM range. I don't have a model just a guestimate based on timing of PR's and time to complete.
Who knows with this market but I am guessing I won't be able to add near where I did last week.
Their PR's are sometimes a little hard to disambiguate but I take it to mean the current back-log is 17.7 less work done in the current quarter.
I get .014
Thanks I'll update my earlier post
Your right, I didn't update my cut and paste and had the q3 numbers the earnings are right though which is not quite .02. I think the numbers are better then I expected.
Looks like Q4 they had revenue of 5,686,314 and income of 206,823
EDIT: Fixed cut/paste wrong Revenue number
They are out now
http://biz.yahoo.com/iw/080922/0436407.html
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: UTHR
ACHN – ACH-1095 (a.k.a. GS-9525) HCV NS4A inhibitor: start phase-1 4Q08.
ACHN – ACH-1625 HCV protease inhibitor: start phase-1 1Q09.
AMLN – LAR NDA submission: mid 2009 if bioequivalence study needed; earlier if not needed.
APPA---3Q08--reports results of its pivotal Phase 3 study in chemotherapy-induced nausea and vomiting (CINV) comparing the efficacy of APF530 (a proprietary, sustained release formulation of granisetron) with Aloxi for the prevention of acute and delayed onset CINV in both moderate and highly emetogenic chemotherapy treatments.
BMY – Apixaban phase-3 ADVANCE-1 trial (VTE prevention following in orthopedic surgery): failure reported by PR 8/26/08, full data at ASH Dec08.
CEGE
- GVAX prostate: VITAL-2 failure reported 8/27/08; unplanned futility analysis of VITAL-1 to be reported Sep08.
- GVAX pancreas: leukemia P2 data 2H08.
CYT.TO - Initiated pivotal A-fib trial Oct/06. Complete enrollment 2nd/half 07. Results 2nd half 08.
CRXX - CRX-102 (Synavive) in Osteoarthritis COMET-1 expected to announce data (per company) in Oct 08
CRXX - Synavive Extension to COMET-1 (in Osteoarthritis) expected 9 months after COMET-1 (so approx Aug 09).
CRXX - CRx-401 Ph ii as add on in diabetes in 80 patients - expected to announce results in 2H08.
DNDN – Provenge 9902b study: interim analysis October 2008; final analysis (304 deaths) 2H09.
ELN – AAB-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.)
GENZ – FDA panel on Myozyme sBLA (this is the version of Myozyme produced at a new manufacturing plant): Oct 2008.
GILD – GS-9525 HCV NS4A inhibitor: see ACHN.
GILD – GS-9190 HCV polymerase inhibitor: new phase-1 trial to test QT-prolongation announced 10/18/2007; further details pending.
GTCB – FDA action on ATryn BLA: PDUFA date is 2/7/09.
GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: report data 2H09.
GTCB – Merrimack MM-093: results of phase-2 extension trial in RA: any day; results of pilot study in uveitis: late 2008.
GTCB – Protexia: see PIP.
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 – See #msg-31933767
ISA.TO-European psoriasis P3 results 2008. Phase II/III Uveitis results 2008.
INSM - Iplex trial in MMD phase IIb, data expected late 2008, final results Q109.(optin moment at that time by ipsen/genentech) .
INSM - Iplex in HARS on hold due to cash.
INSM - Iplex expanded acces program for ALS in italy , ALSFRS scale used to collect data, no targets or clinical endpoints set though.
INSM - NDGA phase II trial run by UCSF in prostate cancer started may 2008. Primary data may 2009.
ITMN – ITMN191 Final MAD monotherapy data at AASLD in Oct08 (data from first four cohorts announced at EASL 4/1/08). Data from 14-day triple- combination study: late 2008 (probably not in time for AASLD; trial started 5/29/08).
ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results January 2009 (72 week treatment period).
LEVP – See VPHM.
MAXY – Maxy-Seven FVIIa analogue: phase-1 trial in UK to start 2H08. (Go-ahead to start received 6/11/08.)
Merrimack – See GTCB.
MNT – PureTox botulinum toxin: report data from first phase-3 trial calendar 4Q08; submit BLA calendar 4Q10 (after completion of two other phase-3 trials).
MNTA – Appellate court ruling on Lovenox patent en banc rehearing: 8/21/08.
MNTA – Lovenox ANDA resubmission: 3Q08. (Prior FDA response received 4/28/08.)
MNTA – M118: report phase-2 data in stable angina: 1Q09/2Q09; ink partnership deal: 2Q09.
MNTA – Copaxone ANDA: possible FDA decision in 2009-2010 (ANDA accepted for review on 7/11/08).
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2008, trial results in 2009.
NVAX - Phase 2 data for pandemic-flu vaccine... safety and immune response in 230 volunteers next month (august?)
NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).
OXGN - 4Q 08 File IND for Zybrestat topical in ophthalmology
OXGN - 2H 08 Phase 1 results Zybrestat/Rad. therapy/Cetuximab
OXGN - 2H 08 Partnership (listen to 2Q CC)
PFE – Apixaban program: see BMY
Pharming – Rhucin submission to FDA possibly in 2008; positive phase-3 data reported 6/16/08.
PIP – Protexia nerve-agent antidote: file IND Aug08; start phase-1 Sep08.
PPHM- Bavituximab (cancer): PII MBC Bavi/Docetaxel 1st stage successful. Trial moves to 2nd stage July 08
PPHM- Bavituximab (cancer): first patient dosed in PII NSC lung cancer trial w/carboplatin/paclitaxel June 08
PPHM- Bavituximab (cancer): approval received to conduct PII MBC trial w/carboplatin/paclitaxel Jan 08
PPHM- Bavituximab (cancer): phase I monotherapy trial, estimated completion Sept 08
PPHM- Bavituximab (viral): phase I trial: HCV / HIV coinfected patients: estimated completion Sept 08
PPHM- Cotara: phase II glioblastoma multiforme trial - next interim update 2H 08
PPHM- Cotara: glioblastoma multiforme US trial - data presented at ASCO 08, estimated completion Sept 08
RDEA – Start phase-2b combination study of RDEA806 in HIV: 4Q08; start phase-1 of RDEA 427 (2nd-gen NNRTI for HIV) 4Q08.
‘
RPRX– Proellex
* Anemia Pivotal PIII trials - results expected by end of 2008
RPRX - Proellex endometriosis ph ii (enrollment ended early (Aug 08) so results estimated by late 4Q08 or early 1Q09)
RPRX - Proellex Uterine Fibroids ph iii (clinicaltrials.org expected end date is March 09)
RPRX - Androxal Phase 2b in male fertility and testicular function: initiated June 2008
SGP – Boceprevir ph-2 trial in treatment-naïve HCV: SVR data for 48-week arms: late 2008 or early 2009. (SVR data for the 28-week arms and SVR12 data for the 48-week arms were reported on 8/4/08: #msg-31189981.)
SRDX - Novocell phase-1/2 trial in type-1 diabetes: top-line data due in 2008 (enrollment complete 8/30/06).
SNTA - Elesclomol Phase III metastatic melanoma: Safety and Futility Interim Analysis (PFS) late 4Q08; Complete enrollment (630) ~ early 1Q09; final PFS analysis (primary endpoint) early 2009; interim OS analysis early 2009 (secondary endpoint)
TARG - PDUFA date for Oritavancin: 12/8/08
UTHR - PDUFA date for Inhaled Treprostinil: 04/30/09
UTHR - Unblind Oral Treprostinil (combo trial) App. Mid November, 2008 [per 9/22/08 UBS conference last patient dosed about 8 weeks to gather and report data]. Note the Oral monotherapy trial will probably complete late Q1/early Q2 (est.)
VPHM – PDUFA date for Cinryze: 10/14/08.
VRTX – PROVE-3 trial in treatment-experienced HCV: SVR data 4Q08, presumably at AASLD. (EoT and some SVR12 data were reported on 6/9/08.)
VRTX – Interim data from BID-dosing phase-2 Telaprevir trial conducted by Tibotec: 2H08.
ZGEN – IFN-Lambda in HCV: report interim ph1 monotherapy data at AASLD in Oct 2008.
ZGEN – IL21 w Nexavar in RCC: interim ph2 data at EORTC in Oct 2008.
ZGEN – IL21 in melanoma: interim ph2 data at ZGEN’s R&D Day Dec 2008.
ZGEN - Atacicept 26 week Ph ii in RA TNF-naive patients 1H10 (but clinicaltrials.org expects in 2H09)
ZGEN - Atacicept 26 week Ph ii in RA TNF inadequate-responders in 2H09
ZGEN - Atacicept small Ph ii in RA in combo with Rituxan. 25 week study with results expected per clinicaltrials.org in 2H10.
ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10
--
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Very Good!
Going back to the comments by DD about good pitchers not being dominant in post season I always thought Bobby Cox did a disservice to the Braves during their glory years. It was clear early on Avery and Smoltz stepped it up a notch in the post season while Glavine and Maddux were quite hittable. I would have put a rotation of Smoltz, Avery, Maddux then Glavine.
Webcast Calendar
[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
2008 UBS Global Life Sciences Conference
Grand Hyatt New York
New York City
September 22-25, 2008
http://events.streamx.us/us/event/eventdetails.aspx?id=ubs20080922
Biotech in Europe Investor Forum
Swissôtel, Zurich
September 23-24, 2008
http://www.sachsforum.com/zurich08/
Oppenheimer 19th Annual Healthcare Conference
New York, NY
November 3-4, 2008
http://www.opco.com/Conferences/Healthcare/index.html
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CTIC(D):
I just noticed their stock price already under a buck with the 10-1 reverse split. I wonder if this is some record for a company to drop below the compliance level before their 20 days with the D is even up!
http://finance.yahoo.com/q/hp?s=CTICD
Date Open High Low Close Volume Adj Close*
19-Sep-08 0.93 0.99 0.91 0.94 58,800 0.94
18-Sep-08 0.92 0.95 0.92 0.93 41,400 0.93
17-Sep-08 1.00 1.00 0.96 1.00 56,800 1.00
16-Sep-08 1.04 1.04 0.98 1.00 40,700 1.00
15-Sep-08 1.20 1.20 1.03 1.05 93,300 1.05
12-Sep-08 1.19 1.48 1.19 1.28 21,600 1.28
11-Sep-08 1.48 1.48 1.16 1.29 62,600 1.29
10-Sep-08 1.43 1.49 1.34 1.34 88,600 1.34
9-Sep-08 1.60 1.65 1.55 1.55 27,300 1.55
8-Sep-08 1.71 1.71 1.55 1.58 111,300 1.58
5-Sep-08 1.83 1.90 1.80 1.90 61,100 1.90
4-Sep-08 2.00 2.00 1.90 1.99 104,700 1.99
3-Sep-08 2.50 2.50 2.06 2.11 107,100 2.11
2-Sep-08 2.50 2.50 2.27 2.32 13,700 2.32
2-Sep-08 1 : 10 Stock Split
29-Aug-08 0.25 0.26 0.23 0.23 45,800 2.30
28-Aug-08 0.26 0.27 0.24 0.25 29,600 2.50
Winningest by number of wins not percentage.
Hint 2. 2 of his teammates for most of that time made your list.
You left out the winningest post-season pitcher in history. Hint he is still active but was injured this year.
Found this article on the company a bit old but gives a little overview and some little tid-bits http://news.therecord.com/printArticle/250894
I posted this on the other board (#msg-32296727) but thought to put it here too.
IRD.TO / IRDYF: (International Road Dynamics)
This is a nice microcap that probably not too many people have even heard of. I see three ways people can play this:
1-As a value play. Not just based on book value but if one would guestimate what an acquirer would pay for them or if they broke up some of their international divisions I suspect it could fetch north of $2 US a share.
2-As a short term turnaround play. They have been announcing a lot of descent sized orders in the past few months couple that with their recent China division acquisition that was doing 10MM a year and they should do quite well in the next few quarters. They are coming off a relatively bad quarter too.
3-[The way I generally like to invest] as a long term growth play. Their revenues from quarter to quarter have varied but looking out on a yearly basis they have been consistently growing. Over the past couple years they have started or acquired divisions in international regions (China, India, Brazil, Chili most recently Nigeria) they are positioning themselves nicely on the international scene. If one looks at what they have done in Brazil for example a small investment a few years ago (40% interest) and they recently announced a CAD$6MM order which also sets them up for more work there.
I’ve been putting together a lot more research on the company and if someone starts a board I’ll contribute more info.
IRD.TO / IRDYF: (International Road Dynamics)
This is a nice microcap that probably not too many people have even heard of. I see three ways people can play this:
1-As a value play. Not just based on book value but if one would guestimate what an acquirer would pay for them or if they broke up some of their international divisions I suspect it could fetch north of $2 US a share.
2-As a short term turnaround play. They have been announcing a lot of descent sized orders in the past few months couple that with their recent China division acquisition that was doing 10MM a year and they should do quite well in the next few quarters. They are coming off a relatively bad quarter too.
3-[The way I generally like to invest] as a long term growth play. Their revenues from quarter to quarter have varied but looking out on a yearly basis they have been consistently growing. Over the past couple years they have started or acquired divisions in international regions (China, India, Brazil, Chili most recently Nigeria) they are positioning themselves nicely on the international scene. If one looks at what they have done in Brazil for example a small investment a few years ago (40% interest) and they recently announced a CAD$6MM order which also sets them up for more work there.
I’ve been putting together a lot more research on the company and if someone starts a board I’ll contribute more info.
BTW their website is pretty good with lots of info its http://www.irdinc.com/ and for filings go to SEDAR http://www.sedar.com/DisplayCompanyDocuments.do?lang=EN&issuerNo=00003866
Should have figured you were adding today when I kept seeing bids ending in .001. I managed to add a fair amount today too, didn't think I would get a chance before earnings. Not that I am expecting this to be a real breakout quarter but should be a nice improvement from recent low.
VRTX:
Did they pass Millennium for biggest cumulative burn? They seem to go through it rather quick!
on your reply to xrymd on Feuerstein I would point to VRTX as an example of his biased reporting. I'll admit to being biased myself (long ITMN) and I do enjoy reading some of his stuff (though I can't recall much lately).
Infergen:
I am just glad Dan Welch sold it to Valeant for what in hindsight was great timing. I believe it held some potential in treatment failures particularly daily dosing (before Protease Inhibitors showed promise). I believe InterMune was to get a milestone upon completion of that (daily dosing) trial but I haven't kept up with what happened.
Thanks for the added info. I was mainly interested in the A-fib aspect I know it is supposed to be very low but had reasons for concern.
The only news around October would be the presentation of Tryztek data at the CF conference and to HOPE that their was something extremely meaningful in why 6 x-US centers had no meaningful improvement.
osteoporosis meds and atrial fibrillation:
Do you mind my asking why you switched to reclst and if you have any concern with A-fib and the bisphosphonates in general in particular for patients with a history of a-fib? I am asking for non-investment purposes TIA
So was Santana pushed yesterday to avoid the pen? I can't imagine Mets fans get too comfy come 7th inning for all the complaining about Wagner I think I'ld want him over anything they have now.
Its looking to be an interesting race for the NL East and NL wild card position. I'll admit to not being a fan of the wildcard but it certainly has kept interest going to the final days.
Braves have had a disastrous season but I think they got up for the Mets. Norton just hit a three run pinch hit homerun to give the Braves the lead.
OT: Biotech Humor
This is posted by Ian on the SI Board.
http://siliconinvestor.advfn.com/readmsg.aspx?msgid=24931515
OT: Biotech Research terminology exposed ...
Mysterious Language of Scientific Research
The following list of phrases and their definitions might help us better understand the language used in reporting results from clinical and pre-clinical research.
"It has long been known"... I didn't look up the original reference.
"Three of the samples were chosen for detailed study"... The other results didn't make any sense.
"Typical results are shown"... This is the prettiest graph.
"In my experience"... once
"In case after case"... twice
"In a series of cases"... three times
"It is believed that"... I think.
"It is generally believed that"... A couple of others think so, too.
"Correct within an order of magnitude"... Wrong.
"According to statistical analysis"... Rumour has it.
"A statistically oriented projection of the significance of these findings"... A wild guess
"It is clear that much additional work will be required before a complete understanding of this phenomenon occurs"... I don't understand it.
"After additional study by my colleagues"... They don't understand it either.
"Thanks are due to Joe Blotz for assistance with the experiment and to Cindy Adams for valuable discussions"... Mr. Blotz did the work and Ms. Adams explained to me what it meant.
"It is hoped that this study will stimulate further investigation in this field"... I quit.
[And I always thought this meant, "We'll be seeking additional funding soon.]
The K is out, nothing to get excited about though. Looks like a slight loss (not counting the accounting for the tax benefit) on sales of about 600k.
I don't recall who pointed it out (maybe penn?) but it is interesting to see the number of working days in the month and August and September have 21 (I am assuming labor day is a holiday for Zynex) October will have 23! Its hard to judge season variation in a rapidly growing stock, though it would appear we are heading into the stronger period and October has done quite well on a relative basis.
I am surprised Raw hasn't gotten on you about the PE. 20 PE for 25% quarterly growth? Though I certainly don't expect that to continue indefinetly.
The bad news is that the volume once again has dried up and the sp has stalled with a wide bid and ask.
I don't see this as bad news. It has just gone back to what it has done in the recent past (low volume, big spread). I think the buyers just found an eager seller in the low .50 range (my theory is a fund wanted to dump some/all of their position and has finished doing so).
Probably a third of my portfolio (# of securities not % of portfolio) is illiquid big spread stocks. I think it will take a few quarters of growth to get regular sustained high volume and a tighter spread. Take a look at ZYXI a couple of years ago it was not uncommon to go days without trading then when it would a spread of over 50% was not uncommon! Today on a modest volume day it is 150k volume and the spread is .5%.
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: TARG Oritavancin PDUFA
ACHN – ACH-1095 (a.k.a. GS-9525) HCV NS4A inhibitor: start phase-1 4Q08.
ACHN – ACH-1625 HCV protease inhibitor: start phase-1 1Q09.
AMLN – LAR NDA submission: mid 2009 if bioequivalence study needed; earlier if not needed.
APPA---3Q08--reports results of its pivotal Phase 3 study in chemotherapy-induced nausea and vomiting (CINV) comparing the efficacy of APF530 (a proprietary, sustained release formulation of granisetron) with Aloxi for the prevention of acute and delayed onset CINV in both moderate and highly emetogenic chemotherapy treatments.
BMY – Apixaban phase-3 ADVANCE-1 trial (VTE prevention following in orthopedic surgery): failure reported by PR 8/26/08, full data at ASH Dec08.
CEGE
- GVAX prostate: VITAL-2 failure reported 8/27/08; unplanned futility analysis of VITAL-1 to be reported Sep08.
- GVAX pancreas: leukemia P2 data 2H08.
CYT.TO - Initiated pivotal A-fib trial Oct/06. Complete enrollment 2nd/half 07. Results 2nd half 08.
CRXX - CRX-102 (Synavive) in Osteoarthritis COMET-1 expected to announce data (per company) in Oct 08
CRXX - Synavive Extension to COMET-1 (in Osteoarthritis) expected 9 months after COMET-1 (so approx Aug 09).
CRXX - CRx-401 Ph ii as add on in diabetes in 80 patients - expected to announce results in 2H08.
DNDN – Provenge 9902b study: interim analysis October 2008; final analysis (304 deaths) 2H09.
ELN – AAB-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.)
GENZ – FDA panel on Myozyme sBLA (this is the version of Myozyme produced at a new manufacturing plant): Oct 2008.
GILD – GS-9525 HCV NS4A inhibitor: see ACHN.
GILD – GS-9190 HCV polymerase inhibitor: new phase-1 trial to test QT-prolongation announced 10/18/2007; further details pending.
GTCB – FDA action on ATryn BLA: PDUFA date is 2/7/09.
GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: report data 2H09.
GTCB – Merrimack MM-093: results of phase-2 extension trial in RA: any day; results of pilot study in uveitis: late 2008.
GTCB – Protexia: see PIP.
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 – See #msg-31933767
ISA.TO-European psoriasis P3 results 2008. Phase II/III Uveitis results 2008.
INSM - Iplex trial in MMD phase IIb, data expected late 2008, final results Q109.(optin moment at that time by ipsen/genentech) .
INSM - Iplex in HARS on hold due to cash.
INSM - Iplex expanded acces program for ALS in italy , ALSFRS scale used to collect data, no targets or clinical endpoints set though.
INSM - NDGA phase II trial run by UCSF in prostate cancer started may 2008. Primary data may 2009.
ITMN – ITMN191 Final MAD monotherapy data at AASLD in Oct08 (data from first four cohorts announced at EASL 4/1/08). Data from 14-day triple- combination study: late 2008 (probably not in time for AASLD; trial started 5/29/08).
ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results January 2009 (72 week treatment period).
LEVP – See VPHM.
MAXY – Maxy-Seven FVIIa analogue: phase-1 trial in UK to start 2H08. (Go-ahead to start received 6/11/08.)
Merrimack – See GTCB.
MNT – PureTox botulinum toxin: report data from first phase-3 trial calendar 4Q08; submit BLA calendar 4Q10 (after completion of two other phase-3 trials).
MNTA – Appellate court ruling on Lovenox patent en banc rehearing: 8/21/08.
MNTA – Lovenox ANDA resubmission: 3Q08. (Prior FDA response received 4/28/08.)
MNTA – M118: report phase-2 data in stable angina: 1Q09/2Q09; ink partnership deal: 2Q09.
MNTA – Copaxone ANDA: possible FDA decision in 2009-2010 (ANDA accepted for review on 7/11/08).
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2008, trial results in 2009.
NVAX - Phase 2 data for pandemic-flu vaccine... safety and immune response in 230 volunteers next month (august?)
NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).
OXGN - 4Q 08 File IND for Zybrestat topical in ophthalmology
OXGN - 2H 08 Phase 1 results Zybrestat/Rad. therapy/Cetuximab
OXGN - 2H 08 Partnership (listen to 2Q CC)
PFE – Apixaban program: see BMY
Pharming – Rhucin submission to FDA possibly in 2008; positive phase-3 data reported 6/16/08.
PIP – Protexia nerve-agent antidote: file IND Aug08; start phase-1 Sep08.
PPHM- Bavituximab (cancer): PII MBC Bavi/Docetaxel 1st stage successful. Trial moves to 2nd stage July 08
PPHM- Bavituximab (cancer): first patient dosed in PII NSC lung cancer trial w/carboplatin/paclitaxel June 08
PPHM- Bavituximab (cancer): approval received to conduct PII MBC trial w/carboplatin/paclitaxel Jan 08
PPHM- Bavituximab (cancer): phase I monotherapy trial, estimated completion Sept 08
PPHM- Bavituximab (viral): phase I trial: HCV / HIV coinfected patients: estimated completion Sept 08
PPHM- Cotara: phase II glioblastoma multiforme trial - next interim update 2H 08
PPHM- Cotara: glioblastoma multiforme US trial - data presented at ASCO 08, estimated completion Sept 08
RDEA – Start phase-2b combination study of RDEA806 in HIV: 4Q08; start phase-1 of RDEA 427 (2nd-gen NNRTI for HIV) 4Q08.
‘
RPRX– Proellex
* Anemia Pivotal PIII trials - results expected by end of 2008
RPRX - Proellex endometriosis ph ii (enrollment ended early (Aug 08) so results estimated by late 4Q08 or early 1Q09)
RPRX - Proellex Uterine Fibroids ph iii (clinicaltrials.org expected end date is March 09)
RPRX - Androxal Phase 2b in male fertility and testicular function: initiated June 2008
SGP – Boceprevir ph-2 trial in treatment-naïve HCV: SVR data for 48-week arms: late 2008 or early 2009. (SVR data for the 28-week arms and SVR12 data for the 48-week arms were reported on 8/4/08: #msg-31189981.)
SRDX - Novocell phase-1/2 trial in type-1 diabetes: top-line data due in 2008 (enrollment complete 8/30/06).
TARG - PDUFA date for Oritavancin: 12/8/08
UTHR - PDUFA date for Inhaled Treprostinil: 04/30/09
VPHM – PDUFA date for Cinryze: 10/14/08.
VRTX – PROVE-3 trial in treatment-experienced HCV: SVR data 4Q08, presumably at AASLD. (EoT and some SVR12 data were reported on 6/9/08.)
VRTX – Interim data from BID-dosing phase-2 Telaprevir trial conducted by Tibotec: 2H08.
ZGEN – IFN-Lambda in HCV: report interim ph1 monotherapy data at AASLD in Oct 2008.
ZGEN – IL21 w Nexavar in RCC: interim ph2 data at EORTC in Oct 2008.
ZGEN – IL21 in melanoma: interim ph2 data at ZGEN’s R&D Day Dec 2008.
ZGEN - Atacicept 26 week Ph ii in RA TNF-naive patients 1H10 (but clinicaltrials.org expects in 2H09)
ZGEN - Atacicept 26 week Ph ii in RA TNF inadequate-responders in 2H09
ZGEN - Atacicept small Ph ii in RA in combo with Rituxan. 25 week study with results expected per clinicaltrials.org in 2H10.
ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10
--
Procedure For Updating Clinical-Trials List
When adding or modifying entries, please follow these steps:
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ITMN:
Sorry for the bad grammar. Too late to fix with an edit here. Hope this is clearer.
I do not understand what you mean. (Did you inadvertently leave a word or two out of this sentence?)
In todays presentation Dan Welch said the 14 day models are a replicon model and a viral mutation model (for 1626 or 7128). Said what will be presented at AASLD is very interesting, [implying it will show] Roche's interest in developing 191 plus one or both of their Polymerase Inhibitors.
What is your estimate of the proportion of ITMN’s fair value that is attributable to Pirfenidone? T.i.a.
A long time ago I had given it more thought (when InterMune was in the mid 30's and the INSPIRE study for Actimmune was on going and after Shionogi announced positive P3 results). I had a rough value of about 12-15/share for Pirfenidone.
With the failure of the INSPIRE study and nothing announced beyond 191 I was concerned a failure could devastate the stock and am glad to see them talking about other programs prior to results. Having an all oral HCV trial get started would be great too! That being said a positive outcome especially one with a trend to showing a survival benefit (FVC is the primary end point) could be worth north of a double of the current stock price and I suspect the sales ramp would be extremely rapid in this scenario too. I am content with Orphan exclusivity as they are working on Pirfenidone analog's so I am less concerned with the patent situation though successful results in January are the major concern.
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: UTHR Inhaled Treprostinil PDUFA
ACHN – ACH-1095 (a.k.a. GS-9525) HCV NS4A inhibitor: start phase-1 4Q08.
ACHN – ACH-1625 HCV protease inhibitor: start phase-1 1Q09.
AMLN – LAR NDA submission: mid 2009 if bioequivalence study needed; earlier if not needed.
APPA---3Q08--reports results of its pivotal Phase 3 study in chemotherapy-induced nausea and vomiting (CINV) comparing the efficacy of APF530 (a proprietary, sustained release formulation of granisetron) with Aloxi for the prevention of acute and delayed onset CINV in both moderate and highly emetogenic chemotherapy treatments.
BMY – Apixaban phase-3 ADVANCE-1 trial (VTE prevention following in orthopedic surgery): failure reported by PR 8/26/08, full data at ASH Dec08.
CEGE
- GVAX prostate: VITAL-2 failure reported 8/27/08; unplanned futility analysis of VITAL-1 to be reported Sep08.
- GVAX pancreas: leukemia P2 data 2H08.
CYT.TO - Initiated pivotal A-fib trial Oct/06. Complete enrollment 2nd/half 07. Results 2nd half 08.
CRXX - CRX-102 (Synavive) in Osteoarthritis COMET-1 expected to announce data (per company) in Oct 08
CRXX - Synavive Extension to COMET-1 (in Osteoarthritis) expected 9 months after COMET-1 (so approx Aug 09).
CRXX - CRx-401 Ph ii as add on in diabetes in 80 patients - expected to announce results in 2H08.
DNDN – Provenge 9902b study: interim analysis October 2008; final analysis (304 deaths) 2H09.
ELN – AAB-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.)
GENZ – FDA panel on Myozyme sBLA (this is the version of Myozyme produced at a new manufacturing plant): Oct 2008.
GILD – GS-9525 HCV NS4A inhibitor: see ACHN.
GILD – GS-9190 HCV polymerase inhibitor: new phase-1 trial to test QT-prolongation announced 10/18/2007; further details pending.
GTCB – FDA action on ATryn BLA: PDUFA date is 2/7/09.
GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: report data 2H09.
GTCB – Merrimack MM-093: results of phase-2 extension trial in RA: any day; results of pilot study in uveitis: late 2008.
GTCB – Protexia: see PIP.
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 – See #msg-31933767
ISA.TO-European psoriasis P3 results 2008. Phase II/III Uveitis results 2008.
INSM - Iplex trial in MMD phase IIb, data expected late 2008, final results Q109.(optin moment at that time by ipsen/genentech) .
INSM - Iplex in HARS on hold due to cash.
INSM - Iplex expanded acces program for ALS in italy , ALSFRS scale used to collect data, no targets or clinical endpoints set though.
INSM - NDGA phase II trial run by UCSF in prostate cancer started may 2008. Primary data may 2009.
ITMN – ITMN191 Final MAD monotherapy data at AASLD in Oct08 (data from first four cohorts announced at EASL 4/1/08). Data from 14-day triple- combination study: late 2008 (probably not in time for AASLD; trial started 5/29/08).
ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results January 2009 (72 week treatment period).
LEVP – See VPHM.
MAXY – Maxy-Seven FVIIa analogue: phase-1 trial in UK to start 2H08. (Go-ahead to start received 6/11/08.)
Merrimack – See GTCB.
MNT – PureTox botulinum toxin: report data from first phase-3 trial calendar 4Q08; submit BLA calendar 4Q10 (after completion of two other phase-3 trials).
MNTA – Appellate court ruling on Lovenox patent en banc rehearing: 8/21/08.
MNTA – Lovenox ANDA resubmission: 3Q08. (Prior FDA response received 4/28/08.)
MNTA – M118: report phase-2 data in stable angina: 1Q09/2Q09; ink partnership deal: 2Q09.
MNTA – Copaxone ANDA: possible FDA decision in 2009-2010 (ANDA accepted for review on 7/11/08).
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2008, trial results in 2009.
NVAX - Phase 2 data for pandemic-flu vaccine... safety and immune response in 230 volunteers next month (august?)
NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).
OXGN - 4Q 08 File IND for Zybrestat topical in ophthalmology
OXGN - 2H 08 Phase 1 results Zybrestat/Rad. therapy/Cetuximab
OXGN - 2H 08 Partnership (listen to 2Q CC)
PFE – Apixaban program: see BMY
Pharming – Rhucin submission to FDA possibly in 2008; positive phase-3 data reported 6/16/08.
PIP – Protexia nerve-agent antidote: file IND Aug08; start phase-1 Sep08.
PPHM- Bavituximab (cancer): PII MBC Bavi/Docetaxel 1st stage successful. Trial moves to 2nd stage July 08
PPHM- Bavituximab (cancer): first patient dosed in PII NSC lung cancer trial w/carboplatin/paclitaxel June 08
PPHM- Bavituximab (cancer): approval received to conduct PII MBC trial w/carboplatin/paclitaxel Jan 08
PPHM- Bavituximab (cancer): phase I monotherapy trial, estimated completion Sept 08
PPHM- Bavituximab (viral): phase I trial: HCV / HIV coinfected patients: estimated completion Sept 08
PPHM- Cotara: phase II glioblastoma multiforme trial - next interim update 2H 08
PPHM- Cotara: glioblastoma multiforme US trial - data presented at ASCO 08, estimated completion Sept 08
RDEA – Start phase-2b combination study of RDEA806 in HIV: 4Q08; start phase-1 of RDEA 427 (2nd-gen NNRTI for HIV) 4Q08.
‘
RPRX– Proellex
* Anemia Pivotal PIII trials - results expected by end of 2008
RPRX - Proellex endometriosis ph ii (enrollment ended early (Aug 08) so results estimated by late 4Q08 or early 1Q09)
RPRX - Proellex Uterine Fibroids ph iii (clinicaltrials.org expected end date is March 09)
RPRX - Androxal Phase 2b in male fertility and testicular function: initiated June 2008
SGP – Boceprevir ph-2 trial in treatment-naïve HCV: SVR data for 48-week arms: late 2008 or early 2009. (SVR data for the 28-week arms and SVR12 data for the 48-week arms were reported on 8/4/08: #msg-31189981.)
SRDX - Novocell phase-1/2 trial in type-1 diabetes: top-line data due in 2008 (enrollment complete 8/30/06).
UTHR - PDUFA date for Inhaled Treprostinil: 04/30/09
VPHM – PDUFA date for Cinryze: 10/14/08.
VRTX – PROVE-3 trial in treatment-experienced HCV: SVR data 4Q08, presumably at AASLD. (EoT and some SVR12 data were reported on 6/9/08.)
VRTX – Interim data from BID-dosing phase-2 Telaprevir trial conducted by Tibotec: 2H08.
ZGEN – IFN-Lambda in HCV: report interim ph1 monotherapy data at AASLD in Oct 2008.
ZGEN – IL21 w Nexavar in RCC: interim ph2 data at EORTC in Oct 2008.
ZGEN – IL21 in melanoma: interim ph2 data at ZGEN’s R&D Day Dec 2008.
ZGEN - Atacicept 26 week Ph ii in RA TNF-naive patients 1H10 (but clinicaltrials.org expects in 2H09)
ZGEN - Atacicept 26 week Ph ii in RA TNF inadequate-responders in 2H09
ZGEN - Atacicept small Ph ii in RA in combo with Rituxan. 25 week study with results expected per clinicaltrials.org in 2H10.
ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10
--
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.
3. Post the updated text in a new message in reply to the message with the old list.
Some Notes from todays presentation cross posted on Biotech Values #msg-31934416
In todays presentation Dan Welch said the 14 day models are a replicon model and a viral mutation model (for 1626 or 7128). Said what will be presented at AASLD is very interesting, [implying it will show] Roche's interest in developing 191 plus one or both of their Polymerase Inhibitors.
Some other things from todays presentation (not all new):
1-The 1B monotherapy nonresponder exploratory cohort completed earlier this year was in null responders (no data given but suspect it is just OK, said warrant further study)
2-The ongoing triple combo study is intended to support an all oral regiment (along with future combo studies of course). Starting at 300mg daily and escalating.
3-Mfg of API from ITMN perspective already at Pharma margin level.
4-The marcocyclic Protease was started a couple years ago is NOT part of Array collaboration (other I think I've posted some links of the company on iVillage board if their site ever comes back up).
5-A little bit of info will be presented on Helicase not a lot of chemical matter patented so could be a leader in field.
6-A good chunck of the company burn is related to the CAPACITY study and perp work for putting together a filing (EU&US).
In this call it is the strongest I have ever heard Dan Welch on the probability of success for Pirfenidone. Yes he is the CEO and should be bullish today was just by far the strongest language/comments (in the Q&A) that I have ever heard.
ITMN:
“Two different models” meaning two animal models? Or two models meaning the replicon and one animal model?
In todays presentation Dan Welch said the 14 day models are a replicon model and a viral mutation model (for 1626 or 7128). Said very interesting and indication of Roche's interest in developing 191 plus one or both of their Polymerase Inhibitors.
Some other things from todays presentation (not all new):
1-The 1B monotherapy nonresponder exploratory cohort completed earlier this year was in null responders (no data given but suspect it is just OK, said warrant further study)
2-The ongoing triple combo study is intended to support an all oral regiment (along with future combo studies of course). Starting at 300mg daily and escalating.
3-Mfg of API from ITMN perspective already at Pharma margin level.
4-The marcocyclic Protease was started a couple years ago is NOT part of Array collaboration (other I think I've posted some links of the company on iVillage board if their site ever comes back up).
5-A little bit of info will be presented on Helicase not a lot of chemical matter patented so could be a leader in field.
6-A good chunck of the company burn is related to the CAPACITY study and perp work for putting together a filing (EU&US).
In this call it is the strongest I have ever heard Dan Welch on the probability of success for Pirfenidone. Yes he is the CEO and should be bullish today was just by far the strongest language/comments (in the Q&A) that I have ever heard.
Do you by chance know what significance there is for a presidential poster of distinctin (at AASLD)?
I have been noticing someone appears to be buying (other then me :)) as the bid drops it seems new bids enter in the 1.60-1.65 range. It is a hard stock to accumulate a position in so it takes patients. IMHO now is a good time for someone wanting to build a significant position. In a tough period for companies in construction and rising steel prices the company seems likely to still turn in a decent profit (though Mr. Menard has stated it will likely be below last year).
If there were any doubts about 191 moving forward into Phase 2 this should pretty much eliminate those. I have not seen specific mention of when and what type of Phase 2's would be conducted. A few things have been alluded too:
1-The trial would at least in part be in the US
2-At some point (late this year/early next) Roche would explore combinations with two or more antivirals.
3-Intermune has said a second generation if taken forward would lead to a similar deal as the 191 deal. The main difference being up-front payment to be negotiated. I have not heard heard the company make recent mention of this though. This could be a nice payday in the mid-future now that we know their is a viable candidate.
http://biz.yahoo.com/prnews/080902/aqtu508b.html?.v=1
InterMune Earns Development Milestone in HCV Protease Inhibitor Collaboration With Roche
Tuesday September 2, 8:00 am ET
- $15 million development milestone payment to InterMune -
- Roche to lead ITMN-191 program in Phase 2 -
BRISBANE, Calif., Sept. 2 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced that InterMune has earned a $15 million development milestone under its development collaboration with Roche for the hepatitis C virus (HCV) NS3 protease inhibitor compound ITMN-191 (referred to as R7227 at Roche), currently in a Phase 1b clinical trial in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin).
Under the terms of their 2006 collaboration agreement, the clinical program for ITMN-191 is now being transitioned to Roche which, starting in Phase 2, will have primary responsibility for completing the global development and registration program.
Nick Cammack, Ph.D., Global Head of the Virology Disease Biology Area, Roche, said, "Protease inhibition is a crucial aspect of our HCV strategy, which is focused on developing clinically differentiated medicines for patients. Our continued enthusiasm for ITMN-191/R7227 underscores our confidence in InterMune and we now plan to rapidly move the program into Phase 2 development."
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are very pleased to have led the preclinical development, conducted three Phase 1 clinical trials and with Roche, optimized the manufacturing of ITMN-191 active pharmaceutical ingredient (API) since the collaboration was announced less than two years ago. We look forward to the continued strong relationship with Roche as we together develop protease inhibitor therapies in combination with current standard of care and with other direct antiviral agents."
About the Roche/InterMune Collaboration
In October 2006, Roche and InterMune announced an exclusive worldwide collaboration to develop and commercialize products from InterMune's HCV protease inhibitor program, including ITMN-191. The companies also collaborate on a research program to identify, develop and commercialize novel second-generation HCV protease inhibitors.
At closing, InterMune received from Roche an upfront payment of $60 million, and in 2007 received a $10 million manufacturing milestone and a $10 million development milestone. In addition to the $15 million milestone being announced today, assuming the continued successful development and commercialization of ITMN-191 in the United States and other countries, InterMune could potentially receive up to an additional $435 million in milestones.
Roche funds 67% of the global development costs of ITMN-191. The companies will co-commercialize the product in the United States and share profits on a 50/50 basis. InterMune will receive royalties outside the United States.
Roche has rights to other HCV protease inhibitor development candidates resulting from the research collaboration. The economic terms for ITMN-191 also apply to additional compounds that InterMune and Roche may develop and commercialize.
In early April 2008, InterMune reported top-line results in the four dose cohorts of treatment-naive patients in a Phase 1b multiple-ascending-dose (MAD) monotherapy trial of ITMN-191 in patients chronically infected with HCV genotype 1. ITMN-191 demonstrated significant and rapid viral kinetic activity and excellent safety and tolerability in all dosage regimens. Also in early April, InterMune announced that 13-week preclinical studies in rats and monkeys were successfully completed which were necessary before initiation of clinical studies in Phase 2 with longer treatment durations than those performed to date with ITMN-191.
In late May 2008, InterMune initiated a 14-day study of ITMN-191 in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin). The study is proceeding as planned. Top-line results from the triple combination study are anticipated to be released in the fourth quarter of 2008.
About Hepatitis C
The hepatitis C virus (HCV) is transmitted primarily through blood or blood products. HCV chronically affects 180 million people worldwide, which makes it over four times more prevalent than HIV. It is a leading cause of cirrhosis, liver cancer and liver failure, despite the fact that many patients can be cured.
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 1b, 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 14, 2008 (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.
Pegasys® and Copegus® are registered trademarks of Roche.
Royalty Question?
I love the royalty even though it is just 3-5% it is a great revenue stream with no overhead! I have a question hope someone may have more background. Does anyone know how safe it is, more specifically how long it goes out (till patent(s) expire?) and how much risk is there that B&L stops selling product(s) using it. TIA
The table appears much better in the link. Basically Brian speculates on Seattle Genetics, Alexion, Medarex, Momenta and Regeneron
http://www.fool.com/investing/high-growth/2008/08/29/will-biopharma-acquisitions-never-cease.aspx
Will Biopharma Acquisitions Never Cease?
By Brian Lawler
August 29, 2008
In both the size and quantity of proposed deals, the past 24 months have been busier than ever for biopharma dealmakers. From industry giants like Genentech and Biogen Idec (Nasdaq: BIIB) to tiny players such as Mirus Bio, nearly every such drugmaker has generated at least rumors of a takeover.
Why now?
There are many factors coming together to make biopharmaceutical drugmakers attractive acquisition targets right now, but two particularly stand out. First, big pharmas like Pfizer (NYSE: PFE), Bristol-Myers Squibb, and Eli Lilly (NYSE: LLY) are currently flush with cash. However, they're also facing patent expirations and rising generic competition against some of their best-selling flagship drugs.
These drugmakers' cash has to go somewhere, either through acquisitions, share buybacks, dividend payments, or paying down debt. Some of these options don't make very much sense right now; with interest rates at historical lows, for example, now's not the time for big pharma to pare down their debt levels. In addition, some drugmakers park a good portion of their cash outside the U.S. for tax reasons, making foreign biopharma acquisitions more attractive.
Given their complex molecular nature and manufacturing processes, many biologically derived drugs and vaccines have innate natural protections against generic competition. In many cases, it can be nearly impossible to make a generic copy of a biopharmaceutical drug, even after its patents have run out.
There are plenty of smaller variables at work, too:
* The weak dollar means foreign large-cap pharmaceutical firms can acquire U.S. drugmakers more cheaply.
* The biopharma industry has matured in the last 10 years.
* Biopharma technologies enjoy increasing validation.
All in all, the the environment for biopharma deals has never been stronger.
What does Big Pharma want?
As with many previous deals for small-molecule drugmakers in the past, big pharma has generally offered its biggest premiums and juiciest deals to mid-sized biopharmaceutical firms with mature assets.
Here's a chart of some of the biggest biopharma acquisitions or proposed deals in the past 24 months:
The deal
Share-price premium*
Main reason for offer
Genentech acquired Tanox for $919 million.
47%
To gain rights to Tanox's share of the asthma drug Xolair
AstraZeneca acquired MedImmune for $15.6 billion .
21%
To get Synagis and vaccines
Takeda acquired Millennium Pharmaceuticals for $8.8 billion.
53%
Multiple-myeloma drug Velcade plus biologics pipeline
Bristol-Myers proposed to buy ImClone Systems (Nasdaq: IMCL) for $4.5 billion.
30%
Cancer drug Erbitux plus biologics pipeline
Roche proposed to buy Genentech for $43.7 billion.
8.8%
To gain more control over Genentech
*Compared to the day before the offer was made.
In addition to heated acquitision activity, drugmakers have forged a slew of record-breaking partnership deals for biopharmaceutical assets. For example, in 2006 GlaxoSmithKline struck a deal with Genmab, worth as much as $2.1 billion, for one of the latter company's late-stage monoclonal antibody drug candidates.
Many of these deals involved drug developers working with technologies that competitors have previously validated, but in recent months, large-cap pharma has even started to bite on new unproven technologies like Cell Genesys' GVAX cancer vaccine. However, these deals have generally drawn smaller amounts of up-front cash (and some bad outcomes, too).
What tempting targets remain?
Even as the biopharmaceutical sector grows by leaps and bounds in the 21st century, with drugs like Millennium's Velcade, Genentech's Avastin, and ImClone's Erbitux entering the market, there are still very few independent pure-play biopharmas. This fact alone boosts these companies' attractiveness to would-be acquirers.
Here's a partial list of some of the juiciest biopharma assets potentially still up for grabs:
Company
Current market capitalization
What they have to offer
Seattle Genetics (Nasdaq: SGEN)
$880 million
2 compounds in later-stage testing, antibody-drug conjugate technology
Alexion Pharmaceuticals
$3.5 billion
One drug already approved to treat a rare genetic disorder, multiple label-expanding studies under way
Medarex
$950 million
Seven compounds in at least phase 3 testing that could generate royalties, fully human monoclonal antibody technology
Momenta Pharmaceuticals (Nasdaq: MNTA)
$530 million
Technology to potentially develop a range of biosimilar drugs
Regeneron Pharmaceuticals
$1.7 billion
One approved compound, another that could compete broadly with Genentech's Avastin
Other drugmakers also have interesting biopharmaceutical assets, like Biogen Idec, Elan (NYSE: ELN), and Genzyme. But for a variety of reasons, including their large size or the nature of their existing partnership agreements, they'd be more difficult for a potential buyer to acquire.
A year from now, I'll be very surprised if every drugmaker on the above list remains independent. There are only so many mature biopharma assets to go around, and as the past months have shown us, big pharma isn't afraid to snap them up.