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t 26 and 52 weeks mean hemoglobin increased by 0.9g/dL and 1.3g/dL, respectively; mean platelet count increased by 18% and 34%; mean spleen volume decreased by 27% and 40%; mean liver volume decreased by 7% and 14%; mean chitotriosidase activity decreased by 30% and 50%.
Does anyone (genisi?) know off hand how this compares to Cerezyme?
Session Information
Session Title: Therapy for Genetic Disorders Session Type: Poster
Session Location: Exhibit Hall C Session Time: Wed 4:30PM-6:30PM, Thu 4:30PM-6:30PM, Fri 10:30AM-12:30PM
Abstract Information
Poster Board Number: 775/T Presentation Time: Thu, Nov 13, 2008, 4:30PM-6:30PM
Keywords: Therapy for Genetic Disorders, KW107 - METABOLIC DISORDER, KW098 - LYSOSOMAL DISEASES, KW133 - PHARMACOLOGIC THERAPY, KW168 - THERAPY
Abstract Content
Preliminary Results of a Phase 2 Clinical Trial of Genz-112638 in Patients with Type 1 Gaucher Disease. N. Watman1, E. Lukina2, E. A. Arreguin3, M. Banikazemi4, M. Iastrebner5, H. Rosenbaum6, A. Zimran7, F. O'Brien8, S. E. Smith8, A. C. Puga8, J. Peterschmitt8 1) Hospital Ramos Mejia, Buenos Aires, Urquiza, Argentina; 2) Hematology Research Center of Russian Academy of Medical Sciences, Moscow, Russia; 3) 2Hematology Research Center of Russian Academy of Medical Sciences, Moscow, Russia; 4) NYU, New York, USA; 5) Instituto Argentino de Diagnostico y Tratamiento, Buenos Aires, Argentina; 6) Rambam Medical Center, Haifa, Israel; 7) Sha’are Zedek Medical Center, Jerusalem, Israel; 8) Genzyme Corporation, Cambridge, USA.
Introduction: Genz-112638, an investigational compound, is a novel oral small molecule inhibitor of glucosylceramide synthase being developed for the treatment of Gaucher disease type 1 (GD1). Objective: To assess the efficacy, safety, and pharmacokinetics of Genz-112638 in patients with GD1. Methods: An ongoing open-label Phase 2 clinical trial of Genz-112638 (50 or 100mg bid orally) enrolled patients with GD1 in Israel, North America, Russia, and South America. The main efficacy endpoints of the study were changes in hemoglobin level, platelet count, and spleen volume after 52 weeks. An extension study will follow. Results: Data were available for up to 21 and 13 patients receiving Genz-112638 at 26 and 52 weeks, respectively. All 9 males and 12 females (age range: 18-55y) were Caucasian. Four were of Ashkenazi Jewish and 1 was of Hispanic descent. At 26 and 52 weeks mean hemoglobin increased by 0.9g/dL and 1.3g/dL, respectively; mean platelet count increased by 18% and 34%; mean spleen volume decreased by 27% and 40%; mean liver volume decreased by 7% and 14%; mean chitotriosidase activity decreased by 30% and 50%. Plasma glucosylceramide levels normalized in all patients. Seven related adverse events were reported in 6 patients and all were mild and transient in nature. Conclusions: Initial observations suggest that Genz-112638 may represent a safe, effective, and convenient oral therapy for patients with GD1. Clinical development of Genz-112638 will proceed in ongoing and additional clinical trials.
Session Information
Session Title: Therapy for Genetic Disorders Session Type: Poster
Session Location: Exhibit Hall C Session Time: Wed 4:30PM-6:30PM, Thu 4:30PM-6:30PM, Fri 10:30AM-12:30PM
Abstract Information
Poster Board Number: 749/W Presentation Time: Wed, Nov 12, 2008, 4:30PM-6:30PM
Keywords: Therapy for Genetic Disorders, KW051 - ENZYME REPLACEMENT THERAPY, KW098 - LYSOSOMAL DISEASES, KW017 - CELLULAR METABOLISM
Abstract Content
Novel Enzyme Replacement Therapy for Gaucher Disease: On Going Phase III Clinical Trial with Recombinant Human Glucocerebrosidase Expressed in Plant Cells. D. Aviezer1, E. Almon-Brill1, Y. Shaaltiel1, G. Galili4, R. Chertkoff1, S. Hashmueli1, E. Galun3, A. Zimran2 1) Protalix Biotherapeutics, Karmiel, Israel; 2) Gaucher Clinic, Shaare Zedek Medical Center, Jerusalem, IsraeL; 3) Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Hospital, Jerusalem,Israel; 4) Plant Sciences, Weizmann Institute of Science, Rehovot, Israel.
Gaucher Disease, characterized by glucocerebrosidase (hGCD) deficiency, provokes glucosylceramide accumulation in cellular lysosomes. Disease clinical pathology includes anemia, thrombocytopenia splenomegaly, skeletal pathology and pulmonary hypertension/infiltration. Current therapy uses mammalian based production of recombinant glucocerebrosidase for enzyme replacement therapy (ERT) that involves post-expression glycan remodeling for exposing mannose structures, required for intake by Macrophages. Protalix has developed a propriety plant cell expressed active form of rh-glucocerebrosidase (prGCD). The unique protalix technology permits control of glycosylation pattern and consistency through targeting to specific plant cell organelles. Hence, prGCD has intrinsic exposed mannose residues and demonstrates batch to batch consistency. prGCD exhibits similar crystal structure and biological activity to that of the currently used CHO expressed Cerezyme using in-vitro assays. Preclinical toxicology studies showed no treatment-related adverse events, no neutralizing antibodies and no clinical findings. Phase I safety clinical trial showed that prGCD administered intravenously in sequential doses (15, 30 and 60 units/kg) was well tolerated, all tests being within normal ranges, with no treatment related adverse events. Pharmacokinetic analysis demonstrated a prolonged half life. All immunological specific tests were within normal ranges. An international multi-center Phase III Pivotal trial is currently ongoing under FDA Special Protocol Assessment approval where 30 untreated patients will be administered with 30U/kg or 60U/kg per infusion over a period of 9 months. Following completion of the protocol, patients are offered to enter an Extension study. In addition, a switch-over study to prGCD is to begin soon.
Session Information
Session Title: Therapy for Genetic Disorders Session Type: Poster
Session Location: Exhibit Hall C Session Time: Wed 4:30PM-6:30PM, Thu 4:30PM-6:30PM, Fri 10:30AM-12:30PM
Abstract Information
Poster Board Number: 768/T Presentation Time: Thu, Nov 13, 2008, 4:30PM-6:30PM
Keywords: Metabolic Disorders, KW098 - LYSOSOMAL DISEASES, KW107 - METABOLIC DISORDER, KW181 - X-LINKED DISEASE, KW133 - PHARMACOLOGIC THERAPY, KW131 - PHARMACOGENETICS
Abstract Content
Phase 2 clinical trials of the pharmacological chaperone AT1001 for the treatment of Fabry disease. R. Schiffmann1, D. P. Germain2, J. Castelli3, A. Shenker3, D. J. Lockhart3 1) Institute of Metabolic Disease, Baylor Research Institute, Dallas, TX, on Behalf of the AT1001 Study Group; 2) Université de Versailles, Hôpital Raymond Poincaré, Garches, France; 3) Amicus Therapeutics, Cranbury, NJ.
PURPOSE: AT1001 (migalastat hydrochloride) is an orally administered, small molecule pharmacological chaperone designed to selectively bind α-galactosidase A (α-Gal A), thereby increasing the enzyme’s stability, trafficking to the lysosome, and cellular activity. METHODS: 18 men and 9 women between the ages of 17 and 65 were enrolled in four open-label, multinational Phase 2 trials designed to evaluate the safety, tolerability and effects of AT1001 given at different doses and dose regimens. Twenty-six subjects completed a primary treatment arm and all entered the optional treatment extension. Seventeen subjects have been treated with AT1001 for at least 48 weeks and 6 subjects have been treated for more than two years. RESULTS: AT1001 was generally safe and well-tolerated at all doses evaluated. Twenty-four of the 26 subjects demonstrated an increase in α-Gal A as measured in leukocytes, kidney, and skin. The average leukocyte α-Gal A increase observed in males was greater than four fold. Kidney globotriaosylceramide (GL-3) levels as measured in urine or biopsies were decreased in subjects who demonstrated greater increases in levels of α-Gal A. Renal and cardiac function results were encouraging, including data in subjects after 96 weeks of treatment. Subjects’ in vivo α-Gal A responses were consistent with predictions based on in vitro testing of Fabry mutations, suggesting a pharmacogenetic approach may be used to select likely responders for future studies. CONCLUSION: These data suggest AT1001 merits further investigation as a potential therapy for Fabry disease.
Session Title: Metabolic Disorders Session Type: Poster
Session Location: Exhibit Hall C Session Time: Wed 4:30PM-6:30PM, Thu 4:30PM-6:30PM, Fri 10:30AM-12:30PM
Abstract Information
Poster Board Number: 596/W Presentation Time: Wed, Nov 12, 2008, 4:30PM-6:30PM
Keywords: Metabolic Disorders, KW098 - LYSOSOMAL DISEASES, KW122 - NEURODEGENERATION, KW011 - BRAIN/NERVOUS SYSTEM, KW006 - BIOCHEMICAL PATHOLOGY
Abstract Content
A biochemical link between Gaucher and Parkinson's diseases suggests a potential approach to treating synucleinopathies. S. Clark1, Y. Sun2, Y. H. Xu2, G. A. Grabowski2, B. A. Wustman1 1) Amicus Therapeutics, Cranbury, NJ; 2) Children's Hospital Research Foundation, Cincinnati, OH.
Mutations in the GBA gene that encodes the lysosomal enzyme glucocerebrosidase (GCase) are a risk factor for Parkinson’s disease and Dementia with Lewy Bodies. Homozygous mutations in GBA lead to Gaucher disease due to reduced enzyme activity and accumulation of glucosylceramide (GlcCer), and a 2-fold increase in α-synuclein is sufficient for Parkinson's. We hypothesized that the decreased GCase activity of carriers and ensuing accumulation of GlcCer may interfere with the normal degradation of synuclein, increasing synuclein levels. We examined a Gaucher mouse model that combines a GBA mutation with reduced expression from the Prosaposin locus. Prosaposin is processed into Saposins including the GCase-activating protein Saposin C. Combining the GBA mutation with reduced Saposin expression results in the accumulation of GlcCer in the brain and viscera. These mice accumulate α-synuclein in the cortex and hippocampus. Mice harboring the GBA mutation, but wild-type expression of Prosaposin, do not accumulate GlcCer or α-synuclein. This suggests accumulation of α-synuclein is correlated with increased GlcCer or a related sphingolipid. Exploring the GCase-α-synuclein relationship further, we utilized a mouse model moderately overproducing wild-type human α-synuclein in the hippocampus, cortex, and olfactory bulb ([PDGFβ]pr-hSNCA). Unlike the Gaucher mouse model, these mice express endogenous, wild-type GCase. The pharmacological chaperone, AT2101 (isofagomine), has been shown to increase GCase activity in mice and humans. Treatment of these mice with AT2101 prevented the age-dependent accumulation of human α-synuclein in neurons in the hippocampus and to a lesser extent in the cortex. We found that AT2101 also prevented an age-dependent increase in Campbell-Switzer-positive aggregates in the hippocampus. This suggests that increase of GCase activity by AT2101 reduces the steady-state level of α-synuclein, leading to reduced accumulation of α-synuclein aggregates in the brain.
Session Information
Session Title: Therapy for Genetic Disorders Session Type: Poster
Session Location: Exhibit Hall C Session Time: Wed 4:30PM-6:30PM, Thu 4:30PM-6:30PM, Fri 10:30AM-12:30PM
Abstract Information
Poster Board Number: 761/W Presentation Time: Wed, Nov 12, 2008, 4:30PM-6:30PM
Keywords: Metabolic Disorders, KW098 - LYSOSOMAL DISEASES, KW107 - METABOLIC DISORDER, KW133 - PHARMACOLOGIC THERAPY, KW116 - MUSCULAR ABNORMALITIES
Abstract Content
Pharmacological chaperone treatment for Pompe disease. J. J. Flanagan, H. V. Do, X. Wu, A. C. Powe, R. Khanna, B. Ranes, K. Tang, C. Pine, H. Williams, R. Soska, L. Pellegrino, J. Feng, M. Zdancewicz, E. R. Benjamin, B. A. Wustman, K. J. Valenzano, D. J. Lockhart Amicus Therapeutics, Cranbury, NJ.
Pompe disease is caused by deficient acid alpha glucosidase (GAA) activity which impairs lysosomal glycogen metabolism. The enzyme deficiency leads to lysosomal glycogen accumulation and results in progressive skeletal muscle weakness, reduced cardiac function, respiratory insufficiency, and CNS impairment at late stages of disease. Genetic mutations in the GAA gene result in either lower expression or produce mutant forms of the enzyme with altered stability, and/or biological activity ultimately leading to disease. Pharmacological chaperones represent a promising new therapeutic approach for the treatment of genetic diseases. In this study, we show that the pharmacological chaperone AT2220 (1-deoxynojirimycin-HCl) binds to mutant GAA and increases its stability. In Pompe patient-derived fibroblasts and in transiently transfected COS-7 cells expressing certain GAA missense mutations, AT2220 significantly increases GAA levels. AT2220 also increased GAA levels in disease-relevant tissues of wild-type mice, rats and monkeys suggesting that AT2220 may be appropriate for Pompe patients with the common IVS 1 (-13 T>G) splicing defect which produces low levels of wild-type GAA. In cell lines derived from late-onset Pompe patients with this common splicing mutation, AT2220 increased GAA levels. We are also investigating the ability of AT2220 to improve the biological properties of enzyme replacement therapy. In rats, the plasma half-life of recombinant human GAA (rhGAA) increased 2-fold when AT2220 (30 mg/kg p.o.) was administered 30 minutes prior to rhGAA injection. In GAA KO mice, the uptake of rhGAA was increased approximately 2-fold in heart and diaphragm when AT2220 (100 mg/kg p.o.) was administered prior to rhGAA injection. These data indicate that co-administration of a pharmacological chaperone with rhGAA may increase the enzyme’s exposure and tissue uptake in vivo.
Humira:
Just to add a little tidbit on this. Cambridge Antibody (now part of AstraZeneca) had a 5% royalty (there was along battle with Abbot on whether it should be 2 or 5% but they prevailed and got the higher rate). I hadn't kept up with it but did some digging and saw Royalty Pharma paid 700 million for the royalty. It seems they are going to get a great return on their investment. I followed them (Royalty Pharma) a bit waiting for them to go public (I believe they pulled at least 1 IPO) they have built a nice portfolio of biotech royalties (among the many they also have Neupogen/Neulasta and Rituxan royalties).
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: Added Natixis, Removed obsolete entries.
Natixis Bleichroeder Second Annual Hidden Gems Conference
The Waldorf Astoria Hotel
New York, NY
October 13-14, 2008
http://www.wsw.com/webcast/nblr2/
(Not all biotech)
Oppenheimer 19th Annual Healthcare Conference
New York, NY
November 3-4, 2008
http://www.opco.com/Conferences/Healthcare/index.html
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Procedure For Updating Calendar
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.
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I don't understand. If any doc believes it has efficacy why not get them to write a script for Increlex which is approved (albiet not for ALS) granted its not cheap?
Neurobiological Technologies Announces Update Call on Viprinex (TM) Phase 3 Trial Program
I guess having a Friday 4pm PR means the interim didn't reach statistical significance. They are already below cash so how much more could they drop?
http://biz.yahoo.com/prnews/081010/aqf502a.html?.v=2
Friday October 10, 4:00 pm ET
EMERYVILLE, Calif., Oct. 10 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI®) (Nasdaq: NTII - News), today announced it will hold a conference call on Monday, October 13, to provide an update on the Viprinex(TM) (ancrod) Phase 3 Trial Program for acute ischemic stroke. Hosting the call will be Paul E. Freiman, president and chief executive officer and Warren W. Wasiewski, chief medical officer.
-- Date: Monday, October 13, 2008
-- Time: 1:00 p.m. (ET), 12:00 p.m. (CT), 10:00 a.m. (PT)
-- Dial-in number: 877-440-5803 U.S. & Canada / 719-325-4942
International
Telephonic Replay: A playback of the conference call will be available
from 1:00 p.m. (ET) on October 13, 2008 to midnight (ET) on October 20,
2008. Replay number: 888-203-1112 U.S. / 719-457-0820 International
Pass code: 9164451
About Neurobiological Technologies, Inc.
Neurobiological Technologies, Inc., (Nasdaq: NTII - News) is a biopharmaceutical company focused on developing novel, first-in-class agents for central nervous system conditions and other serious unmet medical needs. The Company's most advanced product candidate, Viprinex(TM) (ancrod), is in Phase 3 clinical testing as a novel investigational drug for the treatment of acute ischemic stroke. Viprinex has multiple mechanisms of action and is specifically designed to extend the time period that patients can be treated after the onset of a stroke. Acute ischemic stroke is one of the most prevalent, debilitating and costly diseases in the world for which there are few acceptable treatment options. NTI also has early-stage development programs for Alzheimer's and Huntington's diseases and rights to receive payments on an approved drug for Alzheimer's disease and an investigational drug in Phase 3 trials for brain swelling.
IRD:
I think there is some but it is really hard to guestimate how much of an impact especially with their international revenue growing and the US declining (for now anyway). I have not seen it mentioned in detail in the AIF.
The past quarter and the next couple should benefit from some recent orders announced and acquiring 50% in the China operation at the tail end of last year. Their Brazil operation (40%) seems to be doing exceptionally well.
I am quite happy with the numbers (EPS not stock price :) )
IRD.TO / IRDYF: (International Road Dynamics)
They had a great quarter and their international sales are growing at a spectacular rate. As it appears there will be legislation for infrastructure spending next year sometime (if not sooner) the US sales should reverse and be strong. I don't know what this market will do the stock has be getting hammered since my prior post but now it appears unfounded (there was a fund in September that filed about selling in rebalancing so I wouldn't be surprised if that contributed to the weakness. The weakness in the Canadian currency hasn't helped the stock price but it should help the company a bit.
IRD Announces Improved Third Quarter 2008 Results
SASKATOON, SASKATCHEWAN--(Marketwire - Oct. 9, 2008) - International Road Dynamics Inc. (TSX:IRD - News; IRD), the world's largest provider of Weigh-In-Motion systems and solutions for the global Intelligent Transportation Systems (ITS) market, today announced its results for the three and nine months ended August 31, 2008.
Sales for the third quarter of fiscal 2008 were $10.2 million, in line with sales of $10.4 million for the same period last year. For the first nine months of fiscal 2008, sales were $26.4 million compared to $29.8 million for the same period in fiscal 2007.
Offshore sales continued to grow in the third quarter and first nine months of fiscal 2008, rising to $4.2 million and $9.8 million respectively compared to $2.1 million and $8.1 million respectively for the same periods last year. The increase in offshore sales was due primarily to increased revenues from toll systems and a significant weigh station delivery in the Middle East, as well as higher revenues from the Company's subsidiary in Chile.
Revenues in the United States for the third quarter of fiscal 2008 declined to $4.9 million from $7.1 million in the prior year period due primarily to delays in the awarding of new systems contracts. For the nine months ended August 31, 2008, sales in the US were $13.6 million compared to $17.3 million for the same period last year.
Canadian sales were $1.1 million in the third quarter of 2008 compared to $1.2 million in the prior year. For the nine months ended August 31, 2008, sales in Canada were $3.0 million compared to $4.5 million last year. Fiscal 2007 included substantial revenues from the delivery and installation of two large data collection and truck pre-clearance site contracts completed in the first half of the year. There were no similar contracts during the first nine months of fiscal 2008.
With the slowdown in the U.S. economy, the Company is experiencing delays in the awarding of federally-funded contracts for weigh station and data collection systems. In response, the Company has increased its sales efforts in the city, municipal and private sectors, and accelerated its efforts in specific international markets with higher growth potential, including India, China, Chile and Brazil. Through the first nine months of fiscal 2008 new contract awards to the Company's subsidiaries in India and Chile have exceeded forecasts, with the resulting revenues to continue to be realized in the fourth quarter of fiscal 2008 and into early fiscal 2009. In addition, management believes the acquisition of Xuzhou-PAT Control Technologies in China in the first quarter of 2008 will generate increased sales volumes over the longer term.
"While the continued uncertainty in the North American economy has reduced our growth prospects for our U.S.-based businesses, we believe our successful efforts to build our offshore sales will help to offset any contract delays in this market," commented Terry Bergan, President and CEO. "Our efforts in Chile, Brazil, China and India are beginning to reap positive rewards, and we believe they will continue to generate solid results through the remainder of 2008 and going forward." Earnings before interest, taxes, depreciation and amortization (EBITDA) rose to $1.1 million in the third quarter of 2008 compared to $962,000 in the same prior year period. For the nine months ended August 31, 2008 EBITDA was $1.5 million compared to $3.1 million last year. Gross margin as a percentage of sales decreased marginally in the third quarter and first nine months of fiscal 2008 compared to the prior year periods.
Administrative and marketing expenses in fiscal 2008 have risen compared with the prior year due primarily to increased sales and marketing efforts, while research and development costs decreased in the third quarter of 2008 and remained stable through the first nine months of the year compared to the same prior year periods. The Company continues its active development programs to enhance the functionality of its products and systems. Amortization expense has increased in fiscal 2008 primarily due to the commencing of the amortization of the Company's new manufacturing facility completed in the fourth quarter of fiscal 2007.
The Company generated improved net earnings of $0.5 million or $0.03 per common share for the three months ended August 31, 2008 compared to net earnings of $0.3 million or $0.02 per common share for the same period last year. For the nine months ended August 31, 2008, the Company generated net earnings of $0.2 million or $0.01 per common share.
Working capital at the end of the third quarter of 2008 was $5.0 million compared to $9.3 million at the end of November 2007. The change is primarily the result of an increase in the current portion of longterm debt at August 31, 2008 due to the inclusion as current portion of long-term debt of a $4.0 million non-revolving term facility used to acquire Xuzhou-PAT Control Technologies during the quarter. The Company anticipates this loan will be converted to a fixed-term loan in December 2008.
During the third quarter of 2008 IRD established a new subsidiary in Africa to expand its presence in the region. This new venture enhances IRD's global presence and joins the Company's wholly and partially owned operations in Canada, the United States, China, Brazil, Mexico, India and Chile.
"Looking ahead, the long-term prospects for our business remain very strong. Governments and the private sector around the world are increasingly embracing Intelligent Transportation Systems as a pathway to enhanced economic growth. As a proven supplier of leading edge ITS products, services and solutions, we are well positioned to capitalize on this demand," Mr. Bergan concluded.
Financial Highlights (financial statements are available on the Company's
web site) www.irdinc.com
----------------------------------------------------------------------------
----------------------------------------------------------------------------
Three Months Nine Months
----------------------------------------------------------------------------
Period Ended August 31, 2008 2007 2008 2007
----------------------------------------------------------------------------
(in $000's except per share amounts)
Sales 10,209 10,399 26,366 29,819
EBITDA 1,082 962 1,539 3,119
Net Earnings 510 298 181 1,399
Net Earnings per Common Share (basic) $ 0.03 $ 0.02 $ 0.01 $ 0.10
Working Capital 4,998 7,391
Shareholders' Equity per Share $ 1.22 $ 1.20
Common Shares Outstanding 13,963 13,924
----------------------------------------------------------------------------
----------------------------------------------------------------------------
Certain statements in this discussion may include "forward-looking" statements which involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements of International Road Dynamics Inc. to be materially different from any future results, performance or achievements expressed or implied by such forwardlooking statements. When used in this discussion, such statements use such words as "may", "will", "expect", "anticipate", "project", "believe", "plan", and other similar terminology. The risks and uncertainties are detailed from time to time in reports filed by the Corporation with the securities regulatory authorities in applicable provinces and territories of Canada. New risk factors may arise from time to time and it is not possible for management to predict all of those risk factors or the extent to which any factor or combination of factors may cause actual results, performance and achievements of the Corporation to be materially different from those contained in forward-looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward-looking statements as a prediction of actual results.
As used herein, "EBITDA" means earnings before interest, income taxes, depreciation, and amortization, and includes gains or losses from foreign exchange and earnings or losses from the Company's equity investments. EBITDA is not a recognized measure under Canadian generally accepted accounting principles ("GAAP"). Management believes that EBITDA is a useful supplemental measure to net earnings (loss), as it provides investors with an indication of operating performance prior to debt service, capital expenditures and income taxes. Investors should be cautioned, however, that EBITDA should not be construed as an alternative to net earnings (loss) determined in accordance with GAAP as an indicator of the Corporation's performance or to cash flows from operating, investing and financing activities as a measure of liquidity and cash flows. The Corporation's method of calculating EBITDA may differ from the methods by which other companies calculate EBITDA and, accordingly, EBITDA may not be comparable to measures used by other companies.
IRD is a highway traffic management technology company specializing in supplying products and systems to the global Intelligent Transportation Systems (ITS) industry. IRD is a North American company based in Saskatoon, Saskatchewan Canada with sales and service offices throughout the United States and overseas. Private corporations, transportation agencies and highway authorities around the world use IRD's products and advanced systems to manage and protect their highway infrastructures.
The Company's shares trade on the Toronto Stock Exchange under the symbol IRD.
Contact:
Terry Bergan
International Road Dynamics Inc.
President & CEO
(306) 653-6600 or U.S. (303) 355-5998
Francine Senecal-Lepage
International Road Dynamics Inc.
Investor Relations
(306) 653-6603
(306) 653-6609 (FAX)
Email: irdir@irdinc.com
Website: www.irdinc.com
Source: International Road Dynamics Inc.
Sorry I don't think my post was clear, I didn't catch the 1.30, my bids were put in after and my purchases were a bit higher. I was just surprised it dropped so low. Watching it for a while it seemed anytime it dropped below $2 it quickly bounced back and not much volume happened below. Looking to add more today.
If someone becomes a moderator maybe you could update this list? I have been following the stock on and off for a couple years. Would be nice to see some constructive discussion. TIA
http://www1.investorvillage.com/smbd.asp?mb=7224&mn=2&pt=msg&mid=3939722
I got a little today but my bid's weren't always showing up. I couldn't believe it dropped to the 1.30's. I wonder if tomorrow there will be more stocks that take big hits at the open (margin calls?).
The website is back so they are paying their bills :).
I tried to add today but didn't get any fills. Played cat and mouse with someone on the bid though :)
Looks like the domain wasn't renewed in time http://turbosonic.com/ . Hope it doesn't cost them too much to get it back!
Here is the full interview on the charlie rose show (along with past ones) for those Buffetologists :)
http://www.charlierose.com/guests/warren-buffett
I think its hard to correlate what Buffet does with what the market will do. He gets a pretty good return and a kicker if they recover which he has a long enough period to do so. My memory isn't that great but if someone would research I am sure I've read in several of the books about him, that wasn't the first time by any means that he gets a deal average joe couldn't get.
Edit:
Here is a buffet interview blurb link sorry I missed the whole broadcast!
http://cosmos.bcst.yahoo.com/up/player/popup/?rn=3906861&cl=10011243&ch=4226720&src=news
He had a long (7-8 minutes) interview on CNBC too maybe someone has a link for that.
Edit 2:
The CNBC Interview
http://cosmos.bcst.yahoo.com/up/player/popup/index.php?cl=9990957
Isn't this what Lidge did a couple of years ago in the playoffs?
BTW, I didn't copy your picks on purpose! I thought I had obscure picks. Guess not!
My Picks:
Brewers, Dodgers, Rays, Angels
Brewers, Angels
Brewers in 6
I figure go contrary to public opinion :)
Hepatitis C therapies
Just skimming it doesn't appear to be much new just review of current programs, though mentioned some other mechanisms I was not familiar with. Cut and paste below but I would suggest the website link because of the charts, you need to register but its free.
http://www.nature.com/nrd/journal/v7/n10/full/nrd2661.html
Irena Melnikova1
Tom Price, Meltdown PP Tube
Hepatitis C virus (HCV) is the major cause of liver disease worldwide and a potential source of high morbidity and mortality in the future. The World Health Organization estimates that approximately 170 million people, 3% of the world's population, are chronically infected with HCV, and 3–4 million new infections occur each year. According to the Centers for Disease Control and Prevention, over 3 million people have chronic HCV in the US, and the current annual rate of infection is around 30,000.
The current standard of care for HCV is a combination of PEGylated–interferon (PEG–IFN) and ribavirin. PEG-IFNs available on the market include PEG–Intron (Schering–Plough) and Pegasys (Roche). Marketed ribavirin includes Rebetol (Schering–Plough), Copegus (Roche) and various generic versions. The overall clinical success rate, referred to as sustained virological response (SVR), of this combination therapy is only around 50%1. The treatment is lengthy (48 weeks for genotype 1 HCV) and associated with frequent and sometimes serious side effects including neuropsychiatric events, flu-like symptoms and haematological toxicities. It is also contraindicated for many patients1. Overall, it is estimated that only 10% of patients with chronic HCV are successfully treated with the current standard of care.
HCV pipeline
Over two dozen molecules are being studied for their potential to supplement or replace either or both elements of the standard PEG–IFN/ribavirin combination2 (Table 1). Most of the efforts have focused on antiviral therapies, specifically two viral enzymes: the NS3–4A serine protease and the NS5B RNA-dependent RNA polymerase.
Table 1 | Selected HCV drugs in development
Full table
Figures and tables index
Download Power Point slide (112 KB)
As evidenced by a number of high-profile partnerships with big pharma (Table 2), the HCV field has generated multiple value-creation opportunities for smaller biotech companies. Even preclinical programmes have received economics that are more typical of Phase II programmes (Table 2).
Table 2 | Selected HCV partnerships
Full table
Figures and tables index
Download Power Point slide (96 KB)
Protease inhibitors
NS3–4A protease activity is required for viral replication and is partially responsible for the ability of HCV to evade clearance by the immune system of the host. Therefore, protease inhibition could produce a double hit against the virus.
Telaprevir (VX-950; Vertex/Johnson & Johnson/Mitsubishi) is the most advanced novel anti-HCV therapy in development. In the clinical trials conducted so far, telaprevir has demonstrated unprecedented antiviral activity, offering hope for improved efficacy and reduced duration of treatment (24 weeks). Furthermore, telaprevir is the first drug to demonstrate activity in patients who have failed prior therapy. Interim analysis of the Phase IIb PROVE3 trial showed that 52% of patients treated with a 24-week telaprevir-based regimen maintained HCV RNA levels that were undetectable 12 weeks post-treatment (SVR 12)3. Patients who have previously failed standard-of-care treatment represent a significant market opportunity, and Vertex plans to initiate Phase III development in this setting. However, telaprevir is expected to be approved for the treatment-naive population first. A 24-week, Phase III trial of telaprevir compared with current standard treatment in treatment-naive patients with genotype 1 HCV is ongoing. If successful, approval in this setting is anticipated in late 2010/early 2011.
Although telaprevir has the potential to be first to market, there is an increasingly large number of competitive protease inhibitors in development — for example, boceprevir (Schering–Plough), ITMN-191 (InterMune/Roche) and TMC435350 (Tibotec/Medivir) (Table 1) — that may offer better tolerability and more convenient dosing (once a day versus three times a day) compared with telaprevir. However, superior efficacy and reduced duration of treatment are expected to remain major drivers for the adoption of new drugs.
Polymerase inhibitors
The concept of polymerase inhibition for antiviral therapy has been successfully established for HIV, hepatitis B and herpes viruses. Unfortunately, so far, tackling HCV polymerase has proved to be challenging. Several polymerase inhibitor programmes have been discontinued owing to lack of efficacy and/or safety issues. These include valopicitabine (Idenix Pharmaceuticals/Novartis), R803 (Rigel Pharmaceuticals), XTL-2125 (XTL Biopharmaceuticals) and HCV-796 (ViroPharma/Wyeth).
Nevertheless, several new polymerase inhibitors are progressing through the pipeline (Table 1). Roche currently holds a lead position with two compounds, R1626 and R7128; R7128 is licensed from Pharmasset. Experts suggest that out of the two, R7128 might have a more attractive profile as it has been well tolerated so far, whereas R1626 has been associated with fairly significant haematological toxicity (neutropaenia). In treatment-naive patients, R7128 has produced a rapid virological response in comparison with telaprevir when used in combination with standard of care: 85% and 79% of patients, respectively, achieved undetectable levels of HCV RNA after 4 weeks of treatment4. Whether the potent antiviral activities of the new generation of polymerase inhibitors will translate into a clinical benefit remains to be seen for a large majority of the compounds in the pipeline.
Other targets
Similar to HIV, the future of HCV therapy is likely to involve combination therapy with novel drugs that have different modes of action5. In the short-term, such drugs would be added to the current IFN-based regimen (Fig. 1). With time, potent antiviral combinations could displace IFNs altogether. However, lessons learned from the HIV epidemic suggest that owing to the high heterogeneity and high mutation rate of HCV, drug resistance is likely to emerge during treatment with specific inhibitors of viral protease and polymerase even in a combination setting5. Therefore, exploring additional targets that are vital for various stages of the viral life cycle remains important.
Figure 1 | Evolution of HCV therapy.
IFN, interferon; PEG, pegylated; PI, protease inhibitor; PolI, polymerase inhibitor; RBV, ribavirin.
High resolution image and legend (114 KB)
Figures and tables index
Download Power Point slide (153 KB)
Several cyclophilin inhibitors, such as Debio-025 (Debiopharm), NIM811 (Novartis) and SCY-635 (Scynexis), are in Phase I/II clinical trials. Cyclophilin has been demonstrated to be an important host factor that supports HCV replication. Another potentially promising approach to treating HCV infections would be the inhibition of viral entry into the cell. XTL Biopharmaceuticals, Replicor, Progenics Pharmaceuticals, Samaritan Pharmaceuticals and Trimeris have early stage HCV fusion/entry inhibitor programmes.
Hepatitis C therapies | market indicators
In the next 5–10 years, novel therapeutics are expected to produce major breakthroughs in the treatment of HCV, such as increased cure rates, reduced duration of therapy, improved tolerability/side effect profiles and more convenient dosing schedules and routes of administration (oral therapy). Furthermore, an increased number of patients is expected to seek treatment owing to advances in therapy.
The current cost of 48-weeks of therapy is approximately US$35,000. Introduction of novel anti-HCV drugs that will be used in combination with PEG–IFN/ribavirin could double or even triple the full cost of treatment. Therefore, the HCV market is projected to grow from over $2 billion in 2007 to $10–15 billion in 2017.
Links
FURTHER INFORMATION
Clinical trials.gov Medline Plus Health Topics Hepatitis C
Top of pageReferences
Strader, D. B. et al. Diagnosis, management, and treatment of hepatitis C. Hepatology 39, 1147–1171 (2004).
ArticlePubMedISIJensen, D. M. & Ascione, A. Future directions in therapy for chronic hepatitis C. Antivir. Ther. 13 (Suppl. 1), 31–36 (2008).
Vertex. Vertex Reports 52% SVR 12 Rate for a 24-week Telaprevir-based Regimen in Genotype 1 Hepatitis C Patients Who Failed Prior Treatment. Vertex web site [online], (2008).
HIV and Hepatitis.com. R7128 Demonstrates Potent Anti-HCV Activity in Combination with Pegylated Interferon/Ribavirin; Ongoing Trial to be Expanded. HIV and Hepatitis.com web site [online], (2008).
Modi, A. A. & Hoofnagle, J. H. New therapies for hepatitis C. Hepatology 46, 615–617 (2007).
ArticlePubMedChemPortTop of pageAuthor affiliations
Irena Melnikova, Ph.D., is a Senior Associate at TVM Capital, 101 Arch Street, Boston, Massachusetts 02110, USA.
Email: melnikova@tvm-capital.com
Feuerstein:
He seems pretty good when it is negative (though I differ with him on InterMune but his attacks are more pro Vertex). When he is talking about favorable outcomes his record seems no better then average. I seem to recall a few can't misses in Alheimer's and lets not forget Telik.
I think maybe David Miller (perhaps someone else) said about shorting biotechs before trial results on a whole would be profitable and that seems to be my observation too. So one could argue Feuerstein is good at the easy stuff and not so good at the more difficult.
Well they did exactly like they said (little better). Wish I had gotten more.
http://biz.yahoo.com/prnews/080930/cltu112.html?.v=76
Does anyone know if the spread tends to tighten on news/earnings?
WNYN.ob:
I took a quick look at the filing you realize (I hope) that this is a pretty bogus number. 1.8MM is a paper tax credit, 500k is a gain on sale and I didn't look at the rest (as I don't invest in companies in this price/share count range).
I am not a paying member so am posting here and not on the Motherboard where your post was.
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: Adds Maximum, William Blair
JMP Securities
Healthcare Focus Conference
Le Parker Meridien, New York, NY
October 6 - 7, 2008
http://www.wsw.com/webcast/jmp7/
Maxim Group Growth Conference
New York Hyatt NY
October 7, 2008
http://www.wsw.com/webcast/maxim/
(Some Biotechs)
William Blair & Company Small-Cap Growth Stock Conference
Waldorf-Astoria Hotel, New York, New York
October 7, 2008
http://www.wmblair.com/Pages/conferences.asp
http://www.wsw.com/webcast/blair14/
(Sorry don't know password, anyone?)
Oppenheimer 19th Annual Healthcare Conference
New York, NY
November 3-4, 2008
http://www.opco.com/Conferences/Healthcare/index.html
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UTHR:
What do you have against UTHR? The Cialis data will have about 0 effect on them. Everyone thought Viagra/Revatio would be the end of ETA's and Prostacyclin's well UTHR continues to have record sales. They have incredible margins and are one of the more profitable biotechs. Plus, I seriously doubt any Class 4 patient would be given Cialis over IV/sub-q Prostacyclin perhaps in addition but not instead of.
Then you have two late stage drug candidates. The inhaled PDUFA is the end of April and before then we will have news on both oral prostacyclin programs. Assuming the data is good (either is < .01 or both are less than .05) then you are looking at the first front-line prostacyclin treatment in the US (Japan has Beraprost approved) which would have a very significant impact on revenues!
DEWY:
Had a bad quarter EPS wise... however (and much more importantly) the land they are sitting on may actually get monetized!
This is from the 10k
Originally expected in 2005, final regulations and a master plan were recently approved by Governor Corzine on September 5, 2008. At the same time the Governor issued executive order 114 further defining the framework by which the Highlands Council, other State agencies, and both county and municipal governments are to work together. The Company believes that a regulatory environment is now developing within which monetization of the land may be possible. In light of these recent events, the Company is actively assessing its options. However, no assurances can be given that the Company's efforts will be successful, that a satisfactory valuation will be achieved, or that resolution will be timely.
I don't know what it is worth today but if the entire portion of what was to be sold in late '04 is sold for the same price that is $12MM... oh and btw DEWY has 1,362,949 shares outstanding and trades 2.51 - 3.15!
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, Add JMP
JMP Securities
Healthcare Focus Conference
October 6 - 7, 2008
Le Parker Meridien, New York, NY
http://www.wsw.com/webcast/jmp7/
Oppenheimer 19th Annual Healthcare Conference
New York, NY
November 3-4, 2008
http://www.opco.com/Conferences/Healthcare/index.html
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Howard won't do it!
With the Phillies winning and clinching I am sure he will be rested tomorrow so yet again Howard fails to reach 200 k's. His totals for 2007-2008 will be 199, 199. What consistency!
In this era I can't think of any. I dug up a couple of who by today's standards would be mindboggling so-hr ratios
http://www.baseball-reference.com/w/willite01.shtml
and
http://www.baseball-reference.com/d/dimagjo01.shtml
More recently I recall George Brett and Bob Horner not striking out a lot but they were more like in the 30s.
Don't get me wrong I would take Howards numbers (K's and all) but getting 200 k's for a hitter is a bit ridiculous!
If he strikeouts one more time it will be #200. Though he would not be the first to do it this year. I believe this is the first year any hitter has struck out that many times. Well the days of the 300 strikeout season by a pitcher seem gone but they may be coming for a hitter :).
In Actelion's UBS presentation today they said they are almost complete with enrollment of their Tracleer IPF trial. Results expected in 2009.
I was and then I guess not posting in a while I got the boot. If there is something worthwhile to contribute I'll post even if i am not moderator.
If you bought/buy shares welcome aboard. The spread is usually quite big and some brokers seem to do better then others at executions.
The list in #msg-25590766 has all but the most recent acquisition of J&J (which actually turned out to be two companies). For now (and Mr. Menard is quite open to acquiring other business in different segments at the right price) they basically have two segments HVAC (Heating Ventilation and Air Conditioning) and a construction segment which falls mainly under the JM Ahle. The construction does a lot of steel fabrication (rebar) and the like.
I still like the company a lot. Low outstanding is just half of it. Mr. Menard owns an overwhelming majority. There is a fund that own a chunk and then a few others who own fair sized positions who aren't likely to sell anytime soon. so I would guess the float is well under 1 million (perhaps even in the 300-500k range). It took me a couple years to build up a fair sized position!
They have had a few more bumps then I would care for with higher commodity prices. I am a very long-term holder though and its probably as cheap as it will get. Mr. Menard is impressive to read/talk to. I'ld suggest the Wall Street transcipt article in the readme first.
#msg-24930296
I would guess they will do upper teens this year in EPS and they are growing the revenue number even with hard times in some of their business. Mr. Menard is very frugal in his operations and buys companies on the cheap. I think the model is great (min-berkshire if you will).
If you have specific questions please feel free to ask.
CANADA TIP SHEET: Osten Seeks Safety in Health Care
By Stuart Weinberg
Of DOW JONES NEWSWIRES
TORONTO (Dow Jones)--In a tough market, Brandon Osten looks to the
health-care sector as a safe haven.
"There's nothing brilliant about saying it, but people keep getting sick,
people keep getting older," said Osten, portfolio manager of the C$28 million
Venator Founders Fund.
One health-care stock that Osten likes is Futuremed Healthcare Income Fund
(FMD.UN.T). The company, which distributes consumable nursing-home supplies,
has a 95% share of the Ontario market and a 60-70% share in western Canada. Its
recent acquisition of Dismed Inc. means it now controls 40% of the Quebec
market as well, said Stephen Andersons, Osten's partner at Venator. "That
acquisition has not been reflected in the stock yet in our belief," Andersons
said.
Futuremed's annual distribution of 92.5 Canadian cents a unit equates to an
11% yield, Andersons said, adding that he believes the firm will be able to
maintain its yield when it converts back into a corporation. All income trusts,
save real estate investment trusts, are required to convert back into
corporations by 2011.
The Futuremed investment is a good example of what Osten looks for in a
stock, namely growth, value and quality earnings. To identify such stocks, he
uses an elaborate screening process that ranks about 20,000 stocks globally.
"We'll look at different measures of value. We'll look at different measures of
growth.... We'll look at good growth as opposed to high growth. We'll look at
quarterly growth...."
One high-growth company in the portfolio is Zynex Inc. (ZYXI), a maker of
electrotherapy medical devices. Osten said he began buying the stock earlier
this year in the US$1.30-a-share range. The company had earned 7 U.S. cents a
share in 2007, giving it a trailing price-to-earnings multiple of about 18 when
Osten bought it. While that's not inexpensive, Osten said he was willing to pay
because Zynex's earnings are growing rapidly. Indeed, if the second half of
2008 matches the first, Zynex will earn 20 U.S. cents this year, a 233%
increase over the prior year.
The market has caught on to Zynex and the stock now trades at US$-.-- on the
American Stock Exchange. Still, Osten remains a shareholder because he believes
the stock can hit US$10 even if Zynex's annual earnings and revenue growth rate
slows to a mere 60%.
Increased Short Position
Osten invests primarily in small-cap companies and typically holds about 25
stocks in the portfolio. He will buy large caps on occasion if they hit a
pre-set target. For instance, Apple Inc. (AAPL), the big computer and handset
maker, fell to US$120 earlier this year so Osten bought some shares. He sold
the stock when it hit US$150. Osten has since bought back into Apple, as the
share price has pulled back again. "We're not averse to investing in large
caps, it's just tough to find large caps growing at 30% that trade at 8 times
earnings," he said. "It's tough to do that on the small-cap side."
Asked for his view on the economy, Osten's response was typically
straightfoward: "The economy sucks." To help mitigate risk, Osten said he has
increased the fund's short position to 40% from about 30% a year earlier. He is
95% long, giving the fund a net-long position of 55%. "Our attitude is, if
you're worried about the market, take the 20 stocks that you like - you should
be able to find 20 stocks that you think are going up regardless of what the
market does - and then go out and short," he said.
An investor who shorts a stock makes money when the stock's value declines.
The fund's short positions include Iron Mountain Inc. (IRM), a
records-management company, Lamar Advertising Co. (LAMR), an outdoor
advertising company, and BFI Canada Income Fund (BFC.UN.T), a waste-management
company.
Regarding BFI, Osten said it has low growth, low cash flow and a "fairly
high" valuation.
Company Web Site: http://www.venator.ca
-Stuart Weinberg, Dow Jones Newswires; 416-306-2026;
stuart.weinberg@dowjones.com
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09-25-08 0907ET
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09:07 092508
The brewers just took the lead. So which would be the bigger let down if the Brewers don't make it or if the Mets don't?
FYI There was an interview with the Brewers GM in the WSJ (I think todays).
EDIT: GM not owner and it is todays (at least on-line)
Liked this part from the 10-k filed today
http://www.sec.gov/Archives/edgar/data/900393/000120445908001947/turbosonic09230810k.htm
We entered into several new equipment contracts in the second half of our fiscal year totaling $9.25 million, despite a downturn in several industries. A growing number of these contracts are for upgrades to previous evaporative gas cooling and wet electrostatic precipitator installations supplied by our competitors. The lower capital requirements for upgrading existing equipment over replacement with new equipment is expected to continue to have a positive impact on our revenues. Of note, our evaporative gas cooling system sales are primarily driven by process considerations and not by regulations alone. Significant savings in operating cost and reduced maintenance have been reported as a consequence of using our proprietary designs.
We established an office in Milan, Italy in 2007 to diversify our market reach beyond North American economic and market cycles. Opportunities continue to grow in this market as a result of EU anti-pollution rules.
Order backlog has been building steadily since December 2007, enabling a profitable fourth quarter for 2008 and providing a strong start to fiscal 2009.
Update Holdings from 9/24/08 10-k
Name and Address of Beneficial Owner Number of Shares %
Dr. Donald R. Spink, Sr. 1,353,070 8.3%
Edward F. Spink 1,176,968 7.2%
Egbert Q. van Everdingen 366,120 2.2%
Richard H. Hurd 106,673
Julien J. Hradecky 244,423 1.5%
Glen O. Wright 60,000
Andrew T. Meikle 60,000
Ken Kivenko 47,000
Richard C. Gimpel 35,625
All Executive Officers and Directors 3,624,290 22.1%
Heartland Advisors, Inc. 1,250,000 7.6%
Bard Associates, Inc. 1,544,475 9.4%