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Dew, the "top 10 Canadian companies" program seems to be centered in Eastern Canada. The major sponsor appears to be a big law firm. They choose companies in three categories,one of which is life sciences. I found a website for the competition...it is http://topcanadiancompanies.ca/index.html.
When I checked the SSS:TSV website I found they have today received approval to begin their Phase IIb study in stroke. Their interim report showed some very positive results so I look forward to the full final results which will be announced at the International Stroke Conference in February. They should also begin a traumatic brain injury Phase II with snowboarders very soon and an MS study(remylenization)in the new year.
Stem Cell Therapeutics Announces Receipt of No Objection Letter From Health Canada for Its Phase IIb Clinical Trial in Stroke
CALGARY, ALBERTA, Dec 4, 2007 (Marketwire via COMTEX News Network) --
Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE:SSS) is pleased to announce that the Company has received a No Objection Letter (NOL) from Health Canada for the REGENESIS trial (a Phase II prospective, Randomized, double-blind, placEbo controlled study of NTx(TM)-265: human chorionic Gonadotropin (hCG) and EpoetiN alfa (EPO) in acute iSchemIc Stroke patients), its Phase IIb clinical trial in acute stroke investigating efficacy and safety endpoints.
This Canadian based, double-blinded, placebo controlled trial with NTx(TM)-265 in acute ischemic stroke patients will be conducted in association with the Canadian Stroke Consortium. The trial is projected to recruit at approximately 15 to 20 enrolling centers across Canada with a target enrollment of 120 patients. SCT is targeting to have one or two centers activated for recruitment before year-end and to have full enrollment of the trial completed before the end of 2008.
SCT is also pleased to announce the completion of the BETAS trial (Beta-hCG + EryThropoietin in Acute Stroke), an investigator lead Phase IIa clinical trial examining the safety profile, effects, and efficacy of the acute stroke-therapy regimen NTx(TM)-265 after reaching the original target of 12 patients. Results of the Phase IIa acute stroke trial will be presented in February of 2008 at the American Stroke Association's International Stroke Conference in New Orleans, LA.
"We are delighted to receive the NOL from Health Canada as it marks a significant step in our clinical development program. With the hard work and dedication from the clinical team at SCT, we will progress swiftly and confidently into the REGENSIS trial in stroke patients with NTx(TM)-265," said Dr. Alan Moore, President and CEO of SCT. "Additionally, we are pleased with the safety and efficacy information received to date from the patients enrolled in the BETAS trial, and final results will be reported by Dr. Steven Cramer, Principal Investigator for the study, at the International Stroke Conference in New Orleans this coming February."
About NTx(TM)-265: NTx(TM)-265 is a therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin (hCG) and Erythropoietin (EPO), targeting the treatment of stroke. The objective of the regimen is to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke. Animal studies have shown a significant recovery in motor function after receiving the NTx(TM)-265 regimen 24-48 hours post stroke. Similar results have been found in SCT's phase IIa safety trial, BETAS, as announced on April 10, 2007. SCT will be initiating a multi-centre, double-blind, placebo-controlled Phase IIb study, REGENESIS with NTx(TM)-265 by the end of this year.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE:SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells. The company's programs aim to repair neurological function lost due to disease or injury. The company's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases.
Stem Cell Therapeutics Corp. was also recently selected to be one of Canada's Top 10 Life Sciences Companies for the second year running (http://www.topcanadiancompanies.ca/winners/ls_winners.html).
These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available.
I've been following SSS:TSV (Stem Cell Therapeutics). You may want to have a look at all of these companies which have been chosen as 2008 Canada’s Top 10 Companies in the Life Sciences area.
Artenga Inc (Ottawa, Ontario)
Bioniche Life Sciences Inc (Belleville, Ontario)
DiaMedica (Winnipeg, Manitoba)
Genesis Genomics Inc (Thunder Bay, Ontario)
MedGenesis Therapeutix Inc (Victoria, British Columbia)
Norgen Biotek Corp (Thorold, Ontario)
ProDrive Systems (Montreal, Quebec)
Rapid Laboratory Microsystems (Kitchener, Ontario)
REPLICor Inc.(Laval, Quebec)
Stem Cell Therapeutics Corp (Calgary, Alberta)
The recent skin stem cell news is interesting, but it also points out the advantage of the Stem Cell Therapeutics (SSS:TSX-V) approach. This approach involves stimulating the resident stem cell niches in the brain, spinal cord and vital organs to produce more stem cells and then to encourage them to differentiate into the cells that need replacement. They plan to start the phase IIb stroke study in a few weeks. They also hope to get a phase II traumatic brain injury study underway on snowboard accident victims in December or January. I know they would also like to work with the young soldiers who are suffering from TBI from the explosive devices in Iraq and Afghanistan. The full phase IIa stroke results will probably be available at a scientific conference in February. They seem to be very good so far and this is very good news as there is very little apart from tPA which is only useful within a 3 hour window whereas the SSS regime has a window of 24 hours and perhaps as long as 48 hours.
The recent addition of Francesco Bellini to the board tells me he must like the science...and he certainly brings along a lot of financial muscle(he partnered up one of his former companies for $5.9 Billion).
Stem Cell Therapeutics Announces Appointment of Dr. Francesco Bellini to Its Board of Directors
CALGARY, ALBERTA, Nov 13, 2007 (Marketwire via COMTEX News Network) --
Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE:SSS) is pleased to announce the appointment of Dr. Francesco Bellini, Chairman, President and CEO of Neurochem Inc., an industry leader in the development of therapeutic drugs for the Central Nervous System, to its Board of Directors.
In addition to being Chairman, President and CEO of Neurochem Inc., Dr, Bellini is the Chairman of Picchio International, Picchio Pharma, Adaltis, Virochem and Prognomix. Prior to becoming President and CEO of Neurochem Inc. in 2002, Dr. Francesco Bellini was Chairman and CEO of BioChem Pharma, an innovative biopharmaceutical company focused on infectious diseases and cancer which he co-founded in 1986. In 2001, BioChem Pharma merged through an exchange of shares with Shire Pharmaceuticals Group of England valuing Biochem Pharma at C$5.9 billion.
From 1968 to 1984, Dr. Bellini had a prolific career as a researcher at the Canadian subsidiary of a multinational pharmaceutical company, Ayerst. In 1984, Dr. Bellini established the Biochemical Division of the Institut Armand-Frappier at the Universite du Quebec, which specializes in research, manufacturing and the commercialization of fine chemicals. He was the head of this unit until leaving in 1986 to co-found BioChem Pharma.
Born in 1947 in Ascoli Piceno, Italy, Dr. Bellini came to Canada in 1967. He received his Bachelor of Science degree from Loyola College (now Concordia University) in 1972 and his Doctorate in organic chemistry from University of New Brunswick in 1977. He is the author or co-author of some 25 patents and has published numerous articles and papers based on his research. In 2005, Dr. Bellini received the title of Cavaliere del Lavoro, the most prestigious honour granted by the Italian government, for his major contributions to the fields of entrepreneurship, research and the economy. He was named an Officer of the Ordre national du Quebec in 2004, and an Officer of the Order of Canada in 2000.
"We are very pleased to add Dr. Bellini to our Board of Directors given his extensive experience and expertise in pharmaceutical development, including late stage clinical development and drug approval, and importantly, strategy, business development, and a successful merger of one of the companies he co-founded " commented Dr. Alan Moore, President and CEO of SCT. "Dr. Bellini has considerable public biotechnology company experience that will add significantly toward Stem Cell's continued development."
SCT has issued 100,000 stock options to Dr. Bellini at an exercise price of C$0.35 per share in connection with his appointment to the Board of Directors. These options vest immediately and expire November 13, 2012. These options were awarded in accordance with the Corporations Stock Option Plan.
The granting of options is subject to approval by the TSX-Venture Exchange. The options were awarded in accordance with the Stock Option Plan approved by Shareholders at SCT's Annual General Meeting held May 10, 2005 and by the TSX-Venture Exchange on May 18, 2005.
About NTx(TM)-265: NTx(TM)-265 is a therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin (hCG) and Erythropoietin (EPO), targeting the treatment of stroke. The objective of the regimen is to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke. Animal studies have shown a significant recovery in motor function after receiving the NTx(TM)-265 regimen 24-48 hours post stroke. Similar results have been found in SCT's currently enrolling phase IIa safety trial, as announced on April 10, 2007. SCT plans to initiate a multi-centre, double-blind, placebo-controlled Phase IIb study for NTx(TM)-265 with primary endpoints of efficacy by the end of this year.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE:SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells. The company's programs aim to repair neurological function lost due to disease or injury. The company's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases.
These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
SOURCE: Stem Cell Therapeutics Corp.
Stem Cell Therapeutics Corp.Alan Moore, PhDPresident and CEO(403) 245-5495 x224Email: amoore@stemcellthera.comStem Cell Therapeutics Corp.Chloe Douglas-CramptonManager, Investor Relations(403) 245-5495 ext. 221Email: crampton@stemcellthera.comWebsite: www.stemcellthera.comMaisonBrisonJean WalterVice-President(514) 731-0000 ext. 223Email: jean@maisonbrison.com
Copyright (C) 2007 Marketwire. All rights reserved.
PL.. have you looked at SSS:tsx-v? Their approach to stimulating redident stem cells looks to be having great results in treating stroke. They are going into phase IIb before Christmas. They are also looking at TBI and MS.
Stem Cell Therapeutics SSS:tsx-v had an interesting presentation at R&R. Their platform is based on stimulating the resident stem cells that we have in niches around the vital organs in our body...hence no ethical/political issues. They are wrapping up a IIa study and will enter IIb before the end of the year. This sudy is in stroke...a potential $12 Billion market. tPa can only be used in about 3% of stroke cases...and only within a 3 hour window. SSS combines two already approved drugs in a regime they think has a 24 or even 48 hour window. Interim result claim a 40-80% reduction in infarct size as opposed to a 10%+/- shown in the literature. And in the first 4 patients they found that 4/4 improved on functional tests at 40 days that usually are seen in only 1/3 patients at 90 days.
They will be doing a brain trauma IIa study this winter on snow board accident victims...and they are doing pre-clinical studies leading up to MS trials in the new year. They look to re-myelating the nerve cells damaged by MS.
The R&R preentation is at www.wsw.com/webcast/rrhq12/sss.v/.
I would be interested in any reactions...the stock is selling at 32-33 cents. They have enough cash to complete the studies I have mentioned.
BOT I expect a February R&R report. There could be some good news between now and then but (believe it or not) this news may already be priced into the stock! I think R&R will not want to make fools of themselves (all institutions tend to be very cautious)and PPHM should want to wait to have a series of great news releases in a row. The delays which are a part of all biotechs applies not only to the long delays for research approvals but also to partnering deals. If PPHM has a series of great releases there could be a very nice price movement until the really big event...a takeover.
Nov.18,2007 3pm
Yes the results are terrible . I'm glad I only had a little of this sucker....I'm going to listen to thee post-mortum. Sounds like the campothecin trial is their only hope....if they can learn from this one.
We won't know until tomorrow morning whether or not SNUS has a drug with superior efficacy. But even if efficacy is the same the fact that SNUS had a safer drug would be important and would warrant a higher price. So the safety data tomorrow will be important. But the 15 minute administration as opposed to 3 hours means that hospitals and clinics would be able to put through 10 times as many patients in a day. This clearly is an advantage to them by increasing their revenues . But it is also a benefit to the patient...if a member of my family had to undergo these procedures I would be willing to pay for the shorter treatment with greater safety.
Clearly if SNUS announces greater efficacy the drug will demand a premium. But even if the drug has only equivalent efficacy but greater safety I think the advantages to the hospitals and patients would warrant a premium.
Tomorrow morning we will have a lot more information. But I must say that I agree with you on ORR as an endpoint. But I disagree with a lot of FDA decisions....and it does not seem to make any difference!
I would think that hospitals would like the 15 minute administration rather than the 3 hour as it would mean a higher number of patients could be treated each day. And there seems to be some real hope that there would be lower rates of serious neuropathy. Tomorrow mornings news should shed some light on this issue...and of course the efficacy issue. We shall see.
SNUS overview is worth reading. Stockpick077 put this up on Investor Village. Patients would certainly go for a 15 minute rather than 3 hour administration and if it turns out that the side effects are less harsh and it is possibly more effective...Iwould think they have a winner.Here is the posting.
Realistic Analysis on Sonus
Background Info
Efforts have been made in the last few years to improve the effectiveness and reduce toxicities related to the most commonly prescribed chemotherapy for breast cancer drug Paclitaxel. Three such formulations were developed in the last five years – Albumin based, Vitamin E based, and Polyglutamate polymer based.
Albumin-Based Delivery Systems
Albumin-bound paclitaxel is a novel, nanometer-sized paclitaxel formulation developed to improve tumor cell penetration and avoid the toxicities associated with Cremophor.10 It can be safely infused in a colloidal suspension at higher doses, with a shorter infusion schedule than conventional paclitaxel (30 minutes vs. 180 minutes). This mode of delivery was pursued by Abraxis Biopharma (Abraxane) and was approved by the FDA based on their success in a P-III study which showed a 33% ORR compared to Taxol (19%).
Vitamin E Delivery Systems
Sonus’s drug TOCOSOL paclitaxel dissolves paclitaxel in vitamin E oil (tocopherol), which is then emulsified in water with surfactants. This Cremophor-free, vitamin E–based emulsion does not alter the molecular structure of paclitaxel. Potential advantages of TOCOSOL paclitaxel over conventional paclitaxel include a shorter infusion time (15 minutes vs. 180 minutes), no steroid premedication, and the ability to administer higher individual doses with higher cumulative paclitaxel exposure, which might enhance the antitumor efficacy.
Polyglumex Delivery systems
Paclitaxel poliglumex conjugates paclitaxel to a water-soluble polyglutamate polymer. The large size of the macromolecule is believed to lead to exclusion from normal tissues and accumulation in tumor tissues through the leaky vasculature. Paclitaxel poliglumex then enters the cell through pinocytosis and is transported to the lysosomal compartment where the polyglutamate chain is removed via enzymatic action, releasing free paclitaxel. In a xenograft system, the AUC of paclitaxel poliglumex is at least 12-fold higher than that of standard paclitaxel in plasma and tumor tissue. Paclitaxel poliglumex under the brand name of XYOTAX is being developed by Cell Therapeutics currently in pivotal trials for non-small cell lung (NSCLC) and ovarian cancers.
How does TOCOSOL stack up?
As shown in a ASCO poster presentation (http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb6...
), TOCOSOL produces a 67% higher concentration of Paclitaxel compared to Abraxane which increases concentration by 33%.
Albumin-bound paclitaxel preferentially delivers paclitaxel to tumors by interacting with the albumin receptors, taking advantage of the tumor’s increased need for nutrients, and demonstrates a 33% higher concentration in tumor tissue than conventional paclitaxel. In vitro studies have reported a 4.2-fold increase in paclitaxel transport across endothelial cells for albumin-bound paclitaxel compared to conventional paclitaxel (P < .0001).11
In comparision, A 175 mg/m² dose of TOCOSOL Paclitaxel given over 15 minutes produced a mean 67% higher exposure to free paclitaxel, and a mean 108% higher exposure to total paclitaxel, compared to an equal dose of Paclitaxel given over 3 hours. The differences in exposure may reflect differences in rate and/or extent of dissociation of paclitaxel from the tocopherol emulsion formulation compared to cremaphor-ethanol micelles. Single equal doses of TP and P were similarly tolerated. A Phase 3 comparative efficacy study is planned.
Source:
(*** Hanauske AR, Goedhals L, Gelderblom H, et al. Pharmacokinetics (PK) of free and total paclitaxel after equal doses of paclitaxel injectable emulsion and paclitaxel injection. J Clin Oncol 2005; 23(suppl):146s (abstract 2045).
If TOCOSOL is that good, why is the interest in Sonus so muted?
The results definitely were impressive, however there are a few key areas of concern
The trial results were from a 53 patient study – oncologists (and markets) are much more impressed with studies from over 100 patients.
There are also some concerns about the stability of the formulation (i.e. can it continue to deliver active Paclitaxel over a period of time?) and the Sonus’ ability to produce consistent formulations.
Basic information on Previous trials
Check out some of the prior results to measure the bar Sonus is up against. As per the latest webcast from Sonus, their P-III SPA requires non-inferiority by definition of 75% OR BETTER RESULTS with a 97% Confidence level. Below are the relevant trials to be concerned with:
Abraxane Phase III 453 patients (260 milligrams of Abraxane over 30 minutes every three weeks)
Objective RR = 33%
Neutropenia 34%
Neuropathy higher than Taxol
Abraxane Phase II
Overall response rates 48% for all 63 patients.
ORR was 38% for 100 patients
Median time to disease progression was 26.6 weeks
Median survival was 63.6 weeks.
Toxicities included
grade 4 neutropenia (24%),
grade 4 febrile neutropenia (5%)
grade 3 sensory neuropathy (11%),
Taxol (175 milligrams of Taxol over three hours every three weeks)
Objective RR = 19%
neutropenia 53%
TOCOSOL
Required ORR = 14.5% to meet the 75% non-inferiority guideline defined above.
Phase II ORR = 49% (independently audited for 47 patients)
Neuropathy was lower.
Current trial (http://www.clinicalbreastcancer.com/publication/cs_v5n2/f2.gif) measures:
80mg/m2/week of Taxol in the control arm against
100mg/m2/week of TOCOSOL Paclitaxel in the treatment arm.
Based on the ASCO poster presentation above, a 1:1 comparison of Taxol v/s TOCOSOL produces an about of 67% higher exposure of Taxol by the TOCOSOL formulation. Therefore 100mg TOCOSOL v/s 80mg Taxol essentially doubles the exposure of Taxol in the treatment arm compared to the control arm.
Also worth noting – Vitamin E (the emulsion used to deliver Taxol in Sonus’ formula) is used widely to treat the symptoms of neuropathy – therefore its reasonable to expect that Tocosol will provide a better side-effect profile.
Conclusions:
Based on the information seen so far, I would expect a price projection of:
$20+ if Tocosol produces results better than Abraxane in both safety and efficacy. (20% chance of this scenario)
$12+ if Tocosol proves to be better than Taxol in both safety and efficacy but not better than Abraxane (30% chance)
$6-$8 if it proves to be equal to Taxol with a better side effect profile. (30%)
$1-$2 if the results don’t convince. (20%)
I would take a position of being “cautiously long” (long shares with puts or a straddle with 2:1 call-put ratio). I would not recommend being short at this price level.
Comments?
There is a lot of good infomation on the SNUS Investor Village site eg this post by Ivan the Unready
Re: Concerns
Just a couple of minor additional things. If TOCp should manage to show superior efficacy to Taxol, SNUS would not need to use CALGB 9840 or anything else to get FDA approval for weekly dosing. Sonus has made clear in several conference calls that that requirement would apply only if shows non-inferiority.
Second, if TOCp has an Achilles heel it's neutropenia, where the phase 2 trials showed a higher incidence of grades 3 and 4 (24% and 18% respectively) than Taxol showed in CALGB 9840. However, TOCp had only a 2% incidence of febrile neutropenia, which is what oncologists are most concerned about. Hopefully that number will remain in that neighborhood or at least not increase significantly -- SNUS reduced the dose from 120 mg/m2 in most of the P2 trials to 100 mg/m2 in the phase 3 in an effort to minimize side effects. But it's noteworthy that Taxotere, which is the taxane market leader with over $2 billion of the $3.5 billion market, has a very poor neutropenia profile. "At the standard dose of docetaxel, 100 mg/m2, without cytokine support, the incidence of grade 4 neutropenia has been reported to be 48–64%, with febrile neutropenia occurring in 12–25% of patients." That is from p. 792 of this article: http://annonc.oxfordjournals.org/cgi/reprint/14/5/788
Sonus's SPA provides that non-inferior objective response rate is the only primary endpoint. Toxicity isn't an endpoint, though obviously the FDA can take it into account. But if TOCp shows non-inferior ORR then I can't see neutropenia being more than a labeling issue unless the rate of febrile neutropenia jumps substantially from what it was in the phase 2 trials. After all, Abraxane had a worse neuropathy result than Taxol in its phase 3 trial, but that didn't prevent approval. I don't want to make too much of this, but the fact that the FDA, which monitors adverse events throughout clinical trials, has allowed the TOCp trial to proceed into the second (progression-free survival) phase, with some patients no doubt continuing to be treated, suggests to me that it didn't consider the adverse events to be too severe. Of course, from a marketing standpoint, it would be highly desirable for TOCp to show either a trend towards statistical superiority or a better neuropathy profile. If it's better on neuropathy, then I think the neutropenia issue goes away, since as stockpick said neutropenia is manageable.
I am long a small amount on SNUS. The SNUS board is taken up with discussing whether it means good news or bad that the news will be announced on Monday morning rather than Friday after trading. What is your take on this? I must say that Iv'e seen a lot of bad news put out on Fridays!
Great reply Neuro...and like many others I am glad you contribute to this forum.
When do you expect we will get IDM-2101 results? The press release said the "last patient in the study was treated in March 2006" and that there was a "one year follow-up for survival". How can they delay making these results public?
Did anyone else get the impression from the CC that there could be only 4 Phase II studies in India and perhaps more emphasis on speeding up both cancer and HCV/HIV and HCV studies in the US? BP will want to see some US studies I would think.
Thanks vol. Bavi certainly has an amazing target!
Jazz, What do you make of the papeer spanky found. Are there implications for bavi affecting cholesteral levels?
BIG ON, I like your thoughts about what might happen but I think the first week of November is more likely than the first week of October! My experience with all biotechs is that things are always delayed. For example I expected more of the Indian phase II trials to be announced by now. Good luck to all.
Migenix (MGI:TSX) up on CEO letter which says what we already know. The stock was oversold. Also positive analyst reports from Westwind and Canaccord and a investor newsletter, Lou Paquette's "Emerging growth Stocks" has MGI as a "New Pick". To see the CEO letter go to
http://www.migenix.com/newsreleases/CEO%20Message%2021%20final.pdf.
EGS is by subscription at www.emerginggrowthstocks.ca.
Dew, I think Migenix has a lot more in its pipline than is reflected in a 40 cent share price. But in regard to celgosivir...you describe its non-responder results as "not bad' and a NZ virologist describes them as "encouraging". It is no magic bullet...but I don't think there is a magic bullet. It looks like the SOC will be a combination regime of possibly 5 or 6 compounds(as with HIV?). As first(and only?) in class I simply think it will be seen as deserving more research by some BP...and I would rather see a number of companies looking at the data from the non-responder and upcoming niave interim report than Schering alone. I think shareholders stand to gain more out an auction than the former agreement with Schering. It is a very competitive and huge market ($9-10B by 2010)and every little edge could be very important...and some BP may have something that celgosivir is even more synergistic with than Scherings compounds. Only time will tell.
MGI:TSX
Schering passed but are still "interested"...as are other "potential partners" according to management. Analyst update suggests Novartis and Roche have been doing more deals in the HCV area and can now review the non-responder data. The rest of the pipeline looks very good at this sp.
Schering gave no reason but I'm quessing that if they really are still interested, and if other BP are interested it will be in the interim niave treatment results which have been promised for Q3(July-Sept.). If celgosivir has a role as part of a "rescue combination" it still has some value but if it has a role in first-line SOC combination it will be a great deal more.
MGI:TSX
If Schering has had a 2 month window to decide whether they want to do a deal for Celgasivir there will likely be news next week. For background see msg# 48460.
MGI.TSE
There could be some action on this stock in the next 10 trading days. Migenix and Schering-Plough have a MTA and option agreement in regard to Celgosivir. A NZ virologist characterized the small phase II study results in combination with PegI and R on a difficult to treat population who had failed the SOC for HCV as "encouraging". As far as I know Celgosivir is the only glucosidase I inhibitor in the clinic for HCV. It could be part of a cocktail with PegI + R + a PI(The company claims that their studies show that Celgosivir has a synergistic effect on all three!) Those following the stock think that the "very short" period allowed for the assessment of the phase II data should end in the next 10 trading days. If Schering want to negotiate a deal they then have another short timeframe before "several other interested parties" would have a chance. And in the middle of all this there should be an interim report on a phase II study with treatment niave patients.
The company has other irons in the fire....it expects their partner Cadence to conclude a phase III with Omigard (to prevent catheter infections) in IH 2008. Cadence think the market for this drug could exceed $1.5 B.
There should also be phase II results with a partnered Rosacea drug by the end of this year. And they should be entering the clinic with a gram+ antibacterial early next year. This is expected to be able to treat the drug resistant pneumonias that are a growing problem. This could be a very important drug.
Their website is www.migenix.com and from there you can listen to their May 14 presentation at the R&R conference and read the fireside chats from their articulate CEO.
BP's moving to Biotech
NEW YORK (CNNMoney.com) -- Big Pharma is starting to look more like Big Biotech.
The word "biotech" makes most people think of industry leaders Amgen (down $0.02 to $54.55, Charts, Fortune 500) and Genentech (down $0.10 to $77.54, Charts). But now large pharmaceutical companies are aggressively branching into biotech. Some drugmakers -- like Novartis (up $0.04 to $56.12, Charts) and Wyeth (down $0.46 to $57.71, Charts, Fortune 500) -- have diversified so much that they've effectively become pharma-biotech hybrids.
"Big Pharma is moving towards biotech, so it will be interesting to see five or 10 years from now what the biotech landscape looks like," said Robert Hazlett, analyst for BMO Capital Markets. "It may be much more populated by Big Pharma than everyone gives them credit for."
Biotech drugs, which are made out of living cell cultures, instead of the simple molecules used to create traditional pharmaceuticals, are an attractive investment for Big Pharma for two reasons: the industry is fast-growing, and generic competitors can't touch it.
The biotech industry is expanding much more rapidly than pharma. U.S. biotech sales grew 20 percent to $40.3 billion in 2006, while pharma sales grew 8 percent to $275 billion, according to IMS Health. Big Pharma wants a piece of the action that offers the most growth, and that's biotech.
Biotech drugs are also appealing because they're not vulnerable to patent expirations and generic competition, which are the chief concerns of the pharma industry. Big Pharma lost $14 billion worth of annual drug sales to patent expirations in 2006 and is expected to lose another $12 billion in 2007, according to IMS Health. But biotechs don't have this problem. They don't have to compete with "biogenerics" because the Food and Drug Administration hasn't created a system for regulating them, which is a requirement for drug companies to get their products onto the market.
In order to churn out new biotech drugs, pharma companies have been hard at work breaking ground on new factories. In April, Abbott (down $0.09 to $56.37, Charts, Fortune 500) opened a $450 million, 330,000 square foot biotech plant in Puerto Rico. Bristol-Myers Squibb (up $0.02 to $30.05, Charts, Fortune 500) is building a $750 million biotech plant in Devens, Massachusetts. Wyeth's Grange Castle, a 90-acre biotech facility in Ireland that cost $2.4 billion to build, is said to be the biggest biotech plant in the world, rivaling facilities built by industry leaders Amgen and Genentech.
Other pharma outfits are already riding the biotech boom. Abbott built its new plant to make the blockbuster biotech drug Humira, a treatment for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease that contributes heavily to company sales. Humira accounted for $2 billion of Abbott's 2006 sales of $22.5 billion. The company forecasts the product to reach $2.7 billion in 2007.
Abbott, which also has a biotech facility in Worcester Mass., said the Puerto Rican plant is for the production of "future biologics," suggesting that Humira is just the beginning.
Where does Big Pharma stand in the Fortune 500?
"This is a very high profile area for the company, but Abbott is by no means thought of as being in the biotech bucket," said Phillip Nalbone, analyst for RBC Capital Markets. "[But] certainly the effort to establish a bigger, more efficient manufacturing facility would signal that this is a bigger area for development."
The pharmaceutical company Eli Lilly & Co. also relies heavily on biotech drug sales, which contributed nearly $4 billion, or about 25 percent, of total sales in 2006. And in recent years, the drug giants Merck and Pfizer have bought up smaller biotechs to bolster their pipelines.
The bulk of Big Pharma's sales have traditionally come from name-brand drugs that are protected by patents, but only until the patents expire. After that, generic drugmakers can produce low-cost versions of the drug, which will cause sales to decline by up to 80 percent.
But Big Pharma knows that biotech drugs are safe from generic competition, at least until the FDA creates the bureaucratic foundation for a biogenerics industry.
"(Biotechs) clearly offer better patent protection," said Jon LeCroy, analyst for Natexis Bleichroeder. "Instead of having a drug on the market for 10 years, you have a drug that's on the market - right now - forever."
"The profit life cycle of biologics is much longer than it is with small molecules because there's no clear path for biogenerics," said Barbara Ryan, analyst for Deutsche Bank North America.
The FDA is still in the early stages of creating a regulatory pathway for generic biotech drugs, so it will be years before biogenerics pose any real threat to biotechs. But even when a biogeneric industry does take hold in the U.S., the complicated manufacturing process of creating these "biosimilars" might keep most players out of the game.
"There are going to be a lot fewer competitors," said Ryan of Deutsche Bank. "It's not going to be the blood bath that we see in generic competition for [traditional pharmaceuticals]."
Migenix (MGI.T) Celgosivir abstract
Glucosidase inhibitors as antiviral agents for hepatitis B and C.
[My paper] David Durantel , Christine Alotte , Fabien Zoulim
HBV and HCV infections are a major public health concern. New antiviral drugs are urgently needed with improved efficacy. Compounds that specifically target viral enzymes are the most attractive in terms of drug development and are therefore the most studied. However, antiviral strategies based entirely on this class of compounds encounter problems caused by the emergence of viral escape mutants, as already widely described for HIV. One way to prevent or delay viral resistance is to combine antiviral agents that target different steps of the virus life cycle. Future therapy may also combine such virus-specific antivirals with compounds targeting host proteins or functions. In this respect, viral morphogenesis and infectivity represent interesting, and still unexploited, novel molecular targets. Endoplasmic reticulum glucosidase inhibitors have demonstrated anti-HBV and anti-HCV properties by inhibiting viral morphogenesis and infectivity. One such compound, celgosivir, is currently being evaluated in clinical trials against HCV infection, and encouraging phase IIa data have been disclosed. This review will discuss HBV and HCV morphogenesis, with a particular focus on the role of N-glycosylation for viral protein folding and assembly, and will present the antiviral properties of glucosidase inhibitors.
Dew...MGI non-responder trial results seemed to me to be quite good...I take it you were not impressed. I have been away for several months so you may have covered this while I was gone.
Of course PPHM has talked to interested big companies! This technology is too interesting to be ignored. Volgoat does'nt have anthing to prove...it is only common sense!
Bavi plus chemo cancer results sometime in March-April?... 8 weeks of treatment and 4 weeks of follow-up and 4 weeks for data analysis plus whatever time (4 weeks?) for full enrollment. Would the Bavi combo Hep C be available about the same time? IT IS THE COMBO STUDIES WE SHOULD KEEP OUR EYES ON.
This is a great opportunity for a buy-out....what do you think would be a likely offer? And could there be a number of bidders if someone tries to pick it up too cheaply?
If there are 12 companies bidding on a licencing deal why wouldn't one cash rich BP get tired of this process and instead of risking losing this bidding match simply make a buyout offer? The IP portfolio is very exciting and BP could move a lot faster than little Cortex in getting many compounds into trials. And if one BP makes an offer might there not be a buyout bidding war?
Why not a buyout offer from BP?
There are some very big buyouts of companies that have a lot less to offer than the Ampakine platform.
Blade does R&R assign any value to the rest of SPPI's pipeline? Lawsuits are always unpredictable but if Raj's estimates are correct the revenues to SPPI from a success in the November trial could net SPPI close to another $100 million (although Raj quite reasonably keeps percentages of revenues to himself). But LFA should also be in the same ballpark if I recall correctly. Are those the kind of figures that you recall? And I have no idea what EOquin and Ozeralix might contribute.
Blade, I like SPPI's portfolio! Ozarelix and EOquin should be in phase III next year and there could be big dollars coming in from Satraplatin and LFA sales. If they have the good fortune to win the sumatriptan injection court case the week of November 14 this stock should soon hit double digits. As PAR is covering the costs there is nothing to lose!
It takes a lot of money to enforce a patent. Big Phrma have the resources....PPHM does not! Could that explain the lack of action?....and the possible attractiveness of these patents to BP.
If GPCB and Pharmion deserve to go up on the potential of Satraplatin I think SPPI should also benefit. GPCB is examining Satraplatin in 3 phase II studies in combination with Tarceva and Taxol in NSCL and in metastatic breast cancer. It also has a phase I/II combination study with radiation in NSCL and in radiation and Xeloda(oral 5-FU) in rectal. Then there are 3 phase I studies in combination with Xeloda,Taxol and Gemzar.
I would think that if Satraplatin is as effective as other platinums its oral dosage benefits would ensure large sales...How many of these studies will provide successful results remains to be seen but the potential is huge.
SPPI does not spend a cent on these studies but would benefit wonderfully if and when they are successful. But if they are not successful SPPI has a large and varied pipeline with several other drugs ready to go into phase III next year. And both sumatriptan and LFA could provide some nice upside surprises. The next 2 or 3 years will provide a lot of answers.
SPPI at $4.94 still looks good when you consider they have about 25 million shares out and about $60 million dollars in the bank and can get another $20 million in the next year from milestones...and possibly 7-12% share of net sales of Satraplatin which I think could be over a billion as the indications grow.Certainly they will get much higher percentages from EOquin and Ozarelixs. There will be news on both these drugs soon as well as the November litigation results. SPPI has PAR covering the expenses on this litigation so there is no downside but a very big upside on the decision! And they have already filed an NDA for LFA which should launch late 2007. SPPI is not a one trick pony!
You can get the cc at the Spectrum website... it is worth listening to...and I thought there were some good questions and some reasonable answers. I think they have several potential winners in their potfolio of drugs.
As far as Satraplatin is concerned if sales reach over one Billion(as I think they will) and SPPI gets a net 10% at those sales levels...then a royalty of $100 million with say 30 million shares would warrant a very nice share price! And by that time they should have several other products on the market. I certainly can be wrong but I think SPPI is seriously undervalued at $5.
I listened to SPPI cc yesterday...with only some 25 million shares out I like the prospects with Satraplatin approval. I would think an oral platinum drug would be a very popular choice for both patients and doctors who are having to schedule combination treatment with radiation. SPPI should get around $20 million in milestone payments and up to $58 million when sale milestones are reached...royalties on worldwide sales are thought to start netting about 7% to SPPI but rise as sales increase. You can see R&R comments at http://tinyurl.com/n49cv . Lazard has a buy with a $10 target.
The cc mentioned some news soon on Ozarelix and Eoquin and a November court date for the sumatriptan paragraph IV challenge. This stock could soon start to earn some respect IMHO.