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IF the government would start price controls on drugs you may as well say goodbye to investnent in the industry. Why not have price controls on Apple computers
the tremendous margins on approved drugs is what allows the industry to find new drugs.
the european ride our coatails.
Biogen reports 9th case of PML in Tysabri patients
Fri Jun 19, 2009 7:24pm EDT
LOS ANGELES, June 19 (Reuters) - A ninth patient taking Biogen Idec Inc's (BIIB.O: Quote, Profile, Research, Stock Buzz) multiple sclerosis drug Tysabri has developed a potentially deadly brain infection since the drug was reintroduced onto the market in July 2006.
The Cambridge, Massachusetts-based biotech company announced the news late on Friday on its website.
Biogen has said it does not plan to announce each new case of progressive multifocal leukoencephalopathy, or PML, except as a weekly update on its website.
Sales of Tysabri, Biogen's most important potential growth driver, have been curtailed by concerns over PML. The drug was temporarily withdrawn from the market in 2005 before being returned with stricter safety warnings.
Biogen has said physicians are becoming more comfortable with the risk of PML, but sales of Tysabri in the first quarter were $227 million, less than the $246 million analysts had expected.
Biogen sells Tysabri in partnership with Elan Corp Plc (ELN.I: Quote, Profile, Research, Stock Buzz) of Ireland.
Biogen's shares, which fell 32 cents to close at $51.67 on Nasdaq, were slightly higher at $51.74 after hours. (Reporting by Deena Beasley; Editing by Gary Hill)
he probably deleted you post because he didn't want other people throwing money away on a call option that was misunderstood.
to be in the money you need the stock to trade at 50
Genzyme Temporarily Interrupts Production at Allston Plant
On Tuesday June 16, 2009, 8:30 am EDT
genzyme always gives you a reason to sell at 60 before it gets hit again
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corporation (NASDAQ: GENZ - News) today announced that it has detected a virus that impairs cell growth in one of six bioreactors at its Allston Landing manufacturing facility. The company has decided to temporarily interrupt bulk production at the plant to sanitize the facility. Genzyme is collaborating with regulatory agencies as it works to resume production. The company expects the plant to be fully operational by the end of July.
The virus strain, Vesivirus 2117, has not been shown to cause human infection. It is known to interfere with the growth of CHO cells used to produce biologic drugs and was likely introduced through a nutrient used in the manufacturing process. Genzyme has now confirmed that this virus was the cause of declines in cell productivity at its Allston and Geel facilities in two previous instances in 2008, which were subsequently fully addressed. The company was able to detect the virus in this case using a highly specific assay it developed after standard tests were unable to identify the cause of the previous productivity declines. Genzyme is adding steps to increase the robustness of its raw materials screening and viral removal processes.
Current inventories for Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) are not sufficient to meet projected global demand. The timing and extent of the Cerezyme supply constraint is being clarified and will be communicated as soon as possible. The company expects Fabrazyme supply constraints to occur for a limited period beginning in September. The company will work with physicians, patients and regulators to minimize the impact of this constraint.
“The patients who need these therapies are our priority,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We are confident in the quality of the products produced in Allston and in our ability to resolve the issue affecting the plant. The impact will be temporary.”
Genzyme identified the virus at the Allston plant over the weekend. On Monday morning, the company submitted information to the FDA and EMEA on its findings. The company held a conference call with the FDA on Monday afternoon. With regulatory input, Genzyme is finalizing its action plan and assessing the business impact of this situation. The company will provide updated financial guidance as soon as possible.
Conference Call Information
Genzyme will host a conference call today at 12:00 p.m. Eastern. To participate in the call, please dial 773-799-3828 and refer to pass code “Genzyme.” A replay of this call will be available by dialing 402-220-2056 until June 23. This call will also be Webcast live on the investor events section of www.genzyme.com.
I guess this is why they went radio silent yesterday
. Genzyme
By Adam Feuerstein
10:38 a.m. EDT
The biotech rumor mill is aflutter this morning about Genzyme (GENZ Quote) canceling an entire day of meetings with European investors at the last minute. The company has reportedly gone radio silent, leading to speculation that some sort of deal might be in the works.
Might Genzyme be buying someone? BioMarin (BMRN Quote)? AMAG Pharma (AMAG Quote)? I'm totally guessing but so is everyone else.
No positions.
BDSI - The press release reminds me of the CRME saga and, dare I say, the HEB saga, which is still ongoing.
http://finance.yahoo.com/news/BioDelivery-Sciences-Provides-bw-15522035.html?.v=1
I don't own bdsi but their issue has been the REMS. CRME has always been playing fast and loose about their side effect profile and Heb is a scam.
very different.
BioDelivery Sciences International (BDSI) is trading up over 7% after announcing that the company has reached agreement with the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products and a multidisciplinary review team on all aspects of the company's NDA for ONSOLIS (fentanyl buccal soluble film), including the Risk Evaluation and Mitigation Strategy (REMS). Although the FDA did not meet its action date of last Friday for this NDA, the Division has informed the company that FDA will not be issuing a review extension letter as their action on the NDA is forthcoming.
Lallemand said. Iraq, Iran and Syria are among markets where Pfizer is looking to expand its business, he added.
I don't know many posters on this board that would be familiar with companies in these countries. I don't think there would be many pfizer employees that would want to go there and run those companies either.
Looks like a good way for Pfizer to throw away more money.
dorb.
at the end of march they had about 6.5 million in the bank.
when they initiate the trial they get a million milestone payment.
they have a low burn, they probably have about a year of cash.
Ignored cholesterol blamed for heart attacks
Tue Jun 9, 2009 5:00pm EDT
*Findings offers potential new drug target
*Statin drugs have no affect on the cholesterol
By Michael Kahn
LONDON, June 9 (Reuters) - Danish researchers said on Tuesday they have found the strongest evidence yet that an often ignored form of cholesterol can cause heart attacks.
They said people with higher levels of a little-understood form of cholesterol called lipoprotein (a), which varies up to a thousand fold from one person to another, were also more likely to have heart attacks.
Statins -- taken by millions to cut heart attack and stroke risk -- do not affect lipoprotein (a) but the findings may encourage the development of new cholesterol-lowering drugs, said Borge Nordestgaard of Copenhagen University Hospital, who led the study.
The research, published in the Journal of the American Medical Association, showed that people with the highest liporotein (a) levels were two to three times more likely to have a heart attack than those with the lowest levels.
"We have shown that lipoprotein (a) is causing heart attacks," Nordestgaard said in a telephone interview.
Lipoprotein (a) is one of several forms of cholesterol found in the blood, with levels determined almost entirely by genetics.
Statins lower levels of low-density lipoprotein, commonly known as "bad" cholesterol. Top-selling statins include Pfizer's (PFE.N: Quote, Profile, Research, Stock Buzz) Lipitor, known chemically as atorvastatin, and AstraZeneca's (AZN.L: Quote, Profile, Research, Stock Buzz) Crestor, or rosuvastatin.
"This study may explain why statins don't work for some people," Nordestgaard said.
To show the role of lipoprotein (a) role in heart attacks, the Danish team analysed the genes of 45,000 men and women who gave blood samples for a large national survey starting in 1976, tested their lipoprotein (a) levels and then followed them until 2007.
HIGH LEVELS
People with the highest levels of this cholesterol had the most heart attacks, the study found. One certain genetic variation accounted for about a quarter of the cases of high lipoprotein (a). "Liprotein (a) has been around for a long time as a risk factor but people hadn't taken it too seriously because they didn't think it caused heart attacks," Nordestgaard said. "Now we show that, like LDL, it is causing heart attacks."
One problem is that people have little control over the cholesterol, whose levels can vary up to a thousand-fold among individuals, Nordestgaard added.
Niacin, a vitamin often prescribed generically to lower cholesterol, also lowers lipoprotein (a) levels. It can cause uncomfortable flushing, however. Aspirin can also lower lipoprotein (a) levels.
Merck & Co (MRK.N: Quote, Profile, Research, Stock Buzz) markets a drug called Tredaptive in Europe that combines niacin with an anti-flushing agent but the drug has been rejected by U.S. health regulators.
Nordestgaard said he hopes the study will spur drugmakers to begin work on a new drug specifically aimed at lipoprotein(a) levels. (Reporting by Michael Kahn; editing by Maggie Fox)
© Thomson Reuters 2009. All rights reserved. Users may download and print extracts of content from this website for their own personal and non-commercial use only. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters. Thomson Reuters and its logo are registered trademarks or trademarks of the Thomson Reuters group of companies around the world.
Thomson Reuters journalists are subject to an Editorial Handbook which requires fair presentation and disclosure of relevant interests.
Second half could also be within a month.
there are other things happening also
Is it surprising that it's considered ethical to withhold treatment in the placebo arm? Maybe it's not thought ethical in Europe, hence the lack of European sites, unlike in the prior P3?
The first ten days both groups get prednisone which is SOC.
If you fail you get prednisone with is SOC.
the lack of European sites is a benefit for Dor because it will be easier to run the trial without having to do sites in Europe.
The emea seems to be content that the US has sites that will have the proper protocols in place to do a proper study.
ChemGenex's Omacetaxine Shows Activity in Refractory CML
New Clinical Data Presented at EHA Suggests that Omacetaxine May Provide a Useful Treatment Option for CML Patients Resistant to Multiple TKI Therapies
this company's market cap is about 130 million US. Compare that to Allos with a market cap of near 700 million.
On Monday June 8, 2009, 8:00 am EDT
MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--ChemGenex Pharmaceuticals Limited (ASX:CXS - News) announced that positive, updated data from its phase 2/3 clinical trial study of omacetaxine in chronic myeloid leukemia (CML) patients with resistance to multiple tyrosine kinase inhibitors (TKIs) was presented at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany on Saturday.
Dr. Meir Wetzler MD, Chief of the Division of the Leukemia, School of Medicine and Biomedical Sciences, University at Buffalo, Roswell Park Cancer Institute, a lead investigator in the study, presented the data. Dr. Wetzler said, “TKIs are our front line of attack in CML, but significant numbers of patients have developed cross resistance to drugs in this chemical class. As a physician I need alternatives, so it is important to continue the search for new drug entities to treat refractory CML. The data emerging from this study provide encouraging signs that omacetaxine could offer a viable therapeutic option for this patient group.”
Data were presented from 65 patients: 30 in chronic phase, 20 in accelerated phase and 15 in blast phase. Highlights of the data were:
Chronic phase patients
•Complete hematologic response (CHR) rate of 80% with a median response duration 7.5 months
•Major cytogenetic response (MCyR) rate of 20% with a median response duration 2.7 months
Accelerated phase patients
•CHR rate of 60% with a median duration 8.9 months
Blast phase patients
•CHR rate of 40% with a median duration 5.7 months
Tolerability
Investigators reported that omacetaxine is generally well tolerated, and that the most common side effect is reversible and transient myelosuppression.
Commenting on the presentation, Greg Collier, Chief Executive Officer and Managing Director of ChemGenex said, “Omacetaxine has a very different mechanism of action compared to the TKIs, and we have always believed that it may offer the potential to overcome TKI-resistance. The latest results of this study are very encouraging, but this clinical trial is still at an early stage. In the meantime, ChemGenex remains focused on our primary objective of developing omacetaxine as a therapeutic option for CML patients who have developed the T315I mutation. This is one of the most pressing unmet medical needs in the field of CML management.”
Dr. Collier and ChemGenex’s Chief Medical Officer Dr. Adam Craig will host an investor conference call and webcast to discuss the clinical results from both ASCO and the EHA Congress on Thursday 11th of June at 10 am Australian Eastern Standard Time.
Webcast Details
Telephone access (toll free) details are below:
1800 131 617 Australia Free Call
+61 7 3107 0222 International / Metered Number
0800 446 958 New Zealand Free Call
800 120 4406 Singapore Free Call
800 962 283 Hong Kong Free Call
001 803 011 4106 Indonesia Free Call
0044 22 132 558 Japan Free Call
866 746 2596 USA/Canada Free Call
0800 376 8339 UK Free Call
0800 330 2094 Germany Free Call
0805 111 476 France Free Call
0800 001 230 Switzerland Free Call
Online: http://services.choruscall.com/links/chemgenex090611.html
About the trial
CGX-635-CML-203 is a phase 2/3 open-label study using omacetaxine as a subcutaneous injection for the treatment of patients with chronic myeloid leukemia (CML) who are intolerant to or have failed multiple TKIs.
Omacetaxine Overview
Omacetaxine mepesuccinate is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are upregulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc). As omacetaxine acts independently of tyrosine kinase inhibitors, it may have a therapeutic advantage for patients who have developed resistance to TKIs. Omacetaxine is administered subcutaneously.
About ChemGenex Pharmaceuticals Limited (http://www.chemgenex.com)
ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing personalized oncology medicines. ChemGenex harnesses the power of genomics both to discover novel targets and drug compounds, and in clinical trials to develop more individualized treatment outcomes. ChemGenex’s lead compound, omacetaxine mepesuccinate, is currently in phase 2/3 clinical trials for chronic myeloid leukemia (CML). ChemGenex has a second anticancer compound, amonafide dihydrochloride (Quinamed®), which is in phase 2 clinical development for various solid cancers, and a portfolio of assets in pre-clinical development. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS" and on NASDAQ under the symbol "CXSP". For additional information on ChemGenex Pharmaceuticals, please visit our web site at http://www.chemgenex.com.
Details on the clinical trials can be accessed from the following websites;
http://clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9 and http://www.tkiresistantcmltrials.com
I didn't say tekmira's technology would work specifically for RSV.
tekmira seems to be able to deliver sRNAI to the liver so far
in order for Alnylam's technology to work they need to deliver it to the cells properly
I do not believe their RSV product will work for that reason.
the products they have using tekmira's technology have a chance.
MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--ChemGenex Pharmaceuticals Limited (ASX:CXS - News), announced today that the results of pre-clinical research that demonstrated that omacetaxine kills model human leukemic stem cells were presented at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany on Sunday. Human leukemic stem cells are known to be insensitive to tyrosine kinase inhibitors (TKIs), the drug family currently approved to treat Chronic Myeloid Leukemia (CML). The work was carried out in collaboration with Professor Tessa Holyoake at the University of Glasgow, Scotland, UK.
Ms. Elaine Allan, Clinical Scientist of the Scottish National Blood Transfusion Service working at the Paul O'Gorman Leukaemia Research Centre, University of Glasgow in Scotland, UK delivered the oral presentation. Ms Allan said, “Currently licensed drugs target and disable the diseased cells in the blood stream and bone marrow, but they have little, if any, effect on the primitive leukemic stem cells that are at the “root” of this blood cancer. In contrast, we have shown omacetaxine to be not only anti-proliferative, but also to induce apoptosis in human CML stem cells.”
Hagop M. Kantarjian, M.D., Chairman and Professor, Department of Leukemia, at the University of Texas M. D. Anderson Cancer Center, described the study results as exciting. Dr. Kantarjian added, “These results raise the possibility of eradicating the dormant malignant stem cells that are thought to be responsible for relapse in CML patients who discontinue TKIs. I look forward to working with ChemGenex in future trials to evaluate the clinical application of this research."
Dr. Greg Collier, Chief Executive Officer and Managing Director of ChemGenex, said, “The data presented today is entirely consistent with our strategic plans to investigate omacetaxine in combination with selected TKIs in an attempt to eradicate this form of leukemia. In the meantime ChemGenex remains focused on our primary objective of developing omacetaxine as a therapeutic option for CML patients who have developed the T315I mutation. This is one of the most pressing unmet medical needs in the field of CML management.”
Omacetaxine Overview
Omacetaxine mepesuccinate is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are upregulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc). As omacetaxine acts independently of tyrosine kinase inhibitors, it may have a therapeutic advantage for patients who have developed resistance to TKIs. Omacetaxine is administered subcutaneously.
CVM will eventually get a big partner for Multikine, though I have no idea when. If it happens this week, the stock is certainly primed to explode.
Not only would the stock explode but the world as we know it will never be the same. I am working on a rocket ship right now to take my family to a planet far, far away
Exenatide pump controls glucose in short trial
Sat Jun 6, 2009 11:00am EDT
* Pump lowers glucose levels, HbA1c in 4-week study
no wonder Icahn wants to get AMLN sold
* Gap in Amylin patent coverage
By Deena Beasley
LOS ANGELES, June 6 (Reuters) - A pump-delivered version of exenatide, the active ingredient in diabetes drug Byetta, was shown to significantly lower glucose levels in a small four-week trial, according to Intarcia Therapeutics Inc., which is developing the product.
Venture capital-backed Intarcia is using technology involving a matchstick-size implantable pump that would deliver the biologic drug on a sustained basis for up to a year.
Byetta, given twice daily by injection, is marketed by Amylin Pharmaceuticals Inc (AMLN.O: Quote, Profile, Research, Stock Buzz) and Eli Lilly & Co (LLY.N: Quote, Profile, Research, Stock Buzz). The drug had 2008 sales of $751 million and the partners filed in May for U.S. regulatory approval of an exenatide formulation that would be dosed in a weekly injection.
But the companies do not have a composition of matter patent on exenatide or a claim that covers treatment of diabetes, according to Intarcia Chief Executive Alice Leung.
The implanted pump would give patients an immediate, optimized dose of exenatide with consistent, round-the-clock control of blood glucose without having to inject themselves, she said.
Byetta was launched in 2005. It is a member of a class known as GLP-1 drugs, which are designed to stimulate the release of insulin when glucose levels become too high.
Diabetics do not produce enough insulin, or their bodies do not use it effectively, which can cause blood sugar to rise and damage blood vessels and organs. In patients with type 2diabetes, the most common form, both problems exist.
REDUCTION IN FASTING GLUCOSE
The trial found that for diabetes patients implanted with Intarcia's ITCA650, blood glucose levels fell 5.6 milligrams per deciliter of blood at the lowest dose and 28.8 mg/dL at the highest dose. Levels of HbA1c, a measure of glucose control, decreased by 0.5 to 0.6 percentage points.
The drug was also associated with weight loss.
"We saw an almost immediate reduction in fasting glucose," Leung said.
The results from the trial, which enrolled patients on a stable treatment regimen of diet and exercise or common oral diabetes drugs, were reported on Saturday at the annual meeting of the American Diabetes Association.
The 44-patient trial did not look at safety issues, but Byetta has been linked to several patient deaths due to inflammation of the pancreas, or pancreatitis, to which diabetes patients are more prone than the general population.
"If there is a concern, we can take the device out immediately," Leung said, contrasting such "reversible delivery" to the several weeks that it takes for Amylin's once-weekly exenatide to leave the body.
She also said patients using ITCA650 had less nausea than patients treated with Byetta.
Intarcia licensed rights to the Duros continuous drug delivery technology from Alza Corp in 2000, just before Johnson & Johnson's (JNJ.N: Quote, Profile, Research, Stock Buzz) acquisition of Alza.
Amylin and Lilly are using technology developed by Alkermes Inc (ALKS.O: Quote, Profile, Research, Stock Buzz) for once-weekly Byetta.
Intarcia expects to launch a 3-month Phase II trial of ITCA650 in the third quarter and a pivotal trial next year, but will need to sign on a development partner before the Phase III program, Leung said.
"We are a small company with just 41 people. It is not possible for us to cover the world," she said.
© Thomson Reuters 2009. All rights reserved. Users may download and print extracts of content from this website for their own personal and non-commercial use only. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters. Thomson Reuters and its logo are registered trademarks or trademarks of the Thomson Reuters group of companies around the world.
Thomson Reuters journalists are subject to an Editorial Handbook which requires fair presentation and disclosure of relevant interests.
ChemGenex Says Drug Rids Leukemia in Some Patients (Update2)
By Simeon Bennett
June 2 (Bloomberg) -- ChemGenex Pharmaceuticals Ltd., an Australian drugmaker, said its experimental leukemia treatment cleared the disease from the blood of 85 percent of patients who didn’t benefit from Novartis AG’s Gleevec.
Omacetaxine mepesuccinate, as the drug is called, also eradicated the disease from the bone marrow of four out of 40 patients with an early form of chronic myeloid leukemia, according to data presented at the American Society of Clinical Oncology’s annual meeting in Orlando, Florida, today.
“These results suggest that omacetaxine may represent the first viable treatment option for this population of patients who currently have no established treatment options,” Jorge Cortes, who led the study at the M.D. Anderson Cancer Center in Houston, said in a company statement today.
Geelong, Victoria-based ChemGenex, which has never made a profit, plans to use the results from the third and final stage of human testing to complete a marketing application to U.S. regulators by September. Global sales of treatments for the drug-resistant form of the disease may reach $500 million by 2020, said Shane Storey, a biotechnology analyst with Wilson HTM in Brisbane, in a report last month.
ChemGenex shares rose 0.5 Australian cent, or 0.9 percent, to 56.5 cents in Sydney. The shares have gained 22 percent this year, compared with a 7.9 percent gain in the All Ordinaries Index of Australia’s largest 497 companies by market value.
Chronic myeloid leukemia, or CML, is a slow-progressing disease in which a genetic flaw triggers a person’s bone marrow to produce too many white blood cells, which don’t mature and aren’t able to perform their normal infection-fighting role. About 4,830 people were diagnosed with the disease in the U.S. last year, with a median age of 67, according to the National Cancer Institute.
Yew Trees
Omacetaxine is derived from the yew tree known as Cephalotaxus harringtonia. Its medicinal properties were probed in a U.S. National Cancer Institute screening program in the 1970s funded after former President Richard Nixon declared war on cancer. The same project uncovered Bristol-Myers’ breast- cancer drug, Taxol, derived from Pacific yew trees.
Omacetaxine is the most advanced medicine for patients with a genetic mutation that makes them resistant to Novartis’s best- selling cancer drug Gleevec or Bristol-Myers Squibb Co.’s Sprycel. Merck & Co. stopped recruiting patients for trials of a similar product developed with Vertex Pharmaceuticals Inc. in 2007 because of adverse reactions.
Gleevec, also sold as Glivec, earned Basel, Switzerland- based Novartis $3.7 billion last year, according to Bloomberg data.
White Blood Cells
Tests on 66 people with CML showed omacetaxine returned white blood cells to normal levels in 85 percent of 40 patients with the earliest stage, 31 percent of 16 people with a more advanced stage, and 20 percent of 10 people with the most advanced stage, ChemGenex said in the statement. The main side effect was a “reversible and transient” decrease in the bone marrow’s ability to produce white blood cells, the company said.
If approved, the company has said it plans to start selling the drug on its own in the U.S. and seek a partner for sales in Europe. ChemGenex raised A$18.4 million selling new stock this year to help take the medicine to market.
To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net
Last Updated: June 2, 2009 03:04 EDT
I wasn't sure if it was posted before and I believe the GVHD trial has been fully enrolled so the article is important because of the upcoming unblinding of data
Osiris Up to Its Old Tricks Again
Not sure if this has been posted but he is right about this.
Adam Feuerstein
03/27/09 - 12:08 PM EDT
I'm short Osiris Therapeutics(OSIR Quote) in the model portfolio of the Biotech Select newsletter because 1) its adult stem cell drug Prochymal doesn't work; and 2) Osiris management practices the high art of spin-doctoring.
Both are on display in the press release Osiris issued Friday announcing the halt to a phase III study of Prochymal in patients with Crohn's disease.
Let's start with the title of the press release: "Osiris Discontinues Enrollment in Crohn's Study Due to Concerns with Trial Design."
OK, I guess that's sort of what happened, but the more relevant fact is that an independent data monitoring board looked at the study and concluded that Crohn's patients taking one of two doses of Prochymal were not responding any better than patients taking a placebo. In bio-statistical parlance, the Prochymal study failed a futility test.
In plain English, the independent data monitors said Prochymal wasn't working, so there's no point in enrolling any more patients.
Osiris CEO Randy Mills, speaking on a Friday morning conference call, placed the blame for this mishap on a "study design flaw" that led to a higher-than-expected placebo response. Well, I guess when someone outside your control tells you that your drug doesn't work, it constitutes a flaw in the study.
Later in the call, Mills had the temerity to suggest Osiris be excused for its "study design flaw" because the company had only tested Prochymal in nine Crohn's patients before starting the phase III study.
That's not a typo. Osiris based its Prochymal phase III Crohn's program on previous data in nine patients. And even worse, those nine Crohn's patients were treated with a Prochymal dose different from that used in the phase III study. By contrast, in 2002 Biogen Idec(BSX Quote) enrolled 248 patients in a Phase II Crohn's study of Tysabri, which later was approved to treat the disease.
Don't be shocked to learn that Osiris takes shortcuts with drug development, and then dissembles the data that comes out of these bad clinical trials. That's been the company's modus operandi from the beginning.
As I've reported previously, Osiris used easy-to-achieve endpoints, liberal definitions of response and enrolled easy-to-treat patients in phase II studies of Prochymal in graft-versus-host disease. Osiris is now testing Prochymal in two phase III studies of graft-versus-host disease, which aren't likely to turn out any better than Friday's results in Crohn's disease.
In the past, Osiris has tried to pass off Prochymal data in patients with arthritic knees as positive when in fact the study failed.
The company also continues to flog Prochymal as a potential treatment for heart attack victims even though Boston Scientific(BSX Quote), Osiris' former partner, took a look at the cardiovascular data years ago and decided to dump Prochymal from its pipeline.
But don't expect to hear any questions of doubt about Prochymal or complaints about the way Osiris misleads investors from most of the sell-side analyst crew who follow the company. On Friday's call, Leerink Swann's Bill Tanner, JMP Securities' Charles Duncan and Piper Jaffray's Ed Tenthoff were all more than happy to buy into the message that Osiris' chief executive Mills was spinning.
At one point, Duncan asked if the halting of the Crohn's study might actually be a good thing because it could help alleviate the problem Osiris has had manufacturing enough Prochymal for its other phase III studies.
Tanner questioned Mills about whether the data from this failed Crohn's trial may actually help the company enroll the next Crohn's study even faster; while Tenthoff wondered aloud if the data, once it's analyzed, might actually show that the study was a success.
Meantime, the analysts from Jefferies and Lazard Capital, both of whom take a much less sanguine view of Osiris, were noticeably absent from the conference call in which Osiris management got to choose who could ask questions and who could not.
Osiris shares were plunging 23% to $14.10 in Friday trading, which is still too high given the high likelihood that Prochymal amounts to nothing when phase III studies in graft-versus-host disease report data in the third quarter.
The company has gotten a good bit of mileage from a recent Prochymal development partnership with Genzyme(GENZ Quote), but that, too, will likely end when more of the phase III studies fail.
Just as the Crohn's study of Prochymal failed Friday.
Randall E Woods was the Ceo of NovaCardia which is the company that Merck paid 350 million dollars to that resulted in its failed drug today. He was the CEO of a company named Corvas that had a drug for Stroke that was no better than placebo but he had the market convinced that it would work. Corvas then merged with Dendreon to give dendreon cash because Corvas was trading below cash.
If I had a car to sell I would like Randall to sell it for me but I don't think anyone should buy drugs from him. Maybe he should be sent to Afghanistan to sell their drugs?
Here is the press release from the Merck purchase of Novacardia
Published on FierceBiotech (http://www.fiercebiotech.com)
PRESS RELEASE: Merck to Buy NovaCardia for $350 Million to Expand Heart Drug Pipeline
By maureen
Created Jul 25 2007 - 10:34am
Merck to Buy NovaCardia for $350 Million to Expand Heart Drug Pipeline
WHITEHOUSE STATION, N.J. & SAN DIEGO -- Merck & Co., Inc., one of the world's leading research-based pharmaceutical companies, and NovaCardia, Inc., a privately held clinical-stage pharmaceutical company focused on cardiovascular diseases, today announced that they have entered into a definitive agreement under which Merck will acquire NovaCardia.
Under the agreement, Merck will acquire all of the outstanding equity of NovaCardia for $350 million plus the amount of cash on hand at the time of closing, all of which will be paid in Merck stock based on the average closing stock price on the five days prior to closing of the acquisition.
"This acquisition continues to deliver on our strategy of targeted acquisitions in areas of unmet medical need in the therapeutic areas of strategic importance for Merck such as cardiovascular diseases," said Richard Kender, vice president of business development and corporate licensing at Merck.
NovaCardia's lead product candidate KW-3902, an adenosine A1 receptor antagonist, is being studied in Phase 3 clinical trials in patients with acute congestive heart failure (CHF). KW-3902 is believed to block adenosine-mediated constriction of blood flow to the kidneys and inhibit reabsorption of salt and water by the kidney, thereby increasing urine volume and maintaining renal function in patients with CHF. To date, no other vasodilator has demonstrated the selective renal vasodilation attribute of KW-3902 that helps preserve renal function. As renal function deteriorates in patients with CHF, higher doses of diuretics are required in order to reduce fluid overload. Multiple studies have demonstrated that renal dysfunction is a strong independent predictor of worse short- and long-term outcomes in patients with CHF.
"We are excited to see our lead product become part of the superb scientific environment of Merck," said Randall E. Woods, president and chief executive officer at NovaCardia. "NovaCardia demonstrated the potential of KW-3902 in clinical trials, and we believe that Merck can expedite the development of this novel agent."
"Merck is very excited to have the opportunity to bring forward potential new treatments for patients with heart failure," said Richard C. Pasternak, M.D., vice president of clinical research at Merck Research Laboratories. "Our acquisition of NovaCardia enhances Merck's considerable internal research efforts committed to the development of new medicines to treat major cardiovascular diseases that are underserved by existing therapies."
NovaCardia recently presented preliminary results from a pilot Phase 3 trial of KW-3902 at a late-breaking session of the European Society of Cardiology's Heart Failure Congress 2007 that indicated a strong trend toward efficacy for the 30 milligram dose. Patients treated with KW-3902 experienced a higher rate of improvement in dyspnea, or shortness of breath, which is a common symptom of CHF, compared to the placebo group, and KW-3902 also enhanced diuresis and mitigated deterioration of renal function that is often experienced by patients undergoing standard treatment. Two pivotal Phase 3 trials, PROTECT 1 and PROTECT 2, are currently enrolling participants in the United States, Canada, Europe, Israel and Russia. NovaCardia in-licensed KW-3902 from Kyowa Hakko Kogyo Co., Ltd., in 2003.
"NovaCardia's management team has done an exceptional job advancing KW-3902 into Phase 3 clinical trials, demonstrating the compound's potential and building NovaCardia into a successful company," said Eckard Weber, M.D., founder and chairman of NovaCardia and partner at Domain Associates.
In addition to Domain Associates, NovaCardia's investors include Forward Ventures, Montreux Equity Partners, Versant Ventures, Skyline Ventures and InterWest Partners. NovaCardia will spin-out a new corporate entity to support clinical development of the company's second compound, K201 (JTV-519) for atrial fibrillation.
"This acquisition gives Merck the possibility to expand its cardiovascular product pipeline into congestive heart failure, an area of important unmet medical need and significant burden to the healthcare system," said Guy Eiferman, general manager of the atherosclerosis and cardiovascular franchise at Merck.
The acquisition is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The two companies expect to close the acquisition within 45 days.
Merck's 2007 full-year financial guidance, provided on July 23, 2007, did not include the anticipated overall financial impact of any charges associated with the NovaCardia acquisition. Merck will provide an update to the full-year 2007 financial guidance following the closing of the acquisition.
About Congestive Heart Failure
CHF is a widespread and debilitating disease most often caused by a weakening or stiffening of the heart muscle, which leads to a progressive loss in the heart's ability to pump blood effectively throughout the body. There are nearly 5 million people in the United States with CHF, according to the American Heart Association (AHA). With the aging population and more patients surviving the early stages of cardiovascular diseases, the prevalence of CHF is increasing. Approximately 550,000 new cases of CHF are reported in the United States each year, according to the AHA.
About NovaCardia
NovaCardia, Inc. is a clinical-stage pharmaceutical company focused on developing drugs to treat major cardiovascular diseases that are underserved by existing therapies.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
swine and bird flu index
http://www.tickerspy.com/index/Swine-Flu-and-Bird-Flu-Stocks?refer=2000Y3
Otherwise known as stock that will be a lot lower by the end of the month
I never said the ptie trade was a bad one.
trading at cash low burn plus partnership income, how could it be a bad investment. I had an issue with the fact that you made it appear as if you didn't understand they had the potential partnership income
Osteologix OLGX Phase II Studies
The thing to realize is that the drug Protelos has a three hundred million dollar run rate per year in Europe.
link to 10k http://www.sec.gov/Archives/edgar/data/1278129/000136231009004693/c83320e10vk.htm
In November 2007, we completed a phase II double-blind, placebo-controlled randomized study of NB S101 in 289 post-menopausal women with low bone mineral density in order to assess the efficacy of our investigational drug. The trial participants were divided into five groups, with three of these groups receiving different doses of NB S101 (0.75 grams, 1.0 grams, and 2.0 grams), one group receiving placebo and one group receiving the approved 2.0 gram dose of Protelos® in sachet formulation (because Protelos is not in tablet formulation, the Protelos arm was not blinded to the treatment received). The patients in the trial were treated for 12 weeks and followed-up for four to eight weeks following completion of the treatment portion of the trial.
The primary endpoint in the study was the change in patients’ bone resorption, as measured by the biochemical marker CTX-1. We also captured data regarding the effect of NB S101 on bone formation, bone mineral density and a marker of cartilage degradation as well as the levels of strontium in patients’ serum and the side effects. The goal of our phase II study was to document the efficacy of NB S101 and to establish an effective and tolerable dose of NB S101 that will enable us or a pharmaceutical collaborator to initiate phase III clinical trials that would be designed to obtain approval of NB S101.
We met the primary endpoint for all three doses of NB S101 evaluated in the trial, showing a statistically significant reduction in CTX-1 as compared to placebo, in a dose dependent manner. The reductions in serum CTX-1 compared to placebo were 13.5 percent in the group receiving the lowest dose of NB S101 (0.75 grams), 15.5 percent in the group receiving the middle dose of NB S101 (1.0 gram), and 22.2 percent in the group receiving the highest dose of NB S101 (2.0 gram) (p<0.001 for all doses vs. placebo). These reductions in the marker for bone resorption were also numerically superior compared to the approved dose of Protelos (Protelos reduced the marker for bone resorption by 8.5 percent), although only the highest dose of NB S101 was statistically significant compared to Protelos. Data from the primary endpoint of the trial are shown in the chart below.
Primary endpoint — percent change in CTX-1 from baseline to week 12
Placebo Strontium Malonate Protelos®
0.75 g 1 g 2 g
N = 57 N = 57 N = 58 N = 56
Mean change from baseline relative to placebo, in percent N/A -13.48 -15.54 -22.17 -8.50
.001 .001 .001 .03
p-value
versus placebo <0.001
--------------------------------------------------------------------------------
Table of Contents
In addition to meeting the primary endpoint, we also saw increases in BMD among the patients receiving NB S101 in comparison to patients on placebo, as shown in the chart of lumbar spine BMD below.
Lumbar spine — percent change in BMD from screening to week 12
Placebo Strontium Malonate Protelos®
0.75 mg 1 g 2 g
N = 56 N = 56 N = 51 N = 56 N = 55
Mean change from screening relative to placebo N/A 2.29 1.99 2.66 1.96
N/A .020 .049 .008 .048
p-value
versus placebo
--------------------------------------------------------------------------------
Table of Contents
In our phase II clinical trial, NB S101 was well-tolerated and side effects were generally mild in all dose groups. There were no significant differences in the side effect profiles between the different treatment groups. It is our belief that the trial clearly demonstrates the beneficial effect of NB S101 on bone resorption and on patients’ bone mineral density after only a short treatment period and that more advanced clinical trials should be conducted to support the approval of NB S101.
Phase III Studies
We are designing our development plan for NB S101 for osteoporosis to comply with both U.S. and European guidelines. On February 17, 2009, we held a meeting with the FDA regarding the proposed development of NB S101. Based on feedback from the FDA meeting, we believe that the continued development of NB S101 will require an additional phase II trial and only one large, well-controlled phase III trial.
The FDA and EMEA require positive results from phase III studies before they will approve an NDA. In order to obtain approval for a new drug for the treatment of osteoporosis, current regulatory guidelines require placebo-controlled double-blind studies with fracture reduction as the primary endpoint. An adequate fracture-prevention trial represents a significant time and resource investment, as the treatment duration in the required clinical studies can be up to three years, although recent trials have been conducted with a two-year treatment duration and more recently an advisory group has recommended that these trials be reduced to 18 to 24 months in duration. These trials raise ethical questions concerning the use of placebo groups when approved drugs are available to treat osteoporosis, and both European and U.S. regulatory authorities are currently debating whether continued use of such trials can be recommended. If future guidelines prevent or limit the use of placebo control in such studies, we may plan to alternatively conduct a non-inferiority study against an established osteoporosis treatment or otherwise modify our plans based on any new guidelines established for approval of drugs to treat or prevent osteoporosis.
Based on the current FDA and EMEA guidelines and anticipated changes, we anticipate the primary objective of a phase III study will be to evaluate the ability of NB S101 to prevent incident vertebral fracture. We also anticipate that we would collect data on non-vertebral fractures, spine, hip and forearm BMD, and biochemical markers of bone and cartilage turnover. We estimate that the phase III study may enroll up to 3,000 osteoporotic women, comparing one dose of NB S101 to placebo over a two- to three-year treatment period, with a possible two-year extension. Based on continuing analysis of the phase II data and discussions with regulatory agencies, we are continuing statistical assessments before we finalize any phase III clinical trial design and determine the specific number of patients needed.
Our clinical development plans are based on the current profile of NB S101, our experience with preclinical and clinical testing of NB S101, our understanding of current FDA and EMEA guidelines, and our review of publicly available data on potentially competing products. We expect that continuing analysis of all data available on strontium, NB S101 specifically, and potentially competing drugs in development will increase our knowledge in the field, and may lead to our modifying our current development strategy. In addition, changes in market conditions or regulatory requirements may also require us to modify our development plans or perform additional pre-clinical trials.
I find it amazing that you make so many posts on a biotech board, and own pain therapeutics strickly based on cash balances and technicals. You didn't even know whether they have future income coming in from the drugs they licensed.
You seem to have made a lot of money buying these stocks based strickly on their cash balances, but this year has probably been the only one in the last five years that, that method of investing was possible.
You bought stock base on the asco effect also, this has been the first year in the last five that there was an asco effect.
so maybe you should invest every five years because if you use these stratagies in the future you won't have any investable assets left for five years from now.
Pivotal Study Results: ChemGenex's Omacetaxine May Provide the First Viable Drug Treatment Option for Patients With a Highly Resistant Form of CML
Data Intended for NDA Submission Presented at ASCO
Findings Suggest Omacetaxine Offers an Important Breakthrough in the Treatment of CML Patients with the T315I Resistance Mutation
On Monday June 1, 2009, 12:00 pm EDT
MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--ChemGenex Pharmaceuticals Limited (ChemGenex) (ASX:CXS - News) (NASDAQ:CXSP - News) announced that the latest data from its pivotal study of omacetaxine in patients with T315I-positive chronic myeloid leukemia (CML) was the subject of an oral presentation and discussion today at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida. The open label Phase 2/3 study (CGX-635-CML-202) investigated the use of omacetaxine, administered subcutaneously in CML patients who had failed imatinib and who have the highly drug resistant T315I kinase domain mutation.
Dr. Jorge Cortes, MD, Professor of Medicine and Deputy Chair in the Department of Leukemia at The University of Texas, MD Anderson Cancer Center, a lead investigator in the study, presented the data. Dr. Cortes said, “It appears that omacetaxine was well tolerated in this study and durable hematological and cytogenetic responses were observed in some CML patients with the T315I mutation.” He added that “Several novel drugs have already been investigated in this difficult-to-treat population, but they have not had a reasonable risk:benefit ratio. These results suggest that omacetaxine may represent the first viable treatment option for this population of patients who currently have no established treatment options.”
Data were presented from 66 patients: 40 in chronic phase, 16 in accelerated phase and 10 in blast phase. Highlights of the data were:
Chronic phase patients
Complete hematologic response (CHR) rate of 85% with a median response duration 8.9 months
Major cytogenetic response (MCyR) rate of 15% with a median response duration 6.1 months
Accelerated phase patients
CHR rate of 31% with a median duration 4.1 months
MCyR rate of 6% with a median response duration 1.8 months
Blast phase patients
CHR rate of 20% with a median duration 3.3 months
Tolerability
Investigators reported that omacetaxine is generally well tolerated, and that the most common side effect is reversible and transient myelosuppression.
Commenting on the presentation, Dr. Greg Collier, Chief Executive Officer and Managing Director of ChemGenex, said, “This is a very important milestone in the development of omacetaxine and in the evolution of ChemGenex. The data presented today will be provided to the FDA in the final part of our rolling NDA submission; this project remains on target for completion in Q3 this year.” Dr. Collier finished by expressing his deep appreciation for patients and investigators who participated in this important trial.
Dr. Collier and ChemGenex’s Chief Medical Officer Dr. Adam Craig will host an investor conference call and webcast to discuss the clinical results from both ASCO and the EHA Congress on Thursday 11th of June at 10 am AEST. Details of this event will be advised in coming days.
Omacetaxine Overview
Omacetaxine mepesuccinate is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are upregulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc). As omacetaxine acts independently of tyrosine kinase inhibitors, it may have a therapeutic advantage for patients who have developed resistance to TKIs. Omacetaxine is administered subcutaneously.
About ChemGenex Pharmaceuticals Limited (http://www.chemgenex.com)
ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing personalized oncology medicines. ChemGenex harnesses the power of genomics both to discover novel targets and drug compounds, and in clinical trials to develop more individualized treatment outcomes. ChemGenex’s lead compound, omacetaxine mepesuccinate, is currently in phase 2/3 clinical trials for chronic myeloid leukemia (CML). ChemGenex has a second anticancer compound, amonafide dihydrochloride (Quinamed®), which is in phase 2 clinical development for various solid cancers, and a portfolio of assets in pre-clinical development. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS" and on NASDAQ under the symbol "CXSP". For additional information on ChemGenex Pharmaceuticals, please visit our web site at http://www.chemgenex.com.
Details on the clinical trials can be accessed from the following websites; http://clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9 and http://www.tkiresistantcmltrials.com
Safe Harbor Statement
Certain statements made herein (including for this purpose sites to which a hyperlink has been provided) that use the words “estimate”, “project”, “intend”, “expect”, “believe” and similar expressions are intended to identify forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements of the company to be materially different from those which may be expressed or implied by such statements, including, among others, risks or uncertainties associated with the development of the company’s technology, the ability to successfully market products in the clinical pipeline, the ability to advance promising therapeutics through clinical trials, the ability to establish our fully integrated technologies, the ability to enter into additional collaborations and strategic alliances and expand current collaborations and obtain milestone payments, the suitability of internally discovered genes for drug development, the ability of the company to meet its financial requirements, the ability of the company to protect its proprietary technology, potential limitations on the company’s technology, the market for the company’s products, government regulation in Australia and the United States, changes in tax and other laws, changes in competition and the loss of key personnel. These statements are based on our management’s current expectations and are subject to a number of uncertainties that could change the results described in the forward-looking statements. Investors should be aware that there are no assurances that results will not differ from those projected.
Contact:
ChemGenex
Dr. Greg Collier
CEO and Managing Director
Cell (Australia): +61 419 897501
Cell (USA): +1-650-200-8145
collier@chemgenex.com
or
Buchan Consulting
Rebecca Wilson, +61 (0)3 9866 4722
Cell: + 61 (0)417 382 391
Media Relations – Australia
rwilson@bcg.com.au
or
Kureczka/Martin Associates
Joan Kureczka, +1-415-821-2413
Cell: +1-415-690-0210
Media Relations – USA
Jkureczka@comcast.net
When I quoted the fellow from Bristol and saying isn't it obvious I was joking, but it shows how the criteria in tumor response in press releases cannot be relied upon until the independent reviews are performed and announced.
The response rate shrank markedly from the ASCO abstract released in mid May to the actual ASCO presentation. In the abstract, the RR was 10/26 = 38.5% (#msg-37841570); in the actual presentation, the RR was 7/46 = 15.2% (http://finance.yahoo.com/news/Exelixis-and-BMS-Report-Phase-bw-15392385.html ).
Did Dr. Scangos offer any explanation for this discrepancy on the webcast?
Isn't it obvious
The independent review "is a very conservative picture," said Renzo Canetta, head of global oncology development at Bristol-Myers
Is the fact that Sanofi-Aventis is either not capitalized at all in the press release or only Sanofi is capitalized. Most of the time Sanofi is capitalized at the beginning of sentences.
Aventis is never capitalized. Was that on purpose?
Press Release Source: Exelixis, Inc.
Exelixis and Sanofi-aventis Sign Global License Agreement for XL147 & XL765 and Launch Broad Collaboration for Discovery of PI3K Inhibitors
Exelixis to Receive $140 Million Upfront Payment and Guaranteed Research Funding
On Thursday May 28, 2009, 1:00 am EDT
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sanofi-aventis (PARIS:SAN - News) and (NYSE:SNY - News) and Exelixis, Inc. (Nasdaq:EXEL - News) today announced a global license agreement for XL147 and XL765 and a broad collaboration for the discovery of inhibitors of phosphoinositide-3 kinase (PI3K) for the treatment of cancer. Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival and resistance to chemotherapy and radiotherapy. Under the license, sanofi-aventis will have a worldwide exclusive license to XL147 and XL765, which are currently in phase 1 and phase 1b/2 clinical trials, and will have sole responsibility for all subsequent clinical, regulatory, commercial and manufacturing activities. Exelixis will participate in conducting ongoing and potential future clinical trials and manufacturing activities.
Under the discovery collaboration, Exelixis and sanofi-aventis will combine efforts in establishing several pre-clinical PI3K programs and jointly share responsibility for research and preclinical activities related to isoform-selective inhibitors of PI3K. Sanofi-aventis will have sole responsibility for all subsequent clinical, regulatory, commercial and manufacturing activities of any products arising from the collaboration; however, Exelixis may be responsible for conducting certain clinical trials.
Sanofi-aventis will pay Exelixis aggregate upfront cash payments of $140 million under the license and collaboration. Exelixis will also receive guaranteed research funding of $21 million over a three year research term under the collaboration. For the license and the collaboration, Exelixis will be eligible to receive development, regulatory and commercial milestones of over $1 billion in the aggregate, as well as royalties on sales of any products commercialized under the license or collaboration.
“Sanofi-aventis has a track record of success in commercializing innovative cancer therapies and is deeply committed to advancing the care of cancer patients,” said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. “We believe that their expertise and resources will enable us to move aggressively in advancing the development of XL147 and XL765 and other potential PI3K inhibitors. The data generated to date in the XL147 and XL765 clinical programs suggest that these compounds may have utility in treating diverse cancers. Sanofi-aventis and Exelixis are committed to realizing the full potential of these compounds and other PI3K inhibitors to provide cancer patients with new treatment options.”
The effectiveness of the license and collaboration is subject to antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary regulatory approvals.
Osteologix Receives Key U.S. Patent Allowance for Novel Osteoporosis Drug
On Wednesday May 27, 2009, 8:30 am EDT
This is a phase 3 ready blockbuster drug
GLEN ALLEN, Va.--(BUSINESS WIRE)--Osteologix, Inc. (OTCBB:OLGX - News) today announced that is has received a Notice of Allowance from the U.S. Patent and Trademark Office for its U.S. Patent Application Number 11/269,289 titled "Water-Soluble Strontium Salts for Use in Treatment of Cartilage and/or Bone Conditions" reporting allowance of claims covering the treatment of osteoporosis and related bone conditions using NB S101 (strontium malonate), the Company's lead osteoporosis drug candidate. The Company expects the patent will issue in the second half of 2009; the patent's 20-year term would expire in 2024. The company has a number of other pending patent applications covering various aspects of the NB S101 drug program including composition, manufacturing and method of use patent applications.
"Based on the Notice of Allowance and the claims allowed by the USPTO, we believe the intellectual property protections established by this US patent allowance, coupled with our recently upheld European equivalent, will significantly enhance our ability to finalize strong development collaborations with potential partners to complete the Phase III development of NB S101 in osteoporosis," stated Philip J. Young, President and Chief Executive Officer of Osteologix.
About NB S101
NB S101 (strontium malonate) is a novel dual acting bone agent, or DABA, which clinical studies demonstrate, significantly improves bone density. This dual action on bone– a significant medical need that is not served by currently marketed treatments – suggests that NB S101 could fundamentally change the treatment paradigm of patients with osteoporosis. Importantly, NB S101 helps to build bone in a manner similar to the body’s own natural process by gently rebalancing bone metabolism in a way that favors strong bone development.
About Osteoporosis
Osteoporosis is the most common bone disease in humans and, according to the National Osteoporosis Foundation (NOF), 10 million Americans are estimated to have the disease and almost 34 million more are estimated to have osteopenia or low bone mass, placing them at increased risk for osteoporosis. The most severe consequence of osteoporosis is skeletal fracture. Osteoporosis is responsible for more than 1.5 million fractures annually and direct expenditures for hip fractures are estimated to cost society more than $18 billion annually, and by 2025 direct annual expenditures are expected to increase to $25 billion. According to NOF, one in two women and one in four men over age 50 can be expected to have an osteoporosis-related fracture at some time. Osteologix is developing NB S101 with physician thought leaders throughout the world to help treat the low bone mass in osteoporosis and ultimately lower the risk of bone fracture.
About Osteologix
Osteologix is a specialty biopharmaceutical company committed to improving the health of those afflicted with musculoskeletal diseases, such as osteoporosis. Its lead investigational product candidate, NB S101, is a novel pharmaceutical agent for the treatment and prevention of osteoporosis. For more information please visit www.osteologix.com.
ChemGenex Rights Issue Fully Subscribed, Further A$1 Million Placement Completed
- A$7.4 Million Rights Issue Completed - Top-Up Facility Scaled-Back Because of Excess Shareholder Demand - Further A$1 Million Placement, Combined With A$10 Million Placement in April 2009 Brings Total Capital Raise to A$18.4 Million
MELBOURNE, Australia, and MENLO PARK, California U.S.A.
May 27, 2009
ChemGenex Pharmaceuticals (ASX: CXS, NASDAQ: CXSP) announced today the completion of its 1 for 14 non-renounceable rights issue at A$0.43 per share, raising the maximum A$7.4 million. The rights issue was fully subscribed with demand being greater than the 17,122,453 shares available under the rights issue. The company has completed an A$1 million placement (2,325,580 shares at A$0.43 per share) to a small number of institutional investors to partially satisfy the strong demand and reduce the amount of scale-back required for the rights issue top-up facility.
Given the excess demand for new shares under the rights issue, a scale-back of requests for additional shares under the top-up facility will be implemented. Investors are advised that they may not receive the full amount of additional shares applied for under the top-up facility. Holding statements are expected to be dispatched to shareholders on Friday 29 May 2009, which will confirm the number of shares allotted to each applicant. Investors who participated in the top-up facility and want to trade their shares prior to receiving their holding statement should confirm their allocation before doing so.
The A$18.4 million raised through the rights issue and the two placements will be used primarily to:
complete clinical development and regulatory filings in the US and Europe for omacetaxine in in CML patients who have failed imatinib and who have the T315I mutation
further progress discussions with pharmaceutical companies to secure marketing and distribution partners for omacetaxine outside of the US
prepare for the commercial launch of omacetaxine in the US
The funds raised are intended to fund the company through to the launch of its lead product, omacetaxine, in the US (targeted for first quarter 2010).
The rights issue was underwritten by ABN AMRO Morgans Corporate Limited.
Dr Greg Collier, Ph.D., Managing Director and Chief Executive Officer of ChemGenex said, “We are delighted that there has been such a strong interest in this rights issue, and welcome several new institutional investors to the company. Having completed a very successful capital raising, we now look forward to clinical and pre-clinical data on omacetaxine being presented at oral sessions of two major international conferences in the coming weeks, and the completion of the first US and European regulatory submissions for omacetaxine in mid-year.”
About ChemGenex Pharmaceuticals Limited (www.chemgenex.com)
ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing personalized oncology medicines. ChemGenex harnesses the power of genomics both to discover novel targets and drug compounds, and in clinical trials to develop more individualized treatment outcomes. ChemGenex’s lead compound, omacetaxine mepesuccinate, is currently in phase 2/3 clinical trials for chronic myeloid leukemia (CML). ChemGenex has a second anticancer compound, amonafide dihydrochloride (Quinamed®) which is in phase 2 clinical development for various solid cancers, and a portfolio of assets in pre-clinical development. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS" and on NASDAQ under the symbol "CXSP". For additional information on ChemGenex Pharmaceuticals, please visit our web site at http://www.chemgenex.com.
Details on the clinical trials can be accessed from the following websites; (www.clinical trials.gov) and (www.tkiresistantcmltrials.com).
Contacts
ChemGenex Information Media Relations - Australia Media Relations - USA
Dr. Greg Collier Rebecca Wilson Joan Kureczka
CEO & Managing Director Buchan Consulting Kurezcka/Martin Associates
Cell (Australia): +61 419 897 501 Tel: +61 (0)3 9866 4722 Tel: +1 415 821 2413
Cell (USA): +1 650 200 81245 Cell: +61 (0)417 382 391
Email: gcollier@chemgenex.com Email: rwilson@bcg.com.au Email: Jkureczka@comcast.net
Safe Harbor Statement
aryx
I like aryx more for the AF and Propulsid look a likes, and the fact that they can seem to use their platform to make numerous more drugs that have blockbuster potential
To buy the stock here you have to really believe this enhanced warfarin will beat warfarin in the current trial. This is the drug I have my most doubts about.
If this trial fails then you buy the stock with both hands because the AF drug will garner good partnership terms in my opinion.
This drug will be approved early next year
ChemGenex to Present Pivotal Data in T315I Positive CML Patients as Oral Presentation at ASCO
MELBOURNE, Australia, and MENLO PARK, California U.S.A.
May 15, 2009
ChemGenex Pharmaceuticals Limited (ASX:CXS and NASDAQ:CXSP) announced today that updated clinical data from the registration-directed clinical trial of omacetaxine will be presented as an oral presentation at the forthcoming American Society of Clinical Oncology (ASCO) 45th Annual Meeting in Orlando, Florida.
Data from the pivotal study on the use of omacetaxine in chronic myeloid leukemia (CML) patients who have failed imatinib and who harbor the T315I mutation, will be given at 11:30 am on Monday 1st June, by Dr. Jorge Cortes, MD, Professor of Medicine and Deputy Chair in the Department of Leukemia at The University of Texas, MD Anderson Cancer Center. the only drug that has shown efficacy in that mutation
In addition, a poster on the company’s complementary phase 2 study investigating the potential use of omacetaxine in CML patients with resistance to multiple tyrosine kinase inhibitors (TKIs), will be presented between 5-6 pm on Friday 29th May by Dr. Meir Wetzler MD, Chief of the Division of Leukemia, School of Medicine and Biomedical Sciences, University at Buffalo, Roswell Park Cancer Institute.
Commenting on today’s publication of the final program for ASCO, Greg Collier, Ph.D., Managing Director and Chief Executive Officer of ChemGenex said, “We are delighted that our late stage product candidate, omacetaxine, will be presented at a podium session during this prestigious conference.”
Link to their corporate slide presentation
http://www.chemgenex.com/pdf/CXSCorporateOverviewApril152009.pdf
The treatment cost now seems abnormally large.
you bet your bippy it is
your calculator is broken
6200 time 75000 comes to 465 million, not 7500.
I never said it wouldn't work in dystrophies
he is selling it in als and there isn't any data it would work there.
how can Insmed charge these prices without any data that the drug works for ALS
Increlex is IGF-1 and that was the drug that Cephalon tried to get approved and the trials failed, so any doctor prescribing that should be shot.
YM BioSciences (YM.TO) Licenses Monoclonal Antibody, Nimotuzumab, To Daiichi Pharmaceutical (JPN) For Japan; CIMYM BioSciences Inc. To Receive Up-Front Payment Of $14.5 Million
7/31/2006
I don't think Daiichi is unknown
MISSISSAUGA, ON, July 31 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), a company engaged in the acquisition, development and commercialization of oncology and acute care products, today announced that its majority owned subsidiary, CIMYM BioSciences Inc. (CIMYM), has licensed development and marketing rights in Japan for its anti-EGFR humanized antibody, nimotuzumab, to Daiichi Pharmaceutical Co., Ltd. (a wholly owned subsidiary of DAIICHI SANKYO COMPANY, LIMITED, one of Japan's largest pharmaceutical companies).
Under the agreement, CIMYM will receive an up-front payment of US$14.5 million and significant milestone payments at certain stages of development for each of a number of indications as well as payments based on supply of nimotuzumab and sales performance in the territory. Daiichi will develop nimotuzumab for the Japanese market in several cancer indications.
"This is an exceptional agreement that provides nimotuzumab with the prospect of accessing the second largest pharmaceutical market in the world. The license will result in a substantial broadening of the development and commercialization efforts directed to our anti-cancer antibody," said David Allan, Chairman & CEO of YM BioSciences.
In July 2006, nimotuzumab was approved in India for the treatment of head and neck cancer. Nimotuzumab is currently in a Phase IIl trial in Europe in combination with radiation for the treatment of pediatric pontine glioma. A trial in North America in pediatric pontine glioma is also currently in design. Nimotuzumab is being variously developed in non-small cell lung cancer, pediatric glioma and pancreatic cancer in Canada and Europe and YM is preparing to pursue further clinical development of the drug in adult glioma and colorectal cancer as well as a number of other indications. YM's licensor, CIMAB SA, and its parent, the Center for Molecular Immunology, are conducting trials with nimotuzumab in glioma, breast, esophageal, uterine cervix, prostate and head and neck cancers. In the pediatric and adult trials in Europe, the head & neck trial in India, and in trials in Canada and elsewhere, the debilitating side effects of severe rash, diarrhea, conjunctivitis and hypomagnesemia, evident in some or all of the other products in development targeting the tyrosine kinase pathway, were not observed.
About DAIICHI SANKYO COMPANY, LIMITED.
DAIICHI SANKYO COMPANY, LIMITED was established on September 28, 2005 as the joint holding company of two major Japanese pharmaceutical companies - Sankyo Co., Ltd. and Daiichi Pharmaceutical Co., Ltd. DAIICHI SANKYO aims to become a Global Pharma Innovator, continuously generating innovative drugs and services and maximizing its corporate value. Sankyo and Daiichi Pharmaceutical have experience developing and marketing one of the world's leading oncology products, Irrinotecan Hcl, in Japan and have a broad range of major drug products in that market, including the antihypertensive Olmetec® (olmesartan medoxomil) and the synthetic antibacterial agent Cravit® (levofloxacin) and are strongly promoting drug information provision activities. In addition to cancer, both companies are established in the field of cardiovascular disease and have used their cumulative knowledge and expertise as a foundation for developing an abundant product lineup and R&D pipeline.
For further details, please refer to the company Web site, at http://www.daiichisankyo.co.jp/eng.
Conference Call Notice
YM BioSciences will be holding a conference call for Analysts and Portfolio Managers to discuss the licensing agreement on Monday, July 31, 2006 from 11:00am EDT. To participate in the conference call, dial 416-644-3415 or 1-866-250-4910. The conference call will also be audio cast live and archived for 90 days at www.ymbiosciences.com.
Other drug development activities at YM BioSciences
We will still be left with the underlying pothole in the law. I think there is a real policy problem to solve here. Of course, I would like the money. The money would be useful to help me build my company. But it wouldn't save a single life. I don't think at this stage that a lawsuit is going to move any of us forward. Certainly, it is not going to move forward the well-being of any patient. So for us, at this point, we would rather come here and debate the merits of fixing this hole in the law than suing our law firm."
He seems to be complaining that he doesn't want to sue the law firm because that doesn't save any lives. How does keeping his drug branded and not allowing it to become generic, save any lives?
what is he talking about?
according to the article insmed now has permission to give out the drug for compasssionate use and run trials.
they have a 130 million in the bank but aren't sending the drug or paying for the trial
Geoff Alan is a great guy.