August 1, 2008
As many of you know, and believe me, I am not patting myself on the back, I was an early opponent of Tysabri and was early in predicting the removal of Tysabri from the market in 2005.
As many of you also know, I was vehemently opposed to the FDA's decision to approve Tysabri, for re-introduction in the U.S., even with the so-called "black box label." The fact that European drug agencies had approved the drug for the treatment of multiple sclerosis (MS) did not provide me any comfort.
Please, please, take note of the following press release from Biogen-Idec and Elan, manufactures/marketers of Tysabri:
http://www.bloomberg.com/apps/news?pid=conewsstory&refer=conews&tkr=BIIB:US&sid=a40u7vb1OLaw
In short, progressive multifocal leukoencephalopathy has now been found among a small number - very small at this point - of patients taking the drug for MS. Many prominent neurologists - many whom I deeply respect - have been supporters of this "treatment." Again, despite this, I have remained adamantly opposed to the use of this drug.
Why? I am sorry. But the risk of developing a deadly brain virus, even if the manufacturers quantify the risk at very low percentages, just seems a bit too HIGH for me relative to a) the fact that MS, itself, is not deadly, and b) there are other options. AND, while those options are not yet perfect, there are several new drugs in late stage clinical trials, including oral medications, that so far are proving far more effective in treating MS.
Biogen-Idec and Elan state that they have no intention of voluntarily pulling Tysabri from the market - once again.
As the news report from Bloomberg, a major business news sources, reports, the companies still plan to have 100,000 people on Tysabri by 2010. However, as of today, the stock market has made the assumption, by dropping the prices of the stocks, that the market for Tysabri will soon evaporate. As, in my humble opinion, it should.
For far too long, people with MS and others diseases, have been used as a guinea pig population, with the FDA permitting companies to rush new compounds to market. There is a trade-off here. I understand that. People want treatments. They want effective treatments. Many people that suffer from diseases such as MS want new treatments because they feel increasingly feel frustrated - and rightly so (being one of them) - with the persistent march of their illnesses and the negative impacts on the quality of their lives.
I understand all of that. I also understand that two pharmaceutical companies, Merck and Pfizer, that have performed clinical trials on very inexpensive drugs - statins - for the potential treatment of MS, seem to have no interest in pursuing the MS market with those soon-to-be off patent protection Pfizer's Lipitor), or already off patent protection (in the case of Merck's Zocor/simvastatin) drugs. After all, the MS market is far more lucrative if you can offer a new drug for $2,000 - $4,000 monthly instead of $23 - $100 a month. Keep in mind, in the U.S., there are only about 400,000 known cases of MS. So it's not a huge market.
I hope that you can take time to pass this Tysabri news on to people that may be interested.
Let me see. The possibility of death vs. living with MS. For me, however small the risk of progressive multifocal leukoencephalopathy, I will happily live with MS.
Sincerely,
Cary J. Polevoy
A resource for informing patients and caregivers about Multiple Sclerosis, its possible causes, effects, and treatments. Get the most current information on new developments, clinical trials and other important matters for anyone dealing with MS.
Showing posts with label merck. Show all posts
Showing posts with label merck. Show all posts
Saturday, August 02, 2008
Wednesday, October 10, 2007
Merck KGaA's Rebif, Teva's Copaxone similar-study

Wed Oct 10, 2007 5:01am EDT
FRANKFURT, Oct 10 (Reuters) - Merck KGaA's (MRCG.DE: Quote, Profile, Research) Rebif multiple-sclerosis drug is not superior to rival Teva's (TEVA.O: Quote, Profile, Research) Copaxone, a study obtained by Reuters on Wednesday showed.
"The number of events (relapses) was insufficient to establish a statistically significant difference between the two products, despite a trend advantage for Rebif," the report said.
The 96-week Phase IV study involving almost 800 patients will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague.
Merck inherited Rebif through its recent 10.2 billion-euro
($14 billion) acquisition of Swiss biotech company Serono.
Serono had hoped to gain market share from Copaxone in the case of a positive outcome from the head-to-head study.
Merck shares were 1.6 percent lower at 88.20 euros at 0908 GMT, compared with a flat blue-chip DAX index (.GDAXI: Quote, Profile, Research).
((Reporting by Mantik Kusjanto; Reuters Messaging: mantik.kusjanto.reuters.com@reuters.net; E-mail: mantik.kusjanto@reuters.com; +49 69 7565 1203))
© Reuters2007All rights reserved
Tuesday, May 08, 2007
MultiCell Technologies Signs Key Formulation and Supply Agreement With Merck KGaA & Co. Spittal/Drau

Agreement Brings MultiCell Closer to Initiation of Phase IIb Clinical Trials
SAN DIEGO, CA--(MARKET WIRE)--Apr 18, 2007 -- MultiCell Technologies, Inc. (OTC BB:MCET.OB - News) has entered into an agreement with Merck KGaA & Co. Spittal/Drau Austria for the formulation and supply of one of the active components of MCT-125, MultiCell's Phase IIb drug for the treatment of chronic fatigue in patients with multiple sclerosis (MS).
About two million people worldwide are afflicted with MS, and an estimated 10,000 new MS cases are diagnosed yearly in the USA. Over 75% of MS sufferers report chronic fatigue and 50% to 60% report chronic fatigue as the worst symptom of their disease. Chronic fatigue severely affects an individual's quality of life. In approximately 30% of MS patients, chronic fatigue is the first symptom, and there is no FDA-approved treatment available for this disease.
In a 138-patient, multi-center, double-blind, placebo-controlled Phase II clinical trial conducted in the United Kingdom, MCT-125 demonstrated efficacy in significantly reducing the levels of fatigue in all three types of MS patients enrolled in the study. MCT-125 demonstrated effectiveness within 4 weeks of the first daily oral dosing. Patients enrolled in the Phase II trial also reported few if any side effects following daily oral dosing of MCT-125. The initial trials were conducted by Amarin Corporation plc who developed the drug as LAX-202.
"We are pleased to have the opportunity to work with an outstanding company like Merck KGaA & Co. Spittal/Drau, and look forward to a long-term relationship. This contract is another key component required for us to commence planned Phase IIb human clinical trials. We are building a solid foundation for the future development of this much need therapeutic, and each new agreement brings this plan closer to reality," stated Dr. Stephen Chang, President and CEO of MultiCell Technologies.
About Merck KGaA & Co. Spittal/Drau
Merck KGaA & Co. Spittal/Drau Austria manufactures bulk and finished pharmaceutical products for third parties, including solid oral dosage forms, semisolids, and liquid products. Merck KGaA & Co. Spittal/Drau is well known for its high quality, excellent customer service, pharmaceutical technology know-how, and optimizing production processes in coordination with its customers. For more information about Merck KGaA & Co. Spittal/Drau Austria see http://www.merck-spittal.at.
About MultiCell Technologies
MultiCell Technologies, Inc. is developing first-in-class drugs based on advanced immune system modulation technologies, and is an integrated biopharmaceutical company committed to the development of breakthrough therapeutics based on a portfolio of therapeutic candidates and patented drug development technologies. MultiCell's drug development program focuses on modulation of the immune system.
MultiCell's therapeutic pipeline includes:
MCT-125 a Phase IIb drug for the treatment of chronic fatigue in MS
patients.
MCT-175 for the treatment of relapsing-remitting MS.
MCT-275 for the treatment of juvenile diabetes.
MCT-465 for the treatment of virus infection and cancer.
MCT-475 for the treatment of colorectal cancer.
The Company also holds unique cell-based technology for use in drug discovery screening applications, and is a leading producer of the cell lines needed by the pharmaceutical industry to develop new drugs. For more information about MultiCell Technologies, please visit http://www.multicelltech.com.
Caution Regarding Forward-Looking Statements
Any statements in this press release about MultiCell's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). These statements are often, but not always, made through the use of words or phrases such as "believe," "will," "expect," "anticipate," "estimate," "intend," "plan," "forecast," "could," and "would." Examples of such forward looking statements include statements regarding the timing, design, scope, and anticipated results of our clinical development programs. MultiCell bases these forward-looking statements on current expectations about future events. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by any forward-looking statement. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections in the forward-looking statement include, but are not limited to, the risk that we might not achieve our anticipated clinical development milestones, receive regulatory approval, or successfully commercialize our products as expected, the market for our products will not grow as expected, and the risk that our products will not achieve expectations. For additional information about risks and uncertainties MultiCell faces, see documents MultiCell files with the SEC, including MultiCell's report on Form 10-KSB for the fiscal year ended November 30, 2006, and all our quarterly and other periodic SEC filings. MultiCell claims the protection of the safe harbor for forward-looking statements under the Act and each assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Contact:
MultiCell Technologies, Inc.
Dr. Stephen Chang, 858.200.0598
MCETInvestor@MultiCelltech.com
Source: Market Wire (Wednesday April 18, 9:00 am ET)
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