sclerosis drug

Lilly sees pipeline hope in MS drug

Mon, 11 Feb 2008 06:59:54 -0500

An article in the Indianapolis Star details Lilly's development program for MBP9289, a multiple sclerosis drug offering hope to both patients and a drug developer that hasn't launched a new drug for humans since 2005. MBP9289 is currently in Phase II and III trials and has shown promise in delaying progression and worsening of MS. The opportunity here for Lilly is huge--roughly 2.5 million people worldwide have the disease, and MS-related drugs did $6 billion in sales last year. Moreover, those who treat the MS say the disease is under-served by current treatments.

"Given Lilly's prominence in neurosciences, an expansion into multiple sclerosis makes strategic sense," said Linda Bannister, a drug analyst at Edward Jones in St. Louis. "But whether this compound is the answer, it's too soon to say."

- read this IndyStar article

ALSO: Take a look at Lilly's pipeline. Report

Related Articles:
Lilly snares MS drug rights in $497M deal. Report
BioMS gains $38.5 million. Report
Natural protein used to combat multiple sclerosis. Report

ALSO NOTED: Acorda shares bounce on new data; Endo CEO hits the exit door; BioSante in protocol deal; and much more...

Tue, 29 Jan 2008 06:59:50 -0500

> Shares of Acorda Therapeutics took a big bounce yesterday when the company announced new data demonstrating that its multiple sclerosis drug Fampridine-SR does not raise heart-related risks higher than a placebo. Release

> Endo Pharmaceuticals CEO Peter Lankau has handed in his walking papers. Endo says he is leaving March 1 and will be replaced by its COO and CFO on an interim basis. Release

> BioSante Pharmaceuticals has reached agreement with the FDA on a special protocol assessment for its Phase III trials for LibiGel--a therapy for female sexual dysfunction. Report

> Following a recommendation from the FDA, NPS Pharmaceuticals is preparing a confirmatory late-stage study of Gattex in patients with short bowel syndrome. Report

> Shares of Medarex were buoyed yesterday by an analyst's remark that its cancer drug--ipilimumab--which delivered disappointing data in December, may yet demonstrate its ability to improve overall survival rates. Report

> Amsterdam-based Pharming says it expects a final EMEA decision on Rhucin in the second quarter and is close to detailing its request that the EMEA reexamine its application to market Rhucin in Europe. Report

> The FDA issued a warning letter to Replidyne regarding antibiotic faropenem medoxomil 300 mg. Letter

> Pipex Pharmaceuticals announced that its New Drug Application for oral tetrathiomolybdate has not been accepted by the FDA for further review as submitted. Release

> As if questions about the effectiveness of cholesterol meds weren't enough, now research is casting blood pressure remedies into doubt. Report

> Workers at Pfizer's Terre Haute, Indiana, plant where the ill-fated Exubera was made are, shall we say, less than exuberant today. The company has decided to cut 660 jobs there. Report

And Finally... Here's a troubling milestone: Bird flu deaths in Indonesia have hit 100. Report

Sources: Biogen gets bidders, with Pfizer in lead

Thu, 08 Nov 2007 06:59:56 -0500

The Financial Times is reporting some tantalizing details about the bidding for Biogen Idec, the biotech based in Cambridge, MA, that sent stock analysts into an uproar when it put itself up for sale a few weeks ago. Unnamed sources told the London newspaper that the sequence of events leading to that surprise announcement actually began with Pfizer offering $80 per share for the company. Investor Carl Icahn (photo) then made a counter-offer, and the company retained financial advisors to conduct an orderly sale. Even now, Pfizer remains one of the front-runners for Biogen, the sources said, along with Merck and Johnson & Johnson.

Some other buyers have already dropped out of the race, spooked by the "nosebleed prices" expected. Icahn offered $23 billion, so the winning bid is likely to be higher. Are Biogen's assets worth that much? They include the multiple sclerosis drug Tysabri, in partnership with Elan; the lymphoma and arthritis remedy Rituxan, in collaboration with Genentech; and the MS drug Avonex, which is wholly owns. It also has a pipeline of drugs in development, including two promising MS products.

Meanwhile, headhunters are getting calls from Biogen types expecting a sale to lead to the layoff ax. The non-executive staff is anxious, recruiters said, even though the company continues to hire new workers.

- check out the buyout report from the Financial Times
- read about Biogen staff seeking shelter at Inside Recruiting

Related Articles:
Biotech stocks surge as investors anticipate buyouts. Report
Speculation soars over Pfizer's interest in biotech. Report
What's Biogen Idec really worth to Big Pharma? Report
Will Big Pharma buy Biogen Idec? Report
Biogen Idec in play after Icahn makes his move. Report
Who should Pfizer buy? Report

Tysabri gets European backing at EMEA

Thu, 27 Apr 2006 20:01:38 -0400

Tysabri has taken one more step back to the global market, winning a recommendation from the European Medicines Agency that the multiple sclerosis drug be returned for restricted use. The EMEA advised the EU that Tysabri should be marketed for relapsing-remitting MS patients, delaying disability progression and reducing the rate of relapses. An FDA committee recommended that Tysabri be marketed as a first-line therapy for all MS sufferers. Tysabri was pulled early last year after it was linked to three cases of a rare brain disease. Elan's shares surged four percent on the news.

- here's the Marketwatch article for more information

Novartis M.S. drug shows sustained efficacy

Wed, 05 Apr 2006 20:01:39 -0400

Novartis has released impressive results from an extended Phase II study of its oral multiple sclerosis drug FTY720. Two groups taking different dosages experienced a greater than 50 percent reduction in annualized relapse rates during the first six months compared to a placebo. They maintained that rate over the next 12 months. The drug demonstrated high efficacy and tolerability levels. Standard MS treatments have relapse rates of less than 30 percent and often require frequent injections. Novartis is in a race with Serono to gain approval for the first oral M.S. drug. And analysts were clearly impressed by Novartis' prospects if it duplicates these results in a broader pivotal trial.

- read the AFX report for more information

FDA delays decision on Tysabri

Tue, 21 Mar 2006 19:01:39 -0500

In an unexpected move, the FDA has delayed its decision on returning Tysabri to the market. Elan and Biogen Idec said that they had been notified that regulators would now make a decision on or before June 28, three months after a decision had first been expected. An FDA expert committee has voted in favor of returning Tysabri and most analysts had concluded that despite earlier safety problems it was likely that regulators would give the multiple sclerosis drug a green light. The agency's latest move startled investors, sending Elan's shares down in overnight trading.

- here's the AP report for more information

Neurologists criticize Tysabri study

Thu, 02 Mar 2006 19:01:36 -0500

Two prominent Stanford neurologists criticized a trial of the controversial multiple sclerosis drug Tysabri for including a patient that didn't demonstrate symptoms of MS. Dr. Annette Langer-Gould and Dr. Lawrence Steinman write in The Lancet that when a company test a drug that has a potential for harming patients, researchers need to be acutely aware of the risk-benefit balance when enrolling people for a study. One enrolled patient who died, Anita Louise Smith, had actually been diagnosed with MS but didn't have symptoms. It was subsequently determined that she did not have the disease. The neurologists say that researchers should reexamine the rationale for including a patient that had no disability, especially when other, safe drugs were available.

Tysabri was jerked from the market a year ago after two patients died from a rare brain disorder. An FDA committee is scheduled to examine whether Tysabri should be allowed back on the market. New data published this week has supported researchers' view that the drug is safe and effective in the short term.

- read this report from Forbes

NEJM publishes positive 2-year Tysabri data

Wed, 01 Mar 2006 19:01:37 -0500

With an FDA committee meeting looming to review the status of Tysabri, the New England Journal of Medicine published the results of two Phase III trials plus a safety evaluation that concluded the multiple sclerosis drug cut the risk of disease progression by 42 percent. Tysabri also cut the risk of relapse over a year by 68 percent. Tysabri was withdrawn from the market a year ago after three cases of a rare brain disorder called PML were reported among patients taking the drug. Two of those cases were fatal. In an accompanying editorial, the Journal noted that the risk of PML was small with brief use. A number of analysts are looking for the FDA to allow Tysabri's return, but with limited use and strict safety oversight to guard against any new cases of PML.

- here's the report from MarketWatch

FDA allows limited trial of Tysabri

Wed, 15 Feb 2006 19:01:39 -0500

The FDA has decided to allow Biogen Idec and Elan to use Tysabri in clinical trials under limited circumstances, which many analysts see as a step toward eventually allowing the multiple sclerosis drug back on the market. For now, the agency says it will allow the use of Tysabri among trial patients who had earlier shown signs of benefiting from the drug. The FDA will decide whether or not it will allow Tysabri back on the market--possibly in some limited fashion--by the end of March. Tysabri was approved in November 2004 and abruptly jerked from the market a few months later after several patients taking the drug contracted a rare brain disease called PML. Two of those patients died. Researchers say they'll start a trial with Tysabri that closely monitors for PML. The drug will be studied alone. Both of the MS patients that suffered from PML had been taking a combination of Tysabri and Avonex.

- read this article from The New York Times

ALSO: Biogen Idec reported that fourth quarter sales nearly doubled on rising income from its old MS drug and Rituxan. Report

SPOTLIGHT: Novartis touts mid-stage results for MS drug

Sun, 02 Oct 2005 20:01:33 -0400

Novartis said that a mid-stage trial of an oral multiple sclerosis drug demonstrated sustained benefits and good tolerability in patients. The results will clear the way for discussions with the FDA for a Phase III trial to begin next year. Story

Schering: MS drug reduces onset by 50%

Thu, 29 Sep 2005 20:01:39 -0400

Schering has unveiled Phase III trial data that shows its multiple sclerosis drug Betaferon reduced the risk of developing the disease among early-stage patients by 50 percent. Schering said it will seek approval for a wider use of the drug by expanding its label. That would help enhance sales of the drug, which hit $939 million last year. The data was presented at the European Committee for Treatment and Research in Multiple Sclerosis conference in Greece.

- read this story from AFX for more

Biogen requests renewed marketing of Tysabri

Mon, 26 Sep 2005 20:01:38 -0400

Biogen Idec is seeking a revised license to sell the multiple sclerosis drug Tysabri. Biogen and Elan pulled the drug from the market earlier in the year after several patients on the drug contracted a rare brain disease. The application contained data from what Biogen billed as an extensive safety review of the drug. Biogen is also seeking an accelerated review of Tysabri, which could bring an FDA response within six months. The same data is being added to the drug company's European application, which is still pending. Analysts say that any renewed marketing of Tysabri is likely to come with a new warning label.

- read this article from the Boston Globe for more

FEATURE: New generation of biomarkers may reduce health risks

Thu, 21 Jul 2005 20:01:32 -0400

Dr. Mario Ehlers discusses how new biomarkers can reduce the risks from pharmaceutical drugs.

The problem of serious physical risks associated with pharmaceutical drugs is not going away. While the arthritis drug Vioxx, pulled from the market by its manufacturer last year after it was shown to double the risk of heart attack and stroke, remains the most high-profile example, a significant number of pharmaceutical medications have been linked with health risks in recent years.

Rezulin, for type 2 diabetes, was taken off the market in 2000 because of its association with severe liver toxicity. This past year, Celebrex and Bextra, in the same class as Vioxx, made headlines for their adverse effects; and in February, sales of the multiple sclerosis drug Tysabri were suspended after it was suspected of triggering a rare brain disease in three patients, two of whom died from the disease. Most recently, safety concerns have emerged about the heart failure drug Natrecor, and doctors at the Cleveland Clinic are considering curtailing its use, after two medical journal studies reported that it increased kidney problems and death rates among patients.

Some people fault the FDA, claiming that the agency does not sufficiently monitor pharmaceutical drugs for safety during clinical trials. Based on my own years of experience in the biopharmaceutical industry, I consider the FDA to be extremely rigorous in their standards for drug safety during the approval process. But no matter how carefully the FDA and drug companies monitor for safety, the potential for a low incidence of serious side effects will always exist: There is simply no way to guarantee that pharmaceutical drugs will ever be entirely risk-free.

That said, there are actions that legislators and drug-development scientists can take to minimize serious health risks associated with pharmaceutical agents. (On the science front, progress is already underway.) What's more, this can be accomplished without unduly delaying the development of new medical treatments. These measures fall into two categories:

Greater FDA Control Following Drug Approval
Although a pharmaceutical drug cannot be marketed without FDA approval, the agency has insufficient control over what happens to a drug after it reaches the market. Federal laws governing drug safety withdrawals are limited and therefore in the event of reported health risks the FDA generally asks manufacturers to withdraw the drug voluntarily. While drug makers almost always comply, there is a question about the completeness and promptness of product withdrawals.

A recent example: In April, the FDA requested that Pfizer, the maker of Bextra, withdraw the drug after reports of some users experiencing serious skin reactions, as well as concerns about cardiovascular risks. On its website, the FDA posted, "Pfizer has agreed to suspend sales and marketing of Bextra in the US, pending further discussions with the agency." Despite widespread reports in the media that the drug was withdrawn, sales of Bextra have been suspended but the drug has not been formally removed.

To prevent the availability of potentially unsafe medications, legislation is needed that will give the FDA greater resources for post-marketing surveillance and unilateral power to withdraw drugs that the agency regards as posing insufficient benefit or serious risk.

Identifying At-Risk Consumers
As the Genome project and other scientific advances have brought about a greater understanding of human genetics and biology, one extremely promising result has been the increased use of biomarkers in drug discovery and development. A biological indicator that can be used to measure the progress of disease or the effects of treatment (the biomarker hemoglobin A1C, for instance, shows how well a diabetes drug is controlling blood glucose), biomarkers are used today during drug discovery in every therapeutic area.

The newest generation of biomarkers, still in its incubation phase, will enable a new treatment paradigm known as theranostics (for "therapeutic" and "diagnostic"). Theranostics involves a tight coupling between diagnostics and therapies, such that a biological indicator determines in advance which patients will respond to a particular treatment. By targeting these patients, the biomarkers favorably alter the risk-benefit profile of pharmaceutical drugs, allowing non-responders to avoid potential side effects unbalanced by therapeutic gain. These biomarkers promise to eliminate much of the uncertainty involved in prescribing medications -- and result in significant healthcare savings.

The best-known theranostic currently on the market is the biomarker for Herceptin, a drug for suppressing tumor growth in patients with metastatic breast cancer, which is used to test biopsy samples of tumors: A sample that tests positive indicates that the patient can be helped by the drug. Given that Herceptin is effective in only about a quarter of patients, the biomarker for this drug is particularly useful.

The next phase of biomarker research, already underway, is to develop biological indicators identifying patients likely to experience adverse effects from a pharmaceutical drug. Not only will such biomarkers reduce the incidence of side effects from medications -- they will also be a means to help keep widely effective, potentially lifesaving drugs available to the public.

Consider the case of Tysabri, the multiple sclerosis drug removed from the market after three users developed brain disease. As a result of the withdrawal, thousands of MS patients who were not adversely affected by the drug nonetheless lost access to it. Once there is a way to target the tiny minority of individuals who cannot safely take a particular drug, the medication can then remain available to the overwhelming majority of patients able to use it without adverse effect. (Biogen Idec, the maker of Tysabri, announced in April that it is conducting a safety review of the drug to determine whether it can be prescribed to certain patients if they are closely monitored.)

It will be years before these biomarkers become available, but there is already much to be excited about. Virtually every major drug and biomedical companies is now engaged in biomarker research. The companies collect genetic information from patients (via blood samples) at clinical trials, and the FDA, which recently issued guidelines on performing these procedures, is encouraging such collection of genetic material toward further research on the new science of "pharmacogenomics," the link between specific genetic profiles and the effects of drugs. Theranostics is taking us closer to what, arguably, is our ultimate goal: true personalized medicine.

Pharmaceutical drugs will never be 100 percent free of risk. But with greater FDA control of drugs already on the market -- and continued advances in biomarker research -- we can greatly reduce the risk of serious side effects for the millions of people who take these medications.

Mario R. Ehlers, MD, PhD, is chief medical officer of Seattle-based Pacific Biometrics, a central laboratory supporting drug and diagnostics development.

Serono drug draws FDA warning on heart risk

Tue, 24 May 2005 20:01:36 -0400

The FDA issued a warning that Serono's multiple sclerosis drug Novantrone raised the risk of heart damage. A boxed warning has been added to the drug's packaging, and the Swiss company has advised patients to be tested for heart disease before dosing. Patients taking Novantrone can experience congestive heart failure during therapy or even years after therapy is completed. The drug was approved by the FDA in 2000. In recent months the agency has raised a number of drug alerts as it responds to criticism that it ignored earlier signs of unsafe drugs.

- read this story from Dow Jones for more on the warning