Oral Tysabri steps up to the plate
BiopharmaReporter.com - Montpellier,France
The two companies' candidate, currently going by the name CDP323, is an oral VLA-4 antagonist (as is Tysabri) intended for the treatment of ...
See all stories on this topic

UCB And Biogen Idec's Oral VLA-4 Antagonist (CDP323) Enters Phase II Development For Multiple Sclerosis
Medical News Today Sat, 30 Jun 2007 1:08 AM PDT
UCB (Euronext Brussels: UCB) and Biogen Idec (NASDAQ: BIIB) yesterday announced the initiation of a Phase II study of CDP323 - an oral VLA-4 antagonist - under development for relapsing-remitting multiple sclerosis (MS). The double-blind, randomized Phase II study commenced this week with dosing of the first patient. [click link for full article]

Acorda Therapeutics' President and CEO Ron Cohen, MD Named Ernst ...
Business Wire (press release) - San Francisco,CA,USA
Acorda is conducting Phase 3 trials of Fampridine-SR to evaluate its safety and efficacy in improving walking ability in people with MS. ...
See all stories on this topic

1,800,000 U.S. VETERANS HAVE NO HEALTH CARE

by Victor Martinez

Nothing funny about 'Sicko'
Michael Moore's documentary "Sicko," which opens nationwide Friday, is not funny. It is tragic. You will not come out of the movie theater smiling. Hopefully you will leave angry. And you should. "Sicko" is right on target about the mess that is American health care.

Teva, Active Biotech in advanced trial of MS drug
Reuters - USA
ST: Quote, Profile, Research said on Thursday they would start a clinical Phase III trial of relapsing multiple sclerosis drug Laquinimod. ...
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Analyst Available to Comment on Impact to the Pharmaceutical ...
PharmaLive.com (press release) - Newtown,PA,USA
For possible biogeneric forms of Rituxan and Campath, the majority of oncologists said they would prescribe biogeneric versions within one year. ...
See all stories on this topic

Genzyme Stock Rises on Lehman Upgrade
Forbes - NY,USA
Other positive pipeline opportunities include the leukemia drug Campath as a treatment for multiple sclerosis. Questions or comments about this story should ...
See all stories on this topic

Reformulated Rebif right on track
In-PharmaTechnologist.com - Montpellier,France
Although Novartis is not far behind and planning Phase III trials of its compound FTY720 (fingolimod) and both companies hoping to file in 2009, ...
See all stories on this topic

Dads, moms equally likely to pass MS risk to kids
Reuters via Yahoo! News Wed, 27 Jun 2007 1:09 PM PDT
Mothers and fathers with multiple sclerosis are equally likely to pass genetic risk for it on to their children, according to a study countering a previous finding that fathers were twice as likely to do so.

Men and women equally transmit genetic risk of MS to their children
EurekAlert! Wed, 27 Jun 2007 1:07 PM PDT
ST. PAUL, Minn -- Men and women with multiple sclerosis (MS) equally transmit the genetic risk of the disease to their children, according to a study published June 27, 2007, in the online edition of Neurology?, the medical journal of the American Academy of Neurology.

Study Finds Men and Women With MS Equally Transmit Genetic Risk to Offspring
RedNova Wed, 27 Jun 2007 5:23 PM PDT
TORONTO (CP) - A study of Canadian families with a parent who has multiple sclerosis has found men and women transmit the genetic risk of MS equally to their children.

Men, women equally pass on genetic risk of MS
CTV.ca Wed, 27 Jun 2007 1:12 PM PDT
Men and women with multiple sclerosis equally transmit the genetic risk of the disease to their children, a new Canadian study concludes.

Men and Women Equally Transmit Genetic Risk of MS to Their Children
Newswise Wed, 27 Jun 2007 2:20 PM PDT
Men and women with multiple sclerosis (MS) equally transmit the genetic risk of the disease to their children, according to a study published June 27, 2007, in the online edition of Neurology, the medical journal of the American Academy of Neurology. The research contradicts the results of a recent study, which found affected fathers were more likely than affected mothers to transmit the risk of ...

'Cars' Imaging Reveals Clues to Myelin Damage
Newswise Wed, 27 Jun 2007 12:20 PM PDT
Researchers have discovered that calcium ions could play a crucial role in multiple sclerosis by activating enzymes that degrade the fatty sheath that insulates nerve fibers.

Scientists discover a new line of communication between nervous system cells
News-Medical-Net Wed, 27 Jun 2007 5:34 PM PDT
In a host of neurological diseases, including multiple sclerosis (MS) and several neuropathies, the protective covering surrounding the nerves - an insulating material called myelin - is damaged.

Path for generic biologics clears Senate panel
Reuters via Yahoo! News Thu, 28 Jun 2007 6:18 AM PDT
A U.S. Senate panel voted on Wednesday to set a path for generic drugmakers to seek approval of cheaper, copycat versions of expensive biotechnology medicines.

Biogen Idec "neutral," estimates raised
newratings.com - USA
There is a risk of cannibalization of Avonex revenues by Tysabri in the near term, the analysts say. The EPS estimates for 2007, 2008, 2009 and 2010 have ...
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Congressionally Directed Medical Research Program
Position: Every hour, someone in the United States is diagnosed with MS and approximately 400,000 Americans are living with the disease. There is no cure and the treatments are often difficult to endure and very expensive. Despite that, MS research funding is decreasing at the National Institutes of Health (NIH), the leading source of research funding for the disease.
This reality has made it necessary for the National Multiple Sclerosis Society to seek ways to diversify funding avenues. One logical program is the Congressionally Directed Medical Research Programs (CDMRP).
CDMRP is funded through the Department of Defense (DoD), via annual Congressional legislation known as the Defense Appropriations Act. Dollars for the CDMRP are added every year during the budget process by members of Congress, in response to requests by advocates and disease survivors. Because of emerging evidence of a link between combat service and the incidence of MS, we believe this is an appropriate source of funding.
Request: We ask members of Congress to support a $15 million appropriation to the CDMRP for MS research by signing a Dear Colleague letter to the leadership of the appropriations committees. This will provide the resources needed to move us closer to a world free of MS.
Supporting Rationale: CDMRP support for MS research is critical to people suffering with MS and to a large and growing veteran population living with MS, especially as federal funding for MS research decreases at the NIH.
• There is a significant, unmet MS research funding need and research in the CDMRP could help millions of Americans across the country touched by MS.
• Emerging evidence shows that Gulf War veterans might be at increased risk of developing MS. This includes (a) a study in the Annals of Neurology identifying 5,345 cases of MS among veterans that were deemed “service-connected,” which represents a significant increase from previous studies; and (b) an epidemiologic study finding an unexpected, two-fold increase in MS between 1993 and 2000 in Kuwait, which suggests a potential environmental trigger for MS.
• More than 25,000 veterans with MS were enrolled with the Veterans Health Administration between 1998 and 2003. The VA is currently funding two MS Centers of Excellence to provide clinical care and education, and physicians at these institutions have sought funding to explore a potential link between MS and combat service.
• An advisory committee commissioned by the VA recently recommended further study into the potential link between combat service and the increased risk of developing MS. By studying this population, scientists might be able to understand the cause and triggers of MS and develop effective treatments.
• The CDMRP has grown its scope of research and reputation. The research conducted via the CDMRP now includes — breast, prostate, and ovarian cancers and neurofibromatosis, tuberous sclerosis, myelogenous leukemia, prion diseases, and the state of health issues in “minority and underserved populations.” The amounts appropriated for each research program range from $3.2 million to $150 million

Scarring of nerves
Malaysia Star - Malaysia
Multiple sclerosis is a chronic inflammatory disease that affects the central nervous system, and can cause problems with vision, muscle control and mental ...
See all stories on this topic

Another oral MS drug steps up to the plate
In-PharmaTechnologist.com - Montpellier,France
However, the company ahs taken a few punches over the last few years regarding one of its other MS drugs, Tysabri (natalizumab). Tysabri, also a VLA-4 ...
See all stories on this topic

New imaging technique could promote early detection of multiple sclerosis EurekAlert! Wed, 27 Jun 2007 10:08 AM PDT Researchers from Purdue University have studied and recorded how myelin degrades real-time in live mice using a new imaging technique. Myelin is the fatty sheath coating the axons, or nerve cells, that insulate and aid in efficient nerve fiber conduction. In diseases such as multiple sclerosis, the myelin sheath has been found to degrade.

Calcium ions may play key role in MS New Kerala Wed, 27 Jun 2007 10:26 AM PDT WEST LAFAYETTE, Ind., June 27: U.S. medical researchers have determined calcium ions might play a key role in multiple sclerosis by activating enzymes that degrade myelin sheaths.

New insight into the mechanism by which glial cells recognize and myelinate axons News-Medical-Net Wed, 27 Jun 2007 4:04 AM PDT In a host of neurological diseases, including multiple sclerosis (MS) and several neuropathies, the protective covering surrounding the nerves - an insulating material called myelin - is damaged.

Mutliple Sclerosis - AnaSpec Introduces New Anti-MOG (35-55) Antibody Medical News Today Wed, 27 Jun 2007 1:08 AM PDT Leveraging its portfolio of MOG (35-55) and other multiple sclerosis (MS) experimental autoimmune encephalomyelitis (EAE)-related peptides, AnaSpec has introduced its new Rabbit Anti-MOG (35-55) antibody. Myelin oligodendrocyte glycoprotein (MOG), a member of the immunoglobulin superfamily, is expressed exclusively in central nervous system myelin. [click link for full article]

Scarring of nerves The Star Online Tue, 26 Jun 2007 4:53 PM PDT Multiple sclerosis is a chronic inflammatory disease that affects the central nervous system, and can cause problems with vision, muscle control and mental functions, among others.

Cleanliness may be tied to diabetes in children Rocky Mountain News Wed, 27 Jun 2007 0:23 AM PDT A new study finding Type I diabetes on the rise in children has the study's author mulling that kids might be too clean for their own good.

RCMP to question man who took ill wife to commit suicide overseas CBC Wed, 27 Jun 2007 6:02 AM PDT The RCMP are investigating the case of a Nova Scotia man who took his wife to an assisted-suicide clinic in Switzerland where she died.

Bike teams fight MS Richmond.com Tue, 26 Jun 2007 3:07 PM PDT Richmond.com Tuesday, June 26, 2007 Fifteen employees and family members associated with the Richmond Health Systems participated in the 2007 Virginia Credit Union Ride MS 150 in Richmond.

Accentia Biopharmaceuticals, Inc. To Present at the Jefferies Healthcare Conference in New York City on Wednesday, June ...
RedNova Tue, 26 Jun 2007 5:32 PM PDT
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) will present at the Jefferies Healthcare Conference in New York City on Wednesday, June 27 at 9:40 AM/ET. Dr. Frank E.

Oral Tysabri steps up to the plate

By Anna Lewcock



27/06/2007 - With a number of companies competing in the race to develop the first oral treatment option for multiple sclerosis, UCB and Biogen Idec's oral version of the infamous Tysabri has entered Phase II trials.

The two companies' candidate, currently going by the name CDP323, is an oral VLA-4 antagonist (as is Tysabri) intended for the treatment of relapsing-remitting multiple sclerosis (MS). The Phase II trials are expected to yield results by the end of 2008.

Biogen Idec hopped on board to partner with UCB in developing and commercialising the small molecule compound back in October last year, following encouraging Phase I trials. The two companies are initially investigating the compound for the treatment of MS, but will also be considering its use in treating other autoimmune disease indications.

UCB and Biogen are co-developing and co-commercialising the compound, with all commercialisation costs and profits to be shared equally. Over $200m (€149m) will be added to UCB's coffers courtesy of the Biogen deal.

CDP323 is one of the few oral alpha-4 integrin antagonists according to UCB, and it's hoped that by tapping Biogen's expertise in multiple sclerosis the two companies can come up with a competitive product.
Biogen is already responsible for the market-leading MS drug worldwide, Avonex (interferon beta-1a), which brought the company revenues of around $1.7bn over 2006. However, the company ahs taken a few punches over the last few years regarding an existing injectable MS treatment, Tysabri (natalizumab).

Tysabri, also a VLA-4 antagonist, was approved by the US Food and Drug Administration (FDA) for relapsing-remitting forms of MS back in 2004, however was hastily withdrawn three months later after several cases of patients developing a life-threatening viral infection of the brain.

The occurrence of progressive multifocal leukoencephalopathy (PML) in certain patients held Tysabri of the market for a significant period of time, only returning with stringent guidelines in June last year.

Damage to Biogen and Tysabri partners Elan's potential revenues was significant, with original analyst estimates for the treatment predicting annual revenues of up to $3bn, but following its withdrawal and late relaunch the drug only managed to generate $74m over 2006 - split between Elan and Biogen.

Although the companies have initiated risk management plans in the US and Europe to facilitate the correct use of Tysabri, the firms clearly recognise that the damage have may have already been done, with Biogen foreseeing "many rumours and speculation regarding Tysabri and suspected cases of PML" in the future.

Despite the unfavourable aura surrounding the existing version of Tysabri, a spokesperson for UCB told in-PharmaTechnologist.com that the two companies "strongly believe an oral solution is worthwhile exploring," and that the product could potentially become one of the firm's bigger products.

A 24-hour oral formulation of the drug could have significant advantages over the current monthly version of Tysabri in that it could reduce the likelihood of PML taking hold in a patient, as well as the more obvious non-invasive aspect of drug administration.

It's perhaps unsurprising that Biogenis hoping to catch the next big wave in MS treatment by successfully producing an oral formulation whilst simultaneously reaffirming its position in the MS market and hopefully demonstrating the safety of a Tysabri-like treatment option.

In addition to this, the MS market is growing fairly rapidly, and the first non-invasive oral treatment to become available would earn itself a particularly favourable position and at least a temporary monopoly while competitors catch up.

Several firms are fighting to be the first on the market with a non-invasive treatment option for MS sufferers. Only earlier this month Teva and partners Active Biotech announced their oral candidate was entering Phase II trials, and Novartis' hotly tipped oral MS treatment (FTY720, fingolimod) is on track for submissions in 2009.
http://www.in-pharmatechnologist.com/news/ng.asp?n=77706&m=1IPE627&c=ydybdwffvkxmlpi

New Rebif (Interferon Beta-1a) Initiation Pack For Patients With Relapsing Remitting Multiple Sclerosis
Medical News Today Tue, 26 Jun 2007 1:09 AM PDT
Merck Serono has announced the launch of a new Rebif initiation pack for patients with relapsing remitting multiple sclerosis (RRMS). It is important when patients begin interferon beta therapy that the dose is gradually increased over a four week period as this helps minimise possible side effects. [click link for full article]

UCB and Biogen Idec's Oral VLA-4 Antagonist (CDP323) Enters Phase II Development for Multiple Sclerosis
RedNova Tue, 26 Jun 2007 1:07 AM PDT
Brussels (Belgium) and Cambridge, MA (USA) - June 26, 2007- 7:00 am CET - UCB (Euronext Brussels: UCB) and Biogen Idec (NASDAQ: BIIB) today announced the initiation of a Phase II study of CDP323 - an oral VLA-4 antagonist - under development for relapsing-remitting multiple sclerosis (MS).

Clinical Trials Update: June 25, 2007
HealthDay via Yahoo! News Mon, 25 Jun 2007 11:02 AM PDT
(HealthDay News) -- Here are the latest clinical trials, courtesy of Thomson CenterWatch:

MediciNova Announces New Strategic Initiative
RedNova Tue, 26 Jun 2007 6:26 AM PDT
SAN DIEGO, June 26, 2007 (PRIME NEWSWIRE) -- Me

Genzyme Stock Rises on Lehman Upgrade
Houston Chronicle - United States
... toxins that can damage the large intestine. Other positive pipeline opportunities include the leukemia drug Campath as a treatment for multiple sclerosis.
See all stories on this topic

Genmab to get 116.3 mln dkr from GSK in first milestone payment ...
Hemscott - London,UK
Genmab licensed exclusive worldwide rights to co-develop and commercialise ofatumumab to GSK in December 2006. michael.delaine@thomson.com mdl/am.
See all stories on this topic

Market Report -- In Play (MNOV)
MSN Money - USA
... of market opportunities, it will focus its resources on development and commercialization of two assets in its development pipeline, MN-221 and MN-166. ...
See all stories on this topic

MediciNova Announces New Strategic Initiative
CNNMoney.com - USA
MN-166, an oral treatment for multiple sclerosis, demonstrated positive clinical benefits and a superior safety profile after one year of treatment in a ...
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Ahead of the Bell: Biogen Idec
Houston Chronicle - United States
The analyst is also concerned the company does not have enough promising drug candidates, suggesting its multiple sclerosis drug Tysabri may not be approved ...
See all stories on this topic

Commercial Insight: Multiple Sclerosis Continued growth makes the ...
Pharmaceutical Business Review - USA
Growth is driven by the highly successful beta-interferon brands, Teva's Copaxone (glatiramer acetate), and the recent relaunch of Tysabri; the first launch ...
See all stories on this topic

Biogen Idec Inc. (BIIB) Holds Near Recent Peak
Schaeffers Research - Cincinnati,OH,USA
In a post last month, I discussed that zone and the issues surrounding Tysabri. I ended that post saying the chart seemed mildly constructive and the action ...
See all stories on this topic

Genzyme Stock Rises on Lehman Upgrade
Houston Chronicle - United States
... toxins that can damage the large intestine. Other positive pipeline opportunities include the leukemia drug Campath as a treatment for multiple sclerosis.
See all stories on this topic

Based upon many positive anecdotal reports, two Scottish physicans are
in the process of funding a clinical trial of Low Dose Naltrexone (LDN)
for treating multiple sclerosis. For more information, visit

http://www.theherald.co.uk/display.var.1494742.0.0.php

CDC: Number Of Uninsured Adults Rises

The number of adults without health insurance jumped by 2 million from 2005 to 2006, a new federal report says. Uninsured Americans numbered 43.6 million last year, according to the U.S. Centers for Disease Control and Prevention. More...

A Day to Celebrate! FDA Approves First Drug for Fibromyalgia

Today the FDA announced that Lyrica (pregabalin) has been approved for the treatment of fibromyalgia. Lyrica, manufactured by Pfizer, is the very first drug ever to receive FDA approval for fibromyalgia. According to Pfizer, "Fibromyalgia is thought to result from neurological changes in how patients perceive pain, specifically a heightened sensitivity to stimuli that are not normally painful. Lyrica binds ... read more

Why the Danes are so happy, even when they're sick
Health care is free, but it comes with a price -- high taxes.
BY SUSAN AGER
Detroit Free Press

DETROIT --
My doctor told me not to cancel my vacation just because I had blood in my urine, with no other symptoms. But do get checked, he said, as soon as you're back.

Besides, he said, ``You can trust the Danish medical system, maybe more than our own.''

Sixteen hours after our plane landed in Copenhagen, as I lay deep in the death-like sleep of the jet-lagged, a night visitor stabbed me in the back with a pick ax.

Or so it felt.

We waited till dawn to awaken our host and ask for a ride to the ER. He drove us that Saturday morning to Herlev Sygehus (or hospital) in suburban Copenhagen, where I became yet another beneficiary of a truly universal health care system like we'll never see here.

Wracked by pain, I was whisked into the back ahead of others in the ER, none of whom was bleeding from a knife or gunshot wound. Well before my problem was diagnosed, I was handed a pain-killing suppository and told where to put it.

An orderly wheeled me to a room on the 22nd floor of the hospital whose 23 stories make it the tallest building in Denmark. Red, yellow and blue brightened the walls. My husband was offered a meal and told that if I spent the night, he could sleep in the bed beside me.

After a CT scan and a couple of X-rays, the doctor told me, in good English, that I had a kidney stone, not so big it needed to be blasted apart, but big enough that it would cause pain until I passed it. On Monday, she wanted to do a radioactive test to make sure the stone hadn't damaged the kidney.

She asked: Would I like to spend the next couple nights right there, so they could manage my pain?

I blanched. In the United States, a night at a hospital can cost $1,000 or more. I didn't know whether our U.S. insurance would cover care in Denmark. I decided to return to our friend's house, taking with me a handful of suppositories a nurse handed to me, just like that.

Two days later, I was led to my previous bed, which still had my name on it. I snoozed until I was wheeled away for the final test, after which nurses waved good-bye and reminded me I could come back any time if I had problems.

A few hours later, the doctor phoned to say my kidney looked fine.

That's the whole story.

Nobody ever asked for a credit card. Nobody asked for an insurance card. Nobody asked for my address.

It's true Danes pay among the highest taxes in the world. But their system provides not only free health care but free long-term care, including 24/7 home care, and generous unemployment and education benefits.

We'd never stand for taxes so high. But the appeal of such a system is powerful, and it might help explain Denmark's ranking in a huge UNESCO study this year as the happiest nation on Earth.

No one ever need worry, as millions of Americans do, about being sick, broke and alone.



http://www.miamiherald.com/299/story/150380.html

Collaborating for a cure
Worcester Telegram & Gazette Mon, 25 Jun 2007 1:48 AM PDT
It's about time.
Q&A: How Nice works
Guardian Unlimited Mon, 25 Jun 2007 7:44 AM PDT
What is Nice? The National Institute for Clinical Excellence was set up in 1999 to decide which drugs and treatments should be available on the NHS in England and Wales.

Opexa Therapeutics Reports Positive Top-line Data in Phase I/II ...
PipelineReview.com (press release) - Barcelona,Spain
The "per-protocol" analysis of Tovaxin therapy achieved a 92% reduction in annualized relapse rate (ARR) in subjects who received two treatment doses of 30 ...
See all stories on this topic

Opexa's MS vaccine cut relapse rates
United Press International - USA
THE WOODLANDS, Texas, June 21 (UPI) -- US firm Opexa Therapeutics said Thursday a phase 1/2 study of its multiple sclerosis vaccine Tovaxin cut relapse ...
See all stories on this topic

Researcher avoiding politics of fund
Journal and Courier - Lafayette,IN,USA
A drug called Fampridine is being tested by the Federal Drug Administration in humans and may be available for multiple sclerosis patients in a few years. ...
See all stories on this topic

New Report Details Healthcare Industry's Massive Spending in Presidential Campaign, Federal Lobbying

Findings Coincide with Release of 'SiCKO' and Call For End to Insurance Interference with Nation's Healthcare

WASHINGTON, June 22 /PRNewswire/ -- Massive spending by the healthcare industry is swamping the nation's political process, according to the findings of a new report issued today. It coincides with the premiere of Michael Moore's new documentary "SiCKO," a searing indictment of the U.S. healthcare system which opens nationwide June 29.

The research was compiled by the California Nurses Association/National Nurses Organizing Committee's research arm, the Institute for Health and Socio-Economic Policy, based on a comprehensive analysis of publicly available and custom data sets from the Center for Responsive Politics.

CNA/NNOC released the report today as Moore joined nurses and doctors from around the U.S. in a New Hampshire town hall meeting on healthcare with undecided voters. "SiCKO" describes the heartbreaking, systemic denial of care by healthcare industry giants, and links it to escalating profits and the industry's hefty clout in Congress.

"These staggering sums have a crushing impact on policy and are drowning out the voices of patients and other ordinary Americans who can't begin to match the financial clout of the big drug companies, insurers, and other healthcare industry giants," said CNA/NNOC President Deborah Burger, RN.

The avalanche of cash has a direct impact on healthcare policy in Washington and influences positions on healthcare reform taken by candidates for public office, asserts CNA/NNOC.

"That political influence produces huge financial benefits for the healthcare industry," Burger noted. They include blocking bills to protect patients from HMO, hospital, or nursing home abuses, provide greater public oversight of insurers, or permit the re-importation of cheaper prescription medications from Canada or Europe.

Additionally, most healthcare "reform" proposals directly benefit the biggest political spenders, from the insurers to the drug companies to the commercial banks and investment firms now promoting Health Savings Accounts and tax-credits to buy insurance.

In federal lobbying alone, healthcare spending exceeded $2.2 billion the past decade, during which healthcare surpassed all other industry sectors in lobbying expenditures.

Healthcare industry contributions have also become a significant factor in the 2008 presidential contest as well, according to the report.

Political action committees for drug and insurance companies, doctors, hospitals, dentists, and nursing homes are lavishing millions of dollars on both Democratic and Republican candidates, the report found. Democratic Sen. Hillary Clinton and Republican Sen. John McCain together received over 40% of healthcare industry contributions among the 18 major party declared candidates.

Overall, healthcare contributions to the 18 currently announced Republican and Democratic presidential candidates total an aggregate $12.8 million since 1989, over $3.7 million of that amount just in the first quarter of 2007 alone.

"No wonder that in the midst of an escalating healthcare crisis, most of the candidates are unwilling to confront the corporate giants and support reform that takes profiteering out of our healthcare system," Burger said.

A breakdown by industry shows that former Massachusetts Gov. Mitt Romney is the top recipient of pharmaceutical contributions and money from banks and securities and investment firms which are becoming increasingly powerful players in healthcare and political contributions, especially with the rapid growth of Health Savings Accounts and other reform plans that rely on financial institutions. HSAs are typically linked to high deductible health plans, and are a main feature of the Massachusetts health plan that Romney promoted while governor.

Sen. Christopher Dodd, whose home state houses corporate offices for many insurance corporations, is the top beneficiary of insurance and HMO donations. Clinton leads among donations from health professionals and lobbyists.

In Congress, the huge sums spent on lobbying have paid huge dividends for the healthcare industry, Burger noted. One example is the April 2007 vote in the Senate, after heavy lobbying by the pharmaceutical and insurance industry, to kill a bill to amend the 2003 Medicare drug benefit law to let Medicare use its bulk purchasing power to negotiate lower prescription drug prices for seniors.

During the debate on the original bill, pharmaceutical and insurance companies spent so much that they could hire a different firm to lobby each key member of a critical committee (New York Times, Aug., 2005). Not surprisingly, the final bill requires seniors to go through private insurers to qualify for the drug benefit and barred the government from bargaining discounted prices.

As a result, drug prices in the U.S. continue to be 35% or more higher than in other Western nations. "Every day nurses see the consequences," said Burger. "We see families who share prescriptions so none of them get their needed dosage, and individuals who cut pills in half or run out of pills before the end of the month, ask the physician to prescribe a less effective generic drug or, worst of all, simply never fill the prescription due to its cost."

  Among other data in the report:

 -- Scores of former government employees now work as healthcare industry
    lobbyists. One of the best known, as portrayed in "SiCKO," is Wilbert
    "Billy" Tauzin, a chief architect of the Medicare prescription drug
    bill who then gave up his seat in Congress to become the director of
    the Pharmaceutical Research and Manufactures of America (PhRMA), the
    drug industry's chief lobbying group.

 -- Escalating political spending coincides with huge jumps in healthcare
    industry profits. From 2002 to 2006, pharmaceutical profits climbed
    from $64.4 billion to $94.8 billion, and insurance profits from $20.8
    billion in 2002 to $57.5 billion.

 -- Financial firms have become an increasingly bigger player in healthcare
    and in political contributions. Nearly 1,100 banks now offer Health
    Savings Accounts, triple the number from 2005 and some big insurers,
    like Blue Cross/Blue Shield and UnitedHealth are chartering their own
    banks to get into the new lucrative market. The finance industry ranks
    third, behind healthcare and communications/technology, in lobbying
    expenditures.

 -- More families are struggling with huge medical bills and debt.
    One-fifth of working age adults currently have medical debt, and
    one-quarter of adults spend 10% or more of their household income
    annually on out-of-pocket medical expenses and premiums.

Burger noted the comment of PhRMA senior vice president Ken Johnson who said after a screening of "SiCKO" in Sacramento California last week, "Companies have to have an incentive. Otherwise, who's going to do it?" (Sacramento Bee, June 13, 2007)

In fact, "there is an alternative that is universal, comprehensive, assures choice of hospital and physician, controls costs, and gets the insurance companies out of the way," Burger noted.

HR 676 in Congress would establish a single-payer, publicly financed system that works as an expanded and improved Medicare for all. Similar bills exist in several states, such as SB 840 in California. "It's the only solution to our healthcare crisis that also would go a long way to stopping the corruption of our political system by the healthcare industry as well," said Burger.

http://sev.prnewswire.com/health-care-hospitals/20070622/AQF02122062007-1.html

Pharma Sector: Few Newsmakers Of The Week - Pfizer, Opexa, Onyx ...
Trading Markets - Los Angeles,CA,USA
With Opexa reporting encouraging results from an early stage trial with its T cell vaccine, Tovaxin in multiple sclerosis, it remains to be seen if ...
See all stories on this topic

Contracts for Difference are a leveraged way of increasing market ...
Irish Independent - Dublin,Ireland
The instrument hit the headlines two years ago when Elan, a favourite CFD punt among Irish investors, plummeted after it temporarily withdrew its Tysabri ...
See all stories on this topic

More uses for Botox
The Bryan-College Station Eagle Sat, 23 Jun 2007 5:37 AM PDT

Healthcare Horror Stories
http://www.youtube.com/groups_videos?name=SiCKOthemovie&page=3

When Trevis Gleason of Life with MS told us about a step-by-step plan for developing a system of support you can count on, we took his test to see if we have the support we may someday need.

Kids with MS become disabled at early age Reuters via Yahoo! News Thu, 21 Jun 2007 10:48 AM PDT People diagnosed with multiple sclerosis (MS) during childhood take longer than older MS patients to reach the stage where they become irreversibly disabled, but this point arrives at a younger age.

Opexa's MS Vaccine Cut Relapse Rates RedNova Thu, 21 Jun 2007 2:41 PM PDT U.S. firm Opexa Therapeutics said Thursday a phase 1/2 study of its multiple sclerosis vaccine Tovaxin cut relapse rates by 92 percent.

Clinical Trials Update: June 22, 2007
HealthDay via Yahoo! News Fri, 22 Jun 2007 9:02 AM PDT
(HealthDay News) -- Here are the latest clinical trials, courtesy of CenterWatch:

My Turn: Defining Normal When You're Disabled
Newsweek Thu, 21 Jun 2007 6:24 PM PDT
I have made peace with my disability. If only other people could do the same.

Botox Treatment for the Bladder
KABC-TV Los Angeles Thu, 21 Jun 2007 4:42 PM PDT
Frequency means having to go to the bathroom at least every hour. Urgency means you just can't wait. You've got to go right now.

Contentious stem cell bill is defeated KATU Portland Thu, 21 Jun 2007 10:36 PM PDT The final vote was 30 "yes" votes and 29 "no" votes, but a measure needs at least 31 votes to pass. Rep. Larry Galizio, D-Tigard, then changed his vote, opening the door for the bill to return for one more go-around.

June 21, 2007 09:19 AM Eastern Daylight Time

Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin™ for Multiple Sclerosis

Effectiveness Shown in Relapsing Remitting Subjects Across Both Phase I/II Dose Escalation and Extension Trials

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced positive top-line data in an open-label Phase I/II extension clinical trial of the investigational T-cell vaccine, Tovaxin™, for multiple sclerosis (MS). In this one-year, 8-subject extension clinical trial of relapsing remitting (RRMS) and secondary progressive (SPMS) subjects, Tovaxin therapy was shown to be safe and effective. The "per-protocol" analysis of Tovaxin therapy achieved a 92% reduction in annualized relapse rate (ARR) in subjects who received two treatment doses of 30 – 45 x 10⁶ attenuated T-cells eight weeks apart and were monitored for an additional 44 weeks. Subjects in the extension study had previously been treated an average of 5.2±1.8 (1, 8; median 5.4) years earlier at Baylor College of Medicine under the direction of Jingwu Zhang, M.D., Ph.D with a T-cell vaccine developed from myelin basic protein (MBP) reactive T-cells. The safety profile revealed only injection site mild reactions and no severe adverse reactions related to T-cell vaccination.

Both Phase I/II clinical studies have demonstrated that T-cell vaccination depletes myelin reactive T-cells in peripheral blood. In the extension study patient population, the myelin reactive T-cell frequencies were reduced by 84% and 72% at 6 and 12 months on study, respectively. Reductions in myelin reactive T-cell frequencies in the dose escalation study were 76.7% and 64.8% at 6 and 12 months on study, respectively.

All subjects currently are enrolled in a retreatment extension study to collect longitudinal safety and effectiveness data.

Effectiveness data for the 13 RRMS subjects across the two Phase I/II trials showed an 80% reduction in ARR. The Expanded Disability Scoring Scale (EDSS) for the RRMS subjects for a 0.5 point effect was improved, unchanged and worsened by 64.3%, 21.4% and 14.3%, respectively. The EDSS for a 0.5 point sustained (no change over 3 months) effect was improved, unchanged and worsened by 42.9%, 42.9% and 14.2%, respectively. The EDSS for a 1.0 sustained effect was improved, unchanged and worsened by 28.6%, 57.1% and 14.3%, respectively.

Brian Loftus, M.D. of Bellaire Neurology, the Principal Investigator of these Tovaxin studies, commented, “This data, combined with prior data presented on myelin reactive T-cell frequencies and ARR reductions, laid the ground work for the placebo-controlled Tovaxin IIb clinical trial (TERMS). We have shown that myelin reactive T-cells can be identified and used to produce T-cell vaccine which effectively induces the depletion of an individual’s autoreactive T-cells and results in positive clinical outcomes. I anticipate Tovaxin will usher in the age of personalized therapy for MS.”

David McWilliams, president and chief executive officer of Opexa, said, "We are particularly encouraged by the data from this extension trial which indicates that subjects previously treated with T-cell vaccine can be safely and effectively retreated with Tovaxin. This outcome is important to our planned extension trial for subjects currently enrolled in our TERMS trial following the one year core study time period.” In addition, the effectiveness data in RRMS subjects across the two Phase I/II trials indicate strongly positive outcomes in both ARR and EDSS improvements following Tovaxin therapy.”

About TERMS

The Tovaxin Phase IIb clinical study will include 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T-cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate. As of May 17, 2007, Opexa announced the completion of patient enrollment in a 150-patient Phase IIb safety and efficacy study (TERMS). All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

The TERMS study is being conducted at 36 U.S. sites to evaluate the safety and effectiveness of Tovaxin. The TERMS study is registered on the U.S. National Institutes of Health-sponsored website, www.clinicaltrials.gov, where pharmaceutical companies are required to register trials for medicines that will treat serious or life-threatening diseases or conditions. For more information, visit the TERMS website at www.tovaxin.com.

About T-cell Vaccination

For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin(TM). The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in treated patients.

About Opexa Therapeutics

Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product, Tovaxin(TM), a T-cell therapy for multiple sclerosis is in a Phase IIb trial. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com.

Safe Harbor Statement

This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Company Contact:
Opexa Therapeutics, Inc.
Lynne Hohlfeld, 281-719-3421
lhohlfeld@opexatherapeutics.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com

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Opexa Therapeutics Reports Positive Top-line Data in Phase I/II ...
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Multiple sclerosis (MS) is rare in children, but when it starts in childhood it may take longer to worsen, a European study shows.

Costs of disorders of the brain in Europe
News-Medical-Net Wed, 20 Jun 2007 3:34 PM PDT
In 2004 there were about 46 million cases of neurological diseases such as epilepsy, migraines, multiple sclerosis, Parkinson's disease and stroke among the 466 million inhabitants of the EU (excluding the two new members Romania and Bulgaria, but including the non-members Iceland, Norway and Switzerland).

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Fifteen top international specialists in this field will gather from 25-27 June for a conference entitled, "Inflammation and Chronic Disease", part of the "Barcelona BioMed" conference series organised by the Institute for Research in Biomedicine (IRB Barcelona) and the Fundaci??n BBVA. The event will be hosted by the Institut d'Estudis Catalans (IEC). [click link for full article]

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source: Neurology. 2007 Jun 12;68(24):2059-65

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Human therapeutic cloning has moved a step closer after U.S. researchers said they had successfully created embyonic stem cells from monkey embryos.

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Scientists move closer to human therapeutic cloning

Scientists move closer to human therapeutic cloning - Yahoo! News
By Rob Taylor Wed Jun 20, 8:14 AM ET

CANBERRA (Reuters) - Human therapeutic cloning has moved a step closer after U.S. researchers said they had successfully created embyonic stem cells from monkey embryos.

In what would be a world-first breakthrough, scientists told a stem cell research conference in the Australian city of Cairns this week that they had successfully created two batches of embryonic stem cells from cloned rhesus monkey embryos.

"We've been looking for this evidence for a long time," Australian stem cell pioneer Alan Trounson from the Melbourne-based Monash University Stem Cell Centre told Reuters.

"It's very important to have this, to know that we can do this, because it may result in a lot of new cell lines than can help us understand some complex diseases."

Previous efforts to obtain embryonic stem cells from cloned primate embryos have failed. Korean cloning scientist Woo Sook Hwang lost his job over fabricated successes using human eggs.

But Shoukhrat Mitalipov of the Oregon National Primate Research Centre in the United States said he had succeeded using modified Somatic Cell Nuclear Transfer, or SCNT, in which an egg cell nucleus is removed and replaced with a donor nucleus.

The cell eventually forms an early embryo, or blastocyst, with DNA almost identical to the donor organism.

Mitalipov said he used skin cells from a 10-year-old male rhesus monkey and presented the conference with proof of his success using DNA evidence. He also showed slides of the embryonic cells changing into heart cells and neurons.

A switch to using polarized light in labwork instead of dye and ultraviolet light traditionally used to identify cell chromosomes may have led to the breakthrough, he said.

Mitalipov's still-unpublished success may bring scientists closer to producing human embryonic stem cells from cloned adult body cells, reducing the risk of eventual rejection when using external donor cells.

Scientists hope therapeutic or regenerative cloning could help treat diseases including multiple sclerosis, cardiac illnesses and even spinal damage by encouraging embryonic cells to replace damaged nerve, blood or heart cells.

While Mitalipov's findings are yet to be confirmed, they could also bring scientists closer to cloning an adult primate, a group which includes humans, apes and monkeys.

Reuters Photo: A researcher in a file photo. Human therapeutic cloning has moved a step closer after...

Slideshow: Stem Cell Research
"I remain guarded enough to want to see the process completed," Trounson said.
http://news.yahoo.com/s/nm/20070620/hl_nm/stemcells_monkey_dc_2

New strategies to treat neurological disorders
By Mike Nagle

20/06/2007 - Experts from around the world have gathered this week to discuss the best emerging therapies for a number of neurological disorders such as multiple sclerosis and stroke.

Thousands of scientists and clinicians have descended on the island of Rhodes, Greece for the European Neurological Society (ENS) congress and the latest drugs are the centre of attention.

One central topic at the scientific conference is multiple sclerosis (MS), a chronic inflammatory disease that attacks the central nervous system (CNS).

"About 400,000 people in Europe have MS and about one million worldwide," said the ENS president, Professor Giancarlo Comi.

"MS is still not curable. A number of new findings have been made in recent years, however, with regard to the origins of the disease and new therapeutic strategies. These new insights help us to mitigate the course of the disease and delay the development of permanent disabilities."

The scientists took time to focus on the mechanisms underlying the process of axonal degeneration which characterise the progressive phase of the disease. There is some evidence that some of these mechanisms are at least partially independent from inflammation.

According to Prof. Comi, modulating and suppressing the immune system only has a modest effect at best on the progressive phase of the disease.

"One important goal in the treatment of this severe disease has to be to develop therapies that repair the damage MS causes in nerve cells," Professor Comi said. "There is increasing scientific evidence that the course of MS is shaped by different disease mechanisms in its early and late phase."

Researchers from France, Germany and Switzerland believe they have proof for a hypothesis first posited in the late 19th century. According to this new evidence, certain stem cells differentiate very early on in human development into nerve cells or into glia cells - the maintenance and support cells in the CNS.

They showed that there are two different types of stem cells that differentiate into either glia or nerve cells. This finding from Dr Zalc, Hôpital Pitié Salpêtrière, Paris, and colleagues, contradicts the viewpoint that nerve cells form first and that glia cells then develop from them.

Prof. Comi said: "Key fundamental research findings like these could well enable MS therapy to advance in significant ways."

Professor Martin Schwab, from the University of Zurich, presented promising results for his antibody therapy that can restimulate nerve growth in animals, following injury or stroke. In the human brain, nerve fibre growth is restricted to distances below 2mm as it is inhibited by several substances found in myelin sheaths - the protective coverings found on nerves.

One of these substances is the membrane protein Nogo-A. Prof. Schwab and his team have developed an antibody that blocks this target. When they tested its effect in animals, they found that the drug stimulated nerve fibre growth over comparatively long distances substantially improved "functional restoration", such as running, swimming or gripping.

Professor Ioannis Milonas, chairman of the ENS Congress, said: "The new agent is currently being tested in a Phase I clinical study in a European network of centres for spinal cord injuries."

Another possible stroke therapy discussed at the event was developed by a group of Swiss scientists from University Hospital Zurich. Annett Spudich and her colleagues are examining the effectiveness of multidrug resistance-associated protein 1 (MRP1) as a stroke therapy in mice. They injected mice subjected to stroke injury with MRP1 substrates 17betaEG and GSNO immediately and saw a dose-dependent decrease (17betaEG) or increase (GSNO) in brain injury. If MRP1 expression was knocked out completely, these injury effects were also blocked. This indicated that MRP1 was needed by the two substrates in order to gain access to the brain.

"Strokes are the third most common cause of death and the most common cause of severe disability for adults in industrialised countries," said Professor Gerard Said, secretary general of the ENS.

He continued: "They have found that MRP1 might be a substance for transporting drugs across the blood cerebrospinal fluid barrier, a physiological barrier between the central nervous system and the blood stream."

If this proves to be the case, MRP1 could be used as a gateway through which drugs could travel directly to the brain regions affected by a stroke.
http://www.in-pharmatechnologist.com/news/ng.asp?n=77516&m=1IPE620&c=ydybdwffvkxmlpi

'Theory of Everything' for stem cells
By Mike Nagle
20/06/2007 - A team of Canadian scientists have identified which genes help decide a stem cell's fate; a discovery that one day could lead to drugs that invoke their regenerative power.

Oct4 is a POU transcription factor protein; it promotes the transcription of a gene's DNA into messenger RNA. This particular protein is considered to be the master regulator of the stem cell state: it is thought to control what stem cells become, adult stem cell identity and has also been implicated in diseases such as cancer. However, until now, the molecular mechanism of how it does this was poorly understood.

The researchers at the Sprott Centre for Stem Cell Research in Ottawa and Ottawa University found that 1,155 genes are under the control of Oct4. Currently stem cells are commonly defined based on what they will become. However, this research adds to the emerging molecular definition of stem cells; knowledge that will enable scientists to begin designing therapies to control these cells and their ability to regenerate tissue.

"You could call this a 'theory-of-everything' for stem cells," said one of the team, Dr Michael Rudnicki, referring to the often-cited unifying theory of everything for physics.

The study, outlined in today's online issue of the journal PloS One, took a unique approach to identifying the genes. Typically, scientists have measured which genes are switched on in one type of stem cell and then compared this with gene expression in another type of stem cell. In this way, they can see which genes decide the fate of a particular type of stem cell.

However, rather than simply searching for any genes expressed by stem cells, the Canadian scientists decided to look for genes whose expression was also correlated with Oct4. They did this using gene expression profiling coupled with statistical analysis.

The analysis used data from StemBase, the largest stem cell gene expression database in the world. Designed by bioinformaticist Dr Miguel Andrade, the database includes data from thousands of DNA microarrays submitted mainly by scientists in Canada's Stem Cell Network.

The team detected several new ways that Oct4 may regulate stem cell identity: these include regulating chromatin structure (the complex of DNA and proteins that make up chromosomes) to enable stem cells to self-renew and turn into other cell types; and helping activate genes that keep the stem cell ready to respond to signals and differentiate into other cell types.

According to this research, stem cells can be defined as cells that keep their DNA packaged in a flexible format, keep cell division tightly controlled, prevent signals that might trigger death, repair DNA very effectively, and reinforce all of these characteristics by tightly controlling how molecules can move within the nucleus.

"These findings may help us to understand how the key genes which control cell fate are regulated, and how, when regulated improperly, they can lead to disease," said another of the scientists, Pearl Campbell.

"This may ultimately allow us to develop targeted therapies to stimulate adult stem cells within our own bodies to repair damaged tissues, and may provide further areas of exploration for the treatment of cancer."
http://www.drugresearcher.com/news/ng.asp?n=77519&m=1DRG620&c=ydybdwffvkxmlpi

What does a health crisis look like? See Houston
Enlarge	By Thomas B. Shea, for USA TODAY
Angel Martinez, left, who had ankle surgery, waits with his mother, Elvia Martinez, and Jorge Jimenes, who broke his knee, at Ben Taub General Hospital. Non-emergency patients often wait hours for care.

	By Richard Wolf, USA TODAY

HOUSTON — Ijeoma Onye awoke one day last month short of breath, her head pounding. Her daughter, Ebere Hawkins, drove her 45 minutes from Katy, Texas, to Ben Taub General Hospital, where people without health insurance pay little or nothing for treatment.

Onye, 62, waited four hours to be seen. Still, going to the emergency room was faster than getting an appointment. For that, "you have to wait months," Hawkins says.

Ben Taub is the hub of the Harris County Hospital District, a network of hospitals and care centers serving the Houston area's 1.1 million uninsured residents and hundreds of thousands more with little coverage. Here, the national statistic of 45 million uninsured people is more than a number. It's a crisis.

Nationally, more than 15% are uninsured. In Texas it's nearly 24%, the Census Bureau says, the highest percentage among the states. Here in Harris County, it's 30%, according to state figures, the highest rate among the nation's top 10 metropolitan areas.

As the Houston area struggles to deal with a rising tide of uninsured, it offers a lesson for the nation: Let the problem get out of hand — to a point where nearly 1 in 3 people have no coverage — and you won't just have a less healthy population. You'll have an overwhelmed health care system.

http://www.usatoday.com/news/nation/2007-06-18-texas-health-care_N.htm

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