Obama firm on tax rates amid Republican infighting

WASHINGTON (Reuters) - President Barack Obama  dangled the possibility on Tuesday of lowering tax rates in 2013 with a broad U.S. tax code revamp, but he stood firm on insisting rates for the wealthiest must rise as part of a deal to avert the "fiscal cliff," a series of budget cuts and tax increases that will begin taking effect on December 31 unless Congress acts.

Congressional Republicans, looking at yet another poll showing most Americans would blame them for going off the cliff, showed more signs of internal stress over how far to go in compromising with Obama's demands on tax rates.

Outside official Washington, concern mounted about how and when - not to mention if - the politicians might put their disagreements behind them in the short time remaining.

Worry about the fiscal cliff is hurting the economy. The manufacturing sector contracted in November and posted its weakest performance in three years, a report showed on Monday. Companies taking part in the survey said uncertainty over the negotiations in Washington was a factor.

Economists warn that unless a deal is reached, the economy could be thrown back into recession.

A bi-partisan delegation of governors met with Obama and congressional leaders and fretted about their own state budgets, roughly 30 percent derived from federal money.

Members of the governors' group, led by Democrat Jack Markell of Delaware and Republican Mary Fallin of Oklahoma, pointedly noted in comments outside the White House that they were able to work together despite party differences.

After meeting with the governors, the president pressed his agenda in an interview with Bloomberg Television. He reiterated his openness to unspecified reforms in entitlement programs such as Medicare, the government health insurance plan for seniors.

He repeated that as part of any deal, low tax rates on 98 percent of taxpayers should be extended, but that taxes on the top 2 percent should rise. "Let's let those go up," Obama said, referring to a "down payment" for future negotiations.

"And then let's set up a process with a time certain, at the end of 2013 or the fall of 2013, where we work on tax reform, we look at what loopholes and deductions both Democrats and Republicans are willing to close, and it's possible that we may be able to lower rates by broadening the base at that point."

In a written offer made Monday by House of Representatives Speaker John Boehner of Ohio and signed by the House Republican leadership, Republicans continued to reject increases in tax rates. But they said they would consider $800 billion in revenue increases from overhauling the tax code, along with spending cuts and entitlement revisions, as part of a deficit reduction deal.

That amount, which Boehner informally accepted during previous debt-ceiling negotiations in 2011, is not nearly enough for Obama. But it is too much for U.S. Senator Jim DeMint of South Carolina and a number of other conservatives who have built their political reputation around a low-tax philosophy.

"Speaker Boehner's $800 billion tax hike will destroy American jobs and allow politicians in Washington to spend even more," DeMint said in a statement on Tuesday.

Boehner has had persistent problems keeping his party unified since dozens of Tea Party conservatives arrived after the 2010 midterm elections. While dissent from the right does not necessarily cripple Boehner in negotiations, it does not help.

Democrats use it in their public relations campaign to discredit their opponents' views as those of extremists denying tax cuts to the middle class or risking a government default for ideological purposes, as White House Press Secretary Jay Carney did Tuesday as he denounced "factions."

"It is expected that there would be some grumbling, especially among the likes of DeMint," said Helen Fessenden, an analyst at consultancy Eurasia Group, adding that it is more important for Boehner to cement the support of his key lieutenants for the offer.

"Boehner already knows how the numbers shake out. At the end of the day no matter what he does there will be 60 or 80 who defect, no matter how good a deal he can get for them."

Republicans have 241 House members to 192 for the Democrats.

DISCORD COULD BE TROUBLE

Boehner was struggling to keep order among anti-tax Tea Party activists on one extreme and moderates more tolerant of new revenues on the other.

In the House, two first-term Republican Tea Party stalwarts - Tim Huelskamp of Kansas and Justin Amash of Michigan - were removed by party leadership from the powerful Budget Committee in what Huelskamp called "a vindictive move."

The Republican leadership offered no immediate explanation for the unusual removal.

On the moderate wing, a handful of House Republicans - such as Mike Simpson of Idaho and Steve King of Iowa - have said that tax increases on the wealthiest may be tolerable under certain conditions.

Public opinion has held steady since early November, with about half of Americans expecting Obama and the Republicans will be unable to avert a plunge off the cliff, said the Pew Research Center for the People and the Press in a new survey.

About 53 percent of those polled said they would hold Republicans more responsible than Democrats for such an outcome; 27 percent said they would hold Obama responsible.

Washington interest groups are consumed by the cliff, and some are in a bit of a panic about what the talks might bring.

Tensions erupted on Tuesday at a forum convened by a fiscal responsibility group called Fix the Debt, which seeks to cut the government's debt and includes business and political leaders.

Audience members stood and repeatedly interrupted Republican Senator Rob Portman of Ohio as he attempted to make a speech. They urged protections from cuts for the Social Security and Medicare social safety net programs. Others shouted down the protesters until they marched out of the forum.

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Medicare Open Enrollment Period Comes to a Close on Dec. 7

Oklahoma residents age 65 or older and disabled residents have until midnight Friday to make their choices for supplement health insurance and/or prescription drug coverage -- as do the residents in the rest of the nation.

Medicare Open Enrollment 2012

Medicare recipients have the opportunity to choose whether or not to add additional health care coverage to that which Medicare provides during the annual open enrollment period of Oct. 15 through Dec. 7. Medicare recipients can choose between the more traditional supplemental health insurances or the Medicare Advantage plans. The Advantage plans have prescription coverage built into them, while someone who chooses a supplemental plan will likely need to purchase a Part D plan if they wish to have prescription drug coverage.

Where Can Oklahomans, Other Americans Go to Get Help?

Oklahoma senior residents can get free assistance in reviewing policies available in their areas from unbiased, knowledgeable sources via the Medicare Assistance Program provided by the Oklahoma Insurance Department, reported NewsOK.com, by calling 800-763-2828. Use this number also if you'd prefer to find someone in your area with whom you could visit on site or by phone to assist in your open enrollment decision-making.

Any Medicare recipient can also access free assistance and information in choosing the best supplemental or Advantage plan for your needs and area by visiting the Department of Health and Human Service's Plan Finder, at healthcare.gov, medicare.gov or by calling 1-800-MEDICARE.

Do You Have to Change Plans Each Year?

If you like the benefits you are receiving with your current plan, and that plan is still being offered in your area, you don't have to do anything for that same plan to be your coverage for 2013. Many health insurance experts advise you to compare your current plan with new plans that may have become available. Medicare.gov allows you to select and compare plans side by side to determine which is best for your individual situation.

What Other Issues Are Important in Choosing the Best Coverage for You?

The price of a policy is only one factor for your consideration when choosing the best coverage for you. One policy may charge more per month than another policy, but if the higher-priced policy would result in lower health care costs for you, you have to do the math to weigh the differences.

Medicare.gov also provides a star-rating system for each of the insurances, with five stars being the highest rating. This may or may not influence your choices.

Bottom Line

If you want your Medicare supplemental coverage to begin seamlessly on Jan. 1, you must make your choice before midnight on Dec. 7. Don't hesitate any longer to find the information you need to make a good decision for yourself and your health care.

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Chelsea's hypotension drug fails to prove efficacy past week one

(Reuters) - Chelsea Therapeutics Inc said its experimental hypotension drug met the main goal of a study by significantly reducing dizziness in patients at week one, but results beyond that period were not statistically significant.

The U.S. Food and Drug Administration declined to approve the drug, Northera, in March, and asked for data that proved it was effective over two to three months.

The company's shares, which have lost about two-thirds of its value so far this year, fell 22 percent to $1.40 in extended trading after closing at $1.79 on Tuesday on the Nasdaq.

Chelsea said in August that it would modify the main goal of the ongoing 306B study, though the FDA had said the study was unlikely to provide sufficient data for a marketing application and had suggested the company conduct an additional trial.

The drugmaker said on Tuesday that preliminary data showed that beyond week one, dizziness/lightheadedness and standing blood pressure predominantly favored Northera-treated patients over placebo, although the results were not statistically significant.

The drug, known generically as droxidopa, is designed to treat symptomatic neurogenic orthostatic hypotension -- a chronic and often debilitating drop in blood pressure on standing up that is most often associated with Parkinson's disease.

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Obama firm on "fiscal cliff" amid Republican disarray

WASHINGTON (Reuters) - President Barack Obama held his ground on the "fiscal cliff" on Tuesday, insisting on higher tax rates for the wealthiest Americans, while Republicans showed increasing disarray over how far they should go to compromise with Obama's demands.

With less than a month left to confront the budget cuts and tax increases that will begin taking effect in January unless Congress acts, Obama dangled the possibility of lowering tax rates as part of a broad U.S. tax code revamp in 2013.

But he again insisted, in an interview with Bloomberg Television, that tax rates for the wealthiest 2 percent of taxpayers must rise in any deal by the end of the year to avert the assorted measures known as the fiscal cliff.

Obama, a Democrat, may face resistance from his own party if and when he's forced to be specific about how he would cut the cost of entitlements, such as the Medicare health insurance program for seniors.

For the moment, however, the overall political picture Tuesday reflected a relatively solid front of Democrats versus an increasingly shaky group of Republicans.

Mitch McConnell, the Republican minority leader in the Senate, even avoided endorsing the negotiating position of his House of Representatives ally, Speaker John Boehner.

"I think it is important that the House Republican leadership has tried to move the process forward," McConnell told reporters trying to get his views on a proposal Boehner and the House Republican leadership sent to Obama on Monday.

Outside the capital, concern mounted about how and when - not to mention if - the politicians might put their disagreements behind them and deal conclusively with an issue that economists say could trigger another recession.

Corporate chief executives were scheduled to meet with Obama later on Wednesday. The Business Roundtable, a lobbying group for corporations, has arranged the meetings. In addition to prompt action on the fiscal cliff, the group is seeking tax cuts for their companies.

Boeing Co. CEO Jim McNerney, who chairs the group, said its members want "a balanced solution to the nation's fiscal cliff and long-term deficit and debt issues ... including meaningful and comprehensive tax and entitlement reforms."

The manufacturing sector contracted in November and posted its weakest performance in three years, a report showed on Monday. Companies taking part in the survey said uncertainty over the negotiations in Washington was a factor.

U.S. stocks slipped on Tuesday as investors fretted about Washington's ability to avoid a year-end budget crisis.

REPUBLICAN DISARRAY

On Capitol Hill, conservative South Carolina Senator Jim DeMint attacked Boehner, a fellow Republican, over Monday's fiscal cliff offer, which included $800 billion (496.7 billion pounds) in revenue increases from overhauling the tax code, along with spending cuts and entitlement revisions, as part of a deficit reduction deal.

That amount, which Boehner informally accepted during previous debt-ceiling negotiations in 2011, was not enough to satisfy Obama. But it was too much for DeMint and other Republicans who have made opposition to tax increases of any kind a central part of their politics for many years.

"Speaker Boehner's $800 billion tax hike will destroy American jobs and allow politicians in Washington to spend even more," DeMint said in a statement on Tuesday.

Signalling some worry about fragmented sentiment in the House, Republican leaders took the unusual step of removing two hard-line Tea Party conservatives, Tim Huelskamp of Kansas and Justin Amash of Michigan, from the House Budget Committee, where elements of a fiscal cliff deal are likely to be considered.

A few House Republicans, such as Mike Simpson of Idaho and Steve King of Iowa, have said tax increases on the wealthiest may be tolerable under certain conditions.

OBAMA PRESSES ADVANTAGE

The president pressed his agenda on Tuesday, reiterating his openness to unspecified reforms in entitlement programs.

He repeated that as part of any deal, low tax rates on 98 percent of taxpayers should be extended, but that taxes on the top 2 percent should rise. "Let's let those go up," Obama said, referring to a "down payment" for future negotiations.

"And then let's set up a process with a time certain, at the end of 2013 or the fall of 2013, where we work on tax reform, we look at what loopholes and deductions both Democrats and Republicans are willing to close, and it's possible that we may be able to lower rates by broadening the base at that point."

Fuelling concerns among some Republicans about resisting compromise are surveys, like one released by the Pew Research Centre on Tuesday, which showed that about 53 percent of those polled said they would hold Republicans more responsible than Democrats for going over the cliff; 27 percent said they would hold Obama responsible.

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Both sides dig in on "fiscal cliff," but "nothing going on"

WASHINGTON (Reuters) - Republicans and Democrats dug in on "fiscal cliff" talks on Wednesday, with both sides urging quick action but offering no compromises in a political stare-down that shows no signs of breaking.

Less than a month before the onset of spending cuts and tax increases that start to take effect in January unless Congress acts, Republican leaders in the House of Representatives called on President Barack Obama to initiate face-to-face talks and blamed him for a lack of action.

"Where are the discussions? Nothing is going on," House Majority Leader Eric Cantor told reporters. "We ask the president to sit down with us, be serious about the specifics." Cantor later said the House would remain in session until "a credible solution to the fiscal cliff" had been announced.

Meeting with a business group on Wednesday, Obama renewed his call to include tax hikes on the wealthiest 2 percent of Americans as part of the final resolution and for including an increase in the nation's borrowing limit.

No direct talks were scheduled in a confrontation that has become an endless loop of familiar talking points and well-worn positions. Republican leaders have balked at raising any tax rates, and Democrats have resisted Republican calls for cuts in entitlements like the Medicare and Medicaid healthcare programs.

Obama said there could be a quick deal if Republican leaders dropped their opposition to raising tax rates for those making more than $250,000 a year in exchange for spending cuts and entitlement reforms.

"If we can get the leadership on the Republican side to take that framework, to acknowledge that reality, then the numbers actually aren't that far apart," Obama told executives at a meeting organized by the Business Roundtable, a lobbying group for corporations.

"Another way of putting this is we can probably solve this in about a week. It's not that tough, but we need that conceptual breakthrough," he said.

The two sides have submitted proposals to cut deficits by more than $4 trillion over the next 10 years, but they differ on how to get there. Republicans propose $1 trillion more in spending cuts than Obama, while the president wants $800 billion more in tax increases and $200 billion to boost the sluggish economy.

Republicans have shown cracks in their solidarity on taxes, however, with some saying they would be willing to let tax rates rise on the wealthiest 2 percent in exchange for extending low rates for the other 98 percent of taxpayers.

"I'm hearing whispers. I was over on the House side yesterday, I'm hearing whispers of a light going off in some people's minds" on the tax rates, said Republican Senator Bob Corker of Tennessee.

"All he (Obama) is talking about is rates on the upper income, so if the House were to give that to him, where does the discussion then go? It goes to entitlements which is where it ought to be in the first place," Corker said.

PREPARING FOR CUTS

With no resolution in sight and the fiscal cliff looming, the White House budget office has directed the Defense Department to begin planning for automatic budget cuts that will take effect in January without a deal, a Pentagon spokesman said.

About $500 billion in planned Pentagon spending would be slashed over the next decade unless there is a deal.

Economists have predicted that failure to reach an accord could trigger another recession, and investors in the financial markets have watched the back and forth anxiously. They were encouraged by Obama's reference to finishing a deal within a week of reaching agreement on taxes.

"Just the idea that we could have some kind of timeline is enough to eliminate some of the concerns. The fiscal cliff is the headline driver, so anything even slightly positive will move markets," said Todd Schoenberger, managing partner at LandColt Capital in New York.

Senator Tom Coburn, an Oklahoma Republican, said the focus on the end-of-year fiscal cliff was ignoring the long-term threat posed by U.S. debt. He said the path to prosperity would require at least a $9 trillion package of spending cuts and tax increases over 10 years, rather than the $4 trillion being discussed now.

"Personally I know we have to raise revenue. I don't really care which way we do it. Actually, I would rather see the rates go up than do it the other way because it gives us a greater chance to reform the tax code and broaden the base in the future," Coburn said on MSNBC.

Democratic Senator Claire McCaskill of Missouri sounded an optimistic note and said a final deal would include reform of entitlements like Medicare.

"I do think that if there's not a deal by the end of the year, there will be a deal the first week in January. And the markets need to be aware that this is not going to be, you know, some kind of complete meltdown. We will get a deal," she told MSNBC.

Corker said Obama's push to include an increase in the debt ceiling in any final package would complicate the negotiations.

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Moving Mali forward

Every year since 2001 the Festival au Desert has been held near Timbuktu, drawing musicians and listeners from around the world – until now. Next year’s event, according to its Website, is planned as a “Festival in Exile” held in stages in various other countries.

Mali, long considered an island of stability in a turbulent region, was turned upside down last spring as armed groups overran the north and a military coup toppled the democratically elected president.

Yet for some, crisis is also a wake-up call, unmasking Mali’s flaws while offering its people a chance to correct them.

“We need to recover the north,” says Moussa Mara, an accountant and district mayor in Bamako. “But what’s really at stake is how Mali might use this opportunity to move to greater democracy, civic values, justice, and prosperity.”

RELATED: A fabled city of the Sahara: How much do you know about Timbuktu?

AN EARLY SIGN

An attempt at overhauling Mali last occurred in 1991, when Army officers ousted the strongman president, Moussa Traoré, and started the country on a path toward democracy.

Free elections were instituted, and a decentralization plan meant to empower ordinary citizens subdivided regions into 703 small administrative “communes” with locally elected leaders.

International donors showered Mali with loans and development aid. Tourism grew, with desert jaunts and events such as the Festival au Desert among popular attractions.

From 2002, the United States poured around $60 million into training and equipping Mali’s Army to fight Al Qaeda in the Islamic Maghreb (AQIM), Islamist militants who have increasingly used the country’s northern hinterland as a base.

However, AQIM’s presence was also an early sign that, more generally, something was wrong in Mali.

'EVERYONE HAD SOMETHING'

Behind an image of democracy, endemic corruption and slapdash governance paved the way toward crisis, writes Yacouba Kone, Mali country manager for the British charity Christian Aid in a September report.

Malian democracy failed to serve ordinary people, Mr. Kone writes. “Rather, it was the entrenchment of a narrow elite that based its power more on patronage and less on popular support, in a bid to control the central government and the economy – both licit and illicit.”

According to Mr. Mara, the cozy relationship between power and personal interest was reflected in a quiescent political establishment.

“In ATT’s regime, everyone had something, so no one contested,” Mara says, using a common nickname for Amadou Toumani Touré, the former president first elected in 2002. “Political parties and civil society didn’t play their role.”

The result was a weak state that appeased rebellious Tuareg in Mali’s north by pulling back the Army, save in time of revolt, and allowed corruption and drug trafficking that in turn helped fund Islamic militancy.

“We had a feeling of impotence,” says Abdel Kader Sissoko, a former senior official in the northern regions of Kidal and Gao who retired last year. “The administration had neither the means nor the opportunity to combat drug trafficking.”

Last March, Army officers frustrated by the government’s inability to contain Tuareg rebels from the National Movement for the Liberation of Azawad (MNLA) ousted Mr. Touré.

Overnight, Islamist militants who had partnered with the MNLA in a marriage of convenience sidelined it instead, and today control northern cities.

In Bamako, an interim government was named in August. But coup leader Capt. Amadou Sanogo still wields influence, says a Western diplomat who was not permitted to speak on-record.

Today, plans are firming up for potential military intervention to dislodge the Islamists: West African countries have pledged troops, and the US and European countries are offering logistical support.

While intervention could take place next year, Western leaders also hope that dialogue with militants might allow a peace deal instead.

'CHANGE'

Whatever happens, many Malians say their country must not revert to business-as-usual.

The first step, says Mara, is holding presidential elections that were derailed by the coup, which in turn should free up development aid frozen when the government fell.

For Mr. Sissoko, more development is crucial to security in the north.

“If people have enough income they won’t have to rely on those who pay them to do bad things,” he says. “The temptation has always been great.”

Elections would also offer voters a chance to shoot down mainstream political parties, says Mara. He plans to run, presenting himself as an alternative to Mali’s political establishment.

At 37, he is younger than most politicians, he says. Unlike many, he hails from the private sector and founded his own party, Yelema, which means “Change.”

That notion strikes a chord with young Malians like Halachi Maiga, a teacher from the Islamist-held city of Gao, who is also a member of the regional youth council. Last March he watched the city's local elected officials bolt as gunmen invaded.

Leading citizens and civil society members, including himself, assumed the responsibility of managing relations between ordinary people and the Islamists who now run Gao.

“We need to find a way to choose credible leaders,” Mr. Maiga says. “So as not to fall back into the old system of corruption and the corrupt.”

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Ariad drug proves effective in curbing chronic leukemia in study

(Reuters) - An experimental leukemia drug from Ariad Pharmaceuticals Inc eliminated the cancer from the bone marrow  of nearly half of patients with a chronic form of the disease who had stopped responding to other drugs, according to a 12-month follow-up of a pivotal drug trial.

The trial of the drug, ponatinib, which involved 444 patients, including 267 with chronic myeloid leukemia who had previously been treated with older drugs, also showed that 56 percent of chronic patients achieved the study's goal of a "major response," meaning the disease had nearly disappeared from the bone marrow.

Ariad earlier this year presented interim results from the trial, and U.S. Food and Drug Administration agreed in October to an expedited review. The agency is slated to decide by March 27 whether to approve ponatinib.

"We expect FDA approval sometime in the first quarter," said Tim Clackson, Ariad's chief scientific officer. He said the company is prepared to immediately launch sales of the drug. "We believe the overall trial data suggests activity in all forms of resistant disease."

Ponatinib is designed to target an abnormal tyrosine kinase that is closely associated with chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia.

Ariad is also testing the drug in newly diagnosed CML patients. Final results from that trial are expected at the end of 2014, but an interim analysis will occur after half of the trial patients are enrolled, Clackson said.

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Pfizer/Bristol drug cuts recurrence of blood clots - study

(Reuters) - A new blood clot preventer from Pfizer Inc and Bristol-Myers Squibb Co reduced the risk of recurrence of clots in veins and lungs and death by 80 percent with no increase in major bleeding in a study testing extended use of the drug.

In the year-long trial of 2,486 patients who had been previously treated for the condition known as venous thromboembolism (VTE) the drug, apixaban, met the combined primary goal by significantly reducing the recurrence of blood clots and death from any cause compared with a placebo, according to data presented at the American Society of Hematology (ASH) meeting in Atlanta, Georgia.

The rate of recurrence or death was 11.6 percent in the placebo group compared with 3.8 percent for those who got 2.5 milligrams of apixaban and 4.2 percent for the 5 mg dose of the drug. The results were also published in the New England Journal of Medicine.

The incidence of major bleeding, always a concern with blood thinners, was extremely low in all three arms of the trial, researchers said - 0.5 percent for placebo, 0.2 percent for the low dose of apixaban and 0.1 percent for the higher dose.

"Usually when you have an effective antithrombotic you have to pay a price in terms of bleeding. This was not the case in this study," Dr. Giancarlo Agnelli, the study's principal investigator, said in a telephone interview.

"There was no evidence at all of increased major bleeding and this is extremely important because you are comparing an active drug with placebo," he said.

There was a slightly higher rate of clinically relevant nonmajor bleeding, such as nose bleeds that required medical attention, observed in patients taking the higher dose of apixaban at 4.2 percent compared with the low dose and placebo, researchers said.

Apixaban belongs to a new class of blood thinners that aim to replace decades old and difficult to use warfarin. The drug, which will be sold under the brand name Eliquis, is widely considered to be one of the most important new medicines for Pfizer and Bristol-Myers, both of which saw their top selling products lose patent protection in the past year.

AWAITING U.S. APPROVAL

It is approved in Europe and awaiting a U.S. approval decision for preventing blood clots and strokes in patients with atrial fibrillation - a type of irregular heart beat - and is also being tested against warfarin as a primary treatment for VTE with data expected next year.

A rival drug from Bayer and Johnson & Johnson called Xarelto is already approved for both conditions, but based on clinical data analysts have said they believe Eliquis is the best class.

An approval for extended use in VTE patients, during which they would take the drug for at least a year after initial treatment, could significantly boost future sales.

"The evidence is for one year. The next step would be to see whether this clinical benefit is extended after one year," Agnelli said.

VTE consists of deep vein thrombosis, typically blood clots in the legs, and pulmonary embolism, which are dangerous clots in the lungs. Clots that begin in the extremities can travel to the heart and lungs and can be fatal. VTE is typically treated with warfarin for three to six months.

After that, "there is quite a remarkable level of uncertainty about whether to extend or not," explained Agnelli, professor of internal medicine at the University of Perugia in Italy, who presented the data at the ASH meeting.

"Extended treatment might be clinically relevant because the recurrence rate after stopping treatment can be 10 percent in the first year," Agnelli said. "Reducing the recurrence of VTE means reduced hospitalization costs and in some cases fewer fatal events."

Physicians have been looking for alternatives to warfarin, which must be closely monitored to keep levels therapeutic but not toxic. The new drugs do not require monitoring or the dietary and lifestyle changes necessary with warfarin. But they still face an uphill battle as warfarin is far less expensive, and doctors have a comfort level using a drug that has been around for more than half a century despite the challenges.

Patients in the study had received treatment with warfarin for six to 12 months before starting the one-year extension trial that aimed to show further treatment could reduce recurrence rates and to see if the lower dose of apixaban was a viable option.

"It is quite clear that the lower dose is as effective as the higher. For the first time we showed that by reducing the dose of an antithrombotic agent in this clinical setting we can have the same efficacy with no major bleeding," Agnelli said.

"This is actually something that could change clinical practice," he added.

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Roche breast cancer drug extends overall survival

ZURICH (Reuters) - Swiss pharma group Roche's drug Perjeta significantly extended the lives of women with an aggressive and incurable form of breast cancer compared to a placebo, according to new data from a late-stage study presented on Saturday.

The detailed data presented at the San Antonio Breast Cancer Symposium found that the risk of death was reduced by 34 percent in women treated with a combination treatment of the drugs Perjeta and Herceptin plus chemotherapy compared to women treated with Herceptin, chemotherapy and a placebo, Roche said.

Roche is hoping that the Perjeta combination will become the standard treatment for women with a form of cancer known as HER2-positive, which makes up about a quarter of all breast cancers and has no cure.

At the time of the analysis, median overall survival had not yet been reached in people receiving the Perjeta combination, as more than half of these people continued to survive, Roche said.

Median overall survival was more than three years for people who received Herceptin and chemotherapy, Roche said, adding no new safety signals had been observed in the phase III study.

"This treatment combination with Perjeta is the first to have significantly extended survival compared to Herceptin and chemotherapy in people with previously untreated HER2-positive metastatic breast cancer," Roche's Chief Medical Officer Hal Barron said in the statement.

Breast cancer is the most common cancer among women worldwide, with about 1.4 million new cases diagnosed each year and more than 450,000 women dying of the disease annually, according to the World Health Organisation.

Perjeta, also known as pertuzumab, is a personalized medicine that targets a protein found in high quantities on the outside of cancer cells in HER2-positive cancers.

It was granted approval by U.S. health regulators in June. Roche is awaiting a decision from European regulators.

Vontobel analyst Andrew Weiss forecasts peak sales of 2 billion Swiss francs ($2.15 billion) for the drug.

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FDA panel opposes recommending painkiller, cites safety

WASHINGTON (Reuters) - A U.S. Food and Drug Administration panel of outside experts voted against recommending Zogenix Inc's Zohydro painkiller for FDA approval on Friday, citing concerns about the danger of addiction posed by the drug class known as opioids.

But FDA officials said the regulatory agency could still approve the drug for sale in the United States by imposing restrictions to protect public safety.

In an 11-2 vote, advisory committee members said the San Diego-based pharmaceutical company had met narrow FDA targets for safety and efficacy but worried that the drug known generically as hydrocodone bitartrate could become a drug of choice for people addicted to other opioid painkillers including those based on the drug oxycodone.

"The primary thing has to be the public health," said Dr Judith Kramer of Duke University. "And I don't see how we can't see this as a promised repeat performance."

FDA officials will consider the committee's recommendation in deciding by March 1 whether to approve Zohydro for sale in the United States for people who require a round-the-clock painkiller for an extended period of time.

Dr Bob Rappaport, director of the FDA's division of anesthesia, analgesia and addiction products, said regulators must decide whether the panel's decision was based on a tangible difference between Zohydro and opioid-based medications already available in the marketplace.

Otherwise, he told the panel, "you're punishing this company and this drug because of the sins of the previous developers and their products. And from a regulatory standpoint, that's not really something we can do."

POSSIBLE SALES BOOST

Wall Street analysts say FDA approval could bring Zogenix up to $500 million in annual sales from Zohydro by 2019, or more than ten times the pharmaceutical company's expected 2012 annual revenue of $45.5 million.

Trading of Zogenix shares was suspended on Friday because of the FDA hearing. The stock closed at $2.36 on Thursday.

Zohydro is a single-entity, extended-release product containing the narcotic painkiller hydrocodone with no other pharmaceutical ingredient such as acetaminophen, which can lead to liver damage if used too often.

"Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue. However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen," the company said in a statement.

"We remain confident in the measures we have proposed to support safe use of Zohydro and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population," it added.

Health officials say hydrocodone, the active ingredient in Zohydro, is already the most widely abused drug in an opioid class linked to a prescription drug abuse epidemic that has ballooned over the past 20 years.

Law enforcement officials say prescription drugs now pose a bigger public safety hazard than more traditional narcotics, including heroin and cocaine.

An estimated 7 million Americans abuse pharmaceutical drugs. Prescription drugs account for about 75 percent of all drug-related U.S. overdose deaths, according to the U.S. Centers for Disease Control and Prevention. Three of every four deaths from pills involve opioid pain relievers including oxycodone.

SHARPLY CONTRASTING TESTIMONY

Before voting, the panel heard testimony from more than a dozen public witnesses, including chronic pain sufferers who see drugs like Zohyrdo as needed treatments to control their chronic discomfort and allow them to lead normal lives without endangering their health.

But some speakers before the panel implored the experts not to recommend another potentially addictive opioid.

"Today we have a chance to save people," said Avi Israel, father of an 18-year-old boy who suffered from Crohn's disease and committed suicide after becoming addicted to hydrocodone that was prescribed to slow his bowels.

"Ask yourself this question," he added, "do we really need another narcotic pill to help anybody with pain? We can't handle what we have."

Earlier on Friday, the panel conducted separate and sharply divided votes on safety and efficacy.

Committee members voted 9-5 to find that the drug was not safe for treating patients with moderate to severe chronic pain, after voting 7-6 to find the treatment effective against pain. A panel member later changed her vote on efficacy from "no" to "yes," saying she had made a technical error.

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