Factbox: Mitt Romney, Republican presidential candidate

(Reuters) – Republican presidential candidate Mitt Romney, the former governor of Massachusetts, is pursuing the White House for the second time.

Here are key facts about him.

- Romney, 65, espouses traditional Republican positions to cut taxes, reduce federal regulations, shrink government spending and bolster the U.S. military. He vows to create 12 million new jobs in his first term with a plan focused on domestic energy development, expanded free trade, improving education, reducing the deficit and championing small business.

- He lost the 2008 Republican presidential nomination to Senator John McCain but entered this year’s race with a large campaign war chest and the blessing of many in the party establishment. Conservative unease over his reputation as a moderate led to a stiff challenge in the Republican primaries.

- His net worth has been estimated at between $ 190 million and $ 250 million, making him one of the wealthiest people to ever run for the presidency. Romney has been attacked for holding money overseas and for not disclosing as many tax releases as his opponents have demanded.

- Romney proposes to lower individual income taxes across the board to 20 percent while closing some loopholes, which he says would stimulate economic growth without widening the deficit. He supports restructuring the Social Security retirement program and the Medicare health entitlement for the elderly.

- He is a fifth-generation member of the Church of Jesus Christ of Latter-Day Saints, or Mormon church. He was a Mormon missionary in France for more than two years after leaving high school and later became bishop and stake president in Boston, roles akin to being a lay pastor. His faith, however, is viewed with suspicion by some conservative evangelical Christians.

- Born into a well-off family and raised near Detroit, Romney was exposed to politics early. His father, George, was chairman of American Motors Corporation and governor of Michigan from 1963 to 1969. George Romney lost a bid for the Republican presidential nomination in 1968 and served in President Richard Nixon’s Cabinet.

- In 1994, the younger Romney ran for a U.S. Senate seat in Massachusetts as a moderate Republican, but was handily defeated by incumbent Democratic Senator Edward Kennedy. Eight years later, Romney was elected governor of Massachusetts, where he instituted a statewide healthcare reform that became a model for Obama’s 2010 national healthcare overhaul.

- In 1999, Romney took over as head of the committee organizing the 2002 Winter Olympics in Salt Lake City, Utah, which had been plagued by cost overruns and scandal, and produced a successful event that helped establish his national reputation as a premier problem-solver.

- As his party moved to the right, Romney changed his positions on sensitive social issues, including abortion and gay rights. That fueled criticism that he lacked core beliefs and was motivated only by ambition. Romney referred to himself as “severely conservative” during the 2012 primaries but has projected a moderate image during the general election campaign.

- Romney met his wife, Ann, at a high school dance and they married in 1969, while they were still in college. They have five sons and 18 grandchildren. Romney has an English degree from Utah’s Brigham Young University, which is owned and run by the Mormon church, and a joint law degree and MBA from Harvard. He speaks French.

- Romney joined the management consultancy Bain & Company in 1977 and climbed the ranks, and in 1984 co-founded the highly profitable private equity arm Bain Capital, which invested in start-ups and fledgling companies including Staples, Sports Authority and Domino’s Pizza. Critics have highlighted the number of jobs Bain cut while Romney was at its helm.

- Romney has battled a reputation for being uncomfortable and stiff when campaigning and somewhat aloof when relating to ordinary Americans. The New York Times once described his campaign persona as “All-Business Man, the world’s most boring superhero.”

- He has little foreign policy experience. He stumbled in August during a gaffe-filled trip to Britain, Israel and Poland that was meant to burnish his credentials on the world stage. He has labeled Russia as America’s “number one geopolitical foe” and said that preventing Iran from obtaining a nuclear capability should be Washington’s highest national security priority.

(Compiled by Americas Desk; Editing by Paul Simao)

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Barclays faces $470m energy fine

1 November 2012 Last updated at 04:12 ET

Barclays has been threatened with fines of $ 470m (£291m) by US regulators to settle accusations it sought to manipulate the California energy markets from 2006-2008.

The Federal Energy Regulatory Commission has been investigating it, the bank revealed on Wednesday.

Barclays denies the charges. The fine is larger than the one it paid over the Libor rate-rigging scandal.

The bank is also the subject of other regulatory inquiries.

Barclays now has 30 days to contest the fine.

Manipulating prices

The proposed fine is over communications by four traders on Barclays’ West Coast power desk.

The team of four traders – veterans of power firm Mirant, which was fined hundreds of millions of dollars after the California power scandal a decade ago – was said by Ferc to have exchanged messages explaining how they would use certain trades in one market to profit in another.

The traders are alleged to have manipulated power prices to make money with their financial swap positions, causing losses for rival power traders of $ 139m and winning the bank $ 34.9m.

“We believe that our trading was legitimate and in compliance with applicable law,” Barclays spokesman Mark Lane said. “We have co-operated fully with the Ferc investigation, which relates to trading activity that occurred several years ago. We intend to vigorously defend this matter.”

Ferc notified Barclays that it had begun the investigation of Barclays’ Western US power trading on 3 July 2007 – but the bank only informed shareholders on Wednesday.

US authorities are also looking at whether the way that Barclays won business complied with the Foreign Corrupt Practices Act, the other new investigation in a series of scandals that have dented the bank’s reputation.

In June, Barclays was fined £290m by UK and US regulators for attempting to manipulate Libor, an interbank lending rate which affects mortgages and loans.

And in August, the Serious Fraud Office started an investigation into payments between Barclays’ bank and Qatar Holding in 2008, when the bank was raising money in the Middle East during the banking crisis.

The entire financial services industry has come under scrutiny since the financial crisis in 2008.

The industry’s reputation has been battered further by the mis-selling of payment protection insurance (PPI) and of specialist insurance – called interest rate swaps – to small businesses.

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Canada will push to keep bank capital rules on schedule

OTTAWA (Reuters) – Canada will urge all countries to stick to the agreed schedule for implementing tougher bank capital rules at a November 4-5 meeting of finance ministers and central bankers from the Group of 20 nations, a senior finance ministry official said on Thursday.

The so-called Basel III rules are the world’s regulatory response to the financial crisis, forcing banks to triple the amount of basic capital they hold in a bid to avoid future taxpayer bailouts.

They were to be phased in from January 2013 but areas such as the United States and the European Union are not yet ready and U.S. and British supervisors have criticized them as too complex to work.

The Canadian official, who briefed reports ahead of the meeting on condition that he not be named, said it was imperative that the rules, the timelines and the principles behind them be respected and said Finance Minister Jim Flaherty would make that view known to his G20 colleagues.

Canada sees the European debt crisis as the biggest near-term risk to the global economy, and it also expects the U.S. debt crisis to be top of mind at the talks, the official said.

But the meeting takes place just before the U.S. presidential election and U.S. Treasury Secretary Timothy Geithner will be absent, so it remains unclear how much the G20 can pressure Washington on that front.

Some other countries have also scaled back their delegations, raising doubts about how meaningful the meeting will be.

The official dismissed that argument, saying high-level officials substituting for their ministers allowed for extremely important issues to be addressed anyway.

He said holding each country around the table accountable to its past commitments helped keep the momentum going toward resolving global economic problems.

(Reporting by Louise Egan; Writing by David Ljunggren; Editing by M.D. Golan)

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First iPad mini teardown reveals Samsung display

SAN FRANCISCO (Reuters) – Apple Inc’s iPad mini uses a display from South Korea’s Samsung Electronics Co Ltd, one of Apple’s major suppliers and also its fiercest rival in the global mobile-device market that the two companies dominate.

Analysts say the Silicon Valley-based iPhone maker is trying to wean itself off its reliance on Samsung, as both giants are embroiled in a bitter international legal battle over mobile patents, for everything from microchips to displays.

In the first dismantling of the iPad mini, which will be sold in 34 countries beginning Friday, teardown and gadget-repair specialist company, iFixit, discovered a Samsung display driver chip, which indicated that Apple had picked the Korean firm’s screen technology.

Like most producers of mobile hardware, the U.S. company typically employs several suppliers for the same components in its gadgets. Apple has been known to use screens made by LG Display, for instance.

“Though the markings on the back of the LCD (display) don’t turn up much information, the Samsung display driver IC (chip) reveals that Apple, once again, went with Samsung in its display manufacturing,” iFixit said, detailing the teardown on its website.

Supplying parts for Apple’s iPhones and iPads – some of the industry’s most popular and advanced gadgets – is considered a coup for chipmakers and other manufacturers.

The iPad mini also employs SK Hynix Inc flash memory, a Broadcom touch controller, and a number of microchips from Fairchild Semiconductor International Inc, according to iFixit, which acquired one early.

The 7.9-inch iPad mini marks the Apple’s first foray into the smaller-tablet segment. The company hopes to beat back incursions into its home territory – carved out with the original iPad’s launch in 2010 – with 7-inch slates that are popular with consumers, even as it safeguards its lead in a larger tablet space that even deep-pocketed rivals like Samsung have found tough to penetrate.

It has won mostly positive reviews focused on its ability to wrap most of the functions of its full-sized iPad sibling into a smaller package, but critics pointed out the higher price tag of the iPad mini and an inferior display relative to those of rival products like Amazon’s Kindle Fire HD and Google’s Nexus 7.

START YOUR ENGINES

A smaller tablet is the first device to be added to Apple’s compact portfolio under CEO Tim Cook, who took over from predecessor Steve Jobs just before his death a year ago. Analysts said it may have been Google and Amazon that helped influence the decision.

Online sales have run for a week, but Apple has not disclosed sales numbers so far. Friday’s global sales rollout may offer a hint of demand for the gadget, which analysts expect to be strong.

Still, it will be playing catch up. Priced at $ 329 for a Wi-Fi only model, the iPad mini is more expensive than many analysts had expected. Amazon’s Kindle Fire and Google’s Nexus 7, both released at $ 199, have grabbed a chunk of the lower end of the tablet market.

Meanwhile, it is battling Samsung in the smartphone arena, which still yields the majority of Apple’s revenue and profit. The Korean giant last year became the world’s largest maker of smartphones as other rivals lost steam.

Apple and Samsung are engaged in patent disputes across several countries, and Apple is believed to be seeking ways to rely less on Samsung. But the Asian tech powerhouse remains a key supplier for Apple, manufacturing its application processors and providing other components.

Samsung has stopped supplying displays for Apple’s iPhone, and plays a reduced role in the full-sized iPad, according to DisplaySearch. Apple is also buying fewer memory chips from Samsung for the iPhone 5, relying more on Hynix and Elpida Memory.

Many analysts believe Apple will also gradually phase out Samsung as the main producer of the mobile micro-processor and shift business to rival supplier TSMC.

(Editing by Matthew Lewis, Tim Dobbyn and Bernadette Baum)

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Cablevision says Sandy outage hit half of its customers

NEW YORK (Reuters) – Cable operator Cablevision Systems Corp said on Thursday about half of its 3.3 million customers in the New York, Connecticut and New Jersey area had lost power in the wake of superstorm Sandy, causing widespread disruptions to its service.

Cablevision said in a statement that 1.6 million of its customers were without power while 7,265 of the remaining 1.65 million customers who were not affected by power outages still had no access to Cablevision’s service.

The company did not respond to questions about how the disruption would impact its financials.

A Barclays analyst, James Ratcliffe, said in a note that “power outages make a good proxy for storm impact on telcos and cable operators, since the same factors which cause power outages (flooding, downed lines) also cause telecom network failures.”

Cablevision, which provide Internet, television and telephone services under the Optimum brand, said, “Following this unprecedented event, loss of electrical power continues to be the primary cause of widespread disruptions of Optimum service.”

It said it had crews working to restore service and would continue to provide updates.

Last year, Cablevision said it took a hit of $ 16 million because of Hurricane Irene, a storm that affected the New York area in late August 2011.

“For CVC, with 1.6 million of their subscribers still without power, the impact is likely to be significantly greater than the $ 16 million cost of Irene; we estimate a $ 36 million impact,” Barclays’ Ratcliffe said in his note.

Cable operators Comcast Corp and Time Warner Cable were also having service problems.

Time Warner Cable said it has had no reports of significant damage to its network, but said it was hard to assess the situation because many of its customers have no power.

Cablevision had been due to report earnings November 1, but said on Wednesday it rescheduled the release to November 6.

The company, which mainly serves the New York area but also has operations in Montana and Wyoming, is controlled by the Dolan family. The company also owns a newspaper and TV networks.

Comcast Corp and Verizon Communications also said they had service problems in the wake of the storm, but they did not provide details as to how many customers were affected.

Of all the cable companies, Cablevision has the largest percentage of their subscribers in the area hard hit, Ratcliffe said.

Wireless service providers also struggled to maintain service after the storm due to floods and power outages.

Cablevision stock closed at $ 17.46 on Thursday, up 0.22 percent.

(Additional reporting by Sinead Carew; Editing by Leslie Adler)

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UK cost agency backs melanoma drugs after price cuts

LONDON (Reuters) – Two new drugs for skin cancer have been recommended for use on Britain’s state-run health service after the rival manufacturers – Roche and Bristol-Myers Squibb – agreed to cut their prices.

The move underscores the growing pressure on drug companies to cut deals with austerity-hit European governments in order to prove their expensive new medicines offer value for money.

The National Institute for Health and Clinical Excellence (NICE) said on Friday it had issued final draft guidance recommending both Roche’s Zelboraf and Bristol‘s Yervoy after the companies offered undisclosed discounts.

NICE, which determines if products should be used by the National Health Service (NHS), had initially rejected both medicines, despite acknowledging that they represented a breakthrough in treating melanoma.

The list price for Zelboraf, which is only suitable for patients with a particular genetic profile, is 52,500 pounds ($ 84,600) for an average treatment span of seven months.

The price of a four-dose course of Yervoy, which is recommended only for people who have received prior chemotherapy, is 75,000 pounds.

($ 1 = 0.6207 British pounds)

(Reporting by Ben Hirschler; Editing by Mark Potter)

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How Truth and Lies Spread on Twitter

Hurricane Sandy was a huge moment for New York City. It was also a huge moment for how we think about social media.

For many in the superstorm’s path up the Eastern seaboard, social networks quickly became an essential source of information from news organizations, civic organizations, and friends and family. As power went out in lower Manhattan on Monday evening, many residents turned to Twitter and Facebook on their smartphones to learn exactly how the hurricane was impacting their neighborhoods. CBS estimates three and a half million tweets with the hashtag #Sandy during the height of the storm; popular photo-sharing service Instagram saw 10 photos of Hurricane Sandy uploaded per second.

As my colleague Susan Berfield notes, social media’s role in distributing information reflects a growing trend in news consumption: according to the Pew Research Center’s State of the Media 2012 report, 36 percent of people who use Twitter for news said most of the links they follow come from friends and family, while 27 percent say most come from news organizations, and 18 percent mostly follow links from other organizations such as think tanks.

As vital information flooded Twitter and Facebook, misinformation soon bubbled to the top. Shashank Tripathi, a hedge fund analyst and the campaign manager of Christopher R. Wight, the Republican candidate for the U.S. House or Representatives from New York’s 12th Congressional District, pushed rumors on Twitter under the pseudonym @ComfortablySmug that the New York Stock Exchange floor was under three feet of water, a rumor that spread to CNN before an exchange official debunked his claim. Fake photos of scuba divers in the New York subways and enormous storm systems over Manhattan ricocheted across social networks at lightning speed. The entire media ecosystem became embroiled in a perpetual game of “Two Truths and a Lie.”

Twitter proved effective not just as a newswire, but as a medium for distributed fact-checking. As quickly as the falsehoods emerged, journalists and city officials moved to swat them down. BuzzFeeds Jack Steuf quickly revealed the identity of @ComfortablySmug, who issued a public apology Tuesday night. The Atlantic‘s Alexis Madrigal, aided by Atlantic social media editor Chris Heller and MSN international editor Tom Phillips—who runs a microsite ‘Is Twitter Wrong?‘ devoted to debunking rumors on social media—verified the stunning images floating across the Internet. Even the New York Post reported that Mayor Michael Bloomberg planned on barring passenger cars from entering Manhattan, only to be quickly rebuked by press secretary Marc La Vorgna.

After the storm passed, BuzzFeed’s John Herrman argued that Hurricane Sandy established Twitter is a truth machine that, under the right circumstances, systematically vets and destroys rumors as quickly as it propagates them. “Initial misinformation has consequences, and a consensus correction on Twitter won’t stop any number of these rumors from going viral on Facebook,” Herrman writes. “There, your claims are checked by your friends; on Twitter, if they spread, they’re open to direct scrutiny from people who might actually know the truth.” In the echo chamber of social media, truth is louder than fiction.

No matter what, no decentralized network like Twitter or Facebook will be totally free from misinformation, says Jeff Jarvis, associate professor at City University of New York’s Graduate School of Journalism and author of Public Parts: How Sharing in the Digital Age Improves the Way We Work and Live.  But, he adds, “The lie can spread fast, but the truth can spread faster, too.” He provides his own experience with Hurricane Sandy as an example. “As I scroll down in reverse order on Twitter, I see correction after correction. I see 10 times as many corrections as erroneous reports. And the time between them is amazingly small.”

In terms of daily news consumption, a fraction of the U.S. uses Twitter, but everyone talks to their siblings, their parents, their coworkers, their friends. Text messaging, email, and ‘dark social’ networks spread misinformation just as quickly, and to more people. This is a potential problem with Twitter as a medium for truth and lies: what happens on Twitter doesn’t stay on Twitter. If we’re to continue the favored epidemiology metaphor of the Internet-employed, information that goes viral can become airborne: it leaves the Twitter network, where the journalists and reporters and ‘influentials’ who can quickly propagate corrections can’t reach.

I experienced this first-hand during Hurricane Sandy. after retweeting a message warning about muggers in Williamsburg dressed as ConEd workers as an experiment, I received two skeptical responses checking the claim within 15 minutes, both from people who work in the media industry and spend a significant amount of time on Twitter. Within an hour, I received a mass text message from friends of mine who aren’t completely plugged into the social web with the same warning: “I just read a news alert of two seperate reports of people posing as coned workers, knocking on people’s door and robbing them at gunpoint in williamsburg. I just want to pass along the info. Stay safe and maybe don’t answer your door.” Two other friends responded with thanks.

“I know a lot of people, especially on Facebook, who end up believing whatever they see first,” says Kate Gardiner, a social media journalist. “It’s almost impossible to track something back to its point of origin there.”

While the space for distributed fact-checking offered by Twitter and Facebook may not be perfect, it’s a vast improvement over the rumor mills and slow debunking of the past, says Jarvis. “Look, my dear beloved father sends out these emails that have been forwarded 87 times, and my sister, who isn’t a tech saavy person at all, goes to Snopes and says ‘Dad, not true.’ We all have fathers and uncles who send this crap around, but there’s a mechanism now to go out and debunk these things that we haven’t had before. I think it’s an improvement, and looking at the one-in-a-billion lies misses the point.”

Keller is director of social media for Bloomberg News and Bloomberg Businessweek.

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Clinton calls for overhaul of Syrian opposition

ZAGREB (Reuters) – The United States called on Wednesday for an overhaul of Syria‘s opposition leadership, saying it was time to move beyond the Syrian National Council and bring in those “in the front lines fighting and dying”.

Secretary of State Hillary Clinton, signaling a more active stance by Washington in attempts to form a credible political opposition to Syrian President Bashar al-Assad, said a meeting next week in Qatar would be an opportunity to broaden the coalition against him.

“This cannot be an opposition represented by people who have many good attributes but who, in many instances, have not been inside Syria for 20, 30, 40 years,” she said during a visit to Croatia.

“There has to be a representation of those who are in the front lines fighting and dying today to obtain their freedom.”

Clinton’s comments represented a clear break with the Syrian National Council (SNC), a largely foreign-based group which has been among the most vocal proponents of international intervention in the Syrian conflict.

U.S. officials have privately expressed frustration with the SNC’s inability to come together with a coherent plan and with its lack of traction with the disparate internal groups which have waged the 19-month uprising against Assad’s government.

Senior members of the SNC, Free Syrian Army (FSA) and other rebel groups ended a meeting in Turkey on Wednesday and pledged to unite behind a transitional government in coming months.

“It’s been our divisions that have allowed the Assad forces to reach this point,” Ammar al-Wawi, a rebel commander, told Reuters after the talks outside Istanbul.

“We are united on toppling Assad. Everyone, including all the rebels, will gather under the transitional government.”

Mohammad Al-Haj Ali, a senior Syrian military defector, told a news conference after the meeting: “We are still facing some difficulties between the politicians and different opposition groups and the leaders of the Free Syrian Army on the ground.”

Clinton said it was important that the next rulers of Syria were both inclusive and committed to rejecting extremism.

“There needs to be an opposition that can speak to every segment and every geographic part of Syria. And we also need an opposition that will be on record strongly resisting the efforts by extremists to hijack the Syrian revolution,” she said.

Syria’s revolt has killed an estimated 32,000. A bomb near a Shi’ite shrine in a suburb of Damascus killed at least six more people on Wednesday, state media and opposition activists said.

NEW LEADERSHIP

The meeting next week in Qatar’s capital Doha represents a chance to forge a new leadership, Clinton said, adding the United States had helped to “smuggle out” representatives of internal Syrian opposition groups to a meeting in New York last month to argue their case for inclusion.

“We have recommended names and organizations that we believe should be included in any leadership structure,” she told a news conference.

“We’ve made it clear that the SNC can no longer be viewed as the visible leader of the opposition. They can be part of a larger opposition, but that opposition must include people from inside Syria and others who have a legitimate voice which must be heard.”

The United States and its allies have struggled for months to craft a credible opposition coalition.

U.S. President Barack Obama’s administration has said it is not providing arms to internal opponents of Assad and is limiting its aid to non-lethal humanitarian assistance.

It concedes, however, that some of its allies are providing lethal assistance – a fact that Assad’s chief backer Russia says shows western powers are intent on determining Syria’s future.

Russia and China have blocked three U.N. Security Council resolutions aimed at increasing pressure on the Assad government, leading the United States and its allies to say they could move beyond U.N. structures for their next steps.

Clinton said she regretted but was not surprised by the failure of the latest attempted ceasefire, called by international mediator Lakhdar Brahimi last Friday. Each side blamed the other for breaking the truce.

“The Assad regime did not suspend its use of advanced weaponry against the Syrian people for even one day,” she said.

“While we urge Special Envoy Brahimi to do whatever he can in Moscow and Beijing to convince them to change course and support a stronger U.N. action we cannot and will not wait for that.”

Clinton said the United States would continue to work with partners to increase sanctions on the Assad government and provide humanitarian assistance to those hit by the conflict.

(Additional reporting by Ayla Jean Yackley; editing by Andrew Roche)

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Pentagon sees further use of BlackBerry as door opens to others

WASHINGTON (Reuters) – The Pentagon on Wednesday said it would continue to support “large numbers” of BlackBerry phones made by Research in Motion Ltd even as it moves forward with plans that would allow the U.S. military to begin using Apple Inc‘s iPhone and other devices.

The U.S. Defense Department last week invited companies to submit bids for software that can monitor, manage and enforce security requirements for devices made by Apple and Google Inc, with an eye to awarding a contract in April.

The Defense Information Systems Agency (DISA) quietly posted its request for proposals on a federal website on October 22, the same day that the U.S. Immigration and Customs Enforcement Agency said it would end its contract with RIM in favor of Apple’s iPhone.

Losing some of its Pentagon business to other providers could deal another blow to RIM, which once commanded the lead in the smartphone market but has rapidly lost ground to Apple and Samsung’s line of products as customers abandon its aging BlackBerry devices.

For many years, the Pentagon relied solely on BlackBerry phones because RIM met its tough security requirements, but other companies have been improving security on their devices, and a growing number of military commanders are clamoring for rival devices with bigger touch screens and faster browsers.

A Pentagon spokesman said the U.S. military was working toward allowing vendors to supply other smartphones, while maintaining strict security requirements.

He said the department aimed to use commercial mobile technologies as it stepped up the use of “new and innovative applications” to support the military’s evolving requirements.

But the Pentagon also stressed it was not moving away from its use of BlackBerry phones.

“DISA is managing an enterprise email capability that continues to support large numbers of RIM devices while moving forward with the department’s planned mobile management capability that will support a variety of mobility devices,” the spokesman said.

The DISA request for proposals said the software would manage at least 162,500 devices to start, but that number could grow to 262,500 by the end of the contract, which will have a one-year base and four six-month options.

Ultimately, the Pentagon wants the software to support a total of 8 million devices, according to the document.

RIM spokesman Paul Lucier said his company’s BlackBerry Mobile Fusion product could also be used to manage Android and Apple devices, and RIM was “excited for the opportunity to include BlackBerry Mobile Fusion in the DOD’s portfolio.”

Lucier said the product could enable the Pentagon to “support a growing number of mobile devices across multiple platforms.”

Waterloo, Ontario-based RIM is also planning to introduce new smartphones that will run on the BlackBerry 10 operating system, offering a faster and smoother user interface and a better platform for various smartphone applications.

(Reporting By Andrea Shalal-Esa; Editing by Tim Dobbyn)

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Sanofi draws fire over cost of MS drug Lemtrada

PARIS (Reuters) – Medical journal The Lancet warned that Sanofi‘s experimental multiple sclerosis drug Lemtrada may be too costly for patients and health insurers once it gets approved by regulators.

The journal, which published the encouraging results of two late-stage Lemtrada tests on Thursday, also criticized the drugmaker’s decision to withdraw leukemia therapy Campath, the same drug given at a different dosage, depriving MS patients who had been using it off-label.

In an editorial accompanying the test results, The Lancet voiced concerns that Lemtrada would be priced higher than current MS drugs on the market and said the discontinuation of Campath may mean patients who had used it for MS would not be able to continue their treatment.

The injectable drug, chemically known as alemtuzumab, was sold until September 2012 under the name Campath as treatment for leukemia and given more frequently at a higher dosage.

“There is concern that with a license for multiple sclerosis, the cost of alemtuzumab could rise and might become too expensive for many patients and health systems,” the editorial said.

Although Campath remains available free of charge to leukemia patients, Sanofi’s rare disease unit Genzyme pulled it off the market in September to prevent its unauthorized use as an MS drug.

Analysts said the move would allow the company to adjust the price to match that of rival MS drugs on the market.

A full course of Campath, which in 2011 had sales of $ 76 million, cost around $ 60,000 when given three times a week for up to 12 weeks, according to Genzyme.

Lemtrada, instead, is given at less than half the dose of Campath for 5 consecutive days and then again for 3 days a year later. Since the drug has yet to be approved, it remains unclear how much Sanofi will charge for it.

The drug, which works by resetting a person’s immune system, has shown in late-stage trials to be an effective treatment for MS patients who have failed to respond to other therapies.

It has also shown to benefit people not previously treated for the disease, suggesting it could be used as a first-line MS therapy.

But patients need regular monitoring for serious side effects that can include infections and autoimmune diseases.

“It’s important that the appropriate safety monitoring is in place for patients who are prescribed Lemtrada,” Genzyme’s head of MS, Bill Sibold, told Reuters, responding to questions about the Lancet editorial. “Until an approved risk-management program is established, we believe the use of Lemtrada should only occur in clinical trials.”

Lemtrada remains available to patients who are taking part in clinical tests.

Sibold declined to discuss pricing plans for Lemtrada, but said Genzyme has set up programs to make its approved drugs available to patients who cannot afford them. “With Lemtrada it would be no different,” he said.

DRUG FUNDING

But there are concerns that cash-strapped European governments may balk at funding the drug through their public healthcare systems.

Doug Brown, Head of Biomedical Research at U.K. charity MS Society said that while Lemtrada’s results are great news for patients, the drug would only be useful to them if it were available through the country’s publicly funded National Health Service.

“We urge Genzyme to price the treatment responsibly so that if it’s licensed, it’s deemed cost effective on the NHS,” he said.

The U.K.’s cost-effectiveness body National Institute for Health and Clinical Excellence (NICE), whose opinions are also watched closely in other countries, initially rejected Novartis’ MS pill Gilenya, only to make a U-turn after the company agreed to a discounted price.

Sanofi launched its MS pill Aubagio in the U.S. at a price of $ 45,000 for a year’s treatment, making it cheaper than rivals.

Gilenya – the only other MS pill currently on the market – costs 28 percent more, while injectable treatments such as Biogen Idec Inc’s Avonex and Teva Pharmaceutical Industries Ltd’s Copaxone are 8 and 6.5 percent higher respectively.

(Reporting by Elena Berton; Editing by Tim Dobbyn)

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