Number of new drugs picks up in Europe and U.S.

LONDON (Reuters) – The number of new medicines approved or pending approval is on the rise on both sides of the Atlantic, painting an encouraging picture for the global drugs industry as it emerges from a wave of patent expiries.

European regulators said on Tuesday that they expect an increase in new drug applications to about 54 in 2013. In the United States, a total of 34 new drugs have been approved for sale so far in 2012 – the highest level in eight years.

The sector badly needs a pick-up in productivity as companies try to refill their medicine chests after a wave of patient expiries that have peaked this year, depriving leading U.S. and European drug companies of more than $ 30 billion of revenue.

“It bodes well,” said Standard & Poor’s (S&P) analyst Olaf Toelke, who predicts that strong pipelines will allow most large drugmakers to emerge unscathed from the spike in sales losses.

“It shows that companies are addressing the need to find new drugs to replace those facing patent expiration. They have done their homework and it looks as if the industry will be at least stable in future and not fall off the threatened patent cliff.”

The U.S. Food and Drug Administration (FDA), gatekeeper to the world’s biggest pharmaceuticals market, still has just over a week to add more approvals to this year’s tally – and there are signs that the number will increase further.

Three new products for leukemia, anthrax and Cushing’s disease from Ariad Pharmaceuticals, GlaxoSmithKline and Novartis were approved last Friday alone, and the FDA is scheduled to hand down decisions on a further four drugs before the end of the month.

FEWER GENERICS

A green light for all these would take the 2012 tally of new molecular entities (NMEs) approved by the agency’s Center for Drug Evaluation and Research to 38 – two more than the 2004 total of 36.

The European Medicines Agency painted a different picture of improving productivity by announcing that its work program for the year ahead included a forecast for 54 new drug applications, up from 52 in 2012, 48 in 2011 and 34 in 2010. These figures exclude medicines designated for “orphan”, or rare, diseases.

Significantly, the London-based agency is also expecting a sharp drop in the number of applications from companies to sell generic versions of drugs, to 20 in 2013 from 39 in 2012, given the slowdown in patent expiries next year.

Major U.S. drug companies will lose a total of about $ 21 billion in revenue this year from lucrative medicines coming off patent, while the hit for European businesses is about $ 10 billion, according to S&P.

This year’s expiries have included Sanofi and Bristol-Myers Squibb’s heart drug Plavix and AstraZeneca’s antipsychotic Seroquel.

Winning approval from regulators, however, is only part of the battle for drugmakers.

Investors will also be watching closely to see how the new drugs perform commercially once they reach the market, since securing payment for innovative medicines is an increasingly tough fight – especially in austerity-hit Europe.

An analysis by Deloitte and Thomson Reuters this month found that while new drug approvals were increasing, this was offset by lower expected revenues from many individual products.

(Editing by David Goodman)

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Comet collapse to cost UK £49m

17 December 2012 Last updated at 15:35 ET

The collapse of electrical chain Comet will cost the government £49.4m in redundancy payments and tax revenues, administrators Deloitte have revealed.

The redundancy money owed to thousands of former Comet workers totals £23.2m, and will be paid by the government’s Redundancy Payments Service (RPS).

Meanwhile, £26.2m is owed in taxes to HM Revenue & Customs (HMRC).

The last 49 Comet stores will close on Tuesday. Comet went into administration last month.

Big losses

Comet’s demise is one of the biggest High Street casualties of recent years.

The 236-store business, which at the time employed about 7,000 people, was bought last year for the nominal sum of £1 by private equity firm OpCapita.

Continue reading the main story

Founded in 1933 as a business charging radio batteries.

Opened its first store in Hull in 1968.

Bought by Woolworths and B&Q owner Kingfisher in 1984, which expanded Comet into one of the UK’s best-known retail brands.

In 2003 Comet became part of Kesa Electricals, after Kesa was demerged from Kingfisher.

It was announced in November 2011 that Comet would be sold to private equity group OpCapita for just £1.

OpCapita was also given £50m by Kesa as part of the deal.

OpCapita bought the Comet from Kesa Electrical, which also gave OpCapita £46.8m of working capital.

However, OpCapita failed to turnaround Comet’s fortunes, as the company continued to suffer from the fall in UK consumer spending during the recession, and the big growth in online rivals.

Comet was founded in Hull in 1933 and began life selling batteries and radios.

The closure of the final Comet’s stores comes after Deloitte failed to find a buyer for the company.

Deloitte also revealed on Monday that Comet’s losses in the year to April totalled £95m, while its revenues slumped by £200m.

In the subsequent five months, Comet lost a further £31m.

Kesa Electricals was renamed Darty in July this year.

Despite having its headquarters in London, it focuses on the continental market – especially France, where it has more than 200 stores under the Darty name.

BBC News – Business

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N. Korea displays Kim Jong Il a year after death

PYONGYANG, North Korea (AP) — North Korea unveiled the embalmed body of Kim Jong Il, still in his trademark khaki jumpsuit, on the anniversary of his death Monday as mourning mixed with pride over a recent satellite launch that was a long-held goal of the late authoritarian leader.

Kim lies in state a few floors below his father, national founder Kim Il Sung, in the Kumsusan mausoleum, the cavernous former presidential palace. Kim Jong Il is presented lying beneath a red blanket, a spotlight shining on his face in a room suffused in red.

Wails echoed through the chilly hall as a group of North Korean women sobbed into the sashes of their traditional Korean dresses as they bowed before his body. The hall bearing the glass coffin was opened to select visitors — including The Associated Press — for the first time since his death.

North Korea also unveiled Kim’s yacht and his armored train carriage, where he is said to have died. Among the personal belongings featured in the mausoleum are the parka, sunglasses and pointy platform shoes he famously wore in the last decades of his life. A MacBook Pro lay open on his desk.

North Koreans paid homage to Kim and basked in the success of last week’s launch of a long-range rocket that sent a satellite named after him to space.

The launch, condemned in many other capitals as a violation of bans against developing its missile technology, was portrayed not only as a gift to Kim Jong Il but also as proof that his young son, Kim Jong Un, has the strength and vision to lead the country.

The elder Kim died last Dec. 17 from a heart attack while traveling on his train. His death was followed by scenes of North Koreans dramatically wailing in the streets of Pyongyang, and of the 20-something son leading ranks of uniformed and gray-haired officials through funeral and mourning rites.

The mood in the capital was decidedly more upbeat a year later, with some of the euphoria carrying over from last Wednesday’s launch. The satellite bears one of Kim Jong Il’s nicknames, Kwangmyongsong, or “Lode Star,” a moniker given to him at birth according to the official lore.

Cameras were not allowed inside the mausoleum, and state media did not release any images of Kim Jong Il’s body.

With the death anniversary came a hint that Kim Jong Un himself might soon be a father.

His wife, Ri Sol Ju, was seen on state TV with what appeared to be a baby bump as she walked slowly next to her husband at the mausoleum, where they bowed to statues of Kim’s father and grandfather.

There is no official word from Pyongyang about a pregnancy. In addition, Ri is shown wearing a billowing traditional Korean dress in black that makes it difficult to know for sure.

North Koreans are reluctant to discuss details of the Kim family that have not been released by the state. Still there are rumors even in Pyongyang about whether the country’s first couple is expecting.

To honor Kim’s father, North Koreans stopped in their tracks at midday and bowed their heads as the national flag fluttered at half-staff along streets and from buildings.

Pyongyang construction workers took off their yellow hard hats and bowed at the waist as sirens wailed across the city for three minutes.

Tens of thousands of North Koreans gathered in the frigid plaza outside, newly transformed into a public park with lawns and pergolas. Geese flew past snow-tinged firs and swans dallied in the partly frozen moat that rings the vast complex in Pyongyang’s outskirts.

“Just when we were thinking how best to uphold our general, he passed away,” Kim Jong Ran said at the plaza. “But we upheld leader Kim Jong Un. … We regained our strength and we are filled with determination to work harder for our country.”

Speaking outside the mausoleum, renamed the Kumsusan Palace of the Sun, the military’s top political officer, Choe Ryong Hae, said North Korea should be proud of the satellite, calling it “a political event with great significance in the history of Korea and humanity.”

Much of the rest of the world, however, was swift in condemning the launch, which was seen by the United States and other nations as a thinly disguised cover for testing missile technology that could someday be used for a nuclear warhead.

The test, which the U.N. Security Council said violated a ban on launches using ballistic missile technology, underlined Kim Jong Un’s determination to continue carrying out his father’s hardline policies even if they draw international condemnation.

Washington said Monday it has no option but to seek to isolate Pyongyang further.

“What’s left to us is to continue to increase pressure on the North Korean regime and we are looking at how to best to do that, both bilaterally and with our partners going forward until they (North Korea) get the message. We are going to further isolate this regime,” U.S. State Department spokeswoman Victoria Nuland said.

Some outside experts worry that Pyongyang’s next move will be to press ahead with a nuclear test in the coming weeks, a step toward building a warhead small enough to be carried by a long-range missile.

Despite inviting further isolation for his impoverished nation and the threat of stiffer sanctions, Kim Jong Un won national prestige and clout by going ahead with the rocket launch.

At a memorial service on Sunday, North Korea’s top leadership not only eulogized Kim Jong Il, but also praised his son. Kim Yong Nam, president of the Presidium of North Korea’s parliament, called the launch a “shining victory” and an emblem of the promise that lies ahead with Kim Jong Un in power.

The rocket’s success also fits neatly into the narrative of Kim Jong Il’s death. Even before he died, the father had laid the groundwork for his son to inherit a government focused on science, technology and improving the economy. And his pursuit of nuclear weapons and the policy of putting the military ahead of all other national concerns have also carried into Kim Jong Un’s reign.

In a sign of the rocket launch’s importance, Kim Jong Un invited the scientists in charge of it to attend the mourning rites in Pyongyang, according to state media.

The reopening of the mausoleum on the anniversary of the leader’s death follows tradition. Kumsusan, the palace where his father, Kim Il Sung, served as president, was reopened as a mausoleum on the anniversary of his death in 1994.

___

Associated Press writers Hyung-jin Kim in Seoul, South Korea, and Matthew Pennington in Washington contributed to this report. Follow Jean Lee, AP’s bureau chief for Pyongyang and Seoul, at www.twitter.com/newsjean.

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Amazon smartphone reportedly set for 2013 launch

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Amazon adds episodes of alt-comedy show “UnCabaret”

LOS ANGELES (TheWrap.com) – Amazon Instant Video has added four exclusive episodes of “UnCabaret,” an alt-comedy showcase for the likes of Margaret Cho and Andy Dick, to its Prime Instant Video service.

The show was created and hosted by comedian and entertainer Beth Lapides and features performances by such comedy stars as Sandra Bernhard, Garfunkle and Oates, Greg Fitzsimmons and Rob Delaney. Instead of punch-line driven sets, performers are encouraged to show off story-based stream-of-consciousness acts.

Amazon Prime members will get free access to the titles. The episodes will be available for rental or purchase for Amazon Instant Video customers on an a la carte basis.

Amazon Prime costs $ 79 annually and gives members free two-day shipping as well as streaming access to movies and shows from the likes of Paramount and Disney-ABC. The catalog of titles grew a little larger Monday. In addition to “UnCabaret,” Amazon announced an exclusive content licensing agreement with Turner Broadcasting System and Warner Bros. TV to add two TNT shows, “Falling Skies” and “The Closer” to its service.

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Inherited colon cancer risk tied to certain foods

NEW YORK (Reuters Health) – Among people who have a genetic susceptibility to colon cancer, those whose diets are heavy in junk food have an even higher risk, according to a new study.

“These patients have this very high risk because of this (genetic) mutation they have, but it might be that they could reduce the number of (tumors) by having a more healthy lifestyle,” said Akke Botma, the lead author of the study.

Botma’s study is just the first to find a link between certain foods and a higher colon cancer risk in this group, and it can’t prove that the diet is to blame.

All of the people in the study had Lynch syndrome, a genetic disorder that predisposes people to cancer at younger ages and that affects up to one in 660 people.

In Western countries, colorectal and endometrial cancers are the dominant cancers to turn up in people with the syndrome, while in Asia it’s mostly stomach cancer, Botma said.

Up to 70 percent of people with Lynch syndrome will develop colon cancer. Among people without Lynch syndrome, such cancers are thought to be influenced by diet, particularly alcohol and red and processed meat, the authors note in their study, published in the journal Cancer.

Botma and her colleagues at Wageningen University in the Netherlands contacted 486 people with Lynch syndrome from a national database of families with inherited risks for cancer.

At the beginning of the study they surveyed the participants about what they ate, and they ranked each person on whether he ate low, medium or high amounts of foods within four dietary categories.

The food groups included one that was dominated by fruits, vegetables and whole grains; another that was high in meat and coffee; a third dietary group that resembled a Mediterranean diet – fish, leafy greens, pasta, sauces and wine; and a fourth group that was heavy on fried snacks, fast food and diet soda.

Botma and her colleagues found that, over 20 months of follow up, 56 of the participants — or 12 percent — screened positive for tumors in the colon, a precursor to cancer.

Of the four dietary groupings, only the junk food category showed any link with a different risk for developing colon tumors.

Of the 160 people who scored low on the junk food diet, 17 developed tumors, while 18 out of the 160 people who ate the most junk food developed tumors.

The numbers initially seemed similar, but after taking into account smoking and other risk factors, the researchers determined that those in the high junk food group were twice as likely to develop colon tumors.

HOW TO MANAGE RISKS?

“It’s hard to say why” junk food is linked with a greater risk for these tumors, said Dr. Mala Pande, an instructor at the University of Texas MD Anderson Cancer Center in Houston who was not involved in the research.

She said some researchers have suggested that high fat might have something to do with it, but it’s impossible to conclude that from this study.

Although the findings are too preliminary to be used in making dietary recommendations to people with Lynch Syndrome, the study was valuable in launching research into the possible role of certain foods on cancer risk, said Christopher Amos, a professor at the Geisel School of Medicine at Dartmouth College.

“People with Lynch Syndrome are at higher risk, and we’d really like to know how to manage their risks better,” Amos, who was not part of the study, told Reuters Health.

Certain foods have been shown to be linked with different types of cancer, but many of those studies contradict each other and sow confusion (see Reuters Health report of December 5, 2012 here: http://reut.rs/YPuDcs).

Amos said the new study is a good start, but “it would be nice to confirm (it) with additional findings.”

SOURCE: http://bit.ly/SG85JD Cancer, online December 17, 2012.

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Samsung and Apple Duel in Enterprise Tech

Last summer, health-care startup Preventice asked Samsung Electronics if it would create a custom version of its popular Galaxy S II phone. Preventice was putting the finishing touches on a product that used a smartphone to transmit data from a patient’s heart monitor to a doctor, and it needed Samsung to disable downloads, which might interfere with a cellular connection. In less than six weeks Samsung made the necessary changes and agreed to pick up roughly $ 40,000 in engineering costs. “I saw a huge company with huge resources move very quickly,” says Preventice Chief Executive Officer Jon Otterstatter. “Samsung was very aggressive.”

Samsung’s mobile-electronics empire was built mostly on consumers. Now it’s making its first big push to woo companies. This so-called enterprise market includes companies that distribute smartphones and tablets to employees, who use them for checking e-mail and tasks such as tracking sales, as well as companies like Preventice that want to resell the devices as part of their own products. “We’ve made the decision to be No. 1 in enterprise,” says Timothy Wagner, who runs the Texas-based Samsung unit that’s leading the effort.

Few think that’s likely to happen unless Apple (AAPL), which has already made a strong move into the enterprise market, slips up. Thanks to the popularity of the iPhone and iPad with professionals, Apple passed fast-fading Research In Motion (RIMM) to become the top seller of company-issued smartphones this year and will remain in that position at least through 2016, says IDC analyst Stacy Crook. With its small number of products and carefully policed App Store, Apple has made itself safe in the eyes of chief information officers. In its last quarter earnings call on Oct. 25, CEO Tim Cook said more than 80 percent of large companies are at least testing iPhones and iPads for employee use.

Still, Samsung does have an opportunity. While Wagner is aware how difficult it will be to get businesspeople to ditch their iPhones, he says there’s plenty of new business to be had from companies that need something beyond Apple’s one-size-fits-all formula. Apple doesn’t customize its products for anyone, or partner with third-party software makers to target specific industries. Samsung will, Wagner says. “We’re in a unique position to take advantage of an opening that’s being left there by one of our competitors,” he says. Apple spokesperson Natalie Harrison declined to comment on the company’s enterprise business.

IDC’s Crook says the timing of Samsung’s offensive will allow the company to take advantage of BlackBerry’s problems (according to IDC, RIM’s global smartphone market share has dropped from 19.9 percent in 2009 to 4.7 percent this year). Microsoft (MSFT), she notes, has yet to make inroads with its Windows Phone 8 software, introduced in October.

Samsung, which dominates the booming market for devices built on Google’s (GOOG) Android operating system, also could distance itself from other Android rivals in the enterprise market. Its push comes as HTC is struggling and Google focuses elsewhere. In early December, Google closed what was left of 3LM, a mobile enterprise software maker that was acquired by Motorola Mobility in 2011, months before Google bought Motorola. “The fact that Google is shuttering 3LM shows that they’re very focused on the consumer space—but they’re not realizing that consumer devices are being used in enterprise,” says Chris Hazelton, an analyst with 451 Research. “It seems incredibly shortsighted.” Google declined to comment.

Part of Wagner’s strategy for Samsung is to find ways to lower companies’ mobile-computing costs. Many corporations buy smart devices for their employees, but increasingly employees are buying their own and getting reimbursed for a portion of the cost of their data and voice plans. Wagner says Samsung is developing docking stations that would let employees rely on their smartphones’ processing power for their work, eliminating the need for companies to buy them a deskphone or laptop. “As soon as you walk in the room with your phone in your pocket, your monitor, keyboard, and mouse will light up,” Wagner predicts.

Samsung needs to persuade more CIOs to give Android a chance. According to IDC, roughly half of the 125 million iPhones sold by Apple in 2012 were used to run corporate applications, compared with only about 20 percent of Android phones. The biggest obstacle for Samsung is that every Android phone manufacturer uses a slightly different version of the operating system. That means info-tech shops must spend time and money testing each for malware.

With Google showing little desire to solve this problem, Wagner’s team has created a collection of security and management software called SAFE (Samsung for Enterprise) that he says will make all Samsung devices operate the same way. American Airlines is giving Samsung’s Galaxy Note II, a tablet/telephone hybrid, to 17,000 of its flight attendants, who will use it to process payments for onboard purchases of drinks and movies. “The Note was much more enterprise-ready” than other Android devices, says American Airlines CIO Maya Leibman. SAFE lets American disable the device’s camera to protect passengers’ privacy but leaves enough imaging capability to scan bar codes.

Wagner won’t reveal his group’s enterprise sales, but SAFE impressed Samsung’s brass enough that the company will install SAFE products available in Canada, Europe, and South Korea. The company says it’s adding hundreds of new corporate clients each quarter and has recently launched its first corporate-focused ad campaign, with airport ads promising “The Next Big Thing in Business.”

“Some of our partners are calling it Sam-droid,” says Kenneth Daniels, senior director of strategy alliances. “I like that.” Still, Samsung has far to go to prove itself a bona fide corporate power. “They are newbies in the enterprise game,” says Forrester Research (FORR) analyst Frank Gillett. The company is known for high-volume manufacturing efficiency, not for the software expertise and customer support big companies expect. It also has work to do in getting the word out about its new initiatives, says Matt Wallach, co-founder of Veeva Systems, a maker of software for pharmaceutical salespeople. “I asked around,” he says, “and nobody here has even heard of SAFE.”

The bottom line: Samsung aims to pick up enterprise business from RIM and offer better service than Apple and other rivals.

Businessweek.com — Top News

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Egyptians hand Islamists narrow win in constitution vote

CAIRO (Reuters) – Egyptians voted in favor of a constitution shaped by Islamists but opposed by other groups who fear it will divide the Arab world’s biggest nation, officials in rival camps said on Sunday after the first round of a two-stage referendum.

Next week’s second round is likely to give another “yes” vote as it includes districts seen as more sympathetic towards Islamists, analysts say, meaning the constitution would be approved.

But the narrow win so far gives Islamist President Mohamed Mursi only limited grounds for celebration by showing the wide rifts in a country where he needs to build a consensus for tough economic reforms.

The Muslim Brotherhood‘s party, which propelled Mursi to office in a June election, said 56.5 percent backed the text. Official results are not expected until after the next round.

While an opposition official conceded the “yes” camp appeared to have won the first round, the opposition National Salvation Front said in a statement that voting abuses meant a rerun was needed – although it did not explicitly challenge the Brotherhood‘s vote tally.

Rights groups reported abuses such as polling stations opening late, officials telling people how to vote and bribery. They also criticized widespread religious campaigning which portrayed “no” voters as heretics.

A joint statement by seven human rights groups urged the referendum’s organizers “to avoid these mistakes in the second stage of the referendum and to restage the first phase again”.

Mursi and his backers say the constitution is vital to move Egypt’s democratic transition forward. Opponents say the basic law is too Islamist and tramples on minority rights, including those of Christians who make up 10 percent of the population.

The build-up to Saturday’s vote was marred by deadly protests. Demonstrations erupted when Mursi awarded himself extra powers on November 22 and then fast-tracked the constitution through an assembly dominated by his Islamist allies.

However, the vote passed off calmly with long queues in Cairo and several other places, though unofficial tallies indicated turnout was around a third of the 26 million people eligible to vote this time. The vote was staggered because many judges needed to oversee polling staged a boycott in protest.

The opposition had said the vote should not have been held given the violent protests. Foreign governments are watching closely how the Islamists, long viewed warily in the West, handle themselves in power.

“It’s wrong to have a vote or referendum with the country in the state it is – blood and killings, and no security,” said Emad Sobhy, a voter who lives in Cairo. “Holding a referendum with the country as it is cannot give you a proper result.”

INCREASINGLY DIVIDED

As polls closed, Islamists attacked the offices of the newspaper of the liberal Wafd party, part of the opposition National Salvation Front coalition that pushed for a “no” vote.

“The referendum was 56.5 percent for the ‘yes’ vote,” a senior official in the Brotherhood’s Freedom and Justice Party operations room set up to monitor voting told Reuters.

The Brotherhood and its party had representatives at polling stations across the 10 areas, including Cairo, in this round. The official, who asked not to be identified, said the tally was based on counts from more than 99 percent of polling stations.

“The nation is increasingly divided and the pillars of state are swaying,” opposition politician Mohamed ElBaradei wrote on Twitter. “Poverty and illiteracy are fertile grounds for trading with religion. The level of awareness is rising fast.”

One opposition official also told Reuters the vote appeared to have gone in favor of Islamists who backed the constitution.

The opposition initially said its exit polls indicated the “no” camp would win comfortably, but officials changed tack during the night. One opposition official said in the early hours of Sunday that it would be “very close”.

A narrow loss could still hearten leftists, socialists, Christians and more liberal-minded Muslims who make up the disparate opposition, which has been beaten in two elections since Hosni Mubarak was overthrown last year.

They were drawn together to oppose what they saw as a power grab by Mursi as he pushed through the constitution. The National Salvation Front includes prominent figures such as ElBaradei, former Arab League chief Amr Moussa and firebrand leftist Hamdeen Sabahy.

If the constitution is approved, a parliamentary election will follow early next year.

DEADLY VIOLENCE

Analysts question whether the opposition group will keep together until the parliamentary election. The Islamist-dominated lower house of parliament elected earlier this year was dissolved based on a court order in June.

Violence in Cairo and other cities has plagued the run-up to the referendum. At least eight people were killed when rival camps clashed during demonstrations outside the presidential palace earlier this month.

In order to pass, the constitution must be approved by more than 50 percent of those casting ballots. There are 51 million eligible voters in the nation of 83 million.

Islamists have been counting on their disciplined ranks of supporters and on Egyptians desperate for an end to turmoil that has hammered the economy and sent Egypt’s pound to eight-year lows against the dollar.

The army deployed about 120,000 troops and 6,000 tanks and armored vehicles to protect polling stations and other government buildings. While the military backed Mubarak and his predecessors, it has not intervened in the present crisis.

(Additional reporting Yasmin Saleh and Marwa Awad; Writing by Edmund Blair and Giles Elgood; Editing by Tom Pfeiffer)

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Cisco hires bank to sell home wireless router unit: report

(Reuters) – Networking equipment company Cisco Systems Inc has hired Barclays to sell its Linksys home router unit, a report said on Sunday.

The business, which Cisco acquired for $ 500 million in 2003, will likely be valued for less because it has low margins, according to Bloomberg.

The sale is part of Cisco’s strategy to shed its consumer unit and focus on its software and technology services businesses.

Last year, Cisco axed its Flip camera business as part of this strategy.

(Reporting By Olivia Oran; Editing by Marguerita Choy)

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‘Hobbit’ bests ‘Rings’ with $84.8 million opening

NEW YORK (AP) — Peter Jackson‘s “The Hobbit” led the box office with a haul of $ 84.8 million, a record-setting opening better than the three previous “Lord of the Rings” films.

The Warner Bros. Middle Earth epic was the biggest December opening ever, surpassing Will Smith’s “I Am Legend,” which opened with $ 77.2 million in 2007, according to studio estimates Sunday. “The Hobbit: An Unexpected Journey” also passed the December opening of “Avatar,” which opened with $ 77 million. Internationally, “The Hobbit” also added $ 138.2 million, for an impressive global debut of $ 223 million.

Despite weak reviews, the 3-D adaptation of J. R. R. Tolkien‘s first novel in the fantasy series was an even bigger draw than the last “Lord of the Rings” movie, “The Return of the King.” That film opened with $ 72.6 million. “The Hobbit” is the first of another planned trilogy, with two more films to be squeezed out of Tolkien’s book.

While Jackson’s “Rings” movies drew many accolades — “The Return of the King” won best picture from the Academy Awards — the path for “The Hobbit” has been rockier. It received no Golden Globes nominations on Thursday, though all three “Rings” films were nominated by the Hollywood Foreign Press Association for best picture.

Particularly criticized has been the film’s 48-frames-per-second (double the usual rate), a hyper-detailed look that some have found jarring. Most moviegoers didn’t see “The Hobbit” in that version, though, as the new technology was rolled out in only 461 of the 4,045 theaters playing the film.

Regardless of any misgivings over “The Hobbit,” the film was a hit with audiences. They graded the film with an “A” CinemaScore.

“What’s really important, what makes this special is the CinemaScore,” said Dan Fellman, president of domestic distribution for Warner Bros. “All these things point to a great word of mouth. We haven’t even made it to the Christmas holidays yet. Kids are still in school this week.”

The strong opening culminated a long journey for “The Hobbit,” which was initially delayed when a lawsuit dragged on between Jackson and “Rings” producer New Line Cinema over merchandizing revenue. At one point, Guillermo del Toro was to direct the film with Jackson producing. But eventually the filmmaker opted to direct the movie himself, originally envisioning two “Hobbit” films. The production also went through the bankruptcy of distribution partner MGM and a labor dispute in New Zealand, where the film was shot.

The long delay for “The Hobbit,” nearly a decade after the last “Lord of the Rings” film, made it “one of those movies that had everyone scratching their heads as to how it would open,” said Paul Dergarabedian, an analyst for box-office tracker Hollywood.com.

“It’s been a decade since the ‘Lord of the Rings‘ trilogy concluded,” said Dergarabedian. “There’s been so much anticipation for this film and having Peter Jackson back at the helm just made it irresistible both to fans and the non-initiated alike.”

“The Hobbit” was far and away the biggest draw in theaters, with no other new wide release. Paramount’s “Rise of the Guardians” continued to draw the family crowd, with $ 7.4 million, bringing its cumulative total to $ 71.4 million. The Oscar contender “Lincoln” from Walt Disney crossed the $ 100 million mark, adding another $ 7.2 million to bring its six-week total to $ 107.9 million. And Sony‘s James Bond film “Skyfall,” with another $ 7 million domestically, drew closer to a global take of $ 1 billion.

The box office continued to be on the upswing and with anticipated releases like “Les Miserables,” ”Django Unchained” and “The Guilt Trip” approaching in the holiday moviegoing season. Dergarabedian expects the year to break the 2009 record of $ 10.6 billion. With some $ 10.2 billion in revenue thus far, he said, “We’re on track to be in that realm.”

Estimated ticket sales for Friday through Sunday at U.S. and Canadian theaters, according to Hollywood.com. Where available, latest international numbers are also included. Final domestic figures will be released Monday.

1. “The Hobbit: An Unexpected Journey,” $ 84.8 million ($ 138.2 million international).

2. “Rise of the Guardians,” $ 7.4 million ($ 20.1 million international).

3. “Lincoln,” $ 7.2 million.

4. “Skyfall,” $ 7 million ($ 12.2 million international).

5. “Life of Pi,” $ 5.4 million ($ 11.5 million international).

6. “The Twilight Saga: Breaking Dawn, Part 2,” $ 5.2 million ($ 13 million international).

7. “Wreck-It Ralph,” $ 3.3million ($ 4.7 million international).

8. “Playing for Keeps,” $ 3.2 million ($ 1.4 million international).

9. “Red Dawn,” $ 2.4 million.

10. “Silver Linings Playbook,” $ 2 million ($ 370,000 international).

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Estimated weekend ticket sales at international theaters (excluding the U.S. and Canada) for films distributed overseas by Hollywood studios, according to Rentrak:

1. “The Hobbit: An Unexpected Journey,” $ 138.2 million.

2. “Rise of the Guardians,” $ 20. 1 million.

3. “The Twilight Saga: Breaking Dawn, Part 2,” $ 13 million.

4. “Skyfall,” $ 12.2 million.

5. “Life of Pi,” $ 11.5 million.

6. “Wreck-It Ralph,” $ 4.7 million.

7. “26 Years,” $ 3.5 million.

8. “Whatcha Wearin’? (My P.S. Partner),” $ 3 million.

9. “Tutto Tutto Niente Niente,” $ 2.4 million.

10. “Pitch Perfect,” $ 2.3 million.

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Universal and Focus are owned by NBC Universal, a unit of Comcast Corp.; Sony, Columbia, Sony Screen Gems and Sony Pictures Classics are units of Sony Corp.; Paramount is owned by Viacom Inc.; Disney, Pixar and Marvel are owned by The Walt Disney Co.; Miramax is owned by Filmyard Holdings LLC; 20th Century Fox and Fox Searchlight are owned by News Corp.; Warner Bros. and New Line are units of Time Warner Inc.; MGM is owned by a group of former creditors including Highland Capital, Anchorage Advisors and Carl Icahn; Lionsgate is owned by Lions Gate Entertainment Corp.; IFC is owned by AMC Networks Inc.; Rogue is owned by Relativity Media LLC.

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