Merck starts new trial to test Alzheimer’s drug

(Reuters) – Merck & Co Inc has started a new trial of its experimental Alzheimer’s drug, the first mid-stage clinical trial of a promising new class of oral medicines that has the potential to shut down the production of a protein that many researchers believe is the primary cause of the disease.

The drugmaker said on Monday it had started the trial to evaluate the safety and effectiveness of the drug, MK-8931, in patients with mild-to-moderate Alzheimer’s disease.

The Phase II trial, which will compare the drug with a placebo, is a global, multi-center study that includes a group of 200 patients to test safety. The study is expected to eventually enroll up to 1,700 patients in the main Phase III trial.

The drug is the first of its kind to advance to this stage of clinical research.

Eli Lilly and Co is considered the front runner in Alzheimer’s research after its drug solanezumab, in a Phase III trial, was shown in August to slow down cognitive declines in patients with mild symptoms of Alzheimer’s disease. However, the drug failed its overall goal of delaying cognitive and physical decline in patients with mild to moderate Alzheimer’s.

The start of Merck’s new trial of MK-8931 could put the company on an equal footing with Lilly in the race for the first approved drug to delay the progress of the disease.

The Lilly drug is administered intravenously, while the Merck drug is taken orally.

Merck’s drug appears to almost entirely prevent the formation of new beta-amyloid, the toxic proteins that lead to plaques in the brain, while the Lilly drug acts by removing existing plaques, according to Mark Schoenebaum, an analyst with ISI Group. Amyloid plaques are linked to Alzheimer’s disease.

“We do not believe that Merck has any clinical efficacy data at this point upon which it is basing its Phase II/III ‘go’ decision. Thus, one must still view the Phase III as highly speculative,” Schoenebaum wrote in a research note.

Assuming the U.S. Food and Drug Administration asks Lilly to do another confirmatory Phase III trial on its drug, the Merck drug is on roughly the same timeline to potential approval as the Lilly drug, he said.

If the FDA approves the Lilly drug on its existing data, something Schoenebaum thinks is unlikely, then Lilly would be about three years ahead, he added.

Merck shares were up 30 cents to $ 44.60 in morning trade on the New York Stock Exchange, while Lilly shares were down 10 cents to $ 48.94.

Earlier this year, Roche Holding AG more than doubled the size of a clinical trial of its experimental Alzheimer’s drug gantenerumab in patients who have early Alzheimer’s but have not yet developed dementia, putting it in the vanguard of attempts to catch the disease in its early stages.

A successful Alzheimer’s treatment could reap billions of dollars in annual sales. But many experts believe treatment must be delivered before patients show signs of dementia because brain damage may be irreversible after that point.

(Reporting by Debra Sherman in Chicago and Ransdell Pierson in New York; Editing by Gerald E. McCormick and John Wallace)

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Gunmen assassinate peasant leader in Paraguay

ASUNCION, Paraguay (AP) — Gunmen murdered one of the surviving leaders of a peasant movement whose land dispute with a powerful politician prompted the end of Fernando Lugo‘s presidency last June.

Vidal Vega, 48, was hit four times early Saturday by bullets from a 12-gauge shotgun and a .38-caliber revolver fired by two unidentified men who sped away on a motorcycle, according to an official report prepared at the police headquarters in the provincial capital of Curuguaty.

A friend, Mario Espinola, told The Associated Press that Vega was shot down when he stepped outside to feed his farm animals.

Vega was among the public faces of a commission of landless peasants from the settlement of Yby Pyta, which means Red Dirt in their native Guarani language.

He had lobbied the government for many years to redistribute some of the ranchland that Colorado Party Sen. Blas Riquelme began occupying in the 1960s.

By last May, the peasants finally lost patience and moved onto the land. A firefight during their eviction on June 15 killed 11 peasants and six police officers, prompting the Colorado Party and other leading parties to vote Lugo out of office for allegedly mismanaging the dispute.

Twelve suspects, nearly all of them peasants from Yby Pyta, have been jailed without formal charges since then on suspicion of murdering the officers, seizing property and resisting authority. The prosecutor had six months to develop the case and will present his findings Dec. 16.

Vega was expected to be a witness at the criminal trial, since he was among the few leaders who weren’t killed in the clash or jailed afterward.

He wasn’t charged because he was away getting supplies when the violence erupted at the settlement erected by the peasants inside Riquelme’s ranch, the Naranjaty Commission’s secretary, Martina Paredes, told the AP.

“We think he was assassinated by hit men who were sent, we don’t know by whom, perhaps to frighten us and frustrate our fight to recover the state lands that were illegally taken by Riquelme,” she said.

Riquelme, who died of natural causes about a month after the battle in June, occupied the land during the dictatorship of Alfredo Stroessner, whose government gave away land for free to anyone willing to put it to productive use.

A local court in Curuguaty upheld Riquelme’s claim to the land years later. Lugo’s government later sought to overturn the decision, but the case remains tied up in court.

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Nokia debunks rumor that it may be considering shift to Android

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Duke and Duchess of Cambridge expecting a baby

LONDON (Reuters) - Britain's Prince William and his wife Catherine are expecting a baby, destined to be the country's future monarch, the prince's office said on Monday.

"Their Royal Highnesses The Duke and Duchess of Cambridge are very pleased to announce that The Duchess of Cambridge is expecting a baby," the office said in a statement.

"The Queen, The Duke of Edinburgh, The Prince of Wales, The Duchess of Cornwall and Prince Harry and members of both families are delighted with the news."

The couple, officially known as the Duke and Duchess of Cambridge, married in April last year, prompting a global media frenzy and there has been much speculation, particularly in U.S. gossip magazines, about a possible pregnancy.

The statement said Catherine was in the King Edward VII Hospital in Central London suffering from very acute morning sickness. She is likely to remain there for several days.

It said her condition required supplementary hydration and nutrients. There was no detail about when the baby was due, with the statement stating the pregnancy was in its early stages.

"I'm delighted by the news that the Duke and Duchess of Cambridge are expecting a baby," Prime Minister David Cameron said on his Twitter website. "They will make wonderful parents."

William, Queen Elizabeth's grandson, is second in line to the British throne, and their first child will become the third in succession when he or she is born.

Last year Britain and other Commonwealth countries which have the queen as their monarch agreed to change the rules of royal succession so that sons would no longer have precedence as heir, regardless of age.

The agreement also means an end to a ban on a future monarch marrying a Catholic, a stipulation dating back some 300 years.

William and Catherine currently live in north Wales where the prince is based as a Royal Air Force search and rescue pilot.

(Reporting by Michael Holden)

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Led Zeppelin will Reunite – for “Letterman” interview

LOS ANGELES (TheWrap.com) – The surviving members of Led Zeppelin will make a rare appearance together on “Late Show With David Letterman” on December 3, CBS said Friday.

Jimmy Page, Robert Plant and John Paul Jones will drop in on the late-night show for an interview – which isn’t quite the reunion that Zep fans have been patiently waiting for, but it might have to do. With the exception of a one-off tribute concert for Atlantic Records founder Ahmet Ertegun at London’s O2 Arena in 2007 – which was released as the DVD “Celebration Day” in October – Jones has largely been estranged from Page and Plant since the group’s 1980 breakup following drummer John Bonham‘s death.

The “Late Show” appearance won’t be the only time that Letterman hangs out with the rock legends – the group, along with Letterman, will be lauded at the 35th Annual Kennedy Center Honors in Washington, D.C., which will take place December 2 and air December 26 on CBS.

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Germany’s Merck Serono to produce medicines in UAE

ABU DHABI (Reuters) – Germany’s Merck Serono said it would team up with an Abu Dhabi firm to produce medicines for the domestic and regional markets, the first multinational of its kind to make branded products in the United Arab Emirates.

Merck Serono, the pharmaceutical arm of Merck KGaA, will initially produce two of its products at Neopharma‘s facilities in Abu Dhabi, the German firm’s first such partnership in the Middle East, the company’s CEO said.

“The Middle East is very important and the fastest growing region for our products,” Stefan Oschmann told reporters. “We plan to meet 100 percent of the regional demand for the products,” he added.

Oschmann declined to give specific figures but said revenues from emerging markets accounted for a third of Merck‘s total.

The two products to be produced at Neopharma’s facilities are Euthyrox, a synthetic thyroid hormone and Glucophage, for people suffering from type 2 diabetes.

Production of both branded products will start in 2013.

The UAE suffers from a high prevalence of diabetes. Some 827,000 people between the ages of 20 and 79 have diabetes in the UAE, according to the Ministry of Health.

Treatment of diabetes accounts for about 40 percent of the UAE’s overall healthcare expenditure, Amin al Amiri, assistant under-secretary for Medical practice & license at the ministry of health said.

“This alliance will provide increased supply of trusted branded medicines needed to help ease the diabetes crisis which is straining the financial resources of the UAE,” he said.

The Middle East is the largest market for Merck’s diabetes drug, Glucophage, which is currently imported from Europe.

(Reporting By Stanley Carvalho; Editing by Sami Aboudi and Helen Massy-Beresford)

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Italy votes for center-left candidate for premier

ROME (AP) — Italians are choosing a center-left candidate for premier for elections early next year, an important primary runoff given the main party is ahead in the polls against a center-right camp in utter chaos over whether Silvio Berlusconi will run again.

Sunday’s runoff pits a veteran center-left leader, Pier Luigi Bersani, 61, against the 37-year-old mayor of Florence, Matteo Renzi, who has campaigned on an Obama-style “Let’s change Italy now” mantra.

Nearly all polls show Bersani winning the primary, after he won the first round of balloting Nov. 25 with 44.9 percent of the vote. Since he didn’t get an absolute majority, he was forced into a runoff with Renzi, who garnered 35.5 percent.

After battling all week to get more voters to the polling stations for round two, Renzi seemed almost resigned to a Bersani win by Sunday, saying he hoped that by Monday “we can all work together.”

Bersani, a former transport and industry minister, seemed confident of victory as well, joking about Berlusconi’s flip-flopping political ambitions by asking “What time did he say it?” when told that the media mogul had purportedly decided against running.

Next year’s general election will largely decide how and whether Italy continues on the path to financial health charted by Premier Mario Monti, appointed last year to save Italy from a Greek-style debt crisis.

The former European commissioner was named to head a technical government after international markets lost confidence in then-Premier Berlusconi’s ability to reign in Italy’s public debt and push through sorely needed structural reforms.

Berlusconi has largely stayed out of the public spotlight for the past year, but he returned with force in recent weeks, announcing he was thinking about running again, then changing his mind, then threatening to bring down Monti’s government, and most recently staying silent about his political plans.

His waffling has thrown his People of Freedom party into disarray and disrupted its own plans for a primary — all of which has only seemed to bolster the impression of order, stability and organization within the center-left camp.

A poll published Friday gave the Democratic Party 30 percent of the vote if the election were held now, compared with some 19.5 percent for the upstart populist movement of comic Beppe Grillo, and Berlusconi’s People of Freedom party in third with 14.3 percent. The poll, by the SWG firm for state-run RAI 3, surveyed 5,000 voting-age adults by telephone between Nov. 26 and 28. It had a margin of error of plus or minus 1.36 percentage points.

It’s quite a turnabout for Berlusconi’s once-dominant movement, and a similarly remarkable shift in fortunes for the Democratic Party, which had been in shambles for years, unable to capitalize on Berlusconi’s professional and personal failings while he was premier.

But Berlusconi’s 2011 downfall and a series of recent political party funding scandals that have targeted mostly center-right politicians have contributed to the party’s rise as Italy struggles through a grinding recession and near-record high unemployment.

Angelino Alfano, Berlusconi’s hand-picked political heir, seemed again exasperated Sunday after a long meeting with his patron over Berlusconi’s plans. News reports have suggested Berlusconi might split the party in two and re-launch the Forza Italia party that brought him to political power for the first time in 1994.

“We have to work to reconstruct the center-right, and reconstructing it means having a big center-right party,” not a divided one, Alfano said.

He added that Berlusconi didn’t say one way or another if he would run himself. “It’s his choice,” he said. “If there are any decisions in this regard, he’ll be the one to say so.”

___

Follow Nicole Winfield at www.twitter.com/nwinfield

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7 Quirky Christmas Gift Ideas

‘Tis the season to give…bacon-shaped Christmas tree ornaments? Stocking-stuffer candy simulating black lumps of coal? Crime scene tape for wrapping packages? How about a dreidel with Santa’s picture on it?

Yes to all these and more, say fans of quirky gifts.

Online retailers specializing in leg-lamps–the kind made famous by the movie “A Christmas Story”–and in Emergency Santa Kits say business is brisk.

Seattle novelty-seller Archie McPhee, for instance, which makes the Emergency Santa Kit, reports its business is up 20 percent from last year. Each Kit contains an inflatable white beard and red hat. “It’s in case you’re ever on an airplane flight and you suddenly have to play Santa,” explains McPhee’s spokesperson and self-styled Director of Awesomeness, David Wall.

Anything involving bacon, he says, has been selling well—so well that McPhee dedicates a portion of its website to bacon-inspired items, including candy canes, ornaments and toothpaste.

“People just naturally enjoy bacon,” he says. “At a time when everybody is so health-conscious, it’s become a kind of ‘rebel’ food. It seems naughty. To our customers, bacon has become a sign of rebellion against the status quo.”

Online retailer Perpetual Kid sells black, lump-shaped candy-coal. Says vice president Wendy Paula, “We’re definitely seeing people looking for silly products this year—things you buy for their ‘smile value.’ Candy coal has been Christmas season favorite for us for years.” She herself grew up with it. “It’s just got to be in your stocking.”

Unlike some novelty purveyors, says Paula, Perpetual Kid, shies away from anything that could be considered offensive or in bad taste. Not so Things You Never Knew Existed, a website that appears to have cornered the market on flatulent-Santa items. These include a Pull My Finger Santa’ and a spherical ornament simulating Santa’s buttocks.

For a slideshow of quirky items appropriate (or not) for holiday giving, read on.

“The world’s only beanie with a built-in beard,” trumpets website Fab.com. The tightly-knit cap and attached face-warmer is perfect for snowball fights, says the site, and will keep any chin warm on the coldest of days. “A great gift for the facial-hair challenged.” ($ 29)

Website for Perpetual Kid calls this cinnamon-flavored candy coal the perfect stocking stuffer: “You can always tell who has been naughty Christmas morning, since this candy will temporarily turn your mouth blue! Great for office parties and gift exchanges.” ($ 4.49)

The dreidel depicts Santa on one side, a Christmas tree on the other. “Don’t choose between Christmas and Hanukkah,” says Archie McPhee’s website. “Choose Chrismukkah! Imagine the fun you’ll have playing the dreidel game by the light of the menorah while waiting for Santa and his reindeer to arrive.” ($ 4.50)

“Big bacon flavor in a candy cane,” promises Archie McPhee. Canes come in both regular size and colossal. Of the collosal, the site says, “If there were a king of bacon, this would be his scepter. It’s bacon-y Christmas perfection.” For proper dental hygiene, you’ll want to brush afterwards with bacon-flavored toothpaste, also available on the website. (Colossal cane, $ 5.00)

Archie McPhee doesn’t explicitly recommend this tape for sealing up the seams of wrapping paper you have used to decorate your gifts—but just think how festive and disturbing it will look underneath the tree. Alternatively, says the website, you can use it to “mark off the scene of an itty-bitty murder.” ($ 4.50).

Christmas-in-a-tin, Archie McPhee calls its Emergency Santa Kit. “Let’s say you’re on a long flight, and everyone around you is frowning and grumpy,” says the site. Each Kit contains an inflatable white beard and jaunty Santa hat. “Just open the tin, inflate the beard, put on the hat, and shake your belly like a bowl full o’ jelly.” Before you know it, “Everyone will be sitting on your lap.” ($ 12.00)

The morning after Christmas you’ll run no risk of oversleeping if someone has been kind enough to give you this especially aggressive alarm clock. Hit its snooze button once too often, and Clocky takes matters into its own hands (or feet) by rolling away from you on powered wheels. “It will literally jump off your nightstand and scurry way, forcing you to get up out of bed and go get it to turn it off,” says a spokesperson for novelty retailer Fab.com. ($ 45.00)

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'Cliff' talks: Geithner invites GOP counteroffer

WASHINGTON (AP) -- President Barack Obama is ready to entertain Republican proposals for spending cuts, but GOP lawmakers must first commit to higher tax rates on the rich and specify what additional spending cuts they want in a deal to avoid the looming "fiscal cliff," Treasury Secretary Timothy Geithner said.

"The ball really is with them now," Geithner, one of the president's chief negotiators with Capitol Hill, said during appearances on five Sunday talk shows. He acknowledged that Republicans are "having a tough time trying to figure out what they can do, what they can get support from their members for." The White House "might need to give them a little more time to figure out where they go next."

Geithner presented congressional leaders Thursday with Obama's postelection blueprint for averting the combination of hundreds of billions in tax increases and spending cuts that will take effect beginning in January if Washington doesn't act to stop it.

But House Speaker John Boehner, R-Ohio, dismissed the plan as "not serious," merely a Democratic wish list that couldn't pass his chamber.

As outlined by administration officials, the plan calls for nearly $1.6 trillion in new tax revenue over the next decade, while making $600 billion in spending cuts, including $350 billion from Medicare and other health programs. But it also contains $200 billion in new spending on jobless benefits, public works and aid for struggling homeowners — and would make it virtually impossible for Congress to block Obama's ability to raise the debt ceiling.

"I was just flabbergasted," Boehner said, describing his meeting with Geithner. "I looked at him and I said, 'You can't be serious?" The speaker, noting the short time between the Nov. 6 election and the new year, said time has been lost so far "with this nonsense."

With the George W. Bush-era tax cuts expiring and across-the-board spending cuts hitting in under a month, Boehner said, "I would say we're nowhere, period." He said "there's clearly a chance" of going over the cliff.

But Geithner, also in interviews that were taped Friday, offered a somewhat rosier view. "I think we're far apart still, but I think we're moving closer together," he said.

He called the back-and-forth "normal political theater," voicing confidence a bargain can be struck in time, and said all that's blocking it is GOP acceptance of higher tax rates on the wealthy.

"It's welcome that they're recognizing that revenues are going to have to go up. But they haven't told us anything about how far rates should go up ... (and) who should pay higher taxes?" Geithner said.

He said so far, GOP proposals demonstrate "political math, not real math."

Republican leaders have said they accept higher tax revenue overall, but only through what they call tax reform — closing loopholes and limiting deductions — and only coupled with tough measures to curb the explosive growth of Medicare, Medicaid and Social Security.

But Geithner insisted that there's "no path to an agreement (without) Republicans acknowledging that rates have to go up for the wealthiest Americans." He also said the administration would only discuss changes to Social Security "in a separate process," not in talks on the fiscal cliff.

As to spending, Geithner said if Republicans don't think Obama's cutting enough spending, they should make a counter-proposal. "They might want to do some different things. But they have to tell us what those things are," he said.

Republicans have also rejected Obama's debt ceiling proposal. Geithner noted it was Senate Minority Leader Mitch McConnell who first suggested it, as a temporary measure in the summer 2011 deficit deal. The administration would make it permanent. "It was a very smart way by a senator with impeccable Republican credentials to ... lift this ... periodic threat of default," Geithner said. "And that's an essential thing for us."

Geithner voiced sympathy for Republicans leaders, saying they're caught between the voters' endorsement of higher taxes on the rich and a House GOP caucus that thinks all tax increases are job-killers.

"They really are in a difficult position," he said. "And they're going to have to figure out their politics of what they do next."

In the past week, Obama has held a series of campaign-style appearances — including one in a swing district in Pennsylvania — urging lawmakers to accept a Senate-passed measure extending tax cuts for all but the top 2 percent of wage-earners. He'll continue the effort when he meets with governors on Tuesday and speaks to the Business Roundtable on Wednesday.

GOP leaders contend letting top-end tax cuts run out would hit small businesses and cost jobs.

Still, Sen. Lamar Alexander, R-Tenn., said Republicans will "hold our nose and raise some revenues" if the result is a deal that reins in runaway debt. But he said the onus is on Obama to knuckle down to talks.

"I'm ready for the president to get off the campaign trail, and get in the White House and get a result," Alexander told reporters in Nashville on Saturday. "Right now he's got the presidential limousine headed toward the fiscal cliff with his foot on the accelerator."

Geithner appeared on CBS' "Face the Nation," NBC's "Meet the Press," CNN's "State of the Union," ABC's "This Week," and "Fox News Sunday." Boehner was on Fox, too.

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Associated Press Writer Erik Schelzig in Nashville contributed to this report.

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German producers plan Pope Benedict biopic

MUNICH, Germany (Reuters) – Two German producers have bought the film rights to an upcoming biography of Pope Benedict by the Bavarian author of three best-selling interview books with the pontiff.

The Odeon Film company said producers Marcus Mende and Peter Weckert planned a film for international release based on a biography by journalist Peter Seewald due to be published in early 2014.

Seewald’s book-length interviews with Benedict – two as Cardinal Joseph Ratzinger and one as pope – have given readers many insights into the life and thoughts of the shy theologian who now heads the Roman Catholic Church.

Seewald has signed on as a consultant to the scriptwriter, Odeon Film said in a statement on Thursday. It gave no information about the schedule for the film or who might play the main role.

“The producers plan an international film that illustrates all aspects of the extraordinary life and work of Joseph Ratzinger from his birth on Easter night in 1927 in Marktl am Inn in Bavaria to his pontificate today,” it said.

Benedict’s predecessor Pope John Paul was the subject of a dozen documentary films around the world and two major television movies in the United States.

(Reporting by Tom Heneghan; editing by Andrew Roche)

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