Lundbeck anticipates new drug “feast”

LONDON (Reuters) – Danish group Lundbeck is looking forward to a “feast” of new drugs to refresh its product line-up, kicking off next week with a possible European Union green light for a novel medicine to treat alcohol abuse.

In all, there is scope for regulatory approval of three medicines in 2013 – an impressive tally for a small company focused on brain disorders – as well as a potential partnership deal for a drug to fight the symptoms of Alzheimer’s disease.

“Sometimes people say it is feast or famine for this industry and we are in a feast phase, especially considering our size,” chief executive Ulf Wiinberg told Reuters.

Lundbeck needs these new drugs to replace lost sales from antidepressant Cipralex, sold as Lexapro in the United States, which is now coming off patent.

Doubts about the company’s ability to make the transition from reliance on Cipralex has taken its toll on the stock in recent months, with the shares underperforming the European drugs sector by 23 percent this year.

There have even been suggestions the Lundbeck Foundation, which owns a 70 percent stake, might delist the drugmaker.

Wiinberg said this option had not be discussed. “If we were working on it I would say something, but I have nothing to say.”

While Wiinberg has already said earnings will stall until 2015 as a result of patent losses, he is increasingly confident the pieces are in place to lift sales in the medium term.

The next catalyst could come as early as December 13 or 14, when Lundbeck expects the European Medicines Agency to decide whether or not to recommend Selincro for alcohol dependence. A positive decision would lead to approval early next year.

The drug is breaking new ground in an uncertain market, and Wiinberg said it was “a bit of a joker in our portfolio”. Analysts currently pencil in only modest sales.

More important will be the verdict from regulators in North America and Europe later next year on a new antidepressant being developed with Japanese partner Takeda Pharmaceutical that analysts see as a potential $ 1-$ 2 billion-a-year seller.

Developing new treatments for depression has proved an uphill battle for drugmakers in recent times but vortioxetine has produced encouraging clinical trial results and its unique mode of action and flexible dosing could make it a winner.

The third approval prospect for next year is Abilify Maintena, a once-monthly version of schizophrenia drug Abilify that Lundbeck is working on with Otsuka.

Further out, Lundbeck is developing a drug for the symptoms of Alzheimer’s – a more modest ambition than that of disease-modifying treatments which have so far failed to gain much traction in tackling the underlying causes of the disorder.

That drug will be ready to go into final-stage clinical testing next year and Wiinberg said he would look to strike a partnership deal for the product, known as LuAE58054, at the same time as preparing for Phase III trials.

(Editing by Dan Lalor)

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Irish budget sees property tax

5 December 2012 Last updated at 12:20 ET

The Irish government has announced a fresh package of spending cuts and tax rises worth billions of euros in its budget for 2013.

These include a new property tax of 0.18% of the value of a home up to 1m euros ($ 1.3m; £800,000).

These are the latest in a long line of austerity measures imposed on Ireland by international lenders that bailed out the country in 2010.

The government said it would meet its deficit reduction target for this year.

It projected a budget deficit of 8.2%, compared with a target of 8.6%. The deficit would fall steadily to 2.9% by 2015, it added.

These forecasts were based on economic growth of 1.5% next year, rising to 2.9% in 2015.

“There are manifest signs that the country is emerging from the worst of the crisis and that the efforts of the Irish people, despite the hardship, are leading to success,” said Irish Finance Minister Michael Noonan.

Tax exemptions

He added that 2012 had seen the “first signs of stability in both the residential and commercial property markets in six years”.

To help “maintain momentum” in the domestic property market, any new or previously unoccupied homes bought between the beginning of next year and the end of 2016 will be exempt from the new property tax. Equally, any homes bought by first-time buyers in 2013 will be exempt.

For all other homes, the Local Property Tax will be introduced in July next year, and will include a higher rate of 0.25% that kicks in on the balance of any property over and above 1m euros.

However, local authorities will be able to vary the rates by 15% above or below the national rates “to better match their funding needs”.

The government also increased tax on alcohol and cigarettes, and announced that maternity benefit would become a taxable income in July 2013.

Income tax rates, as well as duty on petrol an diesel, were left unchanged.

“The individual measures are modest,” said Mr Noonan. “However, I believe that the combination of the measures will have a significant beneficial impact.”

Analysts highlighted the fact Ireland was taking tough decisions to meet its deficit reduction targets.

“It’s a fairly balanced budget from the market’s point of view,” said Owen Callan at Danske Markets.

“Ireland has gotten this tag that it is willing to do whatever it takes to remain on track, even if some of the measures are unpopular. They are taking a few measures that some other countries have been unwilling to look at.”

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Officials: NATO to decide on missiles for Turkey

BRUSSELS (AP) — NATO foreign ministers are expected to approve Turkey‘s request for Patriot anti-missile systems to bolster its defense against possible strikes from neighboring Syria.

NATO foreign ministers are meeting on Tuesday and Wednesday in Brussels. Parliaments in both nations must approve the deployment, which would also involve several hundred soldiers.

Ankara, which has been highly supportive of the Syrian opposition, wants the Patriots to defend against possible retaliatory attacks by Syrian missiles carrying chemical warheads. NATO leaders have repeatedly said they would provide any assistance Turkey needs.

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Fleetwood Mac readies tour and new music

NEW YORK (AP) — Fleetwood Mac is heading back on the road, and that means the top-selling group will release new music — sort of.

On its 34-city North American tour, which kicks off April 4 in Columbus, Ohio, the band will perform two new songs, and it could mean a new album will follow. Or not.

Stevie Nicks recently sang on tracks that Lindsey Buckingham, Mick Fleetwood and John McVie worked on, calling the sessions “great.” But Nicks also says she’s not sure where the band fits in today’s music industry.

“Whether or not we’re gonna do any more (songs), we don’t know because we’re so completely bummed out with the state of the music industry and the fact that nobody even wants a full record,” she said. “Everybody wants two songs, so we’re going to give them two songs.”

Nicks said depending on the response to the new tracks — which Buckingham calls “the most Fleetwood Mac-y stuff … in a long time” — more material could come next.

“Maybe we’ll get an EP out of it or something,” Buckingham said.

Nicks will continue to record solo albums, though. The group is celebrating the 35th anniversary of the best-selling “Rumours” album, which has moved some 20 million units in the United States. She knows that’s not possible again, despite the success of Adele’s “21,” which has sold 10 million units in America in less than two years.

“This is Adele’s ‘Rumours,’” Nicks said. “She had a baby, she’s going to take a year off to take care of her baby — that’s why I never had any kids. She’s going to go back and start writing again, you never know what the next record’s going to be. Is it going to sell 10 million records? You don’t know,” she said.

Buckingham said he initially wanted to record a new album, but Nicks “wasn’t too into that.” But the guitarist and singer knows that new music isn’t a priority for the band’s fans.

“It wouldn’t matter if they didn’t hear anything new. In a way there’s a freedom to that — it becomes not what you got, but what you do with what you got. Part of the challenge of this tour is figuring out a presentation that has some twists and turns to it without having a full album,” he said.

Fleetwood Mac, which was formed in 1967, last released an album in 2003, though they hit the road in 2009. Nicks and Buckingham — who originally joined the band in 1974 as a couple — both released solo albums and toured last year. Buckingham had suggested that Fleetwood Mac tour last year, but says getting everyone to agree was tough.

“If you look at Fleetwood Mac as a group, you can make the case of saying we’re a bunch of individuals who don’t necessarily belong in the same group together, but it’s the synergy of that that makes us so good. But it also makes the politics a little more tenuous,” he said. “You can say that not only can it be a political minefield, someone’s always causing trouble, right? I caused trouble for years so I can’t point any fingers.”

The tour also includes cities such as New York, Chicago, Boston, Las Vegas and Los Angeles, and will end June 12 in Detroit.

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Online:

http://www.fleetwoodmac.com/

You can follow Music Writer Mesfin Fekadu on Twitter at twitter.com/MusicMesfin

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“Fiscal cliff” struggle prompts Republican infighting

(Reuters) – Republicans in the Congress attacked each other on Tuesday over their leadership’s “fiscal cliff” offer to Democratic President Barack Obama as a group of governors visited the White House to voice concern about the impact on the states of the year-end tax-and-spending deadline.

The disarray in Republican ranks over how far to compromise the party’s anti-tax stance could complicate what are expected to be intense negotiations between House Speaker John Boehner and Obama. Each will need the backing of their respective troops in Congress in order to bargain credibly.

The fiscal cliff refers to steep tax increases and deep automatic spending cuts slated to start to take effect on New Year’s Day. If Congress and Obama do not act to stop them, economists have warned the U.S. economy could be thrown back into recession.

The disagreements among Republicans surfaced as negotiations on a deficit reduction plan designed to supplant and avert the automatic cuts and tax hikes got more serious, with both parties having presented opening offers.

Senator Jim DeMint, a South Carolinian with a following among small-government conservatives, lashed out at an offer sent on Monday to Obama by Boehner, a fellow Republican.

“Speaker Boehner‘s $ 800 billion tax hike will destroy American jobs and allow politicians in Washington to spend even more,” DeMint said in a statement.

In the House of Representatives, two first-term Republican Tea Party stalwarts – Tim Huelskamp of Kansas and Justin Amash of Michigan – were removed by party leadership from the powerful budget committee in what Huelskamp called “a vindictive move.”

The Republican leadership offered no immediate explanation for the unusual action, but Boehner has had problems bringing in line the large Tea Party wing in the House. Elected to Congress in force in 2010, they regard the speaker as too much of a compromiser and tied his hands during talks in 2011 on raising the debt ceiling.

“The GOP leadership might think they have silenced conservatives, but removing me and others from key committees only confirms our conservative convictions,” said Huelskamp.

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

Tensions erupted on Tuesday at a forum convened by a fiscal responsibility group called Fix the Debt, which seeks to reduce the federal government’s debt and includes a range of business, think tank and political leaders.

Audience members stood and repeatedly interrupted Republican Senator Rob Portman of Ohio as he attempted to make a speech. They urged protections from cuts for the Social Security and Medicare social safety net programs.

Others shouted down the protesters until they marched out of the forum, where Democratic Senate Finance Committee Chairman Max Baucus also made remarks.

U.S. stock markets opened slightly higher, with the benchmark Dow Jones industrial average up less than 1 percent after weeks of gyrations tied to the debate on Capitol Hill.

GOP OFFER MADE

In an important step, Boehner on Monday called for steep spending cuts, but gave no ground on Obama’s proposal to raise tax rates on the wealthiest Americans.

The central dispute between the two parties has been what to do about low individual income tax rates that will expire at year-end. The low rates were first signed into law a decade ago by former President George W. Bush.

Obama wants to extend the low rates for 98 percent of taxpayers, but not for the top 2 percent. Republicans have insisted that the low tax rates be extended for the wealthy as well.

The White House dismissed Boehner’s proposal within an hour of its being made public, the same treatment Republicans gave Obama’s deficit reduction plan offered last week.

While the offers and counter-offers between Republicans and Democrats may ultimately create the conditions for actually getting in a room together and bargaining at length, so far the moves have been out in public and mostly for show.

Washington is awash in competing plans to cut the federal deficit. A think tank with ties to the Obama administration laid out another plan on Tuesday, urging the president to go bold and seek more concessions from Republicans on tax hikes.

(Reporting by Thomas Ferraro, David Lawder, Kim Dixon, Fred Barbash, Rachelle Younglai; Editing by Jackie Frank)

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Meet the First Royal Baby Profiteers

Yesterday, St. James’s Palace announced that the Duke and Duchess of Windsor are expecting their first child. Just as the royal wedding produced heaps of Will and Kate-themed tchotchkes, news of the couple’s forthcoming member of the family—who will officially be the third in line for the throne—is sure to inspire its own mountain of merchandise. So who is the first to put something royal baby-themed on the market?

As far as we can tell, it’s the pottery firm Emma Bridgewater, located in Stoke-on-Trent, which is already producing blue, red, and white mugs emblazoned with the words: “A royal baby in 2013.”

Courtesy Emma BridgewaterThe company told the BBC it sold millions of dollars worth of goods for the Queen’s Diamond Jubilee and the royal wedding and expects the babywares to be an equally big hit, even across the pond. “It’s also apparent from the media coverage over the last 24 hours that the American market will be strong too, so we’re hoping this will help us move more sales into the United States,” head of manufacturing Mark Thomas said to the BBC. Emma Bridgewater will make another design with the baby’s name when it is born.

Businessweek.com — Top News

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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 Siemens to sell optical networks unit

FRANKFURT (Reuters) – Mobile telecoms equipment joint venture Nokia Siemens Networks, which is focusing on its core business, is to sell its optical fiber unit to Marlin Equity Partners for an undisclosed sum.

Up to 1,900 employees, mainly in Germany and Portugal, will be transferred to the new company, NSN said on Monday.

The company, owned by Nokia and Siemens, has sold a number of product lines since it last year announced plans to divest non-core assets and cut 17,000 jobs, nearly a quarter of its total workforce.

Nordea Markets analyst Sami Sarkamies said he expected more divestments after the optical unit deal. This disposal was a small surprise, he said, because NSN needed some optical technology – where data is transmitted by pulses of light – for its main mobile broadband business.

The move may hint the company is preparing itself for further consolidation in the sector by cutting overlaps with other players, Sarkamies said.

The telecom equipment market is going through rough times with stiff competition. French Alcatel-Lucent is also cutting costs.

($ 1 = 0.7689 euro)

(Reporting by Harro ten Wold; Editing by Greg Mahlich and Dan Lalor)

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Palace says Duchess of Cambridge expecting a baby

LONDON (AP) — Get the nursery ready: Prince William and his wife Kate are expecting their first child.

St. James’s Palace announced the pregnancy Monday, saying that the Duchess of Cambridge — formerly known as Kate Middleton — has a severe form of morning sickness and is currently in a London hospital. William is at his wife’s side.

The palace said since the pregnancy is in its “very early stages,” the 30-year-old duchess is expected to stay in the hospital for several days and will require a period of rest afterward.

It would not say how far along she is, only that she has not yet reached the 12-week mark.

News of the pregnancy drew congratulations from across the world, with the hashtag “royalbaby” trending globally on Twitter.

Not only are the attractive young couple popular — with William’s easy common touch reminding many of his mother, the late Princess Diana — but their child is expected to play an important role in British national life for decades to come.

William is second in line to the throne after his father, Prince Charles, so the couple’s first child would normally eventually become a monarch.

In recent days, Middleton has kept up her royal appearances — recently playing field hockey with schoolchildren at her former school.

The confirmation of her pregnancy caps a jam-packed year of highs and lows for the young royals, who were married in a lavish ceremony at Westminster Abbey last year.

They have traveled the world extensively as part of Queen Elizabeth II’s Diamond Jubilee celebrations and weathered the embarrassment of a nude photos scandal, after a tabloid published topless images of the duchess.

Joe Little, managing editor of Majesty magazine, said the news bookended a year that saw the royal family riding high in popular esteem after celebrations of Queen Elizabeth II’s 60 years on the throne.

“We’re riding on a royal high at the moment at the end of the Diamond Jubilee year,” he said. “People enjoyed the royal romance last year and now there’s this. It’s just a good news story amid all the doom and gloom.”

Speculation about when the couple would start a family has been rife since their wedding.

William’s mother — the late Princess Diana — got pregnant just four months after her wedding in 1981. Diana reportedly suffered from morning sickness for months and complained of constant media attention.

“The whole world is watching my stomach,” Diana once said.

American tabloid speculation of the pregnancy has been rampant for months. One newspaper even cited anonymous sources talking about Kate’s hormone levels. Others have focused on the first signs of the royal bump.

The palace said the royal family was “delighted” by the news, while British Prime Minister David Cameron wrote on Twitter that the royals “will make wonderful parents.”

Whether boy or girl, the child will be next in line behind William in the line of succession to the throne, Cabinet Office officials have said.

Leaders of Britain and the 15 former colonies that have the monarch as their head of state agreed in 2011 to new rules which give females equal status with males in the order of succession.

Although none of the nations had legislated to make the change as of September 2012, the British Cabinet Office confirmed that this is now the de-facto rule.

On the couple’s recent tour of Malaysia, Singapore, the Solomon Islands and Tuvalu in September, William reportedly said he hoped he and Kate would have two children.

___

Associated Press writers Jill Lawless and Paisley Dodds contributed to this report.

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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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