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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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.

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Is the iPad Mini as Good as the iPad?

The iPad Mini‘s screen doesn’t have the same “resolutionary” Retina display as its bigger brother, but don’t worry: the Apple snobs appear to have gotten over that. After spending time with his new baby-tablet, The New York Times‘s Nick Bilton gave in, calling the gadget his new “Desert Island Device.” (It replaced his iPhone, by the way.) The inferior screen had worried Bilton like it had others, but no longer: ”I used it for two weeks and my concerns about the screen’s quality are completely irrelevant.” It’s not that Bilton prefers the “fuzzy” screen, as he called it. But the portability of the lightweight Mini outweighs that for him, making this tablet, in his opinion, really the best tablet Apple has ever made.

RELATED: Prepare for an iPad Mini This Month

Considering all the fawning over the Retina display on the iPad proper, it’s pretty amazing to see reviewers toss that upgrade for something that Steve Jobs forbid the company to create. Bilton’s not the only one to prefer the new cousin, even if it is technically worse. Noted Apple-phile Jonathan Gruber said he hadn’t touched the fourth-generation iPad that Apple released this year as well “I’ve gone small and fuzzy,” he wrote. When the Retina display first came out, Gruber called it “pure joy” for his “dream iPad.” But a funny thing happened on the way out of the hype cycle: Apple put out something the masses were supposed to like more than the techies, and that just made everyone like it even more. Call it a holiday miracle, but the Apple snobs may be snobs no more.

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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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Tapping citizen-scientists for a novel gut check

WASHINGTON (AP) — The bacterial zoo inside your gut could look very different if you’re a vegetarian or an Atkins dieter, a couch potato or an athlete, fat or thin.

Now for a fee — $ 69 and up — and a stool sample, the curious can find out just what’s living in their intestines and take part in one of the hottest new fields in science.

Wait a minute: How many average Joes really want to pay for the privilege of mailing such, er, intimate samples to scientists?

A lot, hope the researchers running two novel citizen-science projects.

One, the American Gut Project, aims to enroll 10,000 people — and a bunch of their dogs and cats too — from around the country. The other, uBiome, separately aims to enroll nearly 2,000 people from anywhere in the world.

“We’re finally enabling people to realize the power and value of bacteria in our lives,” said microbiologist Jack Gilbert of the University of Chicago and Argonne National Laboratory. He’s one of a team of well-known scientists involved with the American Gut Project.

Don’t be squeamish: Yes, we share our bodies with trillions of microbes, living communities called microbiomes. Many of the bugs, especially those in the intestinal tract, play indispensable roles in keeping us healthy, from good digestion to a robust immune system.

But which combinations of bacteria seem to keep us healthy? Which ones might encourage problems like obesity, diabetes or irritable bowel syndrome?

And do diet and lifestyle affect those microbes in ways that we might control someday?

Answering those questions will require studying vast numbers of people. Getting started with a grassroots movement makes sense, said National Institutes of Health microbiologist Lita Proctor, who isn’t involved with the new projects but is watching closely.

After all, there was much interest in the taxpayer-funded Human Microbiome Project, which last summer provided the first glimpse of what makes up a healthy bacterial community in a few hundred volunteers.

Proctor, who coordinated that project, had worried “there would be a real ick factor. That has not been the case,” she said. Many people “want to engage in improving their health.”

Scott Jackisch, a computer consultant in Oakland, Calif., ran across American Gut while exploring the science behind different diets, and signed up last week. He’s read with fascination earlier microbiome research: “Most of the genetic matter in what we consider ourselves is not human, and that’s crazy. I wanted to learn about that.”

Testing a single stool sample costs $ 99 in that project, but he picked a three-sample deal for $ 260 to compare his own bacterial makeup after eating various foods.

“I want to be extra, extra well,” said Jackisch, 42. Differing gut microbes may be the reason “there’s no one magic bullet of diet that people can eat and be healthy.”

It’s clear that people’s gut bacteria can change over time. What this new research could accomplish is a first look at how different diets may play a role, “a much better understanding of what matters and what doesn’t,” said American Gut lead researcher Rob Knight of the University of Colorado, Boulder.

“We don’t just want people that have a gut-ache. We want couch potatoes. We want babies. We want vegans. We want athletes. We want anybody and everybody because we need that complete diversity,” added American Gut co-founder Jeff Leach, an anthropologist.

One challenge is making sure participants don’t expect that a map of their gut bacteria can predict their future health, or suggest lifestyle changes, anytime soon.

“I understand I’m not going to be able to say, ‘Oh, my gosh, I’ll be susceptible to this,’” said Bradley Heinz, 26, a financial consultant in San Francisco. He is paying uBiome $ 119 to analyze both his gut and mouth microbiomes; just the gut is $ 69.

“The more people that participate, the more information comes out and the more that everybody benefits,” he added.

Participants can sign up for either project via the social fundraising site Indiegogo.com over the next month. They also can send scrapings from the skin, mouth and other sites, to analyze that bacteria. Sign up enough family members or body sites, or be tracked over time, and the price can rise into the thousands. American Gut researchers plan some free testing for those who can’t afford the fees, to increase the experiment’s diversity.

Don’t forget the pets: “We sleep with them, play with them, they often eat our food,” Leach said. What bacteria we have in common is the next logical question.

Already, American Gut researchers are preparing to compare what they find in the typical U.S. gut with a few hundred people in rural Namibia, who eat what’s described as hunter-gatherer fare. Also, Leach will spend three months living in Namibia next year, and is storing his own stool samples for before-and-after comparison.

But diet isn’t the only factor. Your bacterial makeup starts at birth: Babies absorb different microbes when they’re born vaginally than when they’re born by C-section, a possible explanation for why cesareans raise the risk for certain infections. Taking antibiotics alters this teeming inner world, and it’s not clear if there are lasting consequences, especially for young children.

Then there’s your environment, such as the infections spread in hospitals. In February, a new University of Chicago hospital building opens and Gilbert will test the surfaces, the patients and their health workers to see how quickly bad bugs can move in and identify which bacteria are protective.

Whatever the findings, all the research marks “a huge teachable moment” about how we interact with microbes, Leach said.

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EDITOR’S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

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Online:

www.indiegogo.com/americangut

www.indiegogo.com/ubiome

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Citi cuts telecoms head in Europe: sources

DUBAI/LONDON (Reuters) – Citigroup‘s head of technology, media and telecoms in Europe is to leave as part of cost cuts the U.S. bank is making in response to the weak economic climate and due to tougher regulation, sources familiar with the matter told Reuters on Monday.

Daniel Bailey is to leave the bank with immediate effect and his position will be taken on by Citigroup’s European (EMEA) head of M&A, Wilhelm Schulz.

Bailey declined to comment. Citigroup also declined to comment.

Citigroup and other big banks are under pressure from investors to cut costs and scale-back activities in line with lower business volumes and reduced returns in the financial sector since the financial crisis.

The U.S. bank’s new chief executive Michael Corbat, who took the helm on October16, is in the process of reviewing management and executive reporting lines.

Bailey, who joined Citi in 2006 from Morgan Stanley , worked on some of the telecoms industry’s biggest deals, including the $ 183 billion merger of Vodafone with Mannesman in 2000, the largest corporate merger ever at that time.

Schulz will relinquish his role as co-head of German banking to focus on his new responsibilities but will remain head of German coverage. Stefan Wintels will become sole head of German banking.

Citigroup is also expected to cut bonuses this year by about 10 percent and axe around 150 investment banking jobs by year-end, just under one percent of the 17,000 staff in its investment bank, a person familiar with the matter said.

(Additional reporting by David Henry in New York, editing by Sophie Sassard and Jane Merriman)

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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.

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

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Explainer: Why was pregnant duchess hospitalized?

LONDON (AP) — While morning sickness in pregnant women is common, the problem the Duchess of Cambridge has been hospitalized with is not.

In a statement Monday, palace officials said she was hospitalized with hyperemesis gravidarum, a potentially dangerous type of morning sickness where vomiting is so severe no food or liquid can be kept down. Palace officials said the duchess was expected to remain hospitalized for several days and would require a period of rest afterwards.

“It’s not unusual for pregnant women to get morning sickness, but when it gets to the point where you’re dehydrated, losing weight or vomiting so much you begin to build up (toxic) products in your blood, that’s a concern,” said Dr. Kecia Gaither, director of maternal fetal medicine at Brookdale University and Medical Center in New York.

The condition is thought to affect about one in 50 pregnant women and tends to be more common in young women, women who are pregnant for the first time, those expecting multiple babies and in non-smokers. Gaither said that fewer than one percent of women with the condition need to be hospitalized.

Doctors aren’t sure what causes it but suspect it could be linked to hormonal changes or nutritional problems.

Women admitted to the hospital with hyperemesis gravidarum are usually treated with nutritional supplements and given fluids intravenously to treat dehydration. Dr. Dagni Rajasingam, a spokeswoman for the Royal College of Obstetricians and Gynaecologists, said most women hospitalized with the condition are discharged within several days.

“It depends on how well the woman is keeping fluids down,” she said.

If the problem is recognized and treated early, doctors say there are no long-term effects for either the mother or the child. Left untreated, the mother could be at risk of developing neurological problems — including seizures — or risk delivering the baby early.

Gaither said the condition usually subsides by the second trimester.

“The rest of the pregnancy could be entirely uneventful,” she said, adding that pregnant women treated for the condition are usually advised to avoid fatty foods that could aggravate the problem.

Gaither said the duchess would probably be able to meet her usual royal obligations by her second trimester.

“She should be able to meet all her public obligations soon,” she said, advising her to take her vitamins and ensure there are no other underlying health problems. “She should just be looking forward to having a healthy little plump person.”

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