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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Sri Lanka see backlash from Aussie ‘wounded soldiers’

(Reuters) – Sri Lanka captain Mahela Jayawardene has warned his team to be wary of a backlash from Australia in their three-test series after the hosts were stung by their series defeat to South Africa earlier this week.

Australia’s hopes of snatching the Proteas’ top test ranking ended in a crushing 309-run defeat in the third and final test in Perth on Monday, but Jayawardene took little comfort from the home side’s disappointment.

“I see them as wounded soldiers – they could come back stronger against us,” Jayawardene told reporters in Canberra on Wednesday, on the eve of a three-day tour match against a Chairman’s XI side.

“So we just need to make sure we are ready for that and start well.

“We can’t be complacent – we need to make sure we know from ball one we give them a good go at it.”

Sri Lanka have their own problems coming into the first test at Hobart next week, losing their last test at home to New Zealand by 167 runs to level a two-match series 1-1, with key batsmen out of form.

Kumar Sangakkara scored five, nought and 16 in his three innings against New Zealand, but Jayawardene backed the veteran to bounce back in Sri Lanka’s bid to win their first test Down Under.

“I am happy that he went through a lean phase because he’ll be really hungry for runs – that’s Kumar for you,” Jayawardene said of the 35-year-old stalwart.

Jayawardene also said he would weigh up his future as captain after the series, which includes tests in Melbourne and Sydney, after taking on the role for a second time in the wake of Tillakaratne Dilshan’s sudden resignation in January.

“After this, we get a well-deserved four weeks off, after about three years, so it gives me a bit of time to think (about) what I need to do,” said Jayawardene, who captained the team for more than three years in his first stint from 2006.

“We need to groom another leader as well. It’s very important to have that changeover done smoothly while the senior players are still in the side.”

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“The Message” deemed greatest hip hop song ever

LOS ANGELES (Reuters) – The 1982 hit “The Message” by Grandmaster Flash and the Furious Five was named the greatest hip hop song of all time on Wednesday, in the first such list by Rolling Stone magazine to celebrate the young but influential music genre.

“The Message,” which tops a list of 50 influential hip hop songs, was the first track “to tell, with hip hop‘s rhythmic and vocal force, the truth about modern inner-city life in America,” Rolling Stone said.

Grandmaster Flash and the Furious Five, a hip hop collective from the south Bronx in New York, was formed in 1978 and became one of the pioneers of the hip hop genre.

The full list spanned songs ranging from Sugarhill Gang’s 1979 hit “Rapper’s Delight,” which came in at No. 2, to Kanye West‘s 2004 hit “Jesus Walks,” which landed at No. 32.

“It’s a list that would have been a lot harder to do ten or 15 years ago because hip hop is so young,” Nathan Brackett, deputy managing editor of Rolling Stone, told Reuters.

“We’ve reached the point now where hip hop acts are getting into the (Rock and Roll) Hall Of Fame… it just felt like the right time to give this the real Rolling Stone treatment.”

Rolling Stone‘s top 10 featured mostly hip hop veterans, such as Run-D.M.C.’s 1983 track “Sucker M.C.’s,” Dr. Dre and Snoop Dogg’s 1992 hit “Nuthin’ But A ‘G’ Thang,” Public Enemy’s 1990 song “Fight The Power” and Notorious B.I.G’s 1994 hit “Juicy.”

Other influential artists in the top 50 songs included Beastie Boys, who came in at No. 19 with “Paul Revere,” and recordings by Jay-Z, Eminem, Missy Elliot, Outkast, Lauryn Hill, LL Cool J, Nas and the late rapper 2Pac.

The list of 50 songs was compiled by a 33-panel of members comprising Rolling Stone editors and hip hop experts. They included musician Ahmir “Questlove” Thompson of The Roots, who Brackett described as “an incredible encyclopedia” of both old and new hip hop knowledge.

Brackett noted that some songs considered to be one-hit wonders, such as Audio Two’s 1988 hit “Top Billin’,” made the final selection.

“The references in those songs become the building blocks of all these other songs down the road … they become touchstones, really part of the meat of hip hop songs going forward,” Brackett said.

The full list will be released online at RollingStone.com and in the pop culture magazine on newsstands on December7. The issue will feature four different covers of Eminem, Jay-Z, Notorious B.I.G. and 2Pac.

(Reporting By Piya Sinha-Roy, editing by Jill Serjeant)

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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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Longtime editor at DC’s Vertigo imprint leaving

PHILADELPHIA (AP) — DC Entertainment says its executive editor and senior vice president of Vertigo — a groundbreaking imprint whose titles have included “Hellblazer,” ”DMZ” and “Sandman” — is leaving early next year.

Karen Berger will step down in March after nearly 20 years at the helm, saying in a statement released by DC late Monday that she is ready for a professional change.

During her tenure at Vertigo, the imprint saw a wide range of writers and artists — Neil Gaiman, Jill Thompson, Becky Cloonan and Brian Wood, among them — who produced titles beyond the traditional superhero and villain archetype.

Gerard Way of My Chemical Romance and writer of “The Umbrella Academy” tweeted that Berger gave “us weird kids in high school a Sub Pop Records for comics.”

___

Online:

http://www.vertigocomics.com

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China goes crazy for iPhone 5: Preorders hit 100,000 units in under 24 hours

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Julie Bowen and the Danger of Allergies

What are the odds a child will be exposed to two powerful allergens at the same time? It happened to ” Modern Family” actress Julie Bowen’s son. He was stung by a bee – at the same time he was eating a peanut butter sandwich.

The toddler immediately went into anaphylactic shock. His entire face swelled up, including his eyes and lips, and his breathing became labored.

“We took him to the ER, where he was treated with epinephrine, and ever since then we’ve been vigilant about keeping him safe,” the Emmy-winning Bowen told the Los Angeles Times.

Bowen told the paper she’s speaking about the experience publicly because one in 13 children have food allergies and she wants to educate parents about the dangers.

According to Dr. Brian Schroer, a pediatric allergist with the Cleveland Clinic in Ohio, childhood allergies can indeed be serious business. Parents need to know what to watch out for.

“When introducing a new food to a young child, especially a common allergen, watch closely for signs of distress,” he said.

The most common food allergy symptoms are itchiness in the mouth, a rash on the face, the body or both, coughing, wheezing and vomiting.

If a child’s allergy is severe, as in the case of Bowen’s son, there will also be facial swelling, difficulty breathing and low blood pressure. Schroer said the Bowens did the right thing by rushing their son to the emergency room.

“Parents can also give their kids some Benadryl to help symptoms but should still seek urgent care,” he said. “For a child really in distress, call 911.”

Children may not have a reaction the first time they’re exposed to an allergen. Initial reactions can range from mild to severe, with the most profound reactions generally triggered by peanuts, tree nuts and shellfish. Insect strings also tend to produce strong reactions. However, even a mild symptom like itchiness or a light skin rash can portend more serious reactions in the future.

At the first sign of any allergy symptoms, Schroer recommended checking in with a pediatrician or allergist.

“They can take a complete medical history and conduct simple skin challenge tests to determine the cause,” he said.”If there is an allergy, parents should work with their doctor to create a food allergy action plan.”

Once a plan is in place, make sure everyone who cares for your child, including teachers, babysitters and after-school providers, are familiar with it. Schroer said sometimes that means giving a stern lecture to well-meaning grandparents who may not quite believe the child has an issue until they see it for themselves. And any child who is at risk for anaphylaxis should carry an epi-pen and other medications at all times, including school, play dates and vacation.

Bowen hopes there won’t be any more “P Bee and J” situations for her son. But if there are, she said she’s prepared. As she told the L.A. Times, “It’s pretty straightforward. I don’t need to know everything that happens during an anaphylactic reaction; it’s enough for me to know as a parent that it can kill you.”

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Conservative Republicans booted from House budget panel

WASHINGTON (Reuters) - Two of the most conservative Republicans in the House of Representatives have been kicked off the House Budget Committee, a rare move that could make it easier for the panel to advance a deal with Democrats to cut fiscal deficits.

Representatives Tim Huelskamp of Kansas and Justin Amash of Michigan - both favorites of the anti-tax Tea Party movement - are among those Republicans voting most often against House Speaker John Boehner.

Huelskamp and Amash, who both will begin second terms in the House next month, voted against last year's deal to raise the federal debt limit and staunchly oppose any tax increases. Boehner has now included new revenue in his latest offer to avert the "fiscal cliff" of year-end tax hikes and automatic spending cuts. Given their voting records, winning support from Huelskamp and Amash for such a compromise seemed an uphill battle.

Huelskamp released a statement saying the Republican leadership "might think they have silenced conservatives but removing me and others from key committees only confirms our conservative convictions.

"This is clearly a vindictive move and a sure sign that the GOP establishment cannot handle disagreement," he said.

Huelskamp and Amash had said that despite sweeping changes to the Medicare and Medicaid healthcare programs, committee chairman Paul Ryan's budget did not make deep enough cuts to entitlement programs and military spending.

Boehner spokesman Michael Steel declined to be specific on the reasons for their ouster by the House Republican Steering Committee, which occurred Monday in a closed-door meeting.

"The Steering Committee makes decisions based on a range of factors," Steel said.

Huelskamp said he was given "limited explanation" for his removal from the Budget Committee, a move he called "vindictive." A spokesman for Amash could not be immediately reached for comment.

Huelskamp and Amash cast the only House Budget Committee votes against Ryan's budget plan earlier this year.

While there is often wrangling over committee chairmanships just before a new Congress takes office, it is rare for rank-and-file committee members to be stripped of their assignments.

The 34-member Republican steering committee is headed by Boehner and includes members of House leadership, committee chairs and other lawmakers representing different regions of the country.

The same group last week recommended that Ryan, the conservative former Republican vice presidential candidate, be renewed as Budget Committee chairman.

(Editing by Bill Trott)

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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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Conservatives make Boehner's life difficult

WASHINGTON— Conservatives panned the House Republican proposal released Monday to avoid the so-called "fiscal cliff," yet again giving House Speaker and lead negotiator John Boehner little room to maneuver as he works toward a deal with the White House.

The proposal includes extending current tax rates for all income levels and raising revenue by closing loopholes in the tax code.

"Rarely in modern American politics have more counterproductive, more foolish words been set to paper," wrote researchers at the Heritage Foundation in response to part of the letter sent to the White House from seven House leaders that outlined the Republican plan. The Heritage analysis, co-written by Alison Acosta Fraser and J.D. Foster, went on to say: "[T]he Republican counteroffer, to the extent it can be interpreted from the hazy details now available, is a dud. It is utterly unacceptable. It is bad policy, bad economics, and, if we may say so, highly questionable as a negotiating tactic."

Heritage's response echoed the sentiment of many conservatives in Washington who are urging House Republicans to avoid cutting a deal with the president if it means raising taxes.

In an open letter signed by more than 100 prominent conservative activists and organized by the advocacy group Let Freedom Ring, House Republicans were warned that they would not receive support in the future if they "cave" during negotiations.

"In the House, the nation elected in 2012 one of the largest Republican majorities in the past 100 years. You have a mandate to fight for conservative principles that is arguably much broader than the one that narrowly reelected President Barack Obama claims to have for his leftist agenda," the letter read. It was signed by Republican activists like Richard Viguerie, Leadership Institute founder Morton Blackwell, Eagle Forum founder Phyllis Schlafly, Media Research Center president Brent Bozell, and Republican donor Foster Friess.

"And if Republicans cave in now, when it really counts," the letter continued, "next time you will be weaker, because your conservative base will be outraged.  Many who worked hard to elect you in the past will never lift a finger for you again."

In the Senate on Tuesday, South Carolina Republican Sen. Jim DeMint, one of the tea party's staunchest allies in the upper chamber, accused House Republicans of promoting a plan that would "destroy American jobs."

DeMint's remarks this week, however, seemed to be somewhat of a departure from his characterization of a possible deal before the election, when he said Republicans who don't want to see the automatic defense spending reductions set to automatically trigger next year go into effect "might as well cut a deal" that includes tax increases.

"You can't get a deal with Obama without raising taxes on the producing class of folks," DeMint said in September, according to a report by Bloomberg News. "We might as well cut a deal. If Republicans want to maintain the defense, we're going to have to give tax increases to Obama."

In a statement to Yahoo News, DeMint's spokesman moved to clarify the remarks, saying that he had "simply stated the obvious" and would never support a plan with more taxes.

"Before the election, he simply stated the obvious, that Obama would try to use a lame duck session to rush through tax hikes that will hurt the economy," DeMint spokesman Wesley Denton said. "His point then was that if Republican leadership wasn't going to stand strong against tax hikes in the lame duck, they might as well be honest with voters before the election. Sadly, his predictions have proven correct and his long opposition to tax hikes that destroy jobs hasn't changed."

The conservative backlash, of course, could amount to mere noise as Boehner continues his negotiations with the president in search of a deal. The speaker and his allies in the House have spent two years navigating the thorn-riddled path between his party's conservative base and Obama's demands.

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