FDA advisory panel backs J&J TB drug

(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Wednesday voted that an experimental Johnson & Johnson drug for multidrug-resistant tuberculosis appears to be safe and effective, but highlighted potential heart and liver-safety issues.

The medicine, called bedaquiline, targets adenosine triphosphate synthase, an enzyme the tuberculosis bacterium needs to generate its energy. If approved, J&J said it would be the first drug in 40 years with a new mechanism of action against tuberculosis.

J&J said the panel of outside medical experts, in a vote of 18 to 0, found that trial data provide “substantial evidence” of efficacy and safety for bedaquiline in adults, taken in combination with standard treatments. It backed the drug’s safety, by a vote of 11 to 7.

The FDA usually follows the advice of its advisory panels when deciding whether to approve new medicines.

In September, the FDA granted priority review of the drug, based on data from two mid-stage trials that tested it among patients with tuberculosis that is resistant to standard drugs.

J&J’s Janssen drug subsidiary is hoping the agency will grant accelerated approval of its drug, on the basis of favorable data from mid-stage trials. The company plans to begin a larger Phase 3 study early next year.

In a pair of completed Phase 2 trials, two doses of the medicine were tested for 24 weeks, in combination with standard treatments, followed by continuation of standard therapy for a year to 18 months.

In one of the trials, 10 deaths were seen among 79 people taking bedaquiline and standard drugs, compared with only 2 deaths among 81 patients taking only standard drugs.

Some members of the FDA advisory panel expressed concern about that “mortality imbalance,” as well as elevated liver enzymes — a potential sign of liver toxicity — among patients taking the J&J drug.

Patients taking bedaquiline also had increases in the so-called QT interval — suggesting a possible electrical irregularity in the heart — than those not taking the medicine.

But Wim Parys, Janssen’s head of development for infectious disease medicines, said in an interview that the drug’s superiority to standard medicines in the mid-stage trials held sway with the advisory panel.

He said 21 percent fewer patients taking the J&J drug still had signs of the TB bacterium in their sputum after one of the mid-stage studies, than those taking just standard drugs.

“This is a new mechanism of action to treat TB, particularly (bacteria) that have become resistant to first-line treatments,” Parys said.

Cowen and Co has forecast peak annual sales of $ 300 million for bedaquiline, which would make it a fairly modest product for the diversified healthcare company.

Parys acknowledged the drug’s limited sales potential, given that it would be used mainly in poorer developing countries. But he said J&J approved development of the medicine due to a compelling medical need.

The planned larger trial will involve nine months of treatment with bedaquiline, in combination with standard drugs, compared with standard drugs alone for the same period. The total nine-month treatment period would be far shorter than the current 18- to 24-month treatment period for multidrug-resistant tuberculosis drugs recommended by the World Health Organization, J&J said.

Multidrug-resistant tuberculosis is caused by strains of the bacterium that have become resistant to at least isoniazid and rifampin, the two most potent drugs for TB.

Resistance to anti-TB drugs can occur when they are misused or mismanaged, for instance when patients don’t complete their full course of treatment or when doctors prescribe the wrong treatment, wrong dose or length of time taking the drugs.

An estimated 8.7 million people in 2011 fell ill with tuberculosis – which is spread by coughing and sneezing — while 1.4 million died from the disease, according to the World Health Organization. About 310,000 cases of multidrug-resistant TB were reported the same year, the organization said, with almost 60 percent in India, China and Russia.

(Reporting by Ransdell Pierson; Editing by Jan Paschal and Carol Bishopric)

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Two winners in record Powerball jackpot

Winning tickets for the record Powerball jackpot worth more than $579 million were purchased in Arizona and Missouri.

Missouri Lottery official Susan Goedde confirmed to ABC News this morning that one of the winning tickets was purchased in the state, but they would not be announcing a town until later this morning. Powerball's website reports the other winning ticket was purchased in Arizona.

The winning numbers for the jackpot were 5, 23, 16, 22 and 29. The Powerball was 6.

Before the numbers were drawn on Wednesday, the jackpot swelled to $579.9 million, making the cash option $379.8 million.

An additional 8,924,123 players won smaller prizes, according to Powerball's website.

"There were 58 winners of $1 million and there were eight winners of $2 million. So a total of $74 million," said Chuck Strutt, Director of the Multi-State Lottery Association.

In Photos: Biggest Lotto Jackpot Winners

Hopeful players bought tickets at the rate of 131,000 every minute up until an hour before the deadline of 11 p.m. ET, according to lottery officials.

The jackpot had already rolled over 16 consecutive times without a winner. That fact, plus the doubling in price of a Powerball ticket, accounted for the unprecedented richness of the pot.

"Back in January, we moved Powerball from being a $1 game to $2," said Mary Neubauer, a spokeswoman at the game's headquarters in Iowa. "We thought at the time that this would mean bigger and faster-growing jackpots."

That proved true. The total, she said, began taking "huge jumps -- another $100 million since Saturday." It then jumped another $50 million.

The biggest Powerball pot on record until now -- $365 million -- was won in 2006 by eight Lincoln, Neb., co-workers.
As the latest pot swelled, lottery officials said they began getting phone calls from all around the world.

"When it gets this big," said Neubauer, "we get inquiries from Canada and Europe from people wanting to know if they can buy a ticket. They ask if they can FedEx us the money."

The answer she has to give them, she said, is: "Sorry, no. You have to buy a ticket in a member state from a licensed retail location."

About 80 percent of players don't choose their own Powerball number, opting instead for a computer-generated one.
Asked if there's anything a player can do to improve his or her odds of winning, Neubauer said there isn't -- apart from buying a ticket, of course.

Lottery officials put the odds of winning the $579 Powerball pot at one in 175 million, meaning you'd have been 25 times more likely to win an Academy Award.

Skip Garibaldi, a professor of mathematics at Emory University in Atlanta, provided additional perspective: You are three times more likely to die from a falling coconut, he said; seven times more likely to die from fireworks, "and way more likely to die from flesh-eating bacteria" (115 fatalities a year) than you are to win the Powerball lottery.

Segueing, then, from death to life, Garibaldi noted that even the best physicians, equipped with the most up-to-date equipment, can't predict the timing of a child's birth with much accuracy.

"But let's suppose," he said, "that your doctor managed to predict the day, the hour, the minute and the second your baby would be born."

The doctor's uncanny prediction would be "at least 100 times" more likely than your winning.

Even though he knows the odds all too well, Garibaldi said he usually plays the lottery.

When it gets this big, I'll buy a couple of tickets," he said. "It's kind of exciting. You get this feeling of anticipation. You get to think about the fantasy."

So, did he buy two tickets this time?

"I couldn't," he told ABC News. "I'm in California" -- one of eight states that doesn't offer Powerball.

ABC News Radio contributed to this report.

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US rabbi says jailed American in good health

HAVANA (AP) — A prominent New York rabbi and physician visited an American subcontractor serving a long jail term in Cuba and said the man is in good health, despite his family’s concerns about a growth on his right shoulder.

Rabbi Elie Abadie, who is also a gastroenterologist, told The Associated Press in an exclusive interview following Tuesday’s 2 1/2-hour visit at a military hospital in Havana that he personally examined Alan Gross and received a lengthy briefing from a team of Cuban physicians who have attended him.

He said the 1 1/2-inch growth on Gross’s shoulder appeared to be a non-cancerous hematoma that should clear up by itself.

“Alan Gross does not have any cancerous growth at this time, at least based on the studies I was shown and based on the examination, and I think he understands that also,” Abadie said.

Abadie said the hematoma, basically internal bleeding linked to the rupture of muscle fiber, was likely caused by exercise Gross does in jail. He said the growth ought to eventually disappear on its own.

Gross’s plight has put already chilly relations between Cuba and the United States in a deep freeze. The Maryland native was arrested in December 2009 while on a USAID-funded democracy building program and later sentenced to 15 years in jail for crimes against the state.

He claims he was only trying to help the island’s small Jewish community gain Internet access.

Gross’s health has been an ongoing issue during his incarceration. The 63-year-old, who was obese when arrested, has lost more than 100 pounds while in jail.

Abadie, a rabbi at New York’s Edmund J. Safra Synagogue, said Gross’s weight is appropriate for a man his age and height.

Photos that Abadie and a colleague provided to AP of Tuesday’s meeting with Gross showed him looking thin, but generally appearing to be in good spirits.

In one photo, Gross holds up a handwritten note that says “Hi Mom.”

“He definitely feels strong. He is in good spirits. He feels fit, to quote him, physically. But of course, like any other person who is incarcerated or in prison, he wants to be free. He wants to be able to go back home,” Abadie said.

Gross’s family has repeatedly appealed for his release on humanitarian grounds, noting his health problems and the fact that his adult daughter and elderly mother have both been battling cancer.

Jared Genser, counsel to Alan Gross, said late Tuesday that Rabbi Abadie is not Gross’s physician and he would like an oncologist of his choosing to evaluate him.

“While we are grateful Rabbi Abadie was able to see Alan, we have asked an oncologist to review the test results to determine if they are sufficient to rule out cancer. More importantly, if Alan is so healthy, we cannot understand why the Cuban government has repeatedly denied him an independent medical examination by a doctor of his choosing as is required by international law,” said Genser.

Gross and his wife recently filed a $ 60 million lawsuit against his former Maryland employer and the U.S. government, saying they didn’t adequately train him or disclose risks he was undertaking by doing development work on the Communist-run island.

They filed another lawsuit against an insurance company they say has reneged on commitments to pay compensation in case of his wrongful detention.

Separately, a lawyer for Gross has written the United Nations’ anti-torture expert, saying Cuban officials’ treatment of his client “will surely amount to torture” if he continues to be denied medical care.

Rumors have been swirling in U.S. media that Cuba might soon release Gross as a gesture of good will or in the hopes of winning concessions from the administration of President Barack Obama, but Abadie said that those reports appeared to be false.

“As far as I know there is no truth to it,” he said.

Abadie said he met with senior Cuban officials who expressed their desire to resolve the case “as quickly as possible,” but would not say specifically who he spoke with or what they offered.

“They claim that they are more than willing to sit at the table,” he said.

Cuban officials have strongly implied they hope to trade Gross for five Cuban agents sentenced to long jail terms in the United States, one of whom is already free on bail.

Abadie said Gross made clear that he does not want his case linked to that of the agents, known in Cuba as “The Five Heroes,” because he does not believe he is guilty of espionage.

But Abadie said Gross is hoping for a “constructive and productive” dialogue between U.S. and Cuban officials to resolve his case.

___

Follow Paul Haven on Twitter: http://www.twitter.com/paulhaven.

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U.S. author sues filmmaker Tyler Perry over plot of 2012 film

NEW YORK (Reuters) – An American author sued the prolific filmmaker Tyler Perry in a federal court on Tuesday, accusing him of lifting the plot of his 2012 movie, “Good Deeds,” from her book.

Terri Donald, who also writes under the pseudonym TLO Red’ness, says Perry based the film on her 2007 book, “Bad Apples Can Be Good Fruit.”

The lawsuit, filed in Philadelphia, says Donald sent a copy of her book to Perry’s company before production on the movie began.

Donald is seeking $ 225,000 in initial damages as well as an injunction requiring the company to add a credit for her book in the opening and closing credits. The lawsuit also calls for the company to provide an accounting of the movie’s revenues.

The drama, which stars Perry as a wealthy businessman who meets a struggling single mother, earned approximately $ 35 million at the box office after its February release.

Representatives for Perry and Lions Gate Entertainment, which released the film and is also named as a defendant in the lawsuit, did not respond to requests for comment on Tuesday.

Perry is best known for his portrayal in drag of the character Madea in several of his films.

(Reporting by Joseph Ax; Editing by Paul Simao)

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Indian board rejects AstraZeneca’s patent plea on cancer drug

(Reuters) – India‘s patents appeal board has dismissed British drugmaker AstraZeneca‘s petition challenging an earlier ruling that refused patent protection for a cancer-fighting drug, in the latest blow for Big Pharma in the country.

The Indian patents office in 2007 refused patent protection to AstraZeneca’s quinazoline molecule, citing lack of invention. The Intellectual Property Appellate Board (IPAB) on Monday upheld the refusal.

The decision is also a setback for struggling AstraZeneca, which is battling to turn itself around as key drugs lose patent protection.

Global drug companies suffered a high-profile reversal in March when India granted the first ever compulsory license to domestic drugmaker Natco Pharma to sell cheap copies of Bayer’s cancer drug Nexavar. Bayer has appealed the order.

And early this month IPAB revoked a six-year-old Indian patent granted to Roche’s hepatitis C drug Pegasys, citing lack of evidence that the drug was any better than existing treatments.

Multinational drug manufacturers regard India’s $ 13 billion drug market as a huge opportunity, but are wary of what they see as lax protection for intellectual property in a country where generic medicines account for more than 90 percent of sales.

Indian generic companies, which do not need to plough money into future research, can produce drugs at a fraction of the cost of originator firms like Roche or Bayer.

Natco and another domestic drugmaker, G. M. Pharma, had opposed the initial patent application for AstraZeneca quinazoline derivative. The London-listed company filed a review petition, which India’s patent office dismissed in 2011.

A challenge to a review petition does not come under the purview of the IPAB, and even on merit the petition has failed, S. Majumdar & Co, the counsel for Natco Pharma, said in a statement.

AstraZeneca could not immediately be reached for a comment by Reuters. The company has the option to take its case to India’s Supreme Court.

(Reporting by Kaustubh Kulkarni in MUMBAI; Editing by Muralikumar Anantharaman)

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Egyptians challenge Mursi in nationwide protests

CAIRO (Reuters) - Tens of thousands of Egyptians rallied on Tuesday against President Mohamed Mursi in one of the biggest outpourings of protest since Hosni Mubarak's overthrow, accusing the Islamist leader of seeking to impose a new era of autocracy.

Police fired tear gas at stone-throwing youths in streets near the main protest in Cairo's Tahrir Square, heart of the uprising that toppled Mubarak last year. Clashes between Mursi's opponents and supporters erupted in a city north of Cairo.

But violence could not overshadow the show of strength by the normally divided opponents of Islamists in power, posing Mursi with the biggest challenge in his five months in office.

"The people want to bring down the regime," protesters in Tahrir chanted, echoing slogans used in the 2011 revolt.

Protesters also turned out in Alexandria, Suez, Minya and other Nile Delta cities.

Tuesday's unrest by leftists, liberals and other groups deepened the worst crisis since the Muslim Brotherhood politician was elected in June, and exposed the deep divide between the newly empowered Islamists and their opponents.

A 52-year-old protester died after inhaling tear gas in Cairo, the second death since Mursi last week issued a decree that expanded his powers and barred court challenges to his decisions.

Mursi's administration has defended the decree as an effort to speed up reforms and complete a democratic transformation in the Arab world's most populous country.

"Calls for civil disobedience and strikes will be dealt with strictly by law and there is no retreat from the decree," Refa'a Al-Tahtawy, Mursi's presidential chief of staff, told the Al-Hayat private satellite channel.

But opponents say Mursi is behaving like a modern-day pharaoh, a jibe once leveled at Mubarak. The United States, a benefactor to Egypt's military, has expressed concern about more turbulence in a country that has a peace treaty with Israel.

"We don't want a dictatorship again. The Mubarak regime was a dictatorship. We had a revolution to have justice and freedom," 32-year-old Ahmed Husseini said in Cairo.

The fractious ranks of Egypt's non-Islamist opposition have been united on the street by crisis, although they have yet to build an electoral machine to challenge the well-organized Islamists, who have beaten their more secular-minded rivals at the ballot box in two elections held since Mubarak was ousted.

MISCALCULATION

"There are signs that over the last couple of days that Mursi and the Brotherhood realized their mistake," said Elijah Zarwan, a fellow with The European Council on Foreign Relations. He said the protests were "a very clear illustration of how much of a political miscalculation this was".

Mursi's move provoked a rebellion by judges and has battered confidence in an economy struggling after two years of turmoil. The president still must implement unpopular measures to rein in Egypt's crushing budget deficit - action needed to finalize a deal for a $4.8 billion International Monetary Fund loan.

Some protesters have been camped out since Friday in Tahrir and violence has flared around the country, including in a town north of Cairo where a Muslim Brotherhood youth was killed in clashes on Sunday. Hundreds have been injured.

Supporters and opponents of Mursi threw stones at each other and some hurled petrol bombs in the Delta city of el-Mahalla el-Kubra. Medical sources said almost 200 people were injured.

"The main demand is to withdraw the constitutional declaration (decree). This is the point," said Amr Moussa, a former Arab League chief and presidential candidate who has joined the new opposition coalition, the National Salvation Front. The group includes several top liberal politicians.

Some scholars from the prestigious al-Azhar mosque and university joined Tuesday's protest, showing that Mursi and his Brotherhood have alienated some more moderate Muslims. Members of Egypt's large Christian minority also joined in.

Mursi formally quit the Brotherhood on taking office, saying he would be a president for all Egyptians, but he is still a member of its Freedom and Justice Party.

The decree issued on Thursday expanded his powers and protected his decisions from judicial review until the election of a new parliament, expected in the first half of 2013.

In Washington, White House spokesman Jay Carney urged demonstrators to behave peacefully.

"The current constitutional impasse is an internal Egyptian situation that can only be resolved by the Egyptian people, through peaceful democratic dialogue," he told reporters.

New York-based Human Rights Watch said the decree gives Mursi more power than the interim military junta from which he took over.

U.N. Secretary-General Ban Ki-moon told an Austrian paper he would encourage Mursi to resolve the issue by dialogue.

DECREE'S SCOPE DEBATABLE

Trying to ease tensions with judges, Mursi assured Egypt's highest judicial authority that elements of his decree giving his decisions immunity applied only to matters of "sovereign" importance. That should limit it to issues such as declaring war, but experts said there was room for interpretation.

In another step to avoid more confrontation, the Muslim Brotherhood cancelled plans for a rival mass rally in Cairo on Tuesday to support the decree. Violence has flared in Cairo in the past when both sides have taken to the streets.

But there has been no retreat on other elements of the decree, including a stipulation that the Islamist-dominated body writing a new constitution be protected from legal challenge.

"The decree must be cancelled and the constituent assembly should be reformed. All intellectuals have left it and now it is controlled by Islamists," said 50-year-old Noha Abol Fotouh.

With its popular legitimacy undermined by the withdrawal of most of its non-Islamist members, the assembly faces a series of court cases from plaintiffs who say it was formed illegally.

Mursi issued the decree on November 22, a day after he won U.S. and international praise for brokering an end to eight days of violence between Israel and Hamas around the Gaza Strip.

Mursi's decree was seen as targeting in part a legal establishment still largely unreformed from Mubarak's era, when the Brotherhood was outlawed.

Though both Islamists and their opponents broadly agree that the judiciary needs reform, Mursi's rivals oppose his methods.

Rulings from an array of courts this year have dealt a series of blows to the Brotherhood, leading to the dissolution of the first constitutional assembly and the lower house of parliament elected a year ago. The Brotherhood dominated both.

The judiciary blocked an attempt by Mursi to reconvene the Brotherhood-led parliament after his election victory. It also stood in the way of his attempt to sack the prosecutor general, another Mubarak holdover, in October.

In his decree, Mursi gave himself the power to sack that prosecutor and appoint a new one. In open defiance of Mursi, some judges are refusing to acknowledge that step.

(Additional reporting by Tom Perry, Seham Eloraby, Marwa Awad and Yasmine Saleh in Cairo and Michael Shields in Vienna; Writing by Edmund Blair and Tom Perry; Editing by Giles Elgood/Mark Heinrich)

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Mexican beauty queen killed in shootout

CULIACAN, Mexico (AP) — A 20-year-old state beauty queen died in a gun battle between soldiers and the alleged gang of drug traffickers she was traveling with in a scene befitting the hit movie “Miss Bala,” or “Miss Bullet,” about Mexico’s not uncommon ties between narcos and beautiful pageant contestants.

The body of Maria Susana Flores Gamez was found Saturday lying near an assault rifle on a rural road in a mountainous area of the drug-plagued state of Sinaloa, the chief state prosecutor said Monday. It was unclear if she had used the weapon.

“She was with the gang of criminals, but we cannot say whether she participated in the shootout,” state prosecutor Marco Antonio Higuera said. “That’s what we’re going to have to investigate.”

The slender, 5-foot-7-inch brunette was voted the 2012 Woman of Sinaloa in a beauty pageant in February. In June, the model competed with other seven contestants for the more prestigious state beauty contest, Our Beauty Sinaloa, but didn’t win. The Our Beauty state winners compete for the Miss Mexico title, whose holder represents the country in the international Miss Universe.

Higuera said Flores Gamez was traveling in one of the vehicles that engaged soldiers in an hours-long chase and running gun battle on Saturday near her native city of Guamuchil in the state of Sinaloa, home to Mexico’s most powerful drug cartel. Higuera said two other members of the drug gang were killed and four were detained.

The shootout began when the gunmen opened fire on a Mexican army patrol. Soldiers gave chase and cornered the gang at a safe house in the town of Mocorito. The other men escaped, and the gunbattle continued along a nearby roadway, where the gang’s vehicles were eventually stopped. Six vehicles, drugs and weapons were seized following the confrontation.

It was at least the third instance in which a beauty queen or pageant contestants have been linked to Mexico’s violent drug gangs, a theme so common it was the subject of a critically acclaimed 2011 movie.

In “Miss Bala,” Mexico’s official submission to the Best Foreign Language Film category of this year’s Academy Awards, a young woman competing for Miss Baja California becomes an unwilling participant in a drug-running ring, finally getting arrested for deeds she was forced into performing.

In real life, former Miss Sinaloa Laura Zuniga was stripped of her 2008 crown in the Hispanoamerican Queen pageant after she was detained on suspicion of drug and weapons violations. She was later released without charges.

Zuniga was detained in western Mexico in late 2010 along with seven men, some of them suspected drug traffickers. Authorities found a large stash of weapons, ammunition and $ 53,300 with them inside a vehicle.

In 2011, a Colombian former model and pageant contestant was detained along with Jose Jorge Balderas, an accused drug trafficker and suspect in the 2010 bar shooting of Salvador Cabanas, a former star for Paraguay‘s national football team and Mexico’s Club America. She was also later released.

Higuera said Flores Gamez’s body has been turned over to relatives for burial.

“This is a sad situation,” Higuera told a local radio station. She had been enrolled in media courses at a local university, and had been modeling and in pageants since at least 2009.

Javier Valdez, the author of a 2009 book about narco ties to beauty pageants entitled “Miss Narco,” said “this is a recurrent story.”

“There is a relationship, sometimes pleasant and sometimes tragic, between organized crime and the beauty queens, the pageants, the beauty industry itself,” Valdez said.

“It is a question of privilege, power, money, but also a question of need,” said Valdez. “For a lot of these young women, it is easy to get involved with organized crime, in a country that doesn’t offer many opportunities for young people.”

Sometimes drug traffickers seek out beauty queens, but sometimes the models themselves look for narco boyfriends, Valdez said.

“I once wrote about a girl I knew of who was desperate to get a narco boyfriend,” he said. “She practically took out a classified ad saying ‘Looking for a Narco’.”

The stories seldom end well. In the best of cases, a beautiful woman with a tear-stained face is marched before the press in handcuffs. In the worst of cases, they simply disappear.

“They are disposable objects, the lowest link in the chain of criminal organizations, the young men recruited as gunmen and the pretty young women who are tossed away in two or three years, or are turned into police or killed,” Valdez said.

___

Associated Press Writer E. Eduardo Castillo contributed to this report

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Exclusive: Egyptian investor seeks to put stamp on Telecom Italia

DUBAI (Reuters) – Egyptian entrepreneur Naguib Sawiris aims to shake up debt-laden Telecom Italia and steer it towards expansion in Brazil if shareholders warm up to his proposal for a 3 billion euro ($ 3.9 billion) cash infusion.

The billionaire tycoon, who got to know Italy well when he owned the third-biggest mobile operator Wind, has put on the table a capital increase that could make him one of the biggest shareholders in Telecom Italia.

Details on the structure of the proposed transaction are scarce, but Sawiris told Reuters that he proposed that the capital increase be open to all shareholders, not just himself, and that it should be conducted around the current market price of 0.70 euros per share.

That is likely to draw the ire of other Telecom Italia shareholders, including Spain’s Telefonica and the three Italian financial institutions who together own 22.4 percent via an unlisted holding company called Telco.

They value Telecom Italia at 1.50 euros per share in their accounts, and Marco Fossati, whose family’s Findim Group SA owns 5 percent of the Italian operator, on Monday said 1.50 was the “correct price” for any capital increase.

Sawiris, going against a trend of retreating investment in crisis-hit southern Europe, said he might also bring in some of his old Wind associates to put Telecom Italia back on the path to growth.

“This proposal will provide a more stable financial structure for Telecom Italia going forward, more growth in Latin America and Brazil, and improved management through the infusion of people who have an excellent knowledge of the Italian market,” Sawiris told Reuters.

Sawiris initially approached Telefonica and the other shareholders in Telco about the possibility of carrying out a capital increase at the holding company level. He was rebuffed, so decided to approach the Italian group directly.

“We are willing to participate in the capital increase, but shareholders have the choice not to get diluted and join in putting the money,” he said.

“If they do not want to, we will come and replace them. But they will benefit from a higher stock price and a more stable company and a company that will grow.”

It remains to be seen whether his vision for the group will be shared by Telecom Italia’s management and core shareholders.

Telefonica, insurer Assicurazioni Generali, and banks Mediobanca and Intesa Sanpaolo had the Sawiris’ offer dropped onto them as a bombshell two weeks ago, insiders have said.

“Sawiris is not a man to go in without being sure he can drive the strategy,” one source familiar with the thinking of the core shareholders said.

Sawiris told Reuters he was also opposed to a current plan to spin off Telecom Italia’s fixed-line network, which is backed by some core investors as a way to raise badly needed cash, and by the Italian government as a means to speed up broadband investment.

“I believe this is a catastrophe,” Sawiris said. “If Telecom Italia does that, they will lose the only differentiator they have left in the telecom market in Italy.”

Telecom Italia is now in talks with an Italian state-backed investment fund over such a spin-off. Under the plan, the fund would take a minority stake in the new company in exchange for Telecom Italia effectively becoming a wholesaler of broadband capacity to other companies.

Proponents of the spin-off argue the move would help Telecom Italia reduce debt while accelerating the modernization of the woeful Internet infrastructure in Europe’s fourth-largest economy.

STRATEGY CROSSROAD

Telecom Italia’s board will meet on December 6 to discuss the network spin-off and whether to bid for Vivendi’s GVT, a broadband specialist in Brazil, to complement its TIM Brasil mobile business unit in the fast-growing market.

GVT’s owner, Vivendi, is seeking up to 7 billion euros for GVT, which provides fixed telephone, broadband, and TV services in 120 Brazilian cities. Preliminary bids are due in December, sources have told Reuters.

Sawiris is waiting in the wings, though he says he has not had any direct contact from Telecom Italia since sending a letter of interest two weeks ago.

However, advisers from both sides – Lazard for Sawiris and Rothschild for Telecom Italia – have been communicating, according to people familiar with the matter.

Meanwhile, sources close to the telecom group’s shareholders have complained of a lack of detail in the Sawiris proposal.

Nuno Matias, a telecoms analyst at Espirito Santo bank, said while Sawiris’s arguments about seeking growth in Brazil via the GVT takeover were persuasive, the tycoon could face an uphill battle getting the board and shareholders onside.

“Sawiris isn’t alone; there are controlling shareholders of Telecom Italia, and they have their own interests,” he said.

“If Telecom Italia strengthens in Brazil then it sets up a conflict with Telefonica.”

Sawiris pointed out that he tried talking to Telefonica.

“I met with them, but my feeling is that they are conflicted. They are happy where they are today holding Telecom Italia as a hostage and preventing it from growing into Latin America.”

Telefonica and Telecom Italia are the number one and number two players in Brazilian mobile, respectively, and also compete in Argentina. The conflict means that Telefonica cannot take part in board deliberations at Telecom Italia over the Latin American units.

Telefonica’s Chief Financial Officer Angel Vila said last week that the group wanted to remain a long-term shareholder in Telecom Italia, and opposed a capital increase.

Telecom Italia has made debt-cutting a priority since late 2008. Cost cuts and asset sales have trimmed net debt more than 4 billion euros to 29.5 billion at the end of September.

Morgan Stanley predicted its net debt was likely to stand at 27.8 billion euros at year-end, or 2.7 times earnings before interest, tax, depreciation and amortization (EBITDA), above sector averages and in the warning zone for rating agencies.

Sawiris, who sold Wind to Vimpelcom last year, wants to re-enter Italy by investing in the incumbent operator, betting on low valuations and turnaround potential in old-world telecoms.

“I’ve worked in Italy for five years and what I’ve learned that very few investors have the insight on what is the real story in Italy,” Sawiris said.

($ 1 = 0.7713 euros)

(Additional reporting by Leila Abboud in Paris and Lisa Jucca in Milan; Editing by Will Waterman)

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Bin Laden movie “Zero Dark Thirty” based on first-hand accounts

LOS ANGELES (Reuters) – The makers of a Hollywood movie about the U.S. operation to kill Osama bin Laden denied asking for classified material for their film, but say they did conduct interviews with a CIA officer and others at the heart of the decade-long hunt for the al Qaeda leader.

“It was all based on first-hand accounts so it really felt very vivid and very vital and very, very immediate and visceral of course which is very exciting as a filmmaker,” Kathryn Bigelow, director of “Zero Dark Thirty,” told ABC News in an interview airing on Monday.

Bigelow and screenwriter Mark Boal said in a “Nightline” interview that they were originally working on a film about the failed bid to find bin Laden in the Tora Bora mountains of Afghanistan during the U.S-led invasion there in 2001.

But their plans changed swiftly after U.S. President Barack Obama announced in May 2011 that a Navy commando unit had killed bin Laden in a compound in Pakistan.

“I picked up the phone and started calling sources and asking them what they knew and taking referrals and knocking on doors and really approached it as comprehensively as I could,” Boal told “Nightline” according to an advance excerpt.

“I certainly did a lot of homework, but I never asked for classified material,” he said. “To my knowledge I never received any.”

The release of “Zero Dark Thirty” – seen as a strong contender for Oscar nominations – was pushed back to December after the film got caught up earlier this year in a U.S. election year controversy.

The U.S. admiral who oversaw the secret operation in May denied a claim that the Obama administration arranged for Bigelow and Boal to be given special access to top officials while researching their movie.

The film reconstructs the hunt for bin Laden largely through the eyes of a young female CIA officer, played by Jessica Chastain, who helps find him through a long-forgotten courier. Obama only makes a fleeting appearance in the film.

“It was a couple of months into the research when I heard about a woman, part of the team, and she has played a big role and she had gone to Jalalabad and been deployed with the SEALs on the night of the raid,” Boal told ABC News reporter Martha Raddatz in the “Nightline” interview.

While some of the dialogue is word for word and based on interviews with the young CIA officer and others, some of the dialogue is dramatized, said the Oscar-winning makers of 2008′s “The Hurt Locker,” about a U.S. Army bomb disposal team during the Iraq War.

The assault on bin Laden’s Pakistan compound was recreated as accurately as possible, using a full-scale version built in Jordan. The floor, the tile, the carpet, the furniture and the marks on the walls were copied from images seen in ABC News footage that Bigelow said they reviewed frame by frame.

The full interview can be seen on “Nightline” on Monday evening.

“Zero Dark Thirty” opens in U.S. movie theaters on December 19. Nominations for the 2013 Academy Awards are announced on January 10 ahead of the February 24 Oscar ceremony.

(Reporting By Jill Serjeant)

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Outbreak-Tied Peanut Butter Plant Shut

Nov 26, 2012 7:37pm

The Food and Drug Administration today shut down the country’s largest organic peanut butter processor following a salmonella outbreak that sickened scores of people nationwide.

For the first time the FDA has utilized new power granted by the 2011 food safety law and shut down Sunland Inc.’s New Mexico processing plant.

In a statement on their website, the FDA said that the link between the company and the salmonella outbreak that sickened 41 people in 20 states along with “Sunland’s history of violations led FDA to make the decision to suspend the company’s registration.”

Between June 2000 and September 2012 eleven product lots of nut butter tested positive for presence of Salmonella. And, according to the FDA, between March 2010 and September 2012, Sunland Inc. distributed at least a portion of eight product lots after they had tested positive.

The FDA also found the presence of Salmonella in 28 environmental samples during a September and October 2012 inspection.  FDA inspectors reported that employees of Sunland Inc. failed to wash hands, improperly handled equipment used to process food as well as providing  ”no records” to document cleaning of equipment. Additionally, the building housing the production and packaging had no hand-washing sinks even though employees had “bare-handed contact” with the product.

“The super-sized bags used by the firm to store peanuts were not cleaned despite being used for both raw and roasted peanuts.  There was a leaking sink in a washroom which resulted in water accumulating on the floor, and the plant is not built to allow floors, walls and ceilings to be adequately cleaned.

Finally, investigators found that raw materials were exposed to potential contamination.  Raw, in-shell peanuts were found outside the plant in uncovered trailers. Birds were observed landing in the trailers and the peanuts were exposed to rain, which provides a growth environment for Salmonella and other bacteria.  Inside the warehouse, facility doors were open to the outside, which could allow pests to enter.”

In a November 15 statement the president and CEO of Sunland, Jimmie Shearer, emphasized that at “no time” did the company distribute products they knew to be contaminated. The company has submitted a response to the FDA outlining their response to the recall and contaminated product testing.

“We believe that drawing any inferences much less conclusions about the Company’s practices based solely on the observations as set forth in the Form 483 without considering the Company’s response would be wholly premature and unduly prejudicial to Sunland.”

Food Safety Modernization Act, which the FDA acted under to shut down the plant, grants the agency the authority to suspend manufacturing when there is “reasonable probability of causing serious adverse health consequences or death to humans or animals, and other conditions are met.”

Sunland Inc., can request an informal hearing to lift the suspension.  However the 24-year-old company will only have its registration returned after the FDA decides the company has safe manufacturing practices.

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