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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Is SAC Capital’s Steve Cohen Worth Catching?

Preet Bharara started work as the U.S. Attorney for the Southern District of New York on Aug. 13, 2009, less than a year after the most harrowing days of the financial crisis. Bharara’s office is known for prosecuting crime on Wall Street; his predecessors include Elihu Root, Henry Stimson, and Rudy Giuliani. In three and a half years on the job, Bharara has won convictions against Times Square bomber Faisal Shahzad, accused arms trafficker Victor Bout, and multiple corrupt New York politicians. But his claim to fame—the one that earned him the cover of Time last February—is his single-minded devotion to eliminating an insider-trading epidemic that seems to be rampant at certain hedge funds in and around New York City.

Two days before Thanksgiving, Bharara, who has already won some 70 convictions for insider trading, collected another pelt. At his direction, the Federal Bureau of Investigation arrested Mathew Martoma, a 38-year-old former hedge fund manager at SAC Capital Advisors, at Martoma’s 8,000-square-foot Boca Raton (Fla.) mansion. In a statement, Bharara described Martoma’s alleged crime as “cheating coming and going—specifically, insider trading first on the long side, and then on the short side, on a scale that has no historical precedent.” Conspicuously absent from Bharara’s statement was any mention of Martoma’s former boss, Steven Cohen, the founder of SAC Capital. But Wall Street is rife with speculation that Cohen is Bharara’s ultimate target.

The possibility that Cohen might share the fate of fellow hedge fund billionaire Raj Rajaratnam, who was found guilty of conspiracy and securities fraud in May 2011 and sentenced to 11 years in prison, has caused a frisson of anticipation in the financial world. On Nov. 28, the president of SAC Capital, Tom Conheeney, told investors that the Securities and Exchange Commission is considering filing a civil suit against the firm.

Yet Cohen may prove to be an elusive prey. And it’s worth asking whether relentlessly hunting insider-trading suspects like Cohen is a wise use of the government’s resources—especially considering that the people responsible for the worst financial crisis since the Great Depression continue to get off scot-free.

Cohen himself is no small fish. He grew up in Great Neck, Long Island, the third of eight children. His father owned a clothing manufacturer in the Bronx; his mother was a piano teacher. After graduating from the University of Pennsylvania in 1978, Cohen took a job at Gruntal & Co., a small Wall Street brokerage. An amazingly successful if restless trader, he made millions for himself and for Gruntal. In 1992, hungry for a bigger platform, he set up a hedge fund with a $ 25 million grubstake—half of which was his own money. In the first year, the fund was up 17 percent; the next year it was up 51 percent. The rest is the stuff of Wall Street legend, as are his $ 1 billion art collection and his 36,000-square-foot mansion in Greenwich, Conn. SAC Capital now has some $ 14 billion under management.

Bharara has been circling Cohen for years, pursuing a slew of additional insider-trading charges against seven former SAC traders. But he hasn’t snared Cohen. And the Martoma gambit may fall short as well.

The gist of Bharara’s complaint against Martoma is that between 2006 and 2008, Martoma obtained material, nonpublic information from Dr. Sid Gilman, now 80, a neurologist at the University of Michigan, who was a paid consultant to two health-care companies, Elan (ELN) and Wyeth Pharmaceuticals (now part of Pfizer (PFE)), working together to develop a new Alzheimer’s drug. At first, Gilman shared with Martoma the good news that the drug trial was going well. As a result, Martoma and SAC amassed around a $ 700 million stake in Elan and Wyeth. In March 2008, when other executives at SAC Capital were questioning the large investment in the two companies, Cohen defended it by writing that Martoma “anticipated positive news” from the drug trial and he was the person “closest” to it.

On July 17, 2008, just days before he was to share his confidential findings at a health-care conference, Gilman told Martoma there were problems with the drug trial. Martoma then e-mailed Cohen: “Is there a good time to catch up with you this morning? It’s important.” One hour later, Cohen responded with his cell-phone number. According to the sworn affidavit of the FBI agent investigating the case, the two men talked for 20 minutes. At Cohen’s direction, during the next four days, SAC Capital dumped most, but not all, of its stock in the companies. It also put on a large short trade—betting the companies’ stock would fall.

On July 30, after the public announcement about the drug trial at the industry conference, the shares of Elan and Wyeth fell, 42 percent and 12 percent, respectively. According to Bharara, SAC Capital not only made profits of about $ 83 million on its short trade but also avoided losses of about $ 194 million had it not sold its stock in the two companies a few weeks earlier—a $ 276 million swing. (Bharara called it “The most lucrative inside tip of all time.”) In 2008, SAC paid Martoma a $ 9.3 million bonus. In 2010, Martoma was fired from the firm after two years of unsatisfactory performance and because he appeared to be “a one-trick pony with Elan,” according to an SAC e-mail. (His lawyer said in a statement that Martoma is innocent.)

In exchange for his cooperation, Dr. Gilman and the U.S. Department of Justice have entered into a non-prosecution agreement. According to the Wall Street Journal, the FBI and Bharara tried for a year to get Martoma to flip and cooperate with them against Cohen. Unlike the Rajaratnam case, there are no recordings of incriminating conversations involving Cohen and his portfolio managers or outside tipsters. The New York Times described the evidence compiled by the FBI against Cohen as “entirely circumstantial.”

Among other things, Cohen is a brilliant poker player—which means he’s adept at not tipping his hand. In a rare interview with Vanity Fair’s Bryan Burrough in July 2010, he brushed aside the implication that he had done anything like what Rajaratnam was accused of. “I look at my firm, and I don’t see any of that. In some respects I feel like Don Quixote fighting windmills,” he told Burrough. “There’s a perception, and I’m trying to fight that perception. I find it offensive that they lump SAC into these articles. I really do. The press, I mean, they don’t understand what the hell—they don’t understand what they’re writing about.”

When it comes to winning a conviction for insider trading, the law requires not only proof that material, nonpublic information was exchanged but also that the exchange of that information constituted “a breach of duty” to someone—say, shareholders or a board of directors. When Bharara won the conviction of Rajat Gupta, the former McKinsey senior partner who was on the board of directors of Goldman Sachs (GS), the jury found that Gupta had both shared insider information about Goldman with Rajaratnam and violated his duty to Goldman’s shareholders not to do so. That could be a snag in any case against Cohen. To whom did Cohen “breach” his “duty”? Certainly not his fund investors, who benefited tremendously from the trade. Still, the one journalist who has spoken to Cohen in recent years, Burrough, predicted in an e-mail to me, “They’re gonna get Cohen. They wouldn’t be building this pyramid if they didn’t intend to.”

If Cohen and his firm are nothing more than a criminal enterprise engaged in widespread insider trading, then Bharara is absolutely right to spend his time and his office’s resources going after them. Insider trading is justifiably illegal because the proper functioning of the capital markets depends on people having confidence the market is not a rigged game.

The bigger question for government prosecutors, though, is why none of the traders, bankers, or executives at the Wall Street banks who caused the 2008 financial crisis has been brought to justice. After the savings and loan scandal of the 1980s, some 3,500 bankers ended up criminally prosecuted and behind bars. This time around, no one on Wall Street has done jail time. In a June 2011 speech, Bharara said, “We too want to hold accountable anyone who deserves to be punished. … Any case we make, however, will be because it is appropriate and deserved, not because there is overwhelming public pressure to do so.”

It’s true that the only thing worse than allowing the bankers to get away unscathed is prosecutorial misconduct. There’s a world of difference, however, between being meticulous and careful in bringing cases and appearing to do nothing at all when trillions of dollars have been lost and not a soul has been held accountable. That doesn’t mean the government should stop looking into the misdeeds of the likes of Steve Cohen. But it shouldn’t ignore those who did worse.

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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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S.Africa’s rand holds on to surprise gains

JOHANNESBURG (Reuters) – S.Africa’s rand held firm against the dollar Wednesday, consolidating a surprisingly strong performance in the previous session after weaker-than-expected economic growth figures.

The rand was little changed at 0611 GMT, trading at 8.8434 against the greenback after New York’s close of 8.845.

“The international backdrop remains negative this morning but the trend for rand gains remains strong,” Rand Merchant Bank said in a note.

Investors are likely to pay attention to a speech by Reserve Bank Governor Gill Marcus at a conference of the National Union of Metalworkers of South Africa (NUMSA) at 0800 GMT.

Marcus left the repo rate unchanged at a four-decade low of 5.0 percent last week and warned that strikes in the mining sector and beyond since August would lead to job losses in a country already grappling with unemployment of over 25 percent.

Tuesday’s GDP statistics drove home that point, showing that growth slowed sharply in the third quarter after a big contraction in the strike-hit mining sector.

Government bond yields slipped one basis point each to 5.46 percent for the three year bond and 7.555 percent for the longer dated 14-year paper.

Power utility Eskom is due to auction 400 million rand between the EL29 and ES33 bonds at 0900 GMT.

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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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