U.S. panel backs Forest Labs drug for smoker's cough

SILVER SPRING, Maryland (Reuters) - An experimental inhaled lung treatment from Forest Laboratories Inc and Almirall SA won the support of a U.S. advisory panel on Thursday, a boost toward eventually gaining approval for the drug to treat smoker's cough.

A panel of outside expert advisers to the Food and Drug Administration voted 12-2 to recommend approval of the twice-daily drug, known generically as aclidinium bromide.

The drug treats chronic obstructive pulmonary disease (COPD), commonly called smoker's cough as it is often caused by cigarette smoking. It is the fourth-leading killer of Americans from disease.

Panelists said the lung helped patients breathe, but called for the company to do post-approval studies to test safety because some patients died from heart problems during clinical trials.

"I think the efficacy is modest, but with COPD treatments, the efficacy tends to be modest," said panel member Dr. William Calhoun, professor at the University of Texas Medical Branch.

"It seems to me that the critical question here is the safety issue."

The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by April 23.

Shares of Forest, which has a licensing agreement with Almirall to market the drug in the United States, closed up 1.2 percent at $32.21 on the New York Stock Exchange.

Forest is counting on new treatments such as aclidinium to help prop up profits after its blockbuster antidepressant Lexapro is expected to lose U.S. patent protection this year.

Up to 24 million people in the United States, and more than 100 million worldwide, suffer from COPD, which gets worse with age and can persist even if patients stop smoking.

Wall Street expects global sales of COPD treatments to exceed $5 billion in 2014.

COMPETING FOR SMOKERS

FDA staff reviewers earlier this week raised concerns about potential heart problems linked to drugs in the same class.

In the clinical trials for Forest and Almirall's lung drug, four patients taking the drug died from cardiac arrest and one from heart failure, out of a total of about 1,500 people who took the 400 microgram dose of the inhaled powder.

FDA staff said clinical trials may not have been big enough to show whether the problems came from the drug, or because patients with the disease may also have heart problems.

If approved, Forest's drug, which the company plans to sell under the name Tudorza Pressair, would compete with Boehringer Ingelheim and Pfizer Inc's Spiriva, which is also an inhaled drug that opens airways.

Other treatments for chronic lung disease are inhaled steroids such as AstraZeneca Plc's Symbicor and GlaxoSmithKline Plc's Advair.

Forest gained U.S. approval last year for Daliresp, a tablet that treats exacerbations caused by chronic lung disease.

"Today shows our commitment to the COPD community with a second product to treat a very common disease," said Dr. Marco Taglietti, senior vice president for research and development at Forest Laboratories.

"Certainly we're very pleased the committee has agreed the product is effective and has adequate safety to be approved."

(Reporting by Anna Yukhananov; editing by Gary Hill and Andre Grenon)

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US health experts give nod to new obesity drug

More Americans died in 2007 of hepatitis C infection, which causes incurable liver disease, than from the virus that causes AIDS, US health authorities said this week.

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Amalia de Fortabat, 90, Dies; Noted for Art and Scandal

Her family announced her death.

Mrs. Fortabat was married to another man when the cement mogul Alfredo Fortabat, 27 years her senior and also married, asked her to dance. As he recounted the story to biographers, he had followed her to Paris from Argentina to ask that question. She said yes. He told her he loved her. They traveled through France, Italy and the Aegean. He asked her to marry him. She said yes again.

The romance was the talk of Buenos Aires. Soon, two divorces ensued, at a time when that was not easily done in heavily Roman Catholic Argentina. They were married in Uruguay in 1947 and reaffirmed their vows in ceremonies four more times.

Mr. Fortabat died of a stroke in 1976 at the age of 81, leaving Mrs. Fortabat with a cement conglomerate, more than a million acres of ranchland, 170,000 head of cattle, three airplanes, a helicopter, a yacht and real estate around the world, including a 14-room duplex in the Pierre hotel in Manhattan.

After a period of mourning, Mrs. Fortabat went to work managing the company, Loma Negra, Argentina’s biggest supplier of cement and concrete. She became known as the “Dama del Cemento” — the cement lady. She won government contracts from the military dictatorship of the 1970s to build dams, roads and stadiums while tripling the company’s assets. Before long it had captured three-quarters of the nation’s cement business.

“I went to work as if I understood everything,” she said. “And, finally, I understood very well.”

She amassed a fortune estimated at $1.8 billion, though America Economia, a Latin American business magazine, now lists it as $902 million. Still, it made her the third-richest person in Argentina and the richest woman there at her death.

As a businesswoman, she diversified into fields like banks, a newspaper, a radio station and an 1,800-mile railroad. As a volunteer public servant, she was appointed Argentina’s roving ambassador-at-large and president of the National Arts Foundation. As a philanthropist, she gave many millions to various causes, including the arts, the veterans of Argentina’s war with England over the Falkland Islands and refugees from the war in Kosovo in 1999. As a socialite in Argentina, New York and Europe, she was often photographed with friends like David Rockefeller and Henry Kissinger.

As a patron of the arts, Mrs. Fortabat paid $6.4 million in 1980 for J. M. W. Turner’s painting “Juliet and Her Nurse,” at the time a record price for a painting sold at auction. In 2008, she built Museo Fortabat, a modernist museum in Buenos Aires designed by Rafael Viñoly to house her large and much admired art collection. It includes a portrait Andy Warhol did of her in the style of his Marilyn Monroe prints.

Maria Amalia Lacroze de los Reyes Oribe was born in Buenos Aires on Aug. 15, 1921. Her grandfather had established the city’s first streetcar line, and an ancestor was the first president of Uruguay. Known as Amalita, she moved to Paris when she was a year old. Her first language was French, and her second was English. When she was 14, she said, a fortuneteller revealed her future: “You’ll marry a maharaja.”

In 1942 she married a lawyer, Hernan Saenz Valiente Lafuente. They had a daughter, Maria Inez de Lafuente, who survives her, along with three grandchildren.

Amalita was at the theater with Mr. Lafuente, her fiancé at the time, when she met Mr. Fortabat in 1941. He invited them to sail on his yacht, the Tigre Fortabat, but said he could not bear to go to their wedding. Five years later he followed the couple to Paris to ask Mr. Lafuente’s wife to dance.

In recent years, Mrs. Fortabat had respiratory problems and repeated hip replacements. In 2002, she sold some paintings, including a Degas for $16.5 million. She sold the cement company to a Brazilian buyer for $1.025 billion in 2005. Last year, she sold the duplex at the Pierre for $19.5 million.

For all the uproar that her divorce and marriage caused in the 1940s, Mrs. Fortabat was scandalized herself in 1997 during a literary contest that her Fortabat Foundation was sponsoring. A jury had decided to give the prize to “The Anatomist” (1998), a novel by Federico Andahazi that tells of a scientist who studies clitorises, first by examining corpses, then prostitutes. Mrs. Fortabat did not approve.

She bought a newspaper ad saying the subject matter did not “contribute to the exaltation of the highest values of the human spirit.” In the end, she agreed to give Mr. Andahazi the $15,000 award that went with the prize but not the prize itself.

Mr. Andahazi, who is also from Argentina, said he had chuckled at first but then felt something else, telling The New York Times, “Being pitted against the most powerful woman in Argentina sent a shudder down my spine.”

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Baby Boomers at Risk of Hidden Hepatitis C

Due to a number of risk factors, including intravenous drug use and limited testing of the blood supply before 1992, those born from 1946 to 1964 -- baby boomers -- are at the highest risk for having the hepatitis C virus, as reported by CBSNews.com.

Health officials such as those at Montefiore Medical Center were already expressing concern about the health risks associated with the illness that is labeled a "silent epidemic" for baby boomers, even before recent study revealed the mortality rate for hepatitis C in that age group.

Hepatitis C Study Results

The Centers for Disease Control and Prevention funded a study, reported Tuesday in the Annals of Internal Medicine, titled "The Increasing Burden of Mortality From Viral Hepatitis" in the U.S. from 1999 through 2007.

The study researchers concluded that deaths from HCV outnumbered those from HIV by 2007. Even more pertinent for baby boomers are the deaths from HCV were disproportionately high in their age group.

Those numbers might have been higher, but because the physician signing the death certificates were often not the person's primary caregiver, HCV might have been under-reported as a contributing cause of death.

Plans to Address Undiagnosed Hepatitis C

A second study published Tuesday, also in the Annals of Internal Medicine, addresses the cost-effectiveness of a one-time antibody blood test to determine if people born from 1945 to 1965 have the hepatitis C virus present in their bodies. This study, also funded by the CDC and the Division of Viral Hepatitis, concluded it would be cost-effective to perform such blood screening through a person's visit to their primary health care giver.

Importance of Diagnosing Hepatitis C

Milan Kinkhabwala of the Montefiore Einstein Center for Transplantation explains, "The blood test is essential to detecting Hepatitis C because now there are ways to treat the condition, and even reverse damage to the liver."

But people can't receive treatment until they know they have an illness, and HCV can be present in the body for a long period of time before symptoms occur, as the CDC's director of hepatitis division, John Ward, said to Bloomberg. The blood test would reveal the hidden virus and allow health care providers to treat HCV before more liver damage, such a liver cancer, can occur.

Risk Factors for Hepatitis C

There are a number of factors that, if present, indicate your risk of having hepatitis C is greater than people who have no risk factors. The Mayo Clinic lists some of these factors as having HIV; having used illegal, injectable drugs; a health care worker exposed to infected blood; received a blood transfusion or organ transplant prior to 1992; or received clotting factor concentrates before 1987.

Smack dab in the middle of the baby boomer generation, L.L. Woodard is a proud resident of "The Red Man" state. With what he hopes is an everyman's view of life's concerns both in his state and throughout the nation, Woodard presents facts and opinions based on common-sense solutions.

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FDA: New suppliers to ease 2 cancer drug shortages

TRENTON, N.J. (AP) — Federal regulators said Tuesday that they've approved new suppliers for two crucial cancer drugs, easing critical shortages — at least for the time being — that have left patients and parents frightened about missing life-saving treatments.

The news brings a light at the end of the tunnel for some patients, but not for thousands of others, given that there are currently 283 separate drugs in short supply or totally unavailable in this country.

On Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement drug for Doxil, a drug for ovarian and other cancers that hasn't been available for new patients for months.

The agency also has approved another supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL and for high-dose treatment of bone cancer. The version with preservatives can be toxic or cause paralysis in children and other patients getting the drug either via injections into spinal cord fluid or at very high doses.

The FDA also has approved the release of a batch manufactured by Ben Venue Laboratories Inc., shortly before it closed several factories at its complex in Bedford, Ohio, due to serious quality problems. That closing is what turned the on-again, off-again methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that patients would begin missing treatments as soon as the end of this month.

"We have made real progress ... We believe that (suppliers) will be able to meet the demands of patients in the U.S. market" for the two drugs indefinitely, FDA Dr. Commissioner Margaret A. Hamburg told The Associated Press in an exclusive interview. "It's a huge relief for us."

The FDA increasingly has been able to prevent drug shortages, mainly due to a sixfold increase in manufacturers voluntarily notifying the FDA when they anticipate shortages, Hamburg said.

Thanks to such notice, the agency prevented 195 drug shortages in 2011, mostly late in the year after President Obama issued an executive order giving FDA additional powers to address the shortages. Between that order on Oct. 31 and this week, the agency has prevented a total of 114 drug shortages.

Hamburg said that when FDA's much-expanded drug shortages team is notified about impending shortages and contacts other manufacturers, those companies have been "very responsive" as FDA worked with them on finding ways to boost production.

In the latest case, the FDA said it has temporarily allowed importation of an alternative to Doxil called Lipodox, made by Sun Pharma Global FZE. The Indian drugmaker is already known to the agency, and its factory and the production line for Lipodox have been inspected.

The FDA also has given approval to APP Pharmaceuticals LLC to begin making a preservative-free version of methotrexate in addition to its current drug that includes preservatives. The company had made a preservative-free version years ago, but needed to update paperwork and meet other requirements, which the FDA expedited. It's expected to start shipping the medication by the middle of March.

Another maker, Hospira Inc., expected today to start shipping about 31,000 vials of preservative-free methotrexate, more than enough to meet a month's demand, to hundreds of hospitals and treatment centers.

Still, hundreds of other drugs remain in short supply, including many other cancer medicines.

"I don't think we can ever close the book on drug shortages," Hamburg said. "I think we will always have to be vigilant."

Drug shortages have increased dramatically in the U.S. over the past six years, particularly for generic injected drugs. They are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers. At least 15 deaths since 2010 have been blamed on the shortages, which have set a record high in each of the last five years.

So far this year, 27 new shortages have been reported, and about 215 that began in 2010 or 2011 remain unresolved, according to Erin R. Fox, manager of the University of Utah Drug Information Service, which tracks shortages.

"At this time last year, we were on a pace of about one new shortage per day. Thanks to FDA's hard work, that pace is cut in half for this first part of 2012, when we have counted 27 new shortages" in nearly two months, Fox said.

The shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories.

In addition, consolidation among generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs, has led to decreased capacity. That means when one manufacturer suddenly stops production, the small number of others making a drug can't quickly pick up slack.

The inability to get crucial medicines has disrupted not only carefully timed chemotherapy regimens, but surgery and care for patients with infections, pain and other serious conditions.

Meanwhile, some unscrupulous smaller distributors, dubbed "gray marketers," have been exacerbating shortages by charging hospitals many times the normal price for drugs that can't be acquired through normal suppliers. Several bills in Congress are pending that would establish penalties for drugmakers that don't give notice of impending shortages, or by setting penalties for price gouging on prescription drugs.

Of late, the cancer drug shortages have attracted the most attention, partly because missing multiple treatments can sharply reduce the chances of curing the disease. In the case of methotrexate, its use as part of the treatment for acute lymphoblastic lymphoma results in nearly 90 percent of children being cured, so parents and doctors were particularly upset at the prospect of it not being available.

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Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma

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Argentina Train Crash Kills Dozens and Injures 600

The train, which runs from the ring of urban areas that surround greater Buenos Aires, crashed at about 8:30 a.m. at its final stop at the Once Station, not far from downtown Buenos Aires.

The train was carrying more than 800 passengers and traveling at an estimated 16 miles per hour when it entered the station, slamming into the barrier of the platform, destroying the engine.

“It is a very serious accident,” Juan Pablo Schiavi, the national secretary of transportation, said in his initial assessment of the crash during a televised press conference outside the Once Station. Mr. Schiavi said brake failure was the suspected cause.

“The train hit the bumper,” Mr. Schiavi said, “causing one car to crumple into another.”

He said one car pierced into another by nearly 20 feet.

The injured were taken to hospitals in the vicinity, Dr. Alberto Crescenti, head of the state emergency medical system, said on Argentine television on Wednesday. He said around midday that about 30 people were trapped in the wreckage.

Passengers told the local news media that the train, which is operated by the private company Trenes de Buenos Aires, was traveling faster than normal and had struggled to slow down when braking at stations ahead of Once Station.

Trenes de Buenos Aires said in a statement that the reasons for the crash had not been determined, though the company acknowledged that the train “wasn’t able to stop.”

Video footage of the crash taken by people at the scene showed people walking along the platform, with screams audible. People were pulling others out of the wreckage.

“I saw a lot of people bleeding and some who were trapped,” said one survivor, a 23-year-old woman, quoted by the newspaper Clarín.

Last September, a commuter train on the same line crashed into a passenger bus and hit a second train at the Flores Station, killing 11 and injuring more than 200. The bus had crossed the tracks when the barrier was down. In February 2011, four people were killed in a collision of two trains.

The newspaper La Nación said the accident was the third-deadliest in Argentina’s history, surpassed only by a 1972 collision that killed 142 people and a 1978 accident involving trains and other vehicles that left 55 dead.

Charles Newbery reported from Pinamar, Argentina, and Simon Romero from Rio de Janeiro.

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FDA panel backs previously rejected obesity pill

SILVER SPRING, Md. (AP) — A previously rejected weight loss pill won an overwhelming endorsement from public health advisers Wednesday, raising hopes that the drug from Vivus Inc. could become the first new anti-obesity medication to reach the U.S. market in more than a decade.

The Food and Drug Administration has rejected three weight loss pills in the last two years, including Vivus' pill Qnexa, due to safety concerns. Experts agree new weight loss drugs are needed to treat an estimated 75 million obese adults in the U.S., but the string of rejections has raised questions of whether any pharmaceutical treatment is safe enough to win approval.

At a public meeting Wednesday, an FDA panel of outside physicians voted 20-2 in favor of the weight loss drug from Vivus, setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.

Nearly all the panelists backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.

"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.

The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected by mid-April.

In a key question, the physicians said Vivus could conduct the cardiovascular safety study after FDA approval. A requirement to conduct the study ahead of market approval would cost the company millions of dollars and take at least three more years.

"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."

Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA rejected Qnexa in October 2010, citing numerous side effects including elevated heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.

Vivus President Peter Tam said the overwhelming panel vote Wednesday indicates doctors recognize the urgent need for effective weight loss drugs.

"Right now there aren't any good treatments out there besides dieting and bariatric surgery — clearly there's a huge gap," Tam said.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.

Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anti-seizure and anti-migraine drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

Along with heart safety, panelists raised concerns about potential birth defects in women who become pregnant while taking Qnexa: topiramate is known to more than double the risk of birth defects.

There were 34 pregnancies among 3,386 women enrolled in Vivus' studies of Qnexa, despite precautions to make sure women used contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa.

If approved, FDA scientists said they would require Vivus to train prescribers to educate patients on the pregnancy risks of Qnexa. The drug would only be available from 10 mail-order pharmacies.

Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.

Fen-phen is just one example in the decadeslong history of failed weight loss drugs, which have continued to pile up in recent years.

Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke. The drug won approval in 1997 in the wake of the recall of fenfluramine but never achieved widespread use due to modest weight loss and safety concerns. Only 100,000 prescriptions were written in the U.S. during Meridia's last full-year on the market.

Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is sold over the counter as alli by GlaxoSmithKline. The drug is not widely used because of modest weight loss results and unpleasant side effects, including gas and diarrhea.

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