A study funded by Abbott Laboratories offered more detailed evidence that its weight-loss drug Meridia increases heart risks, prompting renewed calls by consumer advocates and others to pull the drug from the market.

Final data from the so-called SCOUT study, published on Wednesday, showed Meridia increases the risk of heart attacks and strokes in patients who already have heart disease. Patients taking the drug lost an average of 8.8 pounds (4 kg).

Patients given Meridia had a 16 percent increased risk of heart problems such as heart attack or stroke compared to those given a placebo, the study showed. There was no increased risk of death, although Meridia patients also saw an increase in blood pressure and heart rate, it said.

The findings come two weeks ahead of a U.S. Food and Drug Administration public hearing to discuss whether to take further action against the drug, which is already withdrawn in Europe.

“When you put those … things together, you have to wonder if the drug should be on the market any longer,” said Dr. Gregory Curfman, executive director of the New England Journal of Medicine, which published the study.

“That’s what you’re trying to prevent through weight loss. You’re trying to prevent people from having heart attacks, and here this drug caused more,” said Curfman, a cardiologist.

Preliminary results from Abbott’s study were initially disclosed to both U.S. and European health officials in late 2009 and led to Meridia’s removal from the European market.

At the same time, the FDA strengthened the drug’s warning about risks to patients with pre-existing cardiovascular disease and called for a public meeting with its outside advisers.

An FDA advisory panel is to meet on September 15 to discuss the drug.

NOT A BIG SELLER

Meridia is not a big seller for the Illinois-based drugmaker, but has drawn attention to the controversial area of prescription diet drugs ever since its U.S. approval in 1997. The company expects Meridia’s 2010 U.S. sales to be less than $30 million.

The trial looked at 10,744 overweight or obese patients who were at least 55 years old and had either heart disease, diabetes or both conditions. It ran from 2003 to March 2009.

Abbott has defended continued use of the drug in the United States, where two out of three people are overweight or obese. The company, along with the study’s authors, said Meridia should still be used, just not by people with heart problems.

Abbott spokesman Scott Davies said the company only studied the drug in riskier patients because regulators required it as a condition for approval, and that Meridia already clearly warns heart disease patients against using the drug.

“If you look at all of the data involved, in the approved patient population there is certainly a positive risk-benefit profile,” he said. Those who are obese with no heart problems and have not lost weight with diet and exercise are ideal candidates for the drug, also known as sibutramine, he said.

Consumer groups and an FDA whistle-blower have long called on FDA to pull Meridia, in part because so many people have undiagnosed heart disease and are at greater risk.

Public Citizen’s Health Research Group Director Sidney Wolfe said the journal’s detailed data shows the FDA should have acted long ago.

“FDA has unconscionably allowed this drug, which should not have been approved in the first place, to stay on the market,” said Wolfe, who petitioned the FDA for Meridia’s removal in 2002. “The agency appears immobilized to act against drugs that have no unique benefits but unique, serious dangers.”

The FDA denied his request, in part saying it would await the results from the SCOUT trial.

FDA spokeswoman Karen Riley said the FDA advisory panel would review the company’s latest analysis, among other information. “There’s going to be a lot more data than what’s being provided in the journal piece,” she added.

Source: Reuters

Popularity: 1% [?]

Some seizure drugs may not raise the risk of suicide for patients with epilepsy as feared, but they more than double the risk for people with depression, researchers reported on Wednesday.

They found evidence that the drugs do not make it more likely that patients with epilepsy will commit suicide. But patients take the drugs for a range of other conditions and some of these had a 65 percent higher risk.

In 2008 the U.S. Food and Drug Administration warned that epilepsy drugs may increase the risk of suicide.

The new study, led by Dr. Alejandro Arana of Risk MR Pharmacovigilance Services in Zaragoza, Spain, culled records from 5 million patients in Britain treated from July 1988 through March 2008. They included 8,212 suicide attempts.

“Our findings suggest that treatment with antiepileptic drugs does not confer an additional risk of suicide-related events among patients with epilepsy,” they wrote in the New England Journal of Medicine.

The drugs tested include topiramate, sold by Johnson & Johnson under the Topamax brand, and also included as part of Vivus’s experimental obesity drug Qnexa.

They include Cephalon’s Gabitril, known generally as tiagabine, UCB Pharmaceuticals’ Keppra or levetiracetam, H. Lundbeck’s Sabril or vigabatrin, Pfizer’s Neurontin or gabapentin and Lyrica or pregabalin, GlaxoSmithKline’s Lamictal or lamotrigine, Novartis’ Trileptal or oxcarbazepine and Eisai’s Zonegran or zonisamide.

They also included valproate, sold by Abbott Laboratories as Depakine and Sanofi-Aventis as Epilim, and carbamazepine, sold as Carbatrol by Shire and Tegretol by Novartis.

The researchers found that people with epilepsy, depression or the abrupt mood swings of bipolar disorder who were not taking epilepsy drugs had a higher likelihood of suicide attempts in the first place.

But taking one of the seizure drugs did not increase the risk of suicide-related events for people with epilepsy or bipolar disorder, or among patients whose epilepsy was combined with depression.

“In general, our results do not confirm the findings previously reported by the FDA,” the Arana team concluded.

Last week a separate group of researchers, who also studied British patients, concluded that attempted suicide or self-harm only occurred in epilepsy patients taking newer drugs that have been linked to a risk of depression.

That study, in the journal Neurology, tracked 453 suicide attempts or incidents of self-harm, a small fraction of the number in the Arana survey.

Source: Reuters

Popularity: 4% [?]

You may have noticed that we like rankings and lists here at FiercePharma. Usually we like to do our own, but we also pass along other people’s interesting work. This time, Motley Fool has done some serious math to peg the 15 most undervalued companies in biopharma.

We’ll let them explain the methodology; suffice it to say here that it’s basically about P/E ratios. As the Fool notes, a plethora of studies have shown that stocks with low P/Es outperform those with high P/Es. The drugmakers that fit the bill include Endo Pharmaceuticals, which tops the list and boasts a P/E of 7.5 and estimated EPS growth of 10 percent.

Rounding out the top five are Gilead Sciences (P/E of 9.7; EPS growth 14 percent); Merck (P/E 10.4; EPS 7 percent); Amgen (P/E 10.7; EPS 9 percent); and Teva Pharmaceutical (P/E 11; EPS growth 13 percent). Abbott Laboratories and Johnson & Johnson also make an appearance on the list.

Source: FiercePharma

Popularity: 2% [?]

The U.S. Food and Drug Administration has warned Abbott Laboratories’ diabetes care unit about manufacturing problems at its Alameda, California plant, a letter released Tuesday said.

In a letter dated July 2, FDA said its inspectors found Abbott’s Freestyle and Navigator blood glucose monitoring products were adulterated and not conforming with codes for good quality system manufacturing practices.

“The letter relates to our corrective and preventative measures and some of our internal validation and documentation procedures,” Abbott spokesman Greg Miley said.

The warning does not affect the availability of those products, he said.

FDA, in the letter, said the company had failed to address the manufacture of empty blister packs and finding of scratches on FreeStyle Lite test strips.

The letter also cited the diabetes care unit for failing to establish and maintain adequate procedures for validating device design.

“Abbott Diabetes Care has taken and continues to take actions necessary to address the items outlined in the letter, and is communicating those actions directly to the agency,” Miley said.

Failure to promptly correct the violations may result in further regulatory action, FDA said.

Source: Reuters

Popularity: 2% [?]

Good news for Merck’s HIV drug franchise. The company’s Isentress drug fought off the virus as well as older drugs did, when used as start-up therapy in combination with Abbott Laboratories’ Kaletra treatment. It’s the sort of research that could affect doctors’ prescribing habits, because physicians are looking for HIV treatments that are safer when used for years, experts tell Bloomberg.

“Patients are now living longer and while viral suppression is still a concern, for many patients the major concern is the long-term effects and premature aging related to the drugs,” explains lead researcher Esteban Martinez of the University of Barcelona.

And Isentress might be free of some of its rival drugs’ known side effects. According to a new study, patients who switched to Isentress from Kaletra kept HIV at bay just as well, and after 48 weeks of therapy, had lower cholesterol than patients still using Kaletra. This research contradicts an earlier company-funded study that found patients who switched were more likely to have a relapse.

Abbott is considering developing a new combination pill–either Kaletra plus Isentress or Kaletra plus Truvada–and that’s why it funded the combination-therapy study. Isentress coupled with Kaletra pushed HIV to undetectable levels in 83 percent of patients, compared with 85 percent of those using Truvada with Kaletra. Abbott says it’s waiting for longer-term data before deciding which combo to bet on–with a particular eye to side effects.

Source: FiercePharma

Popularity: 2% [?]

Who is doing the most to get medicines to the developing world? GlaxoSmithKline, at least according to this year’s Access to Medicines Index, with Merck, Novartis, Gilead Sciences and Sanofi-Aventis rounding out the top five.

This year’s access index–which looks at pricing policies, R&D efforts, patents, access and more–includes six European companies in the top 10, with the remaining four from the U.S. Produced by a Dutch foundation and backed by institutional investors and funds that manage $3.1 trillion in assets–as Reuters notes–the index is designed to help investors compare drugmakers’ social responsibility.

Access to drugs in emerging markets isn’t only a social issue for drugmakers these days, but a key business strategy. Companies such as GSK and Sanofi have cut their prices in the developing world to help spur volume sales. Big Pharma has been buying up and partnering with drugmakers in Africa, India, China and Latin America.

As emerging markets continue to deliver the biggest growth prospects on the globe, no doubt access to Big Pharma drugs will continue to grow. ”[E]merging markets are where the larger growth is,” My-Linh Ngo, associate director of sustainable investments at Henderson, told the Financial Times. “Better access to medicines helps position them.”

Looking at this year’s top 10, we have Roche, AstraZeneca, Novo Nordisk, Johnson & Johnson, and Abbott Laboratories in sixth through tenth place. Among the rest are Pfizer, Bayer, Eli Lilly, and Boehringer Ingelheim. According to the foundation, Bayer, Bristol-Myers Squibb, Merck KGaA and Novo Nordisk dropped in this year’s rankings, while Gilead and Pfizer moved up.

Source: FiercePharma

Popularity: 4% [?]

The U.S. Food and Drug Administration has approved a test that may help slow the spread of HIV by detecting the virus more quickly in the early period when it is most infectious, the agency said on Monday.

The diagnostic test, developed by Abbott Laboratories Inc, detects the virus more accurately in the weeks immediately following transmission, the company said.

The sooner patients are diagnosed and placed into care, the better the chance there is to stop further spread of the virus, said Abbott’s senior director for research and development of infectious disease diagnostics.

“With this test, we can detect probably at least 90 percent of the so-called acute infections, people in those early stages, in those first few weeks before they develop those antibodies,” Abbott’s Gerald Schochetman told Reuters in an interview.

Abbott’s test would be the first U.S. test that directly identifies HIV while currently-available tests detect the antibodies that combat the virus and show up weeks later.

The test also is the first approved by the FDA for pregnant women, which could allow them to more quickly start treatment to limit transmission of the virus to their fetuses.

The test, called ARCHITECT HIV Ag/Ab Combo assay, has been available in Europe since 2004 and is commonly used in countries such as the United Kingdom and France.

Approximately 18 million people in the United States are tested each year for HIV, which can lead to acquired immune deficiency syndrome, or AIDS, according to the U.S. Centers for Disease Control and Prevention. One in five infected individuals doesn’t know they have the virus.

About 56,000 people in the United States are infected with HIV each year, and more than a million are living with HIV, the CDC has said.

Abbott’s test will cost about the same as a standard HIV blood test and should be available by the end of the year, company spokeswoman Darcy Ross said.

Abbott shares closed down 47 cents, or 0.96 percent, to $48.30 on the New York Stock Exchange on Monday.

Source: Reuters

Popularity: 2% [?]

Elan CEO Kelly Martin has a new contract: He’ll step down as CEO in 2012 and leave the drugmaker altogether in 2013. The company says it renegotiated a departure date into Martin’s contract “to provide clarity and continuity on the executive leadership” at Elan. But what’s the rest of the story?

Elan’s management has come under fire from its board of directors, particularly the ex-Abbott Laboratories exec Jack Schuler, who even called for Martin’s head at one point. Shareholders haven’t been too happy either; 28 percent of Elan investors voted against the soon-to-retire Chairman Kyran McLaughlin, who was up for re-election at last month’s annual meeting, Reuters reports.

Critics said management spent too much money, particularly on things they considered unnecessary, such as frequent travel by private plane. They added that Elan hadn’t done enough to market its key multiple sclerosis drug Tysabri. And so on. But as the Financial Times points out, that investor revolt died down somewhat after Elan underwent a big restructuring and attracted a minority partner in Johnson & Johnson.

The dissatisfaction grew again once certain undisclosed details about that J&J deal surfaced. Most recently, some shareholders have written Elan’s board to question the company’s plan to spin off its drug-delivery business, the Wall Street Journal reports.

Now that Martin’s tenure has a definite end–and McLaughlin is on his way to retirement–will the critics back off? Only time will tell.

Source: FiercePharma

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While Abbott Laboratories was capturing headlines for its acquisition of a chunk of India’s Piramal, a Southern Hemisphere deal took aim at the top spot in Australia’s prescription drug market. Africa’s biggest drugmaker, Aspen Pharmacare, launched a takeover bid for Australia’s Sigma Pharmaceuticals, taking advantage of the latter’s recent financial difficulties to offer 60 cents per share, or A$707 million ($585 million), plus assumption of debt, bringing the deal’s total value to A$1.49 billion.

If the merger is successful, Aspen would own 12 percent of the Australian market–a bigger share than pharma giants like Sanofi-Aventis and Pfizer. In 2009, the company filled 6.35 million scrips, while Sigma handled 7.8 million.

However, as The Australian notes, other offshore groups and private equity firms will be “sounded out” regarding their intentions toward Sigma. Industry sources have suggested that Indian pharmaceutical companies like Strides Arcolab and Ranbaxy have been increasingly eyeing assets in Western countries. And some could be interested in Sigma’s drug manufacturing and distribution channel.

Aspen’s offer could touch off a bidding war, but as The Age points out, any buyer would be wary of Sigma’s recent difficulties. Sigma has lots of debt, and its margins have been dropping to government pricing pressure and competition from rival drugmakers. But most spectacular was last month’s brouhaha, when the company took nearly $500 million in write-downs, posted a $390 million loss, and announced its CEO and CFO were stepping down. Since then, its chairman and one non-executive director have chosen to retire.

Indeed, Aspen told investors that its own offer for Sigma was contingent on an investigation of the company’s accounts, and added that the takeover offer could change after due diligence. For its part, Sigma’s board says it’s still considering the buyout proposal.

Source: FiercePharma

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There’s a bit of hand-wringing in India now that Abbott Laboratories has agreed to buy Piramal Healthcare’s generics business for $3.7 billion. That’s because Abbott becomes India’s biggest drugmaker in one dealmaking handshake. According to the Economic Times, that makes foreign companies three of the top five drugmakers in the country–and multinational drugmakers together now command 25 percent of the domestic drug market.

Plus, with analysts predicting more deals, multinationals’ share of the market is only expected to grow. Analysts are telling the ET that multinational drugmakers soon will boast nearly 50 percent of the Indian pharma market. “In the next 3-4 years, foreign players’ market share should cross 40 percent in the domestic retail market,” Yes Bank’s Life Sciences VP Vishal Gandhi tells the newspaper. And as Tarun Shah of MP Advisors tells LiveMint, “At least two more deals (of foreign firms acquiring Indian drugmakers) are likely in the next 18 months.”

This trend reverses gains that Indian drugmakers have made over the last few decades. Back in the 1970s, multinational firms owned more than 75 percent of India’s drug market. Then, thanks to some regulatory changes, the Indian generics business was born–and grew fast. Some Indian drugmakers grew so much that they began snapping up companies on other continents to gain strength in markets such as the U.S. and Europe. The pharma industry became a source of pride for Indian economic boosters.

Now that generics and emerging markets are all the rage among Big Pharma–which is looking to diversify to soften the oncoming onslaught of competition for some mega-blockbuster meds–drugmakers are buying up and tying up in India. Though GlaxoSmithKline and Sanofi-Aventis have been among the Big Pharmas to announce tiered pricing for emerging markets, some in India still worry that drug prices will rise because of the buyouts and other deals. That remains to be seen, of course. But there’s no doubt Big Pharma will carry more weight on the subcontinent.

Source: FiercePharma

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