Americans prefer drugs to talk therapy for depression, with nearly 80 percent taking a pill for the condition, Consumer Reports said on Tuesday.

The most popular class of drugs remain the so-called SSRIs such as Prozac, the group found. People found newer, pricier antidepressants less desirable because of side-effects.

Patients benefited just as much from therapy — almost any kind of therapy, the consumer group found in its survey of 1,500 readers.

Those surveyed said they improved just as much after seven or more sessions of talk therapy as if they took drugs and it did not matter if the therapist was a psychiatrist, psychologist or social worker.

Nearly 80 percent of people who had been diagnosed with depression or anxiety were prescribed antidepressants.

Patients were happiest with the selective serotonin reuptake inhibitors or SSRIs, a class that includes Eli Lilly and Co’s Prozac or its generic equivalent fluoxetine;, Pfizer Inc’s Zoloft or sertraline, and Celexa or citalopram and Lexapro or escitalopram from Forest Laboratories Inc.

People complained of more side-effects from serotonin-norepinephrine reuptake inhibitors or SNRIs, a newer, often more expensive class of antidepressants, the survey found.

These include venlafaxine, made by Pfizer-owned Wyeth under the Effexor brand name and Lilly’s duloxetine, sold as Cymbalta.

The survey found a range of side-effects, but the most common one — loss of sexual interest or ability — was less common than in past surveys, the consumer group said.

Source: Reuters

Popularity: 4% [?]

Drug prices leaped last year by 9.1 percent. That’s the biggest increase in at least 10 years, Express Scripts found in its annual drug-trend report. Some common meds got double-digit increases, such as the 13.6 percent increase for Eli Lilly’s antidepressant Cymbalta, or the 12.1 percent rise on Merck’s cholesterol med Zetia. Could it be that drugmakers were preparing for the agreed-upon Medicare and Medicaid rebates in the healthcare reform legislation?

Pharma companies say no. The rebates will hurt; Lilly just yesterday predicted that revenues would drop up to $700 million next year because of them. And Lilly tells the Wall Street Journal that its prices weren’t affected by the reform package. New pricing depends on “marketplace conditions and recovery of our R&D costs,” a spokesperson tells the Journal. Likewise, Merck blamed its rising prices on R&D investment, among other things. “[P]rice adjustments are independent of healthcare reform,” a spokesman tells the paper.

Express Scripts begs to differ. The increases were “exacerbated by the healthcare reform debate,” Steve Miller, SVP and CMO at Express Scripts, tells the newspaper. But we might also want to blame other drug-payment “gatekeepers” such as insurers, PBMs, and employers, Credit Suisse analyst Catherine Arnold says. Discounts and rebates offered to those customers can inspire price increases to help offset the costs.

All of these reasons seem to underscore the basic complexity of drug pricing and payments–indeed, the healthcare cost-and-payment world in general. Cut costs here and watch them grow somewhere else. Raise prices on some meds and find discounts eating away at revenues for other drugs. No wonder it took more than 1,000 pages of legislation to change the system.

Source: FiercePharma

Popularity: 3% [?]

That $80 billion cost-cutting deal the pharma industry made to help advance healthcare reform is already showing its teeth. In reporting its first-quarter results today, Eli Lilly says it expects higher government rebates to cut $350 million to $400 million from its top line this year, and $600 million to $700 million in 2011. And it’s taking an $85 million charge to earnings for drug subsidies to its retirees.

Healthcare reform was supposed to increase drugmaker revenues by growing the pool of insured patients. However, the cost cuts are going into effect now, and the big expansion won’t happen for several more years. So drugmakers will feel the pain before they get the gain.

What we don’t know is whether the rest of Big Pharma will lower their 2010 forecasts or if they have already built the reform cuts into their predictions. “Now the question is, is everyone else going to lower their guidance,” Deutsche Bank analyst Barbara Ryan tells Reuters. “We don’t know, but everyone is going to worry that that is going to be the case.”

Back to Lilly: The company reported a 9 percent increase in global sales to $5.49 billion, a tad lower than Wall Street estimates. Profits came in at $1.25 billion, down from $1.31 billion a year earlier. Top performers: antidepressant Cymbalta, which posted a 13 percent rise to $803 million; and lung cancer med Alimta, whose sales skyrocketed by 57 percent to $527 million.

Source: FiercePharma

Popularity: 2% [?]

The FDA has issued another wave of letters demanding changes in drug promotions. Warning letters went out to Bayer, Amylin Pharmaceuticals, Eli Lilly and Cephalon, ordering the companies to stop using DTC ads and other promos that either exaggerate a drug’s benefits or downplay its risks–or both. Here are the FDA’s beefs:

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• A Lilly print ad for the antidepressant Cymbalta “entirely omits risk information,” directing readers to another page for that information, the FDA says. Another Cymbalta ad also downplayed the drug’s risk of side effects, the agency adds. A Lilly spokesman tells Reuters that the company is now reviewing all Cymbalta marketing materials.

• Lilly and Amylin, which co-market the diabetes drug Byetta, were cited for a medical meeting last June where company representatives exaggerated Byetta’s ability to help patients lose weight. The FDA also says that the reps exaggerated the drug’s efficacy and promoted off-label uses. Both companies say they are taking action in response to the letter.

• Cephalon got a letter warning it to stop using a dosing card for its lymphoma and leukemia treatment Treanda. Handed out to doctors, the card omitted important risk information, the agency says. The company reports that it has stopped distributing the cards.

• Finally, in what’s surely an unintentionally amusing letter, Bayer has been cited for a program in which its intrauterine device Mirena was promoted in people’s homes. The FDA says the script for those events stated that the IUD could help women “look and feel great.” But the agency doesn’t know about “any evidence suggesting that women who are using Mirena for birth control look great or feel great.”

Source: FiercePharma

Popularity: 3% [?]

Earnings forecast is lower than expected, sending shares down 4%

Can Eli Lilly and Co. keep its sales and profits from plunging off the edge of a cliff in two years? Wall Street apparently doesn’t think so.

Investors dumped 21.2 million shares of the Indianapolis drug maker’s stock Monday, the highest amount in more than two years, after the company suggested that earnings could dip after its biggest products lose patent protection starting in 2011.

That sell-off pushed the stock price down 4 percent, to $35.02 a share, even as the broader markets rose slightly.

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Lilly executives took pains to say the company’s pipeline is full and could produce two new medicines a year, beginning in 2013. But investors have heard similar reassurances before and seemed to be running out of patience.

And some said that even if Lilly achieves its goal, the new medicines will not make up for a wave of drugs whose patents will expire before then.

“Although Lilly had a growing midstage pipeline, these assets remain several years away from the market,” said Chris Schott, a drug industry analyst at JP Morgan in New York, in a research note. He predicted that Lilly’s profits will fall by a “meaningful” degree from 2012 to 2015.

Lilly has been struggling to develop new medicines lately, launching just one in the past four years — the blood thinner Effient, and that is off to a slow start.

The company’s late-stage pipeline includes new medicines for cancer, Alzheimer’s disease and diabetes. The company also hopes to launch a long-acting version of Byetta for diabetes.

Analysts are not sold that Lilly can suddenly begin to launch new products after such a long dry spell, or that new products will make a big difference.

“Effient’s launch has been relatively unimpressive,” Seamus Fernandez, a drug analyst at Leerink Swann in Boston, said in a research note. He added he remains cautious on prospects for speedy government approval of long-acting Byetta.

In recent years, Lilly has been stung by one disappointment after another in its laboratories. Late-stage, experimental drugs for brain cancer, multiple sclerosis, osteoporosis and other ailments have failed to live up to expectations and ended up on the scrap heap.

Now, Lilly’s top-selling drugs, including the antipsychotic Zyprexa, antidepressant Cymbalta and cancer drug Gemzar, will lose patent protection in a wave between 2011 and 2014, allowing competitors to offer low-cost generic alternatives. Lilly must quickly find a way to replace those products, which account for more than 60 percent of revenues.

John Lechleiter, president and chief executive of Lilly, said the company has cut costs, become more productive, speeded up its business model and invested heavily in research and development.

In September, the company said it would cut 5,500 jobs, or 13.6 percent of its worldwide work force, by the end of 2011. On Thursday, the company said it has cut about 25 percent of its sales force this year.

Lechleiter again ruled out a large-scale merger or acquisition as a solution, saying Lilly could compete while remaining independent.

“We’re betting on our scientists and our scientific leaders and the deep insights and advanced technologies increasingly at their disposal,” he told analysts during the company’s annual investor conference in New York City.

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The company said it has 62 compounds in development, including 25 in midstage and late-stage clinical testing. Dr. Steven Paul, Lilly’s top research executive, said the company now has “the strongest pipeline in our history.”

The company said it moved into ninth place worldwide for pharmaceutical sales in the 12 months that ended in June, according to data from IMS Health.

The company said it expects annual revenue of at least $20 billion in the years 2012 to 2014 and beyond. Wall Street has been expecting company revenue in 2011 of about $22.9 billion, Reuters reported. Lilly had revenue of $20.4 billion last year.

Lilly expects to earn $4.65 to $4.85 per share next year, excluding the potential impact of health-care reform. That range represents growth of 6 percent to 13 percent, compared to the company’s profit guidance for this year. Analysts were expecting earnings of $4.74 per share for 2010.

Source: Indystar.com

Popularity: 7% [?]

Over the next several years, Eli Lilly will be facing generic competition for the antipsychotic Zyprexa, antidepressant Cymbalta and other blockbuster drugs that account for a good portion of the company’s sales. But unlike other Big Pharma companies that are facing the same challenge–and turning to mega-M&A deals to survive–Lilly is looking to its own pipeline to get it through the rocky years ahead.

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That according to CEO John Lechleiter who, in an interview with Forbes, says his company won’t be the next to ink a major deal. “We don’t see a compelling case that would indicate these large combinations have created sustained value for shareholders at the bottom line… The byproducts of these large combinations are always a lot of disruption and a lot of distraction for what can be an extended period of time.”

But what will the company do to replace the hole in its revenue when some of it’s bestselling drugs go off patent? Lechleiter says Lilly will identify the most promising of its 60 pipeline candidates and focus on developing the ones that will have the most impact in the next decade. He also points to cancer drug Altima, it’s insulin franchise, and the Japanese market as potentials for growth. And while Lilly won’t be pursuing a big buyout, the company is still in a good position to do other deals.

“We’re looking at opportunities that are going to be smaller than the ImClone acquisition,” says Lechleiter, adding that the company is always in talks for non-M&A deals like licensing opportunities or other partnerships.

Source: FierceBiotech

Popularity: 2% [?]

We all know that Big Pharma has been trying different strategies to boost their drug pipelines and bring more medicines to market. The keys have been to partner up with or buy other companies, often small biotechs, engaged in innovative R&D and to revamp their own research and development units.

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Eli Lilly is doing both. It closed on its $6.5 billion dollar acquisition of ImClone Systems in November. Today, it announced a major R&D restructuring that reorganizes its current pharmaceuticals business into four standalone units — oncology, diabetes, established markets and emerging markets — and hopes to cut an additional $1 billion in costs by the end of 2011.

If reorganization into business units sounds familiar, it could be because Pfizer went a similar route last year, creating separate units for oncology, animal health and biotech drugs. More diversified companies like J&J and Abbott have broken down their company into smaller units for years.

Lilly decided to make these changes when it realized, “Hey, we’re running a company at a $20 billion scale kind of the same way we were running it at $1 billion,” Lilly CEO John Lechleiter told us.

By reorganizing into these standalone units, which will be responsible for their own profits and losses, Lilly hopes to build more accountability and pursue opportunities faster, said Lechleiter. Rather than have just one person making decisions about R&D, now there will be four who focus on more specific markets.

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Interestingly, Lilly’s profitable neuroscience and psychiatric medicines aren’t getting their own unit, J.P. Morgan analyst Chris Schott points out in his research note. Instead, these products, which include blockbusters Zyprexa and Cymbalta, are included in the established markets division.

The company also plans to slash its total headcount to 35,000 from 40,500 by the end of 2011. Lilly hasn’t has specified from where these cuts will come, said Lechleiter.

Source: The Wall Street Journal

Popularity: 4% [?]

Eli Lilly announced Wednesday that the company resubmitted its application for Cymbalta (duloxetine) to the FDA for the management of chronic pain. The company indicated that the revised application now contains data from a recently completed trial in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study, and previously completed studies in pain due to osteoarthritis and chronic low back pain.

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John Hayes, a vice-president of Eli Lilly Research Laboratories, remarked that “the additional chronic osteoarthritis pain and chronic low back pain data were not available at the time of the initial submission [in May 2008]… We believe including these new data in the updated [application] package will provide a broader clinical basis for the FDA to review the application.”

Eli Lilly withdrew its initial application for Cymbalta in chronic pain last November, following discussions with the FDA mainly about statistical methods and study design. The drug is currently approved as a treatment for major depressive disorder and generalised anxiety disorder, as well as for fibromyalgia and pain associated with diabetic peripheral neuropathy.

Source: FirstWord

Popularity: 2% [?]

Two antidepressants, Zoloft and Cipralex, work slightly better and are better tolerated compared with 10 other similar drugs for moderate to severe depression, a new review has found.

In Thursday’s online issue of the medical journal The Lancet, an international team of doctors looked at more than 100 previous studies on antidepressants involving nearly 26,000 patients from 1991 to 2007.

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They concluded that Zoloft, or sertraline, and Cipralex, or escitalopram, were the best options when considering benefits, side-effects, and cost.

Edronax was considered the least effective.

“Such findings have enormous implications,” wrote Dr. Sagar Parikh, a psychiatrist at the University of Toronto, in a commentary accompanying the study.

“Now a clinician can identify the four best treatments, identify individual side-effect profiles, explore costs and patients’ preferences and collaborate in identifying the best treatment.”

The study’s authors weighed the drugs based on whether it reduced depression scores on two standardized tests by at least half and if patients had not stopped taking the medication in the last two months.

All of the antidepressants helped and there were no major differences, said the study’s lead author, Dr. Andrea Cipriani of the University of Verona in Italy.

“If a patient is taking a drug and doing well, he should not stop and switch drugs,” Cipriani said.

The other drugs reviewed were:

• Celexa (citalopram)
• Cymbalta (duloxetine)
• Effexor (venlafaxine)
• Ixel (milnacipran)
• Luvox (fluvoxamine)
• Prozac (fluoxetine)
• Seroxat (paroxetine)
• Remeron (mirtazapine)
• Zyban (bupropion)

Side-effects for the various drugs include nausea, sleeplessness, and sexual dysfunction.

The findings may lead doctors to prescribe Zoloft and Cipralex more often, but psychiatrists should also consider alternatives such as behavioural therapy, said Irving Kirsch, a professor of psychology at Britain’s University of Hull.

The study was paid for by the authors’ academic institutions in Britain, Greece, Italy, and Japan.

Cipriani has not received any grants from pharmaceutical companies. Several of his co-authors reported receiving funding from various makers of antidepressants.

Source: cbc.ca

Popularity: 12% [?]

Forest and Cypress Bioscience announced Thursday that US regulators approved Savella (milnacipran) for the management of fibromyalgia. Forest shares were up 4.3 percent on the news, while Cypress shares jumped 25.4 percent. The companies expect the drug to be on the market by March.

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The companies said that the safety and efficacy of the product was examined in two late-stage clinical trials involving more than 2000 patients with the condition, showing that Savella provided statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function.

Leerink Swann’s Gary Nachman commented that the approval was more timely than anticipated following the FDA’s delayed decision on the product last October. The analyst predicted that Savella could reach sales of $275 million by 2012, but remarked that some warnings on the drug’s label about potential cardiovascular side effects are more severe than on the label of other fibromyalgia medications, which include Eli Lilly’s Cymbalta (duloxetine) and Pfizer’s Lyrica (pregabalin).

Source: FirstWord

Popularity: 4% [?]