It’s the end of an era for the pharmaceutical industry. Tomorrow, the most popular prescription drug in the world, Lipitor, is due to go off-patent in the US. And no product looks set to equal or surpass the cholesterol-lowering agent’s peak annual sales of $13.7 billion, which it achieved back in 2006.

Lipitor, known generically as atorvastatin, is used by nearly 9 million Americans and has made Pfizer more than $130 billion globally since its 1997 launch. As the drug stands poised at the edge of a proverbial patent cliff, analysts at EvaluatePharma forecast that the loss of the megablockbuster will rob the New York–based drug giant of its top spot in the pharmaceutical league rankings by revenue. As the expiry looms large, patients, pharmacies and the drug industry are all holding their breaths, waiting to see how the introduction of generic atorvastatin will affect them.

For long-term Lipitor users, the patent expiry should be great news. Although Pfizer is expected to take a huge hit with the loss of Lipitor’s exclusivity — about $10 billion a-year by some estimates — consumers should save big. The generic substitute for Lipitor is expected to eventually cost up to 90% less than Pfizer’s drug, and co-payments are expected to drop from an average of $25 per month to $10, saving patients about $180 per year, according to CBS News. To begin with, the Indian drugmaker Ranbaxy Laboratories will hold the exclusive right to manufacture and sell generic atorvastatin in the US, which should help keep the price of the drug relatively high through mid-2012. New Jersey-based Watson Laboratories will simultaneously sell a licensed generic, which will be manufactured by Pfizer. But after six months, other generic version of atorvastatin could flood the market, triggering prices to plummet, and thereby saving consumers and the US health system a whole lot of money.

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A small study has lent much hoped-for support to the idea that resveratrol — a natural organic compound found in red wine — can positively affect the metabolism of obese individuals through the activation of the sirtuin-1 gene. These findings give new hope to pharmaceutical drug developers that have been stymied by years of debate about the compound’s efficacy and how exactly it works.

Last year, GlaxoSmithKline-owned Sirtris Pharmaceuticals, based in Cambridge, Massachusetts, abandoned its resveratrol-based drug SRT501 designed to treat multiple myeloma, after kidney failure was seen in patients involved in their phase 2 trial of the compound. Other trials seeking to show its ability to aid weight-loss have similarly fumbled, and researchers had a tough time demonstrating that it acted on the sirtuin-1 gene as purported.

The new study, published today in Cell Metabolism, involved 11 obese men, who received resVida, a resveratrol pill produced by DSM Nutritional Products and widely available as a supplement. Study author Patrick Schrauwen from the University of Maastricht in the Netherlands and his colleagues measured the volunteers’ liver fat and blood sugar, among other things. After taking resVida, the 11 participants experienced a drop in levels of liver fat and blood glucose. Systolic blood pressure also fell by 4% compared with the participants’ blood pressure when on the placebo pill.

Notably, while participants didn’t lose weight, protein analysis indicated that resveratrol increased sirtuin-1 levels and improved mitochondrial function, mirroring the metabolic effects of exercise and restricted calorie intake.

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PhD in peril: Kristen Tamburro.

In virologist Dirk Dittmer’s lab at the University of North Carolina–Chapel Hill, there are two silent rooms. One contains a hulking, quarter million-dollar robot, custom-made to analyze blood samples; the other contains a small protein-synthesis machine. Most days, scientists don’t enter either room. The machines sit there gathering dust while Dittmer’s team waits on a massive clinical trial in African patients with AIDS to begin — a trial that has been delayed indefinitely due to drug shortages.

The issue of drug shortages has posed a growing problem for doctors and patients in the US. In the first eight months of this year, for instance, the country’s Food and Drug Administration (FDA) recorded nearly 200 such shortages, in contrast to the 178 shortages reported in 2010 overall. As a result, hundreds of clinical trials hang in the balance, and the delays are jeopardizing the careers of many clinical investigators.

One person on Dittmer’s research team facing a career dilemma is graduate student Kristen Tamburro, who received a prestigious Howard Hughes Medical Institute fellowship in September 2009. Tamburro joined Dittmer’s lab to pursue translational medicine, tempted by the promise of data from the AIDS trial — which aimed to test Janssen’s Doxil (doxorubicin), currently approved to treat ovarian cancer and multiple myeloma, in patients with AIDS who have developed the deadly cancer Kaposi’s sarcoma. Halfway toward obtaining her PhD, when the trial remained on standby, she realized she needed a new plan.

“Since the samples won’t come in before I graduate, the project has been removed from my thesis,” she says. Although she analyzed several small, observational trials to salvage her thesis, a trial of this magnitude and scale could have transformed her career. “It would have been a great experience to have had,” she says.

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Another paused phase 3 trial aims to treat acute myeloid leukemia (AML) in the elderly. It is waiting for the chemotherapy drugs Cerubidine (daunorubicin), manufactured by Winthrop Pharmaceuticals, and Tarabine PFS (cytarabine), made by several companies, including Hospira. James Foran, a medical oncologist at the Mayo Clinic in Jacksonville, Florida, heads the study. The trial is his baby — he started working on it five years ago and was hoping to have preliminary data in 2013. “This is the sort of trial that can get me promoted to professor someday,” he says. “If it fails, I will have to go straight back to the drawing board.”

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Abbott Laboratories announced plans this morning to split into two companies. The separation is not a bitter one, however; it’s simply a smart way to give the Chicago–based company — the eighth-largest drugmaker in the world, with global sales of around $40 billion in 2010 — a valuation bump in the eyes of investors, analysts say.

The two new companies will have distinct product profiles. The first, as yet unnamed, will be a research-based pharmaceuticals company with Abbott’s trademark brand-name medicines, including the rheumatoid arthritis drug Humira (adalimumab), prostate cancer drug Lupron (leuprolide) and Synagis (palivizumab), a monoclonal antibody targeted at the respiratory syncitial virus. The second company, which will keep the Abbott moniker, will be a diversified medical products business including lab diagnostics, generic drugs, nutrition products and medical devices.

The problem with the status quo, according to Abbott spokesperson Adelle Infante, is that Humira has overshadowed all the company’s other offerings. “I believe this one product alone represents about 20% of the company’s profits,” Infante told Nature Medicine. Consequently, for example, the medical products arm does not get as much attention from healthcare investors, she explains.

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