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As diabetes rates grow, R&D pipelines flow

BY Alaric DeArment

CHARLESTON, W.Va. —Research and development pipelines are flowing with a record number of drugs for treating diabetes and related conditions, according to a report from the Pharmaceutical Research and Manufacturers of America released in late May, which showed 235 medicines in development to treat the disease.

According to the American Diabetes Association, 24 million Americans are living with diabetes, up from 21 million in 2005. The most rapidly growing incidence of the disease, Type 2, has increased along with the incidence of obesity in the United States. The report was unveiled in Charleston, W.Va., a state in which 11.4% of the adult population has diabetes—twice the rate of incidence that West Virginia had in 1994. A Centers for Disease Control and Prevention report based on data from 2006-2008 showed that the Appalachian state has the highest rate of diabetes in the country.

“We released this report in West Virginia because of the state’s alarming rates of diabetes, which unfortunately reflect a trend prevalent throughout the nation,” PhRMA SVP Ken Johnson stated. “Perhaps the most recent and disturbing trend is the rise of diabetes among children, which the American Diabetes Association calls ‘a new epidemic.’”

Drugs listed in the report include a range of pharmaceuticals and biologics in developmental stages ranging from phase 1 to phase 3, as well as those for which developers already have submitted regulatory approval applications.

One notable drug is Eli Lilly’s and Macrogenics’ teplizumab, a monoclonal antibody for treating Type 1 diabetes that has received orphan drug designation from the Food and Drug Ad ministration. GlaxoSmithKline and Tolerx are testing another monoclonal antibody for Type 1 diabetes, otelixizumab, which also is in phase-3 trials with an orphan drug designation. Novartis is testing a monoclonal antibody for Type 2 diabetes, Ilaris (canakinumab), currently in phase-2 and phase-3 trials, and already approved for treating the inflammatory disease cryopyrin-associated periodic syndrome.

Some long-standing drugs that most people wouldn’t associate with diabetes are getting attention as well, such as Johnson & Johnson’s epilepsy drug Topamax (topiramate), in phase-3 trials as a treatment for diabetic neuropathy; Pfizer’s cholesterol drug Lipitor (atorvastatin calcium), the world’s top-selling drug, in phase-2 testing as a treatment for diabetic foot ulcers; and Norditropin, a formulation of the growth hormone somatropin, in phase-1 testing by Novo Nordisk as a treatment for insulin resistance.

A plethora of diabetes drugs may be needed, based on current trends. Type 2 diabetes is on the rise in children because of increases in obesity and lack of physical activity, and if current trends continue, PhRMA said, 1-in-3 American children born in 2000 will develop diabetes in their lifetime.

Meanwhile, it could give a boost to drug companies that long have foreseen and feared the end of the era of blockbuster drugs. At a recent conference of pharmaceutical and bio-technology companies at the New York Athletic Club, one Merck executive invoked Mark Twain’s famous quote about reports of the author’s death being greatly exaggerated in asserting that there would be other blockbusters, while a PricewaterhouseCoopers executive cited diabetes as an area of unmet medical need with potential to generate blockbusters.

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FDA advisory committee shoots down Vivus’ Qnexa

BY Alaric DeArment

MOUNTAIN VIEW, Calif. The possibility of a new drug for treating obesity suffered a setback Thursday as a Food and Drug Administration advisory committee voted against recommending its approval.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10 to 6 against recommending approval for Vivus’ drug Qnexa (phentermine and topiramate), citing safety concerns such as the possibility of psychiatric problems and birth defects.

“We appreciate the advisory committee’s recognition of obesity as a significant health crisis and the challenges associated with the treatment of this disease,” Vivus CEO Leland Wilson said. “We are disappointed with the advisory committee’s vote.”

The company said it would attempt to address the committee’s concerns. An advisory committee vote is a recommendation, and while the FDA will take it into account when deciding whether to approve a drug, it is not bound to follow it.

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Post-it launches Shopping Genius widget

BY Allison Cerra

LONDON 3M has developed a bargain-shopping widget with the help of its Post-it brand.

Inspired by usage of the classic Post-it note as a shopping list, 3M has developed an evolution of the shopping list for the digital age called Post-it Shopping Genius. How it works: Post-it Shopping Genius sits on your computer desktop, keeping an eye on the price changes for you, locating the cheapest price, and letting you know when it changes. The customizable application enables you to choose from thousands of electricals, durables and other consumer goods, and track up to five at a time.

The application — which can be directly downloaded from http://bit.ly/Post-itGenius and is available on iGoogle, Mac OS X desktop and Windows 7 / Vista desktops — displays up-to-date prices on many thousands of products, which are searchable within the tool.

In related news, 3M announced that it is offering a monthly monetary prize of 1,000 GBP ($1,542) or the value of a user’s shopping list if less as an incentive to those who refer the Shopping Genius application to a friend.

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