PHARMACY

IDF: 1-in-10 adults will have diabetes by 2030

BY Allison Cerra

BRUSSELS — In line with World Diabetes Day, which was held Nov. 14, the International Diabetes Foundation projected that the number of people in the world living with diabetes is expected to rise from 366 million in 2011 to 552 million by 2030.

IDF said the statistic equates to approximately three new cases every 10 seconds, or almost 10 million per year. The organization also estimated that as many as 183 million people are unaware that they have diabetes.

The figures were released in the fifth edition of IDF’s Diabetes Atlas.

“In every country and in every community worldwide, we are losing the battle against this cruel and deadly disease,” International Diabetes Federation president Jean Claude Mbanya. “We want World Diabetes Day 2011 to bring these alarming diabetes facts into the global spotlight. We demand that public and world leaders act on diabetes now.”

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GPhA urges congressional super committee not to ban patent settlements

BY Alaric DeArment

WASHINGTON — The generic drug lobby is stepping up its efforts to persuade the congressional super committee to avoid adopting rules that would ban some patent settlements between branded and generic drug makers.

The Generic Pharmaceutical Association took out an advertisement in the Wall Street Journal that quoted several figures — including Federal Trade Commission commissioner J. Thomas Rosch and Sens. Frank Lautenberg, D-N.J.; Tom Carper, D-Del.; Bob Casey, D-Pa.; Kay Hagan, D-N.C.; and former Sen. Arlen Specter, D-Pa. — voicing opposition to FTC chairman Jon Leibowitz’s efforts to ban the settlements.

"The facts are crystal clear — patent settlements save consumers and taxpayers billions of dollars," GPhA president and CEO Ralph Neas said. "The growing chorus of lawmakers urging the super committee to resist efforts to put a patent settlement ban into their recommendations offers further proof — such a ban is bad public policy that would have a detrimental impact on the American public and eliminate billions of dollars in healthcare savings from our country."

Neas also wrote a letter to Politico that criticized an op-ed on the site by Leibowitz and defended the settlements..

"Leibowitz would like readers to believe that these settlements harm consumers by driving up the price of prescription medicines," Neas wrote. "This is inaccurate. Indeed, settlements provide patients early access to lifesaving medicines months, and often years, before a drug’s patent would have otherwise expired — giving consumers a break from more expensive brand products."

Under the Hatch-Waxman Act of 1984, a generic drug company that wishes to launch its version of a branded drug after the latter’s market exclusivity period has expired but before its loss of patent protection, may file a regulatory approval application containing a paragraph IV certification, which asserts that the patent is invalid, unenforceable or that the generic won’t infringe it.

In most circumstances, the branded manufacturer will sue the generic manufacturer for patent infringement. But usually, both companies will reach a settlement of some sort. In some cases, the settlement involves the generic drug company agreeing not to immediately launch a product in exchange for a payment, which sometimes includes cash but usually means that the branded drug manufacturer agrees not to launch a so-called authorized generic — essentially the branded drug marketed under its generic name at a reduced price — during the 180-day period in which the first company to win approval for the generic gets to compete exclusively with the brand manufacturer before the drug becomes commoditized, and any company can market a generic version.

It’s these settlements that have the FTC and Leibowitz, as well as members of Congress, including Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, irked the most. The FTC said the deals cost consumers and taxpayers $3.5 billion per year because they result in delayed entry of cheaper generics into the market.

Click here to view the WSJ ad.

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Actavis launches Kadian authorized generic

BY Alaric DeArment

MORRISTOWN, N.J. — Actavis has launched an authorized generic drug for treating pain, the company said.

The drug maker announced Friday that it had started shipping morphine sulfate extended-release capsules, an authorized generic version of Kadian, which it also manufactures. The authorized generic product was launched on the same day as Watson Pharmaceuticals’ generic version.

Authorized generics are branded drugs marketed under their generic names at a reduced price, either by the branded drug’s manufacturer or a third-party company through a contractual agreement, as a way to provide the branded manufacturer an additional means of competing against the generic manufacturer during the latter’s legally mandated, 180-day market-exclusivity period.

Kadian had sales of $275 million during the 12-month period ended in September, according to IMS Health.

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