PHARMACY

BI announces more than $350 million in U.S. capital investments

BY Alaric DeArment

RIDGEFIELD, Conn. — German drug maker Boehringer Ingelheim Pharmaceuticals invested more than $350 million in its U.S. operations this year, the company said Tuesday.

The investments went toward building on the privately owned drug maker’s drug discovery, development and manufacturing capacity, which include a $65 million 72,000-sq.-ft. research and development center at its U.S. headquarters in Ridgefield, Conn. When finished, the center will handle production of active pharmaceutical ingredients used in early development activities, and products developed there will move on to the company’s full-scale R&D centers in Ohio and Virginia, as well as Germany and Italy.

Other projects include a $42 million drug-safety assessment building in Ridgefield scheduled for competion in 2013; an $89 million vaccine research center in Sioux Center, Iowa, being built for Boehringer Ingelheim Vetmedica, the company’s animal health business; a $100 million expansion of a biological manufacturing facility in St. Joseph’s, Mo.; and a $50 million high containment operations facility in Columbus, Ohio, opened in September by Boehringer Inghelheim Roxane for developing and manufacturing tablets and capsules for Roxane Labs.

"These are exciting projects; ones that increase Boehringer Ingelheim’s research and development capabilities and reinforce our commitment to growth and innovation in the U.S.," saod J. Martin Carroll, president and CEO for BI’s U.S. operations. "Through these investments, we are improving our ability to research, develop and manufacture the medicines of tomorrow and in doing so fulfilling our promise to bring more health to patients and their families."

In addition to the investments, BI gained a presence on the West Coast in March by acquiring Boehringer Ingelheim Fremont from Amgen. The facility manufactures biotech drugs and includes more than 300,000 sq. ft. for labs, manufacturing and process development.

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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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PHARMACY

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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