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FDA approves Sanofi drug for colorectal cancer

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating colorectal cancer that has spread to other parts of the body, the agency said Friday.

The FDA announced the approval of Sanofi’s Zaltrap (ziv-aflibercept) for adults with metatstatic colorectal cancer, in combination with a chemotherapy regimen comprising folinic acid, fluorouracil and irinotecan, commonly known as FOLFIRI. According to the National Institutes of Health, 143,460 people in the United States will be diagnosed with colorectal cancer, and 51,690 will die from it, in 2012.

"This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "An improvement in median survival time was noted with the addition of Zaltrap to FOLFIRI, accompanied by an improvement in response rate and a delay in tumor progression and growth."


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This is the coming of the ‘age of generics’

BY Alaric DeArment

WHAT IT MEANS AND WHY IT’S IMPORTANT — Astrologers would say this is the Age of Pisces, while the Chinese zodiac calls it the Year of the Dragon. For health care, it might be a good time to start calling it the "Great Generic Epoch."

The trend seen in the Generic Drug Savings study, in which generic drugs count for an overwhelming majority of prescriptions written but only about one-quarter of drug spending, has been happening for some time now. But it’s also accelerating, and that means a lot for drug makers and policy-makers alike.

(THE NEWS: Generics saved $1 trillion over last 10 years. For the full story, click here.)

According to a study last month by IMS Health, global spending on generics is expected to rise from $242 billion in 2011 to more than $400 billion by 2016. Much of that will come from volume growth in emerging-market countries, but a lot of it also is because of the transition to generics in developed countries like the United States, and the report noted that limited savings from expiring patents are prompting policy shifts to encourage more use of generics. And this has been going on for some time: Last year, another report by IMS found that while spending on branded drugs decreased by 0.7% in 2010, spending on branded and unbranded generics rose by 4.5% and 21.7%, respectively. That report also found that on average, more than 80% of a brand’s prescription volume is replaced by generics within six months of the expiration of the branded drug’s patent.

As such analysts as like IMS VP industry relations Doug Long have said before, the blockbuster model of drug development is coming to an end. While drug companies might still develop new treatments for widespread disease states, such as cholesterol and gastroesophageal reflux disease, new drugs to treat those conditions are unlikely to see the kinds of sales achieved by the likes of Pfizer’s cholesterol drug Lipitor (atorvastatin), whose sales reached $7.7 billion in 2011, but lost its patent protection in November 2011. Instead, many drug companies are shifting their focus to more expensive drugs to treat disease states with smaller patient populations, including cancers and autoimmune disorders. Meanwhile, the more common conditions will be treated more and more with cheaper generic drugs.

For policy-makers, the move toward generics means drug therapies will become cheaper, which will go a long way toward making health care overall cheaper. For that reason, it behooves them and healthcare providers (ranging from physicians to pharmacists) to make sure patients know when a generic drug for their condition is available so that neither they nor their payers have to spend an arm and a leg to keep them healthy.

This is what makes the reauthorization of the Prescription Drug User Fee Act, signed by President Barack Obama last month, especially timely. One major goal of the reauthorization is to clear the backlog of about 2,500 generic drug applications currently held up at the Food and Drug Administration due to insufficient staff and resources to review them. This will help make generic drug approvals happen faster and more efficiently and ensure that generics get into the hands of patients sooner.

What do you think? Sound off in the comments below.

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Craig Gourley joins Shopko

BY Allison Cerra

GREEN BAY, Wis. — Shopko announced that a former JCPenney executive has joined the company.

Shopko said Craig Gourley will serve as its new SVP and general merchandise manager of home and hardlines. Gourley will be responsible for overseeing all aspects of merchandising for the home division, including developing strategies, negotiation of vendor partnerships and managing the buying team. He will report to EVP and chief merchandising officer Jill Soltau.

Gourley joins Shopko after five years at JCPenney where he served as divisional VP/divisional merchandise manager, managing 60% of JCP’s home business.

"Craig brings strong leadership and extensive experience to our home division at a critical time as we expand our brand to new customers in our Shopko Hometown markets. Throughout his career, Craig has consistently delivered exceptional financial results due to his focus on newness, key items, total brand development and superior planning strategies," Soltau said. "He has a reputation for being a skilled negotiator with both domestic and import vendors and an effective leader and manager. His proven track record of success, coupled with his experience and fresh perspective, will make him a strong addition to our team."

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