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BREAKING: FDA approves Lilly blood-thinner prasugrel

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Eli Lilly and Co. finally won approval today from U.S. regulators to sell prasugrel, its highly anticipated blood thinner, according to Bloomberg News.

The U.S. Food and Drug Administration approved prasugrel to prevent blood clots when patients come in to receive stents or other coronary devices. The drug will have the trade name Effient.

After waiting a year longer than expected, Indianapolis-based Lilly has suffered a setback that likely will make the drug much less lucrative than analysts once anticipated.

Most analysts predict prasugrel sales will reach $900 million to $1.1 billion by the end of 2011, when its main rival Plavix will become available in much cheaper generic versions. Two years ago, analysts’ sales predictions were as much as 70 percent higher than they are now.

Lilly will book half to two-thirds of prasugrel sales, with the rest going to its development partner, Japan-based Daiichi Sankyo Co. Ltd.

“Because of the time and the way things have worked out, it’s just not going to be the driver that people thought it was going to be,” said Les Funtleyder, a health care analyst at Miller Tabak & Co. in New York. However, he added, “It’s still an important factor for Lilly, because it is a new drug that will generate revenue.”

Lilly needs new revenue fast because its bestseller, the antipsychotic Zyprexa, will face generic competition at the end of 2011. Lilly gets $4.7 billion a year, or 23 percent of its sales.

Prasugrel has been on sale in some European countries, under the name Efient, since early April. Lilly will report sales results of the drug on July 22.

Lilly tested prasugrel head-to-head against Plavix in a clinical trial. Prasugrel proved 19 percent more effective at preventing heart attacks and strokes, but it also caused a higher rate of serious bleeding, including more fatalities.

Plavix, made by New York-based Bristol-Myers Squibb Co. and France-based Sanofi Aventis SA, was second-best-selling drug in the world last year, racking up $9.4 billion.

Those double-edged results appeared to cause conflicting views among FDA staff members. In October, The Pink Sheet, a trade publication, reported that prausgrel had sparked a “serious internal disagreement” over whether to approve it.

Things seemed to tip in prasugrel’s favor in February when the FDA’s advisory committee of cardiology experts voted 9-0 to approve the drug. But then news surfaced that the FDA had removed a prasugrel critic from the panel after Lilly asked it to do so.

Consumer groups howled and asked for further delay so the incident could be investigated. They got no official word, but the approval process dragged on for another five months.

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  1. to mention the rest of Molly's experience- she served as Communications Director for the Indianapolis Department of Public Works and also did communications for the state. She's incredibly qualified for this role and has a real love for Indianapolis and Indiana. Best of luck to her!

  2. Shall we not demand the same scrutiny for law schools, med schools, heaven forbid, business schools, etc.? How many law school grads are servers? How many business start ups fail and how many business grads get low paying jobs because there are so few high paying positions available? Why does our legislature continue to demean public schools and give taxpayer dollars to charters and private schools, ($171 million last year), rather than investing in our community schools? We are on a course of disaster regarding our public school attitudes unless we change our thinking in a short time.

  3. I agree with the other reader's comment about the chunky tomato soup. I found myself wanting a breadstick to dip into it. It tasted more like a marinara sauce; I couldn't eat it as a soup. In general, I liked the place... but doubt that I'll frequent it once the novelty wears off.

  4. The Indiana toll road used to have some of the cleanest bathrooms you could find on the road. After the lease they went downhill quickly. While not the grossest you'll see, they hover a bit below average. Am not sure if this is indicative of the entire deal or merely a portion of it. But the goals of anyone taking over the lease will always be at odds. The fewer repairs they make, the more money they earn since they have a virtual monopoly on travel from Cleveland to Chicago. So they only comply to satisfy the rules. It's hard to hand public works over to private enterprise. The incentives are misaligned. In true competition, you'd have multiple roads, each build by different companies motivated to make theirs more attractive. Working to attract customers is very different than working to maximize profit on people who have no choice but to choose your road. Of course, we all know two roads would be even more ridiculous.

  5. The State is in a perfect position. The consortium overpaid for leasing the toll road. Good for the State. The money they paid is being used across the State to upgrade roads and bridges and employ people at at time most of the country is scrambling to fund basic repairs. Good for the State. Indiana taxpayers are no longer subsidizing the toll roads to the tune of millions a year as we had for the last 20 years because the legislature did not have the guts to raise tolls. Good for the State. If the consortium fails, they either find another operator, acceptable to the State, to buy them out or the road gets turned back over to the State and we keep the Billions. Good for the State. Pat Bauer is no longer the Majority or Minority Leader of the House. Good for the State. Anyway you look at this, the State received billions of dollars for an assett the taxpayers were subsidizing, the State does not have to pay to maintain the road for 70 years. I am having trouble seeing the downside.

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