Lilly falls short on 'field goal' attempt

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Eli Lilly and Co.’s “miss” on a new use for its cancer drug Alimta was a rare failure to get an existing drug approved for a new use—even though the company has struggled mightily to get entirely new drugs to market.

The Indianapolis-based drugmaker announced Monday that it will not submit Alimta to regulators as a treatment for head and neck cancer. That’s another setback for Lilly, which is desperately trying to find new sales streams before it starts hemorraghing revenue a year from now when its bestseller Zyprexa loses patent protection in the United States and Europe.

Alimta has been Lilly’s fastest-growing drug the past two years, generating $1.1 billion in sales during the first half of this year. Having approval from the U.S. Food and Drug Administration to use the drug for treating head and neck cancers certainly would have added to that total.

But a Phase 3 clinical trial showed that cancer patients taking Alimta and the chemotherapy agent cisplatin only saw insignificant benefits compared with patients taking cisplatin alone.

In the pharma world, approval for entirely new drugs is like scoring touchdowns—they get the most points (er, dollars) on the board. But approval for additional uses for an existing drug, known as a line extension, are like field goals—they still add to the score.

Line extensions are a big reason why Lilly’s sales soared from 2006 to 2009, rising nearly 40 percent, even though the company won approval for only one new drug. (And that new drug, the blood thinner Effient, has seen insignificant sales to date.)

Some of the line extensions Lilly has won approval for include the antidepressant Cymbalta as a treatment for generalized anxiety and fibromyalgia, the erectile-dysfunction drug Cialis as a treatment for hypertension, the osteoporosis drug Evista to treat breast cancer, and a once-a-month version of the antipsychotic Zyprexa.

But Lilly has drawn far more attention for its high-profile failures on experimental drugs. In August, it halted a trial of an Alzheimer’s medicine because it actually made patients worse. Lilly drugs designed to treat multiple sclerosis, osteoprosis and diabetic eye disease also have failed in recent years.

As a result of Lilly’s innovation drought, the company is looking to acquire molecules from smaller companies that have a shot at producing revenue in 2014. That will be Lilly’s most difficult year, coming right after Lilly’s No. 2 drug Cymbalta will lose patent protection.

"Our company situation means we're particularly interested in late-stage opportunities that can be revenue-generating in 2014," Jan Lundberg, president of Lilly's research arm, told the Wall Street Journal in a September interview.

Lilly has looked at roughly 1,000 potential acquisition targets this year, but has done deals with only a few companies, Lundberg said. He added that the financial struggles of biotech companies since the 2008 financial meltdown give Lilly lots of targets to consider.


  • Zyprexa saga
    Eli Lilly & Co's once-a-month version of its top-selling antipsychotic medicine Zyprexa, while effective, has risks that include excessive sleepiness, U.S. regulators said.

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  1. You are correct that Obamacare requires health insurance policies to include richer benefits and protects patients who get sick. That's what I was getting at when I wrote above, "That’s because Obamacare required insurers to take all customers, regardless of their health status, and also established a floor on how skimpy the benefits paid for by health plans could be." I think it's vital to know exactly how much the essential health benefits are costing over previous policies. Unless we know the cost of the law, we can't do a cost-benefit analysis. Taxes were raised in order to offset a 31% rise in health insurance premiums, an increase that paid for richer benefits. Are those richer benefits worth that much or not? That's the question we need to answer. This study at least gets us started on doing so.

  2. *5 employees per floor. Either way its ridiculous.

  3. Jim, thanks for always ready my stuff and providing thoughtful comments. I am sure that someone more familiar with research design and methods could take issue with Kowalski's study. I thought it was of considerable value, however, because so far we have been crediting Obamacare for all the gains in coverage and all price increases, neither of which is entirely fair. This is at least a rigorous attempt to sort things out. Maybe a quixotic attempt, but it's one of the first ones I've seen try to do it in a sophisticated way.

  4. In addition to rewriting history, the paper (or at least your summary of it) ignores that Obamacare policies now must provide "essential health benefits". Maybe Mr Wall has always been insured in a group plan but even group plans had holes you could drive a truck through, like the Colts defensive line last night. Individual plans were even worse. So, when you come up with a study that factors that in, let me know, otherwise the numbers are garbage.

  5. You guys are absolutely right: Cummins should build a massive 80-story high rise, and give each employee 5 floors. Or, I suppose they could always rent out the top floors if they wanted, since downtown office space is bursting at the seams (http://www.ibj.com/article?articleId=49481).