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Lilly, Bristol-Myers halt enrollment in lung-cancer trial

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Eli Lilly and Co. and Bristol-Myers Squibb Co. stopped enrolling new patients in a clinical trial of an experimental lung cancer drug over concerns about patients developing blood clots, the companies announced Wednesday morning.

The Phase 3 trial of necitumumab gave that drug in combination with Alimta, Lilly’s existing lung cancer drug, and cisplatin, a generic chemotherapy agent, to patients with advanced non-small lung cancer of a type called nonsquamous.

Lilly will continue to study necitumumab in a separate Phase 3 clinical trial, where it is being given in combination with Lilly cancer drug Gemzar and cisplatin. The patients in this second trial have non-small lung cancer of a different type, called squamous.

While stopping enrollment in one of the two Phase III trials is disappointing, the ... Phase III study of necitumumab in lung cancer continues," said Dr. Richard Gaynor, Lilly’s vice president of oncology product development, in a statement.  "Lilly remains committed to developing new medicines that can help treat this devastating disease."

Lilly and Bristol-Myers Squibb are sharing development costs of necitumumab and any potential revenues from the drug in United States, Canada and Japan. Lilly has exclusive commercialization rights in all other countries.

Lilly has had numerous drugs fail or be delayed in Phase 3 clinical trials over the past two years. The company is struggling to launch new drugs that can produce sales to offset a string of five blockbuster drugs that are beginning to face competition from generic copies as their patents expire over the next several years.

Those patent expirations could sap roughly $10 billion in annual revenue from Lilly’s books.

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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).

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