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Lilly shares rise on Alzheimer's study results

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Eli Lilly and Co.’s experimental Alzheimer’s drug slowed cognitive decline 34 percent in patients with mild forms of the disease, according to an analysis of Lilly’s clinical trial data by a group of academic researchers released Monday.

The magnitude of the impact fits what some physicians have said would be meaningful to patients, but Indianapolis-based Lilly still isn’t saying whether it will file for approval of the drug, called solanezumab, or instead conduct another clinical trial.

Lilly’s share price gained more than 5 percent on the news, closing Monday at $50.78.

The stock already had risen nearly 14 percent since Aug. 24, when Lilly first announced that the drug had shown some positive effects. If successful, solanezumab would be the first effective treatment for Alzheimer’s disease on the market, and could bring Lilly $5 billion to $10 billion in annual revenue.
 
“While the path forward has not been determined, we believe these data in patients with mild disease may provide a step toward a potential treatment option,” Dave Ricks, president of Lilly’s Bio-Medicines business unit, said in a prepared statement.

The drug attempts to fight Alzheimer’s disease by binding to the protein amyloid and carrying it out of patients’ brains. The build-up and clumping of excess amyloid proteins is believed to cause Alzheimer’s disease.

Lilly’s two Phase 3 clinical trials of solanezumab failed their primary goal, which was to reduce decline in the ability of both mild and moderate Alzheimer’s patient to think and do daily activities.

But in mild patients, solanezumab appeared to have some effect. In the first of the two clinical trials, solanezumab slowed cognitive decline 42 percent. But it had no effect on patients' ability to do daily activities.

In the second clinical trial, solanezumab slowed patients’ mental decline about 20 percent and their functional decline about 19 percent. However, neither result was statistically significant.

When data from both trials were pooled, the reduction in cognitive decline for mild Alzheimer’s patients was 34 percent, according to a statement released by Lilly. The improvement in daily activities was 17 percent, which was not statistically significant.

Solanezumab also showed an effect on some, but not all, so-called biomarkers, which are measurements of protein levels in patients' blood or spinal fluid. Lilly said it would present more information on the biomarker results at future medical meetings.

The data were produced by the Alzheimer's Disease Cooperative Study, a consortium of academic Alzheiemer’s researchers from around the country.

“The data results from the solanezumab Phase 3 trials were encouraging to the ADCS team,” said Dr. Rachelle Doody, a professor of neurology at the Baylor College of Medicine who presented the results Monday at a meeting of the American Neurological Association in Boston. “These results represent an important step for the medical, academic, and scientific communities in understanding brain amyloid as a target of A.D. therapies."

Dr. Martin Farlow, the associate co-director of the Indiana Alzheimer Disease Center at the Indiana University School of Medicine, said in August interview that an effective Alzheimer’s drug would need to slow patient’s decline 30 percent to 50 percent. He participated in the clinical trials of solanezumab.

“There has to be a derivable clinical benefit that’s demonstrated,” Farlow said before Lilly first released its clinical trial results for solanezumab in August. “It’s very possible that one or more of these studies may demonstrate effects that sort of point the way to the next step.”

Recent research has shown that Alzheimer’s disease begins to damage patients’ brains 10 to 20 years before they can be diagnosed with the disease. As a result, many expect Lilly will need to study solanezumab in a new clinical trial aimed at patients with pre-Alzheimer’s conditions, such as mild cognitive impairment.

Lilly officials said Monday they would continue to discuss the data from the trials of solanezumab to decide whether to file for market approval or to conduct another clinical trial.

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  1. liek the rest of America

  2. These quaint,obsessed musings by the stalkers are certainly entertaining, but I'm trying to figure out what, if anything, all the yelping below has to do with Zak Brown.

  3. It's evident that Moffett was pushing the right buttons and corporate America is now trying to squash him. He just wanted to withdraw the free pilot services provided to the company by the pilots to try and put some pressure on a company that has not been interested in negotiating a contract in over 5 years. The company does not provide a contract because not having one has saved them a bundle of money. Shame on any Republic pilots not standing behind their union leader just because things are getting tough, can you not see such strategic moves by the company as putting the last union president in a corporate position and into THEIR pocket. Do you really believe the last union president is so appalled at the attempts by Moffett, do you not remember his oppositions to the company? We stood behind him. It has been proven over and over again for thousands of years without fail, a man cannot serve two masters. Anyone that believes people vote contrary to their paycheck and livelihood deserve to be taken advantage of, the recent statements by the former union president are laughable as he denounces the current union president from his new corporate position. Have you ever seen a drafted sports player score points for his previous team, it cannot be done, he is not on the pilots side anymore, he gets his money a different way now than you and I do, and he should not be allowed to remain on the seniority list. A drafted player brings strength, credibility, tactical knowledge, and a strategic advantage to his NEW team, he would not be drafted or paid were it otherwise. We are all forced to choose only one side to play for and support, not doing so has many references in life such as insider trading and shaving points, all illegal for good reason. This basic fact is why corporate moguls, scientist, and engineers all sign non-discloser agreements and non-compete clauses, as protection in case they are lured into switching sides as our former union president has done. No NFL coach ever drafted a player so that both teams could benefit and better understand each other, they are recruited to win the game against that former team, period. Likewise the company does not recruit the former union president by accident or mutual understanding, its strategy. Don't confuse playing the game with good sportsman-like conduct in support of common business and prosperity goals, with the requirement to only play for one side. Good men we all love and favor fall subject to this manipulation, often without their knowledge, and it is not a betrayal of their friendship to oppose them when they switch sides. If we did not love and trust them, they would not have been chosen and lured to the other side in the first place. The deception by the drafted player is not made at a conscious level, it's just human nature and it's all about money and power which corrupts our ability to be objective and loyal to two masters. This is why our court system created the defense attorney, and why our military created counter intelligence. Its strategy and its propaganda, and it works, and that's why the "powers to be" manipulate the chess pieces by sometimes changing their colors. Some players know they are being manipulated when their color is changed, but it brings them more money and power so they do not care. The rest have good intentions but do not even realize they are being manipulated. This tactic is also known by another name, Divide and Conquer. In battle sending an imperfect message with an imperfect team is obviously not ideal, but it's still being sent by YOUR team, your union leader, a leader that has common goals and common rewards with you, they are the best, because we have elected them to do a job for us. If you are not backing Moffett but believing the spin by those that have recently switched sides, you are taking food out of your own mouth. Showing unity and backing an imperfect situation still results in taking just as much ground, it's about unity and bargaining power. It's not necessary to wait around for that perfect attack because it will never come, the company will spin and attempt to destroy anyone that gets in their way. Ultimately it's not about any specific attack anyway, ASAP or whatever it makes no difference, it is and always has been only about power. If this company cared about safety it would not build pairings with 8 hour overnights, come on, are you that naive? Besides, do you really think Hoffa cares, no, he got a call from corporate America and was squeezed into denouncing Moffett. If he didn't they would spin the safety card against him and the Teamsters National with implication for truckers, future contracts, insurance rates etc...saying something like the Teamsters use safety as a bargaining chip, blah blah blah... Do you really think any pilot is going to do something unsafe for the contract, absolutely not, the only ones threatening safety here is the company with reduced rest, fatigue, and poverty. Do you not find it odd that Hoffa and the Teamsters are opposing a Teamster president publicly? Would the Teamsters National not normally support and work with one of their own? Why did they not sit down and help him strategize, correct any mistakes, and charge ahead? Would the Teamsters National not normally support and leverage a contract for all those pilots that have been paying Teamster dues, isn't that why we have all been paying Teamster dues in the first place? I sure haven't been paying dues so that the Teamsters National could come along and write this kind of an article undercutting our union leader and our unity. Whose side is the Teamsters National really on, it's obviously not the Republic pilots side.

  4. No matter what Moffatt does the company is going to spin it like he is the terrorist and brainwash people like you into believing it, wake up, back your players that are trying to change things for you and your livelihood. Where has Hoffa been for the last 6 years, except collecting our dues. Seriously, do you really think an FO going for upgrade, signed off by a checkairman ready for the upgrade, who then fails, is not even capable of returning as a First Officer.

  5. whoa!

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