Zyprexa

ALSO NOTED: ASCO already churning out news; Lilly, FDA ironing out Zyprexa shot problems; and much more...

Fri, 30 May 2008 06:59:50 -0400

> Today marks the start of the annual ASCO. Here's a round-up of some of the news coming out of the conference. ASCO report

> More from the Web-marketing frontier, where portals and blogs are passé: An Arizona entrepreneur is working up a site where cancer doctors and drugmakers can mix and mingle. Report

> Pharmacy records could soon become an open book in California. Yesterday, the state Senate passed a bill allowing pharmacies to sell patient info to third-party firms working for drugmakers. Report

> Eli Lilly says it's making progress with the FDA on approval of its long-acting, injectable form of Zyprexa. FDA report

And Finally... Solving the mystery of why type 1 diabetes is so prevalent in Finland could be the key to teasing out the causes of the disease. Report

Lilly readies Phase III Alzheimer's trial

Mon, 31 Mar 2008 07:59:58 -0400

Struggling to right itself after a long dry spell in new drug approvals, Eli Lilly is preparing to a launch a late-stage study of an experimental drug for Alzheimer's. LY450139 is expected to inhibit an enzyme that plays a role in the development of beta amyloid, a plaque that has long been linked to the memory-wasting disease. And they're making the move at the same time a slate of biotech developers are moving toward late-stage studies of their own therapies. Myriad Genetics wrapped its late stage study of Flurizan last week. Eli Lilly last launched a new drug for humans in 2005. There is currently no cure for the disease and up to now, most of the therapies on the market have been noted for their lack of efficacy.

"The new hope is to effect the disease at the very basic pathology, so you're actually stopping it, not just managing the symptoms," Dr. Daniel D. Christensen, professor of psychiatry, neurology and pharmacology at the University of Utah's Neuropsychiatric Institute told the Indianapolis Star.

- here's the release
- read the article in the Indianapolis Star

ALSO: Eli Lilly's new CEO, John Lechleiter (photo), faces a big Zyprexa settlement and the loss of a key patent, but he still sees his glass as half full as new research highlights a host of new drug targets. See why Lechleiter views Lilly as something of a biotech company inside a Big Pharma organization. Report

Related Articles:
Study shows that Alzheimer's drugs don't work. Report
Big pharma sees big payback for Alzheimer's research. Report
New vaccine may stop, slow Alzheimer's. Report

ALSO NOTED: Analysts offer conflicting forecasts for Auxilium; test sheds light on cancer therapy; MAP touts new data; and much

Mon, 24 Mar 2008 07:59:50 -0400

> Two analysts assessed Auxilium Pharmaceuticals' chances in a late-stage study of Xiaflex and came up with radically different conclusions. Data is expected in the second quarter. Report

> A new test that analyzes microRNAs can tell doctors the source of some mysterious cancers and help provide a short-cut for treating them, according to media reports quoting researchers in Nature Biotechnology Monday. Report

> MAP Pharma is touting data from a pharmacokinetic trial comparing the systemic drug exposure of UDB compared to the currently marketed conventional nebulized budesonide. Release

> Isolagen has sold its facility in Switzerland for approximately $6.4 million. Release

> Merck and Schering-Plough officials overseeing the Enhance study saw a threat to Vytorin back in late 2005, the Wall Street Journal reports. Report

> Could full clinical trial data disclosure avert scandals? Report

> As Eli Lilly went up to bat in the big Zyprexa trial in Alaska, the judge said lawsuits play a vital role in drug safety. Without them, claims of safety problems "might well go unaddressed," Judge Mark Rindner told the court. Evidence the State of Alaska presented over the past two weeks, he said, shows that the FDA "isn't capable of policing this matter." Report

> The Securities and Exchange Commission charged Biovail, its founder Eugene Melnyk (photo), and three other current and former executives with fraud, alleging that they repeatedly overstated earnings and hid losses. Report

And Finally... A new UN report on tuberculosis control concludes that efforts to rein in the disease have slowed down. Report

ALSO NOTED: Amgen analysts bearish; FDA hands Kyowa not-approvable letter; Valeant plans review; and much more...

Thu, 28 Feb 2008 06:59:50 -0500

> Oh, the curse of duplication. Schering-Plough embarked on a company-wide downsizing yesterday, eliminating hundreds of jobs in nearly all departments, including finance, research, information technology, and marketing. Report

> Faced with what they see as the likelihood of some significant restrictions on the use of Amgen's anemia drugs--as well as new data on risks associated with the drugs--analysts have been turning distinctly bearish on the biotech giant's stock. Report

> Kyowa Pharmaceutical has received a not-approvable letter from the FDA for istradefylline (KW-6002), its investigational drug for the treatment of Parkinson's disease. Release

> Valeant Pharmaceuticals says it will undertake a strategic review after reporting weak results for the fourth quarter. Release

> The U.S. Patent office has upheld the validity of Geron's patent for human embryonic stem cells. Report

> Any attempt to track down the source of problems with the blood thinner heparin are likely to run into trouble following a convoluted supply trail in China. Report

> The FDA has nixed Eli Lilly's plans for a long-acting formulation of its antipsychotic Zyprexa. Report

> GSK's secret vaccine adjuvant is drawing attention. Report

And Finally... The CDC has greatly expanded the population of people it's recommending for an annual flu shot, saying everyone aged six months to 18 should get the an annual jab. Report

Schering-Plough buoyed by asenapine data

Wed, 17 Oct 2007 06:59:58 -0400

Researchers say that Organon's asenapine was just as effective in controlling episodes of acute mania in two late-stage trials as Eli Lilly's Zyprexa--a drug widely considered the gold standard for this indication. Organon is a subsidiary of Akzo Nobel which is being acquired by a resurgent Schering-Plough. Asenapine is widely viewed as one of Organon's brightest drug prospects and a key reason why Schering-Plough agreed to pay $15.6 billion for the company. The data from the two Phase III clinical studies were presented this week at the 20th European College of Neuropsychopharmacology Congress. Questions have been raised about asenapine's potential ever since Pfizer bailed out of a collaboration on the therapy after a trial failed to establish its superiority to approved therapeutics.

"The complex nature of bipolar disorders suggests that we should have many treatment options available to physicians and patients," said Roger S. McIntyre, M.D., associate professor of psychiatry and pharmacology at the University of Toronto. "As such, a new therapy that provides efficacy while also providing improved tolerability is critical in helping fill this unmet need."

- here's the release on the Phase III data

Related Articles:
Schering-Plough: A good company to work for. Report
Schering-Plough pays $14.4B for Organon. Report
Organon to split from Akzo Nobel. Report

Read more on: Schering-Plough | Zyprexa

ALSO NOTED: Bavarian Nordic earns milestone payment; Cyclacel acquires Align Pharmaceuticals; and much more...

Mon, 08 Oct 2007 06:59:50 -0400

> Bavarian Nordic has earned a $50 million advanced payment for achieving milestones outlined in its contract to provide smallpox vaccine to the U.S. government. Report

> Coley Pharmaceuticals of Wellesley, MA has adopted a shareholder rights program. Release

> Cyclacel Pharmaceuticals has acquired Align Pharmaceuticals for about $3.5 million in cash. Release

> UK-based Shire Pharmaceuticals is selling a block of medicines to Almirall of Spain for $213 million. Report

> A Florida jury ruled for Merck in yet another Vioxx case, bringing the drug maker's record to 11-5 in trials related to the drug. Report

> Eli Lilly is owning up to Zyprexa's ills in new warnings added to the medicine's label. Report

And Finally...Too much debt? Blame it on your genes. New research indicates that our genes may play a key role in our economic behavior. Report

Press Release: Eli Lilly Japan and Shionogi to Co-Develop and Co-Market Duloxetine in Japan

Maureen Martino — Fri, 02 Feb 2007 12:56:26 -0500

Eli Lilly Japan and Shionogi to Co-Develop and Co-Market Duloxetine in Japan

Shionogi & Co., Ltd. and Eli Lilly Japan K.K. today announced that the two companies have signed an agreement to co-develop and co-market duloxetine hydrochloride (codenamed LY248686) in Japan. Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI), approved in more than 70 countries in Europe, Latin America and in the United States, for the treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain, both in adults. Duloxetine is also approved for the treatment of stress urinary incontinence in more than 30 countries. Duloxetine is not approved for use in pediatric patients. Its 2006 worldwide sales were US$1.316 billion.

Underscoring the important synergy created by this partnership, Dr. Isao Teshirogi, Director of the Board and Senior Executive Officer responsible for Research & Development at Shionogi stated, “We fully anticipate that this partnership will leverage the strengths of both companies. Together with Eli Lilly Japan, Shionogi will be better positioned to develop and deliver this innovative medicine to patients in Japan faster.”

“We are very excited that this partnership with Shionogi will be adding duloxetine to our CNS portfolio in Japan,” said Masanobu Kambara, Director, CNS Business Unit for Eli Lilly Japan. “With both duloxetine and Zyprexa, an existing treatment of schizophrenia, Eli Lilly Japan will be able to provide patients and doctors with a broader range of innovative medicines for the treatment of serious mental illnesses and related diseases.”

In Japan, Duloxetine is currently undergoing Phase III and Phase II clinical trials sponsored by Shionogi for the indications of depression and pain related to diabetic peripheral neuropathy. As a result of this agreement, the two companies will collaborate on the development in Japan of duloxetine for pain related to diabetic peripheral neuropathy, while Shionogi will continue sole development of the drug for the indication of depression. Both companies will co-market the drug under the same product name.

About Duloxetine

Duloxetine is believed to potentiate both serotonin and noradrenaline in the brain and the spinal cord, impacting nerve signaling. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and noradrenaline. While the mechanism of action of duloxetine in humans is not fully known, scientists believe its effect on improvement of depressive symptoms and pain perception is due to increasing the activity of serotonin and noradrenaline in the central nervous system.

For more information, contact:
Public Relations Unit, Shionogi & Co., Ltd.
06-6209-7885 (Osaka) or 03-3406-8164 (Tokyo)
Corporate Affairs, Eli Lilly Japan K.K.
Miyuki Watanabe at 078-242-9192

SPOTLIGHT: Lilly settles Zyprexa claims

Thu, 04 Jan 2007 19:01:33 -0500

Eli Lilly has settled another 18,000 claims generated by its controversial antipsychotic drug Zyprexa. Lilly says the settlement won't reduce fourth-quarter profits by more than $500 million. Report

Lilly ignored Zyprexa safety data on weight, blood sugar

Wed, 20 Dec 2006 19:01:38 -0500

The New York Times reports that Eli Lilly initially ignored data gathered on clinical trials related to Zyprexa which showed that 16 percent of patients taking the schizophrenia drug gained more than 66 pounds. Instead, they focused on the results of a smaller group of trials that showed 30 percent of patients gaining 22 pounds. Initial data indicated that patients on Zyprexa were 3.5 times more likely to experience elevated blood sugar levels than volunteers taking a placebo. This new data is likely to fuel a years-long debate over whether Zyprexa is responsible for an elevated risk of diabetes, which is heavily influenced by weight gain and blood sugar levels. Lilly says no link has been established. Zyprexa earned more than $4 billion last year, representing almost a third of Eli Lilly's revenue.

This is the latest in a string of reports that Times' reporter Alex Berenson has put together from internal documents prepared by Eli Lilly and provided by an attorney representing mentally ill patients. The Times recently reported that Eli Lilly reps improperly promoted Zyprexa for dementia, even though it had not been approved for dementia. Using a drug for off-label indications is common, but drug companies are forbidden to promote them.

- read the New York Times article on Zyprexa

ALSO: Eli Lilly has halted studies of its brain cancer therapy Enzastaurin, saying it was no more effective that chemotherapy in treating the disease. Researchers will continue studies to see how effective it is as a therapy for non-Hodgkin's lymphoma. Release

Related Articles:
Lilly accused of promoting off-label Zyprexa use. Report
NYT accuses Lilly of hiding safety problems. Report
Lilly responds to Zyprexa criticism. Release

Lilly hopes to nail Icos bid with sweetened offer

Sun, 17 Dec 2006 19:01:37 -0500

Eli Lilly has sweetened its offer for Seattle-based Icos by $200 million, raising its offer to $2.3 billion in hopes of damping down criticism that its original bid was too low. Icos investors are scheduled to consider the buyout offer--which was described as Lilly's last--on the day after Christmas. The offer raises Lilly's bid to $34 a share from $32.

"We are confident that Icos shareholders will recognize the substantial value and the certainty that Lilly is offering," said Sidney Taurel, Lilly chairman and
CEO, in a statement. "We believe this transaction delivers significant value to Icos shareholders, and it is our final offer."

- read Lilly's press release
- here's the report on the offer from The Indianapolis Star

Related Articles:
Lilly to Icos: Merry Christmas, you're fired. Report
Lilly buying Icos in $2.1B deal. Report

ALSO: Lilly, meanwhile, is attempting to counter a story in The New York Times that it worked for years to hide safety problems associated with the schizophrenia drug Zyprexa. Times' writer Alex Berenson also reports that Lilly encouraged the use of Zyprexa for an unapproved indication. According to company materials, sales reps were urged to suggest that doctors prescribe Zyprexa for dementia. Article

Press Release: Eli Lilly Responds to New York Times Article

Maureen Martino — Sun, 17 Dec 2006 11:51:56 -0500

INDIANAPOLIS, Dec 16, 2006 -- Eli Lilly and Company, in a response to a story about Zyprexa in the December 17, 2006 edition of the New York Times, adds important facts and perspectives that were not evident in the story.

Said Steven Paul, M.D., Lilly's executive vice president of science and technology, "We believe it is critical to physicians and patients that Lilly state some important and relevant facts about our lifesaving medication Zyprexa that are missing from the New York Times article:

"First, contrary to incorrect statements in the Times article, Lilly has conducted more than 23 years of research on Zyprexa. And in the last ten years that the drug has been on the market, Lilly, government bodies such as the National Institute of Mental Health, and competitors -- in numerous studies that sought to show a causal link to Zyprexa and diabetes -- have not found that Zyprexa causes diabetes.

"Second, Zyprexa was approved by the FDA in 1996 and remains on the market today. In that time, it has been used by more than 20 million people worldwide, and doctors continue to prescribe it to deal with some of the most terrible mental illnesses, such as schizophrenia and bipolar disorder. The FDA has looked at the entire body of evidence that Lilly has continued to provide over the years, and has affirmed the benefit that this medicine can give to patients when accompanied by appropriate labeling regarding benefits and risks.

"Third, from the day that Zyprexa was approved, the labeling provided to physicians identified the potentially clinically-significant weight gain that was observed in more than half of all patients treated long-term with Zyprexa, as well as the diabetes-related adverse events observed in clinical trials.

"Fourth, the Times failed to mention that these leaked documents are a tiny fraction of the more than 11 million pages of documents provided by Lilly as part of the litigation process. They do not accurately portray Lilly's conduct. As part of Lilly's commitment to patients and healthcare professionals, many high-level Lilly physicians and researchers -- along with researchers from outside Lilly -- were engaged for a number of years to study the issue of Zyprexa and diabetes. Leaked documents involving these discussions do not represent an accurate view of company strategy.

"And, finally, Lilly deplores the illegal release of select confidential documents. Our concern is that this illegal and selective disclosure of incomplete information will cause unwarranted concern among patients that may cause them to stop taking their medication without consulting a physician. This is the unfortunate result we saw when plaintiffs' lawyers aggressively advertised about Zyprexa in recent years while searching for clients."

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

New schizophrenia drugs no better than generic

Thu, 30 Nov 2006 19:01:36 -0500

The American Journal of Psychiatry has published new research that supports the argument that the $10 billion a year spent on a new wave of schizophrenia drugs is largely being wasted. Zyprexa, Seroquel and Risperdal--which have captured the market in the field--work no better than an older and much cheaper generic drug. Using the generic perphenazine, for example, would be $300 to $600 a month cheaper per patient than the prescription drugs. The authors of the study, though, aren't calling for patients to be switched over immediately. Many of these drugs are prescribed in a hit-or-miss approach and patients who are benefiting from their therapies should stay on them. In many cases, the effectiveness of one of these therapies wears off after a relatively short time, marking a good point at which the generic could be prescribed.

- read the report on the study from The Washington Post

Related Article:
Government widens probes of antipsychotic Risperdal. Report
Study shows that Alzheimer's drugs don't work. Report

Ed. Note: Corrected the figure. Thanks for the comment!

Study shows that Alzheimer's drugs don't work

Wed, 11 Oct 2006 20:01:37 -0400

The primary drugs used to treat a wide range of symptoms of Alzheimer's--including agitation, aggression and hallucinations--are no better than placebos. That's the conclusion of researchers involved in a 33-site study of Zyprexa, Seroquel and Risperdal. Up to half of the patients in the study stopped taking the drugs because they weren't working and up to 24 percent stopped because of side effects. Scientists said the data showed that a new generation of therapies need to be developed which can work for the millions of people who suffer from Alzheimer's.

- read the report on the study from the Seattle Times

Researchers conclude new schizophrenia drugs little better than the old

Mon, 19 Sep 2005 20:01:37 -0400

In a major, government-sponsored study, researchers have concluded that a new group of branded schizophrenia drugs are little or no better than much cheaper, older drugs in the same class. The study compared four new schizophrenia medications with one older one. Three quarters of the patients in the study dropped out, complaining of side effects or discomfort. Zyprexa from Eli Lilly did work longer than the other drugs in controlling symptoms, but patients taking the drug also were more likely to experience weight gain that left them vulnerable to diabetes.

The study could have a major impact on the multibillion-dollar market for schizophrenia drugs. The four new drugs in the study garner $10 billion a year and command 90 percent of the market. Several state Medicaid programs already restrict beneficiaries to the newer drugs and many more are likely to follow in their footsteps following the new study.

- read this article from The New York Times

Lilly agrees to $690M drug settlement

Thu, 09 Jun 2005 20:01:39 -0400

Eli Lilly has agreed to pay $690 million to resolve some 8,000 claims that its antipsychotic Zyprexa triggered diabetes-related health problems. The drug company did not admit any wrongdoing in the settlement, which comes just months before the first of scores of lawsuits were scheduled for trial. The settlement would resolve about 75 percent of the cases faced by Lilly. Most of the claims revolve around accusations that prior to September 2003 the company didn't adequately warn patients about possible side effects of the drug, which was used to treat schizophrenia.

- read this story from the Indianapolis Star