Asenapine therapy was cleared in the U.S. in 2009 to treat schizophrenia and bipolar disorder mania.

Merck & Co’s non-U.S. business, MSD, reported approval throughout the EU for Sycrest®, a sublingual asenapine drug for treating moderate to severe manic episodes in adult patients with bipolar I disorder. Sycrest was first approved in the U.S. in 2009, where it is marketed as Saphris® for the treatment of schizophrenia and mania in bipolar disorder.

EU approval was based on data from trials involving some 1,300 patients with bipolar mania. Studies included two montherapy trials comparing Sycrest with olanzapine and placebo and a 326-patient study evaluating the drug as  adjuctive therapy to lithium or valproate.

The results of the 12-week placebo-controlled trial found that giving asenapine to patients who were partially nonresponsive to lithium or valproate monotherapy resulted in improved reduction of manic symptoms compared to what either approved drug could achieve when given alone.

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According to company sales notes released to a court in South Carolina Tuesday, Eli Lilly allegedly provided certain incentives to physicians, such as paying them to participate in a speakers’ programme, in exchange for prescribing Zyprexa (olanzapine), Bloomberg reported. The court hearing was held to consider a motion by the drugmaker to prevent the state’s case regarding allegations of improper marketing from going to trial later this month.

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One call note reportedly indicates that a company sales representative urged a physician to prescribe more Zyprexa “because we’re paying him so much money” to take part in the speakers’ programme. The same employee, in a note dated August 2001, allegedly advised a colleague to tie a physician’s Zyprexa prescriptions to participation in the programme, suggesting that “if [the doctor's] numbers go up, maybe he can talk.” John Simmons, a lawyer representing South Carolina, also claims that Eli Lilly offered other incentives, including recreational trips and gifts, to doctors who prescribed the drug.

Commenting on the matter, company spokesperson Marni Lemons stated that call notes “are not literal recitations of interactions with physicians.” She added that the notes were being taken “out of context” and “not one physician employed by the state of South Carolina has testified Eli Lilly promoted off-label to them.”

South Carolina is reportedly seeking to recover $200 million it spent on Zyprexa prescriptions as a result of alleged off-label marketing practices to physicians. The trial is scheduled to begin on September 14.

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Eli Lilly indicated Tuesday that it is seeking to reduce its US sales force through a voluntary exit programme ahead of a planned restructuring scheduled to begin in mid-November.

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Approximately 4000 sales employees in the drugmaker’s US diabetes, neuroscience and osteoporosis units will be eligible for the programme, but company spokesman Ed Sagebiel said buyouts would be limited to “a few hundred employees.” He noted “we hope to get that head count down before the restructuring takes place,” adding that the buyouts may lessen the need to implement “other actions.”

Sagebiel explained that the restructuring is aimed at helping sales representatives to “connect more deeply with customers and increase accountability.” Under the new structure, staff will be divided into smaller territories, each with one representative who has “deep therapeutic expertise,” compared with the current larger territories covered by multiple sales partners. He also said the reduction in staff is a response to the “economic environment,” which includes the expected US patent expiry of Zyprexa (olanzapine) in 2011.

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Internal documents unsealed as part of a lawsuit against Eli Lilly are alleged to show that the company hired ghostwriters to prepare articles about Zyprexa (olanzapine) for submission to medical journals, Bloomberg reported. Ensuring that the articles presented study data for the antipsychotic drug in a positive light was one approach for the drugmaker to reach it sales targets, Eli Lilly officials said, according to the unsealed documents.

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The files were made public as part of litigation by insurers and pension funds that are seeking up to $6.8 billion in damages over claims that Eli Lilly downplayed health risks associated with Zyprexa and marketed the drug for off-label uses. Eli Lilly has appealed a ruling in the case by a district court judge, who in September found “sufficient evidence of fraud” against the company and allowed the insurers and other payers to proceed with a class action lawsuit.

Commenting on the news, company spokesperson Marni Lemons said that “plaintiffs are releasing one-sided, cherry-picked documents obtained in discovery to selected news media in an effort to try their cases.” She added that Eli Lilly “remains prepared to defend [itself] against all of these allegations in…a court of law.” Lemons declined to comment specifically about the practice of ghostwriting.

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Separately, Bloomberg reported that the unsealed documents included information that is alleged to demonstrate that Eli Lilly marketed Zyprexa off-label for use by elderly patients with dementia as early as 1999, even though it was aware at that time of study data showing the drug did not alleviate symptoms of the condition in this population. As part of a $1.42-billion settlement reached with the US government earlier this year, Eli Lilly pleaded guilty to a misdemeanour charge regarding its promotion of Zyprexa between 1999 and 2001 for the treatment of elderly patients with dementia. The settlement resolved civil suits and ended a federal criminal investigation into past marketing practices for Zyprexa.

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An FDA advisory panel on Wednesday voted that Pfizer’s Geodon (ziprasidone), AstraZeneca’s Seroquel (quetiapine) and Eli Lilly’s Zyprexa (olanzapine) have been shown to be effective and “acceptably safe” at treating schizophrenia and/or bipolar disorder in younger patients.

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AstraZeneca is seeking approval to market Seroquel for schizophrenia in patients aged 13 to 17 years, and for bipolar disorder in patients aged 10 to 17 years. The drugmaker noted that the committee’s overall vote was positive regarding the safety and efficacy of the drug for both age groups and both indications.

In addition, Eli Lilly indicated that the majority of experts voted favourably that Zyprexa is safe and effective to treat schizophrenia and bipolar disorder in adolescents. The company is seeking approval of the drug as a second-line treatment in the 13-to-17-year-old age group. Panellist Frank Greenway indicated that while he had concerns about metabolic side effects associated with Zyprexa, he believes that “if this is going to be used as the last treatment option then I think having other treatments available to physicians is worthwhile.”

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Regarding Geodon, members of the advisory panel voted by a margin of 8 to 1, with nine abstentions, that Geodon is safe for children and adolescents aged 10 to 17 years with bipolar disorder. The abstaining members were concerned that Pfizer provided incomplete data.

In further comments, panellist Ruth Day remarked that she was “concerned about the lack of true long-term studies” for the atypical antipsychotic drugs, especially in younger patients. A review document prepared by FDA staff and released last week also raised concerns about long-term risks from potentially “significant” side effects, such as weight gain and elevated blood glucose levels.

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In documents posted to the FDA’s website ahead of an advisory panel meeting, agency staff said clinical data showed that Pfizer’s Geodon (ziprasidone), AstraZeneca’s Seroquel (quetiapine) and Eli Lilly’s Zyprexa (olanzapine) appear to be effective at treating schizophrenia and/or bipolar disorder in patients aged 10 to 17 years. However, they noted that the atypical antipsychotics, for which the companies are seeking approval for use by children and adolescents in one or both of these indications, carry “significant” side effects.

The reviewers wrote that the “safety profile of the paediatric population is very similar compared to that of the adult population,” and indicated that although there were no side effects unique to the younger age group, there were differences in the frequency of the effects. Risks associated with the drugs included weight gain and increased blood glucose levels, and Thomas Laughren, director of the regulator’s psychiatric products division, remarked that these risks “are of particular concern in paediatric patients because of the lifelong nature of these disorders.”

Regarding Geodon, for which Pfizer is seeking approval to treat bipolar disorder in patients aged 10 to 17 years, FDA clinical reviewer Mark Ritter suggested regulators include children in a warning currently on the label about a form of irregular heart beat. He remarked that children are “at least as sensitive” to the effects of the condition “and may potentially be at greater risk” for serious irregular heartbeats. Pfizer said that overall, the drug was well-tolerated in younger patients.

With regard to Zyprexa, which Eli Lilly applied to market as a second-line schizophrenia and bipolar disorder treatment in adolescents, FDA reviewers supported the drug’s use in that indication, and noted increased risks of weight gain and other adverse events associated with use of the drug. In addition, AstraZeneca is seeking FDA clearance to market Seroquel for the acute treatment of schizophrenia in adolescents, as well as to children aged 10 years and up with bipolar disorder. According to data provided by the drugmaker, increases in hypertension and appetite were observed more frequently in children than in adults receiving the treatment.

The agency nonetheless acknowledged the need for additional drugs to treat schizophrenia and bipolar disorder in older children and adolescents. Advisory panel experts will convene on June 9 and 10 to vote on whether the products are effective and safe for these patients.

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A US district court judge ruled to exclude the testimony of an expert witness for the plaintiffs in cases involving Eli Lilly’s Zyprexa (olanzapine). The judge explained that the physician, who has testified in about 20 separate cases, “cannot be allowed to testify because his opinions are neither based on sufficient facts or data nor are they the product of reliable principles and methods.”

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Judge Jack Weinstein of the US District Court, Eastern District of New York, noted that the witness, Stephen Hamburger, was “shockingly careless about the facts in the cases he proposes to opine about,” and said the physician gave conflicting answers to questions about the “claimed causal link between Zyprexa intake and medical injury.” Weinstein noted that Hamburger “repeatedly and impermissibly stretched the truth to support findings of causality.”

The plaintiffs are claiming Eli Lilly promoted unapproved uses of the antipsychotic drug to physicians, and the injury claims included in some of the cases allege that use of the product by patients was associated with weight gain and diabetes. The drugmaker said late last month that there were 140 claims related to Zyprexa still pending.

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Eli Lilly reported at the International Congress on Schizophrenia Research that Phase II study results of its experimental schizophrenia treatment LY2140023 were “inconclusive,” due to a greater-than-expected response in patients taking placebo. The company said it plans to undertake an additional mid-stage study on the compound next year, and it explained that the decision to continue development is based in part on previously announced data for the drug.

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The most recent trial enrolled 669 patients with acute schizophrenia, 393 of whom completed the four-week study. A primary analysis showed that none of the four doses of LY2140023 administered twice daily “separated from placebo.” In addition, Eli Lilly noted that for patients who took the comparator drug Zyprexa (olanzapine) once daily, Zyprexa did not separate from placebo. The drugmaker said the higher-than-expected placebo response was approximately double what has typically been observed in schizophrenia clinical trials.

Regarding side effects, findings showed that LY2140023 had a “low association” with adverse events commonly linked with current antipsychotic treatments, and that patients taking LY2140023 showed no appreciable weight gain. However, Eli Lilly also indicated that convulsions were observed in three patients taking its experimental mGlu2/3 receptor agonist.

Commenting on the news, Steven Paul, president of Lilly Research Laboratories, stated that the company “remains optimistic that the novel mechanism of compounds with the ability to reduce glutamate hyperactivity…will someday represent the next generation of breakthrough treatments for schizophrenia.” However, Leerink Swann analyst Seamus Fernandez described the data as a “serious blow” to Eli Lilly’s pipeline, saying that “any additional studies [with LY2140023] should be viewed as exploring the mGlu2/3 mechanism, but the agent should not move forward into Phase III studies due to safety concerns.”

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Eli Lilly announced on Monday that the FDA granted expanded approval for Symbyax (olanzapine/fluoxetine) in the acute treatment of treatment-resistant depression (TRD). The new indication applies to adults with major depressive disorder who have twice experienced failure to respond to other antidepressants during their current episode, and the company said its combination product is the first drug to receive FDA approval for this use.

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The FDA also approved the use of its antipsychotic Zyprexa (olanzapine), in combination with Prozac (fluoxetine), in adults for the acute treatment of bipolar depression and for the acute treatment of TRD, the drugmaker said.

Additionally, Eli Lilly reported that the company updated the labels for Zyprexa and Symbyax to include extra information on weight gain, hyperglycaemia and hyperlipidaemia in patients taking the drug. The move follows an FDA review of study data which the drugmaker submitted to the agency between August 2007 and July 2008.

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The US Attorney’s Office for the Eastern District of Pennsylvania stated that Eli Lilly formally entered a guilty plea to a misdemeanour charge for the off-label promotion of Zyprexa (olanzapine). The drugmaker agreed to the plea earlier this month when it concluded a $1.42-billion settlement regarding a US federal investigation of its past marketing practices for the antipsychotic.

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US federal officials allege Eli Lilly promoted the product to treat dementia in the elder patients, among other unauthorised uses. CEO John Lechleiter stated that “we deeply regret the past actions covered by the misdemeanour plea.”

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