And so Monday is over. Hope yours was as interesting as ours. Now, though, the time has come to catch up on sundry tasks - recycling, for instance, must be carted off the Pharmalot corporate campus this evening - and we hope to indulge later with a good book. See you all in the morning…

Schering-Plough Asthma Inhaler Approved For Children (Yahoo/AP)

Glaxo Vaccine May Prevent Recurrence Of Lung Cancer After Surgery (The Telegraph)

Three Pfizer Employees In Nigerian Court In Trovan Case (Agence France Presse)

Three people have died and several others suffered serious reactions after taking Lamisil, which is used to treat ringworm and nail fungal problems, according to Australia’s Therapeutic Goods Administration. The agency, which notes Lamisil can cause liver problems, received 722 adverse event reports, including 70 liver reactions, and 61 implicated the tablet form as the prime culprit. Half of those affected suffered liver reaction within a month.

“Three (of the reports) describe fatal liver failure, 10 describe hepatitis, and 12 describe jaundice,” according to the TGA’s latest drug reactions bulletin. “Full recovery was noted in 27 reports but 34 cases had not recovered and the outcome is unknown in nine.”

This is the first report linking Lamisil to liver dysfunction but three others dating as far back as 1996 implicate the drug in the blood condition dyscrasia, according to news.com.au. The TGA, which notes the tablet is prescribed when topical treatments don’t work, warns the tablet should only be used as a last resort. A Novartis spokesman tells the site that serious reactions were rare side-effects of oral anti-fungal medications but he agreed with the TGA’s advice.

A new longer-lasting version of the drugmaker’s antipsychotic appears effective, but a small number of patients experienced excessive sleepiness, according to FDA medical reviewers, who posted a briefing document on the agency’s web site in advance of an advisory committee meeting on Wednesday.

Zyprexa, of course, is currently marketed as a once-daily pill to treat schizophrenia and bipolar disorder, while the new formulation is injected into the muscle and is designed to last two to four weeks. But the FDA reviewers plan to ask the Psychopharmalogic Drugs Advisory commitee to assess cases of “profound sedation,” which was seen in 1.2 percent of patients. Most occurred within three hours after injection, by the way.

According to FDA, the side effect is unique to the injectable version of Zyprexa and may require a warning labeling. Based on draft questions posted to its Web site, FDA will ask its advisers whether the drug requires a Black Box warning (see pages 1 and 2 of the briefing document). (The pill is linked to weight gain and diabetes, which prompted Lilly has so far paid $1.2 billion to settle 30,000 lawsuits, and may pay a $1 billion fine for off-label marketing violations).

In its own documents, Lilly argues that the unusual side effect is found in both the pill and the new injectable version. Look on page 56 where it says there were “no differences in the incidence or timing of sedation” events between old and new forms of Zyprexa. In explaining the sedation, the drugmaker suggests the side effects may have been due to docs incorrectly injecting Zyprexa directly into the bloodstream, instead of into the muscle, because absorption takes place in just a few hours instead of days or more.

The White House requested a $2.4 billion budget for the agency for the 2009 fiscal year starting in October, up 5.7 percent from 2008. And the Bush administration includes new funds to speed review of generics and new authority to approve biosimilars, which are also sometimes referred to as generic biologics.

Generic drugmakers have been pushing the FDA for specific guidance on developing biosimilars, an issue that has gained traction as part of the larger health care debate because existing biologics are expensive, often costing tens of thousands of dollars a year per patient.

“A pathway filled with roadblocks to access, including excessive market exclusivity provisions, is an empty promise for countless patients who need these affordable life-saving medicines,” Kathleen Jaeger, ceo of the Generic Pharmaceutical Association, says in a statement.

Drugmakers and medical device makers now pay user fees to the agency to speed review of their products. The agency, in a repeat of a request last year, is seeking fees from generic companies to do the same. Lawmakers would need to pass separate legislation to allow the FDA to charge the generic drug fees. The trade group called for Congress to increase supplemental funding for the FDA’s Office of Generic drugs. Administration officials, meanwhile, will release more details on the budget later this afternoon and the FDA is planning a briefing.

Want to read about FDA performance? Look here, and click on the chart, too. And this is the 2009 proposed budget.

Last fall, a spat emerged over the Medication Guide that drugmakers are required to have distributed with their antidepressants. The guide issued in 2005, shortly after the FDA first required Black Box warnings on the pills, was filled with tips and suggestions for parents and guardians - behavior that can be interpreted as worrisome; a reference to clinical study results, and specific info on when a doctor visit is a good idea.

A revised version is now out and, while similar to the 2005 guide, the language is different. The new two-page guide offers a more generalized alert for children, teenagers and young adults - the populations for which Black Box warnings were issued. But some specifics in the earlier guide are missing or condensed, and the emphasis that was initially placed on children is no longer there. (Old and new guides).

The differences drew a sharp response from Mike Ferguson, a Republican congressman from New Jersey, who accused the agency of taking a step “backwards” and putting children at risk. So he sent a letter to the FDA and demanded the agency scrap the new guide and ensure the older version is distributed. Last week, Ferguson received a reply - and he’s not pleased. That’s because the FDA isn’t budging. “There is always a tension between presenting very extensive information and focusing on the most critical points,” writes Steve Mason, an acting assistant FDA commissioner for legislation.

And so Ferguson is forwarding his files on the issue to the House Subcommittee on Oversight and Investigations, which is already conducting several investigations into pharma and the FDA. “This is a non-response, which took them three months,” says Chris Jones, Ferguson’s chief of staff. “I think we’ve been pretty clear - the new version dilutes the power of the first version. We don’t feel they’re truly addressing the main points. This is not a step forward in helping parents make informed decision for their kids. The bottom line is we’re disappointed.”

Last November, the controversial former Pfizer exec won a significant victory when a federal appeals court ruled that his whistleblower lawsuit against the drugmaker should proceed. A federal judge had previously dismissed the case because Rost “failed to plead his fraud claims with sufficient specificity,” a reference to rule 9b, a provision of the False Claims Act that requires particular info about false claims submitted to the government for payment. This might include amounts charged, drugs prescribed, patient diagnosis and individuals involved in billing.

Given the level of detail required, however, winning the reinstatement looked like the easy part, because the info contained in Medicaid databases may compromise patient privacy. Last week, for instance a whistleblower lawsuit filed by two former sales reps for Johnson & Johnson’s Ortho-Biotech unit was dismissed, in part, because there was a lack of such detail.

Now, though, Rost has filed documents with US District Court in Boston offering examples that may clear this high hurdle (here is the filing). And there are at least two potentially significant developments here. One is the long-term implication for Pfizer, should Rost ultimately prevail. The other is that his efforts may serve as a template for other whistleblowers who are similarly stymied by federal judges seeking details that are, otherwise, very hard to come by.

In his filing, Rost cites approximately 200 instances in Indiana which Genotropin, a human growth hormone, was marketed by Pharmacia (which was bought by Pfizer) for unapproved uses, such as combating aging in adults and treating short stature in children.

Read more »

A state senator wants answers about the money spent by the state’s Medicaid program on psychiatric meds for children after reading a report in The New York Post, which found Medicaid paid $82.8 million in 2006 for numerous pills for thousands of children, even though many of the meds were never approved by the FDA for treating kids.

“It is critical that state agencies be fully responsible and aware of the medical ramifications of psychiatric drugs that are prescribed for children,” Tom Morahan, who chairs the state senate’s Committee on Mental Health and Developmental Disabilities, says in a statement. He’s demanding that the state’s commissioners for health and mental health, respectively, issue a report by Feb. 25.

This comes amid growing debate over antipsychotics, and fears that kids are misdiagnosed; drugs are inadequately studied; some docs presribe the pills too readily, and drugmakers promote the meds improperly. New York health department officials say they don’t know which illnesses Medicaid kids are suffering.

“Pharmacy claims do not require a diagnosis,” a department spokeswoman tells the Post. Claims are paid without question based on a doctor’s judgment that a drug is “medically necessary,” even when not approved for kids, Medicaid officials tell the paper. They add, however, that the state now plans to look closer at how and why some drugs are prescribed.

Read more »

As part of the deal, Takeda agreed to buy Amgen’s unit in Japan, and will pay $200 million, plus as much as another $702 million tied to the development of about a dozen meds for treating such illnesses as cancer and arthritis, among other things. Amgen will also get $275 million for worldwide rights to one particular cancer drug, motesanib. (Here’s the Amgen statement).

The agreement immediately bolsters Takeda’s pipeline as it looks to compensate for declining sales of its Actos diabetes pill. For Amgen, the deal provides needed cash amid a cost-saving restructuring and lower revenues of its key anemia meds.

“Japan is a very complex market with specific regulatory requirements, which make it pretty expensive for a company not established in Japan to be able to launch and commercialize such a large group of products,” sDominique Monnet, Amgen’s vice president of global marketing, tells Bloomberg News. biotech decided to form a partnership with Takeda rather than sell rights to individual drugs with multiple companies, he adds.

Welcome to the working week. We hope you enjoyed yourselves and feel refreshed, especially those of you who spent last night on the edge of your seats watching the Super Bowl. Not a bad contest, eh? Now, though, it is time to catch up with events. So grab a cup of something hot or a bottle of water and try these…

Nigeria’s Case Against Pfizer Set To Resume (Legalbrief.com)

Doubts Over Glaxo’s Cervarix Vaccine Launch Persist (The Financial Times)

Schering-Plough Says AIDS Drug Subdues Virus (Bloomberg News)

Pfizer Gives $1M To Canadian Researchers (The Vancouver Sun)