The FDA has announced a public health advisory about abnormal behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior with Pfizer’s anti-smoking drug. And has provided updated numbers - 491 cases of suicidal thinking or behavior, including 420 in the US. And of those, there were 39 suicides, including 34 in the US.

“We’ve become increasingly concerned as we see a number of cases that truly look like exposure to the drug and not other causes,” says Bob Rappaport, director of the FDA’s division of anesthesia, analgesia and rheumatology products, in a briefing this afternoon with reporters.

As of now, he adds, “there’s no definitive evidence there’s a causal relationship” between Pfizer and the abnormal and suicidal behaviors. Although, the agency notes that “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.”

Pfizer has contended that “some reports may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking, but not all patients with these symptoms had quit smoking.” Rappaport says that it remains unclear whether the adverse events are related to withdrawal symptoms. “We’re not yet absolutely sure it’s related to stopping the drug.” The FDA found evidence some Chantix patients experienced psychiatric problems even though they were still smoking.

The agency, which began reviewing cases last November, announced new changes to the Chantix product labeling, although Pfizer updated the labeling two weeks ago.

Read more »

The drugmaker is offering to pay the biotech a royalty so it can sell its Mircera drug in the US, according to reports citing documents filed in Boston. Why does Roche need to pay Amgen? Although Roche won FDA approval to sell Mircera, the drugmaker last October lost a lawsuit in which a jury decided the anemia drug violated Amgen patents.

So Roche is offering to pay Amgen a royalty that is roughly double what Johnson & Johnson pays Amgen to market Procrit. Specifically, Roche is willing to sell Mircera for about 5 percent less than what Amgen charges for its Aranesp medication and pay a royalty of 20 percent on US net sales for the duration of Amgen’s patents. Roche says that US District Court Judge William Young asked the drugmaker to make a proposal.

“It is projected that under this current proposal that the savings to Medicare and the US. Government and taxpayers for reimbursement for treatments with these pharmaceuticals will be substantial, and easily in the billions of dollars,” Roche wrote in its court filing, according to the paper.

“Is this a reality that’s going to play out? Probably a small chance,” William Burns, head of Roche’s pharmaceutical unit, tells The Wall Street Journal. “It’s now up to Judge Young to take a holistic view of all the evidence he’s seen and make his judgment.”

As of now, Amgen is playing hard to get. “As Amgen demonstrated at the injunction hearing, Roche’s product and marketing proposals confer no clinical benefit, serve no public interest, and would actually increase the cost of treatment to Medicare, especially in the short term,” Amgen says in a statement e-mailed to us. “Roche’s belated royalty proposal is grossly inadequate to compensate Amgen for Roche’s infringement and lacks any merit.”

Read more »

The Canadian drugmaker says the US Attorney in Boston is investigating activities surrounding its 2003 launch of the blood pressure med, and both civil and criminal charges may result. At issue is a program called PLACE - Proving LA through Clinical Experience - that the drugmaker used to encourage docs to prescribe the pill. (LA refers to longer acting).

As the WSJ Health Blog reminds us, Biovail was happily payed docs up to $1,000 and gave office managers as much as $150 to persuade them to participate, a Biovail spokesman at the time explained that the program was supposed “generate physician survey data” that would be published. Nothing like money well spent.

“Biovail has cooperated fully with the investigation, and will continue to cooperate,” Biovail says in a statement. “The corporation has been invited to provide evidence and arguments bearing on the matter to the U.S. Attorney’s Office and intends to do so as soon as practicable.”

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs being announced each month. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone?

TargetRx hired Craig Scott as ceo and president;
Glaxo hired Lon Cardon to head its genetics organization;
Interleukin Genetics named Lewis Bender as ceo;
RxElite named Rick Schindewolf as vp, business development;
TNS Healthcare hired Ceri Thomas as exec vp, global accounts;
BioMarin Pharmaceutical hired Gordon Vehar from Genentech as vp of research;
Cerenis named Robert Scott as chief medical officer;
Cardiokine named Manuel Worce as ceo and president;
Lentigen hired Tim Ravenscroft from Bristol-Myers Squibb as its new ceo;
InNexus added J. Donald Capra to its board;
Barrier Therapeutics named coo Alfred Altomari to succeed Geert Cauwenbergh as ceo on March 31;
Generic Pharmaceutical Association hired US Senate staffer Lisa Layman as associate vp for gov’t affairs;
Institute for Pediatric Innovation hired Stephen Spielberg as principal investigator for its reformulation program;
Solvay Pharmaceuticals hired Stephen Hill as its new ceo as of April 30 to replace the retiring Larry Downey;
NPS Pharmaceuticals elected Peter Tombros as board chairman and Francois Nader as a director.

John Jenkins is the FDA’s director in the Office of New Drugs, and a 16-year agency veteran which means he is constantly in the thick of it. And so The RPM Report, which does a marvelous job tracking the agency and its interaction with pharma, sat down to quiz Jenkins on the latest hot button topics. The following is an excerpt (and for those who would like to read more, follow this asterik* below for instructions).

RPM: With new molecular entity approvals at the lowest number since 1983 and the drug industry spending about 11 times more on R&D than it did 25 years ago, can you comment on what you think the problems are in getting new therapies approved?

Jenkins: We’ve been analyzing these data internally. One thing that struck me is that if you exclude the peak that occurred in 1996 and then a shoulder peak in 1997 for NME approvals, the curve is much flatter than the dramatic fall that we’re all concerned about. Everyone is concerned that in ‘96 and ‘97, we had this peak of about 50 NMEs approved and it’s been downhill ever since. If you flatten out those two aberrant years, the curve is much flatter and looks much less dramatic. One thing we want to further analyze is whether ‘96 and ‘97 might be aberrant years because that may simply have reflected clearing out things backed up before (the reauthorization of the Prescription Drug User Fee Act). We haven’t done that analysis yet. That ‘96 peak may be a false data point.

RPM: You have headed up the Office of New Drugs for almost six years now. Are there approval decisions made today that would have been different if they were made when you started the job?

Jenkins: I don’t think it’s really possible to know the answer to that question. It’s hard to take an application that’s being reviewed in 2008 and try to think what would we have done with this application in 2002. I do feel comfortable in saying that the statutory standards have not changed. We have never - I’ve actually been here 16 years, six years in the current job - systematically issued a directive to our staff that we should slow down or speed up on approvals. I don’t think the standards have changed, but in some cases the science changes. It becomes a hard question of how do you apply the evolving science. We didn’t know as much in 2002 about some of these drug classes as we know today.

There’s no doubt that the climate today that we’re operating in as far as the public scrutiny, investigations, criticism is much more intense than it was in 2002. How much impact that actually has on day-to-day decision-making on applications is very hard to quantitate. We have to recognize that the people in my office that make these decisions are making them based on a judgment of the benefit and risk of the drug. Is it possible that their judgment of a close case is being influenced by the current climate? That’s possible, but we don’t see any data that yet support that it’s actually happening.

RPM: If you could address a room full of biopharma CEOs, what would you say are some of the most important things they could be doing to improve drug development? And what things should they not be doing?

Jenkins: There’s a lot of things that someone could point to…

Read more »

There are reports circulating Thailand that PhRMA is lobbying Washington to take tough action against the country, The Bangkok Post reports.

Puangrat Asavapisit, the Intellectual Property Department’s director-general, says she was informed the trade group met last week in Singapore and that the action would involve the US Trade Representative downgrading Thailand from the current Priority Watch list to Priority Foreign Country, the last and most severe US copyright protection category and subject to trade sanctions. The USTR reviews the status of IP protection for its trading partners every year and classifies problem countries in four categories: Monitoring, Watch, Priority Watch and Priority Foreign Country.

Puangrat says the threat came amid recent news that the outgoing military-appointed government would proceed with the implementation of more compulsory licensing for cancer drugs.”We hope that the new government handles this issue carefully, as PhRMA is the most influential organisation in US politics, and on top of that the US economy is now in poor condition,” said Mrs Puangrat.

However, Puangrat tells the Post she was afraid that the USTR would pressure Congress over the next six months to eliminate trade preferences that currently allow some Thai imports duty-free access to the US. In a bid to prevent adverse effects, the department is preparing to clarify the country’s position to the USTR before the proposed deadline on Feb 15. Thailand was placed on the US Trade Rep’s Priority Watch list in April.

There must be a pharmaceutical angle here somewhere….

Two Springfield, Illinois, doctors and their wives have sued a Merck sales rep for allegedly sending anonymous letters that claimed the couples are heavy drinkers and freeloaders, The Springfield Journal-Register reports.

“These two doctors and their wives feel this conduct can’t be tolerated,” their lawyer, Charles Watson, tells the paper after filing the defamation lawsuit against Beth Kallal, the sales rep. “It’s the type of intimidation that cannot be allowed.”

The lawsuit, filed in Sangamon County Circuit Court by internist Carl Lawyer, family-medicine specialist Paul Smelter and their wives, seeks more than $50,000 in damages from Merck and Kallal, a Springfield resident. Kallal, who previously denied any connection with the letters, couldn’t be reached for comment this week, the paper writes. And a Merck spokeswoman declined comment because the drugmaker hadn’t yet seen the lawsuit.

The lawsuit focuses on letters the couples say were sent after a dinner Merck hosted at Indigo restaurant on Jan. 10, 2007. The dinner, which Kallal attended, was designed to educate the doctors about Merck’s new anti-shingles vaccine, Zostavax, according to court documents filed by the couples.

Lawyer, who practices with Smelter at Physicians Group Associates, said in an affidavit that during the 2007 event, he asked a medical expert provided by Merck to answer a question about potential cardiovascular side effects associated with Zostavax. The paper writes that the expert wasn’t able to answer the question, according to Lawyer’s statement. The doctors’ suit says Lawyer’s question “could be considered embarrassing to Merck.”

Read more »

French authorities have opened a formal investigation into two managers from Glaxo and Sanofi Pasteur over a vaccination campaign in the 1990s, a judicial tells Reuters. Judge Marie-Odile Bertella-Geffroy also opened an investigation for manslaughter against Sanofi Pasteur MSD, a joint venture between Sanofi Aventis and Merck, the same source said.

The investigations follow allegations that the drugmakers failed to fully disclose side effects from an anti-hepatitis B drug used in a vaccination campaign between 1994 and 1998. There was no immediate comment from the companies or the two managers involved.

From 1994 to 1998, almost two thirds of the French population and almost all newborn babies were vaccinated against hepatitis B, but the campaign was suspended after concerns arose about possible secondary effects from the treatments. Some 30 plaintiffs have launched a civil action in the case, including the families of five people who died after vaccination.

Question: What does Bristol-Myers Squibb make besides drugs?

Answer: Bad investment decisions.

As you know, the drugmaker took a $275 million write-off to reflect a sharp drop in the value of debt-related investments, including residential and commercial loans linked to sub-prime mortgages.

“Investors can now add to the list of questions to ask a pharmaceutical company in addition to asking about the studies and pipelines and patent expirations: What is your sub-prime exposure?” Carol Levenson, director of research at Gimme Credit, wrote in a note to clients. The write-down “speaks poorly for the company’s stewardship of its cash.” And she predicts more to come.

Source: The Los Angeles Times

Hat tip to Pharmagossip