And so another exciting day winds down, which means the time has come to kick back, watch a movie, kick back a stiff potion and do a little reading. First, though, we leave you with these….

Tysabri Is Backed By FDA Panel, But With Restrictions (Bloomberg News)

Court Considers Wyeth Motion To Prevent Generic Protonix (press release)

Cephalon Posts A Loss On Settlement Reserve (Bloomberg News)

Alza is eliminating approximately 600 jobs in research, development and support by year’s end, according to The Silicon Valley-San Jose Business Journal. The restructuring came within hours of the announcement by Alza’s parent, Johnson & Johnson, that it plans to cut its global work force by 3 percent to 4 percent, or as much as 4,820 jobs.

Another 200 positions in clinical development, manufacturing, sales and marketing, at both Alza and Scios - another J&J division - will be relocated to other company sites, including its West Coast hub for drug discovery in La Jolla, Calif.

Alza was acquired in 2001 by J&J for $10.5 billion and Scios was acquired in 2003 for $2.3 billion. The two companies will vacate their shared office space at in Mountain View, which is in Silicon Valley, by year’s end, and Alza will seek a buyer for its stake in the property. The company says that its 1,200-person facility in Vacaville will continue to operate without disruption.

For the past week, Wyeth has been on the defensive over Pristiq. Instead of approving the drug as a salve for hot flashes suffered by menopausal women, the agency issued only an approvable letter. The FDA did the same thing when it came to depression earlier this year. So Wall Street is understandably concerned - will this drug ever get approved?

To quell the speculation, Wyeth’s chief scientist, Bob Ruffalo, and chief medical officer, Gary Stiles, spent nearly an hour late this afternoon explaining in slightly greater detail their view of cardiovascular and liver side-effect issues that worry the FDA. Bottom line, says Ruffalo, is that Wyeth believes Pristiq doesn’t present a safety risk. “The safety profile is sound,” says Stiles.

Nonetheless, the agency wants a new, year-long trial, which won’t wrap up until the end of 2008. That’s a big delay. And there’s still no assurance Pristiq will get approved for hot flashes. Meanwhile, Ruffalo says he’s “confident” Pristiq will be approved for depression early next year. They need to be right: the Effexor antidepressant is far and away Wyeth’s biggest seller - last year, sales were $3.7 billion - but the patent expires in 2010.

That’s right. The Whistleblower, as Rost likes to call himself, is going to write about the pharmaceutical industry for a legitimate, reputable publication - BrandWeek. Although, Rost will write only for the magazine’s blog, BrandWeekNRx, since the previous writer is leaving. How do we know? Rost wrote us a private note confirming all this.

Why are we taking up space on this? Rost is a polarizing figure - a trained doctor who worked deep inside big pharma, he openly challenged the industry over pricing and importation, and then filed lawsuits against two employers - Wyeth and Pfizer - over alleged illegal practices of various sorts. In fact, Pfizer wound up paying a $35 million fine for off-label marketing.

Since then, he’s stirred up more trouble, writing about alleged off-label marketing or manipulated clinical trial data at Pfizer, AstraZeneca and Novartis on his unconventional, but widely read blog, Question Authority. And so his new gig is interesting for another reason - a blogger who is hired by the mainstream media to replace a journalist.

So instead of fading away, Rost is being given an even wider, credible platform to follow pharma. This will, no doubt, drive more than a few people inside Pfizer, and some other companies, a little crazy. But for the rest of us, it should be interesting.

Slicing and dicing is a lucrative activity for IMS Health, and so the research firm has just released a Medicare D analysis with a lot of interesting data. As an example, the chart indicates which type of meds beneficiaries sought. A few key findings:

- More than half, or 58 percent of beneficiaries previously had some private drug coverage, while 14 percent previously paid for drugs totally out-of-pocket. And 24 percent previously received coverage under Medicaid. And the previously uninsured benefited the most from Part D, saving 60 percent of their previous cost and increasing their use of meds by 26 percent.

- A quarter of seniors paying for their drugs totally out-of-pocket in 2005 moved to Part D in 2006, but another 55 percent continued to pay cash. This group of about 7.4 million seniors include those who may have decided that participating in this program didn’t make financial sense.

- The uptake of Part D prescription volume increased steadily through June 2006 as enrollment continued and patients grew familiar with the program. During the second half of the year, the Part D share of the retail market stabilized at 17 percent.

Read more »

After filing reports, answering e-mail, catching those phone calls and sitting through meetings, perhaps now is a good time to catch up on a few events….

The Branding Of A Blockbuster: Last year, Lilly spent $157 million on consumer advertising to push the message that Cymbalta can treat depression and the physical pain it causes. And that made Cymbalta the 6th-largest DTC ad campaign in the nation, an enormous leap from No. 92 the year before, according to Nielsen Monitor- Plus. Read more in The Indianapolis Star.

Tysabri Is Effective Against Crohn’s, Elan Tells FDA Panel (Bloomberg News)

Biota Raises Relenza Claim Against Glaxo (press release)

NJ Court Bars Vioxx Lawsuits From The UK (Newsday/Associated Press)

Novavax Begins Human Trials Of Flu Vaccine (Yahoo/bizjournals.com)

Everyone loves to speculate, especially journalists. And so In Vivo’s Roger Longman spent some time the past few days dialing sources, including headhunters, trying to figure out who’s in the running to succeed John LaMattina as Pfizer’s chief scientist. Of course, Pfizer may have a hard time luring someone - anyone - to steer a Queen Elizabeth ocean liner in a bathtub. Then again, as he notes, starting at the bottom isn’t always a bad thing - you can only go up.

So which names are floating by? Bob Ruffalo, Wyeth’s R&D chief, who is remaking the organization with myriad metrics, although he hasn’t yet completed his turnaround trick. John Patterson, who heads development at AstraZeneca and a board member. Joerg Reinhardt, the CEO of Novartis Vaccines and Diagnostics, and a former development head, but he’s believed to be succeeding Dan Vasella. And there’s Jeff Leiden, a former Abbott research head and COO at Abbott, who’s now with Clarus Ventures.

For some reason, Mark McLellan, the former FDA and CMS czar, makes the list. As Longman points out, industry loves him, but he’s more of a policy wonk now and unlikely to be content running a struggling research operation. Who else? Maybe a few research whizzes who’ve never held the top job: Mike Dohlsten, who heads discovery at Boehringer Ingelheim. Allen Oliff, Glaxo’s discovery chief. And Marc Tessier-Lavigne, an academic who is No. 2 at Genentech.

In the end, In Vivo bets on an obvious choice: Pfizer’s own Martin Mackay, who’s worked in research for a dozen years or so and is believed to be the top internal candidate. Pfizer ceo Jeff Kindler may have little choice, though, unless he reaches out to academia, where stock options - even Pfizer’s - are enticing.

The following list of suggestions was compiled by Jim Edwards, who is taking leave of BrandWeek, where he writes the BrandWeekNRx blog, to study at Columbia University. Jim is an astute, sometimes plucky, observer of the pharma scene. And his contributions will be missed.

However, his parting gesture includes some provocative notions, which we repeat here for your edification - and, of course, with thanks to Jim. You may find these intriguing, ridiculous, old hat or helpful. Whatever your reaction, these are on the table for discussion. So dig in…

1. In TV ads for drugs, the FDA should ban disjointed imagery during side-effect warnings: One of the more compelling parts of the FDA’s review process was the presentation by Ruth Day of Duke University. She did a study showing that when drug ads listed benefits, the images on the screen matched the voiceover and moved slowly. But when side effects were listed, the images often became mis-matched to the voiceover and moved much faster or were more distracting. The result is that viewers find it more difficult to remember the side effects than the benefits. Once you know this, you’ll notice that this is a frequent aspect of drug advertising – as soon as they get to the bad stuff spots devolve into an avalanche of unrelated imagery.

2. Reminder ads should be illegal: Promoting a drug but not saying what it does or what its disadvantages could be? This helps neither the patient nor the doctor. The only health issue it promotes is drug companies’ bottom lines.

Read more »

The drugmaker is griping over accusations by the government’s drug-buying agency, Pharmac, that it’s gambling with patients lives, the New Zealand Press Association reports. Pharmac medical director Peter Moodie made the comments about AstraZeneca following protracted and unresolved negotiations over cardiovascular drug Betaloc.

“Pharmaceutical suppliers must realise that when a patent runs out, other suppliers will enter the market and it is not acceptable to hold patients to ransom for commercial gain in such an unethical way,” says Moodie. “It is not acceptable for AstraZeneca to gamble with the lives of acutely ill patients in order to protect itself from competition.”

AstraZeneca’s New Zealand general manager, Lance Gravatt, tells NZPA the drugmaker is a tough negotiator but still cares about patients. “Completely flabbergasted by their statement was my initial reaction when I read it this morning,” says Gravatt. “When the country ran out of adrenaline in January this year, it was AstraZeneca that stepped in at short notice to supply the country and ensure that patients didn’t suffer. So we do definitely care, but we’re also tough negotiators.”

In a bid to pressure the government, AstraZeneca issued a statement that hospital supplies of the drug are in jeopardy over the stalled talks. Now, that’s tough negotiating.

Read more »

The big news from Johnson & Johnson occupied us for awhile, but now is a good time to catch up a bit on other developments. Here are a few that may go well with the stop at the water cooler or the cup of coffee you plan to have…

Celator Pharmaceuticals, a privately held biotech in Princeton, NJ, is exploring ways of combining drugs. In a chat with The Star-Ledger of New Jersey, the little company talks about its technology for determining the exact ratio at which combos perform at their peak. Its lead product, an early-stage colorectal cancer treatment, uses two previously approved cancer drugs in a formulation that ensures an optimum ratio is maintained. “That’s what I think separates us from everybody else,” boasts Andrew Janoff, Celator’s ceo and a co-founder of what used to be Liposome.

ImClone Systems disappointed this morning. The biotech, which is controlled by billionaire Carl Icahn, reported second-quarter profit fell 14 percent after US sales of its Erbitux cancer med declined more than expected, by 6.2 percent to $162.1 million. This follows a new deal with Bristol-Myers Squibb to increase research funding for Erbitux to expand its use beyond head and neck cancers and colon cancers. Meanwhile, ImClone hopes to name a new ceo next month.

In contrast to some rivals, Eli Lilly is using a do-it-yourself approach to entering biotech with in-house research favored over acquisitions. But the drugmaker hasn’t been able to convince Wall Street that it’s a major player. “Lilly is the No. 5 biotech company (by sales), but it doesn’t show up on people’s lists,” a frustrated John Lechleiter, Lilly’s president and chief operating officer, tells The Wall Street Journal (subscription required).

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