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Viagra maker looks to new chief for revival

July 30, 2006

PFIZER, the world’s biggest drugs company, has appointed Jeffrey Kindler as its next chief executive, ushering Hank McKinnnell into early retirement.Kindler, a former McDonald’s executive, was previously Pfizer’s general counsel. The appointment of a lawyer to the top job may indicate the changing priorities in the pharmaceutical industry. In common with many leading companies, Pfizer faces patent battles over its biggest-selling drugs and product liability suits.

 

Pfizer, which makes Viagra, the impotence treatment, was the pharmaceutical industry’s most successful company in the 1990s, but has struggled since McKinnell succeeded Bill Steere in January 2001.

McKinnell’s $60 billion (£32 billion) acquisition of Pharmacia — the company that provided Pfizer with the blockbuster painkiller Celebrex — was poorly received, and contributed to a 37% slide in the company’s share price.

Like other leading companies, Pfizer, which has a substantial research base in the UK, has struggled to find the new medicines it needs to replace those losing their patent protection.

Pfizer’s challenge is particularly acute. In Lipitor, its cholesterol-lowering drug, it has the world’s biggest-selling medicine, one which generated $12 billion of sales last year. Such a product presents an extremely attractive target for the generic companies that seek to produce low-cost copies of successful drugs.

Kindler is 51 and has worked for Pfizer since 2002. To succeed McKinnell as chief executive, he had to see off the challenge from Karen Katen, who heads the group’s pharmaceuticals business, and David Shedlarz, its chief financial officer.

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Reports this weekend suggested internal tensions caused by the succession race prompted Pfizer’s board to make an early decision at a special meeting on Friday. McKinnell will continue as chairman until next February, one year earlier than his scheduled retirement date.

Pfizer is renowned within its industry as an enormously powerful marketing machine. However, this approach — and the numerous calls its sales representatives make to doctors — has come under increasing criticism in recent years.

McKinnell has also had to cope with a slump in the sales of Celebrex after Vioxx, a similar drug from Merck, had to be withdrawn because of serious side-effect problems. Vioxx is now at the centre of a multi-billion-dollar wave of litigation.

Pfizer recently sold its consumer healthcare business to Johnson & Johnson, its American rival, for $16.6 billion. The company has said it plans to spend $17 billion on acquisitions to stimulate growth, and a similar sum on share buybacks.

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Viagra’s makers focus on female sexual dysfunction

July 28, 2006

A new type of drug which increases blood flow to the vagina in animal experiments has now been shown to be safe in rats. Derived from an experimental heart drug, the new compounds could one day help treat women who find it difficult or impossible to become sexually aroused, say researchers at the drugs company Pfizer.

Previous tests have shown that the new compounds, including the most potent one, called R-13, increased vaginal blood flow in animals. New tests now demonstrate that the drugs are safely tolerated by rats.

The ultimate aim is to address female sexual arousal disorder (FSAD) in women. The condition sometimes involves blood flow problems in the pelvic region, which might be restored by a drug intervention.

Experts agree the approach might eventually benefit the small subset of women who suffer sexual dysfunction due to a physiological cause, due to nerve damage in the pelvic area from surgery, for example. But they stress that such drugs would not effectively treat FSAD when it is due to purely psychological factors.

In fact, some question the very existence of FSAD, adding that some women’s sexual dissatisfaction may have to do with the nature of the relationship the women are in (see: Caution over sexual arousal patch for women.

Sex differences

In the late 1990s, the approval of the drug sildenafil (Viagra) made by Pfizer, popularised the idea that men could be treated for erectile dysfunction with a simple pill. It became one of the pharmaceutical giant’s best-selling drugs.

Drug companies’ search for a compound to treat sexual dysfunction in women, however, are complicated by the fact that the disorder appears to have a wider number of causes in women, suggests Lori Brotto at the University of British Columbia in Vancouver, Canada.

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Researchers at Pfizer derived the new compounds from a drug called Candoxatrilat, which was tested in clinical trials during the 1990s for treating chronic heart failure.

Tests show that a precursor of Candoxatrilat appears to disable a key enzyme called neutral endopeptidase, or NEP. This is important because NEP usually degrades a hormone called vasoactive intestinal peptide that promotes blood flow to the vagina. So blocking NEP may allow the hormone to maintain this blood flow.

“Too early”

The Pfizer group found that rats can tolerate NEP inhibitors derived from Candoxatrilat, such as a newly designed compound, R-13. New research carried out by the team also shows that R-13 rapidly inactivates NEP when ingested by laboratory animals. They add that previous experiments have suggested that R-13 can somewhat increase vaginal blood flow in rabbits.

“The objective of the research is to identify a rapid-acting, efficacious and well tolerated compound,� says Joel Morris, a spokesman for Pfizer in Sandwich, Kent, UK.

“A small subgroup of women might benefit from a biological approach,� says Brotto, who studies FSAD. But she adds that because there is such limited testing of the compound in animals, let alone humans, “it’s far too early to conclude anything� about the compound’s potential to treat sexual dysfunction in women

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Pfizer Moves to Counter Sagging Viagra Sales

July 23, 2006

In an effort to reverse slumping sales of Viagra, Pfizer Corp. has begun seeking new means of marketing its chief impotency medication.

“It does seem ironic that Viagra sales should have suddenly become so flaccid,â€? remarked a Pfizer marketing executive. “We believe the problem stems in part from very stiff competition from rival pharmaceutical companies.â€?

Inside sources told reporters that among the most promising options for Pfizer include joint marketing arrangements such as those currently under negotiation with soft drink companies, PepsiCo and Cadbury Schweppes. Although unconfirmed, Pfizer and PepsiCo appear to be near a deal under which Mountain Dew would be marketed in two versions, the traditional Mountain Dew formula and a new Viagra fortified version that would be marketed under the name, “Mount ‘N’ Do.�

Cadbury Schweppes, the candy and bottled drink conglomerate that not so long ago acquired Dr. Pepper, apparently also sees golden opportunities in the potential alliance with Pfizer. A Viagra enhanced formula for Dr. Pepper is being test marketed in retirement communities across Florida. Known as “Dr. Pecker�, the soft drink is said to be very popular in the retirement homes where it has been tested even though “it tastes like carbonated Worcestershire sauce� according to one senior citizen who preferred not to be identified.

Pfizer has enjoyed limited success in combining Viagra with other products including Rogaine, the hair restoration and growth stimulant. “It’s too early to say whether we have a winning combination here� says Viagra marketing vice president, Stan Dupp. “We have high hopes for the Rogaine/Viagra combination and have recently signed Don King to assist us in promoting the product.�

The Pfizer share price has languished for the last three quarters because of a combination of problems including the flagging Viagra sales and the lackluster performance of Pfizer’s newest penile enlargement medication “T-Rex�. The company insists that T-Rex does what it is intended to do “when taken as directed�, but critics point out that the drug’s main problem is that it works all too well.

“It doesn’t really do you much good if the medication enlarges your tally-whacker to such an extent that when you become aroused you invariably pass out as a result of the massive diversion of blood flow away from the brain and other vital organs.

The Food & Drug Administration is looking into complaints that 4 men have died from cerebral hypoxia in the last six months shortly after taking T-Rex pills.

All four men reportedly had to be buried in special coffins with modified lids to accommodate their anomalous condition. Surviving family members are said to be planning to initiate legal actions after the laughter dies down.

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‘St0P Ce11ing I113gal drugs online now!’

July 19, 2006

The Associated Press reported the FDA is now warning consumers not to buy or use so-called dietary supplements being sold online as natural alternatives to impotence drugs or as a way of enhancing sexual performance.

I, for one, am glad the FDA is finally taking a long, hard look at the situation. It has put out a list of products you shouldn’t buy online, no matter how tempting the e-mail subject line might be.

On the list, we have Zimaxx, which sneakily has the same active ingredient as Viagra, a prescription only drug (Google Rush Limbaugh and Viagra for further amusement).

And we have Libidus, a name that gets right down to business, too quickly. Then there’s Neophase, a drug with a name that tries to excite, but just makes you laugh. Let’s not forget about Vigor-25 and Actra-Rx, which sound kind of geeky. And putting “Rx� in the name of an illegal sold prescription drug is kind of ironic. And we have Nasutra, which kind of sounds exotic, but is just posing.

But the best (worst) one yet is 4Everon. A drug overcompensating? Yeah.

All of these drugs contain active ingredients they aren’t supposed to contain, according to the FDA.

So, the FDA sent Herbal Remedies USA and five other companies letters informing them they are selling illegal drugs and advising them they should stop selling said drugs.

Was sending letters the best the FDA could do? Is the FDA really that impotent and boring? It couldn’t find a way to spice things up?

It would have been so much better if, instead of sending out letters, the FDA sent out like a few thousand e-mails to each company with randomly generated subjects and text to sneak through anti-spam software.

The e-mails could have titles like, “St0P Cel1ing 1ll3gal drugs online now!� or “@@@1mportant!!!!@@@ Tired of going to jail and paying fines?!�

If justice truly exists in this world, then that would perhaps be the best example of it.

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PAUL RUFFIN: Mr. Pate spices up his love life

July 15, 2006

We’re sitting on the porch, late. The sun has just finished another day of beating up on the landscape and gone home over the hills, leaving the valley bruised with evening purple. We’ve been just jawing some, mostly about what kind of deer have been taken out of the valley lately and what kind of yield folks are getting from their trotlines on the river. Winship looks around to make certain Mrs. Pate is not within hearing distance of the porch and says to me, quietly and on the old man’s bad-ear side, “Get him to tell you about trying Viagra.�

“Viagra?�

“Yeah, ask him about it.�

So I do. I say, “Mr. Pate, Bob tells me you’ve tried the new drug—you know, the little blue pill, Viagra.�

He leans forward in his chair and smiles at us. “Sure did. Hell of a boost to a man’s drive, you know. Does the job.� He gives me a shrewd look. “Made me feel like a pube again, with slicked-back hair and tight pants and a tee-shirt with the arms tore off, ready to take on the whole cheerleadin’ team.�

“That good, huh?�

“I’ll say.� He scoots his chair closer to mine and lowers his voice. “Gon’ let you in on somethin’, though, that most folks don’t know about.� His eyes grow shrewd again. “There’s a cheaper version than the pills. Them thangs cost ten dollars apiece. I use the powder.�

I glance at Winship, who gives me a knowing wink, then to the old man. “Uh, I didn’t know it came in powder form.�

“More granular, I’d say,� Winship puts in.

“Yeah, granular maybe,� Mr. Pate agrees. “Whatever, you just mix a teaspoon of it in a medium-size glass of water and slug it down. Tastes purty bad, but it’s a hell of a lot cheaper than the pill.�

I say to Winship, “Bob, I don’t follow this. I haven’t heard about a granular form of Viagra.�

Mr. Pate beams again. “Been around for years too. Folks just didn’t know about this perticlar use for it.�

“See, Ruffin,� Winship says, “Mr. Pate gets his potion at the feedstore.�

I look at Bob, then at the old man. “Come on, guys, what gives here? You can’t get Viagra at a feedstore. It’s by prescription. And I don’t think it comes in granular form either.�

“You’d be sprised what you can get at a feedstore. They don’t tell you everthang in the news. If it got out about this cheaper version, there’d be a run on it.�

“Winship, do you know what he’s talking about?�

Bob grins. “Show him the stuff, Mr. Pate.�

The old man rises from his chair and shuffles off into the house. In less than a minute he’s back with a little green box, which he hands me. “There y’are. The real stuff. And it ain’t but $5.95 for enough to last a man weeks, or months if he’s slown down much—well, maybe a year if he’s slown down a lot. And you can get five pounds of it for around fifteen bucks.�

“You didn’t tell him about the side-effects, Mr. Pate,� Winship says.

The old man spits into a coffee can and wipes the corners of his mouth with his hand. “It’s blue too, like the pill, so it gives you a blue tongue, for one thang. And a monstrous headache that makes you feel like your skull is splittin’ wide open. Indigestion too, if you take it on a empty stomach.� He cackles and slaps his leg. “But it’s worth it, I’m tellin’ you, worth it!�

The first stars are blazing away as Winship and I start off to his place. The road dust, hanging deadwind from the last passing truck, has coated the shrubs and trees, and they look white and ghostly. The only sound is the whizzing of faraway traffic on the interstate, our shoes crunching on caliche, and the bark of an axis buck down in the river bottom.

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Senate OK’s Canadian drug import plan

July 12, 2006

The Senate moved yesterday toward opening the way for Americans to import prescription drugs from Canada, seeking to ease a ban on cheaper medicine crossing the border.The proposal, which was approved 68-32, would create a Canadian loophole in a Food and Drug Administration ban on importing prescription medicine into the United States. It was offered as part of a $31.7 billion Homeland Security Department spending blueprint for the fiscal year that begins Oct. 1.

The department’s Customs and Border Protection Bureau began aggressively seizing Tamiflu, Viagra and other incoming medications at borders in November.

Prescription drugs — even those manufactured in the United States — are generally sold at cheaper prices in Canada.

“We should demand that [Customs and Border Protection] focus on the true priority that we face on the war on terror,” said Senator David Vitter, a Louisiana Republican, of efforts to secure US borders. “Stripping small amounts of prescription drugs from the hands of seniors . . . that should not be a priority.”

Vitter’s plan, which was embraced by Democrats, specifically would prohibit Customs and Border Protection from stopping people with doctors’ prescriptions for FDA-approved drugs from bringing the medicine into this country from Canada.

But Republican leaders vociferously opposed the plan for fear, they said, the drugs could be unsafe for consumers — or even present a terror risk.

Senator Judd Gregg, a New Hampshire Republican, said the proposal was an attempt to push the FDA into reversing itself while “creating a massive hole on our capacity to secure our borders and protect ourselves.”

“If I were a creative terrorist, I would say to myself, `Hey, listen, all I’ve got to do is produce a can here that says `Lipitor’ on it, make it look like the original Lipitor bottle, which isn’t too hard to do, fill it with anthrax,” Gregg said.

Lipitor is a cholesterol-lowering drug.

Aides said the drug import plan was likely to be stripped out of the legislation — as it has been in past years — whenever it got to a conference of House and Senate lawmakers who will negotiate the final version.

The administration also has opposed efforts to loosen the restrictions.

Two House spending bills this year — to fund the Homeland Security and Agriculture departments in 2007 — include the drug importation plan, said Kirstin Brost, spokeswoman for Representative David Obey of Wisconsin, the top Democrat on the House Appropriations Committee

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