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Archive for the ‘Boehringer Ingelheim’ Category

One of this week’s major news items in the world of pharma is the less-than-enthusiastic response of an FDA panel to Boehringer-Ingelheim’s experimental “sexual desire for women” pill, flibanserin.

I believe the quest for a “female Viagra” (an inaccurate parallel, by the way) is fundamentally misguided. Here’s why:

There’s a big difference between sexual function and sexual desire. Viagra does something that a pill can, in fact, do – impacts a physiological process. Erectile dysfunction is, in some cases, a medical problem that can be addressed with a medical solution.

But sex is not purely physical. And sexual desire is not some abstraction or isolated function that can be fixed by some sort of medical booster.

Yes, our bodies age and the physiological aspects of libido may be impacted. I’m not denying that. But can any pill really deal with the many elements that make up sexual desire, including:

- a loving relationship

- a climate of trust and freedom

- confidence and a sense of self-esteem

- personal attractiveness (and attracted-to-ness) on multiple levels

- hormonal fluctuations/levels

- physical function that allows fulfilling intercourse

And, in fact, are we even addressing the right question anyway with these proposed treatments? Should our focus be on creating/boosting a physiological desire for sex, or on making better relationships? Physiological aspects are a component of sexual desire…but are we going to keep medicalizing some things that are, to a large extent, simply part of a normal aging process?

I realize that there’s no money to be made by drug companies on the latter, but frankly, I’m forced to conclude that the whole exercise is a futile pursuit of profit at the expense of a healthier focus on the better relationships that will lead to better sex.

A pill is not a substitute for the genuine work of nurturing one’s mate so that a steady desire to please and be one with each other is a natural outgrowth. Viagra can make some things grow that forgot how. But I seriously doubt that any female Viagra will grow something as multi-faceted as sexual desire. Let’s go about curing real diseases.

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TODAY’S NEWS:

Boehringer‘s female sex pill: maybe not. The drug “failed to demonstrate a statistically significant improvement” in sexual desire, Food and Drug Administration staff said in a review released today. It was also linked to appendicitis, depression and loss of consciousness. Side effects led about 15 percent of women to stop treatment with the drug, the review saidmore

What is Eli Lilly paying laid-off workers? This (interesting chart).

Pharma mergers – do they really deliver on efficiencies? Interesting summary.

Sanofi-Aventismore cuts, but future expansion. I’ll leave the math to you!

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Marketers must embrace the connected patient. Amen.

JUST FOR FUN

Starbucks to begin sinister Phase Two of operations. Funny goodness from The Onion, America’s Finest News Source. :>}

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TODAY’S NEWS

Sometimes I can’t help but voice a bit of skepticism, especially when it comes to sexual disorder treatments. So, count me as less than convinced about this experimental treatment from Boehringer-IngelheimData from pivotal Phase III clinical trials demonstrate that a higher proportion of pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD) receiving flibanserin 100mg reported both an improvement in their condition and a meaningful benefit from their treatment, compared to placebomore (the single-question Patient Benefit Evaluation appears to me to be really…ummm…meaningful).

Lung cancer preventer for former smokers? Interesting – A drug approved to treat a range of conditions may also work to prevent lung cancer in people who have given up smoking, U.S. researchers reported on Tuesdaymore

AstraZeneca replaces Nexium sales force with telemarketers. And it works.

J&J‘s recall of OTC products. This is becoming a huge black eye, for a company that managed to keep quite a good reputation over the years. It will be an interesting case study of reputation management and quality improvement, esp. for a company that has been a leader in social media usage in this sector.

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Red Meat – maybe this picture isn’t so simple after all. Intuitively, this result is actually not too surprising. AND – Are you in a Museum?

JUST FOR FUN

I only rarely get to see hailstorms. That’s what makes this video particularly awesome. Must be seen to be believed!

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TODAY’S NEWS

Boehringer‘s Mirapex ER for once-daily Parkinson’s treatment is approved by FDA.

When the FDA surprisingly approves a previously-rejected drug.

Don’t do this.

Can you tell it was a somewhat sparse day for news? Yeah – some days are like that…

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The (Big Pharma) nurse will see you now! Interesting development…

JUST FOR FUN

Didn’t see that coming. Remote with bottle opener (Clicker).

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TODAY’S NEWS

Big news for Novartis on two fronts – Novartis has received a couple of pieces of good news from regulators in the USA this morning who have approved its meningococcal vaccine Menveo and granted a priority review for the Swiss major’s investigational oral treatment for multiple sclerosis fingolimod…more

Avandia – the bad news just won’t quit. The heart attack factor, and the when-did-they-not-share-what-info questions. And a call to just pull it from the market. A rough patch for GSK.

BI gets FDA approval for new Extended Release version of Mirapex (for Parkinson’s)

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From Wendy Blackburn: 7 things I Learned at the ePharma Summit. And, from Betsy Raymond StevensonCuring Pharma. Restoring the industry’s reputation will mean a lot of hard work, not just a PR campaign.

JUST FOR FUN

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This will be the final Impactiviti Daily for 2009. We’ll pick up again in the new year. Have a delightful holiday season!

TODAY’S NEWS

Deals – J&J and Merck get hits, Biogen strikes out.

From PharmaExec – a new commercialization model needed for pharma? – The days when biopharmaceutical companies could rely upon a steady stream of blockbuster products to fuel sales and support large, fixed-cost infrastructures appear to be over. It is clear that with the issues facing the pharmaceutical industry — coupled with a changing future environment — the current commercial model is too cumbersome to deal with hard economic conditions or to react to new stakeholder environmentsmore

Pfizer and BI get expanded label for Spiriva for COPD – Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD). SPIRIVA HandiHaler is already FDA-approved as a once-daily maintenance treatment for breathing problems associated with COPD, which includes chronic bronchitis, emphysema, or bothmore

Cancer genomes revealed – this is pretty cool, actually. A big step toward personalized medicine.

Medical Rep certification – coming soon!

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JUST FOR FUN

Business Week gives their visual and descriptive accounting of the 50 ugliest cars of the last 50 years. There are some…umm…beauties in there.

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It’s Thanksgiving week! We’ll plan on publishing the Daily on Monday/Tuesday, then take the rest of the week off from news reporting. Unless somebody buys somebody else. That, we’ll report!

TODAY’S NEWS

Sanofi chief wants to do things differently. Liked this juicy quote:  Mr Viehbacher added: “The best scientists are often lousy leaders [and] managers. You had a research and development god who hoped a blockbuster emerged. When it didn’t, you merged. The model was flawed. I think the mistake we made in our industry was, we made R&D organisations that were very big, very complex, very difficult to manage, and we killed the innovative spirit”more

Morphine – kill pain, grow tumors?? – Two new studies add to growing evidence that morphine and other opiate-based painkillers may promote the growth and spread of cancer cellsmore

Pfizer reaps one of the consequences of merging: inherited lawsuits – Two Pfizer Inc. units’ hormone- replacement therapy drugs caused an Illinois woman’s breast cancer, making them liable for at least $6.3 million in damages, a Philadelphia jury ruled todaymore

B-I hoping to take a big bite out of warfarin – Just 2.4 percent of patients given Pradaxa for six months after their initial treatment developed clots in the legs and lungs, similar to the 2.2 percent rate for those given the generic drug warfarin, according to an abstract of the so-called Recover study posted on the American Society of Hematology Web site last week. There was no increased risk of major bleeding, a complication of blood-thinning treatmentsmore

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What about that pesky Social Media/ROI question? My thoughts

JUST FOR FUN

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TODAY’S NEWS

So, have we been pursuing the wrong course for GERD all this time? Is it actually caused by immune system cells, not stomach acid?

Maybe cheap/old/tried-and-true really is better. Diuretics for HPB, for instance. Or just plain generic simvastatin for cholesterol.

Pfizer gets good news on Revatio (which is the same as Viagra, by the way) for the treatment of PAH; Spiriva for COPD; and the Prevnar 13 vaccine.

Genzyme: Train wreck?. But wait – there’s more.

Getting excited about sex: not so easy to be excited about B-I‘s experimental treatment for female desire; Vivus‘ competitor to current ED drugs still on track, however.

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Blind Spots and Broken Limbs. I’ve got them, too…

JUST FOR FUN

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Whew! The back-to-back conference marathon is now over, and we can get back to our regular pharma news reporting. Here’s what’s up today…

TODAY’S NEWS

Everyone’s talking about the Zetia/Niaspan study – its results, its significance, its limitations. Bottom line – I can’t see how this can be good for Merck. More here. And Jim Edwards analyzes the damage control spin effort here.

Always a headline topic: female sexual desire treatments. The more you read about this drug (experimental ‘flibanserin’ from Boehringer-Ingelheim), however, the more you wonder if the purported effect will be worth the expense and the side effects.

BMS pushing Mead-Johnson out of the nest. It is amazing to me how drug companies cycle through periods where they diversify, then spin divisions off…

Novartis: half a dose of H1N1 vaccine may be enough. Now that’s how to increase vaccine supply!

If you’re going to blow the whistle, I guess it’s important to get on to the field of play! Whistleblower lawsuit against J&J dismissed.

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Is this drug a frog, or a prince? I dunno, but I like the picture…!

JUST FOR FUN

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Note: Impactiviti Daily is going to be published somewhat irregularly over the next couple of weeks, as we’re in the heart of “conference” season and I’m attending/speaking at several events over the next month. We’ll do our best to keep you updated!

TODAY’S NEWS

FDA approves Arzerra (from GSK) for last-ditch treatment of CLL (cancer)

Boehringer-Ingelheim gets additional approvals for Micardis, including a combo drug (Twynsta)

Vertex gets positive results for its experimental Hep C drug – but I bet this headline gets more traction.

Kids getting fat on Zyprexa.

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My review of last week’s Digital Pharma conference. It was, in some ways, a ground-breaking event.

Business buzz-jargon reaches a new height. You just can’t make this stuff up!

JUST FOR FUN

This is a very cool visual illusion. The curveball.
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Coming up next week:

eComm

Nov. 3-4 – eyeforpharma’s 4th Annual eCommunication and On-line Marketing Summit, Philadelphia, PA. I’ll be part of a panel on social networking, and live-blogging/Twittering. Here’s a discount code to save $400 off your registration: SPEAK

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Subscribe to the Impactiviti blog via e-mail (which will bring you Impactiviti Daily – a brief of the day’s top pharma news)

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