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Archive for March, 2009

When placebos outperform CNS drugs – an interesting article on Seeking Alpha.

Afinitor – new cancer blockbuster for Novartis? – Novartis AG’s cancer pill Afinitor, approved yesterday by U.S. regulators, has the potential to generate several billion dollars in annual sales, according to the company’s head of oncology, David Epstein. Afinitor “could be a multi- or mega-blockbuster, in time,” Epstein said in a telephone interview.

Good news  for once-weekly Byetta – superior results compared to two existing diabetes treatments.

PLUS: The 5-in-1 “polypill”.

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AstraZeneca‘s Crestor reduces risk of blood clots in the veinsA new analysis from the JUPITER study shows that CRESTOR® (rosuvastatin calcium) 20mg significantly cut the risk of venous thromboembolism (VTE) by 43% (p =0.007) compared to placebo among men and women with low to normal cholesterol levels and elevated high-sensitivity C-reactive protein (hsCRP).

Abbott gets a boost with stent results - Abbott Laboratories‘ drug-coated stent, Xience V, is significantly more effective than Boston Scientific Corp.’s Taxus three years after implantation in an artery, according to new long-term data. The data, presented Sunday at the American College of Cardiology meeting in Orlando, Fla., come from a 300-patient, Abbott-sponsored international trial known as SPIRIT II. The data are the longest to date for Abbott’s market-leading stent. Boston Scientific also markets Xience, which was approved last year, under the name Promus.

TriLipix for cholesterol: looking goodA combination of Abbott Laboratories’  new TriLipix triglycerides medicine and a low dose of AstraZeneca Plc’s Crestor cholesterol drug proved better than the individual pills in helping improve heart risk factors, researchers said. The combination did significantly better at lowering bad LDL cholesterol and other blood fats called triglycerides, as well as raising levels of good HDL cholesterol in patients with complex lipid disorders.

PLUS – Eli Lilly on mega-mergers: No“I think we are seeing deals that are really driven more by weakness than what I would describe as strong strategic combinations … That will improve short-term problems but fail to answer the long-term question of research productivity.”

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Farewell, DNA – the Roche takeover of Genentech is a done deal. What will this do to the culture of both companies, I wonder?

DiabetesTV? Forbes explains.

Good news for Amylin and Eli Lilly on Byetta – no cardiovascular risks found. Eli Lilly & Co. and Amylin Pharmaceuticals Inc.’s diabetes drug Byetta wasn’t linked to more heart attacks, strokes or other cardiovascular side effects in an analysis of studies requested by U.S. regulators. The data will be used to support the safety of a once- weekly form of Byetta, which is now given twice a day, the companies said today in a statement. The Food and Drug Administration asked for additional data on the new version of the drug in November.

PLUS – my thoughts on Why Pharma WILL embrace New/Rich/Social Media.

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There’s a fair bit of angst circulating about how pharmaceutical companies will manage to start using some of the new on-line tools such as social media to enter more fully into the communications marketplace.

walksignalI’m reminded of the same anxiety that existed, years ago, with early web adoption, and early eLearning adoption. You can’t go against the tide forever – the discussion, after a while, moves from “if” to “how”. It WILL happen. Here are five reasons why:

1. Networked communications and communities are rapidly becoming ubiquitous. What seems “new” to some of us who have been around the block for more than a couple decades is simply going to be normal life and practice in upcoming years, especially for the rising generation. To not be involved is to occupy the wrong planet. Pharma companies and brands will find a way to be where so many stakeholders already are.

2. The demand for involvement, coming from every level, will increase dramatically. Doctors, patients, caregivers, and employees will want to tap into information on-line and via mobile devices. Some of that information can only come from drug companies and brands. Static information presentation is already giving way before the interactive web. There won’t be a choice anymore.

3. New/rich/social media approaches have the potential to address one of the largest and most pervasive health and business needs for patients and the drug industry – patient adherence (patients filling/re-filling prescriptions, and taking their medicines). To my thinking, this is the THE low-hanging fruit for pharma. Not selling product (“ask your doctor if Viagra is right for you!”), but devising smart ways to add value to the healthcare marketplace by aiding and educating patients. I’m already talking to solution provider firms about this high-potential area, in order to better advise brands that want to move in this arena.

4. Current methods of communication and promotion (DTC, armies of sales reps, etc.) are increasingly coming under fire as being wasteful and inefficient. Smart on-line strategies using social networking are an effective way to engage target audiences with greater precision and at a much lower relative cost.

5. Pharma companies will begin to see the rich vein of information and feedback that is generated through social media approaches, and will (rightly) understand that a huge amount of valuable intelligence, market direction, and thought leader influence is sitting out there on the table. This will be irresistible, as it should be for any business.

But, the big question – what will the FDA think? Actually, the concern there is always the message, not the medium – read this very interesting article just out on that topic, with more in-depth commentary here. Personally, I think well-designed new media apps have to potential to far more accurately communicate the needed messages about fair balance, etc.

I’m sure there are other reasons why adoption WILL occur (feel free to add your thoughts in the Comments!) – yes, there are legal/regulatory hurdles, but there can be no doubt that pharma will put these tools and approaches to use. I, for one, am eager to brainstorm with clients and provider companies on how we’re going to move forward.

(image credit)

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Psychiatrists – no more $$, thanksAmid the flak surrounding several prominent psychiatrists (see here and here) and their ties to the drug industry, the American Psychiatric Association has decided to drop all industry-sponsored meals and educational sessions from its annual conferences, the group announced today.

Novo may dodge Takeda‘s fate with new diabetes drug approval by FDA“Given the Takeda experience, people are more cautious,” said Jack Scannell, a Sanford C. Bernstein & Co. analyst in London. “We’ve gone from a world where people thought liraglutide would sail through the advisory committee to a world where people are aware it’s not a dead certainty.” Scannell expects the drug to “scrape through” the advisory panel meeting, win FDA approval and generate a peak of $1 billion in U.S. revenue by 2013. Its sales potential is limited by gastrointestinal side effects that may lead some patients to opt against it, he said in a telephone interview.

The Pfizer/Ligand osteo drug – Yes in the EU; We’ll see in the United States.

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Just what we need – another takeover rumor! Is GSK interested in Allergan? Or, perhaps, is Allergan interested in its own acquisitions?

Hospira cutting its workforce by 10%.

Dendreon finds a new way to endanger Provenge. This is a head-scratcher…

PLUS – Pfizer grabs its new Oncology Business Unit head from Cephalon.

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Eli Lilly‘s Symbyax finally approved for depression - Eli Lilly has received approval from the U.S. Food and Drug Administration for use of a combo pill called Symbyax to treat treatment-resistant depression. “Until today, there has been no approved medication for treatment-resistant depression,” said Lilly Medical Director Dr. Sara Corya. “Now, after two failed attempts with other antidepressants, doctors and patients have a new treatment option.”

Nycomed: another one up for sale?

The long decline of drug sales reps: a quick summary from the WSJ about some of the data coming out recently.

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