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Archive for the ‘Biotech’ Category

In short, The Antidote is a great read for those of us in the biopharma industry.

book The Antidote

Barry Werth wrote a previous volume, The Billion Dollar Molecule, about the early years of Vertex Pharmaceuticals. This follow-up book outlines the history, the personalities, the processes, and the high-risk-high-reward decisions that went into Vertex advancing its first drug(s) to the marketplace, and morphing itself into a commercial organization.

From the mercurial brilliance of founder Joshua Berger to all the various players who came on board to evolve the company, it’s a fascinating account of how a company struggled to shape and maintain its culture. The blow-by-blow account of deciding on drug candidates, based on the Vertex philosophy of science and medicine (and business), is eye-opening. Some of the language would be a bit technical and arcane for those not involved in the industry, but for pharmaceutical and biotech professionals, this is a great story.

The writing style flows nicely – such a book could become dry; but, in fact, I had a hard time putting this one down each night.

Highly recommended!

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TODAY’S NEWS:

Amgen finally gets approval for Prolia – After months of delay, Amgen finally won FDA approval for Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures. The endorsement is a big boost for the biotech, which has been counting on Prolia to reverse a series of setbacks over the past few years, notably a decline in sales of some of its largest-selling products, Aranesp and Enbrelmore

Encouraging early-early-early result? Sure. Overly optimistic headline? Of course. New vaccine “could eliminate breast cancer.” Sally Church gives us some good cautionary words about over-hyping such results.

Biogen sues multiple rivals over MS drug – seeks royalties. I’m sure the lawyers, at least, are happy about this development.

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JOB OPENINGS

Sales and Account Manager, Training Agency serving Life Sciences (Massachusetts), experience required. From the Impactiviti Job Board.

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Looking Forward to the SPBT Conference – here’s what I’ll be doing, and the workshops that look appealing. Will I see you there? Download my digital business card (see linked post) and let’s get together in Orlando! (SPBT = Society of Pharmaceutical and Biotech Trainers)

JUST FOR FUN

16 Thin Buildings. Actually, I’d prefer to see one thinner consultant, in the mirror. Sigh.

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Note: there will be no Impactiviti Daily for the remainder of this week, as I’ll be away at a conference…

TODAY’S NEWS

Biotech: finally profitable – The biotechnology industry is finally profitable, according to a new report out today from Ernst & Young. The report states that biotech companies in the world’s largest hubs — the United States, Europe, Canada and Australia — achieved collective profitability in 2009, marking the first year the industry has ever crossed into the black. The companies in those regions posted an aggregate net profit of $3.7 billion in 2009, compared to a net loss of $1.8 billion in 2008…more

Making quite a living as a pharma whistleblower – drug rep hits the legal lottery twice.

Merck to close three NJ facilities – not a big surprise, post-merger with Schering.

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What are we Doing….Really?

JUST FOR FUN

You really can’t make stuff like this up: Handyman injured after chopping down branch he leaned ladder against.

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TODAY’S NEWS

What about those bone fracture risks with biophosphonate drugs? The jury is still out – A new study gives reassuring news about the safety of Fosamax and Reclast, bone-building drugs taken by millions of American women. It found that long-term use does not significantly raise the risk of a rare type of fracture near the hipmore

Monthly hepatitis C treatment looking promising – Human Genome Sciences Inc. said Wednesday a midstage study of the potential hepatitis C treatment Zalbin showed a monthly dose of the drug candidate could be as effective as a weekly dose of the standard treatment. The Rockville, Md., company said interim results from the study support evaluation of the monthly dose in a bigger, late-stage trial. The midstage study was conducted by Novartis, which is developing the drug with Human Genome Sciences. It combined the drug with ribavirin in 391 patients with forms of chronic hepatitis Cmore

Massive Multaq Mess Might Mean Major Meltdown – The scale of Sanofi-Aventis (SNY)’s Multaq mess is starting to become apparent: The heart drug, hailed by the company as a €1 billion-plus blockbuster prior to its launch, may miss Wall Street sales estimates by as much as €1.3 billion, according to analysts at Jefferies International. When investors wake up and downgrade their expectations for the atrial fibrillation drug, Sanofi’s stock may suffer, they say…more

Genzyme feeling fines.

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Another reason to like Gilead Sciences (besides the fact that they have the best logo in the industry) – they actually have a rational pay plan for their top executive. What would it look like if pharma upper executive pay were based on annual performance for these measures: Profitability ratio (earnings vs. # of employees – something Gilead excels at, by the way); company share increase over a 3-year running average; and regulatory compliance? We might then see real pay-for-performance!

JUST FOR FUN

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TODAY’S NEWS

Note: if you’re going to engage in questionable marketing practices, documenting it in Powerpoint is probably not a “best practice”! Just saying…

Experiment HIV drug from Merck fails in late-stage studies – Merck & Co  on Wednesday said its experimental HIV treatment vicriviroc proved ineffective in two late-stage studies involving patients who had previously been treated with other HIV medicines...more

Merck diarrhea drug does very well – Merck & Co.’s experimental drug against a germ blamed for increasing rates of deadly diarrhea in U.S. hospitals and nursing homes cut repeat infections by 72 percent, a study in the New England Journal of Medicine saidmore

Orphan drug applications are way up.

Upcoming oral MS drugs are very promising – Study results suggest they are much more effective than expensive “disease modifying” MS drugs such as beta interferon and glatiramer acetate, which have to be injected….more

Top biotech layoffs of 2009.

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E-detailing – Pfizer doubles its spending. I expect this trend to accelerate across the industry. It simply makes sense.

JUST FOR FUN

OCD Medication – instructions.

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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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TODAY’S NEWS

Celgene to buy Gloucester Pharmaceuticals, another company with a focus on developing drugs for blood cancer. I really like Celgene’s laser-like focus in its product portfolio – very smart.

Keep those new blood thinners coming.

AstraZeneca‘s Seroquel gets an expanded label for Major Depressive Disorder (add-on treatment).

Folotyn: 30K/month cancer treatment?? Wow (from NY Times).

The race for the new oral MS drug approval – did Novartis just take the lead?

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Pharma: Socializing in a Straitjacket? A somewhat shallow brushstroke in AdWeek about pharma and social media. AND – only TWO FDA inspectors in all of China (where much drug manufacturing is moving)? I bet that gets changed fast!

JUST FOR FUN

Will a young dog remember a family member who has been gone for 3 months? Watch and see!

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TODAY’S NEWS

Takeda buys into Amylin‘s weight-loss drug portfolio – Takeda will pay $75 million upfront for medicines including Amylin’s pramlintide/metreleptin and davalintide, in the second phase of testing needed for U.S. regulatory approval, Osaka- based Takeda and San Diego-based Amylin said in a statementmore Plus, quickie update on three other anti-obesity drugs being developed by various companies.

New lupus treatment (HGS/Glaxo) looking promising on pathway to approval – Human Genome Sciences Inc said its experimental lupus drug Benlysta was successful in a second large clinical trial, paving the way for approval of the first new treatment for the disease in 50 yearsmore

Vertex HepC drug cures 80%The hepatitis C cure rates of greater than 80% across all four patient groups of the study are also the highest ever recorded in any telaprevir study to date and exceed the cure rates reported in separate studies of boceprevir, a competing hepatitis C drug under development by Schering-Ploughmore

Let’s investigate: Amgen and Shire are the latest.

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Not counting on blockbusters – changes, and the future, at Sanofi-Aventis.

JUST FOR FUN

Bayer turns its headquarters into a giant billboard. Pretty eye-catching (watch the video clip).

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NEWS

Will Provenge take a big bite out of Taxotere? Provenge is an immunotherapy, meaning the vaccine stimulates the immune system to attack a specific target, in this case prostate cancer cells. It incorporates an antigen commonly found in prostate cancer cells as well as so-called antigen presenting cells obtained from the patient’s blood…more

Forest teams up with AstraZeneca for promotion of new anti-infective – Forest’s late-stage drug Ceftaroline is meant for the treatment of complicated skin and skin structure infections (cSSSI) as well as community-acquired bacterial pneumonia (CABP).The contract involves co-development and commercialization of the drug in all markets other than the U.S., Canada and Japan. With this deal, Forest will receive substantial funds from its partner through signing fee, royalties from sales and payments tied to certain specific sales milestones…more

Whistleblower case against J&J (re: Procrit promotion) to proceed – Duxbury claims he sold $13 million of Procrit between 1992 through 1998, and that approximately 80 percent of those sales were “false or fraudulent claims for Medicare reimbursement.” McClennan sold more than $65 million of Procrit, and about 50 percent of his sales were fraudulent Medicare claims, he alleges…more

The changing climate and practices at Henry Ford Hospital for drug reps. Would be surprised to see this as a template for others.

From the Let’s See What the Future Holds files – blood pressure drug with efficacy for MS??

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8 natural phenomena you probably didn’t know about. AND – from my StickyFigure blog – The Power of Inertia. Is “good enough” good enough?

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Novartis gets FDA approval for MS drug Extavia. Extavia is essentially re-branded Betaseron, and marks the entry of a new (and large player) into the MS market. It’s Novartis’ MS pipeline that’s really interesting.

Plus, FDA grants temporary approval for Protalix‘s Gaucher disease treatment. Genzyme’s woes means that a new source was needed stat.

CSL Behring gets approval for Helixate FS (for children with hemophilia).

Shire gets creative with some adult ADHD outreach/educational programs.

And…this isn’t pharma at all. Just thought I’d toss in this quick blog post from this morning, on Successful Calls to Action (from my StickyFigure marketing blog). How did Chris Brogan and my dentist both make me take action?

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