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Archive for the ‘Forest Labs’ Category

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Coming up on May 11th: BDI’s Social Communications & Healthcare event – half day session in NYC with Case Studies and Roundtables (I’ll be leading one of the roundtables). Top speakers from J&J, Pfizer, and more! These are always great networking and learning events. Hope to see you there!

For more information, including registration, please click here to visit the event website. Use promo code IMPACT for a discounted rate of $155.

TODAY’S NEWS

In Celgene‘s pipeline – a promising oral RA (Rheumatoid Arthritis) treatment – Celgene Corp. believes sales of lead development candidate Apremilast will be $2 billion to $3 billion a year in psoriasis and psoriatic arthritis. The drug, which would compete with some of the world’s biggest selling therapies, is expected to enter late-stage trials this year and could be launched in 2014 or 2015, the company said. The projection came during the Summit, N.J., drug maker’s research and development presentation in New York Thursdaymore But, not such good news about low-dose aspirin as a RA preventative.

Oh, by the way – there were a few suicides, too. How not to get approval for Daxas (Forest Labs).

The arguments begin the Novartis discrimination lawsuit. How many isolated incidents indicate a systemic problem? This one’s going to get sticky…

Letting Go. A challenge to think differently.

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“Compulsive Generosity” due to Parkinson’s Rx – an embezzler gets off with an imaginative “the drug made me do it” plea. Ludicrous.

JUST FOR FUN

The Enlightened Stupid Marketer. 3 1/2 minutes of fun with Kevin Nalts.

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TODAY’S NEWS

Keep some Lexapro around for strokes. Forest Laboratories Inc.’s antidepressant Lexapro may help stroke patients recover some of their mental skills, a study said. Patients who took Lexapro recovered more of their visual and verbal memory after 12 months of treatment than those given a placebo or those who underwent therapy without drugs, researchers reported todaymore

Will there be a new dementia treatment coming? – Doctors may learn next month that Dimebon, a 27-year-old hay fever treatment and one of the most mysterious compounds yet tried to fight dementia, is poised to become their newest and perhaps best weapon against Alzheimer’smore

What will the sales rep of the future look like?

Cialis strategy – just charge more!

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Impactiviti‘s new, searchable Pharma Job Board (powered by SimplyHired). Check it out!

JUST FOR FUN

Having a bad day? This little video clip will cure it! Bad Day Cure.

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TODAY’S NEWS

FDA panel to Forest on new use for heart drug: thumbs down – Federal health advisers on Monday unanimously rejected a new use of Forest Laboratories’ hypertension drug for patients at risk of heart failure. The Food and Drug Administration’s outside panel of heart specialists voted 8-0 against approving Bystolic to prevent death or hospitalization caused by heart failure, according to an agency spokeswoman….more

Withdrawal rates, Oxycontin, and selective publication of details. Sigh, Purdue.

Vivus’ new erectile dysfunction drug: fast results – Vivus Inc. on Monday reported positive test results for its erectile dysfunctional drug candidate avanafil, saying most men who took the drug were able to have sex within 15 minutesmore

Vertex lost less than $650 million in 2009. Well, that’s a relief!

The Medicines Company cutting 10% of workforce. Ouch.

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$3M CME grant with NO strings attached? Wow (Pfizer-Stanford)!

JUST FOR FUN

Obnoxious guitar design. Really. Obnoxious.

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TODAY’S NEWS

Abbott to acquire Visiogen for $400m…and, also named a top place to start your career.

Meda Astepro once-daily (for the treatment of the symptoms of seasonal and perennial allergic rhinitis) approved by FDA.

Forest Labs on the hot seat for questionable promotional practices, part 2: ghostwriting budget in 2004. Ouch.

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Virtual launch meetings. Are you looking at sales/launch meetings that can be carried out via the Internet? The Impactiviti Partner network has great vendor/partners who can help you with strategy, technology, and execution. Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for information and recommendations!

PLUS

Some nice stuff here – 50 brilliant and creative advertisements to inspire you.

JUST FOR FUN

Are you all kinds of envious of people with skinny thighs? Maybe you shouldn’t be!

Next week will be a “week off” for Impactiviti Daily. I hope all my readers have a wonderful holiday weekend!

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TODAY’S NEWS

Sepracor to be purchased by Japanese company, according to report – By purchasing Sepracor, which sells drugs to treat central nervous system and respiratory disorders, Dainippon would be able to open a sales channel in the U.S. for its new schizophrenia drug currently in phase-3 clinical studiesmore

Pfizer fined $2.3 Billion (not a typo!) – Officials from the Justice Department and the Department of Health and Human Services said the world’s largest drug company promoted four drugs for use on certain ailments or at dosages that were not approved by the Food and Drug Administrationmore Plus, Jim Edwards adds 10 amazing facts about the settlement.
On the Pfizer fraud (note that the nonsense occurred at Pharmacia, before Pfizer acquired them), here’s the “money quote” from one of the internal whistleblowers, which perfectly underscores my recent blog post on the Gold-in Rule:
“In the Army, I was expected to protect people at all costs,” said the whistleblower, John Kopchinski, a West Point graduate and Gulf War veteran. “At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn’t do that.” (hat tip: PharmaGossip)

Forest Labs on the hot seat for questionable promotional practices – those 88 pages make clear that one of the principal means by which Forest hoped to persuade psychiatrists, primary care doctors and other medical specialists to prescribe Lexapro was by finding many ways to put money into doctors’ pockets and food into their mouthsmore And, more commentary here on Daniel Carlat’s blog.

Novartis reports results on Diovan and reduced cardiovascular events – Novartis presented data at the European Society of Cardiology (ESC) Congress in Barcelona, Spain, which demonstrated that the addition of the angiotensin receptor blocker (ARB) Diovan (valsartan) to a non-ARB-based treatment regimen for high blood pressure provided a significant 45% relative reduction in cardiovascular eventsmore

Promising (though very early) results for a new Genentech cancer drug – In a small study, the drug, known as GDC-0449, shrank tumors in 18 of 33 patients, or 55%, with an advanced form of a skin cancer called basal cell carcinoma. In addition, the drug had a dramatic, though temporary, effect on a 26-year-old patient who had undergone multiple surgeries, chemotherapy and radiation in an unsuccessful battle against a brain cancer called medulloblastoma….more

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Ask the Ten Questions. As a consultant, here’s what I ask to try to help bring shape to your training/marketing initiative.

JUST FOR FUN

We don’t see them too often at this latitude. But here are 30 great aurora borealis shots. One day, I want to see one of these “live”!

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TODAY’S NEWS

Takeda to move forward with new alogliptin study – Takeda Pharmaceutical Co says it is all set to start an additional clinical trial demanded by US regulators on alogliptin, its investigational type 2 diabetes drug. The Japanese drugmaker noted that the US Food and Drug Administration has agreed to the study design for a cardiovascular outcomes trial, titled EXAMINE for alogliptin, a selective dipeptidyl peptidase IV inhibitor (DPP-4) inhibitor also known as SYR-322. The study will involve 5,400 type 2 diabetes patients at around 1,000 facilities in the USA, Europe and Asiamore

Genzyme leukemia drug study: hard to interpret – “The lack of a randomized study combined with the heterogeneous patient population regarding AML prognostic factors makes interpretation of the study results difficult.” Food and Drug Administration staff said in an analysis prepared for the panel, which meets Tuesdaymore

Smoker’s lung treatment: coming soon from Forest and Nycomed? – An experimental once-daily tablet from Nycomed and Forest Laboratories improves lung function in people with “smoker’s lung” and may be a useful add-on to conventional inhaled drugs, experts said on Friday. Privately owned Swiss drugmaker Nycomed, which is working towards a multibillion-dollar flotation, hopes Daxas will reach the market in 2010 and believes it has blockbuster potentialmore

Pharmas that got hurt by debt shenanigans, including BMS and Teva. And, a rash of drug heists.

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PLUS

Younger folks just don’t want to take their cholesterol meds.

JUST FOR FUN

A Danger sign you don’t want to see…
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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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Are you looking for a vendor/partner to help with a Corporate/HR/Training Innovation initiative?  Contact me (stevew at impactiviti dot com) and I’ll point you in the right direction!

PLUS

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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THE BIG DEAL – Pharma and the U.S. government come up with drug discount agreement. More detail here.

New Forest Labs pneumonia drug reaches goals – Forest Laboratories Inc said on Friday its experimental antibiotic proved to be at least as effective as an older medicine in pneumonia patients, reaching its main goal in two late-stage trials. Forest said its drug, ceftaroline, was well tolerated and met its primary goal of similar effectiveness and high clinical cure rates compared with ceftriaxone in patients with moderate to severe community-acquired, bacterial pneumonia requiring hospitalizationmore

Pfizer manager sentenced for off-label Bextra promotions.

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Who doesn’t like a like takeover speculation? In this Seeking Alpha article, Cephalon and Genzyme are discusses as potentially attractive targets.

ZS Associates projects a 25% cut in #of sales reps, from the 100k+ peak, by 2012. At its peak in 2007, the American pharmaceutical industry fielded 102,000 sales reps, said Chris Wright, managing principal for the consulting firm ZS Associates’ U.S. Pharmaceuticals Practice. Drugmakers have slashed the number to 92,000 since then, and ZS projects the number will fall to 75,000 by 2012 at the latest, saving the industry $3.6 billion.

Forest Lab‘s Lexapro approved for depression in adolescents. Forest Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Lexapro (escitalopram oxalate) for the acute and maintenance treatment of Major Depressive Disorder (MDD) in adolescents, 12 – 17 years of age. Lexapro is only the second antidepressant to be approved for the treatment of MDD in adolescents, a medical condition that affects approximately 2 million adolescents in the U.S.

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Prasugrel – the saga continues. Gets approval to launch in the EU; positive study results versus Plavix for a certain group of patients; but controversy swirls around FDA approval process.

Synta‘s Phase III trial for melanoma drug fails badly. In a devastating blow to the company, Synta Pharmaceuticals has halted a Phase III melanoma drug trial after a greater number of people taking elesclomol died than those receiving standard care. The findings were so bad that the company also suspended other ongoing studies of the drug, including a study a trial for metastatic prostate cancer and a monotherapy dose escalation study.

Wearisome to report – more scandals. AstraZeneca buried some Seroquel data? Ranbaxy falsified records and gets major smackdown. Forest accused of off-label marketing practices (anti-depressants for children). And, from Peter Rost’s blog, here’s an interesting chart showing who paid the most/least in government fines and settlements since 2000 (the winner on the “least” scale: Novartis!)

Sanofi gets US clearance to market Apidra pen. Sanofi-Aventis  has won U.S. approval to market its Apidra Solostar injection pen which contains insulin to treat diabetes, the world’s third-biggest drugmaker said on Thursday. The disposable pen is prefilled with Apidra, which is indicated to improve glycemic control in adults and children of at least four years with type 1 diabetes or adults with type 2 diabetes, the most common form of the disease.

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