10/8 New Pface Of Pfizer; 3 Teams With R&D Split Into team Silos
Pfizer Refocuses Marketing Division with New Restructuring Strategy … three smaller units focused on primary care, specialty care, and emerging markets … each unit will have its own marketing and sales divisions …[Pharmaceutical Executive]
Pfizer To Reorganize Business Units In Push To Revive Growth … will move certain drug-development functions out of the traditional research arm and into the commercial groups that also handle sales and marketing …[Dow Jones]
Editor's Note: The current big company paradigm is that there is one mother ship with one R&D machine and a football team of sales units all feeding from the mother ship's teats. 

This is different.  From what I am reading, it will be like a confederation of 3 different companies; less centralized; each division will have it's own marketing shop and a private R&D machine.  (Sure, there will be some R&D overlap but the lines between R&D and the rest of the teams will be clearly defined) 

This modular concept is nice in that if one unit tanks it can be unplugged and replaced with a more profitable organelle.  Or, if you have to add another unit, say a generic unit or a biotech unit, you put together another module and ramp it up without overtaxing the other units.  In addition, ownership and P&L streams are clearly demarcated.  Each module's chief's head on the chopping block for better or worse. 

And in a no-nonsense organization like Pfizer those managers will be either highly compensated or out looking for a job in half a heartbeat depending on how their module performs.


10/8 Lilly Settles More Zyprexa Suits
Eli Lilly to pay $62 million in Zyprexa settlement … settle claims that it improperly marketed its top-selling Zyprexa schizophrenia drug to patients … accused of promoting the drug for unapproved off-label uses and of playing down side effects such as weight gain…[Reuters]
See Also:  Lilly Press Release

10/8 FDA Communiqué: Current Data Indicates Spiriva Not
Associated With Increased Stroke Risk
Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler) …  FDA expects to receive the complete report for UPLIFT in November 2008.  Results from this trial will also help to address some issues raised about tiotropium in the two recent publications …[ FDA Early Communication]
Tiotropium (marketed as Spiriva HandiHaler) …  Audience: Pulmonary care health professionals and patients … 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo. …[ FDA]
See Also: Similar Report From Reuters
Editor's Note: We indexed a report of a meta analysis regarding Spiriva's link to cardio risk on 3/19/08.  That's why you need to check this website every single day! 

10/8 MabThera (Roche), Rituxan (Biogen/Genentech)
New Hope For Leukemia:
Roche Drug Slows Leukemia … in combination with chemotherapy, significantly improved progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia, the most common form of …[Wall Street Journal; $$$]
Genentech And Biogen Score Against Leukemia … Rituxan, was able to slow the progression of lymphocytic leukemia in a late-stage trial that treated patients who had already relapsed  …[Forbes]

10/8 Yaz Period TV Spots Earn Warn Letter
US FDA cites Bayer for misleading birth control ads … kicking, punching and pushing balloons with words such as "irritability," "moodiness" and "bloating." … wrongly suggest the pills are approved for relieving premenstrual syndrome …[Reuters]

10/8 Industry Group Says  Don't Use Cold Drugs For Kids
Under 4; Voluntary Label Change
Pediatric OTC Cough and Cold Remedies Should be Shunned in Toddlers … new labels would begin appearing on store shelves during the 2008-2009 cough and cold season … second voluntary change ... A year ago, they pulled medicines aimed at infants from store shelves …[Medpage Today]

10/8 EU Inches Toward More Direct Communication With Patients
Europe Mulls Easing Drug Rules …  let companies provide "objective and unbiased" information about drugs in print and online but would prohibit outright advertising … would allow them to set up Web sites about their drugs and possibly circulate brochures at pharmacies, activities that …[Wall Street Journal; $$$]
Editor's Note: This is huge.  Imagine a place where drug  websites, coupons, pharmacy brochures, DTC, or any other pump priming tactics are prohibited.  Well, that's Europe.

10/8 So Freakin' Nutty, We're At A Loss For a Snappy Headline
'Thanks, But No Thanks'; Pfizer Sues over Free Viagra Advertising … imminent "tour" of VIAGRA-branded missiles in New York and "twelve other major cities," complete with models distributing free condoms depicting Senators McCain and Obama  ….[Wall Street Journal; FREE]

10/8 Proscar Demonstrates Good Effect On Bones Not Weaken Them
Merck's Prostate Drug Proscar Doesn't Weaken Bones, Study Finds … those who took Proscar had a 23 percent reduced risk of hip fractures versus those who didn't … Proscar works by stopping the male hormone testosterone from converting into a more potent form…[Bloomberg]
Prostate Meds Not Tied to Increased Hip Fracture Risk … [Washington Post]

10/8 Internet Drug News Miscellaneous Short Takes:
Dendron: What Went Up Came Down
AP
Wyeth Says Newer Meningitis Vaccine Would Pack More Punch
Wall Street Journal; $$$
Will a Better Drug Sell Better?
Motley Fool

10/7 Bristol: We Lost Imclone But We're  $1 Billion Richer :)
Bristol says ImClone defeat may have silver lining … financially better poised to pursue other deals. … expects to realize about $1 billion from selling its ImClone stake to Lilly, which will give it more wherewithal to buy other biotech companies or drugs…[Reuters]
Bristol to Sell $1 Billion ImClone Stake to Lilly … [Bloomberg]

10/7 Report: Dr Reddy Proprietary TZD Faces Delay
Dr. Reddy's Falls After Report on Diabetes Drug Delay … Balaglitazone … delayed because of financial problems at Rheoscience A/S, the Danish company conducting the drug's clinical trials…[Bloomberg]

10/7 Provenge Reduces Prostate Death Risk But Approval Still Iffy
Dendreon's Provenge cuts death risk, but analysts wary … reduced the risk of death by 20 percent compared with a dummy drug in a late-stage trial, but analysts remained skeptical…[Reuters]
Editor's Note: Adds that approvable letter was issued last May.

10/7 JNJ Claims Remicade Useful For Chron's
J&J: Adding Remicade To Common Drug In Crohn's Is Effective … more effective than the other drug, azathioprine … ncreased effectiveness of the combination therapy may come at a cost of increased safety risks…[CNN Money]
Efficacy of REMICADE(R) Compared With Azathioprine in Treatment of Crohn's Disease … [Centocor Press Release]
See Also: Similar Report From Reuters

**********
Drugstore Factoid: Did you realize that shares in RiteAid are down more than 80% from a year ago?
**********

10/7 FDA Review Timeline: What & When;
FDA Calendar of 70 Decision Dates … needs more time to review the application rather than something more ominous such as requiring additional clinical trials … [ MikeRx.com]
Editor's Note: Internet Pearl! The above blog post is a rare find.  Our editor Yuen Kim came across the above doing an intelligence report.  The post includes a  spread sheet of  the FDA decision que for 70 products.

10/7 Researchers: Drug Samples For Kids Not Such A Good Idea
Study Questions the Value of Free Drug Samples for Kids … four of the 15 most popular samples given to kids got new or revised black box warnings … …[Wall Street Journal; FREE]
Study Says Drug Samples May Endanger Children … often lack instructions for children or information about what parents should do in the event of an overdose … lowest income group were no more likely to receive the samples than were those in the highest income group …[NY Times]

10/7 Medicated ADHD Kids Less Likely To Abuse
ADHD Stimulant Meds Cut Young Girls' Drug Abuse Risk … does not increase the risk of future substance abuse or smoking in girls with ADHD and at least delays the onset of cigarette smoking and substance abuse …[HealthDay]

10/7 Internet Drug News Miscellaneous Short Takes:
Mail Carriers Can Have Antibiotics for Anthrax Plan
Bloomberg
Drugstore Chains Are Hurting
AP
Guy Who Discovered HPV/Cancer Link Wins Nobel Prize
Qiagen Press Release
Dendreon Shares Climb on Promising Prostate Cancer Data
Wall Street Journal; FREE
Moody's may downgrade Lilly after ImClone buyout
AP
Avastin-Tarceva combo fails in lung cancer trial
AP

10/6  Lilly Makes a Bid For Imclone
Eli Lilly Set to Buy ImClone For $6.1 Billion … aggressive move by Lilly further into the business of selling cancer drugs, a business beleaguered pharmaceutical companies view as increasingly attractive …[ NY Times]
Lilly Set To Acquire Imclone … Cancer is one of the three main areas of research focus at Eli Lilly, along with diabetes and neuroscience. Eli Lilly's has a robust oncology business, but its largest product, Gemzar, loses patent protection in 2012 …[ NY Times]

10/6 Merck Pulls Plug On Acomplia-Like Product Taranabant
Merck Can't Fight the Munchies … effectiveness and adverse events are dependent on dose levels … Merck wasn't able to find a dose level that adequately minimizes the safety risk while helping people lose weight …[NASDAQ]
Editor's Note: I have written about this topic before - the obesity scientists got it backwards.  Rather than blocking the CB1 receptors, what we need is an agonist that stimulates the CB1 receptors [which are also stimulated by the endogenous cannabinoid-like neurotransmitter anandamide also known as arachidonoylethanolamide or AEA] to cause hunger and weight gain.  There are no highly effective non-steroidal appetite stimulators.  A compound like this would be useful in treating cachexia.  Anyone who has seen a friend or relative die from AIDS or cancer knows that they starve to death.  A potent, titratable  anti-cachexia drug  would have wide implications in AIDS, cancer, CHF, COPD and certain incidences of schizophrenia. 

10/6 Raptiva Patient Comes Down With Rare Deadly Brain Disease;
Sends Warn Letter
Genentech Announces Patient Treated with Raptiva Develops Progressive Multifocal Leukoencephalopathy (PML …  70-year-old patient being treated for chronic psoriasis with its drug Raptiva (efalizumab) for more than four years …[ Network Medica]
Editor's Note: Last month they reported a case of the same disease on a Rituxan (rituximab) patient.

10/6 Uncle Sam May Back Off In Ranbaxy Investigation
Ranbaxy Gains in Mumbai After U.S. Says It May Withdraw Motion ...U.S. government offered to withdraw a motion seeking to force the South Asian company to turn over audit …[Bloomberg]
Justice Reviews Ranbaxy Papers to Decide on Motion … The Justice Department is going to review almost 500,000 pages of electronic documents related to an audit of Ranbaxy Laboratories before deciding whether to withdraw its July 3 motion to compel generic drugmaker Ranbaxy and contract research organization Parexel to release records …[ FDA News]

*******
Drug Reps In The News:
   Item 1: A Las Vegas pharmaceutical sales rep was on the jury that convicted OJ Simpson of armed robbery last week.
   Item 2: Drug Rep Cleared Of Rape but sentenced 6-23 months for different sexual crime ***********

10/6 Sanofi To Lay Off 1/3 Of Sales Force (In France)
Sanofi to cut 817 French reps ...2,900 sales jobs were cut away in the U.S. and Europe by February 2008 ... the sales ranks thinned by 18 percent to 7,800 people …[Fierce Pharma]

10/6 Kiplinger: Mylan Good Buy
Get a Deal on Mylan … debt-free as recently as 2006, the company now owes almost $5 billion … This maker of generic drugs is priced as if it were a fading company. The facts show otherwise. … 67% of the U.S.'s prescription volume is now generics, according to IMS  … [Kiplinger]
Editor's Note: Mentions failed  Dey spin-off, generic biologics, anticipated p/e ratio of 11; stock is down 60% from last year.

10/6 FDA: Kid Cold Med Ban Not Good Idea
Ban on cold medicines for young children opposed … FDA is also worried that a ban - as sought by leading pediatricians' groups - might only drive parents to give adult medicines to their youngsters …[AP]
See Also> Similar Report From NASDAQ

10/6 Spiriva: Bettwe Quality Of Life But Meager Term Lung Improvement
Spiriva shows little aid to long-term lung function … did document improvement in some secondary measures such as quality of life … seemed to forestall some worsening of the disease… should not be prescribed in hopes of changing the progression of COPD, but only for the alleviation of symptoms …[Reuters]
See Also: Beohringer Ingelheim Press Release

10/6 Psychiatric Thought Leader In Trouble Over Taking $$$ From Glaxo
Doctor Didn't Disclose Glaxo Payments, Senator Says … In 2006, he stepped down as editor of the journal Neuropsychopharmacology after The Wall Street Journal reported he wrote favorably in the publication about a depression-treating device but didn't disclose he was a paid consultant to its maker…[Wall Street Journal; $$$]
Grassley Says Emory Psychiatrist Didn't Report $500,000 in Payments …[Wall Street Journal; FREE]

10/6 2 Health Web Sites Merge; Could Unsead WebMD As #1
Look out WebMD: Waterfront Media to merge with Revolution Health … Hypothetically, the combined properties would surpass WebMD's roughly 17 million users … [WebMD] still has the largest reach in terms of consumer recall of sites visited in the past 12 months …[MM&M]
Editor's Note: Revolution Health was founded by Steve Case with the money he made from AOL

10/6 Internet Drug News Miscellaneous Short Takes:
Biotechnology shares rise as Congress OKs plan
AP
Morgan Stanley cuts Walgreen, says prefers CVS Caremark
Reuters
Roche Cuts Price Of Tarceva In UK To Get On National Formulary
Reuters
Sun Pharmaceutical Extends Tender Offer for Taro
Sun Pharma Press Release
Elan drug delivery unit sale delayed by credit crisis
Reuters
*****************************************************