Pharmaceutical News Harvest ™
        (Click HERE for last Week's News)

12/7 Reinstated Lipitor Patent Means Teva, Apotex Sandboxed Until 11/2011
Pfizer Gets US Patent Office Nod For Reissue Application For Lipitor Enantiomer Patent … The '893 patent covers the racemic mixture, while the '995 patent covers the enantiomer version, which had failed the test of obviousness in most markets, including the United States …[NASDAQ]
Pfizer Wins New Lipitor Patent Expiring in June 2011 … U.S. agreed to reissue a patent on the drug's key ingredient that had been invalidated by an appeals court. … bolsters its efforts to prevent Apotex Inc. and Teva Pharmaceutical Industries Ltd. from selling a copy before November 2011…[Bloomberg]

12/7 Warner Chilcott Gets Experimental Viagra-Like Product From Korea
Warner Chilcott and Dong-A Sign U.S. License Agreement For Erectile Dysfunction Treatment … develop and market their orally-administered udenafil product, a phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED) in the United States. Dong-A has successfully completed Phase 2 studies of the product in the United States …[ Warner Chilcott]
Editor's Note: Adds that Udenafil is approved in Korea; the literature indicates that Udenafil has demonstrated a half life of 7.3-12.1 hours.

12/7 Health Care Spending Velocity Downshifts On Generic Growth
Health Care Spending in U.S. Grew at Lowest Rate in a Decade … Due to slower spending on prescription drugs, health-care spending in the United States grew at the lowest rate in a decade in 2007, a new federal report found …[HealthDay]
Tough Drugs Market Slows Growth in Health Spending … main reason for the overall slowdown was the 4.9% growth in prescription drug spending, the lowest rate in decades…[Wall Street Journal; FREE]
U.S. health spending hits $2.2 trillion in 2007 … [Reuters]

12/7 FT Hints Pharma Out To Swallow Biotech
Pharma buying spree could swallow biotechs … leading pharma companies are seeking to compensate for an estimated drop of more than $100bn in sales over the next five years on blockbusters such as Pfizer's Lipitor, Wyeth's Effexor, Merck's Singulair and Eli Lilly's Zyprexa …[ FT.com]

12/7 Ratinoid/Benzoyl Peroxide Combo Gel Approved
Epiduo(TM) Gel, the First and Only Combination Treatment with a Retinoid and Benzoyl Peroxide to Treat Acne … treats both inflammatory and non-inflammatory lesions with no evidence of promoting antibiotic resistance, simplifying the management of mild-to-moderate acne … [ Company Press Release ]

12/7 Endo Indevus Tie Up Carries Risk
Analysts mixed on Endo, Indevus tie-up … positive benefit of additional products but some concern over regulatory risks … [AP]

12/7 Brain Stimulation Device For Parkinson's Delivers Results, Risk
Parkinson's patients greatly improve with brain pacemaker, but risks are high, study finds … 40 percent of the patients who received these "brain pacemakers" suffered serious side effects, including a surprising number of falls with injuries …[AP]
Study backs deep brain stimulation for Parkinson's … small electrical device is implanted surgically in the chest, with wires leading to electrodes in the brain … no cure and drugs used to control symptoms can lose their effectiveness over time or cause bad side effects … [Reuters]

12/7 Internet Drug News Miscellaneous Short Takes:
Coffee may protect against oral cancers
Reuters
China confirms woman died of bird flu in Beijing
Reuters
AstraZeneca aims to sell nasal flu vaccine in EU
Reuters

12/6 Pharmalot Folds; Elsevier Snags Uber Pharma Blogger Ed Silverman
Pharmalot… Pharmanot… So Long, Folks … not just another site for information or the equivalent of a morning newspaper, but also a place where people could meet to discuss and debate all sorts of issues concerning the pharmaceutical industry …[Pharmalot.com]
Pharmalot, R.I.P.; Long Live, Ed Silverman … Ed's work will appear in a variety of publications, including In Vivo and the Pink Sheet …[Wall Street Journal; FREE]

12/6 Merck Seeks Gardasil For Males
Merck Seeks FDA Approval for Gardasil in Boys … asked the FDA to approve the Gardasil vaccine's use in males ages 9 to 26 years to prevent genital warts and other lesions…[Wall Street Journal; FREE]

12/6 FDA Eyes Behind The Counter As 3rd Drug Class
FDA Awaits GAO Report To Guide Behind-The-Counter Policy … on other countries' behind-the-counter programs before making decisions on a third class in the U.S.; report expected in late January/early February …[PinkSheet $$$]

12/6 Pfizer: Financial Times Report Sparks Tempest In A Teapot
Pfizer eyes merger deal with large rival … stark contrast to those of his peers, who have increasingly focused on small-scale deals and partnerships while turning against the "mega-mergers …[FT.com]
Pfizer Merger Is Just Speculation … no such luck. The headline was built on a foundation of nothing more than this little quote from Jeff Kindler, Pfizer's chief executive: "The real goal is to grow revenues… [The Street.com]

12/6 FDA To UCB: Cimzia Safety Update Needed To Back Arthritis Claim
UCB Receives Complete Response Letter From U.S. FDA for Use of Cimzia(R) in Rheumatoid Arthritis Patients … UCB is confident and committed to making Cimzia® available to people living with moderate to severe rheumatoid arthritis and other inflammatory conditions as soon as possible. UCB will work diligently with the FDA to fulfill their request …[UCB Press Release]

12/6 Tysabri Gestalt Sinks Biogen
Biogen shares fall on JP Morgan downgrade … saying the multiple sclerosis drug Tysabri could continue facing challenges in 2009 while the company lacks any catalysts to drive new revenue …[AP]

12/6 Heart Doc Experts: Don't Rush To Stentify
Panel Issues New Criteria For Treatment Of Heart Blockage … new criteria for treating patients with clogged arteries and said artery-opening procedures weren't necessary for patients with milder symptoms who weren't treated with drugs …[NASDAQ]

16/6 Internet Drug News Miscellaneous Short Takes:
Merck sells vaccine lab to PPD in research deal
Reuters
Endo to buy Indevus Pharmaceuticals for $370 mln
Reuters

12/5 Fosamax Linked To Cancer
Osteoporosis drugs linked to esophageal cancer … since the initial marketing of Fosamax, known generically as alendronate, in 1995, the FDA has received 23 reports in which patients developed esophageal tumors … Typically, two years lapsed between the start of the drug and the development of esophageal cancer. Eight patients died…[Reuters]

12/5 Prasugrel Gets Another Bite At The Apple
FDA Cardio Renal Advisory Committee to Review Daiichi Sankyo, Lilly Drug Prasugrel … on February 3, 2009 … We have full confidence in the data submitted to the FDA and the overall benefit-risk profile of prasugrel, and we look forward to this next step …[Lilly Press Release]
US FDA advisers to review Lilly, Daiichi clot drug … fared better in Europe, where a panel of experts recommended its approval earlier this month… public hearing was inevitable after the FDA twice delayed a decision on the drug …[Reuters]

12/5 Yoda Of Drug Industry Says Prasugrel Not Big Enough To Carry Lilly
FDA Gets Outside Help for Lilly Review … prasugrel revenues wouldn't be sufficient to make up for losses from patent expirations. "Lilly needs three or four prasugrels, not just one … approvable drug, but you can't say that with a high degree of confidence, given the controversy…[Wall Street Journal; $$$]
Corey Says: "In my opinion, sell side pharma analyst Timothy M. Anderson of Sanford Bernstein (formerly with Prudential) is one of the most influential Pharma Wall Street egg heads; he has the ability to move markets with one sentence.  But don't take my word for this - ask your CEO and see what he says." 

12/5 252 Rupees??? Ranbaxy Deal Means Daiichi Lost $3.3 Billion
Daiichi Sankyo Co. to post $3.3 billion loss on Indian unit … to reflect the declining share price of its Indian subsidiary Ranbaxy Laboratories Ltd., according to a report in the Monday morning edition of the Nikkei newspaper …[MarketWatch]
Daiichi Sankyo to Write Down Stake in India's Ranbaxy … stuck to his offer price for Ranbaxy even after the stock fell last year, as markets declined worldwide and the company faced a U.S. import ban. … Shares of India's largest drug company have lost 66 percent of their value since Tokyo-based Daiichi Sankyo paid 737 rupees…[Bloomberg]

12/5 Time Release Tramadol Finally Gets Nod
FDA Approval of Once-Daily RYZOLT(TM) (Tramadol HCL Extended Release Tablets) … marketing partner for its product in the United States, Purdue Pharma L.P., anticipates launching RYZOLT tablets in 100 mg, 200 mg and 300 mg dosage strengths in the second quarter of 2009 …[Labopharm Press Release]

12/5 Ultram Recalled
Biovail Recalls Ultram Painkiller … certain batches were found to be "out-of-specification" by about one percent regarding "maximum dissolution at the eight-hour mark …[NewsInferno]

12/5 50 MCG/HR  Duragesic Patch Recalled
PriCara(R) Recalls 50 mcg/hr DURAGESIC(R) (fentanyl transdermal system) CII Pain Patches … possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel …[ JNJ Press Release]

12/5 Abuse Resistant Narcotic Review Delayed
FDA extends review of King Pharma's Embeda … review will likely extend into early 2009 … inner core of naltrexone, a drug that reverses morphine's effect. The naltrexone is released when Embeda is tampered with…[Reuters]
See Also: King Press Release
Editor's Note: King inherited Embeda when it bought Alpharma.

12/5 Novartis Grooms Tekturna As Diovan Successor
But Generic Cozaar Could Eviscerate Renin Modulating Antihypertensives
Novartis Girds for the Day Blockbuster Loses Patent … Cozaar will lose U.S. patent protection in 2010 ...investing millions of dollars in a hypertension pill called Tekturna… risk that Diovan sales will begin dropping even before the drug's U.S. patent expires …[Wall Street Journal; $$$]

12/5 After 52 Years, Darvon Faces FDA Gauntlet
Darvon, Painkiller Since 1957, Faces Review by U.S. …after a consumer group accused the government of failing to ban the medicine in spite of its link to thousands of deaths …[Bloomberg]

12/5 Deaths Prompt Innohep Warning Update
Celgene warns that anticlot drug linked to deaths …13 percent in the group getting Innohep had died of various causes, versus 5 percent in a comparison group getting heparin, a widely used anticlotting drug …[AP]
See Also: http://www.fda.gov/cder/foi/appletter/2008/020484s011ltr.pdf

12/5 Free Drugs (Free Drugs)
Super G, Giant Food offer free antibiotics … Consumers need only a doctor's prescription to get up to a 14-day supply of nine medications, including amoxicillin and penicillin. All six Super G and Giant Food supermarkets in Delaware are participating .,..[ DelawareOnline]

12/5 Internet Drug News Miscellaneous Short Takes:
Cough medicine ingredient noscapine may treat prostate cancer
Reuters
High As A Kite, Flushed Like A Toilet
Acura, King Press Release
Doctors test tea tree oil body wash for MRSA
Reuters
Propholactic ICU Antibiotics Reduced Mortality
Reuters
Bird flu re-surfaces in crowded Indian state
AFP
Watson Gets FDA Approval for Mint Coated Nicotine Gum
Watson Press Release

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