Pharmaceutical News Harvest ™

3/19 Teva Gets Ratiopharm; Seeks to Grow Outside the U.S.
Ratiopharm Gives Teva 'Last Ticket' to German Generics Market ... Teva offered at least 200 million euros more than competing bidders... A last-minute increase by New York-based Pfizer wasn't enough to match Teva's bid ... [Bloomberg]
See also; Pfizer's Kindler KO'd by Teva's Yanai [CNBC]

3/19 Roche Unveils Pipeline; Claims Dominant Position in Cancer
Roche CEO: Nobody Can Touch Avastin ... CEO Severin Schwan insists that a likely new use for Avastin in ovarian cancer (where the drug worked in a big recent trial) and expansion into overseas markets where the drug is not as frequently used can keep the growth going ... [Forbes]

3/19 Medicines Company Gets Reconsideration of Missed Deadline
A Company Races to Keep a Drug Patent ... In the past year, Medicines has been trying — so far unsuccessfully — to get language added to the health care overhaul legislation to resolve its patent dispute. It has also commissioned studies to make the case that longer patent life for Angiomax would actually save the health care system billions of dollars over the next two decades ... [NY Times]

3/19 First Seroquel Case Goes to Defense
AstraZeneca Wins Trial on Seroquel Diabetes Claim ... The state court panel in New Brunswick, New Jersey, deliberated a total of six hours over two days before finding the company's warnings to Ted Baker's doctors absolved AstraZeneca of responsibility for his injuries ... [Business Week]

3/19 If You Lead Them by the Wallet, Their Hearts and Minds Will Follow
Diabetes Drug Supporters Had Financial Tie to Glaxo, Study Says ... Almost 90 percent of scientists who wrote positive articles, reviews or commentaries about Avandia had financial ties to London-based Glaxo... Almost three of every four authors who expressed negative views of the drug had no financial ties to manufacturers of diabetes medicines ... [Bloomberg]

3/19 Carbaglu Reduces Blood Ammonia Levels in NAGS Deficiency
FDA approves Carbaglu ... Carbaglu (carglumic acid) tablets, made by Orphan Europe, are used for treating N-acetylglutamate synthase deficiency, an extremely rare genetic disorder that can show up in babies soon after birth ... [Drug Store News]

3/19 Cheap Generics Not Coming Fast Enough; FTC Disappointed by Failure of Amendment
Pay-To-Delay Ban Dropped From Healthcare Reform ... The amendment was dropped from part of the health care reform bill because of concerns it wouldn't pass muster with congressional rules ... [Pharmalot]

3/19 Feds to Ease Way for Combination Therapies
FDA Looks to Streamline Rules for New Drug Cocktails ... Drug cocktails have been a big step forward in thwarting drug resistance because more mutations have to occur to block the effects of several drugs working together than are needed to escape just one medicine. ... [WSJ Health Blog]

3/19 Silenor Gets OK on Third Try; Somaxon Spent $170 million to Win Approval
Somaxon receives FDA approval for insomnia drug ... Silenor is a low-dose oral tablet form of doxepin for use in insomnia. Doxepin has been long prescribed as a treatment for depression and anxiety at dosages typically ranging from 75 mg to 300 mg per day ... [Business Week]
See also; Somaxon (finally) wins FDA approval for sleep drug Silenor [Fierce Biotech]

3/19 Pharma Moving Income Offshore for Better Tax Rates
US drug companies' foreign profits grow. Suspiciously. ... Foreign profits at Pfizer and six other US drug companies quadrupled between 1997 and 2008 while their domestic profits fell by a third. ... [Christian Science Monitor]

3/19 Internet Drug News
Miscellaneous Short Takes:
Drug-resistant TB at record levels worldwide, the WHO says
LA Times Booster Shots blog
USA Drug, owner of Ike's and Super D, will be out of Memphis by March 23
Memphis Commercial Appeal
Alzheimer Results From J&J May Be Pushed Back to 2012
Bloomberg


3/18 Pfizer Eyes Consolation Prize as Auction Proceeds
Pfizer may target Stada if it loses Ratiopharm ... In many ways, Stada would actually be a better fit for Pfizer than Ratiopharm ... [Reuters]

3/18 Most Quit Smoking without Help
Are Antismoking Drugs Cost Effective? ... Researchers contend that medicine has become so obsessed with stop-smoking drugs and fancy behavioral treatment that doctors ignore the fact that three-quarters of quitters kick the habit on their own, without any help ... [Forbes]

3/18 Buying Time at a Stiff Price
Study Evaluates Costs and Benefits Associated With New Colon Cancer Therapies ... Among those who received the new chemotherapy agents, life expectancy increased by 6.8 months and lifetime costs increased by $37,100, equating to a cost of $66,200 per year of life gained. After additional adjustments, the cost for each quality-adjusted life year (a year of life in perfect health) gained was $99,100 ... [Science Daily]

3/18 Think Global
AstraZeneca Maps 'Selective' Expansion in Emerging Markets ... Emerging markets are forecasted to contribute around 70% of pharma-industry growth in the next five years, with branded generics accounting for a large chunk of that expansion ... [WSJ Health Blog]

3/18 Biomarkers Consortium Joins FDA, NCI, NIH and Major Pharma
Breast cancer drugs to get faster screening ... The five-year, $26-million-US study will screen several drugs at once and identify which treatments work best for specific types of patients with high-risk, fast-growing breast cancers ... [CBC]
See also: The Future of Oncology: Interview with Dr. Susan Desmond-Hellmann [Pharma Strategy Blog]

3/18 Abraxane on Path to Broader Indication
Abraxis Jumps After Successful Trial of Cancer Drug ... The Abraxis product, Abraxane, combines paclitaxel with a human protein to administer it in higher doses... Abraxane showed a more successful response rate in treating non-small cell lung cancer than paclitaxel alone ... [Business Week]

3/18 ED Patent War Truce
Pfizer Drops Patent Lawsuit Against Lilly Over Cialis ... The agreement to drop the suit came a month after the U.S. Patent and Trademark Office said one aspect of the Pfizer patent in the case covered a treatment similar to a Chinese herb known as Horny Goat Weed ... [Bloomberg]

3/18 $90 Billion in New Drug Sales in Emerging Markets
Drug Giants Lag Where Sales Boom, Study Says ... Annual growth of pharmaceutical sales in mature markets like the United States and Western Europe has slowed to the low single digits in the last eight years, but 17 emerging markets are poised for significant growth ... [NY Times]

3/18 Wired Medical Practices Cut Prescribing Errors from 42.5 per 100 to 6.6 per 100
E-prescriptions cut medication errors: study ... Among 12 New York State primary care practices, the six that had adopted "e-prescribing" systems reduced their prescribing errors by nearly seven-fold over one year ... [Reuters Health]

3/18 Manufacturers Want Trusted Mark for Web Links
Big Pharma Urges FDA to Adopt New Rules for Web Marketing ... After conducting searches on Google relating to eight different Pfizer products last month, the drug maker found that only 22% of first-page results and linking sites were regulated by the FDA. The remaining 78% of the search results took users to unregulated sites such as international pharmacies, spam sites, user-generated sites, blogs and attorney sites for lawsuits. ... [Advertising Age]

3/18 Internet Drug News
Miscellaneous Short Takes:
White House Expected To Nominate Nobel Laureate Harold Varmus As NCI Director
Cancer Letter
Bristol combination diabetes drug Onglyza:metformin under review
AP
Newer Genetic Info Adds Little to Predicting Breast Cancer
HealthDay
Lipidemia Improves with Growth Hormone Tx
Medpage Today
Actavis Receives Approval Of Alprazolam ODT In The U.S
TheStreet
WHO Suspends Sanofi Shan5 Child Vaccine Amid Probe
Bloomberg

3/17 Filled But Not Taken Home Rise 68%
Scripts going unfilled at 'unprecedented' rate … prescriptions submitted to a pharmacy but never picked up--known as abandonment--rose 24% in 2008 and is up 68% since 2006 among brand-name drugs …[MM&M]

3/17 DDMAC Demands Corrective Message For 3 Products
Whose Marketing Materials Violated Rules
DDMAC demands corrective messaging from three companies … materials for two treatments for pain and inflammation associated with eye surgery - ISTA Pharmaceuticals' Xibrom and Sirion Therapeutics' Durezol - and a heavy-duty pain drug, Actavis' Kadian …[MM&M]
Editor's Note: Kadian.com has been down for 2 weeks.

3/17 $70 Mln Worth Of Pills Stolen From Lilly Warehouse
$70 million in drugs stolen from Eli Lily warehouse … Sophisticated thieves in Connecticut scaled the walls, cut a hole, rappelled down and took enough pallets of Prozac, Cymbalta and Zyprexa to fill a large trailer …[LA Times]
Editor's Note: Why not activate the  Lo-Jack and locate them?"  GPS jamming devices are inexpensive and readily available.

3/17 Ancient Drug Useful In Diabetes
Arthritis drug shows promise in Type 2 diabetes study … low-cost drug known since the time of the Pharaohs improved diabetes symptoms in a Boston study being published today, and its success … [Boston.com]

3/17 Generic Lipitor Deal : Ranbaxy Meltdown Could Win Pfizer $4 Bln
Pfizer-Ranbaxy: Could There Be Trouble Brewing? … in return for the settlement of patent violations, Ranbaxy agreed to delay selling Lipitor …  If it cannot make the pills, it cannot sell the pills and PFE gets to keep 100% market share at very high prices for another six months …[Seeking Alpha]

3/17 Oy Vey: Drug Coated Stents Linked To Increased Death Risk
Long-term safety of drug-coated stents questioned … more patients who got drug-coated stents right after suffering a heart attack later died from heart-related problems than those who received older, cheaper bare-metal …[Reuters]
Another Heartbreak for Boston Scientific …[Barron's]

3/17 Diabetes: Preventative Maintenance Fairy Tale
Drugs Are For Sick People …  no difference between a diabetic on a diabetes drug and a pre-diabetic on a diabetes drug,… whole idea of preventing diabetes is "a sleight of hand by pharmaceutical sponsors…[Forbes]

3/17 Lilly Reaches For Underarm Testosterone Lotion
Lilly Buys Right to Lotion for Low-Testosterone Men … called Axiron for men whose low hormone levels impair their sex drive and memory … could provide a new treatment option for men suffering from low testosterone … [Bloomberg]
See Also: Similar Report From CNBC

3/17 Alpharma Pays $42.5 Mln Fine For Kadian Promo Tactics
Alpharma to Pay $42.5M to Settle Lawsuit … suit alleged that Alpharma misrepresented the safety of Kadian and paid doctors to prescribe the medicine from 2000 through 2008 … [Wall Street Journal]

3/17 How To Get Docs To Attend Your Speaker Programs
Drug Companies Increase Interactions Between Speaker Program Attendees and Company Reps … best drivers of physician attendance are personalized invitations from medical science liaisons (MSLs) and sales representatives … One surveyed company, for example, seeks out popular speakers by polling physicians in a given area. It then invites the most sought-after speakers to headline its events …[Cutting Edge]

3/17 Daily Aspirin Use May Cause Harm For Many
The Danger of Daily Aspirin …   concern is that aspirin's side effects, which can include bleeding ulcers, might outweigh the potential benefits when taken by many healthy or older people …[Wall Street Jornal]

3/17 Internet Drug News Miscellaneous Short Takes:
Mylan, Ranbaxy, Watson Takeda work out deal on generic Actos due out 8/2012
Google News
Sanofi Pays $15M To Settle Sex Discrimination Suit
Pharmalot
IMS: China to be 3rd largest pharma market in 2011
AP
AstraZeneca Maps 'Selective' Expansion in Emerging Markets
NASDAQ
Brilinta (Ticagrelor,): patients less likely to die after bypass with AZN experimental blood thinners
Reuters
Emerging Markets To Make Half Of Pharma Sales Growth By '13 Study
NASDAQ
Eli Lilly licenses testosterone drug from Acrux
AP
Women more likely to die after heart attack: study
Reuters

3/16  "I Hate Her Uterus" (Serono Cuts Loose)
Serono Tries a Taboo Tactic in Drug Advertising: Sarcasm and Humor… They're pregnancy tests, they're not scratch-off tickets … it just seems like Jane can run into a pole and get pregnant … [BNET]

3/16 Amylin Soars As FDA Red Lights Once Weekly Byetta
FDA Says "No Way!" Market Says "Yeah, Baby!" … only question now is whether the FDA will deem the response to be class 1 (with review likely finished in two months) or class 2 (review finished in six months)…[Motley Fool]
See Also: Amylin, Alkermes Gain as FDA Needs No New Byetta …[Bloomberg]
See Also: Amylin Press Release
Related: Has Amylin Hit a Top? … Amylin Pharmaceuticals is up 55 percent in the last three months, and traders are calling a top … investors … [Option Monster; FREE registration required]
Editor's Note: The market punishes uncertainty; the invisible hand has decided that the Bydureon rejection is not insurmountable.  (If you don't know what the "invisible hand is" look it up on Wikipedia or as someone smart).

3/16 Sales Call Receptiveness Dynamics
Access to docs flat, but appointments on the rise … 10 or more docs, for example, denied access to reps 42.1% of the time, and the same offices required appointments at a rate of 54.9%. Offices with only one or two physicians barred reps at a rate of 13.4%…[MM&M]

3/16 Hassan: Pharma's Midas Takes Reins Of Bausch & Lomb
Fred Hassan Finds New Perch … still trying to fully recover from a contact-solution recall in 2006 after links to fusarium keratitis, a rare fungal eye infection…[Wall Street Journal; FREE]
See Also: New CEO, chairman appointed at Bausch & Lomb ...AP
Editor's Note: Hassan is the A-Rod of the drug industry; the only question is how long it will take him to turn around B&L, who he's going to sell it to and what does he do with all that money? (He supposedly even makes more money than Tim Anderson).

3/16 Cardio Illness AND Impotence? Better Have a Seat …
Impotence plus heart disease ups death risk … Men with heart disease who also complain of erectile dysfunction …  twice as likely to die from any cause and twice as likely to have a heart attack …[Reuters]

3/16 MannKind Plummets As Inhaled Insulin Faces Another Setback
FDA seeks more data on MannKind's inhaled insulin … did not request an additional clinical trial, nor did it cite any safety concerns. But it did ask for updated safety data. The agency also requested changes to the proposed labeling …[Reuters]
FDA Grinds MannKind On Diabetes Drug … Afrezza still has to be taken several times per day, so it's not any more convenient than injectable insulin … [Forbes]
Editor's Note:  I am slightly bullish on Afrezza*.  The inhaler's small size compared to the Exubera delivery device (which was possibly modeled after a one-hit bong) can make a difference in uptake.  In order for them to win, Mannkind  should market it to patients who will bug their doctors to try it rather than using the traditional sales rep demand creation model.
*Disclaimer: nobody at Internet Drug News INC owns Mannkind or ANY pharmaceutical stocks.

3/16 Tricor Study Blowback: Trilipix Label, Crestor Combo Pill Questioned
FDA TO Review Labeling Of Abbott's Trilipix … limit the commercial potential of a drug co-development by Abbott and AstraZeneca Certriad, a single-pill combination of Trilipix and Astra's cholesterol-lowering drug Crestor …[Wall Street Journal]
Related: Impax challenges Trilipix patent …[Impax Press Release]

3/16 Black Box Richter Scale: Plavix, Effient,Tysabri
Warning: Not All Boxed Warnings Are Equal … drug's label don't carry skulls and crossbones, but they can sometimes be a death sentence … rugs with boxed warnings have stricter advertising requirements, including a ban on reminder ads …[Motley Fool]

3/16 Plavix: More Not So Good News
Study Casts Doubt On Long-Term Plavix Use After Stents … Patients who stay on the anti-clotting drug Plavix more than a year after getting a drug-coated stent don't have added protection against death or heart attacks …[NASDAQ]

3/16 Internet Drug News Miscellaneous Short Takes:
Ranbaxy Settles Actos Patent Dispute With Takeda
Bloomberg
Watson Receives FDA Approval for Generic Cardizem(R) LA
Watson Press Release
Pradaxa: (Dabigatran Etexilate) B.I. Anti-Stroke Pill Beats Warfarin in Low-Risk Patients
Bloomberg
Merck: experimental blood thinner Betrixaban Greater Effectiveness than Warfarin
Merck Press Release
UK's NICE:   Humira, Enbrel should be 1st choice for psoriatic arthritis
Reuters
Abbott CEO White's Total Compensation Falls 7% In 2009
Dow Jones
Boston Scientific suspends defibrillator sales
Boston.com

3/15 DENIED: Once Weekly Byetta Jab (Bydureon) Shot Down
FDA denies approval of Amylin, Lilly diabetes drug … Food and Drug Administration also requested finalization of the product labeling with accompanying risk evaluation and mitigation strategy…[Reuters]
NDA for BYDUREON: FDA issues complete response letter … no requests for new pre-clinical or clinical trials.  Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes …[Amylin Press Release]

3/15 Birth Control Pills Make You Live Longer (Girls Only)
Women on the pill may live longer … cut women's risk of dying from bowel cancer by 38 percent and from any other diseases by about 12 percent. … [AP]

3/15 Plavix Gets Boxed Warning
Sanofi-aventis and Bristol-Myers Squibb Announce Important Updates to PLAVIX U.S. Prescribing Information … patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form …[Sanofi/Bristol press Release]
See Also: Similar Report From: AP | Wall Street Journal | Reuters

3/15 Another Legal Blow To Autism Vaccine Activists
US court rules again against vaccine-autism claims …  advocates for the idea that vaccines are dangerous said they would not give up. "We hope that Congress will intervene … [Reuters]

3/15 Diabetics: Tricor + Statins Didn't Reduce Cardio Risk
No heart benefit seen with fibrates in diabetics … result did not approach statistical significance … 8 percent risk reduction from the combination therapy compared with the statin plus placebo …[Reuters]
Abbott's TriCor Fails To Beat A Sugar Pill … After five years, there was no difference in the rate of heart attacks, strokes and deaths in the patients who got Tricor versus those who took a sugar pill …[Forbes]
See Also: Abbott Press Release

3/15 Diabetics; Diovan: Disappoints In Cardio Risk Department
Novartis drugs fail to help high-risk patients … reduced progression to diabetes by 14 percent compared to a placebo but failed to reduce the risk of serious heart problems, such as heart attack and stroke…[Reuters]
NAVIGATOR: Valsartan slowed progression to diabetes, no effect on CV events … reduced progression to diabetes in patients with impaired glucose tolerance and cardiovascular risk factors, but did not reduce the rate of CV events, …[Endocrinology Today]
See Also: Similar Report From Wall Street Journal

3/15 Once Weekly Byetta Update
Amylin's Byetta Plant Faulted Over Quality Control … not something that would necessarily derail the approval process  … issues were "minor" and "would not hinder the FDA from completing its decision on today's" deadline …[Bloomberg]

3/15 Analyst On Vytorin: Sales Decay Expected; Nissen Still Ruffled
NJ's Merck could see further decline in Vytorin sales … despite an interim study showing the medicine is effective and safe … likely to continue to be hurt by fierce competition from alternative brand medicines as well as generics …[Star Ledger]
Analyst: Merck's Vytorin sales will keep dropping … Steven Nissen said he thinks public release of the interim analysis -- a normally confidential step in a study -- "was unwise and probably intended to support the commercial goals of the company …[AP]

3/15 Targeted Cancer Drugs: Pfizer Cancer Stable Shows Cracks
Cancer Drugs May Not Cure Pfizer …  serious questions about the wisdom of drug companies betting so heavily, in follow-the-leader fashion, on targeted cancer drugs. … odds of them coming up with a whole slate of multi-billion drugs for common tumors appears to be dimming fast ..[Forbes]

3/15 2,600 Words On Doc Speakers: Milwaukee Sentinel Investigative
As universities tighten ethics policies, drug firms turn to private physicians to promote products … paid up to $3,000 a talk and spoke 15 times in the three-month period, the company said. In the last year, Dall said, she has given at least 60 lectures …[Milwaukee Sentinel]

3/15 Peek At Launch Plans For Unapproved Diet Pill
Arena to sell lorcaserin with partner or alone … Lorcaserin works in a way similar to fenfluramine, which was part of the fen-phen diet cocktail that was withdrawn in 1997 after being linked to heart valve damage … Expects 2010 spending of up to $114 million…[Reuters]

3/15 Internet Drug News Miscellaneous Short Takes:
Merck is Shocked -- Shocked! -- to Discover That Some Drug Ads Are "Deceptive"
BNET
Grassley Tells PBMs To Disclose Ties To Pharma
Pharmalot
GlaxoSmithKline shakes up executive responsibilities for vaccines
AP
FDA On Merck's Fosamax Suggest No Problems
NewsOxy
Abbott Seeks FDA Approval of a New Six-Month 45-mg Formulation of Lupron(R) Depot
Abbott Press Release
Glaxo, Ligand Announces Approval for Platlet Booster Revolade® in Europe
Ligand Press Release
Pfizer's 3 Points of Failure
Motley Fool
PhRMA Spends $6.3M Lobbying in 4Q
DDMAG
Caraco: FDA green lights generic Eloxatin
Caraco Press Release
Rumor Mill: Vanda Is Takeover Bait
RTT
Teva Sues Mylan Over LoSeasonique, Seasonique
Globes
FDA panel backs Medtronic epilepsy gadget: AP
MarketWatch

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