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Pharmaceutical News Harvest ™

4/23 $25B Novartis Makeover
Novartis-Glaxo Unit Swaps Show Industry Overhaul .... Novartis agreed to buy cancer drugs for as much as $16 billion while selling most of the vaccines division to Glaxo for up to $7.1 billion and its animal-health unit to Lilly for $5.4 billion. Glaxo and Novartis also will form a consumer-health joint venture. .... [Bloomberg]
Novartis Builds a Major Overhaul on a Flurry of Deals .... Deals this year in the health care sector — driven primarily by acquisitions by pharmaceutical companies — have resulted in global transactions worth about $64.1 billion through April 10 .... [NY Times]
Q&A: What the Deal Frenzy Says About Pharma's Future .... The bigger your business is, the more development costs and regulatory costs and marketing costs you can share... So this means you have more flexibility [that] you can provide customers. .... [WSJ Corporate Intelligence blog/Ed Silverman]

Got Resume?

4/23 When You Charge $1,000 Per Pill, the Profits Add Up
Gilead profit triples, hepatitis C drug revenue reaches $2.3 bln .... Revenue doubled to $5 billion, beating by a wide margin the $3.98 billion average Wall Street analyst forecast .... [Reuters]

4/23 Slower Demand for Amgen's Lead Products
Amgen profit falls on costs, disappointing sales .... Product sales, while up from a year ago, declined 9 percent from the previous quarter, which the company said was primarily due to inventory stocking late in 2013 .... [Reuters]

4/23 This Would Make a Heck of a Street Drug, But it Doesn't Look Like it Will Make it to Market
QRxPharma Fails to Win Panel Backing for New Painkiller .... Moxduo combines morphine and oxycodone. If approved, the medicine would be the first combination pill with two opioids .... [Bloomberg]

4/23 Job Hop Prompts Nasty Suit
BMS sues ex-account manager, claiming she took PD-1 marketing secrets to Merck agency .... Given her work on nivolumab's anticipated launch and branding strategies, the plaintiffs say, Schulman shouldn't have been allowed to take up her new post. .... [FiercePharmaMarketing]

4/23 Samples Called 'Highly Effective' in Driving Prescriptions
Doc offices that nix free samples cut way back on branded scripts: JAMA study .... Only 17% of prescriptions for adult acne meds were for brand-name drugs at the academic medical center, where samples were verboten. In private offices, which tend to hand out free samples, the proportion of branded scripts was 79% .... [FiercePharmaMarketing]

4/23 Sarepta's Promising DMD Treatment Could be Filed by Year End
FDA relents in battle against the cruel disease Duchenne muscular dystrophy .... The agency has detailed a potential path forward for eteplirsen and indicated a willingness to consider it for accelerated approval .... [St. Louis Post-Dispatch]
See also: What Sarepta Needs To Do Next To Get Its Muscular Dystrophy Drug Approved [Forbes/Matthew Herper]

4/23 All-Oral HCV Combo drug for HCV Genotype 1
AbbVie files all-oral HCV drug with FDA .... The investigational drug combo has demonstrated SVR12 (cure) rates of over 95% in trials .... [MM&M]

4/23 BI Promises Lantus, Humira, Avastin and MabThera/Rituxan Clones
Boehringer lines up biosimilars of major drugs .... The company's most advanced biosimilar so far is a version of Sanofi's insulin Lantus, which is being developed in partnership with Lilly and is currently undergoing regulatory review in Europe with a view to launch some point this year in the region. A US launch is planned to follow in 2015 .... [PMLiVE]

4/23 Internet Drug News Fast Takes:
Wikipedia seen as useful tool to predict flu outbreaks
MedCity News
Former NJ drug exec faces sentencing in stock scam
NorthJersey.com
AHRQ: The conditions that cause the most readmissions
Advisory Board
America's (Other) Most Wanted: FDA Takes Aim at Drug and Device Fugitives
Regulatory Focus


4/22 Fast Takes
INVOKANA™ (canagliflozin)  A Blockbuster in the Making?
Motley Fool
CVS launches new bill pay service for health insurance premiums
Drugstore News
Let Medicare negotiate drug prices: Our view
USA Today
Rite Aid acquires RediClinic, one of the nation's leading operators of retail clinics
Drugstore News
Pfizer Agrees to Pay $190 Million to Settle Neurontin Case
Bloomberg
Lilly's Gastric Cancer Drug Cyramza (ramucirumab) Wins Approval From U.S. FDA
Bloomberg


4/22
VA Says:  Wait Till They Are Dying To Give Solvaldi
- Don't waste it on  symptom free Hepatitis C virus carriers
VA, California Panels Urge Costly Hepatitis C Drugs For Sickest Patients … high clinical benefit, but not everyone needs to be treated immediately … Limiting the number of patients treated with the drugs may prove controversial but necessary … "It's not unreasonable for payers to figure out ways not to treat everyone …[LA Times]
Chronic Hepatitis C Virus (HCV) Infection: Treatment Considerations … not been studied in non-liver transplant settings …  should be considered in patients with advanced cirrhosis, selected patients awaiting liver transplant, post-transplant recipients with cirrhosis …[U.S. Department of Veterans Affairs Communiquι]

4/22
Astra Zeneca Rejects Pfizer Buyout Offer;
Some Experts Say Pfizer Will Try Again
Spurning Merger Approaches, AstraZeneca Pursues Own Path … AstraZeneca views the approaches as opportunistic and ill timed, with too small a takeover premium …  Acquiring AstraZeneca would take Prizer in a direction that is the polar opposite of what management has been discussing for about the past three years …[NY Times]
AstraZeneca cancer pipeline seen as draw for Pfizer … Pfizer could return to the fray, given the attractiveness of AstraZeneca's pipeline … Pfizer move on AstraZeneca might flush out other bidders …  [Reuters]

4/22
How Johnson & Johnson Became A Household Name
How Johnson & Johnson Became A Household Name … 70% of our sales come from products with the number one or number two global market share position …  Two-fifths of Johnson & Johnson's revenue derives from its medical devices, another two-fifths via pharmaceuticals …  [Investopedia]
Editor's Note: A wonderful article explaining JNJ's business model, where and how it gets its money and why it is soo successful.

4/22
Lay Media Has Field Day Regarding Codeine For Kids
- Sensationalist retrospective analysis  sparks media frenzy
ER trips for kids' pain and coughs often end with codeine … children dying from normal doses of codeine have been reported  … black children were also less likely to receive a prescription than non-Hispanic white kids…. between about 559,000 and 877,000 kids were still receiving the drug …[Reuters]

4/22
Biogen Sets Price Of New Hemophilia Drug Low End Of Price Point
- Charges same price as older, less convenient therapies
Exclusive: Biogen prices hemophilia drug on par with older therapies …  to cost U.S. patients, and insurers, about the same per year as older, less convenient therapies whose price can reach about $300,000 annually … move could pressure rivals such as Pfizer Inc to lower prices for existing hemophilia treatments … urrent drugs are typically needed about two to three times a week, Alprolix is taken once a week or every 10 days …[Reuters]

4/22
43% Of Sovaldi Rx's Are Rejected Or Never Mnake It To Drugstore
- If docs try to combine Sovaldi + Olysio, PBM's reject it
Sovaldi Rx are being filled, despite payer angst  … 57% of prescriptions filled, while the remainder have been denied (around 11%) or are currently in limbo mode … payers have not been covering prescriptions that use both Gilead's Sovaldi and Janssen's Olysio, even though the combination is cheaper … rejected drug regimen costs around $150,000 for 24 weeks, compared to $168,000 …[MM&M]
Related: Blockbuster Drug Boycott? What ESI's Sovaldi Threat Means to Big Pharma … If payers are unwilling to pay for such drugs, or band against manufacturers that make such drugs, where does pharma go from here … even at a price-point 20% to 30% less, Sovaldi would still have created budget issues for payers--is that Gilead's responsibility to manage? …[MM&M]

4/22
Allergan Is Hostile Takeover Bait
- Billionaire hotshot & 2nd tier drug company team up to force Allergan to the block
Billionaire Bill Ackman, Valeant Want To Take Over Botox-Maker Allergan …  unlikely combination of activist investor and corporate conglomerate … Allergan and Valent are similarly-sized, with about $42 billion in market capitalization….[Forbes]
Valeant, Ackman's Pershing Will Bid to Acquire Allergan … Valeant said its goal is to join the ranks of the world's five biggest drugmakers, which would mean a market value of about $170 billion, just ahead of Merck and behind Pfizer …[Bloomberg]

4/22
Xarelto Winning Scripts From Warfarin and Pradaxa
Warfarin's Loss is Johnson & Johnson's Gain … important shift that began in 2010 is having a profound effect on warfarin's dominance -- the approval of a new class of anticoagulants … Xarelto is displacing both warfarin and Pradaxa, and in the process is driving significant revenue growth for J&J …[Motley Fool]

4/21
Report: Pfizer Looking To Take Over Astra Zeneca
Pfizer Made $101 Billion Bid for AstraZeneca: Sunday Times of London … merger of this reported size would top Pfizer's 2000 purchase of Warner-Lambert Co. for $87 billion, the industry's largest deal … We'll look at any type of acquisition -- never say never to a larger acquisition that made sense …[Bloomberg]
Report: Pfizer Mulls $101B Bid for AstraZeneca … Pfizer could use cash it has accumulated through overseas subsidiaries, which if repatriated to the U.S. would be heavily taxed … Novartis and larger British peer Glaxo have been mentioned as potential suitors, although GSK has publicly said it is not interested …[Reuters]

4/21 Generic Copaxone Could Arrive Next Month
- Spreemes reject Teva last ditch legal maneuver
Teva Rejected by U.S. Justice on Generic Copaxone Delay … Momenta and Sandoz are positioned to start selling generic Copaxone in late May, although they would risk having to pay damages if Teva ultimately wins its patent-infringement case … Might face new competition starting May 24 …[Bloomberg]
Supreme Court Denies Teva Request for an Injunction Relating to Generic Copaxone®; Clears Legal Hurdle for Mylan to Launch  …[Mylan Press Release]

4/21
Abbvie Refuses To Discuss Price Of Upcoming Hepatitis Pill
- Will it be cheaper than Sovaldi?  Insurers hope price war starts
Insurers Fret Hepatitis C Pill Costs More Than Obamacare … unclear whether Abbvie will launch at a lower price, potentially causing some competition that would allow health plans to reign in some of the costs. … UnitedHealth, the country's largest publicly-traded health plan, disclosed that Hepatitis C prescriptions cost $100 million to the company in the quarter "across the Medicaid, commercial and Medicare part D" plans it sells … [Forbes]

4/21
Potiga (ezogabine) Use Linked To Reduction In Thirst For Alcohol
- Preliminary data; more study needed
Potential New Treatment for Alcoholism: Ezogabine … Ezogabine acts by opening a particular type of potassium channel in the brain, called the Kv7 channel, which regulates activity in areas of the brain that are believed to regulate the rewarding effects of alcohol … [Forbes]

4/21
More On Diovan
The Law of Gravity Isn't Working for This Off-Patent Drug … safety concerns over Ranbaxy's factories in India have kept the company from selling its Diovan version. Since other drugmakers can't market their own generics until Ranbaxy's pill has been on sale for 180 days, Novartis continues to be the only seller of the heart pill in the U.S.--at a price that's 37 percent higher than what the company charged when the medicine was under patent …[BusinessWeek]

4/18
China Flip Flops On Drug Price Control (Kinda Sorta)
- Drugmakers stopped making certain drugs when they couldn't make money off them
- Poster child was Tapazole; nationwide shortage when Commies set prices too low
China backs away from price controls on basic drugs … will loosen price controls on a list of "commonly used low-cost medicines", allowing pharmaceutical companies to set prices as long as the daily cost of taking the drug "remains in a certain range" … pharmaceutical companies had told Reuters they were unwilling to continue supplying loss-making products … "We stopped producing in June 2012 because the price was too low …[Reuters]

4/18
FDA Cracks Down On Opiate Labeling; No More Moderate Pain
- Black box reminds docs when, when not ; admits it's only a recommendation, docs have final say
FDA wants stronger warning labels for long-acting opioids … requiring labels of all long-acting opioids to say they should be used strictly for patients in severe pain … Currently, the labels indicate they are appropriate for patients with moderate and severe pain … DA has acknowledged the agency really has no ability to ensure that doctors actually restrict their prescriptions to patients with severe pain …[Reuters]

4/18
Study: Derms Are Suckers For Drug Samples
- Claims sample docs patients spend  $465 versus $200 for no-sample docs
Free samples of prescription drugs are costly to patients, study says … $6.3 billion worth of free samples  in 2011 … 25% of their [dermotologist] prescriptions came with a free sample … 79% of acne prescriptions in private practices were for name-brand or branded generic drugs, compared with 17% of prescriptions written by the academic dermatologists …[LA Times]
Editor's Note: Flawed methodology; authors fail to make the case that samples were the causative effect.  Academic docs in general write more generics than private practice docs; was it the really samples that made the difference?  Maybe it was another factor. Is it realistic to compare the prescribing habits of a Veterans Admin dermatologist to a 5th avenue dermatologist?   Read the article for yourself.  Article talks about the "harms of samples".  Really? Really? JAMA is anti-pharma.  In general, JAMA publishes negative articles regarding samples, sales reps, branded drugs, coupons, etc, yet they cheerfully accept millions of dollars from drug companies for advertising.  They never misses a chance to malign the industry; this is no exception. 

4/18
Diovan Quirk: Patent Expired, Price Increased,
Branded Product Still Going Strong
- Legal loophole empowers Novartis to charge 37% more than before patent expired
The Law of Gravity Isn't Working for This Off-Patent Drug …  safety concerns over Ranbaxy's factories in India have kept the company from selling its Diovan version. Since other drugmakers can't market their own generics until Ranbaxy's pill has been on sale for 180 days, Novartis continues to be the only seller of the heart pill in the U.S.--at a price that's 37 percent higher than what the company charged when the medicine was under patent …[Bloomberg]

4/18
Glaxo: 5 Bribery Scandals Later, Hypes Strategy To Take Incentives Away From Salesmen, Docs
GSK, facing bribery claims, battles to build new sales model … aims to become the first in the industry to stop paying outside doctors to promote its products, end payments for medics to attend conferences and delink incentives for sales representatives from individual sales targets …  insiders - say GSK's unilateral move risks putting it at a marketing disadvantage, particularly in emerging markets …intends to make much greater use of digital technologies, such as webcasts and webinars …[Reuters]

4/17
Fast Takes
Mylan Launches First Generic ORTHO EVRA® Patch
Mylan Press Release
Reckitt leans towards pharmaceuticals spin-off
Reuters
Antidepressant Use in Pregnancy Tied to Autism Risk
WebMD
IMPAX Launches Authorized Generic RENVELA®
BioSpace
Can Once Daily GLP-1 Lyxumia Be The Next Major Growth Driver For Sanofi?
Seeking Alpha
Ex-Sanofi Executive Gets 16 Months for Insider Trading
Bloomberg


4/17
Stolen Herceptin, Fake Herceptin Turns Up On Open Market
- Thought to be stolen from hospitals in Italy
Stolen Vials of Cancer Drug Reintroduced as Counterfeits… Vials of the cancer drug Herceptin probably stolen in Italy have been tampered with and reintroduced into the medicine supply chain, the European Medicines Agency said. … didn't say how much of the drug was stolen, or where and when it was taken.  … [Bloomberg]

4/17
Primary Care Docs:  16 Mins Per Patient, Other Interesting Stats
Survey finds pay doesn't make doctors happy …   55% said they spent 16 minutes at most ...42% pushed past the 17-mark … 72% said they "regularly or occasionally discuss the cost of treatment … orthopedists are the highest paid physicians ($413,000 per year … cardiologists who reported $351,000 …[MM&M]
Related: If Being A Doctor Is So Horrible, Why Are Med School Applications At A Record High? … [Forbes]

4/17
30,000 Foot View: Side Effect Profile, Efficacy of Diabetes Drugs
- Free Report; Data mining of FDA adverse data reporting database for  branded diabetes drugs
- Goes so far as to name the safest drug in each class
The Comparative Safety of Type 2 Diabetes Medications: … SLGT2 inhibitors are, as expected, associated with elevated  urinary infection risks but may also be linked to more serious events … GLP-1 and DPP-4 inhibitors (especially sitagliptin) have elevated associations with pancreatitis and pancreatic cancer, but  neither class appears to have strong links to presumed renal and  hepatic complications …[Fierce Pharma]
Editor's Note: FREE Download; sign-up required; 23 pages; 7,500 words; many statistics; suggested reading if you market a type 2 diabetes product; has relative risk data for all drugs, A1C lowering  potential of all NIDDM meds; not copy approved, do not use for promotion. 
See Also: New report finds Bydureon safest of new class of diabetes drugs … Janumet and Januvia from Merck Tradjenta from Boehringer Ingelheim and Eli Lilly ($LLY), and Nesina from Takeda, may be linked to more serious side effects than has generally been believed. It found that Nesina raised the most concern … [Fierce Pharma]

4/17
Glaxo New Once Weekly GLP1: Not Gonna Be Easy
Newly minted GlaxoSmithKline diabetes drug faces formidable foes in GLP-1 market … data doesn't give it an efficacy edge on Victoza, so its once-weekly dosing--compared with the Novo drug's once-daily schedule--is Glaxo's best talking point. But Bydureon is a once-weekly drug, too …[Fierce Pharma]

4/17
Cancer Drugs: Beginning Of End  Of Blank Check Mentality?
Cancer Doctors Plan to Compare Value of Expensive Drugs … world's largest organization of cancer doctors plans to rate the cost effectiveness of expensive oncology drugs, and will urge physicians to use the ratings to discuss the costs with their patients. … framework for a scoring system that will give doctors and patients options to discuss in determining how to proceed with care … [Bloomberg]

4/17
Former Novo Drug Rep, Murderer To Get New Trial (His 3rd)
- Judge allowed non-kosher evidence that swayed jury
Raleigh Convicted Murderer Jason Young Granted Third Trial … Young did not have charges filed against him for years until investigators said they had gathered enough evidence against him.  He first went to trial in 2011 and after a mistrial was declared, he was put on trial again in 2012 …  judge  made an error in the second murder trial when he allowed evidence to be entered into the criminal trial that was from a previous civil lawsuit … [Raleigh Telegram]

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