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Pharmaceutical News Harvest (TM) for Monday May 4th

5/4 Fast Takes
Mylan Disagrees With Itself in Effort to Spurn Teva Takeover
Pharma Frets as Local Governments Adopt Drug Take-Back Programs`
Will Sanofi's Big Bet On Vaccines Pull It Out Of Its Diabetes Slump?
No More C.O.D Only; Insurance Covers Four In Five Visits To CVS And Walgreen Clinics

Express Scripts Unit Pays $60 Mln To Settle Bribery Allegations
- Used payola to induce pharmacists to switch drugs
Express Scripts to Pay $60M to Settle Novartis Kickback Scheme … settlement stems from litigation that originated with a former Novartis sales manager who  filed a whistleblower lawsuit claiming the drug maker used different plans - including rebates - to induce specialty pharmacies to boost prescriptions for various drugs …  pharmacists [were induced to]  counseled patients on the benefits of Exjade and mentioned common side effects, but not more serious, potentially life threatening adverse events, such as kidney failure …[Pharmalot]
Novartis faces more kickback scrutiny after $45M Express Scripts settlement … Using the lure of kickbacks disguised as rebates, Novartis co-opted the independence of certain pharmacists and turned them into salespeople for one of its drugs ...Novartis caused the public to pay tens of millions of dollars for kickback-tainted drugs." …[Fierce Pharma]

Breo Elipta Unlikely To Rescue Glaxo
- Breo Elipta approval (adults only) may be too little to late to have huge impact
Breo's Watershed Moment Unlikely To Rescue Glaxo … asthma could account for half of Breo's revenue, which in 2020 is expected to reach $1.1bn … this is a paltry amount compared against the glory days of asthma/COPD products like Advair … not helped by Glaxo's general lack of involvement in highly lucrative areas like oncology, which makes the group a big pharma laggard …[Seeking Alpha]
Related: Glaxo drops the ball in fierce US respiratory pricing climate …[EP Advantage]

The Wacky World Of Drug Prices & Why Uncle Sam Deliberately Lies
- CMS Data Dump conveniently left out rebate amounts, stats are all bogus
Why Medicare's List Of Costly Drugs Is Kind Of Bogus … in 2014, the year Nexium generics were introduced in the U.S., IMS estimated U.S. sales of $5.9 billion and actual sales were $1.9 billion. That's a 68% discount … next big test will be from new cholesterol drugs being developed by Amgen and Regeneron. The data for the medicines look very similar; will that mean that there will be competition on price? …[Forbes]

What Happens When There Are No More Small Companies Left To Take Over?
Are Drug Mergers In Their Final Act? … Everybody's chasing after someone who's chasing after somebody else. … after years of consolidation in the space where a small number of players rapidly bought up companies, the big consolidators can only turn to -- or on -- each other…[Investor']

5/4 Why Are There 2 Drug Companies Named "Merck"
-One great name, 2 great companies; lots of confusion
A tale of two Mercks: Confusion mounts over shared brand name … Both were originally part of the same company until the American business was confiscated by the US government during the first world war … The problem was highlighted last year when demonstrators mistakenly turned up outside the London offices of German Merck to protest against alleged unethical behaviour by US Merck in Africa …[FT]

Maybelline Introduces Line Of Injectable Makeup To Enhance Appearance Of Internal Organs
Maybelline Introduces Line Of Injectable Makeup To Enhance Appearance Of Internal Organs … With our new injectable makeup options, women can finally have the type of flawless, gorgeous-looking digestive and cardiopulmonary systems they've always wanted," …[SATIRE; The Onion]

5/1 Part D Data Dump — Feds Release for the First Time
AstraZeneca's Nexium Tops Spending in Medicare Drug Program .... The data cover about 35.7 million people in Medicare Part D, which includes those over 65, as well as some people who are disabled or have kidney disease. About 68 percent of all Medicare beneficiaries enrolled in the prescription drug coverage. .... Bloomberg
Direct link to CMS Download Page: Medicare Provider Utilization and Payment Data: Part D Prescriber
See also: Medicare Releases Detailed Look at Prescription-Drug Spending [$$WSJ]
See also: Medicare Itemizes Its $103 Billion Drug Bill [Kaiser Health News]

5/1 Gilead Blows Away Quarterly Target; Sovaldi/Harvoni Sales $1 Billion More than Forecast
Gilead first-quarter profit doubles on strong hepatitis C drug sales .... Product sales for the quarter rose 52 percent to $7.41 billion, including $4.55 billion for hepatitis C drugs Sovaldi and Harvoni. Wall Street analysts, on average, had expected hepatitis C product sales of $3.54 billion, according to Deutsche Bank .... Reuters

5/1 Breo Ellipta Approved for Adults; Not for Young People
FDA approves Glaxo, Theravance's Breo Ellipta asthma drug .... The drug consists of a corticosteroid, which reduces inflammation, and a long-acting beta-agonist called vilanterol, which is designed to open the airways .... Reuters

5/1 Raplixa Approved
FDA approves Medicines Co's blood clotting agent .... Raplixa is used to control bleeding during surgery when conventional aids are found ineffective. The treatment is a combination of two human plasma-derived blood-clotting proteins, fibrinogen and thrombin .... Reuters

5/1 Afrezza Not Catching a Tailwind
Early sales of MannKind inhaled insulin drug disappoint Wall Street .... First-quarter U.S. sales came in at about $1.1 million .... LA Times
See also: MannKind Afrezza Contributes to Sanofi's Subpar Diabetes Unit Sales [The Street]

5/1 Pfizer Bidding for a Supplier
Pfizer is mystery bidder for rare disease drugmaker Sobi .... Sobi manufacturers a hemophilia treatment called ReFactor AF, which Pfizer sells .... Reuters

5/1 New Uses for Drugs Drive Shire Profits
Binge Eating Drug Helps Shire Deliver First-Quarter Earnings Beat .... Sales of Vyvanse increased by 17 percent to $417 million .... NY Times

5/1 Half of Health Plans Don't Comply with Obamacare Standards
Some Insurers Stint on Mandated Birth Control Coverage .... Health insurance plans around the country are failing to provide many legally-mandated services including birth control and cancer screenings .... Kaiser Health News via Medpage Today

5/1 COO Schultz Out at Novo Nordisk
Novo's purported CEO-to-be is out the door amid executive reshuffle .... The Danish drugmaker is shuffling top management to add several people to its executive committee, including U.S. commercial chief Jesper Høiland, European commercial chief Jerzy Gruhn, and supply chain chief Henrik Wulff .... Fierce Pharma

5/1 Aripiprazole Lauroxil Launch Pending
Alkermes looks to schizophrenia drug approval as sales jump 24% .... Alkermes is investing heavily in three drug candidates targeting depression, schizophrenia and multiple sclerosis .... Irish Times

5/1 Internet Drug News Fast Takes:
80% of antibiotics sold in America aren't used to treat people
First results from psychology's largest reproducibility test
Group therapy may work as well as drugs to prevent depression relapse
Reuters Health
FDA says more data needed on safety, efficacy of widely-used hospital sanitizers
Minneapolis Star Tribune
FDA approves the Medicines Co's pain drug device Ionsys

4/30 Not April Fool's: Congressional Proposal Opens Door to Much Easier FDA Approvals
FDA could approve drugs for new uses on less data: draft law .... A bill drafted by the House Energy & Commerce Committee's health panel would eliminate the need for randomized, controlled clinical trials, the gold standard for assessing whether a product is safe and effective. Instead companies could submit data from observational studies, in which researchers have no control over the experiment, ongoing surveillance studies and other clinical experience. .... Reuters

4/30 FDA Approves Kybella for Double Chin
FDA approves ATX-101 for treatment of submental fat .... Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered less than 1 month apart.... Results of two clinical trials including 1,022 adult participants with moderate-to-severe submental fat were used to establish the safety and effectiveness of the treatment. .... Healio

4/30 Balance of Benefits/Harms for Statins for Seniors
Statins Carry Some Risk for Seniors .... The researchers estimated that 105,000 heart attacks and 68,000 deaths could be prevented if all U.S. adults aged 75 to 93 who did not have heart disease took statins over the next decade. However, the benefits of giving statins to this group of people would be offset by a 10 percent to 30 percent increase in the risk of side effects such as muscle pain and weakness, and slight declines in thinking and memory .... Health Day News

4/30 Panel Recommends T-Vec for Melanoma
FDA panel recommends approval for Amgen's skin cancer immunotherapy .... The panel voted 22-1 supporting an approval for the therapy, talimogene laherparepvec or "T-Vec", an engineered virus that kills cancer cells when injected into tumors and also primes the immune system to attack the disease. .... Health Day News

4/30 Gluten-Free Movement Spurs Race for Treatments
As Celiac and Gluten Sensitivities Gain Prominence, Drug Companies Race to Find Treatments .... In the last 15 years or so, studies have found that around 1 percent of the population, both adults and children, have the disease, meaning it affects about three million Americans. .... NY Times

4/30 $ESRX Promises War on Cancer Drug Prices
Express Scripts says controlling cancer-drug costs a tough new focus .... Pharmacy benefit manager Express Scripts Holding Co, which has aggressively negotiated lower costs of new hepatitis C drugs, has announces a new "focus area" will be subduing costs of a growing wave of pricey biotech cancer drugs .... Express Scripts

4/30 Mylan Raises Bid as Teva Circles
Mylan ups bid again for Irish-based drug manufacturer Perrigo; Perrigo quickly says no .... Mylan's latest bid is for $75 in cash and 2.3 Mylan shares for each share of Perrigo, up from $60 in cash and 2.2 shares .... Pittsburgh Post-Gazette

4/30 Agency Takes Dim View of Aripiprazole Graphic
FDA takes aim at Abilify marketing material .... The April 17 letter to the drug's manufacturer, Otsuka, focuses on a visual aid that shows three dimmer switches with the switch at low, high and middle heights to represent chemical states. The mid-height slider is meant to represent Abilify's ability to modulate mood .... MM&M

4/30 Low Public Esteem for Pharma; Perhaps Lower for Pharma Marketers
Pharma earns failing marks for integrity, but it beats advertising .... "Who practices integrity?" Consumers replied: Newspapers (10%), financial institutions (9%), the legal profession (9%) and pharma (9%) .... Fierce Pharma Marketing

4/30 Viekira Pak Sales 40% Below Expectations
AbbVie says disappointing Viekira sales numbers are misleading .... Next-gen hep C therapy Viekira--rival to Gilead's ($GILD) soaring Harvoni--posted just $138 million in U.S. sales last quarter, AbbVie reported recently, falling short of the $236 million analysts expected .... Fierce Pharma Marketing

4/30 Internet Drug News Fast Takes:
Rubella (German measles) eradicated from Americas
Sofía Vergara's Ex-Fiancé: Our Frozen Embryos Have a Right to Live
NY Times
Drug resistant bacteria common for nursing home residents with dementia
Society for Healthcare Epidemiology of America
What urine reveals about obesity
LA Times
Drug Testing, Now Without the Chimp
Bloomberg (autoplay video)

4/29 Fast Takes
Melanoma Tumor 'Dissolves' After 1 Dose of New Drug Combo
GSK shingles vaccine shows benefits across all age groups
Teva Launches Argatroban Injection in the United States
Teva Press Release
Flush with Q1 success, Merck touts coming launches in hep C, lung cancer
Fierce Pharma

Takeda agrees $2.4 bn settlement for 8,000 Actos Cancer Lawsuits
- $296K per plaintiff, less depending on smoking history
- settlement comes after losing 5 jury trials
Takeda Agrees to Pay $2.3 Billion to Settle Actos Cases …  $296,000 per case to those who sign up for the settlement. The payment may be reduced depending on a patient's age, smoking history and exposure to toxins …[Bloomberg]
Takeda agrees $2.4 bn settlement for diabetes drug suits … resolve lawsuits representing some 8,000 people who used the treatment and claimed the company did not warn them that it increases the risks of cancer … Actos continues to be available as a treatment option in the US, Japan and other countries …[AFP]

Bristol-Myers Squibb sales rise, led by Eliquis and Opdivo
Bristol-Myers Squibb sales rise, led by Eliquis and Opdivo …  PD-1 inhibitor Opdivo (nivolumarkeb) brought in $40 million in sales in its first full quarter … Melanoma drug Yervoy (ipilimumab), had $325 million in sales for the quarter …[DEBORAH WEINSTEIN; MM&M]

Obama Proposes That Medicare Be Given the Right to Negotiate the Cost of Drugs
- Super expensive specialty drug prices seen as impetus
Obama Proposes That Medicare Be Given the Right to Negotiate the Cost of Drugs … asked Congress to let Medicare officials negotiate prices with drug manufacturers -- a practice explicitly forbidden by current law … rising cost of specialty drugs has the potential to bankrupt our health care system. What good is a miracle drug if you can't afford it?"

Major Pharma Companies Announce Good Results
Pfizer, Merck and Bristol-Myers Squibb Report Solid Results … pharmaceutical companies have made big pushes into the oncology market … Since last summer, each company has begun selling a new cancer drug that is expected to generate blockbuster sales, following unusually rapid drug development and regulatory review timelines …[WSJ]

FDA: Go Forth & Sell Generic Abilify
FDA approves generic versions of antipsychotic drug Abilify … Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms. …[FDA]

FDA Rejects Merck Anesthesia Antidote Once Again
Merck says FDA again declines to approve Bridion, needs more data …  largely due to concerns about potentially dangerous allergic reactions to the product …[Reuters]

Valeant Buys Nitropress, Isuprel, Jacks Up Prices 525% and 212% Respectively SAME DAY
- Horizon, Malinckrodt: similar shenanigans
Pharmaceutical Companies Buy Rivals' Drugs, Then Jack Up the Prices … 24 Ofirmev vials jumped almost 2½ times to $1,019.52 … first day selling Vimovo, Horizon raised the list price for 60 tablets to $959.04, a 597% increase … Since 2008, branded-drug prices have increased 127%, compared with an 11% rise in the consumer price … [WSJ]

Afrezza (Inhaled Insulin) Soon To Be Offered in 12 Unit Dose
- Currently only available in 4 Unit, 8 Unit
MannKind to Manufacture 12 Unit Cartridge Strength of AFREZZA(R) Following FDA Approval … The 12 unit cartridge was approved by the U.S. Food and Drug Administration on April 17, 2015 and is expected to be launched by Sanofi in the second half of 2015 … [Mannkind Press Release]

Januvia Diabetes Doesn't Add to Heart Risk
- Finally a dose of good news for Januvia
Merck Gains as Januvia Diabetes Drug Doesn't Add to Heart Risk … met the primary goal of the cardiovascular study, showing that type 2 diabetes patients didn't experience a cardiovascular problem -- such as heart attack or stroke …[Reuters]

Mylan Executive Chairman Badmouths Teva
- Mudslinging begins, it's becoming hostile
Teva is 'Poorly Performing' and has a 'Dysfunctional Culture:' Mylan Chief Exec … Teva stock is frequently referred to as "toilet paper" inside Mylan. … Teva has faced a constantly changing and flip-flopping strategy, rotating leadership, shareholder outrage … hided Teva for a "dysfunctional culture;" and disparaged what he called a "poorly performing, troubled company" …[Pharmalot]

Mylan To Teva: If You Want Us
Expect To Pay More Than $100 A Share Not $82 You Offered
Mylan rejects Teva's $40.1 billion buyout offer … Rumors that Teva would try to buy Mylan have circulated since early March, boosting the price of Mylan stock … Mylan, with about 25,000 employees, had $929.4 million in net income and $7.72 billion in revenue in 2014. It has over 1,400 drugs …[AP]

Fast Takes
GSK readies "bubble boy" drug as big pharma bets on gene therapy
Biogen to Spend $2.5 Billion Before Alzheimer's Drug Results
Opioid Overdoses Decrease After Abuse-Deterrent Painkillers Enter Market, Propoxyphene Exits
Medtronic to halt manufacture of pain SynchroMed drug pump -U.S. regulators

Don't Look So Good For Amgen Cancer Vaccine Prospects
FDA review challenges Amgen on a questionable T-Vec study …  red flags for this drug, presenting some thorny questions for the company's regulatory team to answer … questions of investigator bias in assembling the final data, excluding some patients--cherry-picking would be another way of phrasing it …[Fierce Biotech]
FDA staff cite concerns over Amgen's cancer vaccine data … concerns over the late-stage study's design, including if the main goal of showing consistency for the duration of the study was meaningful …[Reuters]

Meta Analysis: Pricey Anti-Cholesterol Injections May Be Worth The Money
- Pooled data says reduction in heart attack, all cause-death rates
More Preliminary Signs That The New Cholesterol Drugs May Improve Outcomes … Amgen's evolocumab and Sanofi's alirocumab- dramatically lower LDL cholesterol and offers additional preliminary evidence showing that they are safe and may confer a mortality benefit …[Forbes]
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta-analysis …  rate of myocardial infarction was significantly reduced with use of PCSK9 antibodies …  reduced all-cause mortality and cardiovascular mortality …[Ann Intern Med. 28 April 2015 doi:10.7326/M14-2957]

MS Drugs: Perenniel Price Increases Draw Attention, Ire
Multiple Sclerosis Drug Prices Rose at an 'Alarming' Rate: Study … three so-called first-generation MS treatments, which originally cost between $8,000 and $11,000 annually, now cost about $60,000. This worked out to an average increase of 21% to 36% annually … prices for the newer oral medications rose 8% to 17% annually since their approvals … [Pharmalot]
How Much Would You Pay for an Old Drug? If You Have MS, a Fortune …  all the MS drugs cost between $50,000 and $65,000 a year, including the ones that went for less than $10,000 when they made their debut … It's not clear why the cost of MS drugs is increasing so much faster than drug prices overall. There are no generic versions of MS therapies on the market …[Bloomberg]

FDA gives Boehringer's Pradaxa antidote a boost with fast-track review
FDA gives Boehringer's Pradaxa antidote a boost with fast-track review … Pradaxa is set to become the first next-gen anticoagulant to get an FDA-approved antidote …  Portola Pharma has been testing andexanet alfa with Eliquis and Xarelto; both drugs work by inhibiting Factor Xa, whereas Pradaxa is a direct thrombin inhibitor …[Fierce Pharma]

Fast Takes
Bristol-Myers says hepatitis C drug combination with Solvaldi succeeds in study
5 Life-Threatening Infections You Can Get from Using A Porta-Potty
Yahoo Health
Merck's answer to Solvaldi claims  95% cure rate
Market Watch
Problems found with Glaxo's malaria vaccine; loses efficacy over time
Heart block possible when combining hep C drugs with amiodarone
Angry Over Drug Prices, More States Push Bills for Pharma to Disclose Costs
Sanofi dumps an ImmunoGen cancer drug as it scales back in oncology
Fierce Pharma

Gilead Strategy Of Discounting Solvaldi, Harvoni Torpedoes AbbVie's Viekira Pak
Can You Guess Which State Won't Pay for Hepatitis C Drugs? … Gilead's decision to discount these drugs to several pharmacy benefits managers has hurt Viekira Pak's launch in a big way … Viekira Pak was once believed to have the potential to rake in over $2 billion in sales this year. Per its first-quarter number of $231 million, though, the drug is on track to miss this lofty estimate by about 40% …[Motley Fool]
Related: AbbVie Experimental No-Inteferon-Needed Free Hep C med to get 6-month review …[AbbVie Press Release]

Mylan Tries To Fend Off Teva with Hostile $31.2 Bln bid for Perrigo
Mylan tries to fend off Teva with bigger bid for Perrigo … Ups the ante with $33 billion takeover proposal … Mylan hopes its new offer, consisting of $60 cash and 2.2 shares of its stock for every Perrigo share, will do the trick. That amounts to roughly $222 per share …[MarketWatch]

4/27 Antibiotic Shortages? Yes
Growing Antibiotic Shortages Threaten Patient Care … Antibiotics accounted for 15% of all drug shortages from 2001-13, affecting 148 anti-infectives … 46%-of the shortages involved antibiotics needed for difficult-to-treat resistant organisms like carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA), and Pseudomonas aeruginosa, and C. difficile …[Forbes]

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