Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Gilead Wins 2-Year Battle & Continues to Hide Hep C Drug Clinical Trial Data

Gilead Wins 2-Year Battle & Continues to Hide Hep C Drug Clinical Trial Data | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After a two-year battle, a pair of public health advocacy groups obtained sought-after clinical trial data from regulators for two hepatitis C treatments sold by Gilead Sciences. But they failed to gain access to the most coveted information that would allow researchers to independently verify test results which were originally generated by the company.

 

The Yale Global Health Justice Partnership and Treatment Action Group sought patient-level data in order to better understand the safety and effectiveness of the two medicines. But they encountered a familiar argument from the company — as well as the Food and Drug Administration — that revealing such raw data may compromise trade secrets and patient confidentiality.

 

The FDA redacted certain data, “which would permit analysis, including validating the results that were reported by the company,” Dr. Joseph Ross, an associate professor at the Yale School of Medicine, who worked with the groups, wrote us.

 

The effort began nearly three years ago when the groups asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. As we wrote at the time, they sought this data because the medicines have been widely prescribed, thanks to high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.

 

Gilead, however, balked at releasing any data, so the groups then turned to the FDA, since the company had filed all sorts of clinical trial information with the agency in order to win regulatory approval to sell the drugs. But the agency indicated the Freedom of Information request would take up to two years to fulfill, so in June 2015, groups filed a lawsuit to force the FDA to cough up the data.

 

The advocacy groups argued in their lawsuit that doctors “lack(ed) the benefit of any independent assessment of the data.” And given the high cost of the drugs, the groups contended it is “crucial that policymakers be able to evaluate the cost-effectiveness … based on the underlying clinical data. …” The list prices for the drugs were $84,000 and $94,500 for 12-week regimens, before rebates.

 

Further Reading:

  • “What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data”; http://sco.lt/8R5T7J
  • “NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C”; http://sco.lt/5FuPeT
Pharma Guy's insight:

I'm on record for wondering if, in the long run, the claims of enduring cure of Hepatitis C may be over optimistic. There were reported relapses occurring in short clinical trials, so I would expect even more relapses in the real world long-term.

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Gilead’s New Hep C TV Campaign Urges Baby Boomers to Get Off Their Butts & Get Tested

Gilead’s New Hep C TV Campaign Urges Baby Boomers to Get Off Their Butts & Get Tested | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Gilead's hep C blockbusters are in freefall, and its pool of eligible patients has shrunk dramatically thanks to the success of its meds. If all baby boomers got tested for the virus, though? That could help stem the tide—and it's exactly the move the company is recommending with its latest awareness push.

 

With its second awareness effort—the first began in 2014 before its hep C combo Harvoni hit the market—the Big Biotech reaches out to the almost 75 million people born between 1945 and 1965, following the age range used by the CDC in its recommendation that all baby boomers get tested for hepatitis C.

 

"For millions of baby boomers, there's a virus out there. A virus that's serious, like HIV, but it hasn't been talked about much," a narrator says over images of active boomers looking out over majestic nature scenes. "One in 30 boomers has hep C, yet most don't even know it," the narrator notes, before going over the disease's liver damage and cancer risks and reminding viewers that testing is "the only way to know for sure."

 

While the first awareness campaign sought to re-engage people diagnosed with hep C, the current campaign, dubbed “Forgotten Virus,” goes out more broadly to baby boomers who may not know about the disease, to encourage testing and also to let them know that if they do have it, it can be cured, said David Johnson, Gilead VP, U.S. sales and marketing for liver diseases, in an email interview. Boomers are about five times more likely to have hep C than other adults.

 

The campaign comes at a time when sales of one-time record-breakers Harvoni and component med Sovaldi are slumping; Gilead recently reported that Harvoni sales dropped by 34% in 2016, thanks to competition (read “Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition”; http://sco.lt/8bunVB), payer discounting and the inevitable slowdown of patients, as many people who had hep C when the combo launched have now been treated (read "Will Gilead’s Hep C Sales Implode or Just 'Hit Equilibrium?'"; http://sco.lt/69RQUz).  Targeting unaware baby boomers could unearth new patients that need treatment.

Pharma Guy's insight:

HA HA! The ad shows baby boomers lounging on bent trees and wandering aimless through the landscape as if they are in a trance and have nothing better to do! No doubt millennials are in charge of the storyboards for these ads and it's their way of getting back at their baby boomer parents!

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High Cost, Lack of DTC Advertising, & Physician Unawareness are Major Factors for Truvada’s Failure

High Cost, Lack of DTC Advertising, & Physician Unawareness are Major Factors for Truvada’s Failure | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Although Truvada was approved as a preventive drug four years ago, less than one-tenth of those who could benefit from it take the drug [Meanwhile, “Grindr Poll Says 25% of Gay Men Taking Truvada”; http://sco.lt/70Mnqb]. The need is greatest among blacks and Latinos, who are disproportionately affected by AIDS, and gay men under 30, whose rates of infection are growing.

 

Also known as PrEP — for post-exposure prophylaxis — the medicine serves as a backstop to other methods of avoiding infection for those who are at high risk. It’s considered one of the most significant advances in the fight against AIDS.

 

Critics questioned the wisdom of giving powerful drugs to healthy people, and worried that access to a preventive drug would encourage promiscuity or lead to a spike in other sexually transmitted diseases by reducing condom use.

 

In 2012, the first year PrEP was on the market, only 6,210 people nationwide started the drug, according to data from Truvada’s maker, Gilead Sciences. By the end of 2015, more than 79,000 people had started PrEP since the regimen was introduced.

 

What’s the problem?

 

Primary care doctors often don’t know enough about PrEP to feel comfortable offering it. [Read, for example, “Lack of DTC Advertising Means Many Doctors Unaware of Truvada, Drug for Preventing H.I.V.”; http://sco.lt/6XYebR ]

 

Another challenge is the commitment required: In addition to taking a daily pill, patients must come back every three months to test for HIV and other sexually transmitted diseases, and to check for kidney problems, an uncommon but serious side effect.

 

And cost can be an obstacle. The list price for the drug is $1,500 a month, although most insurers negotiate discounts.

 

Pharma Guy's insight:

Gilead did not begin direct-to-consumer advertising of Truvada until January, 2016 (http://bit.ly/2bUyr8q - I'm happy to see that Gilead may have followed my recommendations. Find them here: http://bit.ly/1AGU2ZY).

 

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Will Gilead’s Hep C Sales Implode or Just "Hit Equilibrium?"

Will Gilead’s Hep C Sales Implode or Just "Hit Equilibrium?" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Boom and bust has been a feature of the hepatitis C virus treatment market, but as its own franchise starts to show some weakness, Gilead is hoping to buck that trend.

 

The US pharma company has reaped the benefits of stellar sales for its directly-acting HCV therapies since it first launched Sovaldi (sofosbuvir) in 2013 and two-drug follow-up Harvoni (sofosbuvir/ledipasvir) the following year.

 

However, sales showed a sizeable fall-off in the second quarter of the year – down around a third in the US and Europe and 43% in Japan – and overall fell by around $900m (19%) to $4.0bn.

 

[This is a quarter sales number. Read “Gilead's Investors Shed Croc Tears Despite a 69% Profit Margin for Q1 2016”; http://sco.lt/55ACYL]

 

Gilead attributed the decline in HCV sales to a slowdown in the rate of eligible HCV patients presenting for treatment, in particular sicker patients with liver fibrosis who were among the first to gain access to the new drugs. As these patients are treated with them for longer, shortening treatment durations are also a factor, along with a price cut in Japan and healthcare budget restrictions in countries like the UK.

 

New entrants such as AbbVie's Viekirax (paritaprevir, ombitasvir and ritonavir) and Exviera (dasabuvir) and Merck & Co's Zepatier (elbasvir/grazoprevir) have also played a role, although Gilead maintains that this is happening mainly in the Medicaid market sector in the US where access to the newer therapies remains a little more restricted to less sick patients.

 

The big question is whether the HCV market will implode – as occurred with the HCV protease inhibitors – or experience a slow and managed decline as the pool of infected patients starts to dwindle.

 

Gilead chief executive John Milligan said that increasing diagnosis rates will help prevent a dramatic fall-off, as will a shift towards treatment of less severely ill patients. In the US alone there are an estimated 3m infected people, with just over half of those diagnosed at present, he noted.

 

“I think ... there will continue to be a gradual decline in new patient starts, but an equilibrium will be eventually hit,” he told investors.

Pharma Guy's insight:

This seems to be a worse case than  Bloomberg Intelligence's "Scenario #3": Read “Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition”; http://sco.lt/8bunVB

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Merck Lied in Sovaldi Patent Trial! Judge Overturns $200-Million Verdict Against Gilead

Merck Lied in Sovaldi  Patent Trial! Judge Overturns $200-Million Verdict Against Gilead | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The public already holds drug manufacturers in low esteem – and now they’ve got more fuel for their opinion. Federal Judge Beth Labson Freeman of San Jose last week found that Merck & Co. lied to a business partner and to the court itself. Freeman threw out a patent infringement judgment Merck had won against Gilead Sciences, and overturned a $200-million jury award.

 

This was a big deal, involving one of the most profitable drugs on the market today — Foster City, Calif.-based Gilead’s blockbuster Sovaldi treatment for the hepatitis C virus — and the world’s fourth-largest drug company Merck.

 

Merck's misconduct includes...misusing Pharmasset's confidential information..., and lying under oath at deposition and trial.

 

It’s also an enormous black eye for Merck, whose activities the judge said consisted of “systematic and outrageous deception in conjunction with unethical business practices and litigation misconduct.”

 

The evidence examined by Freeman strongly suggests that Merck flagrantly manipulated the patent process to gain unfair advantage.

 

Freeman’s ruling has given Gilead the upper hand, for now, in trying to settle the dispute with Merck, which plans to appeal.

Pharma Guy's insight:

For some background, read “Will Patent Cases Prevent Sovaldi from Yielding an Expected 20-to-1 ROI?”; http://sco.lt/9JdVIX

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Disaster! Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition

Disaster! Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Real fans (of intense fights over drug pricing) don't leave the stands early. The most fascinating pharma battle in recent years has been over new drugs that can rapidly cure hepatitis C (HCV). This fight has everything: Sky-high prices, congressional hearings, concerns about patient access, lawsuits, and a price war. Oh, and a mere $38 billion in combined sales since the first of these drugs launched in late 2013.  

 

In April, Gilead, the leader in this space, reported the first-ever year-over-year sales decline of its lead HCV drug. That prompted some observers to assume the frenzy had peaked -- these drugs are cures, so patient numbers should decline over time. But there are still plenty of patients who need treatment, according to a new analysis by Bloomberg Intelligence analyst Asthika Goonewardene. And a new generation of potentially quicker and more broadly effective drugs means more price wars and market-share brawls may lie ahead for Gilead and competitors such as AbbVie and Merck.

 

This status quo won't last. All three firms are working on more potent drug cocktails that could cut treatment time and work for more types of patients. As these drugs start to arrive over the next few years, things will start to get interesting.

 

BI's model takes a look at how much just one company's pricing decision on one drug -- in this case AbbVie's -- could shift billions in revenue (see chart above).

 

Scenario 1: AbbVie prices its next-generation drug at a big premium to Viekira Pak, keeping prices high across the board.

 

Scenario 2: In a second scenario, it makes that premium a little smaller.

 

Scenario 3: In a third (and probably less-likely) scenario, AbbVie prices the new drug extra-low to grab market share. A big AbbVie price cut could force Gilead to cut its own prices, and its sales could drop to $14 billion by 2018. [DISASTER!]

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Harvoni: Huge Price Tag, Huge DTC Ad Spend, Flat Sales 

Harvoni: Huge Price Tag, Huge DTC Ad Spend, Flat Sales  | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A $100 million ad blitz has whipped up patient demand for Harvoni, the $1,100-a-pill hepatitis C treatment, even as the drug’s price has drawn a barrage of lawsuits, state investigations, and sharp condemnation from members of Congress.

 

Like most drug advertisers, Gilead last year devoted the majority of its TV ad dollars for Harvoni to the big broadcast networks ABC, NBC, CBS, and FOX — which draw increasingly aging viewers, including baby boomers between the ages of about 50 to 70, who are five times more likely than other adults to have hepatitis C.

Harvoni ads also target more niche audiences. Consider the $600,000 worth of Harvoni ads last year in the magazine of the American Association of Retired Persons. Or the $3 million Gilead spent advertising on Black Entertainment Television and in Ebony magazine — which makes sense given that African-American baby boomers are twice as likely as others in that age group to have hepatitis C.

Men are also disproportionately likely to have hep C, which may explain Gilead’s investment last year in a collective $13 million worth of ads on ESPN and the Golf Channel and in Sports Illustrated and Men’s Journal.

Gilead is wooing patients directly at a time when both private insurers and Medicaid programs are balking at the high price of Harvoni. In some cases, they’re only agreeing to pay for treatment for the sickest patients, leaving those with relatively healthy livers unable to get treated. Other insurers will only pay for a competitor’s lower-priced drug.

Doctors, too, have proved a barrier; some are encouraging patients to hold out for cheaper therapies.

“A lot of physicians are taking a wait-and-see attitude,” said John Mack, who publishes Pharma Marketing News. As a result, he said, Gilead is going directly to patients, trying to “push them” into talking with their doctors and requesting the medication by name.

Dieterich, of Mount Sinai Hospital, said that physicians sometimes have to “do a little fast-talking” to reassure patients that other medications can work just as well as the brand-name drug they’ve seen so often on TV. Competing hepatitis C drugs Viekira Pak and Zepatier aren’t being advertised, so Gilead has the field to itself.

“We’re battling their successful direct-to-consumer advertising,” Dieterich said.

Gilead has said it’s expecting sales from Sovaldi and Harvoni to flatten this year, but the ads may well continue.

Pharma Guy's insight:

Gilead's "Ready" DTC advertising theme is meant to encourage "diagnosed patients who are ready to seek treatment and ready to be cured" to talk to their doctors, David Johnson, Gilead VP, U.S. sales and marketing for liver diseases, said.

  

The ads feature "cure" in large font-size text and audio several times, but points out in small type (not audio), "Cure means no virus detected in blood 3 months after treatment ends."

 

I wonder, however, are there any data about detection AFTER 3 months? Note that the NIH is leading a Study to Assess Long-Term (10 years) Outcome of Harvoni for Treatment of Hep-C; http://sco.lt/5FuPeT Unfortunately, by the time that study is complete, the Harvoni sales cycle will have ended.

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#Pharma Nerds Cost Medicare More Than Do Pharma Bros

#Pharma Nerds Cost Medicare More Than Do Pharma Bros | Pharmaguy's Insights Into Drug Industry News | Scoop.it

There are many important differences between the “Pharma Nerds” developing innovative life-saving drugs – including Gilead Sciences’ Sovaldi – and the “Pharma Bros” exploiting loopholes to profit from generics like Daraprim.


Daraprim should be inexpensive.  It’s an old drug, without any significant manufacturing challenges.


But it’s expensive by design.


Contrast this with other high priced branded drugs.  Arguably, the biggest backlash went against Gilead Sciences’ Sovaldi and Harvoni, essentially cures for hepatitis C (HCV). The two drugs list price is $84,000 and $94,500 respectively for 12-weeks of therapy – over $1,000 a pill. To date, only a fraction (about 2%) of U.S. HCV patients have been treated.



Pharma Guy's insight:

Drugs developed by the "nerds" cost Medicare the most money. Daraprim is not even on the list.

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Alden Murray's curator insight, November 14, 2017 9:45 AM
Generic Harvoni: Best for Hepatitis C Infection
Generic Harvoni have combination of Sofosbuvir 400 mg and Ledipasvir 90 mg in one tablet. The ledipasvir/sofosbuvir combination is indicated for the treatment of Hepatitis C infection. Allrxgenmeds provides wide range of Hepatitis C Medicines at best price. Read more https://goo.gl/ihM9PE
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Grindr Poll Says 25% of Gay Men Taking Truvada

Grindr Poll Says 25% of Gay Men Taking Truvada | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The gay hookup app Grindr recently surveyed users about Truvadaand found some noteworthy trends. They’re particularly interesting considering the Centers for Disease Control and Prevention said last month that one out of four gay and bisexual men should take the pill.

Among Grindr users who took the survey, more than 25 percent said they were currently taking the pill, which is known as PrEP — short for “pre-exposure prophylaxis.”

More than 55 percent of respondents said they are interested in taking it.

One out of ten respondents said they struggled to get a doctor to prescribe it. Black men, who have a higher rate of H.I.V. infection than the general population, were twice as likely to get pushback from doctors, Grindr found. Some doctors have expressed concerns about the potential long-term side effects of the pill and argued that it could encourage risky behavior that results in other types of infections.

Among respondents, Latino men were the least likely to be taking Truvada.

Physicians don’t appear to be pushing the pill enthusiastically. The majority of those surveyed said they heard about the pill from friends, rather than from a doctor.

Pharma Guy's insight:

Meanwhile, a third of primary care doctors and nurses in the United States have never heard of Truvada. See http://sco.lt/6XYebR Also, read "Gilead, Support Your 'Truvada Whores!'" http://bit.ly/1AGU2ZY 

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Game of Dethrones: Pricey Hep C Drugs Dethrone Pfizer as No. 1 #Pharma Company!

Game of Dethrones: Pricey Hep C Drugs Dethrone Pfizer as No. 1 #Pharma Company! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The runaway success of its hepatitis C pill has seen Gilead overtake Pfizer as the biggest pharma firm in the US when it comes to drug sales.


Sovaldi, which made more than $10bn in sales in its first full year in 2014, has pushed it to the top of the rankings with a 175% growth on 2013.


Meanwhile, Pfizer has now slipped to third place - after being top for the past decade - as sales in the US dropped 7%. This was due predominately from the ongoing generic competition to its once $13bn a year statin Lipitor (atorvastatin), which recorded just $2.8bn in sales last year.


Johnson & Johnson has also made a major leap into second place after being fifth last year as drug revenue grew by an impressive 25% on the year before period to reach more than $17bn.


The firm's drugs unit Janssen was bolstered by an array of new and diverse products, including its new hep C drug Olysio (simeprevir) and prostate cancer pill Zytiga (abiraterone acetate), as well as the type 2 diabetes drug Invokana (canagliflozin) and blood cancer treatment Imbruvica (ibrutinib).

Pharma Guy's insight:


Who ever thought Pfizer would be dethroned as #1!

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Calif Newspaper CEO Calls Gilead a "Good Pirate" that Knows Certain Captives are Worth More. What About Amgen?

Calif Newspaper CEO Calls Gilead a "Good Pirate" that Knows Certain Captives are Worth More. What About Amgen? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

"Pharmaceutical company pirates hold Californians hostage," says Jeff vonKaenel is the president, CEO and majority owner of the News & Review newspapers in Sacramento, Chico and Reno.


Perhaps Gilead spent so much time and money researching and developing this wonder drug that they deserve a fair return on their investment? Well, no. Gilead did not create the drug. Another company, Pharmasset, developed Sovaldi.


After Pharmasset conducted successful clinical trials for treating hepatitis C in 2011, their stock price soared, tripling in value. Then in November 2011, Gilead bought them for $11 billion, 89 percent higher than the stock price.


Why did Gilead pay such a premium for Pharmasset? Perhaps they wanted the right to jack up the price of the wonder drug. Pharmasset had planned to charge only $36,000 for a course of the drug. But Gilead saw the huge profit potential. And, as any good pirate knows, one should not have the same ransom price for each captive. Certain captives are worth more.


So while Gilead charges Americans $84,000, they charge the Germans $66,000 and the English $57,000. And they charge the Egyptians only $900 for a supply of the drug. While this ransom pricing has been good for Gilead stockholders, who have seen their stock rise from $20 in October 2011 to $102 last week, it has not been so good for the millions of people who are waiting to be cured of hepatitis C. Only a small percentage of the world’s population who would benefit from the drug can now afford to pay for it.


Ransom pricing instead of reasonable pricing means that many people will die needlessly. And millions will suffer. We should say “no” to the Big Pharma pirates and empower our government to regulate the pharmaceutical companies so that we can get similar prices and access to drug treatment that people in other countries do.

Pharma Guy's insight:


LOL! But vonKaenel should also take a look at another Calfornia drug company: Amgen, which sells Blincyto (blinatumomab) for  $178,000 per two-cycle course, making it one of the most costly drugs on the market. For more on that, read Et Tu, Amgen? Blincyto's Bling! Bling! Price Tag!

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Sovaldi: It's not a price problem, but a "cost-burden" problem. Seriously?

Sovaldi: It's not a price problem, but a "cost-burden" problem. Seriously? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Gilead Sciences' hepatitis C drug Sovaldi may be worth the sticker price. But it's too expensive for the U.K.'s health system to bear. That's the assessment in some National Health Service documents obtained by the Health Service Journal.


Apparently, behind closed doors at the health service, there's some doubt about that. According to the journal, cited in Pharmafile, offering Sovaldi via the NHS would put 20,000 patients in line for treatment. That's where the problem lies. It's not a price problem, but a cost-burden problem. [my emphasis]

Pharma Guy's insight:


What a way to spin the story! Of course, if the price were lower then it wouldn't be a "cost burden." Let's make sure we put the horse before the cart!


Treating 20,00 UK patients would cost £1 billion. Meanwhile, the cost of treating 3 million hepatitis C patients in the States would top the cost of treating all other patients with all other drugs, combined. Now that's a cost burden!

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How Much? Gilead Will Charge $900 for Sovaldi in India

How Much? Gilead Will Charge $900 for Sovaldi in India | Pharmaguy's Insights Into Drug Industry News | Scoop.it
India has become the latest country where the Sovaldi hepatitis C treatment will be offered for $900 per patient. The move, which was reported by The Times of India, comes a few weeks after the manufacturer, Gilead Sciences, is making the medication available for the same price in Egypt.


The pricing reflects an effort by Gilead to forestall the sort of criticism the pharmaceutical industry has often encountered when selling life-saving medicines in poorer countries, which have often complained bitterly that many of its citizens have been unable to afford some treatments.

Pharma Guy's insight:


Some interesting comments to this post are reproduced below,


Commenter #1 believes drug companies charge more for drugs in the U.S. to offset the losses of selling the same drugs for MUCH less money in  foreign countries. It's an interesting twist on pharma's rationale that they charge high prices to recoup research investment (see commenters #2 & #3):


Commenter #1: "In fact the price you pay for drugs in the US is to cover the subsidizing of these other countries (which include the poor countries of Canada, the UK, Netherlands, Denmark). Only way they can do this is someone has to pay and it is us….. I do not blame the drug companies (like most of you do). They have to make money and if they lose money selling it in these other countries, they have to make money somewhere."


Commenter #2: "New chemical entities are enormously expensive to develop and innovation is expensive. R&D must be paid back and more. Otherwise, the is little reason to invest the great sums needed.
That said, Gilead seems to be shooting itself in the foot with great expertise. While this drug, in particular, really is cost-effective at the US price, the PR has been badly done."


Commenter #3: " Gilead did NO RESEARCH, bought Sovaldi maker company for $11B instead of spending money to develop their own. Acquired PHARMASSET patent and is holding up patients in highway robbery to pay ransom for the drug made with John Hopkins research mostly at taxpayer expense"


Here's my analysis of recouping the costs of bringing Sovaldi to market: Gilead has racked up $5 billion in Sovaldi sales in the first half of 2014. According to a JAMA viewpoint article, it may have cost Gilead $11 billion to "develop" Sovaldi - this is based on the price Gilead paid to acquire Pharmasset, which discovered and initially tested Sovaldi. If all of the approximately 3.6 million Hep C patients with chronic liver disease in the United States were treated with Sovaldi at current prices, Gilead would net more than $300 billion dollars, or better than a 27-to-1 return on its investment, "suggesting that pricing is inappropriately high."

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Gilead's Harvoni Ads Ramp Up the "Cure" Message

Gilead's Harvoni Ads Ramp Up the "Cure" Message | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Gilead is adjusting its message in new advertising for hepatitis C drug Harvoni, replacing its two-year-old introductory ad with a spot highlighting patients' relief after treatment. Three key words: "I am cured."

 

“Let Go” replaces “I Am Ready” as the new theme in the marketing effort, which is meant to reach patients who've been diagnosed with hep C, but haven't undergone treatment, a spokeswoman for Gilead said. In a just over one week on the air, the TV ad has tallied more than $6.4 million in national media spending, with the bulk of airings occurring in primetime, according to data from real time TV ad tracker iSpot.tv.

 

In the ad, dozens of people walk through a desert carrying Chinese lanterns, which they light and release skyward as the day turns into night. The voiceover assures viewers: "I no longer live with the uncertainties of hep C, wondering what if? I let go of all those feelings because I am cured, with Harvoni."

 

Further Reading:

  • “Gilead’s New Hep C TV Campaign Urges Baby Boomers to Get Off Their Butts & Get Tested”; http://sco.lt/9KSHIn
  • “Scoop.it!
  • “Will Gilead’s Hep C Sales Implode or Just Hit Equilibrium?"; http://sco.lt/69RQUz
  • “NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C”; http://sco.lt/5FuPeT
Pharma Guy's insight:

This is another arm of the DTC ad campaign to tramp up flagging sales and possibly anticipating that long-term outcome NIH studies may prove that "cure" is an overstatement.

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Consultants Advise Pharma to Act More Like Biotech to Revive ROI for New Drugs

Consultants Advise Pharma to Act More Like Biotech to Revive ROI for New Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The an­a­lysts at De­loitte con­tinue to cal­cu­late a dwin­dling re­turn for Big Pharma’s R&D dol­lars. Their lat­est num­ber crunch­ing for the world’s top 12 bio­pharma com­pa­nies con­cludes that ROI on their in­vest­ment cash has shrunk to 3.7%, the low­est level yet after hit­ting 10.1% in 2010.

What’s killing these com­pa­nies’ num­bers, De­loitte says, is that while de­vel­op­ment costs on new drugs has plateaued at about $1.5 bil­lion on each pro­gram, their rev­enue keeps falling. There’s been an 11.4% drop in rev­enue year-on-year over 6 years, which has now fallen to $394 mil­lion in av­er­age peak an­nual sales.

A hunt for any sil­ver lin­ing in this new re­port can be des­per­ately hard. The De­loitte guys — Colin Terry and Neil Lesser — con­clude that the num­ber of block­busters pro­duced by this crowd has dwin­dled by more than half, so they keep spend­ing big in search of smaller drugs. And as they focus more and more on their own pipeline, they are ig­nor­ing the ex­ter­nal pro­grams that can de­liver bet­ter re­turns — set­ting up a push, per­haps, for a surge in M&A as the re­al­iza­tion sinks in that they are on the wrong track.

The best ap­proach, they add, is to think and act like a biotech. Smaller biotech groups sim­ply do bet­ter than Big Pharma at R&D. And the big com­pa­nies that stay fo­cused on core dis­eases do far bet­ter than the com­pa­nies that keep shift­ing R&D spot­lights.

Pharma Guy's insight:

What's the best way to emulate biotech companies to increase ROI? Raise prices like Gilead did, of course (read, for example, “Gilead Dodges Taxes While Gouging Prices, Says Advocacy Group”; http://sco.lt/7IjyXR). Or hire consultants to be CEO like Valeant did.

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Gilead Dodges Taxes While Gouging Prices, Says Advocacy Group

Gilead Dodges Taxes While Gouging Prices, Says Advocacy Group | Pharmaguy's Insights Into Drug Industry News | Scoop.it

An advocacy group is urging the US Internal Revenue Service and the US Treasury Department to investigate Gilead Sciences for allegedly shifting billions of dollars of income offshore in order to avoid paying taxes. The request from Americans for Tax Fairness comes one month after the group released a report (https://www.statnews.com/pharmalot/2016/07/13/gilead-hepatitis-c-taxes/) accusing the drug maker of dodging $10 billion in taxes.

 

The move also comes shortly after the federal government went to court to force Facebook to respond to summonses in connection to an investigation into whether the firm shifted certain property rights to an Irish subsidiary. The social media site may owe anywhere from $3 billion to $5 billion in back taxes, and the advocacy group maintained that Gilead is worthy of the same scrutiny.

 

Gilead is using “a similar highly aggressive use of transfer pricing,” a maneuver that involves shifting properties between entities, “to avoid US taxes and benefit from substantially reduced tax rates. We urge the administration to bring the full force of your enforcement capabilities against Gilead to collect the tax dollars that rightfully belong to the American people,” the group wrote the federal agencies in a letter Wednesday.

 

There has been controversy about US companies that exploit loopholes to avoid paying taxes. Drug makers, in particular, have been singled out for attempting to acquire rivals based overseas to enjoy lower tax rates. The Treasury Department recently issued new rules to thwart such deals, known as tax inversions, prompting Pfizer to scuttle a plan to acquire Allergan [for more on that, read: “Obama Knocks Pfizer HQ Out of Ireland Back Into the USA”; http://sco.lt/87fU13 ]

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How Gilead Manipulates HIV Drug Patents at the Expense of Patient Safety & Affordability

How Gilead Manipulates HIV Drug Patents at the Expense of Patient Safety & Affordability | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Gilead Sciences won a victory last week when a federal court judge tossed a lawsuit in which an AIDS activist group accused the drug maker of manipulating the patent system in order to thwart competition for its HIV medicines.

 

At issue was tenofovir, or TDF, which until recently had been a cornerstone of the widely used combination HIV treatments sold by the company. The patent on the TDF compound expires in December 2017, and Gilead is replacing it with a modified version known as TAF. But the patent on TAF doesn’t expire until May 2022, providing another five valuable years without generic competition.

 

TAF is also more potent and causes fewer side effects, notably bone damage and kidney toxicity. AHF argued Gilead knew of the safety benefits dating back to 2001, but the company delayed testing TAF in humans until 2011. In doing so, AHF charged Gilead purposely waited to seek regulatory approval for drugs containing TAF until shortly before its older TDF-based products lost patent protection.

 

This maneuvering meant that Gilead would be able to forestall patent challenges on its TAF-based drugs for a few years, but meanwhile, HIV patients faced side effects unnecessarily. Moreover, AHF maintained that since TAF is simply a modified form of TDF, the drug maker does not deserve patent protection and sought to have the TAF patents invalidated.

 

But in a ruling last Wednesday, Judge William Alsup of the US District Court in San Francisco shot down the arguments made by the nonprofit, which buys medicines for the 46 health centers it operates in the United States. “Gilead’s patents gave it a monopoly over both TDF and TAF. It had no obligation to introduce the improved product at an earlier date,” he wrote.

           

The decision, by the way, came less than a week after Gilead raised prices on two older HIV medications — Complera and Stribild — that contain TDF and face patent expiration. In fact, it was the second time in six months the company boosted list prices — which do not reflect rebates offered payers — a break from its usual strategy of increasing prices annually.

 

At the same time, Gilead left intact prices for two much newer versions of these drugs — Odefsey and Genvoya — which contain TAF. And these newer medicines are now priced higher than the older treatments. AIDS activists criticized the company for raising payer and patient costs.

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Gilead et al Investigated by Feds for Contributions to Co-Pay Charities

Gilead et al Investigated by Feds for Contributions to Co-Pay Charities | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Federal investigators have launched a number of investigations into how drugmakers might be setting or maintaining high prices on some of their drugs, looking into pricing on generics and relationships with so-called specialty pharmacies. Now three drugmakers have been subpoenaed for information on their relationships with drug charities.

Gilead Sciences ($GILD), Biogen ($BIIB) and Jazz Pharmaceuticals ($JAZZ) have disclosed in filings that they have been hit up by the feds for documents related to their support of nonprofits that assist patients, reports Bloomberg, which has taken a deep look into such relationships.

As the news service points out, drug companies are not allowed to give direct copay help to patients who get treatments paid for by Medicare. That would be deemed a kickback. But they can make contributions to charities that assist Medicare patients to pay for drugs. That is, so long as those donations don’t have any strings attached and charities are not favoring one company’s drugs over another.

Bloomberg reports that drugmakers donated $1.1 billion to charities in 2014, more than double the amount from just four years before. The charities are important because if their support means patients sometimes continue to take expensive drugs instead of less expensive alternatives, meaning drugmakers benefit.

The charities Bloomberg spoke to claim independence. They point out they have no sway over drug prices and that their donors have no say in their operations. But the news service also spoke to a handful of former employees from one charity that claimed patients taking Jazz’s $90,000 a year narcolepsy drug Xyrem got quick help while those taking a competing drug might get waitlisted, a charge the charity denied.

These kinds of relationships came up three years ago when The New York Times reported that the Chronic Disease Fund, the largest copay assistance charity at the time, had put new administrators in place after questions were raised about favoritism towards patients taking Questcor Pharmaceuticals’ H.P. Acthar Gel, a drug that had come under criticism for its $28,000-per-vial price.

Pharma Guy's insight:

Also read “The Real Reason Big Pharma Wants to Help Pay for Your Prescription”; http://sco.lt/6mipsX

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Gilead's Investors Shed Croc Tears Despite a 69% Profit Margin for Q1 2016

Gilead's Investors Shed Croc Tears Despite a 69% Profit Margin for Q1 2016 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The drugmaker Gilead Sciences has seen its fortunes buoyed by its blockbuster hepatitis C drugs in the last two years. But that cash flow is slowing down — and it’s hitting the company’s bottom line.

 

Combined sales for the powerful drugs, sold as Sovaldi and Harvoni, were $4.3 billion in the first quarter of this year, missing the average analysts’ estimate by nearly $300 million and falling $600 million below the previous quarter, Gilead reported on Thursday. That helped drive a lower-than-expected profit margin for the company.

 

The company has said it expects its US sales of its hepatitis C drugs to flatten this year.

 

The high prices of Sovaldi and Harvoni have made the drugs flash points in the public and political uproar over drug prices. The medications are priced at $84,000 and $94,500, respectively, for a full course of treatment, though patients and their insurers generally pay far less thanks to negotiated discounts.

 

With revenue from the hepatitis C drugs slowing, some investors are clamoring for Gilead to strike new deals. Earlier this month the company said it would pay $400 million for a drug from Nimbus Therapeutics to treat fatty liver disease. CEO John Milligan said it’s open to doing more.

 

“We are actively assessing options,” he said, “and we will make moves when the right opportunities present themselves.”

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Harvoni TV Commercial Suggests Patients Do Not Want to Wait for Cheaper Competing Drugs

Gilead's "Ready" theme is meant to encourage "diagnosed patients who are ready to seek treatment and ready to be cured" to talk to their doctors, David Johnson, Gilead VP, U.S. sales and marketing for liver diseases, said.

 

It's also a nod to many hep C patients who've been told by healthcare providers to hang on for new drug developments--or forced by insurers to wait until symptoms worsen.

 

"We believe we have a responsibility to let people living with HCV know there may be a cure available to them," Johnson said. "The campaign is designed to improve awareness of this advancement, encourage patients with HCV to connect with a qualified health care provider, and support a better conversation between patient and provider to increase patients' understanding of their disease and explore treatment options."

Pharma Guy's insight:

"I don't want to live with the uncertainties of Hep C," says the opening voice over. "I wonder if I should seek treatment," says one patient. "I am ready," says another. The ad ends with the phrase "The ONE you've been waiting for."

 

The ad mentions "cure" in large font-size text and audio several times, but points out in small type (not audio), "Cure means no virus detected in blood 3 months after treatment ends."

 

I wonder, however, are there any data about detection AFTER 3 months, or hasn't Harvoni been on the market that long?

 

Note that the NIH is leading a Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C; http://sco.lt/5FuPeT Unfortunately, by the time that study is complete, the Harvoni sales cycle will have ended.

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Gilead's "Tone-deaf Pricing" of Sovaldi "Exploits" Our Veterans

Gilead's "Tone-deaf Pricing" of Sovaldi "Exploits" Our Veterans | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The chairman of the House Veterans Affairs Committee is slamming an American pharmaceutical company for "price gouging.


The target of Miller's wrath is Gilead Sciences of Foster City, California, which Miller said earned about $10 billion in the first year its treatment for chronic liver disease hit the market in 2012.


"Gilead's tone-deaf pricing strategy also fails to take into account the fact that without the Department of Veterans Affairs, the drug at the center of this debate would not even exist," Miller wrote. "Sofosbuvir was invented by a team led by a VA doctor, who sold the company that developed the drug to Gilead in 2012."

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What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data

What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences’ hepatitis C treatments on a timely basis.


Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. They sought the data because the drugs are widely prescribed, thanks to very high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.


As far as the health groups are concerned, the accelerated process “may increase the risk that gaps in drug efficacy will go undiscovered, or that side effects or [interactions with other drugs] will go unnoticed,” according to the lawsuit. “Independent analysis of patient-level clinical trial data is essential to identify and bring to light unresolved safety and efficacy issues.”


Specifically, the groups hope to learn about different responses that different patients experienced during clinical trials. Tracy Swan of Treatment Action Group points to relapses in a Harvoni clinical trial that occurred only among African-Americans. The groups also want to perform an independent analysis of poor prognostic factors among people who were not cured in order to identify a patient profile.


In their lawsuit, the groups maintain doctors “lack the benefit of any independent assessment of the data.” And given the high cost of the drugs, the groups argue in their lawsuit that it is “crucial that policymakers be able to evaluate the cost-effectiveness… based on the underlying clinical data…” Sovaldi and Harvoni cost $84,000 and $94,500, respectively, for 12-week regimens, before discounts.


But Gilead never replied to their requests last November for trial data, according to the lawsuit.


So last December, the groups turned to the FDA and submitted a Freedom of Information request for the data, since the drug maker had submitted the information to the agency as part of the drug approval process. However, the groups say the FDA denied their request for “expedited processing” and maintained it would take from 18 to 24 months to fork over the data, according to the lawsuit.


“This delay will leave doctors and patients in the dark for too long,” says Amy Kapczynski, a Yale Law School professor who heads GHJP, in a statement. “Doctors write thousands of prescriptions for these drugs every week, straining budgets of state health care programs. Prompt disclosure of this information, which the FDA already collects, will allow doctors and policymakers to make more informed treatment choices with real and immediate consequences for public health and spending.”

Pharma Guy's insight:


I'm on record for wondering if, in the long run, the claims of enduring cure of Hepatitis C may be over optimistic. If there were relapses occurring in short clinical trials, wouldn't you expect even more relapses in the real world following months after treatment?

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An OTC Allergy Drug May Be an Effective Hep C Treatment, Claims NIH!

An over-the-counter drug indicated to treat allergy symptoms limited hepatitis C virus activity in infected mice, according to a National Institutes of Health study. The results suggest that the drug, chlorcyclizine HCl (CCZ), potentially could be used to treat the virus in people. Results were published April 8 in Science Translational Medicine 


The hepatitis C virus (HCV) causes liver inflammation and often leads to serious complications such as cirrhosis. Early diagnosis and treatment of HCV can prevent liver damage. Drugs are available to treat HCV, but costs can reach tens of thousands of dollars.


“Although hepatitis C is curable, there is an unmet need for effective and affordable medication,” said lead author T. Jake Liang, M.D., senior investigator at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “CCZ is a promising candidate for part of a treatment regimen for this potentially life-threatening disease.”

Conducted at the NIH campus in Bethesda, Maryland, the study found that CCZ blocked the early stage of HCV infection likely by impairing the ability of the virus to enter human liver cells grafted in the mice. The outcome was similar to that of commonly used antiviral drugs but without those drugs’ toxic side effects.


“Using an innovative high-throughput screening process, we identified CCZ as a potent inhibitor of hepatitis C,” said Anton Simeonov, Ph.D., acting scientific director of NIH’s National Center for Advancing Translational Sciences (NCATS), which collaborated in the study. “Identifying already approved drugs from the NCATS Pharmaceutical Collection may offer a faster route to potential discovery of treatments for all diseases.”


The researchers will next study how the drug affects people. CCZ is currently used for the treatment of allergies, not for HCV. “People should not take CCZ to treat their hepatitis C until it has been demonstrated that CCZ can be used safely and effectively for that purpose,” cautions Liang.


“NIH research is vital to finding creative solutions for some of today’s most serious public health issues,” said NIDDK Director Griffin P. Rodgers, M.D. “The CCZ medication may eventually provide an affordable alternative to costly options, especially in low-resource communities where hepatitis C infection is widespread.”


HCV infection affects an estimated 185 million people worldwide. People with hepatitis C interested in participating in clinical research on CCZ may call 1-866-444-2214 (TTY 1-866-411-1010) or visit www.clinicaltrials.gov (Clinical Trial # NCT02118012) for information. Support for both studies comes from the intramural research programs of the NIDDK and NCATS and from Hiroshima University.

Pharma Guy's insight:


Wow! Sell your Gilead stock now!

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Krishan Maggon 's curator insight, April 9, 2015 2:32 AM
Sci Transl Med 8 April 2015: 
Vol. 7, Issue 282, p. 282ra49 
Sci. Transl. Med. DOI: 10.1126/scitranslmed.3010286RESEARCH ARTICLE

DRUG DISCOVERY

Repurposing of the antihistamine chlorcyclizine and related compounds for treatment of hepatitis C virus infectionShanshan He1, Billy Lin1, Virginia Chu1, Zongyi Hu1, Xin Hu2, Jingbo Xiao2, Amy Q. Wang2,Cameron J. Schweitzer1, Qisheng Li1, Michio Imamura3, Nobuhiko Hiraga3, Noel Southall2, Marc Ferrer2,Wei Zheng2, Kazuaki Chayama3, Juan J. Marugan2 and T. Jake Liang1,*
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Gilead, Support Your "Truvada Whores!" HIV activists target Gilead for holding back on Truvada marketing

Gilead, Support Your "Truvada Whores!" HIV activists target Gilead for holding back on Truvada marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Gilead Sciences is no stranger to criticism. Consider the years-long outcry over HIV and hep C drug prices. But now the California-based company finds itself in a strange--yet somehow familiar--spotlight. At a time when the pharma industry is drawing fire for marketing its drugs to doctors, Gilead is drawing fire for not marketing enough.


The issue is Truvada, Gilead's HIV treatment that's also approved to prevent infection with the virus. It's the only drug blessed by the FDA for that use. It's backed by the U.S. Centers for Disease Control and Prevention (CDC) for pre-exposure prophylaxis, or PrEP.


But more than two years after that much-publicized approval, a year after the CDC recommended its routine use, few at-risk people are actually taking Truvada. In fact, as Bloomberg reports, only 3,200 Truvada scripts were written for prevention through March 2014.


Gilead "does not view PrEP as a commercial opportunity and is not conducting marketing activities around Truvada as PrEP," spokeswoman Cara Miller told the news service.

Pharma Guy's insight:


Gilead, however, needs to go beyond a drug.com website to get the message out. In fact, this sounds like a problem tailor-made for a mass-media (TV and print) direct-to-consumer advertising solution! But Gilead has no plans to advertise Truvada for prophylaxis, even though the FDA approved it for that use back in 2012.

Why not?

Not advertising helps Gilead avoid controversy, but I contend that in this case not advertising is itself controversial considering that Truvada is 99% effective in preventing HIV infection and that based on the "number needed to treat" data, Truvada is FOUR TIMES more likely to save lives than statins, another widely promoted preventive drug regimen (see chart above).

If Gilead decides to advertise Truvada for prophylaxis, I have some recommendations. Find them here.

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Gilead's (Too?) Clever Deal to Sell Sovaldi in Poor Countries

Gilead's (Too?) Clever Deal to Sell Sovaldi in Poor Countries | Pharmaguy's Insights Into Drug Industry News | Scoop.it
In a bid to forestall criticism over the price of its expensive Sovaldi hepatitis C treatment, Gilead Sciences has reached licensing deals with seven large generic drug makers based in India to sell lower-cost versions in 91 developing countries.


The 91 countries covered by the deal – including Egypt, Vietnam, India and many countries in Africa – have a per capita income of nearly $1,900 and account for about 54 percent of those with hepatitis C, according to Knowledge Ecology International, a non-profit that tracks drug access and patents.


Nonetheless, more than three dozen patient advocacy groups say the licensing deals do not go far enough, because the deals excludes many middle-income countries – such as Brazil, China, Turkey, Thailand and Ukraine – where governments and individuals may not be able to afford the Gilead drug.


The patient groups are concerned the licenses will preclude the generic drug makers from selling lower-cost versions to those countries and potentially excluding millions of patients with hepatitis C from gaining access to treatment. For this reason, Doctors Without Borders says the deal “falls short.”


Tamir Ahin of the Initiative for Medicines, Access & Knowledge says this is designed to thwart generic competition in middle-income countries, since the deal involves some of the largest generic suppliers in the world. “In one fell swoop, Gilead has locked up the main competition” for generics.


Pharma Guy's insight:


These are the type of deals that sound good on the surface, but when you dig deeper you discover they tend to benefit the drug company more than patients.

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