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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Report questions safety of the newest hepatitis C drugs

Report questions safety of the newest hepatitis C drugs | Pharmaguy's Insights Into Drug Industry News |

Over the past few years, billions of dollars have been spent on new hepatitis C medicines because they could eliminate the virus in 90 percent or more of patients. But a new report ( finds that hundreds of cases of liver failure were associated with the drugs, and the authors suggest that regulators may have been too quick to embrace the treatments as a panacea.


Specifically, 524 cases of liver failure were found, along with another 1,058 reports of severe liver injury, according to side effects reports that were filed with the US Food and Drug Administration and reviewed by the Institute for Safe Medicine Practices. The nonprofit group also noted 761 instances in which the reported side effect was a failure of the medicines to combat the virus. The report arrives just three months after the FDA issued a warning that the drugs could reactivate hepatitis B.


…The study authors maintain their findings should be seen as a warning about the “negative consequences” of the drugs. The medicines “should be ranked as a major medical advance, [but] the large number of cases of liver failure and death, as well as antiviral failure, show the need for further investigation of the serious adverse effects of this expensive new class of drugs.”


Indeed, the latest generation of hepatitis C treatments has been revolutionary, offering a desirable combination of high cure rates and manageable side effects. They include the Sovaldi and Harvoni treatments sold by Gilead Sciences. But the drugs come at a cost, literally. List prices range from $54,600 to $94,500, depending upon dosing and regimens, although these do not reflect rebates or discounts.


Spending per patient has ranged from $55,000 to $125,000 per patient, according to the ISMP report, citing data from QuintilesIMS, and about 250,000 patients were treated in 2015. The study authors noted that list-price spending for the drugs exceeded similar spending for antibiotics, and cholesterol and blood pressure drugs, each with patient populations measured in tens of millions.


“These new data raise more questions than they resolve about the adverse effects of direct-acting antiviral drugs…. The FDA and pharmaceutical companies were also overoptimistic in labeling as a ‘cure’ the results of a laboratory assay at 12 weeks indicating undetectable levels” of the virus.


“This is an example of the price we pay for faster drug approval with reduced clinical testing,” said Thomas Moore, a senior scientist at ISMP and one of the study authors. “Don’t we really want to know more than this about a new drug treatment on which we spent more than $10 billion to $20 billion in 2015 alone? We spent more than twice as much on these direct-acting antivirals for about 250,000 patients as the NIH did on all research into all infectious diseases in one year.”


Not everyone is convinced, however, that the report should alter medical practice.


More here…


Further Reading:

  • “What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data”;
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. Now, in addition, there are serious side effects associated with these drugs.

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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 |

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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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 |

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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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 |

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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End of Winter Sale: Half Off Sovaldi & Harvoni, Gilead's Hepatitis C Drugs

Gilead Sciences, the maker of Sovaldi® and Harvoni®, two of the highly-effective but expensive new drugs for hepatitis C infection, recently announced that in 2015 it expects to give an average discount of 46% off the original list prices of these drugs.  This discount would produce an average price of approximately $40,000 for a course of treatment with Harvoni, assuming two-thirds of patients can benefit from a shorter 8-week regimen.  At this price, not only does Harvoni (or comparable treatment options) represent a high value in the care of individual patients, but its likely budget impact across broader patient populations will meet the threshold at which the California Technology Assessment Forum (CTAF) would identify it as a "high value" for most health care systems.   

The announcement of steep price discounts follows a brief period of intense negotiations between Gilead and insurance companies following the FDA approval of a rival drug treatment, Viekira Pak®, made by AbbVie.  At its meeting on December 18, 2014, the independent review panel of CTAF [a core program of the Institute for Clinical and Economic Review (ICER)] voted that the evidence was insufficient to distinguish between the clinical effectiveness of the Gilead and AbbVie drug regimens, both of which have demonstrated hepatitis C viral clearance in over 90% of patients treated.  At the time of the CTAF meeting, the AbbVie drug was not yet FDA approved and did not have a list price, but the CTAF panel voted that Harvoni, with a list price of about $95,000 for a 12-week course of treatment, represented a "low" health system value on the basis of its potential to push up state Medicaid costs by over 5% in a single year if all patients with known infections were treated.  


The CTAF panel vote was informed by a drug pricing analysis performed by researchers at the University of California at San Francisco and ICER that suggested that a price range for Harvoni - or any other comparably effective drug regimen - of $34,000-$42,000 for an average course of therapy would serve as a benchmark for keeping health system cost increases below a threshold of 0.5%-1.0%.  The ICER report notes that this threshold budget impact for a single new treatment is viewed by many payers as manageable without resorting to severe treatment delays or cuts in other services.

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According to @matthewherper "Me Too" Drugs Essential for Lower Drug Prices

According to @matthewherper "Me Too" Drugs Essential for Lower Drug Prices | Pharmaguy's Insights Into Drug Industry News |

 For biotech investors, the news that AbbVie has cut a deal with Express Scripts to sell its new hepatitis C treatment, the Viekira Pak, at a significant and undisclosed discount to its $83,319 seems nothing short of disaster. It means that Gilead Pharmaceuticals will have to compete on price, not just efficacy with its $84,000-per course Sovaldi and $95,000 Harvoni (they are inarguably better drugs). As Adam Feuerstein at The Street points out, that could put limits on the incredible pricing power that is fueling the biotech boom.

But there is another, longer view on this news: this is a reminder of the way the pharmaceutical market has always worked and of the importance of me-too drugs, which have been heavily criticized as proof that drug companies are not innovative, in controlling prices. In areas outside cancer and rare diseases, this is how the pharmaceutical market has always been. It’s not an out-and-out disaster for Gilead, which still has the first and best drug in what could be one of the modern era’s biggest pharmaceutical markets. But it shows that there is price competition pharma, and that is a good thing. Drug prices are too high, and they are rising too fast, and it would be best for everyone if we can find a free-market solution for fixing that problem. This is exactly that.

But today Express Scripts announced that it had made a deal with AbbVie to sell Viekira Pak exclusively [ESRX now says: "Harvoni will be available to those who fail Viekira"]. Twenty-five million patients on its plans will not be able to get Sovaldi at all, and will have to use Viekira. In return, AbbVie is going to pay a huge rebate. The move will probably cause negotiations with other plans, and Gilead may have to offer rebates too.

Patients may protest loudly enough that health plans will opt out of Express Scripts’ decision. For many, taking Viekira instead of Harvoni will mean taking many more pills, taking ribavirin, and being on medicine for another month. Those aren’t minor concerns.

Pharma Guy's insight:

I'm not sure Viekira qualifies as a "Me Too" drug in the classic sense - at least compared to Harvoni. It's difficult to say that one biologic has a nearly identical chemical composition as another, which is typical of me too drugs. Plus, as Herper points out, Viekira must be taken with ribavirin, whereas Harvoni includes that in a single dose. 

The real travesty of "me too" drugs is when a new Rx brand drug is introduced to compete with an older nearly identical cheaper generic version of the drug. A case in point is LOVAZA, which is an Rx drug that is a "me-too" of existing over-the-counter dietary supplements. I am talking about LOVAZA, aka omega-3-acid esters approved by the FDA for the treatment of high triglycerides. Is LOVAZA different than the OTC (over-the-counter) product I have in my kitchen cabinet? (Read more about that here).

At least LOVAZA is more convenient than the cheaper drug. It seems that Viekira does not compete on the convenience level with Harvoni. I expect to see this as a major message in future Harvoni DTC ads.

NOTE: Herper points out an interesting factoid: More relatively healthy patients are getting Sovaldi than very sick ones. "Insurers did very little to restrict Sovaldi to the patients who were most likely to lose liver function as a result of the virus. The severity of a patient’s liver disease is measured by a fibrosis score of between F1 (least severe) and F4 (most severe). As of June 2014, 60% of the patients getting Sovaldi had fibrosis scores of F1 or F2, according to investment bank Evercore ISI."

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Solvaldi Sales Rocket, then Nose Dive. Why? One word: Harvoni. For Gilead, It's All Good

Solvaldi Sales Rocket, then Nose Dive. Why? One word: Harvoni. For Gilead, It's All Good | Pharmaguy's Insights Into Drug Industry News |

Authored by ISI’s Mark Schoenenbaum, and presented here, courtesy of Drug Channels Institute, it tells us that Gilead’s Sovaldi literally ‘blew out the lights’  in U.S. “specialty drug” sales during its first full year on the market. This remarkable prescription drug will come in somewhere between $10 and $11 billion dollars in sales for 2014. And thinking about the first year performances of other first class, heavy weight “specialty drugs” — like Gleevec,  Avastin,and Revlimid, — Sovaldi’s sales numbers are all the more amazing.

Pharma Guy's insight:

Sovaldi scripts are sinking as patients instead opt for Harvoni, Gilead's hep C wonder combo, which boasts cure rates as high as 99.1%. Analysts expect Harvoni to rack up $10 billion a year in sales, becoming the fastest-growing drug of all time on the way there. But if all of that's the case, then why are U.S. scripts lagging behind forecasts? More...

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117,000 Hep C Patients - Out of 130 Million - Received Sovaldi. Gilead Makes $8.5 Billion in 9 Months!

117,000 Hep C Patients - Out of 130 Million -  Received Sovaldi. Gilead Makes $8.5 Billion in 9 Months! | Pharmaguy's Insights Into Drug Industry News |

Gilead Sciences' blockbuster hepatitis C drug Sovaldi has been used in around 117,000 people since its launch at the end of last year, said the company in its latest financial report.

Sovaldi (sofosbuvir), which allows patients to be treated without the need for weekly injectable interferon, has been the most lucrative pharma launch of all time, and has recorded revenues of $8.5bn in the first nine months of 2014 and $2.8bn for the three-month period between July and September.

This uptake has been despite criticism from some corners of the US unhappy with the drug's high price – around $84,000 per standard course of treatment – with senators asking Gilead to justify the cost of Sovaldi.

Around 70% of US state Medicaid programmes have implemented controls on Sovaldi prescribing - including prior authorisation requirements based on disease severity  - amid warnings that some healthcare systems may buckle under the strain of providing the drug.

Nevertheless the massive revenues so far put Sovaldi way ahead of Gilead's second biggest selling medicine Atripla, a combination of several HIV treatments. The drug made $2.5bn for the first nine months of the year and just under $900m over the third quarter, both slightly down on the same periods last year.

The huge boost from Sovaldi saw Gilead's total revenues rocket from $8.1bn for the first nine months of 2013 to $17.5bn for the same period in 2014.

Net income was also up, with Gilead taking $8.6bn for the first nine months of 2014 compared to $2.3bn a year previous.

Pharma Guy's insight:

If, say, 100,000 of those patients were in the U.S., that represents just 3% of people with Hep C in U.S. Looks like it will take a generation to treat all of them at this rate! No matter, Gilead is raking it in while the raking is good!

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The Hepatitis C Escalation: 1 Million People with Hep C in US May Develop Cirrhosis by 2020

The Hepatitis C Escalation: 1 Million People with Hep C in US May Develop Cirrhosis by 2020 | Pharmaguy's Insights Into Drug Industry News |
There’s never been anything quite like this. The latest ripple effect of the 1945-65 baby boom will be a drug bill so high, that paying it, says Australia’s advisors, “is not possible.”

Hepatitis C virus can clear spontaneously without doing any harm. But most people will develop chronic infection. It’s hard to know how many will go on to develop serious liver damage, called cirrhosis, though. Estimates range from about 10%within 20 years with some more later, to around 30%. Cirrhosis is life-threatening, with liver transplantation to try to prevent early death. Cirrhosis can also lead to liver cancer.

The number of people in the US with cirrhosis from HCV could peak at 1 million in 2020, with the peak for liver cancer coming later.

But the cost for the sofosbuvir alone is around $1,000 a pill – and $84,000 for the course: closer to $95,000 when you count in the drugs used alongside. Forbes reports that is the price set for Harvoni.

Last month, CVS reported that about 10% of people were quitting sofosbuvir treatment without finishing. Restrictions are in place in many parts of the US to contain costs, but more will be needed now. And there’s fierce debate about just how far the manufacturer is willing to go to make the drug even close to affordable in less wealthy countries: that company has a dreadful track record on this for HIV drugs. And whether the costs can be carried in rich countries is debatable, too.

Pharma Guy's insight:

Only 10% non adherence ... sounds reasonable considering, I'd like to know, however, more about thee patients, such as, income. I'm betting  early adopters of Sovaldi have the $ for the co-pay, whereas poorer patients may be waiting for cheaper alternatives to reach the market.

Krishan Maggon 's curator insight, October 15, 2014 5:55 AM



The images of the hepatitis C virus and developing liver fibrosis are from Tarik Asseleh et al, Gene expression and hepatitis C virus infection, Gut 2009, 58(6):846-858.

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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 |
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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AbbVie aims to truck ahead with hep C testing promo campaign

AbbVie aims to truck ahead with hep C testing promo campaign | Pharmaguy's Insights Into Drug Industry News |

AbbVie's  waiting for FDA approval on a hepatitis C combo therapy. OraSure makes a rapid test to detect the virus. And professional truck drivers in the U.S. are more than 5 times as likely as other Americans to have it.

Put it all together, and you've got the makings for a brand-new marketing campaign, "Truckers Rolling Against Hepatitis C." Together, AbbVie and OraSure--parties to a copromotion agreement focused on testing individuals with the latter's OraQuick HCV Test--have teamed with the Healthy Trucking Association of America to educate drivers about HCV and encourage them to get tested.

The campaign will kick off at--where else?--The Great American Trucking Show, coming up later this week in Dallas. From there, the companies will keep it going with local HCV testing events across the country.

Pharma Guy's insight:

#1: I did not know truckers were 5X as likely to have Hep C. Keep on Truckin' indeed!

#2: Just because there will be competition to Sovaldi doesn't mean that prices for these treatments will drop:

From: Don't worry about a hep C pricing war, analysts tell Gilead-watchers

No price war on hepatitis C drugs? That would be a disappointment to payers worried about the cost of treating millions of patients with super-expensive, yet highly effective drugs. But to investors, that reassurance sounds really good.

As Barron's points out today, Bernstein analysts issued a report to assuage fears of an all-out pricing competition when Gilead Sciences' Sovaldi is joined on the market by new treatments from AbbVie, Bristol-Myers, and Merck.

"One of the near-term bear arguments is the expected approval of a competitive all-oral HCV regimen from AbbVie, and the potential for aggressive pricing tactics by AbbVie," Bernstein's Geoffrey Porges and Wen Shi wrote in a note to investors.

Obviously, major undercutting of Sovaldi's notorious $84,000-per-treatment-course price could either force Gilead to slash the cost of its own meds, or relinquish market share to AbbVie. And as the analysts point out, payers are encouraging AbbVie and its fellows to do just that.

"However, we believe the risk of a price war hurting Gilead's HCV revenue in the next 1-2 years is overblown," they wrote.

For three reasons, basically. Even if AbbVie's regimen is cheaper, payers have "limited tools" to use to restrict access to Gilead's therapy, which will probably include a new combo pill by year's end. AbbVie has said--and recently--that it's not interested in a price war. That sort of competition isn't necessarily a good move in the hep C market, where awareness is growing and diagnosis is expected to increase, which means the entire pie is bigger for everyone.

And besides, if Gilead were to face lower-priced rivals, the company "has counter strategies to mitigate the impact of any potential price war by AbbVie on a payer-by-payer basis," the analysts write. Behind-closed-doors negotiations, maybe?

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Today is World Hepatitis Day: Access to New Treatments for Hep C Difficult, Says WHO

Today is World Hepatitis Day: Access to New Treatments for Hep C Difficult, Says WHO | Pharmaguy's Insights Into Drug Industry News |

Every year on 28 July, WHO and partners mark World Hepatitis Day to increase the awareness and understanding of viral hepatitis and the diseases that it causes.

Viral hepatitis – a group of infectious diseases known as Hepatitis A, B, C, D, and E – affects hundreds of millions of people worldwide, causing acute and chronic liver disease and killing close to 1.4 million people every year. But hepatitis remains largely ignored or unknown.

In April this year, WHO issued new recommendations on treatment of Hepatitis C. In May, World Health Assembly delegates from 194 governments adopted a resolution to improve prevention, diagnosis, and treatment of viral hepatitis.

On World Hepatitis Day, 28 July 2014, WHO and partners will urge policymakers, health workers and the public to 'Think again' about this silent killer.

World Hepatitis Day provides an opportunity to focus on specific actions, such as:

  • strengthening prevention, screening and control of viral hepatitis and its related diseases;
  • increasing hepatitis B vaccine coverage and integration of the vaccine into national immunization programmes;
  • coordinating a global response to viral hepatitis.

The date of 28 July was chosen for World Hepatitis Day in honour of the birthday of Nobel Laureate Professor Baruch Samuel Blumberg, discoverer of the hepatitis B virus.

Pharma Guy's insight:

From the Hep C Fact Sheet:

Scientific advances have led to the development of new antiviral drugs for hepatitis C, which are much more effective, safer and better-tolerated than existing therapies. These therapies, known as oral directly acting antiviral agent (DAAs) therapies simplify hepatitis C treatment by significantly decreasing monitoring requirements and by increasing cure rates. Although the production cost of DAAs is low, the initial prices set by companies are very high and likely to make access to these drugs difficult even in high-income countries.

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PhRMA Debunks the Myths of Treating Hepatitis C

PhRMA Debunks the Myths of Treating Hepatitis C | Pharmaguy's Insights Into Drug Industry News |
A national dialogue is needed around the value of new medicines and cures and the role they play in improving patient health and helping to manage long-term spending in the U.S. health care system.   Unfortunately, the debate around hepatitis C has, for the most part, been twisted to the point that modern-day cures are seen as a nuisance rather than a monumental step forward in the battle against disease.  For this reason, it is important to set the record straight on some of the misperceptions about the value of new and forthcoming hepatitis C treatments.
Pharma Guy's insight:

"Debunk": expose the falseness or hollowness of (a myth, idea, or belief).

I haven't read this entire post yet, so I'll refrain from "double debunking." For more on the "myths" PhRMA is debunking, read "Why is PhRMA Defending Gilead's Sovaldi Pricing."

One little "double debunk": Of course, it's easy to debunk a "myth" -- who's going to defend a "myth?" So, right off the bat, PhRMA is setting up a straw man to knock down. 

OK, as I read PhRMA's post, I'll add more comments. The post says: "Among those in the commercially insured market, PricewaterhouseCoopers estimates that only about 60,000 hepatitis C patients will be treated in 2014." But already Sovaldi sales = $5 billion, which coincidentally is enough to treat 60,000 Hep C patients. Perhaps many of these sales went to treat Medicaid or other non-commercially-insured patients. Nevertheless, the estimate of 60,000 seems way too low. What do you think?

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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 |

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?”;

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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 |

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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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 |
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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Drug Spending Surged 13% in 2014: Specialty Drugs Accounted for 32% of the Overall Spend

U.S. prescription drug spending shot up 13.1% last year, according to a new report from Express Scripts ($ESRX). And the vocal price critic says it knows just who's to blame.

The pharmacy benefits manager pinned the leap on a new group of ultrapricey hepatitis C meds, led by Gilead's ($GILD) Sovaldi and Harvoni. Those treatments helped specialty drugs--which account for only 1% of all prescriptions countrywide--put up 31.8% of 2014's overall drug spend. They also took hep C spending up by 742.6% from 2013


The numbers apply to commercially insured patients, where spending per member per year amounted to $979.96 in 2014. Of that amount, $668.75 went to pay for traditional meds, while the rest--$311.11--paid for specialty drugs. More patients used specialty meds in 2014 compared with the previous year, the report says, but most of the increase came from higher prices. Price-wise, mainstream drugs went up 6.5%, the PBM says. Specialty drug prices leapt by 25.2%.

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#Pharma Marketing Evolution: Targeting Rich Consumers

#Pharma Marketing Evolution: Targeting Rich Consumers | Pharmaguy's Insights Into Drug Industry News |

If it can adapt, a lucrative new niche is opening up for pharma

Some newspapers ran a provocative headline just recently - The Million Euro Patient. It referred to the apparently imminent approval, by Germany's Federal Joint Committee, of Glybera, a gene therapy for lipase deficiency. The cost of treating each patient (only about 200 in Europe) is about €1.1m so, by itself, Glybera isn't going to have much impact on governments' straining healthcare budgets. But it will be very significant for Chiesi, the clever Italian company that is bringing it to market and it is an important early indication of market change.

While the theory suggests that rich government niches will be the first place expensive therapies will occupy, it also suggests that they won't stop there. That's because another emergent property of the system is unequal wealth distribution; there are already more millionaires in the world than Australians and the number of us able and willing to pay more than our government is able to is increasing all the time. This creates a large, global segment of rich people willing to pay for expensive treatments. If, for example, Glybera was the best option for your child, could your family find the money?

This means that marketers of very innovative treatments will need to evolve from selling to only governments to also selling to rich consumers. That means new marketing capabilities, some of which will be very alien to our industry. Some life science companies, even if they are lucky enough to get their hands on a great technology, will fail to learn the new skills needed to exploit all their market habitats.

Pharma Guy's insight:

Yep! Lucrative indeed! For more on that, read Sovaldi - A Cure for the One to Ten Percenters

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.@RichMeyer Defends a $1000 Pill, Disses Journalists, Fails to Cite Sources for Data

.@RichMeyer Defends a $1000 Pill, Disses Journalists, Fails to Cite Sources for Data | Pharmaguy's Insights Into Drug Industry News |

Rich Meyer: If you want to understand why so many people are turning away from traditional journalists as news sources look no further than an article in VOX entitled “This drug costs $84,000, And there’s nothing the US health-care system can do to stop it.”  It’s time to look beyond the cost and instead look at the value of these medications.

Cost must be balanced with value and this is especially true when it comes to prescription drugs.  Hepatitis C is a chronic infectious disease affecting perhaps 3.2 million Americans. Hepatitis C virus, or HCV, infection is often asymptomatic — but its severity fluctuates, and it can progress after many years. Eventual complications include cirrhosis of the liver in 20% to 30% of patients, with grave consequences in terms of health and costs.

Treating HCV infection costs about $85,000, but it is all paid in a matter of weeks. Using treatments available before the introduction of sofosbuvir, the present lifetime medical costs are about $175,000 to $200,000. If HCV infection progresses, there is often cirrhosis of the liver and, in some cases, the need for a liver transplant. Taking into account the upfront cost of treatment — but also the lifetime benefits — researchers have found that sofosbuvir regimens are highly cost-effective, even at current prices.

Pharma Guy's insight:

I don't think people are turning away from traditional journalists because they write sensational stories about pills that cost $1000 each. If anything, they flock to journalists who write such stories.

In any case, Rich makes some good points. I'm not so sure about the risk of transmittal of Hep C by public shaving, however.

Rich cites some numbers like previous lifetime treatment costs of $175,000 to $200,000, but like a bad journalist, he doesn't cite his source for that data. Oh, well, If you want to understand why so many people are turning away from bloggers as news sources look no further than this post!

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Dendreon's Bankrupt High Price Cancer Drug Strategy

Dendreon's Bankrupt High Price Cancer Drug Strategy | Pharmaguy's Insights Into Drug Industry News |

Follows poor sales of cancer vaccine Provenge

Cancer vaccine company Dendreon has put itself up for sale for the second time in as many years after filing for bankruptcy protection.

The company - which did not flush out any interested parties when it looked for buyers last year - has put a price tag of $275m or more for the business and says it will continue to operate in the interim "as we seek to complete the sale of our assets or a plan of reorganisation or liquidation."

The company has struggled with low sales of its Provenge (sipuleucel-T) prostate cancer vaccine since it was launched in 2010, thanks to a hefty price tag and competition from cheaper conventional drugs such as Johnson & Johnson's Zytiga (abiraterone) and Astellas/Medivation'sXtandi (enzalutamide).

Pharma Guy's insight:

Could this be a lesson for other short-sighted pharma companies that  keep drug prices too high when they have a government-sanctioned monopoly? I'm thinking of Gilead/Sovaldi

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Gilead's Fake Sovaldi Content Marketing Ploy

Gilead's Fake Sovaldi Content Marketing Ploy | Pharmaguy's Insights Into Drug Industry News |
Pharma Guy's insight:

I subscribed to receive e-mail messages from "Your SOVALDI Team" which is really Gilead. I don't have Hep C, but Gilead doesn't know that.

Today, I received the message "Why should you consider treatment" from my Sovaldi team. I was surprised to see a link to an "arcticle" as shown in the screen grab above.

I expected to be taken to a real article discussing Hep C and treatment with Sovaldi. This, I thought, was an example of "Content Marketing," which relies on useful, unbiased information, perhaps from an independent 3rd-party, to get readers to visit your website or see an associated ad for you product. 

Unfortunately, the link in the Gilead e-mail (i.e., from "In this article") brought me directly to a branded Sovaldi web page that looks just like any other site. It wasn't an "article" at all!

Oh well. I'm a fake patient, so I guess I deserve a fake content marketing ploy.

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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 |
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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Drug pricing: Patients Benefit Least from High Prices

Drug pricing: Patients Benefit Least from High Prices | Pharmaguy's Insights Into Drug Industry News |

There were 36 novel drugs launched in 2013, including 10 for cancer and 17 for rare diseases, the highest number in a decade.

These new treatments come with high price tags. Drugs for rare genetic disorders cost $300,000 to $400,000 per year. Therapies for cancer, multiple sclerosis, rheumatoid arthritis, and HIV, which belong to a category called “specialty medicines,” often cost north of $100,000 per year. These medicines accounted for 29 percent of the $329 billion spent on drugs in the United States in 2013, even though they comprised only about 1 percent of all prescriptions.

Unfortunately, it’s the patient who benefits the least from high list prices. A recent analysis by the consulting firm Avalere Health of more than 600 exchange plans across 19 states found that a large proportion (38 percent of platinum plans, 56 percent of gold, 59 percent of silver, and 75 percent of bronze) are asking patients to pay at least 30 percent of the list price of expensive drugs.

Pharma Guy's insight:

Sovaldi is being labeled the canary in the coal mine of excessively priced drugs, with John Rother, CEO of the National Coalition on Health Care, warning of an upcoming “tsunami of expensive medicines that could literally bankrupt the health care system.” For more on that, read "Sovaldi - A Cure for the One to Ten Percenters"

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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 |
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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Many Hep C Patients Who Really Need Sovaldi Are Not Getting It

Many Hep C Patients Who Really Need Sovaldi Are Not Getting It | Pharmaguy's Insights Into Drug Industry News |

While Congress and payors have been quick to sermonize Gilead on the price of Sovaldi, the Foster City, CA, drugmaker's earnings report suggests those lectures have fallen on deaf ears, and have done little to keep the drug off formularies or slow down its sales.

For the second quarter of 2014, Gilead's total product sales in the US were slightly over $4.8 billion—Sovaldi total sales reached $3.4 billion with $3 billion in the US alone—meaning nearly three-quarters of the drugmaker's domestic revenue comes from that one, thousand-dollar pill. Gilead estimates that 9,000 Sovaldi patients have been cured of hepatitis C—a total they believe will grow rapidly as the drug gains traction.

Physician penetration, too, proved strong. Seventy percent of targeted doctors have written a script for Sovaldi, according to the drugmaker. As a comparison, Biogen's blockbuster MS pill Tecfidera saw 62% penetration after launch.

Despite AHIP (American Health Insurance Plans) calling for the drugmaker to lower the price, and Kaiser Permanente calling the price “outrageous,” only three states are currently not covering Sovaldi, and of those remaining 47 states half require prior authorization and half require a certain level of fibrosis (i.e. liver damage).

However, of the patients treated so far, 60% had “low fibrosis scores,” Schoenebaum wrote, which could signal that the hard-to-treat patient is still a pressing unmet need.

Also of note was how, and to whom, the drug has been prescribed. Sixty percent of patients treated had genotype 1 (the most common subset of the disease), and 70% of usage was for interferon-free regimens, including combination with J&J's Olysio.

Pharma Guy's insight:

Aside from who gets Sovaldi and who doesn't, Gilead is claiming that 9,000 patients have been "cured," which means "a fully suppressed viral load." Remember the baby who was supposedly "cured" of HIV because no viruses could be detected? What if the same thing happens for Hep C patients who are "cured" by Sovaldi? Will they have to undergo another $84,000 round of treatment with the drug? I don't think the clinical trail was designed to detect that scenario. Only use in the real world will answer my question.

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