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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Regeneron CEO Len Schleifer vs Allergan Chief Brent Saunders re Controversial Native American Tribe Patent Deal

Regeneron CEO Len Schleifer vs Allergan Chief Brent Saunders re Controversial Native American Tribe Patent Deal | Pharmaguy's Insights Into Drug Industry News |

One of the drug industry’s most persistent critics happens to be one of its most famous faces. And Dr. Leonard Schleifer, founder and CEO of Regeneron Pharmaceuticals, didn’t disappoint in his latest performance.


“It’s nuts,” Schleifer said Thursday of Allergan’s controversial move to protect patents by transferring them to a Native American tribe. Brent Saunders, Allergan’s CEO, made waves and headlines alike last year with a promise to do right by society. To Schleifer, the patent deal violates Saunders’s vaunted social contract and, plainly, “makes your company look bad.”


The debate, which took place at Forbes’ annual health care conference, was classic Schleifer, whose schtick routinely breaks up the monotony of drug industry panels that tend to feature wealthy white men agreeing with one another before a live audience.


But some analysts caution that Schleifer’s tell-it-like-is persona might have a downside — that he, like Saunders, may one day find his bold words used against him.


Further Reading:

  • “Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics”;
  • “Regeneron CEO Len Schleifer vs Pfizer CEO Ian Read on Drug Prices Redux”;
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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 |

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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Pfizer's Weird Patent Game: Threaten Doctors Who Prescribe Lyrica (pregabalin) Off-Label

Pfizer's Weird Patent Game: Threaten Doctors Who Prescribe Lyrica (pregabalin) Off-Label | Pharmaguy's Insights Into Drug Industry News |

Trying to force people to avoid generic competition is increasingly widespread. [Here's a] disturbing, story about Pfizer directly threatening doctors should they decide to prescribe generic versions of pregabalin, an anti-epilepsy drug, that will go off patent in 2015. But here's the tricky part: Pfizer holds a different patent on the same drug if it's used to treat pain (rather than epilepsy). Pfizer is claiming that prescribing the generic version for pain use would lead to serious problems -- even though it's the same damn drug.

You will see that, whilst the basic patent for pregabalin has expired and regulatory data protection for Lyrica expired in July 2014, Pfizer has a second medical use patent protecting pregabalin's use in pain which extends to July 2017. Pfizer conducted further research and development on pregabalin leading to the invention of its use in pain and hence was granted a second medical use patent for this indication. This patent does not extend to pregabalin's other indications for generalized anxiety disorder (GAD) or epilepsy. 

As a result of the pain patent, we expect that generic manufacturers will only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder and not for pain, whilst Pfizer's pain patent is in place. Generic pregabalin products therefore are expected not to have the relevant information regarding the use of the product in pain in the PIL (Patient Information Leaflet) and SmPC (Summary of Product Characteristics). In other words, the generic pregabalin products are expected to carry so-called "skinny labels" and will not be licensed for use in pain. In the circumstances described above, Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the UK would infringe Pfizer's patent rights. This would not be the case with supply or dispensing of generic pregabalin for the non-pain indications, but we believe it is incumbent on those involved to ensure that skinny labeled generic products are not dispensed and used for pain. 

In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indication. Without information, guidance and practical solutions from the authorities, Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act. This runs contrary to the government's established policy of rewarding additional research by the granting of a second medical use patent.

As Cory Doctorow notes in the article above, Pfizer here seems to be trying to take its own "stupid problem" and make it everyone else's stupid problem:

Weirder still is that Pfizer wants to make their stupid problem into everyone else's stupid problem. The fact that it's hard to enforce this kind of secondary patent is Pfizer's business, not doctors'. Doctors' duty is to science and health, not Pfizer's profit-margins. Scientifically, there's no difference between the two compounds. Doctors who prescribe generics leave their patients (or possibly the NHS) with more money to pursue their other health goals. 

If your dumb government monopoly is hard to enforce, maybe you shouldn't be banking on it. But in the world of corporatist sociopathy, where externalising your costs on others isn't just a good idea, it's your fiduciary duty to your shareholders, Pfizer's actions are practically inevitable.

Pharma Guy's insight:

Meanwhile, I have noticed an up tic in Lyrica DTC advertising on TV. Five drugs on the 2013 Top 20 DTC spending list - Viagra, Celebrex, Lyrica, Xeljanz, and Chantix - are marketed by Pfizer. For more on that, read The Top 20 DTC Ad Spenders in 2013 Virtually Ignored Digital

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The Top 10 U.S. Drug Patent Losses for 2017

The Top 10 U.S. Drug Patent Losses for 2017 | Pharmaguy's Insights Into Drug Industry News |

Among the many meds that’ll lose patent protection in the U.S. this year are 10 drugs that each contribute in a big way for top drugmakers. Eli Lilly, Pfizer, Takeda, Bristol-Myers Squibb and Gilead are each set to hit the patent cliff this year with some of their respective big sellers.


Together, they brought in more than $10 billion last year in the U.S. and cover a range of indications: multiple sclerosis, HIV, erectile dysfunction and cancer, among others. They’ll be hot targets as generic rivals rush to steal share with cheaper options.


Just when a drug will lose market exclusivity isn’t always clear, with add-on patents and legal settlements occasionally clouding the picture. We've focused not only on drugs that will lose their patent shields in 2017, but those that, because of patent litigation or settlements, will find themselves vulnerable to generic or biosimilar competition.

Via Richard Meyer
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As Blockbuster Drugs Near Lifecycle End, #Pharma TV Ad Spending Rises

As Blockbuster Drugs Near Lifecycle End, #Pharma TV Ad Spending Rises | Pharmaguy's Insights Into Drug Industry News |

The list of top pharma TV spenders for April featured blockbusters and cliffhangers. The top three spenders Lyrica, Humira and Latuda, in fact, have been major blockbusters for their manufacturers, but are also facing sooner-rather-than-later patent expirations.


No. 1 Pfizer’s pain and seizure drug Lyrica spent almost $26 million for the month, easily doubling its ad spend from the previous month and unseating AbbVie's Humira from its top-spender position, according to real time TV tracker


Pfizer's top seller, Lyrica has been in the news as it tries to fight off generics by defending its pain-indication patent. Pfizer lost that battle in the U.K., where generics have since made their debut, but in the U.S., a patent decision blocks generics until 2018. The Lyrica TV spot that garnered the most spending was Coach, a new creative execution about a female softball coach focused on fibromyalgia pain.


Up next on the April TV spender list was Humira, which until now has held the top spot every month in 2016. The AbbVie anti-inflammatory brand split $24 million on TV ads among its three indications for arthritis, Crohn’s disease and colitis, and psoriasis, according to iSpot’s data. Humira’s main patent expires this year; but AbbVie remains confident that it won't face biosimilars in the immediate future. The company sees Humira sales – which make up more than half of its revenue – increasing through 2018, with only small decreases in the following two years.


The No. 3 spender, Sunovion’s anti-psychotic Latuda, also faces a patent expiration this year, and it dropped more than $17 million on TV ads in April. A new ad launched last month continues its ongoing story of bipolar depression sufferer Amy, but told through the perspective of her husband Scott.


Three diabetes drugs also made April’s top 10 – AstraZeneca’s Farxiga, Novo Nordisk’s Victoza and Sanofi’s Toujeo – as competition remains fierce in that disease.


Overall spending rebounded among the top 10, totaling $138.6 million in April for a 30% increase over the $108 million spent in March.

Pharma Guy's insight:

For a more in-depth analysis, read "TV DTC Advertising Is Not Dead Yet!"; 

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Fire in the Blood: Will History Repeat Itself re Ebola Vaccine? See the Movie.

Fire in the Blood: Will History Repeat Itself re Ebola Vaccine? See the Movie. | Pharmaguy's Insights Into Drug Industry News |
When big pharma blocks essential HIV/AIDS medication to the third world, it is the poor who suffer.

The award-winning documentary Fire in the Blood exposes the challenges NGOs, doctors and activists face in their fight against big pharma and patent laws that prevent millions of HIV/AIDS patients in the developing world from accessing lifesaving drugs.

Oscar winner William Hurt narrates the documentary which was shot in eight countries, across four continents.

The film's contributors include Bill Clinton, Desmond Tutu and Nobel laureate economist Joseph Stiglitz, along with key figures in the struggle to get essential HIV/AIDS drugs to countries of the global south.

Fire in the Blood will screen in two parts on Al Jazeera English on October 31 and November 7, 2014.

Pharma Guy's insight:

I know that pharma companies such as Johnson & Johnson have pledged hundreds of millions of dollars to ratchet up their Ebola vaccine research (see, for example, J&J to spend up to $200 million in push to speed up potential Ebola vaccine development), but there is no pledge that once developed they will donate the vaccine to poor countries in Africa. That's why I ask if history will repeat itself.

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