Pharmaguy's Insights Into Drug Industry News
194.4K views | +0 today
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy!

Lyrica's Success Story: Pfizer's Development & Marketing, University Research

Lyrica's Success Story: Pfizer's Development & Marketing, University Research | Pharmaguy's Insights Into Drug Industry News |

Pfizer’s Lyrica leads drug sales for the company--but it’s also doing big things for another of the med’s developers.

Royalties on the nerve pain and seizure med have powered the endowment at Northwestern University--which helped develop Lyrica--to $10 billion, making it the eighth largest endowment in the U.S., Bloomberg reports.

Lyrica is responsible for about $1.4 billion of that tally, the news service notes.

The drug has been a strong performer for Pfizer in recent years. It edged out anti-TNF giant Enbrel for the top spot in the pharma giant’s innovative products portfolio, and totted up $3.66 billion in sales last year. Only the Prevnar franchise of vaccines--which hauled in $6.25 billion last year--was a bigger moneymaker for the company.

The Pfizer-Northwestern relationship isn’t an unusual one. Universities increasingly rely on royalty income to fund research, and the pharma industry increasingly relies on--and partners with--academia on early-stage R&D. Princeton University, for one, collected $524 million in licensing income after Eli Lilly cancer therapy Alimta took off.

No comment yet.
Scooped by Pharma Guy!

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

No comment yet.