Case Studies -Franchise Campaigns for Drugs: MIlestones
Three major drugs that were originally used for treating a single, specific disease or illness but are now franchised and campaigned to a wider audience with more uses are Humira, Neurontin, and Lyrica. Since 2003, Humira was used as a drug for treating rheumatoid arthritis (RA), but after 2005 whenever it received FDA approval for treating other diseases, the owner pharmacy company Abbott began campaign franchising the drug. Neurontin was first approved in 1993 as a drug for treating seizures in adults, and by 1996 the pharmacy company Pfizer — owner of Neurontin — was accused of marketing the drug illegally for other uses. In 2004, Lyrica was first approved by the FDA as a drug for treating diabetic nerve pain, but by 2005 it also began being marketed as a treatment for onset seizures. Below you will find a breakdown of the timeline for each of these drugs and when they began franchise marketing campaigns in the U.S., as well as an explanation as to what led each pharmacy company to begin franchising each of these drugs.
2001: Abbott purchases Knoll Pharmaceuticals and obtains Humira
2003: Humira was first approved to treat rheumatoid arthritis
2005: FDA approval to treat psoriatic arthritis
2007: Approved to treat Crohn's disease
2008: Humira is approved to treat chronic plague psoriasis
2008: Juvenile idiopathic arthritis added to indications
2012: Approved to treat ulcerative colitis
2015: FRA approval for hidradenitis suppurativa
2016: Panuveitis added to list of approved indications
At the time of Abbott's purchase of Knoll, there was no direct indication of franchise use of Humira. This is likely due to the fact that Abbott only realized the potential for Humira (then called D2E7) after their purchase of Knoll, which was initially tested and approved only as a treatment for rheumatoid arthritis in 2003. A later press release from Abbott (later merged into AbbVie) states that the company had clinical studies in place for additional uses for Humira instantly after its first FDA approval. Only a few months prior to approval of Humira did studies begin on Humira's effectiveness on juvenile rheumatoid arthritis and Crohn's disease. An article from CNN in 2006 stated that Abbott long had many clinical trials in a "sturdy pipeline" to find as many indications for Humira as possible. With this information in mind, it is possible to conclude that Abbott began franchise marketing Humira after the drug was approved as treatment for a second disease in 2005, and has since had plans to continue building upon this scheme with additional FDA approvals.
1993: Approved for treatment of seizures in adults
2000: Extended to treat pediatric epilepsy
2002: Neurontin is approved to treat postherpetic neuralgia
Neurontin, the branded version of gabapentin, was first approved in late 1993 as a medication for treating seizures in adults. The drug is widely-known for being marketed by its manufacturer, Pfizer, for many off-label uses like bipolar disorder, ADD, neuropathic pain, migraines and more. In 2003, a study found that up to 95% of Medicare Neurontin takers were doing so for non-FDA approved indications.
In 1996, a lawsuit by a former salesperson of Pfizer accused the company of actively marketing the drug for up to 10 off-label indications. This individual stated that the company had a "systematic strategy" promoting the drug far outside of its treatment for seizures. According to court documents, the original manufacturer, Warner-Lambert (later bought by Pfizer), was unhappy with the slow sales and limited market for the drug, so they employed aggressive strategies to encourage doctors to prescribe Neurontin for other indications. Warner-Lambert was accused of paying prescribing doctors to encourage their peers, writing medical articles under the guise of doctors hosting luxurious events for doctors, and of directly bribing doctors to prescribe the drug. According to the New York Times, the company had originally decided not to pursue FDA approval for the additional indications as it had believed it would lose its patent protection too quickly to make the investment worth it.
Eight years later, Pfizer settled in the case above, pleading guilty to illegally marketing Neurontin for off-label purposes. This ruling, however, did not seem to deter Pfizer from continuing to subtly market Neurontin for other uses. In 2014, it settled another lawsuit with Kaiser that alleged it had promoted the drug for off-label uses. The FDA had apparently written many warning letters to the manufacturers, demanding it ceases marketing the product for uses outside of its approval. After the settlements in 2014, there are no further accusations or reports of Pfizer actively marketing the drug for other indications. According to the clinical trial database, Pfizer does not appear to be actively pursuing any new indications for Neurontin, despite it still being commonly prescribed for off-label use. Pfizer's website also does not point to any developments in this pipeline. With this information in mind, although illegally and without FDA approval, Pfizer has seemingly had a franchise campaign for Neurontin since it's original approval in 1993.
2004: Approved for diabetic neuropathic pain and postherpetic neuralgia
2005: Partial onset seizures added to indications
2007: Lyrica approved for use with fibromyalgia
2012: Added indication for pain associated with spinal cord injury
Lyrica was originally FDA approved in 2004 for treating diabetic neuropathic pain and postherpetic neuralgia. The drug was approved in the European Union and Russia for treating anxiety for over 12 years, but FDA approval has never been been forthcoming. It was rejected in 2004 and 2009 for "insufficient evidence". According to CenterWatch, manufacturers of Lyrica are actively pursuing a strategy of finding new indications, and they have completed several studies and trials for further uses. There is also clear evidence that off-label prescription of Lyrica is popular in the US despite lack of FDA approval.
In 2017, Pfizer gained approval for a new extended release version, dubbed Lyrica CR, and reportedly spent $33.8 million on ads in the U.S. for Lyrica treating fibromyalgia and diabetic nerve pain in 2017. A report from NHS Wales showed that around 22% of prescriptions were for fibromyalgia and diabetic nerve pain. Of Europe's $438 million in Lyrica sales, this could amount to around $96.36 million in revenue from anxiety-related Lyrica prescriptions. With this information in-hand, it is visible that since Lyrica was first approved for treating neuropathic pain in 2004, manufacturers have been franchise campaigning this drug for other uses, especially anxiety.
Humira, Neurotin, and Lyrica are just three examples of drugs that were originally FDA approved for treating one disease or illness, but eventually grew to be mass marketed or franchised for the treatment of many other illnesses in the U.S. Although Neurontin did so illegally, the drug was still widely marketed as a product that could treat an array of diseases, including seizures, postherpetic neuralgia, and ADD. Humira and Lyrica were drugs that received FDA approval for secondary uses prior to beginning a franchise campaign.