Eli Lilly says Indianapolis-based Premier Weight Loss is cracking open auto-injector pens containing its blockbuster drug and repackaging them into separate doses.
The latest threat to Eli Lilly’s weight loss business is coming right from the pharma’s own backyard. On Monday, the company filed a lawsuit against an Indianapolis-based med spa alleging patent infringement and false advertising of its blockbuster drug tirzepatide.
Lilly says that Premier Weight Loss (PWL) is cracking open auto-injector pens containing the GLP-1 treatment, then reportioning them into multiple doses and reselling them, without the critical package insert that would certify the product’s legitimacy. The Big Pharma filed a complaint against the spa in the U.S. District Court for the Southern District of Indiana on Monday, asking for an order to block PWL’s use of the altered drugs and Lilly’s branding trademarks to market them. Lilly is also seeking unspecified damages.
Prior to the complaint, PWL offered patients access to four different prescription drugs for weight loss, Lilly’s Zepbound and Mounjaro (both tirzepatide) and Novo Nordisk’s Ozempic and Wegovy (both semaglutide). The spa offered an initial consultation for $49,then a monthly $75 membership to monitor weight loss. Monthly doses of Ozempic were priced at $300 while Zepbound was on offer for $350. According to Lilly, splitting the dosing allows PWL to profit about $1,000 per month per pen.
“By cloaking itself in the goodwill and assurances associated with Lilly’s medicines, PWL explicitly contrasts the products it offers from the knock-off, untested, and unapproved products offered by other compounding pharmacies and med spas,” Lilly’s complaint read.
In a promotional video, PWL promised a quick turnaround for patients to receive a prescription after their initial visit. “What’s unique about us is that not only do we have the ability to prescribe GLP-1 medications, but we also have the ability to dispense them,” the video promises. “Meaning, if you qualify, you can come in for an initial appointment and leave with your prescription in hand.”
In a social media post from March, PWL offered free consultations to any patients looking to “switch to the FDA-approved name brand medications” as compounded medications are phased out. The FDA ordered compounding pharmacies to stop manufacturing copies of both Novo and Lilly’s products as they were removed from the shortage list.
PWL said in the post that some compounders are considering adding ingredients to their products to try to flout the ban. “There is very little transparency at this point in what additional ingredients will do to the efficacy or safety of the medications. Or if the addition of an ingredient will save them from litigation (it likely will not),” the post reads. The spa also has posts lobbying against using telehealth companies like Ro or Hims for weight loss, arguing that patients should be monitored.
Accrording to Lilly, however, PWL is no better. “PWL engages in this dangerous and deceptive scheme while masquerading as a paragon of safety,” the pharma’s complaint stated.
Specifically, Lilly asserts that PWL is selling “altered, unsterile products that have been unsealed, repackaged, and re-dosed to stretch Lilly’s single-use auto-injector pens into five lower-dose injections,” according to the complaint. The spa buys higher dosage strength products and then separates the doses for multiple patients, Lilly alleges.
The complaint continues: “PWL promotes its business [using] Lilly’s 150-year reputation as a pharmaceutical manufacturer.”
Lilly’s rival Novo is similarly battling copycats of semaglutide. The Danish pharma’s CEO Lars Fruergaard Jorgensen recently admitted that compounded versions of the drugs are hurting business. He warned that patients need to be leary of whether they are injecting the real stuff. “There’s only one semaglutide. That’s what is in our products and patients should really check the product before they inject it,” Jorgensen said during a recent investor presentation.
‘NOT safe’
According to Lilly’s complaint, PWL customers receive altered doses of Zepbound in “clear plastic bags affixed with PWL’s prescribing information and bearing the Lilly marks, with the drug itself contained in nondescript third-party insulin syringes.” The packages do not have the FDA-required documentation, nor do they bear the batch number of each medicine that Lilly can use to trace the drug back to the manufacturing process.
“In the event of a serious adverse event, PWL’s tampering makes it impossible to trace the original source of the Lilly medicine that PWL manipulated,” the complaint read.
Lilly added in the suit that the FDA has specifically warned against “dose-splitting,” and that the practice is dangerous. “Cracking open Lilly’s single-use auto-injector pens or vials to create multiple doses—as PWL does—destroys sterility and introduces serious risk to patients who use the unsterile product.”
The company warns that once the pen is cracked open, it becomes “a breeding ground for bacteria,” and a resulting infection could lead to sepsis, abscesses or death.
“None of this is hyperbole,” Lilly said in the complaint. “There are countless examples of companies causing patients serious harm and even death by engaging in the same or similar practices as PWL.”
