Recently acquainted under the banner of investment firm Altaris, two CDMO veterans are gearing up to wed their decades-old drug delivery businesses.
Kindeva Drug Delivery is merging with ex-Pfizer subsidiary Meridian Medical Technologies to spawn a globetrotting drug-device contract development and manufacturing organization (CDMO), the companies said Tuesday.
Healthcare investment firm Altaris recently snapped up both halves of the new CDMO-in-waiting. The companies will continue to run their drug delivery businesses separately until the deal’s close, they said, without providing a projected timeline.
Prior to its 2021 Altaris takeover, Meridian—which specializes in emergency response auto-injectors—was owned by Pfizer. Over the past several years, the company found itself embroiled in EpiPen controversies related to manufacturing and pricing of the popular epinephrine injector.
Kindeva, for its part, started flying the Altaris banner a few months earlier in 2020. Altaris offered $650 million for the company, which previously went by the name 3M Drug Delivery Systems.
The companies’ new CDMO will wed Kindeva and Meridian’s respective tech and know-how to tackle parenteral drug delivery projects plus administration of medicines via inhalation, skin absorption and just-under-the-skin injections. Meridian CEO Milton Boyer will helm the new venture.
Much like Kindeva, drug delivery has always been in Meridian’s DNA. In fact, right around the time Kindeva was inventing the first metered dose inhaler in the 1950s, Meridian says it was pioneering rescue auto-injector technology. After more than 60 years in the game, Meridian has built up some 300 patents related to auto-injector drug device combinations, according to the company.
But a string of EpiPen entanglements threatened to overshadow that legacy in recent years.
It all started when Mylan recalled thousands of Meridian-made epinephrine injectors back in 2017. It soon became clear Meridian was continuing to produce the pens despite mounting evidence that many were failing during life and death emergencies.
In September of that same year, the FDA slapped the former Pfizer unit with a warning letter for failing to thoroughly investigate hundreds of complaints about faulty EpiPen and EpiPen Jr. products. During a February 2017 manufacturing inspection, agency investigators discovered Meridian’s facility near St. Louis received a whopping 171 complaints about misfiring devices since the FDA’s last visit several years prior.
Production issues aside, Pfizer and Meridian faced public and political backlash in the past over Mylan’s habitual EpiPen price hikes. EpiPen rights holder Mylan merged with Pfizer’s Upjohn unit in 2020 to form generics major Viatris.
Back in the summer of 2021, Pfizer and Meridian, plus fellow subsidiary King Pharmaceuticals, agreed to pay $345 million under a proposed settlement to resolve lawsuits over alleged anticompetitive conduct on the popular product. The case stretched back to 2016, when multiple class-action lawsuits accused the EpiPen partners of stifling competition to defend inflated prices.