Who Owns Retavase?

Reteplase is a recombinant tissue plasminogen activator developed in the early 1990s as a second-generation thrombolytic agent. The molecule is a modified version of human tPA, engineered by deleting several domains from the native protein. The resulting molecule retains the protease domain responsible for clot dissolution but has a longer half-life than first-generation alteplase, allowing bolus administration rather than prolonged infusion.

The original developer was Centocor, a biotechnology company based in Malvern, Pennsylvania, that was also known for its monoclonal antibody research. Centocor conducted the clinical development program for reteplase, including the RAPID-1 and RAPID-2 trials that compared reteplase against alteplase for acute myocardial infarction. These trials demonstrated comparable or superior reperfusion rates for reteplase, supporting the regulatory filing.

The FDA approved Retavase on October 30, 1996 for the management of acute myocardial infarction. The approved indication covered improvement of ventricular function following AMI, reduction of congestive heart failure incidence, and reduction of mortality associated with AMI. The dosing regimen consisted of two 10-unit bolus injections administered 30 minutes apart, a simpler protocol than the 90-minute infusion required for alteplase.

Centocor was acquired by Johnson and Johnson in 1999 for approximately 2.8 billion USD. The Retavase assets subsequently transferred to PDL BioPharma, which held the cardiovascular portfolio through the mid-2000s. PDL BioPharma, based in Incline Village, Nevada, was a biotechnology company focused on antibody royalties and cardiovascular products.

In February 2008, PDL BioPharma sold Retavase and its other cardiovascular products (Cardene IV, Cardene SR, and ularitide) to EKR Therapeutics. EKR was a privately held specialty pharmaceutical company founded around 2005 to 2006 in Bedminster, New Jersey, focused on acute-care hospital therapeutics. EKR marketed Retavase to hospital pharmacies and emergency departments.

In June 2012, Cornerstone Therapeutics acquired EKR Therapeutics for approximately 125 million USD in initial cash, plus milestone payments tied to regulatory approval of a new active ingredient supplier for Retavase and sales targets. Cornerstone, based in Cary, North Carolina, was publicly traded on NASDAQ under the ticker CRTX. Chiesi Farmaceutici, the Italian pharmaceutical company, was Cornerstone's largest shareholder and provided financing for the EKR acquisition through credit agreements.

In 2014, Chiesi Farmaceutici completed its acquisition of Cornerstone Therapeutics, taking the company private. The U.S. operations were rebranded as Chiesi USA, Inc. Retavase became a Chiesi USA registered trademark, and the prescribing information was updated to list Chiesi USA as the manufacturer, with production at Patheon Italia in Monza, Italy.

The Retavase prescribing information was most recently revised in September 2024. However, FDA NDC directory records show that the product codes were reported as discontinued by the firm, with the listing certified through September 2024. The BLA remains on file. The product's current commercial availability is uncertain based on these regulatory filings.