EKR Therapeutics, Inc.

Does EKR Therapeutics still exist?
No. EKR Therapeutics was acquired by Cornerstone Therapeutics Inc. in June 2012 and became a wholly-owned subsidiary. Cornerstone was subsequently acquired by Chiesi Farmaceutici in 2014 and rebranded as Chiesi USA, Inc. EKR Therapeutics no longer operates as an independent entity. The Retavase trademark that EKR acquired in 2008 is now held by Chiesi USA.

What products did EKR Therapeutics own?
EKR Therapeutics owned two hospital pharmaceutical products acquired from PDL BioPharma in February 2008: Retavase (reteplase), a thrombolytic agent for acute myocardial infarction, and Cardene IV (nicardipine hydrochloride), an intravenous antihypertensive. Both products were used in acute-care hospital settings.

When was EKR Therapeutics founded?
EKR Therapeutics was founded around 2005 to 2006. Different sources provide slightly different founding years, with CB Insights and Preqin listing 2006, while Mergr and Purdue University's CDEK database list 2005. The company was headquartered in Bedminster, New Jersey.

Who acquired EKR Therapeutics?
Cornerstone Therapeutics Inc. (NASDAQ: CRTX) acquired EKR Therapeutics in June 2012 for approximately 125 million USD in initial cash, plus contingent milestone payments related to regulatory approval of a new Retavase manufacturing supplier and sales targets. Cornerstone was a publicly traded specialty pharmaceutical company whose largest shareholder was Chiesi Farmaceutici S.p.A.

What happened to Retavase after EKR was acquired?
Retavase passed from EKR to Cornerstone Therapeutics in 2012, then to Chiesi USA in 2014 when Chiesi Farmaceutici acquired Cornerstone. Retavase is currently a registered trademark of Chiesi USA, Inc. The prescribing information was last revised in September 2024, and the FDA NDC directory lists the product codes as discontinued by the firm as of September 2024.

Was EKR Therapeutics publicly traded?
No. EKR Therapeutics was a privately held company throughout its existence. It did not file periodic reports with the SEC and did not have publicly traded shares. The company was acquired by Cornerstone Therapeutics, which was publicly traded on NASDAQ under the ticker CRTX before being taken private by Chiesi Farmaceutici in 2014.

EKR Therapeutics was founded around 2005 to 2006 in Bedminster, New Jersey, by a team of pharmaceutical industry professionals with experience in hospital specialty products. The company was privately held from its founding through its acquisition in 2012.

The defining transaction in EKR's history occurred on February 4, 2008, when EKR entered into an Asset Purchase Agreement with PDL BioPharma, Inc. (NASDAQ: PDLI). Under this agreement, EKR acquired PDL's cardiovascular product portfolio, which included Retavase (reteplase), Cardene IV (nicardipine hydrochloride), Cardene SR, new Cardene formulations in development, and the development product ularitide. The agreement also included related trademarks, patents, intellectual property, product inventory, and other assets.

The purchase price for the PDL BioPharma assets included cash payments at closing plus contingent payments. EKR agreed to pay PDL BioPharma 25 million USD upon the marketing approval of a new Cardene formulation by the FDA, along with additional milestone and royalty payments. The acquisition gave EKR two marketed hospital products: Retavase for acute myocardial infarction and Cardene IV for short-term treatment of hypertension when oral therapy was not feasible.

Following the acquisition, EKR focused on commercializing Retavase and Cardene IV to hospital pharmacies and emergency departments. The company built a specialty sales force to reach acute-care prescribers. Retavase, a thrombolytic agent approved by the FDA in 1996 for acute MI, required ongoing medical affairs support and supply chain management. Cardene IV, an intravenous antihypertensive, was used in hospital settings for blood pressure management.

EKR operated as an independent private company for approximately four years after the PDL BioPharma acquisition. During this period, the company generated revenue from Retavase and Cardene IV sales and pursued regulatory activities related to manufacturing supply for Retavase, which required FDA approval of a new active ingredient supplier.

In June 2012, Cornerstone Therapeutics Inc. (NASDAQ: CRTX) announced the completion of its acquisition of EKR Therapeutics. The acquisition was structured as a merger in which EKR became a wholly-owned subsidiary of Cornerstone. The initial cash payment was approximately 125 million USD, with additional payments contingent on regulatory approval of a new active ingredient supplier for Retavase and sales of Retavase during approximately the first three years following commercial relaunch.

Cornerstone financed the EKR acquisition partly through a credit agreement with Chiesi Farmaceutici S.p.A., its largest shareholder. Chiesi provided a five-year Term Loan A of 60 million USD and a five-year Term Loan B of 30 million USD. The Term Loan B included a conversion option allowing Chiesi to convert it into Cornerstone common stock at 7.098 USD per share.

Following the acquisition, Cornerstone assumed responsibility for marketing and promoting Cardene IV immediately. For Retavase, Cornerstone targeted FDA approval of a new active ingredient supplier and relaunch of the product in 2013. The EKR brand and corporate entity were absorbed into Cornerstone's operations.

In 2014, Chiesi Farmaceutici completed its acquisition of Cornerstone Therapeutics, taking the company private. The U.S. operations were rebranded as Chiesi USA, Inc., headquartered in Cary, North Carolina. The Retavase trademark transferred to Chiesi USA, and the prescribing information was updated to reflect Chiesi USA as the manufacturer. EKR Therapeutics ceased to exist as a corporate entity.

As a privately held specialty pharmaceutical company that operated for approximately six to seven years, EKR Therapeutics did not publish sustainability reports or ESG disclosures. The company's small size and private status meant it was not subject to the public reporting requirements that apply to publicly traded pharmaceutical companies.

EKR's business model of acquiring and commercializing established hospital products meant it did not engage in drug discovery or early-stage clinical development, where ethical concerns about clinical trial conduct and animal testing are most prominent. The company's operations focused on commercial promotion, medical affairs, and supply chain management for products with existing FDA approvals.

The ethical considerations relevant to EKR's products centered on access and pricing of acute-care medications. Retavase and Cardene IV were used in emergency settings where patients cannot choose alternative products, creating inherent pricing power for the manufacturer. However, no specific pricing controversies or regulatory enforcement actions against EKR have been publicly documented.

No specific awards or recognitions for EKR Therapeutics have been documented in publicly available records. The company operated as a private entity for approximately six to seven years and did not maintain a public profile beyond its product commercialization activities. The acquisition by Cornerstone Therapeutics in 2012 was the most significant public event in EKR's history.

EKR Therapeutics did not face significant public controversy or regulatory scrutiny during its operating period. The company acquired products with existing FDA approvals and focused on commercialization rather than clinical development, reducing its exposure to clinical trial-related regulatory risks.

The primary regulatory challenge EKR faced was related to Retavase manufacturing supply. When EKR acquired Retavase from PDL BioPharma, the product required FDA approval of a new active ingredient supplier to ensure continued manufacturing. This regulatory process was ongoing when Cornerstone acquired EKR in 2012, and Cornerstone stated it was targeting FDA approval and relaunch in 2013. The eventual transition to manufacturing at Patheon Italia in Monza, Italy under Chiesi USA ownership reflects the completion of this supply chain restructuring.

No FDA Warning Letters, product recalls, or enforcement actions specific to EKR Therapeutics have been documented in publicly available regulatory records.