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Regeneron To Defend Allegations On Contributions To Patient Assistance Charity

Regeneron Pharmaceuticals Inc. (REGN) said that there is no merit to the civil complaint filed by the U.S. Attorney for the District of Massachusetts. It is unfortunate that a misguided lawsuit is attempting to assign wrongful intent to entirely legal conduct.

Regeneron said it has fully cooperated with the government's investigation and will vigorously defend the company's case.

In 2017, Regeneron disclosed it was among a large number of companies that received subpoenas in connection with a government inquiry related to charitable organizations that provide financial assistance to patients. Regeneron has not settled the case because the Company did not engage in illegal or wrongful conduct.

The complaint relates to lawful, charitable donations Regeneron made in 2013 and early 2014 to an independent charitable patient assistance foundation to assist financially disadvantaged elderly patients with wet age-related macular degeneration or "wet AMD" gain access to treatments designed to prevent blindness. Many wet AMD patients who could not afford their medicines historically turned to repackaged, off-label medicines in the hope of maintaining their vision.

Separately, the U.S. Attorney for the District of Massachusetts said that the government has filed a civil False Claims Act complaint against drug manufacturer Regeneron.

The complaint alleged that Regeneron paid tens of millions of dollars in kickbacks for its macular degeneration drug Eylea, using a foundation as a conduit to cover co-pays for Eylea.

The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration - which includes money or any other thing of value, including coverage of co-pays - to induce Medicare patients to purchase the companies' drugs.

EYLEA Injection is a vascular endothelial growth factor inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor, two growth factors involved in angiogenesis.

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