Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today stated 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 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 ("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.

Regeneron is proud of the Company's legacy of supporting patients in need through donations to charitable foundations to help ensure elderly patients are able to access the medicines prescribed by their physician. Advanced age-related macular degeneration is a leading cause of irreversible blindness and vision impairment around the world. As many as 11 million people in the U.S. have some form of age-related macular degeneration. Wet AMD accounts for approximately 10 percent of cases, but results in 90 percent of legal blindness.

"It is unfortunate that the government chose to bring these baseless allegations related to our 2013 and early 2014 patient assistance donations at a time when Regeneron employees have been coming to work in the epicenter of the COVID-19 pandemic with the goal of providing an effective treatment. We look forward to having our case heard and will file a motion to dismiss," said Joseph LaRosa, Executive Vice President, General Counsel and Secretary, Regeneron. "We believe our actions are legal and have helped preserve and restore the vision of elderly patients. Regeneron's donations to independent charity foundations help elderly patients access medicines that are prescribed by their physicians."

EYLEA® (aflibercept) Injection is a vascular endothelial growth factor (VEGF) 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 (vascular permeability) in the eye by blocking VEGF-A and placental growth factor ("PLGF"), two growth factors involved in angiogenesis. In the U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes eight pivotal Phase 3 trials.

IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

• EYLEA (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
• Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.
• Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
• There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.
• Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment.
• The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.